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 .
Priority
This Application is a 371 of PCT/IB2022/057883, filed August 23, 2022, and claims foreign priority to IT102021000022427, filed August 27, 2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on February 23, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Status
Claims 1-20 are currently pending and subject to examination.
Claim Rejections – 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
“(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.”
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
“The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.”
Claims 1-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
One of ordinary skill in the art cannot determine the metes and bounds of claims 1-9 because claims 1-9 are use claims which attempt to claim a process without setting forth the steps involved. See MPEP 2173.05(q):
Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. For example, a claim which read: "[a] process for using monoclonal antibodies of claim 4 to isolate and purify human fibroblast interferon" was held to be indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986).
MPEP § 2173.05(q).
One of ordinary skill in the art cannot determine the metes and bounds of claims 3-5 and 10-14 because the claim 10 recites the phrase “preferably” and it is unclear if these preferences are limitations. “If stated in a single claim, examples and preferences lead to confusion over the intended scope of the claim. In those instances where it is not clear whether the claimed narrower range is a limitation, a rejection under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph should be made.” (MPEP § 2173.05(c)). “Description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim. In those instances where it is not clear whether the claimed narrower range is a limitation, a rejection under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph should be made.” (MPEP § 2173.05(d)). Claims 11 to 14 are dependent upon claim 10 and do not resolve this ambiguity and are therefore also indefinite.
Claim 13 is also indefinite because there is insufficient antecedent basis for “the composition comprising from 400 IU to 5000 IU of vitamin D3 and from 2 to 50 mg of sphingomyelin.” The composition recited in claim 10 does not have a specified amount of vitamin D3 and sphingomyelin.
Similarly, there is insufficient antecedent basis for the term “the composition for oral administration” in claim 18. Claim 13 does not recite a composition for oral administration and is directed towards a method which does not require oral administration.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
“Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.”
Claims 1-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because these claims are use clams which do not set forth any steps involved in a process:
"Use" claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101. In re Moreton, 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961)("one cannot claim a new use per se, because it is not among the categories of patentable inventions specified in 35 U.S.C. § 101 "). In Ex parte Dunki, 153 USPQ 678 (Bd. App. 1967), the Board held the following claim to be an improper definition of a process: "The use of a high carbon austenitic iron alloy having a proportion of free carbon as a vehicle brake part subject to stress by sliding friction." In Clinical Products Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966), the district court held the following claim was definite, but that it was not a proper process claim under 35 U.S.C. 101: "The use of a sustained release therapeutic agent in the body of ephedrine absorbed upon polystyrene sulfonic acid."
MPEP § 2173.07(q).
Claims 10-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. The claim(s) recite(s):
A method for promoting, supporting or optimizing the formation and outgrowth of neurites of the cells of the nervous system comprising the step (i) of administering to a mammalian, preferably to a human being, a composition comprising vitamin D3 and sphingomyelin.
Independent claim 10;
A composition for oral administration comprising from 400 I to 5000 I of vitamin D3 and from 2 to 50 mg of sphingomyelin, wherein the ratio of vitamin D3 to sphingomyelin is equal to or greater than 50:1(IU/mg).
Independent claim 15.
This judicial exception is not integrated into a practical application because the claims are directed towards a method of promoting, supporting or optimizing the formation and outgrowth of neurites of the cells of the nervous system, which is a normal part of mammalian growth and development. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the composition claims only recite components which are present in mammalian milk, a naturally occurring product, which are ingested by mammalian infants and young in a naturally occurring process (nursing) which promotes and optimizes the growth and development of the mammalian nervous system. The claims do not recite the treatment or prophylaxis of any particular disease or medical condition.
Step 1: Are the claims directed towards a statutory category? Yes. The claims are directed towards a statutory category, either a process or a composition of matter.
Step 2A: Are the claims directed to a judicial exception? Yes. The claims are directed towards a judicial exception because the claimed mixture and process occur in nature (vitamin D, sphingomyelin, DHA, Vitamin E, medium-chain triglycerides, glycerophospholipids, ceramides and mixtures thereof and administering a composition comprising the same to a mammal to promote, support or optimize the growth and development of neurites). There is no indication in the specification that the mixture has any characteristics (structural, functional or otherwise) that are different from naturally occurring mammalian milks or avian eggs. Thus, the mixture and process do not have markedly different characteristics from what occurs in nature and is a “product of nature” or “natural phenomenon” exception. Accordingly, the claim is directed to an exception.
For example, see Foroutan et al., Chemical Composition of Commercial Cow’s Milk, 67 J. Agri. & food Chem. 4897-4914 (2019). Foroutan teaches that Vitamin D3 and sphingomyelin are naturally occurring components of cow’s milk:
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Foroutan, p. 4905, Table 2, List of Milk Metabolites Detected by LC–HRMS along with Their Measured or Reported Concentrations and Their Standard Deviations and/or Ranges (As Measured in Micromolar);
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Id., p. 4908, Table 4: List of Milk Vitamins Detected by LC–MS/MS along with Their Measured or Reported Concentrations and Their Standard Deviations and/or Ranges (As Measured in Micromolar).
Foroutan also shows that cow’s milk contains Vitamin E (Table 4), medium chain triglycerides (Table 1; Table 3), glycerophospholipids (Table 2), and ceramides (Table 2). DHA is also a naturally occurring component in milk. See, e.g., Huang et al., DHA content in milk and biohydrogenation pathway in rumen: a review, PeerJ, Dec. 2020, 1-24.
Vitamin D and sphingomyelin in breast milk naturally varies in concentration. Human breast milk can contain high concentrations of Vitamin D3 (cholecalciferol). Oberhelman et al., Maternal Vitamin D Supplementation to Improve the Vitamin D Status of Breast-fed Infants: A Randomized Controlled Trial, 88 Mayo Clinic Proc. 1378-1387 (2013), demonstrates that maternal breast milk can contain up to 39.7 + 16.2 ng/mL of cholecalciferol (Oberhelman, Table 2, p. 1382). Converting to IU of Vitamin D3 (1 IU = 25 ng), this shows that human breast milk can contain 1.588 + 0.648 IU/mL of Vitamin D3. Blaas et al., Structural Profiling and Quantification of Sphingomyelin in Human Breast Milk by HPLC-MS/MS, 59 J. Agric. Food Chem. 6018-6024 (2011) teaches that the “total amount of SM [sphingomyelin] in human breast milk varied from 3.87 to 9.07 mg/100 g fresh weight” (Blaas, Abstract). It is therefore within the teachings that human breast milk could contain greater than 50 IU/mg of vitamin D to sphingomyelin ((1.588+0.648 IU/mL)/(3.87 mg/100g*1mg/100g*1g/mL) = 57.8 IU/mg). A cup of this human breast milk (236.588 mL) would contain about 529 IU of Vitamin D3 and 9.16 mg of sphingomyelin, like the claimed ranges and amounts.
