Ex Parte Nash et al

Board of Patent Appeals and Interferences

Mar 26, 2007

09616843 (B.P.A.I. Mar. 26, 2007)

The opinion in support of the decision being entered today was not written
for publication and is not binding precedent of the Board.

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
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Ex parte PETER NASH,
JOHN W. ROSEVEAR, and
DONALD L. ROBINSON,
__________

Appeal 2006-3378
Application 09/616,8431
Technology Center 1600
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ON BRIEF
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Before ADAMS, GRIMES, and LINCK, Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This appeal involves claims to methods of decreasing the waste of
dietary protein in food animals. The examiner has rejected the claims as
obvious. We have jurisdiction under 35 U.S.C. § 134. We reverse.

1 This application a divisional parent of Serial No. 10/025,567, which is
pending before us as Appeal No. 2006-2575, with similar issues.
Appeal No. 2006-3378
Application No. 09/616,843

BACKGROUND
The bacteria Peptostreptococcus anaerobius, Clostridium
aminophilum, and Clostridium sticklandii are among organisms “responsible
for wasting up to 25 percent of the protein in cattle diets. This is a loss of as
much as $25 billion annually to cattle producers . . . .” (Specification 2.)
The Specification discloses that these organisms act by degrading
protein consumed by the host to ammonia. (Id.) The ammonia is then
“converted to urea by the liver and kidneys and thus lost to the host when
excreted as urine. These deleterious organisms also compete with beneficial
organisms which the host needs for the efficient utilization of ammonia.”
(Id.)
Antibodies to these deleterious organisms can be produced by
inoculating female birds with the organisms, and then harvesting the eggs
from the inoculated birds. (Id. at 6.) “The total antibody-containing
contents of the eggs are [then] separated from the shells and dried.” (Id.)
The dried antibody-containing egg material may be mixed with animal feed.
(Id. at 6-7.)
The Specification discloses that orally administering the dried
antibody-containing egg preparations will inhibit the “ability of colony-
forming protein-wasting organisms, such as P. anaerobius, C. sticklandii
and C. aminophilum . . . to adhere in the rumen or intestinal tracts of food
animals and thus reduce their ability to multiply, grow and colonize.” (Id. at
8 (underlining omitted).)
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Appeal No. 2006-3378
Application No. 09/616,843

DISCUSSION
1. CLAIM CONSTRUCTION
Claims 14-16, 19-24, and 27-32 are pending and on appeal.
(Answer 2.) Claim 14 is representative and reads as follows:
14. A method of promoting the growth of food animals by
decreasing the waste of dietary protein caused by the presence of a
protein-wasting immunogen in the rumen or intestinal tracts of food
animals by inhibiting the ability of the immunogen to adhere to the
rumen or intestinal tracts of food animals to reduce the ability of the
immunogen to multiply, said protein-wasting immunogen is P antigen
from P.anaerobius, said method comprising:
A. Inoculating female birds, in or about to reach their egg laying
age, with P antigen from P.anaerobius;
B. Allowing a period of time sufficient to permit the production in
the birds and eggs laid by the birds of antibody in the eggs to P
antigen from P.anaerobius, said antibody in the eggs including IgY
immunoglobulins in the yolks of the eggs and IgM and IgA
immunoglobulins in the albumin of the eggs;
C. Harvesting the eggs laid by the birds;
D. Separating the entire contents of said harvested eggs from the
eggshells;
E. Drying said separated entire contents of said harvested eggs;
F. Distributing said dried entire contents of said harvested eggs
substantially uniformly in animal feed or water to provide
antibody-containing animal feed or water; and
G. Supplying the resulting dried entire contents of said harvested
eggs and animal feed or water to food animals whereby the IgY
immunoglobulins bind to the protein-wasting immunogens, to inhibit
adherence of the protein-wasting immunogen in the intestinal tracts of
the animals thereby promoting the growth of the animals.

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Appeal No. 2006-3378
Application No. 09/616,843

Thus, claim 14 is directed to a process of promoting the growth of
food animals by inhibiting the waste of protein within the animals’ digestive
tract. The claim recites the steps of making an antibody-containing dried
egg composition, distributing the composition in animal feed or water, and
then supplying the feed or water to the animal.
The antibody-containing composition is made by inoculating birds in
or about to reach egg laying age with P antigen from P. anaerobius, waiting
for the birds to produce IgY, IgM, and IgA antibodies to the antigen,
harvesting the birds’ eggs, separating the entire contents of the eggs from the
shells, and drying the separated entire contents of the eggs. The antibody-
containing dried egg composition is then fed to the animals.
The Specification discloses that P antigen can be prepared by
culturing P. anaerobius in broth, recovering the culture by low speed
centrifugation, removing whole cells by centrifugation, and recovering the P
antigen as the supernatant from the separated whole cells. (Specification
17.)
Claims 15 and 16 recite essentially the same processes as claim 14.
However, instead of P antigen from P. anaerobius, claims 15 and 16 recite
that the birds are immunized with CS antigen from Clostridium sticklandii
and CA antigen from Clostridium aminophilum, respectively. The
Specification discloses that these antigens can be prepared by culturing
C. sticklandii or C. aminophilum in broth, recovering the culture by low
speed centrifugation, removing whole cells by centrifugation, and recovering
the CS or CA antigen as the supernatant from the separated whole cells.
(Specification 17-18.)
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Application No. 09/616,843

