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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 April 23, 2026 has been entered.
Claim Status
The status of the claims upon entry of the present amendments stands as follows:
Pending claims:
1, 6-7, 9
Withdrawn claims:
None
Previously canceled claims:
10
Newly canceled claims:
2-5, 8
Amended claims:
1, 6
New claims:
None
Claims currently under consideration:
1, 6-7, 9
Currently rejected claims:
1, 6-7, 9
Allowed claims:
None
It is noted that claims 1 and 6 are designated as “(Previously Presented)”. However, the amendments submitted in the Response After Final were not entered because they raise new issues that would require further search and consideration (see Advisory Action mailed April 8, 2026). Thus, claims 1 and 6 are considered presently amended.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Yan (US 20200170289 A1) and Geng (CN 110151796 A)(IDS Reference).
Regarding claim 1, Yan teaches of a nutritional composition (Abstract) that can be in the form of a powder ([0110]) comprising fructose-oligosaccharide ([0125]) in an amount of 0.4 to 15 g/100 g of the composition when in powder form (which encompasses the claimed amount of “3 g per 100 grams”, [0133]-[0137]) and probiotics in an amount of 10e3 to 10e12 CFU per gram of the composition (equivalent to 10x105 to 10x1014 per 100 gram, which encompasses the claimed value of “1x108”, equivalent to 10x107; [0099]). Yan also teaches that the probiotics selected from Lactobacillus helveticus, Lactobacillus rhamnosus, Lactobacillus acidophilus, Bifidobacterium longum, Bifidobacterium animalis, and any mixture thereof. Additionally, Yan teaches an embodiment comprising oligofructose (i.e., fructose oligosaccharide) and optionally 2FL and/or LNnT ([0170]; Table 2). Because the additional oligosaccharides are listed as optional, one of ordinary skill would recognize that this embodiment can comprise fructose oligosaccharide with no other oligosaccharides.
With respect to the overlapping ranges, MPEP §2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
Yan does not teach that the probiotics include Bifidobacterium bifidum and does not teach the ratio of the probiotics as 30:35:5:15:10:5.
However, in the same field of endeavor, Geng teaches a powder composition ([0019]) comprising Bifidobacterium bifidum ([0048]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the composition of Yan with the inclusion of Bifidobacterium bifidum as taught by Geng. MPEP §2144.06(I) states "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from there having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Therefore, it would have been obvious to combine the probiotic compositions of Yan with the probiotic Bifidobacterium bifidum taught by Geng to form a third probiotic composition useful for the same purpose of promoting the ecological balance of intestinal flora (Geng, [0005]).
Although the cited prior art does not teach the ratio of the probiotic compositions, Geng teaches that taking an appropriate amount of probiotics can produce one or more special functional health benefits to the host ([0005]). Therefore, one of ordinary skill in the art would have adjusted the ratio of the probiotic compositions during routine optimization to find the ratio that results in a composition with an appropriate amount of probiotics. MPEP §2144.05(II) states where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The claimed ratios would thus be obvious.
Although the cited prior art does not explicitly state that there are no other pre- or probiotics present in the milk powder, Yan teaches that the composition may comprise “at least one probiotic” ([0097]). Thus, one of ordinary skill would recognize that an embodiment exists of Yan in view of Geng that comprises the claimed probiotics without any addition probiotics. Yan also teaches that the product “can comprise” further prebiotics ([0090]). One or ordinary skill would recognize that use of the word “can” demonstrates that any prebiotics in addition to the fructo-oligosaccharide are optional. Thus, one of ordinary skill would arrive at the claimed invention without any additional prebiotics.
Claims 6, 7, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Yan (US 20200170289 A1) and Geng (CN 110151796 A) as applied to claim 5 above, and further in view of Gaygadzhiev (US 2014/0037813 A1).
Regarding claim 6, Yan in view of Geng teaches all elements of claim 1 as described above.
Yan also teaches the composition comprising niacin, folic acid, vitamin A, vitamin D, vitamin K, vitamin B1 ([0114]) and DHA ([0164]).
The cited prior art does not teach wherein every 100 g of the maternal milk powder also comprises: 5-6 mg of Niacin, 950-1000 µg of Folic Acid, 500-650 µg of Vitamin A, 5.0-6.0 µg of Vitamin D, 35.0-40.0 µg of Vitamin K, 0.9-1.2 mg of Vitamin B1, 30-40 mg of DHA.