As another example of a natural product containing both vitamin D and sphingomyelin is egg yolk. See Yao et al., Effects of vitamin D3-enriched diet on egg yolk vitamin D3 content and yolk quality, 78 J. Food Sci. C178-183 (2013). Yao teaches that supplemented hens on diet 5 can produce egg yolks that contain 34815 + 3560 IU/100g Vitamin D3 (Yao, C181). Typical egg yolks have a sphingomyelin content of about 190 + 9 mg/100g. Zhao et al., Measurement of phospholipids by hydrophilic interaction liquid chromatography coupled to tandem mass spectrometry: The determination of choline containing compounds in foods, 1218 J. Chromatography A 5470-5479, 5478 (2012). Therefore, the ratio of Vitamin D3/sphingomyelin (IU/mg) in these egg yolks is about 183:1, like the ratios of the claims. A typical egg yolk weighs about 17g (calculated as the average weight of egg yolks in Table 2 (16.5+15.9+14.9+15.7+21.4+17.3)/6). See Hisasaga et al., Survey of egg quality in commercially available table eggs, 99 Poultry Sci. 7202-7206, 7203 (2020). Therefore, the average amount of vitamin D3 and sphingomyelin in one of Yao’s egg yolks from a supplemented hen on diet 5 is about 5919 IU Vitamin D3 (34815/100*17) and 32.3 mg of sphingomyelin (190/100*17) (see Yao, p. C181), like the claimed amounts. The amount of vitamin D and sphingomyelin in a yolk from a hen on diet 4 is about 410 IU Vitamin D (2411/100*17) and 32.3 mg of sphingomyelin (190/100*17) (see id.). Claim 17 is directed towards a composition with 400 mg IU vitamin D3 and 2 mg of sphingomyelin. This is approximately equivalent to one sixteenth of an egg yolk from a hen on diet 5 (5919/16 ~ 370 IU; 32.3/16 ~ 2 mg). Dividing a natural product does not make it a different product.
Step 2B: Do the claims include additional features that could add to significantly more than the judicial exception? No. The claims does not include any additional features that could add significantly more to the exception. The claims are only directed towards the judicial exception (a composition comprising naturally occurring compounds, and a method of promoting the growth and development of neurites in the central nervous system). The claims to do recite the treatment of any disease or condition. The patient population can be any mammal, whether healthy or not. Moreover, it is well known that sphingolipids and vitamin D3 regulate the growth and development of neurites in central nervous system.
For example, Schneider et al., Sphingomyelin in Brain and Cognitive Development: Preliminary Data, eNeuro, Vol. 6, no. 4, 1-13 (2019) teaches that sphingomyelin plays a role in brain development in neonates and promotes the maturation and differentiation of oligodendrocyte precursor cells:
Sphingomyelin (SM) supports brain myelination, a process closely associated with cognitive maturation. The presence of SM in breast milk suggests a role in infant nutrition; however, little is known about SM contribution to healthy cognitive development. We investigated the link between early life dietary SM, later cognitive development and myelination using an exploratory observational study of neurotypical children. SM levels were quantified in infant nutrition products fed in the first three months of life and associated with myelin content (brain MRI) as well as cognitive development (Mullen scales of early learning; MSEL). Higher levels of SM were significantly associated with higher rates of change in verbal development in the first two years of life (r 0.65, p 0.001), as well as, higher levels of myelin content at 12–24 months, delayed onset and/or more prolonged rates of myelination in different brain areas. Second, we explored mechanisms of action using in vitro models (Sprague Dawley rat pups). In vitro data showed SM treatment resulted in increased proliferation [p 0.0133 and p 0.0434 at 4 and 10 d in vitro (DIV)], maturation (p 0.467 at 4 d DIV) and differentiation (p 0.0123 and p 0.0369 at 4 and 10 DIV) of oligodendrocyte precursor cells (OPCs), as well as increased axon myelination (p 0.0005 at 32 DIV). These findings indicate an impact of dietary SM on cognitive development in healthy children, potentially modulated by oligodendrocytes and increased axon myelination. Future research should include randomized controlled trials to substantiate efficacy of SM for cognitive benefits together with preclinical studies examining SM bioavailability and brain uptake.
Schneider, Abstract.
Eyles, Vitamin D: Brain and Behavior, JMBRPlus, Vol. 5, No 1, 1-13 (2020) teaches that vitamin D3 (1,25(OH)2D3) is important in neural growth and development and regulates neurite outgrowth:
We were the first group to show the addition of 1,25(OH)2D3 to embryonic hippocampal explant cultures increased neurite outgrowth.(46) This finding was replicated more recently in individual hippocampal neurons using the same concentration of 1,25(OH)2D3.(47) Both groups described a small, but significant elevation in NGF and assumed this effect was causal. Another group chose to examine the ability of ergocalciferol (vitamin D2) to enhance axon regeneration after peripheral denervation. These authors chose ergocalciferol based on an older study that claimed this was more potent than cholecalciferol in elevating 25OHD2 levels in rats.(120) These authors were able to demonstrate increased axogenesis, axon diameter, and higher functional recovery if ergocalciferol treatment was initiated immediately after lesioning.(121) We also now have new unpublished data replicating the neurite promoting potential of 1,25(OH)2D3 in developing DA neurons differentiated from (i) a neuroblastoma cell line, (ii) primary mesencephalic DA neurons, and (iii) explant mesencephalic cultures. We conclude that like all other neurosteroids, vitamin D enhances neurite extension. We are now exploring the molecular mechanisms for these effects.
Eyles, p. 5-6.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.”
