NESTEC S.A.Download PDFPatent Trials and Appeals BoardAug 13, 20212020006635 (P.T.A.B. Aug. 13, 2021) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 16/061,121 06/11/2018 Nora Schneider 3712036-03122 7528 29157 7590 08/13/2021 K&L Gates LLP-Nestec S.A. P.O. Box 1135 Chicago, IL 60690 EXAMINER GEMBEH, SHIRLEY V ART UNIT PAPER NUMBER 1615 NOTIFICATION DATE DELIVERY MODE 08/13/2021 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): USpatentmail@klgates.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte NORA SCHNEIDER, JONAS HAUSER, SEAN DEONI, TAMAS BARTFAI, and JONATHAN O'REGAN Appeal 2020-006635 Application 16/061,121 Technology Center 1600 Before ERIC B. GRIMES, JEFFREY N. FREDMAN, and RACHEL H. TOWNSEND, Administrative Patent Judges. TOWNSEND, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims to a method to reduce a risk of or mitigate sub-optimal de novo myelination trajectory in a formula fed infant up to 12 months of age as being obvious and for obviousness-type double patenting. We have jurisdiction under 35 U.S.C. § 6(b). 1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R. § 1.42(a). Appellant identifies the real party in interest as Société des Produits Nestlé S.A. (Appeal Br. 2). Appeal 2020-006635 Application 16/061,121 2 We REVERSE the obviousness rejection, but AFFIRM the obviousness-type double patenting rejections. STATEMENT OF THE CASE “[B]rain structure, in particular the amount and/or spatial distribution of myelin throughout the brain, [] affects brain connectivity e.g.[,] via what pathway and how quickly and efficiently, messages in the form of neural impulses are communicated within the brain and in particular between different brain regions.” (Spec. 2.) Infant formula is used as an alternative to mother’s milk. (Spec. 1.) “However, studies have shown that infant formula does not always induce identical effects on the body as mother’s milk.” (Id.) According to Appellant’s Specification: In a recent study it was demonstrated that the brain structure, in particular the amount and/or temporal-spatial distribution of myelinated matter throughout the brain, []of exclusively breastfed infants can differ from infants fed infant formula. (Id. at 1.) Appellant’s Specification indicates: there is a need to find ways to promote, support or optimise de novo myelination, in particular the de novo myelination trajectory, and/or brain structure, in particular the amount and/or spatial distribution of myelinated matter throughout the brain, and/or brain connectivity in a subject, in particular a formula fed subject. (Id. at 2.) Appellant’s invention is directed at the use of a composition to support de novo myelination trajectory in a formula fed infant. (Id.) Claims 1, 6–9, 12, 19, and 27 are on appeal. Claim 1, reproduced below, is illustrative of the claimed subject matter: Appeal 2020-006635 Application 16/061,121 3 1. A method to reduce a risk of or mitigate sub-optimal de novo myelination trajectory in a formula fed infant up to 12 months of age, the method comprising administering to the formula fed infant a synthetic nutritional composition comprising sphingomyelin in an amount greater than 300 mg/kg dry weight of the synthetic nutritional composition. The prior art relied upon by the Examiner is: Name Reference Date Rueda et al. US 2008/0003330 A1 Jan. 3, 2008 Fleith et al. US 2012/0171178 A1 July 5, 2012 James Farquharson et al. Effect of diet on the fatty acid composition of the major phospholipids of infant cerebral cortex, 72 Archives of Disease in Childhood, 198–203 1995 The following rejections are before us on review: Claims 1, 6–9, 12, 19, and 272 under 35 U.S.C. § 103 as being unpatentable over Rueda, Fleith, and Farquharson. Claims 1, 6–9, 12, and 19 provisionally under the judicially created doctrine of obviousness-type double patenting over claims of the following 2 The Examiner’s rejection identifies claim 20 as being rejected. However, prior to the final rejection, claim 20 had been canceled by amendment dated January 10, 2020 and claim 27 was added as a new claim. We understand the Examiner’s rejection to have inadvertently referenced claim 20, instead of claim 27. Appeal 2020-006635 Application 16/061,121 4 copending applications in view of Rueda: 16/061,099, 16/061,063, 16/061,061, and 16/061,047.3 DISCUSSION A. Claim 1 The Examiner found that Rueda teaches administering infant formula that contain phospholipids to infants between 0 and 12 months promotes brain development, accelerates neural migration and cognitive development in the infant. (Final Action 4 (citing Rueda Abstr.).) The Examiner further found that Rueda teaches “the preferred phospholipids include sphingomyelin,” among others and that the “[m]ost preferred are combinations of . . . five phospholipids[, sphingomyelin, phosphatidyl ethanolamine, phosphatidyl choline, phosphatidyl inositol, and phosphatidyl serine,] especially