Berseth, Carol Lynn. et al.Download PDFPatent Trials and Appeals BoardMay 27, 20202019005180 (P.T.A.B. May. 27, 2020) 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. 13/595,296 08/27/2012 Carol Lynn Berseth 254750.000026 (MJN15220) 2283 6980 7590 05/27/2020 TROUTMAN SANDERS LLP 600 Peachtree St., NE, Suite 3000 Atlanta, GA 402214 EXAMINER MOORE, WALTER A ART UNIT PAPER NUMBER 3619 NOTIFICATION DATE DELIVERY MODE 05/27/2020 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): jim.schutz@troutman.com patents@troutman.com ryan.schneider@troutman.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte CAROL LYNN BERSETH, KELLY WALSH, DEBORAH SCHADE, and ANA CECILIA MUNOZ-ESPADA Appeal 2019-005180 Application 13/595,296 Technology Center 1700 ____________ Before LINDA M. GAUDETTE, KAREN M. HASTINGS, and MICHAEL P. COLAIANNI, Administrative Patent Judges. COLAIANNI, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 27 and 29–39. We have jurisdiction under 35 U.S.C. § 6(b). Oral arguments were heard in this appeal on May 18, 2020. We AFFIRM. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as Mead Johnson Nutrition Company. Appeal Br. 3. Appeal 2019-005180 Application 13/595,296 2 Appellant’s invention is directed to premature infant formula fortifiers that are useful in supplementing premature infant formula (Spec. ¶ 1; Claim 27). Claim 27 is representative of the subject matter on appeal: 27. A premature infant formula fortifier comprising: a protein component, wherein about 14 to 22% of the caloric content of the fortifier is from protein, a fat component, wherein about 30 to about 40% of the caloric content of the fortifier is from fat, a carbohydrate component, and about 100 to about 150 international Units (IU) of vitamin D per 7.5 kcal of the fortifier. Appellant appeals the following rejections: 1. Claims 27 and 29–30 are rejected under 35 U.S.C. § 103 as unpatentable over Barrett-Reis ‘632 (US 2006/0204632 A1, published Sep. 14, 2006) in view of Agostoni (C. Agostoni et al., Enteral Nutrient Supply for Preterm Infants: Commentary From the European Society for Paediatric Gastroenterology, Hepatology, and Nutrition Committee on Nutrition, 50 JPGN 85–91 (2010), Barrett-Reis ‘206 (US 6,294,206 B1, issued Sep. 25, 2001) and Etcheverry (P. Etcheverry et al., Calcium, Zinc, and Iron Bioavailabilities from a Commercial Human Milk Fortifier: A Comparison Study, 87 J. Diary Sci. 3629–3637 (2004). 2. Claims 31 and 33 are rejected under 35 U.S.C. § 103 as unpatentable over Barrett Reis ‘632 in view of Agostini, Barrett- Appeal 2019-005180 Application 13/595,296 3 Reis ‘206, Etcheverry and Euber (US 2008/0286416 A1, published Nov. 20, 2008). 3. Claim 32 is rejected under 35 U.S.C. § 103 as unpatentable over Barrett-Reis ‘632 in view of Agostini, Barrett-Reis ‘206, Etcheverry, Puski (US 2006/0233915 A1, published Oct. 19, 2006). 4. Claim 34 is rejected under 35 U.S.C. § 103 as unpatentable over Barrett-Reis ‘632 in view of Agostini, Barrett-Reis ‘206, Etcheverry, Puski, and Euber. 5. Claim 35 is rejected under 35 U.S.C. § 103 as unpatentable over Barrett-Reis ‘632 in view of Agostini, Barrett-Reis ‘206, Etcheverry, and Wittke (US 2010/0316619 A1, published Dec. 16, 2010). 6. Claim 36 is rejected under 35 U.S.C. § 103 as unpatentable over Barrett Reis ‘632 in view of Agostini, Barrett-Reis ‘206, Etcheverry, Euber, and Janda (US 5,418,010, issued May 23, 1995). 7. Claims 37 and 38 are rejected under 35 U.S.C. § 103 as unpatentable over Barrett-Reis ‘632 in view of Agostini, Barrett- Reis ‘206, Etcheverry, Euber, Janda, and Zimmerman (Michael B. Zimmermann et al., Chapter 7: Encapsulation of Iron and Other Micronutrients for Food Fortification, Michael B. Zimmermann and Erich J. Windhab, 187-188). 8. Claim 39 is rejected under 35 U.S.C. § 103 as unpatentable over Thompson (US 2007/0243290 A1, published Oct. 18, 2007) in view of Sahay (Manisha Sahay et al., Rickets-vitamin D Appeal 2019-005180 Application 13/595,296 4 deficiency and dependency, 16(2) Indian Journal of Endocrinology and Metabolism 164–176 (Mar.