Claim(s) 1-4, 7-16, and 19-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yao et al., Effects of vitamin D3-enriched diet on egg yolk vitamin D3 content and yolk quality, 78 J. Food Sci. C178-183 (2013) as evidenced by Zhao et al., Measurement of phospholipids by hydrophilic interaction liquid chromatography coupled to tandem mass spectrometry: The determination of choline containing compounds in foods, 1218 J. Chromatography A 5470-5479, 5478 (2012) and Hisasaga et al., Survey of egg quality in commercially available table eggs, 99 Poultry Sci. 7202-7206, 7203 (2020).
Zhao and Hisasaga are cited to show the inherent properties of egg yolks.
Claim 1 recites: “Use of a composition comprising vitamin D3 and sphingomyelin to promote, support or optimize the formation and outgrowth of neurites of the cells of the nervous system.” Claim 10 recites: “A method for promoting, supporting or optimizing the formation and outgrowth of neurites of the cells of the nervous system comprising the step (i) of administering to a mammalian, preferably to a human being, a composition comprising vitamin D3 and sphingomyelin.”
The claims read on consumption of a composition comprising vitamin D3 and sphingomyelin. The claim does not recite any particular patient population but rather read on the administration of a composition comprising vitamin D3 and sphingomyelin to heathy people. Any person consuming the composition would experience the promotion, support, and optimization of the formation and outgrowth of neurites in the central nervous system as recited in the claim.
Yao teaches that egg yolks high in vitamin D should be consumed by the public to enhance vitamin D consumption in the population:
Research has shown that vitamin D level in eggs can be readily increased by feeding the laying hens with vitamin-D-enriched diet because of the efficient transfer of lipid and lipid soluble molecules from the diet to eggs (Mattila and others 1999, 2003, 2004). Since eggs are versatile food or ingredient and are well accepted in most cultures, production of a high vitamin D egg may provide a unique opportunity to enhance human vitamin D consumption without greatly altering food consumption patterns.
Yao, p. C178.
Yao teaches that egg yolks specifically contain vitamin D3 (cholecalciferol):
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Id., p. C180.
Yao also teaches that egg yolks contain sphingomyelin, and that the amount of sphingomyelin in egg yolks was unaffected by a high vitamin D diet:
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Id., p. C182.
Therefore, claims 1 and 10 are anticipated.
Claim 2 recites: “Use of a composition comprising vitamin D3 and sphingomyelin according to claim 1, wherein the composition comprises from 400 IU to 5000 IU of vitamin D3 and from 2 to 50 mg of sphingomyelin.”
Yao teaches that the peak amount of vitamin D3 in an egg yolk from a hen on diet 4 is about 2411 + 291 IU/100 g egg yolk.
Typical egg yolks have a sphingomyelin content of about 190 + 9 mg/100g. Zhao et al., Measurement of phospholipids by hydrophilic interaction liquid chromatography coupled to tandem mass spectrometry: The determination of choline containing compounds in foods, 1218 J. Chromatography A 5470-5479, 5478 (2012). Therefore, the ratio of Vitamin D3/sphingomyelin (IU/mg) in these egg yolks is about 183:1. A typical egg yolk weighs about 17g (calculated as the average weight of egg yolks in Table 2 (16.5+15.9+14.9+15.7+21.4+17.3)/6). See Hisasaga et al., Survey of egg quality in commercially available table eggs, 99 Poultry Sci. 7202-7206, 7203 (2020).
The amount of vitamin D and sphingomyelin in a yolk from a hen on diet 4 is therefore about 410 IU Vitamin D (2411/100*17) and 32.3 mg of sphingomyelin (190/100*17) (see id.).
Thus, claim 2 is anticipated.
Claim 3 recites: Use of a composition comprising vitamin D3 and sphingomyelin according to claim 1, wherein the composition comprises vitamin D3 and sphingomyelin in a ratio vitamin D3/sphingomyelin equal to or greater than 10:1 (IU/mg), preferably equal to or greater than 50:1(IU/mg).
Claim 4 recites: “Use of a composition comprising vitamin D3 and sphingomyelin according to claim 3, wherein the ratio vitamin D3/sphingomyelin ranges from 10:1 (IU/mg) to 400:1 (IU/mg), preferably from 50:1 (IU/mg) to 400:1 (IU/mg), still more preferably from 150:1 (IU/mg) to 350:1 (IU/mg), still more preferably from 160:1 (IU/mg) to 250:1 (IU/mg).
Yao teaches that supplemented hens on diet 5 can produce egg yolks that contain a peak content of 34815 + 3560 IU/100g Vitamin D3 (Yao, C181). Typical egg yolks have a sphingomyelin content of about 190 + 9 mg/100g. (Zhao, p. 5478). Therefore, the ratio of Vitamin D3/sphingomyelin (IU/mg) in these egg yolks is about 183:1 (34815/190), which falls within the claimed range of equal to or greater than 10:1, and most preferably from 160:1 (IU/mg) to 250:1 (IU/mg).
Therefore, claims 3 and 4 are anticipated.
Claim 7 is directed towards: “Use of a composition comprising vitamin D3 and sphingomyelin according to claim lany one of claims 1-6, wherein the composition further comprises at least one additional component selected from the group consisting of docosahexaenoic acid (DHA), Vitamin E, medium-chain triglycerides, glycerophospholipids, ceramides, cholesterol and mixtures thereof.”
Yao teaches that eggs further comprise glycerophospholipids such as phosphatidylethanolamine and phosphatidylcholine (Table 3, p. C182) as well as cholesterol “Unsaponifiable matters of egg yolk lipids of the 5 diet treatments were about the same, 1.1% of dry yolk lipids on average (Table 5).Unsaponifiable matters include carotenoids, cholesterol, vitamin D, and other sterols, of which cholesterol is the major component” (id., p. C182, col. 2).
Therefore, claim 7 is anticipated.
Claim 8 is directed towards: “Use of a composition comprising vitamin D3 and sphingomyelin according to claim l, wherein the composition is for oral administration.” As shown in the rejection of clam 1, Yao teaches that eggs are a food for human consumption (oral administration). Therefore, claim 8 is anticipated.