Thus, the pending claims all recite that the antibody-containing dried
avian egg composition is obtained by inoculating birds with a bacterial
antigen which can be separated from whole cells in culture by
centrifugation.
2. OBVIOUSNESS OF CLAIMS 14-16
Claims 14-16 stand rejected under 35 U.S.C. § 103(a) as being
obvious in view of Tokoro,2 Krause,3 Coleman,4 and Pimentel.5
The Examiner cites Tokoro as disclosing a method having the steps of
inoculating egg laying hens with immunogens such as E. coli, harvesting the
antibody-containing non-shell components of the egg, drying the non-shell
components of the egg by lyophilization or spray drying to form a powder,
and adding the dried powder to animal feed. (Answer 5.) The Examiner
notes that Tokoro discloses that “the method of making bird antibody to any
bacteria of interest is particularly advantageous due the fact that the
procedure is simple, efficient and inexpensive.” (Id.)
The Examiner further notes that Tokoro does not disclose inoculating
hens with P antigen, CS antigen, or CA antigen. (Id. at 5-6.) To meet this
deficiency, the Examiner cites Krause as disclosing that, by converting
amino acids in the rumen to ammonia, P. anaerobius, C. aminophilum, and

2 Tokoro, U.S. Patent, 5,080,895, issued January 14, 1992
3 Krause et al., “An rRNA Approach for Assessing the Role of Obligate
Amino Acid-Fermenting Bacteria in Ruminal Amino Acid Deamination,”
Applied and Environmental Microbiology, Vol. 62, No. 3, pp. 815-821
(1996).
4 Coleman, U.S. Patent, 5,585,098, issued December 17, 1996
5 Pimentel, U.S. Patent 5,741,489, issued April 21, 1998

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Application No. 09/616,843

C. sticklandii waste significant amounts of feed protein in livestock, thereby
reducing the animals’ growth. (Id. at 6.) The Examiner notes that Krause
teaches that the antibiotic monensin lessened certain negative effects of P.
anaerobius and C. sticklandii, but not C. aminophilum. (Id.)
The Examiner cites Coleman as disclosing that egg antibodies
produced against bacteria, or parts thereof, such as the pilus of E. coli, can
inhibit the critical disease-causing step of adhesion of the bacteria to the
digestive tract of hosts, including food animals. (Id. at 7.) The Examiner
notes that Coleman describes a number of advantages of egg antibodies,
including the fact that “there would be no problem with consumption of milk
from dairy cattle treated with egg yolk antibodies, and no mandatory milk-
withholding period, in sharp contrast to antibiotics.” (Id.)
The Examiner cites Pimentel as disclosing that “egg antibodies are
more resistant to degradation by gastric acidity when they are prepared from
whole egg as compared to purified antibodies from the yolk.” (Id.) The
Examiner notes that Pimentel “further teaches that egg antibodies (IgY) are
effective in decreasing the adhesion of enterotoxigenic E. coli onto
enterocytes within the intestinal tract and thereby increasing feed conversion
and body weight gain in food animal such as piglets and calves.” (Id.)
The Examiner concludes that it would have been obvious “to
substitute the immunogen E. coli as taught by [Tokoro] or [Pimentel] for the
immunogens such as P. anaerobius, C. sticklandii, and
C. aminophilium [sic] that are responsible for protein wasting in food
animal[s] as taught by Krause”; to produce antibody-containing eggs to
those organisms by the methods taught in Tokoro, Coleman, and Pimentel;
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Application No. 09/616,843

and to feed the antibody-containing compositions to feed animals “to
prevent the adherence of P. anaerobius, C. sticklandii, or
C. aminophilium [sic] in the intestinal tract of the animal as a method of
promoting the growth of food animal taught by [Tokoro], [Pimentel], Krause
et al and [Coleman].” (Id. at 7-8.)
As motivation for practicing the claimed process the Examiner cites
the teaching in Krause that P. anaerobius, C. sticklandii, and
C. aminophilum are responsible for protein waste in food animals, as well as
the teachings in Tokoro, Coleman, and Pimentel regarding the advantages of
using antibodies from bird eggs to inhibit deleterious microorganisms in the
digestive tracts of food animals. (Id. at 8.)
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the
initial burden of presenting a prima facie case of obviousness. Only if that
burden is met, does the burden of coming forward with evidence or
argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532,
28 USPQ2d 1955, 1956 (Fed. Cir. 1993).
When evaluating claims for obviousness, the examiner must consider
(1) whether the prior art would have suggested to those of
ordinary skill in the art that they should make the claimed
composition or device, or carry out the claimed process; and (2)
whether the prior art would also have revealed that in so
making or carrying out, those of ordinary skill would have had
a reasonable expectation of success.