Regarding the composition comprising 30-40 mg of DHA, Gaygadzhiev teaches a nutritional creamer composition (Abstract) that may be provided in a powder form ([0005]) comprising about 25 to 200 mg of docosahexaenoic acid (i.e., DHA) per 100 g of the nutritional composition ([0007]), which encompasses the claimed range of “30 to 40 mg of DHA per 100 g”.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the composition of Yan to include the amount of DHA as taught by Gaygadzhiev. One of ordinary skill would have been motivated to make this modification because Gaygadzhiev teaches that DHA helps promote synaptogenesis in human subjects ([0059]).
With respect to the overlapping ranges, MPEP §2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
Although the cited prior art does not teach the values of the vitamins and minerals, Yan teaches that the composition can provide 100% of the nutritional needs of target populations, or can be a supplement in addition to a regular diet ([0108]). Therefore, one of ordinary skill in the art would have adjusted the amounts of vitamins and minerals in the composition during routine optimization to arrive at a composition that provides the desired amount of nutritional supplementation. MPEP §2144.05(II) states where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The claimed ranges would thus be obvious.
Regarding claim 7, Yan in view of Geng and Gaygadzhiev teaches all elements of claim 6 as described above.
Yan does not teach wherein every 100 g of the maternal milk powder, also comprises: 5.6 mg of Niacin, 986 µg of Folic acid, 600 µg of Vitamin A, 6.0 µg of Vitamin D, 40.0 µg of Vitamin K, 1 mg of Vitamin B1, 37 mg of DHA.
Regarding the composition comprising 37 mg of DHA, Gaygadzhiev teaches a nutritional creamer composition (Abstract) that may be provided in a powder form ([0005]) comprising about 25 to 200 mg of docosahexaenoic acid (i.e., DHA) per 100 g of the nutritional composition ([0007]), which encompasses the claimed range of “37 mg of DHA per 100 g”.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the composition of Yan to include the amount of DHA as taught by Gaygadzhiev. One of ordinary skill would have been motivated to make this modification because Gaygadzhiev teaches that DHA helps promote synaptogenesis in human subjects ([0059]).
With respect to the overlapping ranges, MPEP §2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
Although the cited prior art does not teach the values of the vitamins and minerals, Yan teaches that the composition can provide 100% of the nutritional needs of target populations, or can be a supplement in addition to a regular diet ([0108]). Therefore, one of ordinary skill in the art would have adjusted the amounts of vitamins and minerals in the composition during routine optimization to arrive at a composition that provides the desired amount of nutritional supplementation. MPEP §2144.05(II) states where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The claimed ranges would thus be obvious.
Regarding claim 9, Yan in view of Geng and Gaygadzhiev teaches all elements of claim 6 as described above. Yan also teaches probiotics in an amount of 10e3 to 10e12 CFU per gram of the composition (equivalent to 10x105 to 10x1014 per 100 grams; [0099]) which overlaps with the claimed value of “1x108”, equivalent to 10x107. Yan also teaches fructose-oligosaccharide ([0125]) in an amount of 0.4 to 15 g/100 g of the composition when in powder form (which encompasses the claimed value of “3 g per 100 grams”, [0133]-[0137]). Yan also teaches the composition comprising sodium, vitamin A, vitamin D, vitamin E, vitamin K, vitamin B1, vitamin B2, vitamin B6, vitamin B12, vitamin C, niacin, folic acid, pantothenic, choline, phosphorous, potassium, magnesium, calcium, iron, zinc ([0114]) and DHA ([0164]).
Yan does not teach the amounts of energy, protein, fat, carbs, sodium, vitamin A, vitamin D, vitamin E, vitamin K, vitamin B1, vitamin B2, vitamin B6, vitamin B12, vitamin C, niacin, folic acid, pantothenic, choline, phosphorous, potassium, magnesium, calcium, iron, zinc, and DHA per 100 grams of the composition.