Claim 9 is directed towards: “Use of a composition comprising vitamin D3 and sphingomyelin according to claim l, wherein the composition is in a form selected from a capsule, a tablet, a water-soluble powder, a liquid solution, a hydroalcoholic solution and an edible product.” As shown in the rejection of claim 1, Yao teaches that eggs are a food (an edible product). Therefore, claim 9 is anticipated.
Claim 11 is directed towards the “method according to claim 10, wherein the step (i) comprises orally administering the composition comprising vitamin D3 and sphingomyelin.” As shown in the rejection of claims 1 and 10, Yao teaches that eggs are a food for human consumption (they are orally administered). Therefore, claim 11 is anticipated.
Claim 12 is directed towards the “method according to claim 11, wherein the step (i) comprises orally administering the composition comprising vitamin D3 and sphingomyelin in a form selected from a capsule, a tablet, a water-soluble powder, a liquid solution, a hydroalcoholic solution and an edible product.” As shown in the rejection of claim 1, Yao teaches that eggs are a food for human consumption (an edible product). Therefore, claim 12 is anticipated.
Claim 13 is directed towards the method according to claim 10, “wherein the composition comprising from 400 IU to 5000 IU of vitamin D3 and from 2 to 50 mg of sphingomyelin”
Yao teaches that the peak amount of vitamin D3 in an egg yolk from a hen on diet 4 is about 2411 + 291 IU/100 g egg yolk.
Typical egg yolks have a sphingomyelin content of about 190 + 9 mg/100g. Zhao et al., Measurement of phospholipids by hydrophilic interaction liquid chromatography coupled to tandem mass spectrometry: The determination of choline containing compounds in foods, 1218 J. Chromatography A 5470-5479, 5478 (2012). A typical egg yolk weighs about 17g (calculated as the average weight of egg yolks in Table 2 (16.5+15.9+14.9+15.7+21.4+17.3)/6). See Hisasaga et al., Survey of egg quality in commercially available table eggs, 99 Poultry Sci. 7202-7206, 7203 (2020).
The amount of vitamin D and sphingomyelin in a yolk from a hen on diet 4 is therefore about 410 IU Vitamin D (2411/100*17) and 32.3 mg of sphingomyelin (190/100*17) (see id.).
Therefore, claim 13 is anticipated.
Claim 14 is directed towards, the method of claim 10, wherein the step (i) comprises administering to a mammalian, preferably to a human being, from 400IU to 5000IU of vitamin D3 and from 2 to 50 mg of sphingomyelin at least once a day.
Yao teaches eating an egg with high vitamin D content at least once a day to satisfy the daily vitamin D requirement:
The recently released Dietary Reference Intakes for calcium and vitamin D increased the recommended daily intake of vitamin D for children and adults from 200 to 600 IU a day, and from 600 to 800 IU a day for elder people. The safe upper limit on daily intake has been increased from 2000 IU to today's 4000 IU for most age groups (Institute of Medicine 2010). Few natural foods contain significant amount of vitamin D, which necessitates fortification of the diet or specific foods with vitamin D to satisfy the current recommendations. For instance, fortified milk with vitamin D is an important dietary source of vitamin D; however, it supplies less than 50% of the current daily value. Another important natural foodstuff rich in vitamin D is egg. According to USDA national nutrient database, one large egg (about 50 g) contains approximately 41 IU vitamin D (concentrated in the yolk). However, the normal consumption level of eggs still cannot provide adequate amount of vitamin D to meet the daily requirement. Research has shown that vitamin D level in eggs can be readily increased by feeding the laying hens with vitamin-D-enriched diet because of the efficient transfer of lipid and lipid soluble molecules from the diet to eggs (Mattila and others 1999, 2003, 2004). Since eggs are versatile food or ingredient and are well accepted in most cultures, production of a high vitamin D egg may provide a unique opportunity to enhance human vitamin D consumption without greatly altering food consumption patterns.
Yao, p. C178.
Therefore, claim 14 is anticipated.
Claim 15 recites: “A composition for oral administration comprising from 400 IU to 5000 IU of vitamin D3 and from 2 to 50 mg of sphingomyelin, wherein the ratio of vitamin D3 to sphingomyelin is equal to or greater than 50:1(IU/mg).”
Claim 16 recites: “The composition for oral administration according to claim 15, wherein the ratio vitamin D3/sphingomyelin ranges from 50:1 (IU/mg) to 400:1 (IU/mg), still more preferably from 150:1 (IU/mg) to 350:1 (IU/mg), still more preferably from 160:1 (IU/mg) to 250:1 (IU/mg).
Yao teaches that supplemented hens on diet 5 can produce egg yolks that contain a peak content of 34815 + 3560 IU/100g Vitamin D3 (Yao, C181). Figure 1 shows that after the peak, egg yolks from hens fed diet 5 at e.g. week 15 have a lesser content of vitamin D, about 25000 IU/100g:
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Yao, p. C180.
Typical egg yolks have a sphingomyelin content of about 190 + 9 mg/100g. (Zhao, p. 5478). Therefore, the ratio of Vitamin D3/sphingomyelin (IU/mg) in these egg yolks is about 131:1 (25000/190), which falls within the claimed range of equal to or greater than 50:1. A typical egg yolk weighs about 17g (calculated as the average weight of egg yolks in Table 2 (16.5+15.9+14.9+15.7+21.4+17.3)/6). See Hisasaga et al., Survey of egg quality in commercially available table eggs, 99 Poultry Sci. 7202-7206, 7203 (2020). Therefore, the average amount of vitamin D3 and sphingomyelin in one of Yao’s egg yolks from a supplemented hen on diet 5 is about 4250 IU Vitamin D3 (25000/100*17) and 32.3 mg of sphingomyelin (190/100*17) (see Yao, p. C181), falling within the claimed range.
Therefore, claims 15 and 16 are anticipated.
Claim 19 is directed towards the composition for oral administration of claim 15, further comprising at least one additional component selected from the group consisting of DHA, Vitamin E, medium-chain triglycerides, glycerophospholipids, ceramides and mixtures thereof.
Yao teaches that eggs further comprise glycerophospholipids such as phosphatidylethanolamine and phosphatidylcholine (Table 3, p. C182) as well as cholesterol “Unsaponifiable matters of egg yolk lipids of the 5 diet treatments were about the same, 1.1% of dry yolk lipids on average (Table 5).Unsaponifiable matters include carotenoids, cholesterol, vitamin D, and other sterols, of which cholesterol is the major component” (id., p. C182, col. 2).
