DSM IP ASSETS B.V.Download PDFPatent Trials and Appeals BoardMar 1, 20212020001414 (P.T.A.B. Mar. 1, 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. 15/481,332 04/06/2017 Elger FUNDA BHD-4662-3392 6598 23117 7590 03/01/2021 NIXON & VANDERHYE, PC 901 NORTH GLEBE ROAD, 11TH FLOOR ARLINGTON, VA 22203 EXAMINER PRAKASH, SUBBALAKSHMI ART UNIT PAPER NUMBER 1793 NOTIFICATION DATE DELIVERY MODE 03/01/2021 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): PTOMAIL@nixonvan.com pair_nixon@firsttofile.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte ELGER FUNDA and KARIN LEUTHARDT Appeal 2020-001414 Application 15/481,332 Technology Center 1700 Before JEFFREY B. ROBERTSON, N. WHITNEY WILSON, and JANE E. INGLESE, Administrative Patent Judges. WILSON, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s September 28, 2018 decision to finally reject claims 1–6 and 8– 10 (“Final Act.”). We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 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 DSM IP Assets BV (Appeal Br. 2). Appeal 2020-001414 Application 15/481,332 2 CLAIMED SUBJECT MATTER Appellant’s disclosure is directed to a process for preparing a dry powder of probiotic-containing beadlets (Appeal Br. 4). The process includes the steps of (a) forming an aqueous solution of at least one probiotic compound and at least one starch or starch derivative, and (b) converting the solution into a dry powder by spray drying (Spec. 3). The claimed process has a number of specific steps and is said to be a practical and effective way to obtain such dry formulations which allows for the production of beadlets having a high amount of water-dispersible probiotic bacteria (e.g., an amount of 40 wt.%–85 wt.%, based on the total weight of the beadlets) with good overall properties. Claim 1, reproduced below from the Claims Appendix, is illustrative of the claimed subject matter: 1. A process for preparing a dry powder of probiotic-containing beadlets comprising the steps of: (a) forming an aqueous probiotic-containing solution consisting of: (i) at least one probiotic in an amount of 40 wt.%–85 wt.%, based on the total weight of the beadlets, and (ii) at least one starch and/or starch derivative, and thereafter (b) converting the aqueous probiotic-containing solution into a dry powder of probiotic-containing beadlets by spray drying the probiotic-containing solution into a fluidized bed of a collecting powder to form beadlets comprising the at least one probiotic, wherein step (b) is practiced by the steps of: (b1) dehumidifying hot atomizing air to a water content of less than about 3 g/kg to obtain hot dehumidified atomizing air; (b2) atomizing the aqueous probiotic-containing solution into a spray zone of a spraying tower at a solution temperature of from about 15°C to about 80°C with the hot dehumidified Appeal 2020-001414 Application 15/481,332 3 atomizing air at a temperature sufficient to provide a spray zone temperature of about 60°C to about 120°C; while (b3) fluidizing the fluidized bed of the collecting powder within a bottom of the spraying tower with cold fluidizing air at a temperature of between 5°C to 20°C at a ratio of hot atomizing air flow to cold fluidizing air flow in a range of 1:8 to 1:4 to achieve a temperature of the fluidized bed of the collecting powder of between about 5°C to 20°C, (b4) controlling the temperature of the fluidized bed of the collecting powder by controlling the supply and temperature of the cold fluidizing air, and (b5) covering the beadlets by a powder coating layer comprised of at least one coating material selected from the group consisting of starches, calcium silicate, calcium aluminum silicate and tri-calcium phosphate so that the beadlets comprise at least 5 wt.%, based on the total weight of the beadlets, of the powder coating layer. REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Runge et al. US 7,037,708 B1 May 2, 2006 Sanguansri et al. US 2007/0122397 A1 May 31, 2007 Yano et al.2 JP 02-086766 A March 27, 1990 Schaffner WO 2004/062382 A1 July 29, 2004 Trophardy WO 2007/135583 A2 November 29, 2007 REJECTION Claims 1–6 and 8–10 are rejected under 35 U.S.C. § 103(a) as unpatentable over Sanguansri in view of Yano and Runge, and further in view of Schaffner and Trophardy (Final Act. 2). 2 Yano is in Japanese. The Board, the Examiner, and Appellant each make reference to the English-language Abstract of record. Appeal 2020-001414 Application 15/481,332 4 DISCUSSION Appellant argues the claims together (see Appeal Brief 6–10). Accordingly, our analysis will focus on the rejection of independent claim 1. The remaining claims will stand or fall with claim 1. The Examiner’s findings supporting the rejection are set forth at pages 2–4 of the Final Action. The Examiner finds that Sanguansri discloses a process for preparing beadlets comprising a probiotic compound by forming an aqueous solution of the probiotic compound and a starch, and converting the solution into a powder by spray drying (Final Act. 2, citing Sanguansri ¶¶ 28, 32, 33, and 35). The Examiner relies on Yano to teach the claimed load of probiotic on the beadlets (40 wt.