Ex Parte 6,812,009 et al

Board of Patent Appeals and Interferences

Mar 23, 2012

95001082 (B.P.A.I. Mar. 23, 2012)

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.
95/001,082 09/15/2008 6,812,009 L111 7007 7061
91335 7590 03/23/2012
Sterne, Kessler, Goldstein & Fox P.L.L.C
1100 New York Avenue, N.W.
Washington, DC 20005
EXAMINER
PONNALURI, PADMASHRI
ART UNIT PAPER NUMBER
3991
MAIL DATE DELIVERY MODE
03/23/2012 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

LONZA AG
Requester & Respondent

v.

MARTEK BIOSCIENCES CORPORATION
Patent Owner & Appellant
____________

Appeal 2011-011342
Reexamination 95/001,082
Patent 6,812,009
Technology Center 3900
____________

Before RICHARD E. SCHAFER, ROMULO H. DELMENDO, and RICHARD M.
LEBOVITZ, Administrative Patent Judges.

LEBOVITZ, Administrative Patent Judge.

DECISION ON APPEAL

Appeal 2011-011342
Reexamination 95/001,082
Patent 6,812,009

2 

This is a decision on the appeal by the Patent Owner of U.S. Patent No.
6,812,009 from the Patent Examiner’s rejections of claims in an Inter Partes
reexamination proceeding and on the cross-appeal by the Requester from the
Examiner’s refusal to adopt a proposed ground of rejection. The Board’s
jurisdiction for this appeal is under 35 U.S.C. §§ 6(b), 134(b), and 315. We affirm.

STATEMENT OF CASE
U.S. Patent No. 6,812,009 (hereinafter “the ‘009 patent”) issued November
2, 2004. A “Request for Inter Parte Reexamination” of the issued claims of the
‘009 patent was filed by Lonza AG of Basel, Switzerland on September 19, 2008
pursuant to 35 U.S.C. §§ 311-318 and 37 C.F.R. § 1.912. Reexamination was
ordered. The reexamination processing culminated in the Examiner rejecting all
pending claims under 35 U.S.C. § 103.
Patent Owner and Appellant (“Martek”) appeals the Examiner’s decision to
reject all the pending claims. Requester (“Lonza”) filed a Respondent’s Brief
pursuant to 37 C.F.R. § 41.68. Requester also cross-appeals the Examiner decision
not to adopt a rejection under 35 U.S.C. § 112, first paragraph of the claims.
This appeal is related to the ex parte reexamination of U.S. Patent No.
6,372,460 (Reexamination 90/010,464). An appeal was filed in that case and
decided on September 19, 2011 (Appeal 2011-101532).
The ‘009 patent claims are directed to a particulate material prepared by
spray drying a lipid material obtained from microbes, and methods of making the
particulate material. The material is described in the patent as useful as an
aquaculture feed (col. 1, ll. 66-67) and for human nutrition (col. 5, ll. 11-20 & 49-
50). The microbes comprise docosahexaenoic acid (“DHA”) and arachidonic acid
Appeal 2011-011342
Reexamination 95/001,082
Patent 6,812,009

3 

(“AA” or “ARA”), fatty acids that are nutritionally important (col. 1, ll. 44-47 &
col. 5, ll. 49-50). The claims comprise a step (product-by-process in the
composition claims) of obtaining a “polar lipid fraction” which comprises
“phospholipids and proteins of the microbes.”
Claims 1-2, 4-11, 13-29, 43-55, 58-59, and 73-93 are pending and stand
rejected by the Examiner as follows:
Ground 18: Claims 1, 2, 6-10, 17-24, 27, 29, 44, 46-52, 54-55, 59, 81, 87-88,
and 92-93 as obvious under 35 U.S.C. § 103(a) over Van den Burg1 and Kyle
‘591,2 and further in view of Durrani,3 and Henderson,4 Beach5 and Kendrick,6 as
evidence and further in view of Dr. Ward declaration7 as evidence of inherency.
Ground 19: Claims 1-2, 4-11, 13-16, 24-25, 27, 29, 44-53, 55, 58-59, 73-77,
79-80, and 81-82 under 35 U.S.C § 103(a) as obvious over Barclay8 in view of
Kyle ‘7679 and Kyle ‘591, and further in view of Durrani, and Henderson, Beach