Therefore, claim 19 is anticipated.
Claim 20 is directed towards: “The composition for oral administration according to claim 15 in a form selected from a capsule, a tablet, a water-soluble powder, a liquid solution, a hydroalcoholic solution and an edible product.”
As shown in the rejection of claims 1 and 10, Yao teaches that eggs are a food for human consumption (an edible product).
Therefore, claim 20 is anticipated.
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.”
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-5, 7-17, and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yao et al., Effects of vitamin D3-enriched diet on egg yolk vitamin D3 content and yolk quality, 78 J. Food Sci. C178-183 (2013) as evidenced by Zhao et al., Measurement of phospholipids by hydrophilic interaction liquid chromatography coupled to tandem mass spectrometry: The determination of choline containing compounds in foods, 1218 J. Chromatography A 5470-5479, 5478 (2012) and Hisasaga et al., Survey of egg quality in commercially available table eggs, 99 Poultry Sci. 7202-7206, 7203 (2020), as applied to claims 1-4, 7-16, and 19-20 above.
The rejection of claims 1-4, 7-16 and 19-20 above is incorporated herein by reference. As such, claims 1-4, 7-16 and 19-20 were prima facie obvious at the time of filing.
Claim 5 recites: “Use of a composition comprising vitamin D3 and sphingomyelin according to claim 3, wherein the ratio vitamin D3/sphingomyelin is 200:1 (IU/mg). Claim 17 recites: the composition for oral administration according to claim 15, wherein the wherein the ratio vitamin D3/sphingomyelin is 200:1 (IU/mg).
Yao teaches that supplemented hens on diet 5 can produce egg yolks that contain 34815 + 3560 IU/100g Vitamin D3 (Yao, C181). Typical egg yolks have a sphingomyelin content of about 190 + 9 mg/100g. Zhao et al., Measurement of phospholipids by hydrophilic interaction liquid chromatography coupled to tandem mass spectrometry: The determination of choline containing compounds in foods, 1218 J. Chromatography A 5470-5479, 5478 (2012). Therefore, the ratio of Vitamin D3/sphingomyelin (IU/mg) in these egg yolks is about 183:1.
Regarding claim 17, a typical egg yolk weighs about 17g (calculated as the average weight of egg yolks in Table 2 (16.5+15.9+14.9+15.7+21.4+17.3)/6). See Hisasaga et al., Survey of egg quality in commercially available table eggs, 99 Poultry Sci. 7202-7206, 7203 (2020). The average amount of vitamin D3 and sphingomyelin in one of Yao’s egg yolks from a supplemented hen on diet 5 is about 5919 IU Vitamin D3 (34815/100*17) and 32.3 mg of sphingomyelin (190/100*17) (see Yao, p. C181), like the claimed amounts.f
One of ordinary skill in the art would have a reasonable expectation of success to arrive at this ratio by routine optimization because 183:1 is very similar to 200:1 and Yao teaches that the amount of vitamin D in eggs is variable depending on the feed given to hens. (Yao, Fig. 1). See MPEP § 2144.05:
Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties."). See also Warner-Jenkinson Co., Inc. v. Hilton Davis Chemical Co., 520 U.S. 17, 41 USPQ2d 1865 (1997) (under the doctrine of equivalents, a purification process using a pH of 5.0 could infringe a patented purification process requiring a pH of 6.0-9.0); In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%); In re Scherl, 156 F.2d 72, 74-75, 70 USPQ 204, 205-206 (CCPA 1946) (prior art showed an angle in a groove of up to 90° and an applicant claimed an angle of no less than 120°); In re Becket, 88 F.2d 684 (CCPA 1937) ("Where the component elements of alloys are the same, and where they approach so closely the same range of quantities as is here the case, it seems that there ought to be some noticeable difference in the qualities of the respective alloys."); In re Dreyfus, 73 F.2d 931, 934, 24 USPQ 52, 55 (CCPA 1934)(the prior art, which taught about 0.7:1 of alkali to water, renders unpatentable a claim that increased the proportion to at least 1:1 because there was no showing that the claimed proportions were critical); In re Lilienfeld, 67 F.2d 920, 924, 20 USPQ 53, 57 (CCPA 1933)(the prior art teaching an alkali cellulose containing minimal amounts of water, found by the Examiner to be in the 5-8% range, the claims sought to be patented were to an alkali cellulose with varying higher ranges of water (e.g., "not substantially less than 13%," "not substantially below 17%," and "between about 13[%] and 20%"); K-Swiss Inc. v. Glide N Lock GmbH, 567 Fed. App'x 906 (Fed. Cir. 2014)(reversing the Board's decision, in an appeal of an inter partes reexamination proceeding, that certain claims were not prima facie obvious due to non-overlapping ranges); In re Brandt, 886 F.3d 1171, 1177, 126 USPQ2d 1079, 1082 (Fed. Cir. 2018)(the court found a prima facie case of obviousness had been made in a predictable art wherein the claimed range of "less than 6 pounds per cubic feet" and the prior art range of "between 6 lbs./ft3 and 25 lbs./ft3" were so mathematically close that the difference between the claimed ranges was virtually negligible absent any showing of unexpected results or criticality.).
MPEP § 2144.05.
Therefore, claims 5 and 17 were prima facie obvious at the time of filing.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Steenhout & Voss (US 2012/0276057 A1) in view of Casey et al., Vitamin D Supplementation in Infants, Children, and Adolescents, 81 Am. Family Physician 745-748 (2010).
Claim 1 recites: “Use of a composition comprising vitamin D3 and sphingomyelin to promote, support or optimize the formation and outgrowth of neurites of the cells of the nervous system.” Claim 10 recites: “A method for promoting, supporting or optimizing the formation and outgrowth of neurites of the cells of the nervous system comprising the step (i) of administering to a mammalian, preferably to a human being, a composition comprising vitamin D3 and sphingomyelin.”
