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
The examiner acknowledged the amendment made to the claims on 12/12/2025.
Claims 52-84 are pending in the application. Claims 52-56 are currently amended. Claims 57-62 are previously presented. Claims 63-84 are withdrawn without traverse in response to the restriction requirement. Claims 52-62 are hereby examined on the merits.
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Any objections and/or rejections that are made in the previous actions and are not repeated below, are hereby withdrawn.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 § 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.
Claims 52-58 are rejected under 35 U.S.C. 103 as being unpatentable over Tossavainen WO 03/094623 A1 (cited in the IDS submitted 08/23/2023, hereinafter referred to as Tossavainen) in view of Augustin, “Skim milk powder with enhanced foaming and steam-frothing properties”, Dairy Sci. Technol., 2008, 88, pages 149-161 (hereinafter referred to as Augustin).
Regarding claim 52, Tossavainen teaches a lactose free milk powder obtained from ultrafiltering (UF) milk to obtain a UF retentate and a UF permeate, nanofiltering (NF) the UF permeate to obtain a NF retentate and a NF permeate, concentrating the NF permeate by reverse osmosis (RO) to obtain a RO permeate and a RO retentate, adding the RO retentate as a salt source to the UF retentate to form a mixture, enzymatically hydrolyzing the mixture to obtain a lactose free milk, drying the lactose free milk to obtain the lactose free milk powder having a composition that is very near ordinary skimmed milk and tastes like skimmed milk (0018; 0025; 0027-0028; Example 1 and Example 3; Fig. 1). Further, Table 1 of Tossavainen discloses that the lactose amount in the lactose free milk is less than 0.01% and the dry matter content is 8.84%, thus, the resulting lactose free milk powder will have a lactose content of less than 0.01%/8.84% = ~0.1%, given that after drying there is only marginal amount residual water (0040). 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).
Tossavainen is silent regarding that the lactose free milk powder comprises 1.5-2.5% pure citrate on dry matter basis.
Augustin teaches a method of making a citrate milk powder comprising adding a mixture of citric acid and trisodium/tripotassium salt thereof to a skimmed milk before drying, wherein the amount of citrate added is 0.1-0.2 mol per 1 kg of milk solids non-fat (Abstract; page 151, section 2.2 “Manufacturing of milk powders”). Augustin further teaches that such a proportion of citrate in the milk powder helps to improve the whipping properties and/or the steam-frothing properties of the milk, due to the role of citrate in dissociating casein micelles (Abstract).
Both Tossavainen and Augustin are directed to milk powders, and where Tossavainen teaches a lactose free milk powder having a composition that is very near ordinary skimmed milk and tastes like skimmed milk, Augustin teaches that adding a mixture of citric acid and its trisodium/tripotassium salt to a skimmed milk at an amount of 0.1-0.2 mol per 1 kg of milk solids non-fat before drying would deliver the benefit of improving the whipping properties and/or the steam-frothing properties of the milk. 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 Tossavainen by including 0.1-0.2 mol citrate per 1 kg of milk solids non-fat for the aforementioned benefit.
The amount of pure citrate as disclosed by Augustin overlaps with the range as recited in the claim (calculation: the amount of citrate in 100 g of lactose free milk would be 0.01-0.02 mol x 189 g/mol/ 100 g= 1.9-3.8%, knowing that the MW of citrate is 189 g/mol). 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).
Regarding claim 53, Tossavainen discloses that glucose + galactose amount in the lactose free milk is 3% and the dry matter content is 8.84% (Table 1), thus the resulting lactose free milk powder will have a glucose + galactose content of ~3%/8.84% = ~34%, given that after drying there is only marginal amount residual water (0040).
Regarding claim 54, Tossavainen discloses that the protein content in the lactose free milk is 3.21% and the dry matter content is 8.84% (Table 1), thus, the resulting lactose free milk powder will have a protein content of ~3.21%/8.84% = ~36%, given that after drying there is only marginal amount residual water (0040).
Regarding claim 55, Tossavainen discloses that the fat content in the lactose free milk is 1.5% and the dry matter content is 8.84% (Table 1), thus, the resulting lactose free milk powder will have a fat content of ~1.5%/8.84% = ~17%, given that after drying there is only marginal amount residual water (0040).
Regarding claim 56, Tossavainen discloses that the ash content in the lactose free milk is 0.79% and the dry matter content is 8.84% (Table 1), thus, the resulting lactose free milk powder will have a glucose + galactose content of ~0.79%/8.84% = 9%, given that after drying there is only marginal amount residual water (0040).
Regarding claim 57, Tossavainen teaches that the fat content starting milk is 0-7% (0025); further, Tossavainen teaches in Example 1 using milk that has 1.5% fat as the starting milk, and fat-free or 3.5% fat-containing lactose-free milk can be produced by the method (0031; 0035), therefore, as stated in MPEP 2144.06, "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 their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Further, Tossavainen as modified by Augustin will introduce a mixture of citric acid and trisodium/tripotassium salt thereof to a skimmed milk that inherently contains sodium and potassium, which necessarily results in a final lactose free milk powder that contains sodium citrate and potassium citrate.
Additionally, since example 3 of Tossavainen teaches a lactose free milk powder which contains fat, the product of Tossavainen as modified by Augustin is materially indistinguishable from the composition of claim 57. In other words, since the final produce is a homogeneous milk powder, one would not be able to tell the difference between the milk of example 3 and another one obtained from mixing a whole milk and a skim milk.
Regarding claim 58, Tossavainen discloses in Table 1 that the lactose free milk contains 3.21% protein, 3% glucose + galactose, and 1.5% fat and a dry matter content of 8.84%, thus the resulting lactose free milk powder will roughly have a protein content of ~3.21%/8.84% = ~36%, a glucose + galactose content of ~3%/8.84% = ~34%, and a fat content of ~1.5%/8.84% = ~17%, given that after drying there is only marginal amount residual water (0040). Therefore, the energy content of 100 gram of lactose free powder will have 36 x 17 kJ + 34 x17 kJ + 17 x 38 kJ = ~1836 kJ, knowing that 1 gram of protein or carbohydrate is 17 kJ and 1 gram of fat is 38 kJ.
Claims 59-62 are rejected under 35 U.S.C. 103 as being unpatentable over Tossavainen as modified by Augustin as applied to claim 52 above, and evidenced by Kallioinen WO 2013/004895 A1 (cited in the IDS submitted 08/23/2023, hereinafter referred to as Kallioinen).
Regarding claims 59-62, skimmed milk powder as evidenced by Kallioinen contains 419 mg sodium/ 100 g, 1827 mg potassium/ 100g, 1290 mg calcium/ 100 g and 129 mg/ 100 g (sample calculation: according to Kallioinen Table 1, 100 gram of liquid skimmed milk contains 39 mg sodium and has a dry matter content of 9.3 g, thus the amount sodium in 100 gram skimmed milk powder is: 39 mg x100 g/ 9.3 g = ~419 mg, assuming the skimmed milk powder contains no residual water. The content of potassium, calcium and magnesium can be calculated by the same method). Given that Tossavainen teaches that the lactose free milk powder has a composition that is very near ordinary skimmed milk (0034), it logically follows that the prior art has the above amount of sodium, potassium, calcium or magnesium. The amount of each cations as disclosed by prior art either falls with the range as recited in the claims (e.g., sodium, potassium or calcium; note that Augustin teaches sodium citrate or potassium citrate), or is very close to upper bound as recited in the claim (e.g., magnesium) that one of ordinary skill in the art would expect them to have the same properties, given that both prior art and the claimed invention are directed to lactose free milk powder. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (MPEP 2144.05).
Response to Arguments
Applicant's arguments filed 12/12/2025 have been fully considered but they are not persuasive.
Applicant argues on pages 8-9 of the Remarks that Tossavainen does not inherently disclose the citrate range as claimed.
The argument is considered. However, the examiner notes that nowhere in the rejection issued 09/19/2025 is suggesting that Tossavainen inherently teaches the citrate amount as claimed. Rather, the rejection relies on the teaching of Augustin for the limitation.
Applicant argues on page 9 of the Remarks that Augustin teaches away from the proposed modification. In particular, applicant argues that dissociating casein by citrate “fundamentally alters the structure and mouthfeel of the milk”, thus foregoing the benefit of providing a milk that has organoleptic properties as taught by the primary reference Tossavainen, although the foaming and steam frothing properties of milk is enhanced by citrate.
The argument are considered but found unpersuasive because:
First, by asserting that dissociation of casein micelles will fundamentally alters the structure and mouthfeel of the milk, applicant is making a conclusive remarks that lacks evidentiary support. Further, the examiner notes that applicant does not elaborate on how the mouthfeel of a milk is altered as a result of casein micelle dissociation. Is it worse, or is it better? Applicant further fails to shed light on what proportion of casein micelle in the milk is dissociated by adding 1.9-3.8% citrate as suggested by Augustin . Applicant is encouraged to submit evidence to support his assertion.
Second, even if, in arguendo, that incorporation of citrate in the milk of Tossavainen somehow degrades the organoleptic properties of milk as a result of casein dissociation, nothing in the prior art teaches that the proposed modification would have resulted in an ‘inoperable’ milk product that has no desirable properties, rather, the resulting milk has improved whipping properties and/or the steam-frothing properties, even if that means sacrificing the benefit of Tossavainen. To this end, the attention of the applicant is drawn to the session of MPEP 2143. 01 V that discusses a legal precedent In re Urbanski 809 F.3d 1237, 1244, 117 USPQ2d 1499, 1504 (Fed. Cir. 2016) (The patent claims were directed to a method of enzymatic hydrolysis of soy fiber to reduce water holding capacity, requiring reacting the soy fiber and enzyme in water for about 60-120 minutes. The claims were rejected over two prior art references, wherein the primary reference taught using a longer reaction time of 5 to 72 hours and the secondary reference taught using a reaction time of 100 to 240 minutes, preferably 120 minutes. The applicant argued that modifying the primary reference in the manner suggested by the secondary reference would forego the benefits taught by the primary reference, thereby teaching away from the combination. The court held that both prior art references "suggest[ed] that hydrolysis time may be adjusted to achieve different fiber properties. Nothing in the prior art teaches that the proposed modification would have resulted in an ‘inoperable’ process or a dietary fiber product with undesirable properties."
For the reasons set forth above, applicant’s arguments regarding Kallioinen failing to cure the deficiencies of Tossavainen and Augustin are not persuasive, either.
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