-Apr. 2012), and/or Walsh (US 2012/0135103 A1, published May 31m, 2012). Appellant argues claims 27 and 39 separately (Appeal Br. 7–18). Any claim not argued separately will stand or fall with our analysis of claim 27. 37 CFR § 41.39(c). FINDINGS OF FACT & ANALYSIS The Examiner’s findings and conclusions regarding the rejection of claim 27 over Barrett-Reis ‘632 in view of Agostini, Barrett-Reis ‘206, and Etcheverry are located on pages 3– 8 of the Non-Final Action. Appellant argues that the applied references cannot be combined to suggest the claimed subject matter (Appeal Br. 11). Appellant contends that the claims relate to a premature infant formula fortifier to supplement the nutritional value of commercially available premature infant formulas (Appeal Br. 11). Appellant contends that none of the applied references discloses from about 100 to about 150 international units (IU) of vitamin D per 7.5 kcal of formula fortifier (Appeal Br. 12). Appellant argues that Barrett-Reis ‘632 is directed to fortifiers for human milk or other baby formulas (Appeal Br. 12). Appellant contends that Barrett-Reis ‘632 does not teach that the concentration of vitamin D in claim 27 (Appeal Br. 12). Appellant argues that Barrett-Reis ‘632’s vitamin D concentration is 3 IU per 7.5 kcal which is much lower than the concentration required in claim 27 (Appeal Br. 12). Appellant contends that Barrett-Reis ‘632 does not suggest Appeal 2019-005180 Application 13/595,296 5 increasing the amount of vitamin D to a level recited in claim 27 (Appeal Br. 13). Appellant argues that a person of ordinary skill in the art would have understood that the commercially available fortifiers already contain sufficient concentrations of vitamin D (Appeal Br. 13). Appellant argues that Agostoni teaches a recommended vitamin D intake for preterm infants of 800 to 1000 IU/day but is silent about Appellant’s identified problem that commercially available premature infant formulas do not contain the adequate amounts of certain nutrients such as protein and vitamin D (Appeal Br. 13). Appellant argues that Barrett-Reis ‘206 is directed to human milk fortifier, not premature infant formula as claimed and does not teach the claimed amount of vitamin D (Appeal Br. 14). Appellant contends that Etcheverry studies human milk fortifiers that are added to human milk and does not teach adding a fortifier to a commercially available preterm infant formula (Appeal Br. 14). Appellant argues that Etcheverry teaches the importance of supplementing human milk in order to not have to utilize commercially available infant formulas such that there would have been no reason to supplement preterm infant formula based on Etcheverry’s teachings (Appeal Br. 14). Appellant’s arguments attack the references individually instead of addressing what the combined teachings would have suggested to one of ordinary skill in the art. In the present case, the Examiner finds that Barrett- Reis ‘632 does not teach the amount of vitamin D recited in claim 27 (Non- Final Act. 7). The Examiner finds that Agostoni discloses that the major goal of enteral nutrition is to achieve similar foetal growth coupled with satisfactory functional development (Non-final Act. 7). The Examiner finds that Agostoni recommends between 800 to 1000 IU per day of vitamin D, Appeal 2019-005180 Application 13/595,296 6 which Agostoni discloses is important for supporting a large number of physiological processes such as neuromuscular function and bone mineralization (Non-final Act. 7). The Examiner finds that Barrett-Reis ‘206 teaches liquid and powdered forms of milk fortifiers that are added to human milk to meet the nutritional needs of the infant (Non-Final Act. 8). The Examiner finds that Barrett-Reis ‘206 discloses a milk fortifier composition containing 112.5 IU/7.5 kcal vitamin D (Non-Final Act. 8). The Examiner finds that Etcheverry discloses a milk fortifier used to overcome nutrient deficiencies that comprises, inter alia, 150 IU of vitamin D per 7.5 kcal (Non-Final Act. 8). The Examiner concludes that it would have been obvious in light of Barrett-Reis ‘632, Agostoni, Barrett-Reis ‘206 and Etcheverry to produce