Steenhout teaches method for supporting and/or improving overall cognitive performance in a child comprising administering a composition comprising sphingomyelin and vitamin D to a child:
In an aspect, the nutritional composition supports and/or improves cognitive development of a child. In particular, the nutritional composition supports one or more selected from sensorimotor development, exploration and manipulation, object relatedness, concept formation, memory, habituation, visual acuity, visual preference, object recognition, visual attention, or other aspects of cognitive processing. In dependence of the age, the nutritional composition supports and/or improves cognitive development and/or capacities in one or more of the areas selected from counting (with one-to-one correspondence and cardinality), visual and tactile exploration, object assembly, puzzle board completion, matching colors, comparing masses, representational and/or pretend play, discriminating patterns.
Steethout, Spec., para. [0127];
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Steenhout, para. [105], Table 4.
Steethout demonstrates that children administered the growing up milk of example 1 comprising 30 mg of sphingomyelin/ 100g and 6.8 micrograms of Vitamin D (Table 10, para. [0146]) “have better results in the areas of memory, in particular short term memory, alertness, learning capacity, attention capacity, concentration capacity and language ability.” (para. [0154).
While Steethout does not teach the form of Vitamin D in the composition, one of ordinary skill in the art would have a reasonable expectation of success to include vitamin D3 in the composition because it is well known in the art that Vitamin D3 is the preferred form of vitamin D for supplementation in children.
For example, Casey teaches “Vitamin D3, known as cholecalciferol, is the preferred form of vitamin D for supplementation.” (Casey, col. 1, p. 747).
The claims to do recite the treatment of any disease or condition. The patient population can be any mammal, whether healthy or not. Moreover, “promoting, supporting or optimizing the formation and outgrowth of neurites of the cells of the nervous system” is merely an explanation of the prior art’s functioning and does not impart patentability to the invention. “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999).” See MPEP § 2112.I. The claimed use and method is substantially identical to the prior art.
Therefore, claims 1 and 10 were prima facie obvious at the time of filing.
Claim 2 recites: “Use of a composition comprising vitamin D3 and sphingomyelin according to claim 1, wherein the composition comprises from 400 IU to 5000 IU of vitamin D3 and from 2 to 50 mg of sphingomyelin.” Claim 13 is directed towards the method according to claim 10, “wherein the composition comprising from 400 IU to 5000 IU of vitamin D3 and from 2 to 50 mg of sphingomyelin.”
As shown in the rejection of claim 1, Steenhout teaches preferred range of Vitamin D is 2 to 10 micrograms per 100g, corresponding to 80 to 400 IU of vitamin D per 100 g and a preferred range of 10 to 200 mg of sphingomyelin per 100g. These amounts overlap with the claimed ranges.
In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In reWertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In reWoodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of “about 1-5%” while the claim was limited to “more than 5%.” The court held that “about 1-5%” allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of “50 to 100 Angstroms” considered prima facie obvious in view of prior art reference teaching that “for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms].” The court stated that “by stating that ‘suitable protection’ is provided if the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range.”). See also In re Bergen, 120 F.2d 329, 332, 49 USPQ 749, 751-52 (CCPA 1941) (The court found that the overlapping endpoint of the prior art and claimed range was sufficient to support an obviousness rejection, particularly when there was no showing of criticality of the claimed range).
MPEP § 2144.05.I.
Therefore, claims 2 and 13 were prima facie obvious at the time of filing.
Claim 3 recites: Use of a composition comprising vitamin D3 and sphingomyelin according to claim 1, wherein the composition comprises vitamin D3 and sphingomyelin in a ratio vitamin D3/sphingomyelin equal to or greater than 10:1 (IU/mg), preferably equal to or greater than 50:1(IU/mg).
Claim 4 recites: “Use of a composition comprising vitamin D3 and sphingomyelin according to claim 3, wherein the ratio vitamin D3/sphingomyelin ranges from 10:1 (IU/mg) to 400:1 (IU/mg), preferably from 50:1 (IU/mg) to 400:1 (IU/mg), still more preferably from 150:1 (IU/mg) to 350:1 (IU/mg), still more preferably from 160:1 (IU/mg) to 250:1 (IU/mg).
As shown in the rejection of claim 2, Steenhout teaches a composition with 80 to 400 IU of Vitamin D and from 10 to 200 mg of sphingomyelin. Therefore, Steenhout teaches ratios of Vitamin D: sphingomyelin between 0.4:1 and 40:1, overlapping the claimed ranges.
Therefore, claims 3-4 were prima facie obvious at the time of filing.
Claim 5 recites: “Use of a composition comprising vitamin D3 and sphingomyelin according to claim 3, wherein the ratio vitamin D3/sphingomyelin is 200:1 (IU/mg).
While Steenhout does not teach a ratio of 200:1, one of ordinary skill in the art would have a reasonable expectation of success to arrive at the claimed ratio through routine optimization because the amounts of Vitamin D and sphingomyelin are recognized as result-effective variables in the composition.
For example, Steenhout teaches that vitamin D has an important role in brain development and function and teaches amounts of at least 1.5 μg per 100g:
According to an embodiment, the nutritional composition comprises vitamin D. There is biological evidence to suggest an important role for vitamin D in brain development and function. The composition preferably comprises at least 1.5 μg vitamin D per 100 g of dry weight of the nutritional composition. According to an embodiment, the composition comprises 2-10, preferably 3.5-9, more preferably 5-8 μg vitamin D per 100 g of dry weight of the nutritional composition.
Steenhout, Spec., para. [0082].
Steenhout also teaches that sphingomyelin is an important nutrient to facilitate normal nerve function, and can be present in varying amounts in the composition:
According to an embodiment, the nutritional composition comprises sphingomyelin. Sphingomyelins are a subgroup of sphingophospholipids, which in turn are part of the larger group of sphingolipids in general. Sphingomyelins consist of a ceramide moiety (for example sphingosine) and a phosphacholine as a polar head group. Sphingomyelin is a structural component of cellular membranes and is found in the membranes of neurons and glia cells, and also in axons. Sphingomyelin facilitates the efficient and rapid propagation of nerve electrical signals. In particular, sphingomyelin is a component of the myelin sheath surrounding the nerve cell axons. In the present nutritional composition, sphingomyelin is mainly naturally provided as a natural component of milk, in particular cow's milk, or milk fat globule membrane…
The nutritional composition of the invention preferably comprises at least 10 mg sphingomyelin per 100 g of the dry weight of the nutritional composition. According to an embodiment, the nutritional composition comprises 10-200, preferably 20-150, more preferably 25-100 mg sphingomyelin per 100 g of the dry weight of the nutritional composition.
