Ex Parte Tricarico et al

Patent Trial and Appeal Board

Mar 31, 2017

13028176 (P.T.A.B. Mar. 31, 2017)

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.
ALLTE-31385/US-2/ORD 8213
EXAMINER
TARAZANO, DONALD LAWRENCE
ART UNIT PAPER NUMBER
1791
MAIL DATE DELIVERY MODE
13/028,176 02/15/2011
7590119996
Alltech, Inc.
Legal Department - Intellectual Property
3031 Catnip Hill Pike
Nicholasville, KY 40356
Juan M. Tricarico
04/03/2017 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JUAN M. TRICARICO, KARLA. DAWSON, and
JAMES D. JOHNSTON1
Appeal 2016-001607
Application 13/028,176
Technology Center 1700
Before TERRY J. OWENS, RAE LYNN P. GUEST, and
CHRISTOPHER L. OGDEN, Administrative Patent Judges.
OGDEN, Administrative Patent Judge.
DECISION ON APPEAL
Appellants appeal under 35 U.S.C. § 134(a) from the Examiner’s
decision2 finally rejecting claims 14—20, 22, 23, 26, 27, 29, 30, and 32—34 in
the above-identified application. We have jurisdiction pursuant to 35 U.S.C.
§ 6(b).
We AFFIRM.
1 Appellants identify Alltech, Inc. as the real party in interest. Appeal Br. 3,
May 29, 2015.
2 Final Office Action, April 6, 2015 [hereinafter Action]; Examiner’s
Answer, Sept. 23, 2015 [hereinafter Answer],
Appeal 2016-001607
Application 13/028,176
BACKGROUND
Appellants’ invention is directed to methods of administering dietary
supplement compositions, comprising protein derived from yeast3 extract, to
ruminant animals (e.g., cattle). Spec. 1. Independent claim 14 is
representative:
14. A method of increasing amino acid and protein
absorption within the intestine in a ruminant comprising
providing a dietary supplement composition comprising about
6.5-7.8% nitrogen, about 40-50 % crude protein, and about
0.5% to about 1.5%) ammonia on a dry matter basis, wherein
the crude protein is derived from yeast extract, and wherein said
composition is made up of dried particles of 0.100-0.500 mm in
size, wherein the particles have no applied protective barrier,
and administering the dietary supplement composition to the
ruminant under conditions such that the components of the
dietary supplement composition are intestinally available,
wherein the dietary supplement composition increases the
amount of amino acid and protein that escape ruminal
fermentation in the rumen of the ruminant administered the
dietary supplement composition compared to the amount of
amino acid and protein that escape ruminal fermentation in the
rumen of a ruminant not administered the dietary supplement
composition.
Appeal Br. 29 (emphasis of key disputed limitations added). Claims 15 and
26 are also independent, and comprise similar limitations. Id. at 29, 30-31.
The Examiner maintains the rejection of claims 14—20, 22, 23, 26, 27,
29, 30, and 32—34 under 35 U.S.C. § 103(a) as being unpatentable over
3 According to the Specification, “[t]he invention is not limited to any
particular type of yeast or yeast strain.” Spec. 4.
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Application 13/028,176
Linton4 in view of Merry,5 Ferguson,6 Scott,7 Roth,8 Parker,9 10and
Wasserman.10 See Action 2—15.
In the Appeal Brief, Appellants argue claims 14—17, 19, 20, 22, 26, 27,
29, and 32 as a group. See Appeal Br. 9-23. Appellants also separately
argue claim 18, claim 23, and the group of claims 30, 33, and 34. See id. at
23—27. Therefore, consistent with 37 C.F.R. § 41.37(c)(l)(iv) (2016), we
limit our discussion to claims 14, 18, 23, and 30. Claims 15—17, 19, 20, 22,
26, 27, 29, and 32 stand or fall with claim 14, and claims 33 and 34 stand or
fall with claim 30.
DISCUSSION
Claim 14
The Examiner finds that Linton teaches a method of providing an
animal feed supplement that is “a colloidal mixture of spent brewer’s yeast
in water.” Action 3. The Examiner cites Merry, Ferguson, Scott, Roth,
Parker, and Wasserman as teaching the numerical limitations in claim 14.