In re Vaeck, 947 F.2d 488, 493, 20 USPQ2d 1438, 1443 (Fed. Cir. 1991).
A proper § 103 analysis also requires “a searching comparison of the
claimed invention – including all its limitations – with the teaching of the
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prior art.” In re Ochiai, 71 F.3d 1565, 1572, 37 USPQ2d 1127, 1133 (Fed.
Cir. 1995) (emphasis added). Thus, “obviousness requires a suggestion of
all limitations in a claim.” CFMT, Inc. v. Yieldup Intern. Corp., 349 F.3d
1333, 1342, 68 USPQ2d 1940, 1947 (Fed. Cir. 2003) (citing In re Royka,
490 F.2d 981, 985, 180 USPQ 580, 583 (CCPA 1974)).
Appellants contend that the Examiner has not established a prima
facie case of obviousness. (Br. 10-14.) We agree. In our view, the
Examiner has not demonstrated that the references would have suggested
inoculating birds with the P antigen recited in claim 14.
As discussed supra, P antigen is prepared by centrifuging the cultured
whole cells of P. anaerobius and collecting the supernatant. Therefore, as
also discussed supra, we interpret claim 14 to require immunization of birds
with an antigen which has been isolated from whole cells.
We agree with the Examiner that, because Krause identifies P.
anaerobius as causing the waste of dietary protein in food animals, the
reference suggests inoculating birds with cells of the organism, so as to
produce antibodies to the organism in the birds’ eggs. However, we do not
see, and the Examiner does not point to, any evidence suggesting that
immunizing birds with whole cells of P. anaerobius would yield antibody to
P antigen specifically. That is, the record does not contain any evidence
suggesting that immunizing birds with intact cells of the organism would
necessarily result in immunizing with P antigen, as required in claim 14.
Moreover, the Examiner has not shown the cited references would
have suggested to one of ordinary skill in the art seeking to produce
protective antibodies against P. anaerobius that it would have been desirable
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Application No. 09/616,843

to separate the cells of the organism from the culture supernatant, and
inoculate birds with the P antigen-containing culture supernatant rather than
the cells. Nor has the Examiner shown that one of ordinary skill would have
had a reasonable expectation that inoculating birds with the culture
supernatant of P. anaerobius, rather than whole cells, would have yielded
antibodies capable of inhibiting the organism in the digestive tracts of food
animals.
Thus, in our view, the Examiner has not established that one of
ordinary skill would have been motivated to inoculate birds with P antigen
from P. anaerobius, with a reasonable expectation that inoculating birds
with P antigen would have successfully produced antibody capable of
inhibiting P. anaerobius.
Because the Examiner has not demonstrated, and we do not see, how
the references suggest all of the limitations in claim 14, we reverse the
obviousness rejection of claim 14.
As discussed supra, claims 15 and 16, like claim 14, require the
practitioner to inoculate birds with an antigen recovered as a culture
supernatant separated from whole cells. The obviousness analysis applied to
claim 14 therefore applies equally to claims 15 and 16.
Because the Examiner has not shown, and we do not see, how the
cited references suggest inoculating birds with CS antigen as recited in
claim 15, or CA antigen as recited in claim 16, we reverse the obviousness
rejection of claims 15 and 16.
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Appeal No. 2006-3378
Application No. 09/616,843

3. OBVIOUSNESS OF CLAIMS 19-24 AND 27-32
Claims 19-24 and 27-32 stand rejected under 35 U.S.C. § 103(a) as
being obvious in view of Tokoro, Krause, Coleman, and Pimentel, as applied
to claims 14-16, and further in view of Adalsteinsson6 and Betz.7
(Answer 9.)
We reverse this rejection as well.
Each of claims 19-24 and 27-32 recites, or depends from a claim that
recites, the inoculation of a bird with either P antigen, CS antigen, or CA
antigen. As discussed supra, the Examiner has not shown, and we do not
see, where Tokoro, Krause, Coleman, and Pimentel suggest these
limitations. We see nothing in Adalsteinsson, Betz, or the Examiner’s
reasoning, which remedies the deficiencies of Tokoro, Krause, Coleman, and
Pimentel. We therefore reverse the obviousness rejection of claims 19-24
and 27-32.

6 Adalsteinsson et al., U.S. Patent 6,086,878, issued July 11, 2000
7 Betz et al., U.S. Patent 4,166,867, issued September 4, 1979
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Application No. 09/616,843

SUMMARY
Because the Examiner has not established that the cited references
suggest all of the limitations in claims 14-16, 19-24, and 27-32, we reverse
the obviousness rejections of those claims.

REVERSED

Donald E. Adams )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
Eric B. Grimes )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
)
Nancy J. Linck )
Administrative Patent Judge )

EBJ/jlb
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Appeal No. 2006-3378
Application No. 09/616,843

Richard O. Bartz
6750 France Avenue South
Suite 350
Edina, MN 55435
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