Braun, Marcel et al.

Patent Trials and Appeals Board

Jun 25, 2020

13379185 - (D) (P.T.A.B. Jun. 25, 2020)

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.
13/379,185 03/16/2012 Marcel Braun 3712036-01473 4872
29157 7590 06/25/2020
K&L Gates LLP-Nestec S.A.
P.O. Box 1135
Chicago, IL 60690
EXAMINER
PRAKASH, SUBBALAKSHMI
ART UNIT PAPER NUMBER
1793
NOTIFICATION DATE DELIVERY MODE
06/25/2020 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):
USpatentmail@klgates.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte MARCEL BRAUN and CAROLINE NIEDERREITER

Appeal 2019-004652
Application 13/379,185
Technology Center 1700
____________

Before ROMULO H. DELMENDO, BEVERLY A. FRANKLIN, and
MONTÉ T. SQUIRE, Administrative Patent Judges.

DELMENDO, Administrative Patent Judge.

DECISION ON APPEAL
The Appellant1 appeals under 35 U.S.C. § 134(a) from the Primary
Examiner’s final decision to reject claims 1, 4–6, 9, and 27–31.2 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. The Appellant identifies “Nestec S.A.” as the real party in
interest (Appeal Brief filed November 8, 2018 (“Appeal Br.”) at 2).
2 See Appeal Br. 4–10; Reply Brief filed May 21, 2019 (“Reply Br.”) at
2–5; Final Office Action entered August 8, 2018 (“Final Act.”) at 2–8;
Examiner’s Answer entered March 22, 2019 (“Ans.”) at 3–8.
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I. BACKGROUND
The subject matter on appeal relates to a process for manufacturing a
milk powder composition in which lactase is stabilized such that the
symptoms of gastro-intestinal intolerance in mammals caused by lactose are
alleviated (Specification filed December 19, 2011 (“Spec.”) 1, ll. 3–16; 8, ll.
5–8). Representative claim 1 is reproduced from the Claims Appendix to the
Appeal Brief, as follows:
1. A process for the manufacture of a milk powder
composition comprising 5-70% lactose and 0.05-0.5% lactase
based on dry weight, the process comprising:
mixing, a lactase solution consisting of water and lactase
in an amount corresponding to a lactase activity of 500-5000
IU/100 g powder, with a milk composition; and
spray-drying the mixture to form the milk powder
composition, the drying step occurring within 0.1 to 120 minutes
from the mixing of the lactase with the milk composition in the
presence of water, and an outlet temperature of the spray-drying
being 72-75°C.
(Appeal Br. 11 (emphasis added)).
II. REJECTION ON APPEAL
On appeal, the Examiner maintains a rejection under pre-AIA 35
U.S.C. § 103(a) of claims 1, 4–6, 9, and 27–31 as unpatentable over
Vasiljevic et al.3 (“Vasiljevic”), Clark et al.4 (“Clark”), and Enzyme

3 T. Vasiljevic & P. Jelen, Retention of β-Galactosidase Activity in Crude
Cellular Extracts from Lactobacillus delbrueckii ssp. Bulgaricus 11842
Upon Drying, 56 INT’L J. DAIRY TECH. 111–16 (2003).
4 US 6,835,402 B1, issued December 28, 2004.
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Development Corporation: A Buyer’s Guide to Enzymes5 (“Buyer’s Guide”)
(Ans. 3–8; Final Act. 2–8).
III. DISCUSSION
1. Grouping of Claims
The Appellant relies on the same arguments for all claims on appeal,
focusing primarily on independent claim 1 (Appeal Br. 5–10). Although
claim 28 is discussed under a separate subheading (id. at 9), the arguments
are the same as those offered for claim 1. Therefore, we decide this appeal
on the basis of claim 1, which we designate as representative pursuant to 37
C.F.R. § 41.37(c)(1)(iv). Claims 4–6, 9, and 27–31 stand or fall with
claim 1.
2. The Examiner’s Position
The Examiner finds that Vasiljevic describes a method (i.e., a process)
for preparing a stabilized lactase preparation by spray-drying a milk
composition containing added lactase (Ans. 3–4; Final Act. 3–4). Regarding
the contested claim limitation highlighted in reproduced claim 1 above (“an
outlet temperature of the spray-drying being 72–75°C”), the Examiner
acknowledges that Vasiljevic’s process differs from the claimed subject
matter in that it controls the spray-drying outlet temperature to 45, 55, or
65°C (Ans. 5; Final Act. 4). The Examiner asserts, however, that:
[i]t is well established in the art that the outlet temperature in
spray drying is determined by a number of factors, the most
important being the required residual moisture content of the
powder, the temperature and humidity of the drying air, total
solids content of the feed and the design of the dryer; and the
inlet temperature is selected such that the temperature of powder