such combinations in which sphingomyelin represents at least 20% by weight of total phospholipids.” (Id. (citing Rueda ¶ 51).) The Examiner found, however, that Rueda does not teach the claimed sphingomyelin concentration of an amount greater than 300 mg/kg. (Id.) The Examiner found that Fleith “teaches a method supporting improving cognitive [performance] in a child,” by “administering phospholipid” which “will promote or optimize de novo myelination and/or brain structure.” (Final Action 5 (citing Fleith ¶¶ 22, 53).) The Examiner 3 Additional provisional non-statutory obviousness rejections were made over claims in copending applications 16/061,106 and 15/103,424 in view of Rueda. However, those applications have been abandoned and thus the rejections have been obviated. We further note that the Examiner did not include claim 27 in these rejections. This would appear to be an inadvertent error in light of the claims pending in the related applications. Appeal 2020-006635 Application 16/061,121 5 found that Fleith “teaches the composition is an infant formula or growing up milk.” (Id. (citing Fleith ¶ 42).) The Examiner noted that, Fleith teaches that in addition to including the vitamin, folic acid; the minerals, iron, zinc, and calcium; and, the fatty acids, docosahexanoic acid and arachidonic acid, the milk includes sphingomyelins at between 20 and 220 mg/100g dry matter. (Id. (citing Fleith ¶¶ 78 (sphingomyelin).) The Examiner further found that Fleith teaches a particular composition where sphingomyelin is included in an amount that is higher than 300 mg/kg. (Id. (citing Fleith Table 7).) The Examiner determined that it would have been obvious “to include the composition of Fleith” to “expand the teachings of Rueda” in order “to reduce a risk of de novo myelination trajectory with a reasonable expectation of success because Rueda recognizes that their formula promotes brain development, accelerate[s] neural migration, and cognitive development in the infants upon administration.” (Id. at 5–6.) The Examiner indicated that the risk reduction would “necessarily occur” by administering the composition because Appellant’s claimed method only requires that single step. (Id. at 6.)4 “[T]he examiner bears the initial burden, on review of the prior art or on any other ground, of presenting a prima facie case of unpatentability.” In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). We conclude that the Examiner has failed to establish a prima facie case because we disagree that there is an objective teaching from the prior art or asserted by the Examiner 4 The Examiner only relies on Farquharson for teaching that one would compare formulation of an infant formula to human breast milk. (Final Action 4–5.) Appeal 2020-006635 Application 16/061,121 6 to be knowledge generally available to one of ordinary skill in the art that would lead one to feed an infant greater than 300 mg/kg dry weight of a nutritional composition of sphingomyelin as required by the claims. It is true that Fleith teaches a composition that “provides nutrients useful to contribute to the development of the brain and its proper functioning” (Fleith ¶ 41), noting that the fatty acid DHA is important in order to develop the brain (id. ¶ 54, 55) as is iron (id. ¶ 67) and vitamin D (id. ¶ 74) whereas sphingomyelin is noted to be important in brain functioning (id. ¶ 78). However, as Appellant explained, Fleith teaches that the “growing up milk” is for use with children three to six years old, not an infant formula as the Examiner asserted. (Appeal Br. 7; see, e.g., Fleith, Abstr. ¶¶ 22, 42.) The Examiner has provided no evidence that the composition of an infant formula and a nutritional drink for a three to six year old would necessarily be expected to include the same ingredients in the same amounts. Appellant, on the other hand, has established that Fleith does not consider the two formulations to be the same and that the nutritional needs of infants and children are different. (See Fleith ¶¶ 2–4; Appeal Br. 7.) Furthermore, Fleith teaches that the sphingomyelin is “preferably provided as a natural component of milk, in particular cow’s milk, the latter being preferably used for the preparation of the composition.” (Fleith ¶ 78; see also id. ¶ 80 (“With respect to the nutrients iodine, sphingomyelin and sialic acid, these nutrients are not specifically added to the nutritional composition, but are present due to their presence in milk components, in particular, whole milk, skimmed milk and/or buttermilk, for example.”).) Infants are preferably not given cow’s milk. Thus, we do not agree with the Examiner that one of ordinary skill in the art Appeal 2020-006635 Application 16/061,121 7 would have been motivated to combine the composition of table 7 of Fleith, with its sphingomyelin amount at more than 300 mg/kg, with the infant formula composition of