DSM IP ASSETS B.V.

Patent Trials and Appeals Board

Mar 1, 2021

2020001414 (P.T.A.B. Mar. 1, 2021)

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
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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.
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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
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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.).
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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.

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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