Id., para. [0073], [0075].
The Applicant has failed to demonstrate that the claimed ratio is critical. Figures 6 and 7 demonstrate that ratios of 200:1 and 10:1 produce similar percentages of cells with neurites and lengths of neurites in vitro.
Therefore, claim 5 was prima facie obvious at the time of filing.
Claim 6 recites: “Use of a composition comprising vitamin D3 and sphingomyelin according to claim l, wherein the composition comprises 400 IU of vitamin D3 and 2 mg of sphingomyelin.” Claim 18 recites: “The composition for oral administration according to claim 13 comprising 400I of vitamin D3 and 2mg of sphingomyelin.”
As shown in the rejection of claim 1, Steenhout teaches a composition with 80 to 400 IU of Vitamin D and from 10 to 200 mg of sphingomyelin.
The range of sphingomyelin recited in Steenhout is so close to the claimed amount that one of ordinary skill in the art would have a reasonable expectation of success to arrive at the claimed amount by routine optimization of this result-effective variable. See MPEP § 2144.05:
Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties."). See also Warner-Jenkinson Co., Inc. v. Hilton Davis Chemical Co., 520 U.S. 17, 41 USPQ2d 1865 (1997) (under the doctrine of equivalents, a purification process using a pH of 5.0 could infringe a patented purification process requiring a pH of 6.0-9.0); In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%); In re Scherl, 156 F.2d 72, 74-75, 70 USPQ 204, 205-206 (CCPA 1946) (prior art showed an angle in a groove of up to 90° and an applicant claimed an angle of no less than 120°); In re Becket, 88 F.2d 684 (CCPA 1937) ("Where the component elements of alloys are the same, and where they approach so closely the same range of quantities as is here the case, it seems that there ought to be some noticeable difference in the qualities of the respective alloys."); In re Dreyfus, 73 F.2d 931, 934, 24 USPQ 52, 55 (CCPA 1934)(the prior art, which taught about 0.7:1 of alkali to water, renders unpatentable a claim that increased the proportion to at least 1:1 because there was no showing that the claimed proportions were critical); In re Lilienfeld, 67 F.2d 920, 924, 20 USPQ 53, 57 (CCPA 1933)(the prior art teaching an alkali cellulose containing minimal amounts of water, found by the Examiner to be in the 5-8% range, the claims sought to be patented were to an alkali cellulose with varying higher ranges of water (e.g., "not substantially less than 13%," "not substantially below 17%," and "between about 13[%] and 20%"); K-Swiss Inc. v. Glide N Lock GmbH, 567 Fed. App'x 906 (Fed. Cir. 2014)(reversing the Board's decision, in an appeal of an inter partes reexamination proceeding, that certain claims were not prima facie obvious due to non-overlapping ranges); In re Brandt, 886 F.3d 1171, 1177, 126 USPQ2d 1079, 1082 (Fed. Cir. 2018)(the court found a prima facie case of obviousness had been made in a predictable art wherein the claimed range of "less than 6 pounds per cubic feet" and the prior art range of "between 6 lbs./ft3 and 25 lbs./ft3" were so mathematically close that the difference between the claimed ranges was virtually negligible absent any showing of unexpected results or criticality.)…
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[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) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1848 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989)(Claimed ratios were obvious as being reached by routine procedures and producing predictable results); In re Kulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990)(Claimed amount of wash solution was found to be unpatentable as a matter of routine optimization in the pertinent art, further supported by the prior art disclosure of the need to avoid undue amounts of wash solution); and In re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362, 1366 (Fed. Cir. 1997)(Claims were unpatentable because appellants failed to submit evidence of criticality to demonstrate that that the wear resistance of the protective layer in the claimed thickness range of 50-100 Angstroms was “unexpectedly good”); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree “will not sustain a patent”); In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) (“It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.”). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416, 82 USPQ2d 1385, 1395 (2007) (identifying “the need for caution in granting a patent based on the combination of elements found in the prior art.”)
MPEP § 2144.05.
Therefore, claim 6 was prima facie obvious at the time of filing.
Claim 7 recites: “Use of a composition comprising vitamin D3 and sphingomyelin according to claim l, wherein the composition further comprises at least one additional component selected from the group consisting of docosahexaenoic acid (DHA), Vitamin E, medium-chain triglycerides, glycerophospholipids, ceramides, cholesterol and mixtures thereof.”
Steenhout teaches that the composition further comprises these components:
According to an embodiment, the nutritional composition of the present invention comprises DHA. Preferably, the nutritional composition comprises at least 10 mg (milligram) DHA per 100 g of the dry weight of the nutritional composition. According to an embodiment, the nutritional composition comprises 15-40, more preferably 17-30, and most preferably 20-26 mg DHA per 100 g of the dry weight of the nutritional composition.
Steenhout, Spec., para. [0060];
The lipid source includes lipids useful form human nutrition of any origin, such as vegetal and animal oils or fat, for example. Animal oils include fish oil. Lipid sources include lipids obtained from milk, fish, eggs, seeds, nuts, fungi, microorganisms such as yeast and bacteria, for example. Lipid sources include sources containing phospholipids, mono- di-, triglycerides, fatty acids, sterol-related compounds such as cholesterol, sphingosines, ceramides, glycosphingolipids, gangliosides and the like. Preferred sources of lipids are milk, vegetal oils and fish oil.
Steenhout, Spec., para. [0057].
Tables 7-10 demonstrate that the formulation further comprises vitamin E.
Therefore, claim 7 was prima facie obvious at the time of filing.
Claim 8 is directed towards: “Use of a composition comprising vitamin D3 and sphingomyelin according to claim l, wherein the composition is for oral administration.” Claim 11 is directed towards the “method according to claim 10, wherein the step (i) comprises orally administering the composition comprising vitamin D3 and sphingomyelin.”
Steenhout teaches that the composition is a nutritional complement useful as a growing up milk, i.e. it is for oral administration:
Remarkably, the nutritional composition as defined by the present invention and its preferred embodiments, if used as nutritional complement in children of 1 to 6, preferably 1 to 3 years, provides nutrients useful to contribute to the body's build-up of the brain and to its proper functioning.
