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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/7/26 has been entered.
Claim Objections
Claim 91 is objected to because of the following informalities: it ends with a “;”. Appropriate correction is required.
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 78-94 are rejected under 35 U.S.C. 103 as being unpatentable over Ur Rehman et al [US 2018/0153184A1] in view of Fan et al [US 2021/0212334A1], Youzhong et al [CN 109692571A], and Ur-Rehman et al (‘175) [US 2018/0228175A1] as evidenced by Lactose Free Skim Milk NPL [nutritionvalue.org].
Ur Rehman et al teach a method for processing milk and dairy products (paragraph 0071) by providing lactose-free skim milk as the dairy product (paragraph 0047) which would naturally contain 0% fat, 0% lactose, about 3.4% protein, about 9.5% solids, about 0.5% minerals as evidenced by Lactose Free Skim Milk NPL; subjecting the dairy product to forward osmosis to remove water (paragraph 0034), the concentrated dairy product having 10-40% solids (paragraph 0038), adding polyphenols and removing water from the concentrated milk to attain 40-50% solids (paragraph 0054), heating the concentrated dairy product using UHT sterilization or pasteurization (paragraph 0061), fresh raw milk commonly possessing 87% water, 12% solids, 3-4% protein, 4-5% carbohydrates 3-4% fat, and 0.3-0.7 % minerals (paragraph 0024, 0073); the concentrated dairy product containing 4-30% protein, 2-30% carbohydrates, less than 1.5% lactose, 1-10% minerals, and 0.1-30% fat (paragraph 0034, 0037); adding a lactase enzyme to reduce the lactose content to less than 0.1% (paragraph 0060), adding ingredients such as flavors (paragraph 0039), and drying the milk into a powder by spray drying (paragraph 0056, Abstract).
Ur Rehman et al do not explicitly recite a membrane pore size of less than 0.001 µm (claim 78), less than 60% of the original volume (claim 78), steam infusion (claim 78), a pressure up to 75 psig and a temperature of 5-50C (claim 80), UHT at 135-145C for 1-10 seconds (claim 82), the draw solution comprising sodium, potassium, chloride, or lactose (claim 88), a draw solution comprising RO retentate fraction (claim 89), removing water from the diluted draw solution (claim 90), 800-2,000 ppm Na, 5,000-9,500 ppm K, 3,000-8,000 ppm Ca in the dairy concentrate and aseptic dairy composition (claim 92).
Fan et al teach a method for preparing dairy products by forward osmosis (title) comprising a membrane system with single or multiple membrane modules (paragraph 0074), the membrane having micropores of 0.3-10 nm or 0.0003-0.01 µm (paragraph 0046, 0074), a pressure of 1-3 bar or 14-43 psi (paragraph 0049), a temperature which does not exceed 30C (paragraph 0043), the draw solution including calcium chloride (paragraph 0028), the dairy product being defatted milk (paragraph 0224), raw milk having 12.2% solids, 3.36g/100g protein, 3.68 g/100g fat, 1,190 mg/kg calcium, and 41 mg/100g sodium (page 14, Table 7); and the cold concentrated product having approximately 24-59% solids, 10-16 g/100g protein, 2-17 g/100g fat, 3,000-5,700 mg/kg or ppm of calcium, and 100-300 mg/100g sodium (page 14, Table 7, Examples 1-10).
Youzhong et al teach a milk concentrating method based on forward osmosis technology (title) comprising a membrane system having a single-stage or multiple-stages (paragraph 0009, 0114), the draw solution being sodium chloride, calcium chloride, magnesium chloride, ammonium carbonate, or sugars (paragraph 0010), regeneration of the draw solution by use of reverse-osmosis (paragraph 0028), achieving a solids content of 30-70% (paragraph 0011), using a pressure of 0.1-2 bar or 1.45-29 psi (paragraph 0054), the first membrane stage removing 40-60% of the water and providing a volume concentration of 1.5-2.5 times (paragraph 0071), and an example using milk as the starting material with 3.04 g/100g protein, 1210 mg/kg Calcium, 34.7 mg/100g Sodium, and 12.4 g/100g solids (paragraph 0099) to produce a concentrated milk with 15.2 g/100g protein, 5230 mg/kg Calcium, 821 mg/100g Sodium, and 61.6 g/100g solids (paragraph 0099).
It would have been obvious to one of ordinary skill in the art to incorporate the claimed forward osmosis features into the invention of Ur Rehman et al, in view of Fan et al and Youzhong et al, since all are directed to methods for concentrating milk products, since Ur Rehman et al already included forward osmosis concentration but simply did not describe it in detail, since milk concentration methods using forward osmosis commonly included a membrane with micropores of 0.3-10 nm (paragraph 0046), a pressure of 1-3 bar or 14-43 psi (paragraph 0049), a temperature which does not exceed 30C (paragraph 0043), the draw solution including calcium chloride (paragraph 0028) wherein calcium was a mineral commonly present in milk as shown by Fan et al, since forward osmosis systems for milk also commonly included a single membrane system as shown by both Fan et al (paragraph 0074) and Youzhong et al (paragraph 0009, 0114), since Youzhong et al also disclosed concentration of solids to 30-70% (paragraph 0011), since Youzhong et al also disclosed using only a single stage when lower concentration levels were sufficient (paragraph 0114), and since the claimed forward osmosis features would have been used during the course of normal experimentation and optimization procedures due to factors such as the type of dairy product used as the starting material, the desired production rate, and/or the desired flavor characteristics of the concentrated product of Ur Rehman et al, in view of Fan et al and Youzhong et al.