Rueda. Moreover, we do not find that there would have been motivation from Fleith in general to include sphingomyelin at greater than 300 mg/kg in the Rueda composition. Despite Fleith teaching that sphingomyelin is found in myelin and its function in propagating nerve electrical signals, it does not provide a reason that one would expect the range taught to be useful in a nutrition formulation for a child between the ages of 3 and 6 to assist in proper brain functioning, i.e., between 20 mg–200 mg/100 g of dry weight of the nutritional composition (Fleith ¶ 78), to be the same amounts necessary or useful for an infant. Nor does Fleith provide any direction to select an amount of greater than 30 mg/100 g of dry weight of the nutritional component from that range for use with infants.5 In fact, Fleith teaches with respect to sphingomyelin included as a nutrient in the formulation for children ages 3 to 6 that: the exact amounts are subject to fluctuations, which are dependent on the origin of the milk in terms of the animal from which it is harvested (cow, goat, etc[.]), from the geographical origin, and also from the season. The values given herein are 5 Although Rueda teaches that there is a need for infant formulas to contain the natural ingredients found in human milk (Rueda ¶ 6) and is directed to infant formulas “with select concentrations and types of those compounds inherently found in human milk” (Id. ¶ 7), the Examiner has not established that human breast milk is known to have at least 30 mg/100 g (i.e., 300 mg/kg) of sphingomyelin. We are aware of prior art that indicates that the amount of sphingomyelin in postpartum human breast milk is between 4.7 and 12.8 mg/100 g. See, e.g., Francesca Giuffrida et al., Quantification of Phospholipids Classes in Human Milk, 48 Lipids 1051–1058, 1056 (2013). Appeal 2020-006635 Application 16/061,121 8 thus approximations and may be considered as medium to long term averages. (Fleith ¶ 80.) Moreover, we also disagree with the Examiner’s position that one of ordinary skill in the art would have had a reasonable expectation that sphingomyelin in the amounts used in Fleith would result in a reduction in a risk of sub-optimal de novo myelination trajectory. Rueda, although describing phospholipids generally as having a positive effect on neuroblast migration (Rueda ¶ 11–13), does not describe any particular function of sphingomyelin in its formulation, much less in myelination. Although Fleith teaches that “sphingomyelin is a component of the myelin sheath” (Fleith ¶ 78), it does not indicate that sphingomyelin provided in formulations for ingestion by 3 to 6 year old children affects myelination itself. Rather, Fleith describes the sphingomyelin as assisting in propagation of nerve electrical signals. (Fleith ¶ 78.) Farquharson, which teaches “[m]yelination . . . proceeds rapidly after birth,” indicates that fatty acids from human milk or infant formula help synthesize “the complex hydrocarbon structures necessary for the creation of neurotransmitter membranes,” (Farquharson 198) but does not discuss sphingomyelin or sphingolipids. Indeed, all that is provided is an analysis of cerebral cortex phosphatidylcholine, phosphatidylethanolamine, phosphatidylserine and the associated fatty acids of infants fed human or formula milk in the first months of life. (Id. at 199–203.) Thus, Farquharson does not make up for the deficiencies noted above. Thus, for the foregoing reasons, we do not affirm the Examiner’s rejection of claims 1, 6–9, 12, 19, and 27 as being obvious from Rueda, Fleith, and Farquharson. Appeal 2020-006635 Application 16/061,121 9 B. Nonstatutory obviousness double patenting rejections The Examiner provisionally rejected claims 1, 6–9, 12, and 19 under the judicially created doctrine of obviousness-type double patenting over claims of the following copending applications in view of Rueda: 16/061,099, 16/061,063, 16/061,061, 16/061,047. We note that Application 16/061,099 has been allowed and thus the rejection is no longer provisional. Appellant does not contest the Examiner’s rejection and Appellant also has not filed terminal disclaimers in this application to obviate the obviousness-type double patenting rejections. Therefore, we summarily affirm the Examiner’s obviousness-type double patenting rejections. Hyatt v. Dudas, 551 F.3d 1307, 1314 (Fed. Cir. 2008) (“When the appellant fails to contest a ground of rejection to the Board . . . the Board may treat any argument with respect to that ground of rejection as waived.”). DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 6–9, 12, 19, 27 103 Rueda, Fleith, Farquharson 1, 6–9, 12, 19, 27 1, 6–9, 12, 19 Nonstatutory Double Patenting 1, 6–9, 12, 19 Overall Outcome 1, 6–9, 12, 19, 27 Appeal 2020-006635 Application 16/061,121 10 TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED-IN-PART Copy with citationCopy as parenthetical citation