1 WO 97/35487 (filed Mar. 21 1997_) (published Oct. 2, 1997).
2 U.S. Patent No. 5,397,591 (filed Feb. 4, 1991) (issued Mar. 14, 1995).
3 WO 91/16882 (filed May 6, 1991) (published Nov. 14, 1991).
4 R. James Henderson et al., Lipid Composition and Biosynthesis in the Marine
Dinoflagellate Crypthecodinium Cohnii, 27 Phytochemistry 1679-1682 (1988).
5 D.H. Beach & G.G. Holz, Jr., Environmental Influences on the
Docosahexaenoate Content of the Triacylglycerols and the Phosphatidycholine of
a Heterotropic, Marine Dinoflagellate, Crypthecodinium Cohnii, 316 Biochimica
at Biophysica Acta 56-65 (1973).
6 Andrew J. Kendrick & Colin Ratledge, Microbial Polyunsaturated Fatty Acids of
Potential Commercial Interest, 42 SIM Indus. Microbiology News 59-65 (1992).
7 Dr. Owen P. Ward Declaration, Jan. 27, 2009. Dr. Owen P. Ward Second
Declaration, Oct. 13, 2009. 
8 William Barclay & Sam Zeller, Nutritional Enhancement of n-3 and n-6 Fatty
Acids in Rotifers and Artemia Nauplii by Feeding Spray-dried Schizochytrium sp.,
27 J. World Aquaculture Soc’y 314-322 (1996).
9 U.S. Patent No. 5,658,767 (filed Jan. 3, 1995) (issued Aug. 19, 1997).
Appeal 2011-011342
Reexamination 95/001,082
Patent 6,812,009

4 

and Kendrick as evidence and further in view of Dr. Ward declaration as evidence
of inherency.
Ground 20: Claims 1-2, 4-7, 11, 50-51, 53, 55, 73-77, 79-82 and 86-91
under 35 U.S.C § 103(a) as obvious over Barclay in view of Kyle ‘767 and Kohn,10
and further in view of Durrani, and Henderson, Beach and Kendrick as evidence
and further in view of Dr. Ward Declaration as evidence of inherency.
Ground 21: Claims 26, 78, and 83 under 35 U.S.C § 103(a) as obvious over
Barclay, Kyle ‘767, Kyle ‘591, and Durrani and Henderson, Beach and Kendrick
as evidence as applied to claims 1-2, 4-11, 13-16, 24-25, 27, 29, 44-53, 55, 79-80,
58-59, 81-82, 84 and 86-93 above (Ground 19), and further in view of Kitagawa.11
Ground 22: Claims 28 and 85 under 35 U.S.C. § 103(a) as obvious over
Barclay, Kyle ‘767, Kyle ‘591, and Durrani and Henderson, Beach and Kendrick
as evidence as applied to claims 1-2, 4-11, 13-16, 24-25, 27, 29, 44-53, 55, 79-80,
58-59, 81-82, 84 and 86-93 above (Ground 19), and further in view of Herbert12
and Ratledge.13
Ground 24: Claim 43 under 35 U.S.C. § 103(a) as obvious over Van den
Burg, Kyle '591, Durrani and Henderson, Beach and Kendrick as evidence of
inherency as applied to claims 1-2, 6-10, 17-24, 27, 29, 44, 46-52, 54-55, 59-60,
66-67, and 71-72 above (Ground 18), and further in view of Barclay.
Claims 1 and 10 are representative and read as follows (underlining and
brackets show amendments made during the reexamination proceeding relative to
the original claims):

10 U.S. Patent No. 5,539,133 (filed May 27, 1993) (issued July 23, 1996).
11 U.S. Patent No. 4,906,479 (filed May 11, 1988) (issued Mar. 6, 1990).
12 U.S. Patent No. 4,851,343 issued July 25, 1989.
13 C. Ratledge, Biotechnology of Oils and Fats, 2 Microbial Lipids 567-583. 
Appeal 2011-011342
Reexamination 95/001,082
Patent 6,812,009

5 

1. A particulate material containing phospholipids with docosahexaenoic acid
(DHA) residues and arachidonic acid (ARA) residues prepared by obtaining
lipid extract from DHA-containing microbes and ARA-containing microbes
followed by separating polar lipid fraction from the lipid extract, wherein the
polar lipid fraction comprises phospholipids and proteins of the microbes,
preparing a slurry comprising the polar lipid fraction, and spray drying [a] the
slurry to obtain the particulate material. [comprising a polar lipid extract from
DHA-containing microbes and ARA containing microbes.]
10. A method for preparing a DHA- and ARA-containing particulate material
comprising drying a slurry containing a polar lipid [lipids] fraction of a lipid
extract of[extracted from] dinoflagellates and fungi, the polar lipid fraction
comprising phospholipids and proteins of the microbes, wherein the dried
material is in the form of particles having a mean particle diameter between 5
and 10 microns.