% to 85 wt.%), and determines that having this amount of probiotic on the beads would have been obvious because a person of skill in the art would have wanted a high load of probiotic to reduce the level of carrier starch and calorie content (Final Act. 3). The Examiner relies on Runge to teach the claimed spray drying conditions (Final Act. 3), Schaffner to teach the details of the fluidized bed post drying step (Final Act. 4), and Trophardy to teach the powder coating step (Final Act. 4). Appellant first argues that the evidence of record does not support the Examiner’s finding that Yano teaches the preparation of a spray dried powder comprising over 70% active probiotics (Appeal Br. 7–8). Appellant contends that Yano states that its treating solution contains 70% or more probiotic, but that there is no indication that the beadlets resulting from drying that solution contain such a high content of probiotic (Appeal Br. 8). Appellant’s argument is not persuasive of reversible error. The Examiner finds that Sanguansri discloses a process for making beadlets Appeal 2020-001414 Application 15/481,332 5 containing probiotic and a starch, while Yano discloses producing a spray dried culture in solid form with low levels of carrier compounds (Ans. 7). Appellant does not dispute these findings. The Examiner further finds that a person of ordinary skill in the art preferring a high load of probiotics in a powder to reduce the level of carrier starch, and hence caloric content, would be motivated to include a high load of probiotics in Sanguansri’s system with a reasonable expectation of success because both references are directed to a solid form of probiotics dried with starch (id.). Appellant does not dispute these findings either and, therefore, does not demonstrate reversible error in them. In re Jung, 637 F.3d 1356, 1365 (Fed. Cir. 2011) (“[I]t has long been the Board’s practice to require an applicant to identify the alleged error in the examiner’s rejections”) (citing Ex parte Frye, Appeal 2009-006013, at 9-10, 2010 WL 889747 (BPAI Feb 16, 2010) (precedential) (“The panel then reviews the obviousness rejection for error based upon the issued identified by appellant, and in light of the arguments and evidence produced thereon.”)). Next, Appellant argues that Runge and Schaffner are improperly combined because Runge is directed towards the preparation of dry microorganisms, while Schaffner is directed to particular spray drying conditions to form beadlets of fat soluble substances (i.e. not microorganisms) (Appeal Br. 8). Therefore, according to Appellant, a person of skill in the art would not consider that a process for forming beadlets of fat soluble substances as disclosed by Schaffner would or could be employed to form beadlets comprised of microorganisms as disclosed by Runge (id.). Appeal 2020-001414 Application 15/481,332 6 This argument is also not persuasive. Appellant has not meaningfully addressed, and therefore has not shown error in, the Examiner’s explanation (Ans. 8–9) that Runge and Schaffner disclose overlapping conditions for drying temperature-sensitive materials and, therefore, could have been reasonably combined by a person of skill in the art. With regards to Trophardy, Appellant argues that Trophardy teaches that its spray drying process occurs at high temperatures because its components are not sensitive to heat and using high temperatures allows for faster water evaporation and a shorter drying time (Appeal Br. 9–10). Appellant contends that it was surprising that it could employ a spray drying process at lower temperatures (to take into account the heat-sensitive probiotics) and yet still produce powder coated beadlets which are not sticky (Appeal Br. 10). This argument is not persuasive because, as noted by the Examiner (Ans. 9), temperature conditions in spray drying beadlets in Trophardy and the physical nature of the encapsulant are not relevant to the coating step as coating occurs after spray drying, and the air temperature in the fluidized bed where coating occurs is at lower temperatures in the range of 20°C to 100°C. For the foregoing reasons, we determine that Appellant has not demonstrated reversible error in the rejection. Appeal 2020-001414 Application 15/481,332 7 CONCLUSION In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1–6, 8–10 103 Sanguansri, Yano, Runge, Schaffner, Trophardy 1–6, 8–10 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 Copy with citationCopy as parenthetical citation