Ex parte DUTOT

Board of Patent Appeals and Interferences

Jul 29, 1998

07755610 (B.P.A.I. Jul. 29, 1998)

Application for patent filed September 5, 1991. According to1
applicant, this application is a continuation of Application
07/453,359, filed December 19, 1989, now abandoned; which is a
continuation of Application 07/223,120, filed July 22, 1988, now
abandoned. Applicant claims the benefit under 35 U.S.C. § 119 of
French Application 87.10407, filed July 23, 1987.
THIS OPINION WAS NOT WRITTEN FOR PUBLICATION
The opinion in support of the decision being entered today
(1) was not written for publication in a law journal and
(2) is not binding precedent of the Board.
Paper No. 43
UNITED STATES PATENT AND TRADEMARK OFFICE
____________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________
Ex parte GUY DUTOT
____________
Appeal No. 94-0591
Application 07/755,6101
____________
ON BRIEF
____________
Before WINTERS, JOHN D. SMITH, and GRON, Administrative Patent
Judges.
GRON, Administrative Patent Judge.
DECISION ON APPEAL UNDER 35 U.S.C. § 134
Appeal No. 94-0591
Application 07/755,610
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1. Introduction
This is an appeal from an examiner’s rejection of
Claims 1-9, 11, 12 and 16-20, all claims pending in this
application. All claims stand rejected under 35 U.S.C. § 103
over the combined teachings of Bilton, WO 84/02271, published
June 21, 1984; Wruble et al. (Wruble), U.S. 3,085,939, patented
April 16, 1963; and Babayan et al. (Babayan), WO 86/01715,
published March 27, 1986. All claims stand or fall together
(Appellant’s Brief (Br.), p. 3). Independent Claim 1 is
representative of the claimed subject matter and reads:
1. A lipid emulsion suitable for use as a
parenteral or enteral foodstuff, comprising from
5 to 50% by weight, relative to the total weight
of the emulsion, of a lipid phase in water, said
lipid phase consisting essentially of a mixture of
long-chain fatty acids in which 15 to 45% by weight
of the total fatty acids are essential fatty acids,
the essential fatty acids being linoleic acid and
α− linolenic acid.
2. Claim interpretation
The claimed lipid emulsion comprises a lipid phase in water
(5-50% by weight lipids relative to the total weight of the
emulsion), “said lipid phase consisting essentially of a mixture
of long-chain fatty acids” (Claim 1). Of the total fatty acids
present in the lipid phase, 15-45% are selected from the group of
essential fatty acids consisting of linoleic acid and α− linolenic
acid.
Appeal No. 94-0591
Application 07/755,610
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We interpret the phrase “said lipid phase consisting
essentially of a mixture of long-chain fatty acids” in Claim 1 to
close the lipid phase to other fatty acids and/or lipids which
“materially affect the basic and novel characteristics” of the
lipid phase of the claimed lipid emulsion. Atlas Powder Co. v.
E.I. du Pont de Nemours & Co., 750 F.2d 1569, 1574, 224 USPQ 409,
412 (Fed. Cir. 1984); In re Herz, 537 F.2d 549, 551, 190 USPQ
461, 463 (CCPA 1976); and In re Janakirama-Rao, 317 F.2d 951,
954, 137 USPQ 893, 896 (CCPA 1963). Appellant’s specification
describes the basic and novel characteristics of the lipid phase
of the claimed lipid emulsion as follows (Specification (Spec.),
pp. 2-3, bridging para.):
The present invention seeks to provide a
more balanced lipid emulsion having a lower content
of polyunsaturated fatty acids, which, while ensuring
that the essential fatty acid requirements are covered,
has the following advantages:
better utilization of the essential fatty acids
to form their higher derivatives, avoiding the risk of
inhibition of conversion of the fatty acids by excess
substrate,
smaller intake of polyunsaturated fatty acids,
enabling lipid peroxidation to be limited, in particular
in subjects suffering from inflammatory syndromes, with
the production of free radicals.
Based on the specification’s description of the basic and
novel characteristics of the lipid emulsion and the oils
appellant employs to formulate the lipid phase of his lipid
Appeal No. 94-0591
Application 07/755,610
We note here Babayan’s teaching at p. 3, last para., 2
that “[t]he long chain triglycerides may be polyunsaturated
vegetable oils such as, corn oil, peanut oil, safflower oil,
soybean oil, sunflower seed oil, and fish oils. The preferred
long chain triglyceride oils are safflower oil, soybean oil, and
sunflower seed oil.” Consistent with our holding that the “long-
chain fatty acids” of Claim 1 encompass the triglycerides thereof,
appellant stated at page 6, 1st full para., of their Appeal Brief
(emphasis added):
Since Appellant’s invention consists essentially of only
long-chain fatty acids, Babayan teaches away from the
claimed invention. Babayan is specifically directed
to a composition comprising a mixture of medium-chain
triglycerides and long-chain triglycerides. Babayan
requires the use of both medium-chain triglycerides and
long-chain triglycerides to increase protein synthesis
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emulsion, we conclude that the “lipid phase” of the claimed lipid
emulsion is open to fatty acids which are not long-chain fatty
acids and other lipids, including triglycerides of medium-chain
fatty acids, but only in those abnormal amounts that persons
skilled in the art would not expect to find in “oils selected
from apricot, almond, groundnut, avocado, wheat, safflower,
rapeseed, coconut, cottonseed, lupin, maize, hazelnut, walnut,
olive, oenothera, palm, palm-kernel, peach, grape, rice, rye,
sesame, soybean, sunflower, tomato, linseed and citrus oils”
(Spec., p. 3, l. 17-22). See dependent Claim 2. Moreover, we
hold that the “long-chain fatty acids” of which the lipid phase
of the claimed lipid emulsion essentially consists read on long-
chain fatty acids in the form of their triglycerides found in
polyunsaturated vegetable oils (Babayan, p. 3, last para.).2
Appeal No. 94-0591
Application 07/755,610
in subjects undergoing severe metabolic stress. To
the extent that Babayan purportedly discloses the use
of long-chain fatty acids, it teaches away from the
present invention in that it teaches the use of a high
polyunsaturated acid content.
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However, the claimed “lipid emulsion” comprises but 5 to 50%
by weight lipid phase. Accordingly, while the lipid phase is
closed to other components which materially affect its basic and
novel characteristics, the non-lipid phase of the emulsion “does
not exclude additional, unrecited elements.” Moleculon Research
Corp. v. CBS, Inc., 793 F.2d 1261, 1271 n. 6, 229 USPQ 805, 812
n. 6 (Fed. Cir. 1986). The emulsion appellant claims is not only
open to “plant, animal or synthetic phospholipids” (Spec., p. 4,
l. 17-19), “tonicity-regulating agents such as glycerol, glucose,
a polyol or an amino acid” (Spec., p. 5, l. 1-2), “amino acids,
carbohydrates, vitamins, carnitine, trace elements or keto
analogues of amino acids” (Spec., p. 5, l. 3-8), pharmaceuticals,
solvents, and adjuvants (Spec., p. 5, l. 9-13), but also to
unrecited components.
3. Findings
A. Bilton
The object of Bilton’s invention is “to provide a
composition which will enhance the lymphatic absorption of
naturally-occurring essential fatty acids” (Bilton, p. 3, 3rd
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Application 07/755,610
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full para.), more particularly “linolenic acid, di-homo-gamma-
linoleic acid and arachidonic acid . . . [which] have been
shown to be necessary for the tissue biosynthesis of the
prostaglandins, which perform vital hormone-like activities in
the transmission of genetic information in all cells,” “cannot be
manufactured by the body,” and therefore “are essential dietary
components” (Spec., p. 1, 2nd para.). To that end, Bilton
formulates oil-in-water emulsions by (Spec., pp. 4-5, bridging
para.):
. . . emulsifying a vegetable or animal oil rich
in polyunsaturated, long-chain fatty acids with an
emulsifying agent in the presence of one or more
polyhydric alcohol stabilizers, and antibacterial
or antifungal preservatives. Oil-soluble nutrients,
such as the naturally-occurring amino acids, vitamins
and their analogs may also be included in the emulsions,
as well as minor amounts of coloring and flavoring.
Buffers may also be included when necessary.
According to Bilton (Spec., p. 5, 2nd full para.):
The vegetable or animal oil or mixture of oils will make
up the major proportion of the oil phase of the present
emulsions, and preferably will comprise 5-45% by weight
of the entire emulsion, most preferably about 10-30%.
Most pertinent to the invention appellant describes is Bilton’s
description of the animal or vegetable oils useful in his
emulsions. Bilton employs those oils (Spec., p. 5, 1st full
para.; emphasis added):
. . . which contain a high proportion of unsaturated
C -C fatty acids to C -C saturated fatty acids, 12 18 14 18
since it is the polyunsaturated fatty acids which
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Application 07/755,610
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have been implicated in the in vivo biosynthesis of
biologically active prostaglandins. The preferred oils
possess an unsaturated fatty acid to saturated fatty
acid ratio of from 10:1 [to] about 5:1. Preferred
vegetable oils include primrose oil, safflower oil,
sunflower oil, sesame oil, cottonseed oil, etc.
B. Wruble
Wruble describes stable oil-in-water emulsions for oral
administration comprising an edible unsaturated oil and
sitosterol (Wruble, col. 1, lines 11-20). According to Wruble
(Wruble, col. 1, l. 56-61):
In contradistinction to other preparations containing
an edible unsaturated oil and sitosterol, it was found that
the present preparation possesses unexpected stability
and palatability. It was found that averting contact
in the final product between the sitosterol and the oil
provides a superior product. Averting said contact is
accomplished by preparing separately an emulsion of the
oil and an aqueous dispersion of the sitosterol, preferably
utilizing protective colloidal materials and emulsifiers.
With respect to component proportions, Wruble teaches
(Wruble, col. 2, l. 31-36):
The amount of the [edible unsaturated] oil can vary
from about 1 to about 35 percent by volume of the
preparation, with from 22 to about 33 percent preferred.
The amount of sitosterol can vary from about 1 to about
17 percent weight/volume, with from about 10 to about
15 percent preferred.
Wruble defines the term edible unsaturated oils as (Wruble,
col. 2, l. 5-19; emphasis added):
. . . those edible oils containing unsaturated fatty acids.
The unsaturated fatty acids include, for example, oleic
acid (1 double bond), linoleic acid (2 double bonds),
linolenic acid (3 double bonds), moroctic acid (4 double
Appeal No. 94-0591
Application 07/755,610
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bonds) and the like. The edible unsaturated oils include,
for example, olive, palm, cottonseed, peanut, soybean,
sesame, corn, sunflower seed, linseed, rapeseed, sardine,
menhaden, tung, safflower, poppyseed, rice bran, almond,
wheat germ oils, and the like. Oily dispersions of the
unsaturated fatty acids can be used. In the present
preparation it is preferred to use the edible unsaturated
oils having substantial percentages of linoleic acid, for
example, soybean oil, safflower oil, corn oil, sunflower
seed oil, and mixtures thereof.
C. Babayan
Babayan describes “triglyceride preparations for enteral or
parenteral administration to prevent catabolism and to increase
protein synthesis in subjects undergoing severe metabolic stress”
(Babayan, p. 1, 1st para.), i.e., the “invention provides medium
chain and long chain fatty acids chemically synthesized into
structured triglycerides (lipids) for enteral or parenteral
administration as the lipid calorie source” (Babayan, p. 3, 1st
para.; emphasis added). Babayan states (Babayan, p. 3, l. 6, to
p. 4, l. 5):
The structural lipids of this invention are randomly
rearranged mixtures of medium chain triglycerides (MCT)
and long chain triglycerides (LCT). They may be represented
by the following formula,
CH OCOR2 1
\
CH OCOR2 2
/
CH OCOR2 3
wherein R and R may be independently a C to C acid, 1 2 6 12
Appeal No. 94-0591
Application 07/755,610
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or a C to C ’acid, and R may be a C " or C "’ acid. 12 18 3 18 18
Preferably, R may be a C to C acid, and R a C to 1 6 12 2 12
C ’ acid.18
C ’,C " and C "’represent the number of double 18 18 18
bonds in the fatty acid moiety being one, two and three
double bonds respectively.
The medium chain triglycerides may be lauric oils
such as, balassee oil, coconut oil, cohune oil, palm
kernel oil, tucum oil and fractions thereof. The
preferred medium chain triglyceride oil is coconut oil.
The long chain triglycerides may be polyunsaturated
vegetable oils such as, corn oil, peanut oil, safflower
oil, soybean oil, sunflower seed oil, and fish oil. The
preferred long chain triglyceride oils are safflower oil,
soybean oil, and sunflower seed oil.
Preferably, the percent composition of mixtures of
medium chain triglycerides to long chain triglycerides
of this invention may be 70 to 30%, 80 to 20%, 85 to 15%,
or 90 to 10%. The 80 to 20%, and the 85 to 15% mixtures
are most preferred.
4. Discussion
Whether the long-chain fatty acids which form the lipid
phase of the lipid emulsions described by Bilton are present in
the lipid phase as long-chain fatty acids or as triglyceride
derivatives of long-chain fatty acids, the vegetable and animal
oils employed are “rich in polyunsaturated, long-chain fatty
acids” (Bilton, p. 4, final para.). Bilton’s disclosure would
have led persons having ordinary skill in the art away from
emulsions wherein essential fatty acids constitute no more than
15-45% of the total fatty acids in the lipid phase of the lipid
emulsion. Bilton’s “preferred oils possess an unsaturated fatty
Appeal No. 94-0591
Application 07/755,610
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acid to saturated fatty acid ratio of from about 10:1 [to] about
5:1" (Bilton, p. 5, 1st full para.). On the other hand, while
the calorie-rich lipid compositions Babayan describes are
formulated with polyunsaturated vegetable or animal oils
comprising the long-chain triglyceride content found in corn oil,
peanut oil, safflower oil, soybean oil, sunflower seed oil, and
fish oils (Babayan, p. 3) and have a final long-chain fatty acid
triglyceride content 10 to 30% by weight of the total fatty acid
triglyceride content (Babayan, p. 4, 1st para.), Babayan’s
compositions require a high percentage of medium-chain fatty acid
triglycerides in the lipid phase, i.e., Babayan teaches away from
compositions comprising a lipid phase “consisting essentially
of a mixture of long-chain fatty acids” in accordance with
appellant’s claims. Moreover, we find no reasonable suggestion
in the combined prior art teachings of Bilton and Babayan either
to reduce the amount of essential fatty acids in Bilton’s
compositions or to increase the long-chain triglyceride content
in Babayan’s compositions. Accordingly, to sustain the
examiner’s rejection, the suggestion to reduce the amount of
essential fatty acids in the lipid phase of Bilton’s emulsions or
to increase the long-chain triglyceride content and decrease the
medium-chain triglyceride content in the lipid phase of Babayan’s
emulsions must come from the combined teachings of Bilton,
Appeal No. 94-0591
Application 07/755,610
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Babayan and Wruble. However, the examiner has not explained
where Wruble describes an oil-in-water emulsion encompassed by
appellant’s claims or would have reasonably suggested that
persons having ordinary skill in the art make and use a lipid
emulsion appellant claims. Accordingly, on this record, we find
that the combined teachings of Bilton, Wruble and Babayan would
not have led persons having ordinary skill in the art to the
invention appellant claims and must reverse the rejection of all
claims under 35 U.S.C. § 103.
Wruble teaches that the edible unsaturated oils which
constitute the oil phase of his oil-in-water emulsions for oral
administration (Wruble, col. 2, l. 10-14):
include, for example, olive, palm, cottonseed, peanut,
soybean, sesame, corn, sunflower seed, linseed, rapeseed,
sardine, menhaden, tung, safflower, poppyseed, rice bran,
almond, wheat germ oils, and the like.
However, Wruble indicates that oily dispersions may be prepared
from the unsaturated fatty acids apart from the oils (Wruble,
col. 2, l. 14-15). We find that Wruble expresses a distinct
preference for using “edible unsaturated oils having substantial
percentages of linoleic acid, for example, soybean oil, safflower
oil, corn oil, sunflower seed oil, and mixtures thereof” (Wruble,
col. 2, l. 15-19). Combined with the teachings of Bilton and
Babayan with regard to the fatty acid content of the same oils,
we find no reasonable suggestion in Wruble to reduce the amount
Appeal No. 94-0591
Application 07/755,610
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of essential fatty acids in the lipid phase of Bilton’s emulsions
or to increase the long-chain triglyceride content and decrease
the medium-chain triglyceride content in the lipid phase of
Babayan’s emulsions.
We are at a loss to understand why the combined prior art
teachings reasonably would have led persons having ordinary skill
in the art to use a lipid emulsion as a parenteral or enteral
foodstuff which comprises a lipid phase consisting essentially of
long-chain fatty acids in which 15 to 45% by weight of the total
fatty acids are essential fatty acids. It would appear that
absent some reason, incentive, or motivation to reduce the
quantity of high-calorie, essential fatty acids in an enterally
or parenterally deliverable foodstuff composition, persons having
ordinary skill in the art would have been led by the combined
prior art teachings to make and use oil-in-water emulsions
decidedly “rich in” essential fatty acids (Bilton, p. 4, final
para.), i.e., oil-in-water emulsions including “substantial
percentages of” essential fatty acids (Wruble, col. 2, l. 17).
Thus, we reverse the examiner’s rejection of Claims 1-9, 11, 12
and 16-20 under 35 U.S.C. § 103 in view of the combined teachings
of Bilton, Wruble and Babayan.
5. Other issues
Appeal No. 94-0591
Application 07/755,610
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We understand from the specification at p. 3, l. 17-22, and
p. 4, the Table, and dependent Claim 2 on appeal that the lipid
phase of the claimed lipid emulsion “consisting essentially of a
mixture of long-chain fatty acids in which 15 to 45% by weight of
the total fatty acids are essential fatty acids” (Claim 1) may be
prepared simply by mixing together a mixture of “oils selected
from apricot, almond, groundnut, avocado, wheat, safflower,
rapeseed, coconut, cottonseed, lupin, maize, hazelnut, walnut,
olive, oenothera, palm, palm-kernel, peach, grape, rice, rye,
sesame, soybean, sunflower, tomato, linseed and citrus oils”
(Spec., p. 3, l. 17-22; emphasis added). The lipid emulsion to
which Claim 2 is drawn appears to be a lipid emulsion wherein the
“lipid phase comprises a mixture of two or more oils selected
from the groups consisting of apricot, almond, groundnut,
avocado, wheat, safflower, rapeseed, coconut, cottonseed, lupin,
maize, hazelnut, walnut, olive, oenothera, palm, palm-kernel,
peach, grape, rice, rye, sesame, soybean, sunflower, tomato,
linseed and citrus oils” (Claim 2; emphasis added). Considered
in that light, we must remand the case to the examiner (1) to
determine the metes and bounds of the subject matter claimed,
and thereafter, (2) to evaluate the significance of Wruble’s
teaching under 35 U.S.C. § 102. Wruble teaches that the edible
Appeal No. 94-0591
Application 07/755,610
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unsaturated oils useful in formulating his oil-in-water emulsions
also may include (Wruble, col. 2, l. 10-19; emphasis added):
. . . olive, palm, cottonseed, peanut, soybean, sesame,
corn, sunflower seed, linseed, rapeseed, sardine,
menhaden, tung, safflower, poppyseed, rice bran, almond,
wheat germ oils, and the like. Oily dispersions of the
unsaturated fatty acids can be used. In the present
preparation it is preferred to use the edible unsaturated
oils having substantial percentages of linoleic acid, for
example, soybean oil, safflower oil, corn oil, sunflower
seed oil, and mixtures thereof.
The examiner should consider whether Wruble would have
“described” an invention encompassed by Claim 2 on appeal to
a person having ordinary skill in the art within the meaning of
the term in 35 U.S.C. § 102(a) and (b). The examiner should
ascertain in the first instance whether or not Wruble’s
disclosure of mixtures of edible unsaturated oils “having
substantial percentages of linoleic acid” (Wruble, col. 2, l.
17), preferably “soybean oil, safflower oil, corn oil, sunflower
seed oil, and mixtures thereof” (Wruble, col. 2, l. 18-19),
inherently describes “a mixture of long-chain fatty acids in
which 15 to 45% by weight of the total fatty acids are essential
fatty acids” (Claim 1) and accordingly placed an invention within
the scope of appellant’s claims in the possession of the public.
The record is unclear on this issue.
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Application 07/755,610
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In reevaluating the claimed subject matter in light of
Wruble’s disclosure, the examiner may wish to consider the
following:
(1) Claims are to be given their broadest reasonable
interpretation consistent with the description of the invention
in the specification. In re Zletz, 893 F.2d 319, 321, 13 USPQ2d
1320, 1322 (Fed. Cir. 1989).
(2) An examiner should refrain from inquiring whether
claimed subject matter is novel until after having ascertained
what subject matter is being claimed. In re Wilder,
429 F.2d 447, 450, 166 USPQ 545, 548 (CCPA 1970).
(3) Where the claimed subject matter and the prior art
subject matter reasonably appear to be identical or substantially
the same, it is proper to find a prima facie case of inherency.
In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-434; In re
Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
(4) All disclosures of the prior art must be considered,
including nonpreferred embodiments. In re Lamberti, 545 F.2d
747, 750, 192 USPQ 278, 280 (CCPA 1976).
(5) Specific preferences in the prior art are material to
an analysis under 35 U.S.C. § 102. Merck & Co., Inc. V. Biocraft
Laboratories Inc., 874 F.2d 804, 807, 10 USPQ2d 1843, 1846 (Fed.
Cir.), cert. denied, 493 U.S. 975 (1989).
Appeal No. 94-0591
Application 07/755,610
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Furthermore, in reversing the examiner’s rejection of all
claims under 35 U.S.C. § 103 in view of the combined teachings of
Bilton, Wruble, and Babayan, we indicated that the cited prior
art would not have provided persons having ordinary skill in the
art with reason, incentive, or motivation to reduce the amount of
essential fatty acids relative to the amount of total fatty acids
in the lipid phase of the prior art oil-in-water emulsions so to
make and use the lipid emulsions appellant claims. Put simply,
persons having ordinary skill in the art would not have been led
by Bilton, Wruble, and Babayan to solve unknown problems.
However, in a Supplemental Information Disclosure Statement filed
April 26, 1995 (Paper No. 39), appellant submitted of record a
copy of UK Patent Application GB 2067587, published July 30,
1981. The new reference teaches at p. 2, l. 10-17 (emphasis
added):
An additional consideration for a humanized fat
composition made of vegetable oils is to provide a
physiological level of linoleic acid. Inadequate
amounts of dietary essential fatty acids produce a
nutritional deficiency disease. Excessive levels
of linoleic acid can be harmful. The foregoing
literature survey has revealed that milk fat from
lactating mothers contains from about 6% to 16%
linoleic acid.
On consideration of this additional prior art teaching that
“[e]xcessive amounts of linoleic acid can be harmful” and that 6%
to 16% linoleic acid is optimum for simulated human mother’s milk
Appeal No. 94-0591
Application 07/755,610
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formulations, the examiner should determine in the first instance
the patentability of the subject matter appellant claims under
35 U.S.C. § 103 in view of the combined teachings of the prior
art herein applied and UK Patent Application GB 2067587.
6. Conclusion
We reverse the examiner’s rejection of Claims 1-9, 11, 12
and 16-20 under 35 U.S.C. § 103 in view of the combined teachings
of Bilton, Wruble, and Babayan.
We remand this case to the examiner to determine the metes
and bounds of the subject matter claimed, and thereafter, to
consider its patentability under 35 U.S.C. § 102 over Wruble’s
disclosure and under 35 U.S.C. § 103 in view of the Bilton,
Wruble, Babayan, and GB 2067587.
Appeal No. 94-0591
Application 07/755,610
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This application, by virtue of its “special” status,
requires an immediate action, M.P.E.P. § 708.01(d). It is
important that the Board be informed promptly of any action
affecting the appeal in this case.
REVERSED and REMANDED
SHERMAN D. WINTERS )
Administrative Patent Judge)
)
)
)
JOHN D. SMITH ) BOARD OF PATENT
Administrative Patent Judge) APPEALS AND
) INTERFERENCES
)
)
TEDDY S. GRON )
Administrative Patent Judge)
Appeal No. 94-0591
Application 07/755,610
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Fleit, Jacobson, Cohn, Price,
Holman & Stern
400 Seventh Street, N.W.
Washington, DC 20004