Regarding the amount of protein, fat, carbs, and DHA per 100 grams of the composition, Gaygadzhiev teaches a nutritional creamer composition (Abstract) that may be provided in a powder form ([0005]) comprising about 14 to about 25 grams of protein (which encompasses the claimed value of “23.0”), 8 to about 19 grams of fat (which encompasses the claimed value of “13.8”), about 50 to about 65 grams of carbs (which encompasses the claimed value of “52.7”), and about 25 to 200 mg of docosahexaenoic acid (i.e., DHA) per 100 g of the nutritional composition (which encompasses the claimed value of “37 mg of DHA per 100 g”)([0007]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the composition of Yan to include protein, gat, carbs, and DHA in the amounts taught by Gaygadzhiev. One of ordinary skill would have been motivated to make this modification because Gaygadzhiev teaches that the composition is nutritionally complete and contains a suitable amount of lipids, carbohydrates, and protein ([0070]).
With respect to the overlapping ranges, MPEP §2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
Although the cited prior art does not teach the values of the vitamins and minerals, Yan teaches that the composition can provide 100% of the nutritional needs of target populations, or can be a supplement in addition to a regular diet ([0108]). Therefore, one of ordinary skill in the art would have adjusted the amounts of vitamins and minerals in the composition during routine optimization to arrive at a composition that provides the desired amount of nutritional supplementation. MPEP §2144.05(II) states where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The claimed ranges would thus be obvious.
Response to Arguments
Claim Objections: Applicant has overcome the objections to the claims based on amendments in the Claims. Accordingly, the objections have been withdrawn.
Claim Rejections – 35 U.S.C. §103 of claims 1-5 over Yan and Geng; claims 6, 7, and 9 over Yan, Geng, and Gaygadzhiev; and claim 8 over Yan, Geng, Gaygadzhiev, Penhasi, Longoni, and Zhang: Applicant’s arguments filed April 23, 2026 have been fully considered but they are not persuasive.
Applicant argued that the present application relates to a different intended use than that of Yan and Geng, and that they do not fall within the scope of MPEP §2144.06(I) (Remarks, p. 6, ¶ 5-7).
This argument has been considered. In response to applicant's argument that the intended use of the claimed invention is distinct from that of the prior art, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Furthermore, it is noted that the features upon which applicant relies (i.e., the intended use of the claimed invention) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Because the claims do not recite anything regarding the use of the invention, Yan in view of Geng render claim 1 obvious.
In response to Applicant’s argument that MPEP §2144.06(I) does not apply in the present case, the Examiner maintains that it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the composition of Yan with the inclusion of Bifidobacterium bifidum as taught by Geng. MPEP §2144.06(I) states "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from there having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Therefore, it would have been obvious to combine the probiotic compositions of Yan with the probiotic Bifidobacterium bifidum taught by Geng to form a third probiotic composition useful for the same purpose of promoting the ecological balance of intestinal flora (Geng, [0005]).
Applicant further argued that substantially different technical solutions cannot be obvious to combine. Applicant argues that there would be no motivation to combine the infant formula of Yan with the weight loss control of Geng to be applicable to pregnant women. Applicant further argued that Geng relies upon synergistic effects of its probiotic strains (Remarks, p. 7, ¶ 2- p. 9, ¶ 2).
This argument has been considered. However, the examiner maintains that it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the composition of Yan with the inclusion of Bifidobacterium bifidum as taught by Geng. MPEP §2144.06(I) states "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from there having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Therefore, it would have been obvious to combine the probiotic compositions of Yan with the probiotic Bifidobacterium bifidum taught by Geng to form a third probiotic composition useful for the same purpose of promoting the ecological balance of intestinal flora (Geng, [0005]). Although the intended use of Yan and Geng differs, that does not negate the fact that probiotic compositions are known to have the same purpose of promoted the ecological balance of intestinal flora (Geng, [0005]).
Additionally, MPEP §2144(IV) states “The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006)”. Furthermore, it is noted that the features upon which applicant relies (i.e., administering the composition to pregnant women) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Additionally, although Geng teaches a synergistic effect of the selected probiotic strains, MPEP §2123(I) states “A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments.” Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989) and “The court held that the prior art anticipated the claims even though it taught away from the claimed invention. ‘The fact that a modem with a single carrier data signal is shown to be less than optimal does not vitiate the fact that it is disclosed.’” Celeritas Technologies Ltd. v. Rockwell International Corp., 150 F.3d 1354, 1361, 47 USPQ2d 1516, 1522-23 (Fed. Cir. 1998). Thus, one of ordinary skill would have found it obvious to include Bifidobacterium bifidum even though Geng teaches a synergistic effect of specific strains.