See id. 4—7.
For example, the Examiner finds that Wasserman teaches microbial
fermentations of Saccharomyces fragilis with nitrogen and crude protein
levels within the range of claim 14; therefore, the Examiner finds “that the
4 Linton et al., U.S. Patent 4,055,667 (issued Oct. 25, 1977).
5 Merry et al., U.S. Patent 3,829,564 (issued Aug. 13, 1974).
6 Ferguson et al., U.S. Patent 3,619,200 (issued Nov. 9, 1971).
7 Scott et al., U.S. Patent 3,925,560 (issued Dec. 9, 1975).
8 Roth et al., U.S. Patent 4,199,561 (issued Apr. 22, 1980).
9 Parker, U.S. Patent 2,921,854 (issued Jan. 19, 1960).
10 Aaron E. Wasserman, Amino Acid and Vitamin Composition of
Saccharomyces Fragilis Grown in Whey, 44 Dairy Sci. 379 (1961).
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Application 13/028,176
ammonia in the prior art would, likewise, fall within the claimed ranges.”
Id. at 7. According to the Examiner, Wasserman teaches compositions
containing brewer’s yeast in which nitrogen values are 7.8—8.9%, and
teaches that crude protein levels may be obtained by multiplying the
nitrogen values by 6.25; thus, Wasserman teaches a crude protein range from
48.75—55.6%. Id. at 6—7 (citing Wasserman 381 & Tbl. 1). Because
Wasserman “use[s] the same type of yeast, brewer’s yeast, and since the
crude protein and nitrogen ranges of the prior art and the claimed invention
[are] the same or overlapping or touching,” the Examiner finds that “the
ammonia in the prior art[] would, likewise, fall within the claimed ranges.”
Id. at 7.
Appellants argue that the Examiner erred in using Wasserman because
the nitrogen values that the Examiner relied on are for “whole cell
preparations” rather than for yeast extracts. See Appeal Br. 13—14 (citing
Wasserman 381). Appellants contrast the whole cell preparation nitrogen
values with material 2, an extract of S. fragilis with a nitrogen content of
9.58%, which would correspond to a protein content of 60% (9.59x6.25).
See id. at 14. Appellants argue that the material 2 values are higher than the
corresponding whole cell value for S. fragilis corresponding to material 1
(showing 7.97% nitrogen, which would correspond to 7.97x6.25=49.8%
protein) and are outside the range of claim 14. See id. at 13—14.
We do not find these arguments persuasive of reversible error. To the
extent that whole cell nitrogen results may vary for S. fragilis based on
whether the sample is a whole cell sample or an extract, Appellants have not
shown how this would affect the Examiner’s findings regarding brewer’s
yeast in both Wasserman and Linton. The Examiner finds that Linton
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Application 13/028,176
discloses a protein content of about 37% for a supplement based on brewer’s
yeast. See Action 3 (citing Linton 12:10—55). The Specification does not
define the term “about,” and we find nothing in the Specification that is
inconsistent with interpreting the crude protein range in claim 14 to include
about 37% protein. Thus, based on the preponderance of the evidence on
this record, we determine that the broadest reasonable interpretation of the
phrase “about 40-50% crude protein,” consistent with the Specification,
includes about 37%.
We also note that Wasserman teaches that “[t]he total nitrogen
contents of the yeast will vary” based on factors such as the choice of media.
See Wasserman 383. For example, Wasserman states that “A frag ills
growing in whey alone may have a nitrogen content of 4.9%, whereas in the
media containing 1% (NFL^SCL, the growing cells may contain 8.2% N.”
Id. Thus, Wasserman teaches a broader range of total nitrogen content for S.
fragilis than just the two values measured for materials 1 and 2. This
broader range substantially overlaps the range in claim 14, which does not
specify the conditions under which the yeast is grown.
Appellants also argue that “it is known in the art that ammonia levels
can significantly vary and are not fixed for all brewers’ yeast slurries.”
