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 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.
Claims 31-40, 45, 49, and 58 are rejected under 35 U.S.C. 103 as being unpatentable over Kuang et al. (herein referred to as Kuang, CN 107920574 A) in view of the USDA (“Whey Protein Concentrate (WPC)”) and evidenced by Vaghela et al. (herein referred to as Vaghela, Lipid Composition of Whey Protein Concentrates Manufactured Commercially and In the Laboratory”)
With regard to Claim 31, Kuang teaches a milk-based nutritional compositions suitable for administration to a pediatric subject which comprises sphingomyelin ([0002]). Kuang teaches sphingomyelin is a polar lipid and polar lipids, including sphingomyelin, promote functional neuronal maturation in pediatric subjects ([0013]). Kuang teaches the sphingomyelin can be provided by milk-based whey protein concentrates which are rich in milk fat globule membranes ([0054], [0072]) and sphingomyelin is present in the nutritional composition in an amount of about 0.15 mg/100 Kcal to about 75 mg/100 Kcal sphingomyelin ([0071]). Kuang teaches the quantity of polar lipids, such as sphingomyelin, can vary significantly depending on the source ([0072]). Therefore, although there is no direct conversion from Kcal to g available with the information provided by Kuang, one with ordinary skill in the art would reasonably select source which contained the desired quantity of sphingomyelin to promote the desired functional neuronal maturation in pediatric subjects. See MPEP 2144.05(II)(A) "[W]here 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). Additionally, this is evidenced by Vaghela which shows different manufacturing practices can influence the sphingomyelin concentration in whey protein concentrates (Introduction, tables 5-6).
Lastly, it is important to note that in some of Kuang’s examples, the references teaches using enriched whey protein ([0175]-[0181]). Kuang defines enriched as being enriched with milk fat globule membranes not alpha-lactalbumin as defined in the applicants specification (page 4, lines 1-12). Therefore, because the milk fat globule membranes are a limitation of the claim and the definition of “enriched” in the applicants specification is pointed to alpha-lactalbumin, Kuang does read on the claimed limitation of not using enriched milk product to an enriched whey protein extract.
However, Kuang is silent to the milk fat content in the whey protein concentrate.
The USDA teaches the FDA has designated WPC as Generally Recognized as Safe (GRAS) ingredient (page 6). Specifically 21 CFR § 184.1979c. teaches whey protein, which may be derived from milk, has a fat content of 1 to 10 % (page 6).
Therefore, to be compliant with the code of federal regulations, it would have been obvious to one with ordinary skill in the art that to utilize whey protein in accordance with the GRAS, the whey protein concentrate must have a fat content of 1 to 10 %.
With regard to Claims 31-35, Kung is silent to the milk fat content in the whey protein extract.
The USDA teaches the FDA has designated whey protein concentrate as Generally Recognized as Safe (GRAS) ingredient (page 6). Specifically 21 CFR § 184.1979c. teaches whey protein, which may be derived from milk, has a fat content of 1 to 10 % (page 6).
Therefore, to be compliant with the code of federal regulations, it would have been obvious to one with ordinary skill in the art that to utilize whey protein in accordance with the GRAS, the whey protein concentrate must have a fat content of 1 to 10 %.
With regard to Claims 36-39 and 49, Kuang teaches the sphingomyelin can be provided by milk-based whey protein concentrates which are rich in milk fat globule membranes ([0054], [0072]) and sphingomyelin is present in the nutritional composition in an amount of about 0.15 mg/100 Kcal to about 75 mg/100 Kcal sphingomyelin ([0071]). Kuang teaches the quantity of polar lipids, such as sphingomyelin, can vary significantly depending on the source ([0072]). Therefore, although there is no direct conversion from Kcal to g available with the information provided by Kuang, one with ordinary skill in the art would reasonably select source which contained the desired quantity of sphingomyelin to promote the desired functional neuronal maturation in pediatric subjects. See MPEP 2144.05(II)(A) "[W]here 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). Additionally, this is evidenced by Vaghela which shows different manufacturing practices can influence the sphingomyelin concentration in whey protein concentrates (Introduction, tables 5-6).
With regard to Claim 40, , Kuang teaches a milk-based nutritional compositions suitable for administration to a pediatric subject which comprises sphingomyelin ([0002]). Kuang teaches sphingomyelin is a polar lipid and polar lipids, including sphingomyelin, promote functional neuronal maturation in pediatric subjects ([0013]). Kuang teaches the sphingomyelin can be provided by milk-based whey protein concentrates which are rich in milk fat globule membranes ([0054], [0072]). In addition, Kuang teaches whey protein concentrate is utilized as a protein source in the composition ([0100]).
Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to utilize whey protein in an amount which provided the composition with the desired amount of protein, as well as an amount of sphingomyelin which would promote functional neuronal maturation in pediatric subjects. See MPEP 2144.05(II)(A) which states "[W]here 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).
With regard to Claim 45, Kuang teaches the sphingomyelin can be provided by milk-based whey protein concentrates which are rich in milk fat globule membranes ([0054], [0072]) and sphingomyelin is present in the nutritional composition in an amount of about 0.15 mg/100 Kcal to about 75 mg/100 Kcal sphingomyelin ([0071]). Kuang teaches the quantity of polar lipids, such as sphingomyelin, can vary significantly depending on the source ([0072]). As stated above, this is evidenced by Vaghela which shows different manufacturing practices can influence the sphingomyelin concentration in whey protein concentrates (Introduction, tables 5-6).
Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to select the whey protein source from the desired manufacturing practice which provides the sphingomyelin in an amount which would achieve the desire result of promoting functional neuronal maturation in pediatric patients. See MPEP 2144.05(II)(A) which states "[W]here 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).
With regard to Claim 58, Kuang teaches the composition comprises prebiotic, particularly PDX and GOS ([0069]).
Claim 54 is rejected under 35 U.S.C. 103 as being unpatentable over Kuang (CN 107920574 A) in view of the USDA (“Whey Protein Concentrate (WPC)”) and Zhang et al. (herein referred to as Zhang, “Determination of disialoganglioside GD3 and monosialoganglioside GM3 in infant formulas and whey protein concentrates by ultra-performance liquid chromatography/electrospray ionization tandem mass spectrometry”) and evidenced by Vaghela et al. (herein referred to as Vaghela, Lipid Composition of Whey Protein Concentrates Manufactured Commercially and In the Laboratory”).
With regard to Claim 54, Kuang teaches whey protein concentrate is a suitable source of gangliosides. However, Kuang is silent to the gangliosides being GD3 and the amount within the whey protein.
Zhang teaches a method for the determination of GD3 levels in infant formulas and whey protein concentrates (abstract). Zhang teaches gangliosides play important roles in memory formation, stabilizing neuronal circuits, synaptic transmissions, intercellular signal recognition, and transmembrane signal transduction. In addition, Gangliosides from breast milk and infant formulas are proven to be essential bioactive and nutritional compounds for normal neuron development of the newborn. They may regulate the immune system, support intestinal maturation, have protective functions against enteric pathogens, and stimulate bifidobacteria proliferation in the gut of infants (1. Introduction). Zhang teaches seasonal changes and lactational variations have been reported to impact the ganglioside levels in bovine milk and these variations along with manufacturing processes will impact the GD3 levels measured in infant formulas and whey protein concentrates (3.3.5 Method Application). Zhang teaches the levels of GD3 in whey protein concentrate ranged from 218–564 mg/100 g (2,180-5,640 mg/kg. 3.3.5 Method application). See MPEP 2144.05(I) a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close.
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Kuang in view of Zhang to utilize whey protein concentrate with a GD3 level ranging from 218–564 mg/100 g. This amount may be optimized through routine optimization to achieve the desired GD3 concentration in the whey protein concentrate. Variables such as seasonal changes and manufacturing processes can impact GD3 levels. GD3 in the reported range are advantageous for regulating the immune system, supporting intestinal maturation, having protective functions against enteric pathogens, and stimulating bifidobacteria proliferation in the gut of infants.
Claims 52 and 56 are rejected under 35 U.S.C. 103 as being unpatentable over Kuang (CN 107920574 A) in view of the USDA (“Whey Protein Concentrate (WPC)”) and Rowan et al. (herein referred to as Rowan, PH 12010500862 B1) and evidenced by Vaghela et al. (herein referred to as Vaghela, Lipid Composition of Whey Protein Concentrates Manufactured Commercially and In the Laboratory”).
With regard to Claim 52, Kuang is silent to the phospholipid concentration in the whey protein concentrate.
Rowan teaches one or more complex lipids for maintaining or increasing growth or maintaining or increasing cognitive development of a foetal, infant, or child subject (page 2, lines 13-15). Rowan teaches an infant formula which utilizes a milk fat extract wherein the milk fat extra can be whey protein concentrate (page 12 line 16 – page 13 line 21). Rowan teaches Preferably the concentration of at least one phospholipid and at least one ganglioside in an extract useful herein is at least about 0.5, 1, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, or 100% higher than the concentration in naturally occurring non-human mammalian milk fat (page 12 lines 18-21).
Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Kuang in view of Rowan to utilize a whey protein concentrate with the desired amount of phospholipid so the resulting composition has a phospholipid concentration higher than the concentration in naturally occurring non-human mammalian milk fat.
With regard to Claim 54, Kuang is silent to the GD3 concentration in the whey protein concentrate.
Rowan teaches an infant formula which utilizes a milk fat extract wherein the milk fat extra can be whey protein concentrate (page 12 line 16 – page 13 line 21). Rowan teaches Preferably the concentration of at least one phospholipid and at least one ganglioside in an extract useful herein is at least about 0.5, 1, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, or 100% higher than the concentration in naturally occurring non-human mammalian milk fat (page 12 lines 18-21). Rowan teaches gangliosides, and specifically GD3, are reported to have beneficial effects on neural development (page 2 line 1 and page 3 lines 16-20).
Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Kuang in view of Rowan to utilize whey protein concentrate with a GD3 content in an amount wherein the composition has a higher than the concentration in naturally occurring non-human mammalian milk fat and beneficially effects the neural development of an infant.
Response to Arguments
Applicant’s arguments with respect to claim(s) 31-40, 45, 49, 52, 54, 56, and 58 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
THIS ACTION IS MADE FINAL. 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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/K.I.D./Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792