5 Publication date unknown.
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particles do not exceed the point where protein denaturation
which results in a loss in enzyme activity occurs.
(Id.). Based on these findings, the Examiner concludes that “it would have
been obvious to one of ordinary skill in the art to adjust such conditions in
spray drying to suit the water content in the feed and the desired moisture
content of the final product, the added adjuncts and the type of lactase
enzyme used” (id.). According to the Examiner,
it would have been obvious to one of ordinary skill in the art to
have experimentally optimized these conditions to obtain a dried
product with a lower residual moisture content for example, in
the range of 2%-5%, by employing higher temperatures than
those applied in Vasiljevic in spray drying by the use of
appropriate adjuncts and an appropriate lactase preparation as a
residual moisture content in this range is reported in the prior art
. . . to be conducive to retention of lactase activity in the dried
product during prolonged storage.
(Ans. 8).
The Examiner also finds that Vasiljevic does not disclose a specific
lactase content of 0.05–0.5% in the dry milk composition, as required by
claim 1 (Ans. 6; Final Act. 5). To resolve this difference, the Examiner
relies on Clark and concludes that a person having ordinary skill in the art
would have arrived at such contents (id.). As for Buyer’s Guide, the
Examiner merely relies on this reference as evidentiary support for the
presence of a standardizing agent, also known as a carrier or filler (Ans. 4;
Final Act. 4).
3. The Appellant’s Contentions
The Appellant contends that the Examiner’s rejection is flawed
because Vasiljevic teaches away from “an outlet temperature of the spray-
drying being 72–75°C” as specified in claim 1 (Appeal Br. 6). According to
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the Appellant, Vasiljevic teaches spray-drying at outlet temperatures of
45–65°C or freeze-drying, but that spray-drying at 65°C “substantially
lowered” β-galactosidase activity in whey and skim milk (id. (citing
Vasiljevic 112 (Fig. 1), 115). The Appellant argues that, therefore,
Vasiljevic would have dissuaded a person having ordinary skill in the art
from substantially increasing the outlet temperature of the spray-drying to
72–75°C, as required by claim 1 (id.). In the Appellant’s view, “one would
not have been led to substantially exceed the outlet temperature of Vasiljevic
to achieve the claimed process . . . unless the outlet temperature is
recognized as a result-effective variable and the optimization is purposeful”
(id. at 7) (emphasis omitted).
As for Clark and Buyer’s Guide, the Appellant argues that these
references do not remedy the perceived deficiencies of Vasiljevic relative to
claim 1’s subject matter (id. at 7–8). According to the Appellant, Clark is
silent regarding spray-drying and is not reasonably pertinent to the particular
problem addressed by the Inventors (id. at 7). Similarly, the Appellant
argues that Buyer’s Guide does not disclose or suggest spray-drying (id. at
8).
4. Opinion
The Appellant’s arguments fail to identify reversible error in the
Examiner’s rejection. In re Jung, 637 F.3d 1356, 1365 (Fed. Cir. 2011).
Vasiljevic discloses the effect of various spray-drying outlet
temperatures (45, 55, or 65°C) or freeze drying on the activity retention of
β-galactosidase extract from Lactobacillus delbrueckii ssp. bulgaricus 11842
(Vasiljevic Abstract, 113–15), which is undisputedly a lactase (Ans. 3).
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Specifically, the effects are summarized in Vasiljevic’s Figure 1, reproduced
as follows:

Vasiljevic’s Figure 1 reproduced above shows the effects of adding skim
milk components, whey, or skim milk on the activity retention of crude
β-galactosidase extract from Lactobacillus delbrueckii ssp. Bulgaricus
11842 at three different spray-drying outlet temperatures (45, 55, or 65°C)
and freeze-drying (Vasiljevic 113).
As shown in Vasiljevic’s Figure 1, the activity retentions of crude
β-galactosidase extract at a spray-drying temperature of 65°C appear to be
well over 40% for skim milk and over 50% for whey. Thus, although
Vasiljevic states that a spray-drying outlet temperature of “65°C
substantially lowered the retained β-galactosidase activity in whey and skim
milk CCEs [crude cellular extracts] as compared to freeze-dried
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preparations” (id. at 115, left column (emphasis added)), the reference does
not say that a spray-drying outlet temperature of 65°C is an absolute upper
limit for spray-drying outlet temperature or that temperatures at or even
somewhat above this level (e.g., 72°C) provide unsuitable results or
otherwise render the prior art process inoperable. In re Fulton, 391 F.3d
1195, 1200 (Fed. Cir. 2004) (“[C]ase law does not require that a particular
combination must be the preferred, or the most desirable, combination
described in the prior art in order to provide [the] motivation [or reason] for
the current invention.”); In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994)
(“Even reading [the prior art]’s description as discouraging use of epoxy for
this purpose, Gurley asserted no discovery beyond what was known to the
art.”).
Given the general guidance in Vasiljevic—i.e., activity retention may
be affected by different enzyme origin, the presence of mineral salts, final
moisture content achieved, drying conditions such as selection of drying
adjuncts, and processing parameters used during drying (Vasiljevic
114–115), a person having ordinary skill in the art would have determined,
through routine experimentation, the outer limits of the operating parameters
(e.g., spray-drying outlet temperature) that provide successful, useful results.
Indeed, as the Examiner aptly finds (Ans. 8), Vasiljevic encourages such
experimentation (Vasiljevic 115, right column (“Further investigation is
required to elucidate the putative effect of lactose on the activity retention of
β-galactosidase in CCE preparations and to clarify the influence of different
drying adjuncts, as well as the processing parameters used during drying.”)).
In re Applied Materials, Inc., 692 F.3d 1289, 1295 (Fed. Cir. 2012) (quoting
In re Aller, 220 F.2d 454, 456 (CCPA 1955) (“[W]here the general
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conditions of a claim are disclosed in the prior art, it is not inventive to
discover the optimum or workable ranges by routine experimentation.”)).
Thus, contrary to the Appellant’s allegation, Vasiljevic explicitly
informs one skilled in the relevant art that spray-drying outlet temperature is
a result-effective variable. Applied Materials, 692 F.3d at 1297 (“A
recognition in the prior art that a property is affected by the variable is
sufficient to find the variable result-effective.”).
The Appellant’s arguments that Clark and Buyer’s Guide do not
disclose spray-drying is ineffective, because the Examiner’s rejection is
based on the collective teachings found in the prior art, including Vasiljevic,
which teaches spray-drying. In re Merck & Co., Inc., 800 F.2d 1091, 1097
(Fed. Cir. 1986) (“Non-obviousness cannot be established by attacking
references individually where the rejection is based upon the teachings of a
combination of references.”).
Finally, we discern no persuasive merit in the Appellant’s cursory
argument that Clark does not address the problem with which the Inventors
were concerned. That approach was criticized by the Supreme Court of the
Unites States, and, therefore, is no longer dispositive in an obviousness
analysis. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 420 (2007) (“The first
error of the Court of Appeals in this case was to foreclose this [obviousness]
reasoning by holding that . . . patent examiners should look only to the
problem the patentee was trying to solve.”).
For these reasons, and those well-stated by the Examiner, we uphold
the Examiner’s rejection.

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IV. CONCLUSION
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 4–6, 9,
27–31
103(a) Vasiljevic, Clark,
Buyer’s Guide
1, 4–6, 9,
27–31

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED