Ex Parte Nash et al

Patent Trial and Appeal Board

Dec 22, 2016

10775557 (P.T.A.B. Dec. 22, 2016)

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.
10/775,557 02/10/2004 Peter Nash C101.12-0016 1455
27367 7590 12/22/2016
WESTMAN CHAMPLIN & KOEHLER, P.A.
SUITE 1400
900 SECOND AVENUE SOUTH
MINNEAPOLIS, MN 55402
EXAMINER
HINES, JANA A
ART UNIT PAPER NUMBER
1645
MAIL DATE DELIVERY MODE
12/22/2016 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 PETER NASH and BRADLEY M. MITTENESS
Appeal 2015-006795
Application 10/775,557
Technology Center 1600
Before RICHARD M. LEBOVITZ, JEFFREY N. FREDMAN, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This appeal involves claims directed to a method of decreasing
respiratory illness in animals comprising administering whole eggs contents
to the respiratory tract. The Examiner rejected the claims as obvious under
35 U.S.C. § 103(a). We have jurisdiction under 35 U.S.C. § 134. The
obviousness rejections are reversed.
STATEMENT OF CASE
Claims 61—66 and 73—81 stand finally rejected by the Examiner over
six grounds of rejection as set forth in the Final Rejection (“Final Rej.”)
Appeal 2015-006795
Application 10/775,557
(Apr. 3, 2014). All six grounds1 rely on the combination of Stolle2 and
Greenblatt3 to teach the claimed steps of “inhibiting the ability of microbial
organisms causing respiratory illnesses to adhere and multiply in the
animals’ respiratory tract” by administering whole egg contents “into the
respiratory tract of the animal to produce a mist that coats the nasopharynx
of the respiratory tract.” The whole egg contents are administered nasally
(“a mist that coats the nasopharynx”) to prevent microbial organisms
causing respiratory illness in the animal to adhere “to the mucous
membranes and bronchi and alveolar cells of the animals’ respiratory tract.”
All the rejections in this appeal turn on the question of whether it
would have been obvious to have carried out these steps based on the
teachings in Stolle and Greenblatt. Consequently, we confine our discussion
to these two publications.
CLAIM
Claim 61, the only independent claim on appeal, reads as follows:
61. A method of decreasing respiratory illnesses in animals
comprising:
inhibiting the ability of microbial organisms causing
respiratory illnesses to adhere and multiply in the animals’
respiratory tract, wherein the inhibition is generated by an egg
mixture comprising whole egg contents separated from the egg
shells and produced in eggs laid by female birds [,] the birds
inoculated with an organism mixture comprising one or more
microbial organisms causing respiratory illnesses, wherein the
egg contents comprise adherence inhibiting material and
1 Final Rej. 6, 13, 15, 17, 19, and 23. A rejection under 35 U.S.C. § 112,
first paragraph (pre-AIA) was made in the Final Rejection, but subsequently
deemed overcome by the Examiner.
2 U.S. Pat. No. 4,748,018, patented May 31, 1988.
3 U.S. Publ. Pat. App. 2002/0012666 Al, publ. Jan. 31, 2002.
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Application 10/775,557
wherein the egg mixture is administered into the respiratory
tract of the animal to produce a mist that coats the nasopharynx
of the respiratory tract and prevents the microbial organisms
causing respiratory illnesses from adhering to the mucous
membranes and bronchi and alveolar cells of the animals’
respiratory tract.
CLAIM INTERPRETATION
We begin with the interpretation of “egg mixture comprising whole
eggs contents separated from the egg shells.”
The Specification explains that birds accumulate antibodies in eggs as
they are formed. Spec. 123. “Once immunized, the hen layers the unique
IgY types immunoglobulins in the yolk while depositing the common
chicken IgM and IgA immunoglobulins in the albumin.” Id. The
Specification discloses that the “albumin helps add resistance to the whole
egg preparations and helps protect the avian antibodies.” Id. The
Specification also teaches that the “albumin, IgM and IgA immunoglobulins
increase binding in the mucous tissue of the respiratory tract of the antibody
containing material which provides longer sustaining effect of the antibody
containing material.” Id. The Specification further teaches that “[bjatches
of eggs from predetermined groups of chickens are cracked, the contents are
separated from the shells and mixed and preferable pasteurized to eliminate
potential pathogenic microorganism from the chicken and thus reduce
potential contamination.” Id. 125. The batches can be blended with other
egg batches. Id. Additives may also be added. Id. The Specification
teaches:
The eggs will be collected and material from the whole cracked
egg will be mixed in the proper concentration with a carrier
mixture such as molasses, soy oil, DMSO, PBS buffer and
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Application 10/775,557
Vitamin E solution. This solution is optimized so it can be
sprayed, squirted, injected intra-nasally, gelled, or used on top
feed and in lick tubs. . . . The preferred method is by direct
intra-nasal injection with a spray using IT dose per nostril or a
combination of direct nasal spray plus top feed, lick tub, squirt
applicators.
Id. 126.
Example 12 of the Specification describes “Stock Production Whole
Egg Reagents” involving removing the shell from whole eggs and testing the
egg content for activity. Id. at p. 18—19.
Based on these teachings, including the advantages of albumin and
yolk from a whole egg, we interpret the claimed “egg mixture comprising
whole eggs contents separated from the egg shells” to mean whole eggs to
which additives have optionally been added, but without purification or
enrichment of the antibodies present in the whole eggs. This mixture is
administered intra-nasally without purification or enrichment of the
antibodies present in the whole eggs.
REJECTION
The Examiner found that Stolle describes feeding a mammal a whole
egg mixture having an enhanced titer against an antigen. Final Rej. 7—9.
The Examiner stated that Stolle does not teach which antigens can be used
for decreasing respiratory illness in animals or administration of the egg
mixture by respiratory aerosolization (“a mist that coats the nasopharynx of
the respiratory tract”) as required by claim 61. Id. at 9. The Examiner found
that Greenblatt describes “administering to said animal an effective amount
of an egg product, wherein the egg product is the whole egg and the egg
product is obtained from an egg-producing animal which has been
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hyperimmunized with an immunogenic vaccine.” Id. Further, the Examiner
found that Greenblatt teaches administering its vaccine intranasally, leading
the Examiner to conclude that Greenblatt “clearly teach[es] intranasal
administration of whole eggs contents.” Id.
Upon review of the disclosures of Stolle and Greenblatt, we conclude
that the Examiner’s findings that these publications disclose or suggest “an
egg mixture” administered into the respiratory tract of the animal to produce
a mist that coats the nasopharynx of the respiratory, where the egg mixture
comprises “whole egg contents separated from the egg shells and produced
in eggs laid by female birds the birds inoculated with an organism mixture
comprising one or more microbial organisms causing respiratory illnesses”
is not supported by a preponderance of the evidence.
Stolle describes administering whole eggs to a mammal to make it
tolerant to the avian antibody protein. Stolle, Abstract. The reason for this
step is to avoid serum sickness, anaphylactic shock, and allergic reactions
caused by the foreign avian proteins when the antibody is subsequently
administered to the mammal. Id. at col. 2,11. 57—68, col. 3,11. 6—24.
Stolle teaches:
In order to develop a tolerance for avian antibody protein in a
mammal, material having a significant, tolerance-inducing
amount of antibody titer against the antigen obtained from the
food product of a domesticated fowl immunized against the
antigen is fed the mammal until the mammal develops
substantial tolerance to the antibody. Normally, this is
accomplished by providing a diet containing egg material. . .
Id. at col. 5,11. 44—53.
The material fed to the mammal should be normal eggs
or may have an enhanced titer against the given antigen. The
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material can either be whole eggs, or fractions thereof, such as
the egg yolk, where most avian antibodies tend to concentrate.
Id. at col. 6,11. 4—8.
After the mammal is made tolerant to the avian antibody by feeding it
egg material, including whole eggs, Stolle teaches that “purified antibody in
the administration stage of the invention” is provided to the mammal. Id. at
col. 8,11. 29—35. While Stolle describes other modes of administration, such
as oral, intraperitoneal or parenteral, these routes are for antibodies
“obtained from serum or egg products” in the conventional ways in which
mammals are immunized against antigens. Id. at col. 4,11. 47—55. The
evidence does not support a finding that Stolle teaches using such
administration routes for whole egg contents as found by the Examiner.
In sum, the whole egg administration of Stolle has a different purpose
than the claimed purpose of decreasing respiratory illness in animals
comprising administering the egg mixture comprising whole egg contents to
animals to inhibit “the ability of microbial organisms causing respiratory
illnesses to adhere and multiply, in the animals’ respiratory tract.” In Stolle,
eggs are fed to the animals to produce tolerance to the antibodies in it to
avoid serum sickness, anaphylactic shock, and allergic reactions; in the
claims, eggs are administered to decrease respiratory illness. Thus, while
Stolle does describe whole egg administration, it is not to decrease
respiratory illness and the Examiner did not establish that Stolle’s whole egg
feeding would inhibit “the ability of microbial organisms causing respiratory
illnesses to adhere and multiply in the animals’ respiratory tract” as recited
in the claims. The Examiner also did not establish that eggs administered
for Stolle’s purpose would be administered by one of ordinary skill in the art
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“into the respiratory tract of the animal to produce a mist that coats the
nasopharynx of the respiratory tract.”
Greenblatt describes increasing weight gain in both healthy and sick
individuals comprising administering a hyperimmune egg to a subject in
need of weight gain. Greenblatt, Abstract. Greenblatt teaches that the
hyperimmune egg product is “provided as a spray dried egg powder and is
obtained from laying hens vaccinated with a panel of human enteric
pathogens.” Id. 149. The Examiner found that Greenblatt describes
administering the whole egg product intranasally. Ans. 9. However, this
finding is not supported by Greenblatt. Greenblatt teaches:
Finally, it is generally known in the art that the yolk and/or
white fractions contain the agent or agents responsible for the
beneficial properties observed and referred to above. Those
having ordinary skill in the art would clearly recognize that
further separation could provide more potent fractions or
elimination of undesirable components, and would allow for
other modes of administration such as administering egg
productparenterally, subcutaneously, intravenously,
intramuscularly, intraperitoneally, intranasally, orally or
topically. Such further separation will provide for the ability to
make encapsulated products and pharmaceutical compositions
with said egg or fraction thereof.
Greenblatt 172 (emphasis added).
Thus, as pointed out by Appellants, when Greenblatt describes
administering egg product by “other modes of administration such as . . .
intranasally,” Greenblatt describes performing “further separation” on the
egg. For this reason, the Examiner’s statement that “Greenblatt clearly
teach[es] intranasal administration of whole eggs contents” (Final Rej. 9) is
not supported by a preponderance of the evidence.
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Based on these express disclosures, we conclude that the Examiner’s
determination that claim 61 would have been obvious to one of ordinary
skill in the art based on Stolle, Greenblatt, and the other cited publications is
not supported by the evidence.
To summarize, Stolle describes administering whole egg products to
induce tolerance to avian antibodies which in subsequent steps are
administered in a purified form to mammals to immunize them.
Consequently, the Examiner did not establish that Stolle suggests
administering whole eggs to a mammal by routes other than feeding to
immunize it against an antigen. Greenblatt administers whole eggs by
feeding for weight gain. When Greenblatt discloses intranasal
administration, it limits that intranasal administration to products resulting
from separations of the egg product. The claims, as we have interpreted
them, exclude further separation steps performed on the whole eggs
contents. Because neither Stolle nor Greenblatt describe or suggest an egg
mixture comprising whole egg contents administered “into the respiratory
tract of the animal to produce a mist that coats the nasopharynx of the
respiratory,” we are compelled to reverse to the rejection of claim 61, and
claims 62—66 and 73—81 which depend from it.
REVERSED
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