It further would have been obvious to one of ordinary skill in the art to incorporate the claimed volume reduction and mineral concentrations into the invention of Ur-Rehman et al, in view of Fan et al and Youzhong et al, since all are directed to methods concentrating dairy products using forward osmosis, since Ur-Rehman et al used milk as the starting material (paragraph 0071), since applicant also used milk as the starting material (page 6, line 28 of the application), since Ur-Rehman et al disclosed fresh milk commonly possessing 87% water and 12% solids (paragraph 0024, 0073) and the concentrated composition having 40-50% solids (paragraph 0054), since Fan et al disclosed raw milk having 12.2% solids, 3.36g/100g protein, 3.68 g/100g fat, 1,190 mg/kg calcium, and 41 mg/100g sodium (page 14, Table 7) and the cold concentrated product having approximately 24-59% solids, 10-16 g/100g protein, 2-17 g/100g fat, 3,000-5,700 mg/kg or ppm of calcium, and 100-300 mg/100g sodium (page 14, Table 7, Examples 1-10); since forward osmosis was commonly accepted to only remove water from a starting material, since water removal would have been expected to provide an increased concentration of the remaining constituents of the concentrated product of Ur-Rehman et al, in view of Fan et al and Youzhong et al; since Youzhong et al also disclosed the first membrane stage removing 40-60% of the water and providing a volume concentration of 1.5-2.5 times (paragraph 0071), since potassium was a mineral commonly found in milk as shown by Milk NPL, since the potassium concentration would be expected to increase after water removal during the forward osmosis concentration step of Ur-Rehman et al, and since the claimed volume reduction and mineral contents would have been achieved during the course of normal experimentation and optimization procedures based upon factors such as the desired nutritional content, final texture, and final dryness of the concentrated composition of Ur-Rehman et al, in view of Fan et al and Youzhong et al.
It further would have been obvious to one of ordinary skill in the art to incorporate the claimed draw solution features into the invention of Ur Rehman et al, in view of Youzhong et al, since both are directed to methods of processing edible materials, since Ur Rehman et al already included forward osmosis but simply did not describe how the draw solution was treated, since forward osmosis systems commonly included a draw solution comprising RO and removing water from the diluted draw solution (paragraph 0028) as shown by Youzhong et al, and since reusing the draw solution would have reduced the amount of waste generated by the system of Ur Rehman et al, in view of Youzhong et al.
Ur-Rehman et al (‘175) teach a dairy method including UHT sterilization using steam infusion (paragraph 0031) at 135-145C for 1-10 seconds (paragraph 0030).
It would have been obvious to one of ordinary skill in the art to incorporate the claimed steam infusion conditions into the invention of Ur Rehman et al, in view of Ur-Rehman et al (‘175), since both are directed to methods of processing milk, since Ur Rehman et al already included UHT processing but simply did not describe it in detail, since dairy products were commonly sterilized by steam infusion (paragraph 0031) at 135-145C for 1-10 seconds (paragraph 0030) as shown by Ur-Rehman et al (‘175), and since the claimed UHT features would have been used during the course of normal experimentation and optimization procedures due to factors such as the type of milk, the form of the desired end product, and/or the heat stability of any other ingredients in the method of Ur Rehman et al, in view of Ur-Rehman et al (‘175).
In conclusion, all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art.
Claims 95-97 are rejected under 35 U.S.C. 103 as being unpatentable over Ur Rehman et al, in view of Fan et al and Youzhong et al, as evidenced by Lactose Free Skim MiIlk NPL, and further in view of Maron et al [US 8,329,237B2].
Ur Rehman et al, Youzhong et al, and Fan et al teach the above mentioned concepts. Ur-Rehman et al also disclose UHT sterilization treatment (paragraph 0061). Ur Rehman et al do not explicitly recite UHT with steam injection (claim 95).
Maron et al teach a method for heat treatment of milk (title) comprising reverse osmosis concentration of the milk followed by heat treatment to create an aseptic product (Figure 1), wherein the heat treatment includes a UHT temperature of at least 288F (or 142C) for 4 seconds (column 7, line 59) by use of steam injection (column 7, line 3).
It would have been obvious to one of ordinary skill in the art to incorporate the claimed UHT parameters into the invention of Ur Rehman et al, in view of Maron et al, since both are directed to methods of processing milk, since Ur Rehman et al already included UHT processing but simply did not describe it in detail, since concentrated milk products were commonly sterilized by a UHT temperature of at least 288F (or 142C) for 4 seconds (column 7, line 59) by use of steam injection (column 7, line 3) as shown by Maron et al, and since the claimed UHT features would have been used during the course of normal experimentation and optimization procedures due to factors such as the type of milk, the form of the desired end product, and/or the heat stability of any other ingredients in the method of Ur Rehman et al, in view of Maron et al.
Response to Arguments
Applicant's arguments filed 5/7/26 have been fully considered but they are not persuasive.
Applicant argues that Fan et al did not disclose the claimed dairy product starting material. However, the primary reference (ie Ur Rehman et al) disclosed providing lactose-free skim milk as the dairy product (paragraph 0047) which would naturally contain 0% fat, 0% lactose, about 3.4% protein, about 9.5% solids, about 0.5% minerals as evidenced by Lactose Free Skim Milk NPL. Regardless, Fan et al also disclosed using a defatted milk as the dairy product starting material (paragraph 0224).
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/DREW E BECKER/Primary Examiner, Art Unit 1792
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