Appeal Br. 14. As evidence of this, Appellants submit J.D. Steckley et al.,
Brewer’s Yeast Slurry, I. Composition as Affected by Length of Storage,
Temperature, and Chemical Treatment, 62 J. Dairy Sci. 941 (1979)
[hereinafter Steckley]. Appellants argue that Steckley shows that the
ammonia level of yeast slurries increases upon storage unless the slurries are
chilled to such low temperatures as 4 °C during the storage period. Appeal
Br. 14—15 (citing Steckley 943, Fig. 5). Appellants note that Linton teaches
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that yeast slurries should be “stable” for 30 days, including at ambient
temperatures. Id. (citing Linton 2:54—63, 6:24—36, 7:14—17). Thus,
Appellants argue that because of the instability of the ammonia content
during storage, “the nitrogen and crude protein information provided by
Wasserman on brewers’ yeast does not permit any presumptions to be made
about specific ammonia levels that may be inherent to brewers’ yeast in
Linton at the time of administration to a ruminant.” Id. at 15 (citing Par
Pharm., Inc. v. TWIPharms., Inc., 773 F.3d 1186, 1195-96 (Fed. Cir. 2014)).
We do not find these arguments persuasive of reversible error. Claim
14 does not specify any particular storage temperature, or require any
storage period before administration to the animal. It would be within the
scope of claim 14 to administer the supplement to the animal immediately
after preparation or after a period of chilled storage. Although Linton
teaches a benefit for long storage at ambient temperatures, Appellants do not
persuasively argue that Linton teaches away from either immediate
administration or cold storage. As Appellants acknowledge, Steckley
teaches that with no storage time, the ammonia content is 1.5%, and if the
yeast is kept in cold storage, the ammonia content remains low. See Appeal
Br. 14 (citing Steckley 943, Fig. 5).
Next, regarding the claim 14 limitation that “the particles have no
applied protective barrier,” the Examiner finds that “Linton teaches that the
yeast particles are not coated” because it teaches a colloidal mixture of spent
brewer’s yeast in water. Action 8. The Examiner also finds that Merry,
Scott, Ferguson, and Roth teach “that particle size is important in bypassing
the rumen, thus preserving the protein and amino acid[] nutrients in the
yeast.” Id.', see also Answer 16—17. Thus, the Examiner shows that particle
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Application 13/028,176
size, at least in part, performs the function of protecting proteins during
passage through the rumen.
Appellants argue that Linton is silent about whether the particles are
coated or uncoated, and that Merry, Ferguson, Roth, and Scott teach away
from leaving the particles uncoated. See Appeal Br. 16. According to
Appellants, these secondary references teach “that a protective coating is
necessary for the supplements as sized therein to avoid or reduce
degradation of such supplement particles in the rumen.” Id. Appellants
argue that the nutrients can only be protected by the combination of the
protective coating and the small particle size. See id. at 17.
We do not find these arguments persuasive of reversible error. First,
while Linton does not positively disclose that the particles have no
protective coating, Appellants have pointed to no persuasive reason why a
person of ordinary skill in the art would have understood that the particles
are coated, given that Linton gives details about preparing the supplement
but no coating is mentioned. Thus, it was known in the art to use small
particle sized nutrients without a protective coating as claimed.
Second, Linton’s lack of teaching of a protective particle coating
would have suggested to a person of ordinary skill in the art that the coating
was not critical and could be eliminated. See In re Thompson, 545 F.2d
1290, 1294 (CCPA 1976) (eliminating the cost of an additional step would
have been sufficient motivation for doing so). According to Appellants’
Specification, the invention “takes advantage of one or more of the
following’'’ factors in order to ensure that the protein rich supplement can
escape ruminal fermentation and provide effective nutrition for the animal:
1) the composition of the material (e.g., having a specific nitro­
gen and/or amino acid profile; 2) the fine particle size ... of the
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Application 13/028,176
material (e.g., that allows it to partition into the ruminal liquid
fraction; 3) the relatively low fractional rate of degradation of the
material (e.g., 0.175 h_1); and/or 4) the relatively high fractional
rate of liquid outflow from the rumen (e.g., 0.12 h_1).