a composition comprising vitamin D in the amount recited in claim 27 in order to meet the nutritional needs of the infant as suggested by Barrett-Reis ‘632, Etcheverry, and Barrett-Reis ‘206 (Non-Final Act. 8). The Examiner’s stated rejection is based upon what the combined teachings would have suggested to one of ordinary skill in the art regarding the compositional requirement of a fortifier in order to meet the nutritional needs of the infant. See also, Ans. 31. The Examiner provides specific findings that Barrett-Reis ‘206 discloses using amounts of vitamin D within the claimed concentration range in conventional infant milk fortifiers (Non- Final 8). The Examiner finds that Etcheverry and Agostoni further support that it is desirable to use higher amounts of vitamin D to meet the nutritional needs of an infant (Non-Final Act. 7–8; Ans. 31–32). Barrett-Reis ‘632 teaches that the fortifiers may be added to either human milk or other premature infant formulas such that modifying Barrett-Reis ‘632 to include a Appeal 2019-005180 Application 13/595,296 7 vitamin D concentration of 100 to 150 IU per 7.5 kcal of the fortifier would have been obvious (¶ 28; Ans. 29). We agree with the Examiner’s analysis (Ans. 29–31). Specifically, the Examiner finds that the addition of or elimination of ingredients in a recipe fails to provide any patentable distinction to the claimed subject matter because such is considered to be merely a change in proportion that carries forward an original concept of controlling the amount of vitamin D in a fortifier composition (Ans. 30–31; Non-Final Act. 8). We agree that vitamin D is recognized as a result effective variable in the applied art that would have been optimizable to deliver the desired nutrition to a premature infant. We disagree, however, with the Examiner’s determination that the preamble recitation “[a] premature infant formula fortifier” is a statement of intended use and does not patentably distinguish the claimed product from the prior art (Non-Final Act. 3). We agree with Appellant that claim 27 is limited to a premature infant formula fortifier as the claim refers to “the fortifier” in the body of claim 27. Nevertheless, Barrett-Reis ‘632 teaches that the nutritional value of a fortifier may be tailored to a premature infant and added to human milk or other suitable infant formula (¶¶ 22, 28, 66). Barrett-Reis ‘632 recognizes that the human milk fortifier may be added to “other suitable infant formula” and is concerned with preterm infants (¶¶ 22, 28, 66, 68, 92). We agree with the Examiner’s finding that Appellant has not shown any criticality in the claimed vitamin D range (Ans. 29). The Examiner has established that it was known to add vitamin D in concentrations to infant formulas and fortifiers that overlap with the concentration in claim 27 (Ans. 31-32; Non-Final Act. 7–8). The Examiner has established that the claimed Appeal 2019-005180 Application 13/595,296 8 vitamin D concentration would have been an obvious amount to use in fortifier compositions. In other words, we determine that the Examiner has established a prima facie case of obviousness so that the burden shifted to Appellant to rebut the prima facie case. In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). Appellant has not provided any evidence that the claimed concentration of vitamin D is critical or otherwise yields unexpected results (Appeal Br. generally). Appellant argues that Euber and Puski do not teach premature infant formula fortifier (Appeal Br. 15). Appellant contends that Euber and Puski are directed to human milk fortifier or human milk supplement and would not have suggested a vitamin D amount for premature infant formula (Appeal Br. 15). Appellant’s arguments are not persuasive with regard to the rejection of claim 27 because the Examiner does not rely on Euber or Puski to reject the subject matter of claim 27 (Non-Final Act. 3). Rather, Euber is used in the § 103 rejection of claims 31, 33, 34, and 36–38 to teach the pH and use of pectin (Non-Final Act. 11, 13, 15, 17). Puski is used in the § 103 rejection of claim 32 to teach