Furthermore, the nutritional composition is useful as a growing up milk, contributes to or even improves the normal mental, behavioural, emotional, language and intellectual development of a child.
Steenhout, Spec. para. [0024-0025].
Therefore, claims 8 and 11 were prima facie obvious at the time of filing.
Claim 9 is directed towards: “Use of a composition comprising vitamin D3 and sphingomyelin according to claim l, wherein the composition is in a form selected from a capsule, a tablet, a water-soluble powder, a liquid solution, a hydroalcoholic solution and an edible product.” Claim 12 is directed towards the “method according to claim 11, wherein the step (i) comprises orally administering the composition comprising vitamin D3 and sphingomyelin in a form selected from a capsule, a tablet, a water-soluble powder, a liquid solution, a hydroalcoholic solution and an edible product.”
Steenhout teaches that the composition of their invention is provided in the forms of a liquid solution and water-soluble powder:
The nutritional composition of the present invention may be provided as a ready-to-drink liquid form or in the form of a dry powder to be reconstituted with water, or another water containing liquid (less preferred). Preferably, the nutritional composition is provided in powdered form, and reconstituted by addition of water by the consumer shortly (for example 1 minute to 2 hours) before consumption.
Steenhout, Spec., para. [0019].
Therefore, claims 9 and 12 were prima facie obvious at the time of filing.
Claim 14 is directed towards, the method of claim 10, wherein the step (i) comprises administering to a mammalian, preferably to a human being, from 400 IU to 5000 IU of vitamin D3 and from 2 to 50 mg of sphingomyelin at least once a day.
Steenhout teaches to administer amounts which overlap/ are close to these amounts, preferably 2 to 3 times per day:
If the nutritional composition is provided in the form of a powder, it is preferably reconstituted by mixing 12-20 g powder in 1 dl water, preferably 14-20 g powder, more preferably about 16-18 g powder in 1 dl (0.1 liter) water.
The typical serving size is about 200 ml, that is, in two times the quantity defined above (for example, 32 g) is added to 200 ml water. Per day, ideally 2 to 3 serving sizes are consumed per child of 1 to 3 years.
Steenhout, Spec., para. [0120-0121].
A child therefore could receive about 100g of powder from three 32-36g daily servings, which has 80 to 400 IU of vitamin D per 100 g and 10 to 200 mg of sphingomyelin per 100 g (see the rejection of claims 1-2).
Therefore, claim 14 was prima facie obvious at the time of filing.
Claim 15 is directed towards: “A composition for oral administration comprising from 400 IU to 5000 IU of vitamin D3 and from 2 to 50 mg of sphingomyelin, wherein the ratio of vitamin D3 to sphingomyelin is equal to or greater than 50:1 (IU/mg).” Claim 16 is directed towards: “The composition for oral administration according to claim 15, wherein the ratio vitamin D3/sphingomyelin ranges from 50:1 (IU/mg) to 400:1 (I/mg), still more preferably from 150:1 (IU/mg) to 350:1 (IU/mg), still more preferably from 160:1 (I/mg) to 250:1 (I/mg).” Claim 17 is directed towards: “The composition for oral administration according to claim 15, wherein the wherein the ratio vitamin D3/sphingomyelin is 200:1 (IU/mg).”
As shown in the rejection of claim 2, Steenhout teaches a composition with 80 to 400 IU of Vitamin D and from 10 to 200 mg of sphingomyelin, overlapping the claimed amounts. As such, Steenhout teaches ratios of Vitamin D: sphingomyelin between 0.4:1 and 40:1.
While Steenhout does not teach a ratio of greater than 50:1, specifically 200:1, one of ordinary skill in the art would have a reasonable expectation to arrive at this range through routine optimization. The rejection of claims 3-6 is incorporated herein by reference.
Therefore, claims 15-17 were prima facie obvious at the time of filing.
Claim 19 is directed towards the composition for oral administration of claim 15, further comprising at least one additional component selected from the group consisting of DHA, Vitamin E, medium-chain triglycerides, glycerophospholipids, ceramides and mixtures thereof.
Steenhout teaches that the composition further comprises these components:
According to an embodiment, the nutritional composition of the present invention comprises DHA. Preferably, the nutritional composition comprises at least 10 mg (milligram) DHA per 100 g of the dry weight of the nutritional composition. According to an embodiment, the nutritional composition comprises 15-40, more preferably 17-30, and most preferably 20-26 mg DHA per 100 g of the dry weight of the nutritional composition.
Steenhout, Spec., para. [0060];
The lipid source includes lipids useful form human nutrition of any origin, such as vegetal and animal oils or fat, for example. Animal oils include fish oil. Lipid sources include lipids obtained from milk, fish, eggs, seeds, nuts, fungi, microorganisms such as yeast and bacteria, for example. Lipid sources include sources containing phospholipids, mono- di-, triglycerides, fatty acids, sterol-related compounds such as cholesterol, sphingosines, ceramides, glycosphingolipids, gangliosides and the like. Preferred sources of lipids are milk, vegetal oils and fish oil.
Steenhout, Spec., para. [0057].
Tables 7-10 demonstrate that the formulation further comprises vitamin E.
Therefore, claim 19 was prima facie obvious at the time of filing.
Claim 20 is directed towards: “The composition for oral administration according to claim 15 in a form selected from a capsule, a tablet, a water-soluble powder, a liquid solution, a hydroalcoholic solution and an edible product.”
Steenhout teaches that the composition of their invention is provided in the forms of a liquid solution and water-soluble powder:
The nutritional composition of the present invention may be provided as a ready-to-drink liquid form or in the form of a dry powder to be reconstituted with water, or another water containing liquid (less preferred). Preferably, the nutritional composition is provided in powdered form, and reconstituted by addition of water by the consumer shortly (for example 1 minute to 2 hours) before consumption.
Steenhout, Spec., para. [0019].
Therefore, claim 20 was prima facie obvious at the time of filing.
Given the above teachings, the invention as a whole was prima facie obvious at the time of filing.
Conclusion
No claim is found to be allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HEATHER DAHLIN whose telephone number is (571)270-0436. The examiner can normally be reached 9-5.
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/HEATHER DAHLIN/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