Spec. 13—14 (emphasis added). However, the Examiner has shown that the
composition and particle size are already present in Linton without the
additional use of a coating, which is a teaching that is consistent with
Appellants’ Specification. The remaining two factors (3 and 4) are not
recited in claim 14. Appellants have not disputed the Examiner’s finding
that Merry, Scott, Roth, and Ferguson teach that small particle size may
result in ready passage through the rumen. See Answer 16—17; Reply 3.
Although Merry, Scott, Roth, and Ferguson teach in favor of particle
coatings, we weigh those teachings against the teachings of Linton, which
includes data, in the absence of a coating, indicating improvements in milk
quality and average daily milk production for dairy cows. See Action 3
(citing Linton 15:1—19); see also In re Young, 927 F.2d 588, 591 (Fed. Cir.
1991) (when there are apparently conflicting teachings, all the references
must be considered for their power to suggest solutions to an artisan of
ordinary skill). Thus, based on the preponderance of the evidence on this
record, we determine that claim 14 simply omits a particle coating which the
prior art teaches is not necessary when there is a small particle size.
Appellants also argue that the Specification demonstrates unexpected
results over the prior art. See Appeal Br. 20—23 (citing Examples 1 and 2;
Figs. 3, 7). According to Appellants, the Examples demonstrate
that increases in energy-corrected milk (ECM) production, fat-
corrected milk (FCM) production, milk fat content, milk yield,
and protein yield were obtained in dairy cattle fed the inventive
dietary supplement composition as compared to the control (no
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Application 13/028,176
supplement, basal diet only), while not affecting dry matter in­
take or blood metabolites BHBA and NEFA.
Id. at 20-21 (citing Spec. 25—26, 31, Figs. 3, 7). Appellants argue that
Example 2 further “shows that the unexpected improvements were achieved
using the supplement composition even though a protein source in the basal
diet amount had been correspondingly reduced.” Id. at 22.
We do not find Appellants’ evidence persuasive of unexpected results.
Such evidence must be commensurate with the scope of the claims. See In
re Peterson, 315 F.3d 1325, 1330—31 (Fed. Cir. 2003). However, the data
from the two examples cited by Appellants does not show that the effect is
unique to the particle size, ammonia content, the absence of a protective
barrier, or any other particular limitations in claim 14. Further, “when
unexpected results are used as evidence of nonobviousness, the results must
be shown to be unexpected compared with the closest prior art.” In re
Baxter TravenolLabs., 952 F.2d 388, 392 (Fed. Cir. 1991). The Examples
only compare the results to feed with no supplements, which is not sufficient
to show an unexpected improvement over the use of any of the prior art
supplements.
For the above reasons, we find no reversible error in the Examiner’s
decision to reject 14, and we affirm the Examiner’s rejection. For the same
reasons, we affirm the rejection of claims 15—17, 19, 20, 22, 26, 27, 29, and
32.
Claim 18
Claim 18 requires that “the dietary supplement composition is
administered to the ruminant to provide 1.5%—2.5% of the ruminant’s total
daily dry matter intake.” Appeal Br. 30. The Examiner finds that “[o]ne of
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ordinary skill in the art would recognize that the average dairy cow
consumes at least about 13 kg dm [dry matter] per day.” Action 9. Based on
this, the Examiner calculates that in Linton, “the maximum contribution of
yeast to the dry matter consumed per day is about 8%.” Id. (citing Linton
3:13—15, 8:30—31, 15:12—16). Alternatively, the Examiner calculates that in
Linton, there would be 0.3—1.7% yeast in the feed per day. Id.
Appellants argue that the Examiner’s value of 13 kg dry matter per
day is too low, and cites Appellants’ Specification for a value of 23 kg dry
matter per day. See Appeal Br. 24. Based on that higher value, Appellants
argue that the percent of the supplement in the ruminant’s daily dry matter
intake as taught by Linton would be outside the scope of claim 18. See id. at
24—25. Appellants also argue that “the yeast in Linton’s supplement is used
in combination with other kinds of nutrients,” and therefore, “the increased
milk production indicated at column 15, lines 4—7 of Linton should not be
attributed solely to the yeast component.” Id. at 25.
We do not find these arguments persuasive of reversible error. The
Specification uses 23 kg of dry matter per day as an example for calculating
the amount of dietary supplement composition intake. Spec. 5. However,
the Specification does not state that this amount of dry matter is typical for a
cow, and Appellants do not point to any persuasive evidence that the animals
in Linton would have been fed at that higher rate, feed rates likely vary and
Appellants have no shown that the Examiner’s finding is erroneous or
untenable.
As to Appellants’ argument that all of Linton’s increased milk
production cannot be attributed solely to the yeast component, Appellants
have not explained how this would alter the Examiner’s calculation of the
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Application 13/028,176
amount of yeast in the ruminant’s total daily dry matter intake, so as to take
it outside the scope of claim 18. Thus, we find no reversible error in the
Examiner’s rejection of claim 18.
Claim 23
Claim 23 requires that the “crude protein contains about 40-45%
soluble protein and about 55—60% insoluble protein.” Appeal Br. 30. The
Examiner finds that Wasserman teaches a ratio of soluble to insoluble
protein of 45:55, calculated from the total and combined extractable amino
acid content in Wasserman’s Table 2. Action 10.
Appellants argue that “Wasserman states that the protein fraction was
not pure protein, and that the results were affected by the presence of
extraneous nonprotein nitrogen and carbohydrate compounds.” Appeal Br.
26 (citing Wasserman 382,11. 3—14, 383,11. 20-27). Thus, Appellants argue
that the soluble to insoluble ratio cannot be calculated from Table 2 of
Wasserman. See id.
We do not find this argument persuasive of reversible error. To the
extent that the raw numbers in Table 2 of Wasserman may be affected by
other nitrogen sources in the sample, Appellants have not pointed to any
persuasive evidence or reason why this would affect the ratio of soluble to
insoluble protein such that the supplement falls outside the scope of claim
23. Thus, we find no reversible error in the Examiner’s rejection of claim
23.
Claim 30
Claim 30 requires that “the composition is made up of dried particles
of 0.100-0.250 mm in size.” Appeal Br. 31. The Examiner cites Merry,
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Application 13/028,176
Ferguson, Scott, and Roth as teaching particles with the size of 0.1 to 1 mm.
See Action 12—14. Because this range overlaps that of claim 30, the
Examiner determines that a prima facie case of obviousness has been
established. See id. The Examiner also cites Parker as teaching particles
“on the order of 4—20 microns in diameter.” Id. at 12 (citing Parker 1:31—
35).11
Appellants argue that the particles in Parker are not the final product,
and that they are later aggregated to produce larger aggregate particles. See
Appeal Br. 27. Despite this,12 Appellants do not point to evidence to rebut
the Examiner’s prima facie case of obviousness based on the overlapping
particle size ranges taught by Merry, Ferguson, Scott, and Roth. See Appeal
Br. 27. Consequently, Appellants’ arguments do not persuade us that the
Examiner reversibly erred in rejecting claim 30. For the same reasons, we
find no reversible error in the Examiner’s rejection of claims 33 and 34.
11 We further note that Linton teaches a particle size of 325 mesh (44
microns or 0.044 mm), which is significantly smaller than the recited
particle size. See Linton 13:54. Appellants have shown no criticality to the
claimed particles size range, particularly to the lower end of the claimed
particle size range and, to the contrary, specifically indicates that the particle
size ranges are not critical. See Spec. 5:2—5 (describing a size as small as
0.0625 mm and stating that “larger and smaller particles sizes may also be
used”).
12 We note that Parker teaches a final product size of 150-60 mesh (about 0.1
to 0.25 mm), with most of the products having a 60 mesh size (0.25 mm),
falling squarely within the range recited in claim 30. See Parker 4:59-65,
5:10-15.
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DECISION
The Examiner’s decision is affirmed.
No time period for taking any subsequent action in connection with
this appeal maybe extended. See 37 C.F.R. § 1.136(a)(l)(iv) (2016).
AFFIRMED
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