Applicant further argued that overlap in numerical ranges does not constitute obviousness. Applicant stated that Yan does not disclose the amount of fructo-oligosaccharides and probiotics when HMOs are excluded from the invention (Remarks, p. 9, ¶ 3).
This argument has been considered. However, Yan discloses that when present, the nutritional composition may comprise from 0.1 to 20 g of oligofructose (i.e., fructo-oligosaccharides) per 100 g of the composition ([0132]). There is nothing to suggest that the presence or absence of HMOs in the composition impacts the disclosed amount of oligofructose or probiotics to include. Yan teaches an embodiment comprising oligofructose (i.e., fructose oligosaccharide) where 2FL and/or LNnT are both optional compounds and not required ([0170]; Table 2). Thus, one of ordinary skill would recognize that the 0.1 to 20 g per 100 g would apply to a composition not comprising any additional oligosaccharides.
With respect to the overlapping ranges, MPEP §2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
Applicant also argued that according to the results of the supplemented study, the claimed composition effectively increases the abundance of intestinal Bifidobacterium in pregnant and postpartum women compared to ordinary milk powder (Remarks, p. 9, ¶ 4).
This argument has been considered. However, it is noted that the features upon which applicant relies (i.e., the impact of the composition on the Bifidobacterium in the intestine of pregnant and postpartum women) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant further argued that for the reasons stated above, there is not overlap between the ranges of claim 1 and those described in Yan (Remarks, p. 9, ¶ 5).
This argument has been considered. However, MPEP §2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness. Because the ranges of the prior art overlap with those of the claimed invention, a prima facie case of obviousness has been established.
Applicant further argues that the experiment of the Declaration provides a showing of unexpected results (Remarks, p. 10, ¶ 2).
This argument has been considered. However, for the reasons stated below in the consideration of the Declaration, a showing of unexpected results has not been established.
Applicant provides an explanation for the necessity of the Declaration and why the Declaration was not filed previously in prosecution (Remarks, p. 10, ¶ 3- p. 11, ¶ 3). Full consideration of the Declaration submitted April 23, 2026 is below.
The declaration under 37 CFR §1.132 filed April 23, 2026 (hereinafter “Declaration”) is insufficient to overcome the rejection of the claims based upon Yan and Geng as set forth in the office action.
MPEP §716.01(c)(III) states “In assessing the probative value of an expert opinion, the examiner must consider:
The nature of the matter sought to be established,
The strength of any opposing evidence,
The interest of the expert in the outcome of the case, and
The presence or absence of factual support for the expert’s opinion.”
Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 227 USPQ 657 (Fed. Cir. 1985), cert. denied, 475 U.S. 1017 (1986)
The Declaration seeks to establish the claimed maternal milk powder increases the amount of Bifidobacterium in pregnant and postpartum women (Declaration, p. 5, ¶ 2, 4).
Regarding the strength of the opposing evidence, no information was provided regarding the composition of the maternal milk powder that was given to the test group or the control group. As such, the data provided cannot be used in a showing of unexpected results because there is no way to determine if the maternal milk powder of the experiment is commensurate in scope with the claimed invention. MPEP §716.02(d) states that “Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980)” and “To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960).” It is unclear if the experiment composition falls within the claimed values.
Furthermore, the experiment only tests use of the composition in pregnant or postpartum women. However, the claimed invention does not specify that the composition is used only with pregnant or postpartum women. Additionally, the composition of the cited prior art is the same as that of the claimed invention. MPEP §2112.01 states where the claimed and prior art are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Thus, the strength of the opposing evidence is not sufficient to overcome the rejection of the claims over Yan and Geng.
Regarding the interest of the expert in the outcome of the case, the Declaration is submitted by inventor Lijun Chen, who is considered an interested party in the outcome of the case. An affidavit of an applicant as to the advantages of their claimed invention, while less persuasive than that of a disinterested person, cannot be disregarded for this reason alone. Ex parte Keyes, 214 USPQ 579 (Bd. App. 1982); In re McKenna, 203 F.2d 717, 97 USPQ 348 (CCPA 1953).
Regarding the presence or absence of factual support for the expert’s opinion, it has been found that the statement is unsupported by the provided evidence. For the reasons stated above, the data does not provide a showing of unexpected results.
The rejections of claims 1, 6-7, 9 have been maintained herein.
Conclusion
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/A.S.H./Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793
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