the amount of DHA added to the fortifier (Non-Final Act. 12). Appellant has not separately argued any of these claims. Appellant argues that the Examiner’s finding that the ranges of Barrett-Reis ‘632’s fortifier overlap with the ranges recited in claim 27 is based on unsupported assumptions and does not provide a basis to conclude that the values are indeed taught or suggested by the prior art (Appeal Br. 16). As noted by the Examiner, Appellant’s argument is not supported by any specific challenge to the Examiner’s calculations (Ans. 37). We agree. Appeal 2019-005180 Application 13/595,296 9 Appellant’s argument fails to provide any specific reversible error in the Examiner’s calculations. Regarding claim 39 Appellant argues that neither Thompson nor Walsh teaches or describes an infant formula fortifier, nor suggests combining an infant formula fortifier with a premature infant formula to provide the amount of protein, vitamin D and kilocalories per ounce of composition as recited in claim 39 (Appeal Br. 18). Appellant argues that claim 39 requires that the combination of the fortifier and infant formula results in a composition having a certain level of vitamin D in addition to other features (Reply Br. 7). Appellant contends that the cited art must disclose an infant formula fortifier meeting the requirements of claim 27 in addition to a combination with that fortifier and an infant formula (Reply Br. 7). With regard to the interpretation of claim 39, the Examiner finds that the recited fortifier of claim 27 and an infant formula are two intermediate products that do not patentably distinguish the final product recited in claim 39 (Final Act. 18). We agree. The preamble of claim 39 recites that the composition is formed from the fortifier of claim 27 and a premature infant formula, but once these two compositions are mixed, the resulting composition has the recited protein amount, vitamin D concentration and energy density. In other words, the Examiner correctly interprets claim 39 as a final composition having protein, vitamin D and the recited energy density, regardless of how that composition was formed (Final Act. 18). Claim 39 may be viewed as a product-by-process claim where the final product is formed by the process of mixing the fortifier and infant formula together. As a product-by-process claim patentability is based on the Appeal 2019-005180 Application 13/595,296 10 product limitations implied by the process only. See In re Thorpe, 777 F.2d 695, 698 (Fed. Cir. 1985) (“E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.”). In this case, the Examiner is correct that the end product is merely a composition having the recited protein amount, vitamin D concentration, and energy density. The Examiner makes fact findings and conclusions regarding Thompson, Sahay and Walsh which are not specifically challenged by Appellant (Non-Final Act. 18–21). Appellant’s assertion that the prior art does not teach the subject matter of claim 39 is not sufficient to show reversible error with any of the Examiner’s specific fact findings and conclusions. On this record, we affirm the Examiner’s § 103 rejections (1) to (8). DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 27, 29, 30 103 Barrett-Reis ‘632, Agostoni, Barrett- Reis ‘206, Etcheverry 27, 29, 30 Appeal 2019-005180 Application 13/595,296 11 Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 31, 33 103 Barrett-Reis ‘632, Agostoni, Barrett- Reis ‘206, Etcheverry, Euber 31, 33 32 103 Barrett-Reis ‘632, Agostoni, Barrett- Reis ‘206, Etcheverry, Puski 32 34 103 Barrett-Reis ‘632, Agostoni, Barrett- Reis ‘206, Etcheverry, Puski, Euber 34 35 103 Barrett-Reis ‘632, Agostoni, Barrett- Reis ‘206, Etcheverry, Wittke 35 36 103 Barrett-Reis ‘632, Agostoni, Barrett- Reis ‘206, Etcheverry, Euber, Janda 36 37, 38 103 Barrett-Reis ‘632, Agostoni, Barrett- Reis ‘206, Etcheverry, Euber, Janda, Zimmerman 37, 38 39 103 Thompson, Sahay, Walsh 39 Overall Outcome 27, 29– 39 Appeal 2019-005180 Application 13/595,296 12 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 Copy with citationCopy as parenthetical citation