CLAIM 1
Claim 1 is drawn to particulate material “containing phospholipids with
docosahexaenoic acid (DHA) residues and arachidonic acid (ARA) residues.” The
material is prepared by the following steps (lettering is added for convenience, but
is not part of the original claim):
a) obtaining a lipid extract from DHA-containing microbes and ARA-
containing microbes;
b) “followed by” separating a polar lipid fraction from the lipid extract,
wherein the polar lipid fraction comprises phospholipids and proteins of the
microbes;
c) preparing a slurry comprising the polar lipid fraction; and
d) spray drying the slurry to obtain the particulate material.
Claim 1 is a “product-by-process” claim because it defines the product in
terms of how it is made. The Examiner, Appellant, and Requester interpreted the
Appeal 2011-011342
Reexamination 95/001,082
Patent 6,812,009

6 

claim to require that the particulate matter be made from a polar lipid fraction
which is then spray dried. We thus will treat the limitations in the same way they
were treated during the proceeding before the Examiner.

GROUND 18
The Examiner found that Van den Burg described a particulate material
comprising DHA and ARA residues as claimed, relying on Henderson, Beach, and
Kendrick as evidence to establish this fact (RAN 6). Van den Burg’s material was
made by adding polyunsaturated fatty acids (PUFAs) to solid carrier particles. The
Examiner also found that Van den Burg described preparing a slurry of the PUFAs
and spray drying it (RAN 7). The Examiner found that Van den Burg did not
describe a “polar lipid fraction” as recited in the claim, but found that Kyle ‘591
and Durrani did, and that the fractions described in Kyle ‘591 and Durrani
inherently comprised proteins and phospholipids as required by the claims (RAN
6-7). A declaration by Dr. Owen P. Ward, provided by the Requester, was cited as
evidence that the polar lipid fractions of Kyle ‘591 and Durrani would comprise
proteins (Ward Declaration (“Decl.”), dated January 27, 2009). Dr. Ward was a
professor of microbial biotechnology at the University of Waterloo at the time the
declaration was executed, and testified that he had 30 years of experience in the
study, development, and application of microorganisms and fermentation processes
to produce microorganisms.
The Examiner found that a person of ordinary skill in the art would have
been “motivated to combine the polar lipid extract of Kyle ‘591 with Van den
Burg’s slurry to create a spray dried product since the references both disclose
infant formula.” (RAN 7.) The Examiner reasoned that the “combination would
Appeal 2011-011342
Reexamination 95/001,082
Patent 6,812,009

7 

increase the DHA, ARA, and protein concentrations in the finished particulate
product, which is desirable for food stuff.” (RAN 7.)
With regard to the limitation that the particulate material is prepared by
“separating the polar lipid fraction from the solid extract” of the microbial cells
(step b) listed above), the Examiner found that Kyle ‘591 described preparing a
lipid extract followed by a second polar lipid extraction (RAN 7).

Van den Burg
Findings of Fact (“FF”)
[FF1] Van den Burg describes polyunsaturated fatty acids (PUFAs) for
“foods, such as infant formula,” where the PUFAs are provided on solid carrier
particles (Van den Burg 1:2-3; 2:35 to 3:22).
[FF2] Van den Burg describes a prior process of preparing an infant formula
with PUFAs involving a spray drying step of an emulsion comprising PUFAs (Van
den Burg 1:10 to 2:2; 2:25-27).
[FF3] Van den Burg discloses:
A preferred process for preparing a foodstuff comprising a
polyunsaturated fatty acid (PUFA) the process comprising:
a) providing an oil phase and an aqueous phase;
b) mixing and homogenising the oil and water phases to obtain
an emulsion;
c) sterilising and/or drying the emulsion to obtain a sterile
liquid or a dried material; and
d) adding solid carrier particles onto which have been absorbed,
or that are coated with, at least one PUFA.
(Van den Burg 5:23-31.)
Appeal 2011-011342
Reexamination 95/001,082
Patent 6,812,009

8 

[FF4] Van den Burg discloses that heating, drying, and homogenization can
degrade PUFAs (Van den Burg 5:37 to 6:2).
[FF5] Van den Burg discloses that heating can occur during a number of
places, including homogenization and sterilization (Van den Burg 6:2-6).
[FF6] Van den Burg discloses:
The process of the invention seeks to minimise the exposure of the
PUFAs to these various steps [heating, drying, and homogenization]
in order to maximise the preservation of the PUFA, and therefore to
minimise degradation. . . . The PUFA may therefore be added after
one or more heating and/or drying stages. Preferably, the PUFA is
added after the drying step in (c). This drying may comprise spray
drying.
(Van den Burg 6:6-15)
[FF7] Van den Burg discloses:
More than one PUFA can be added. In this case, two or more PUFAs
may be from a different source, and therefore one may add either the
PUFAs separately (as separate compositions) or mix the two PUFAS
(to give a single composition) before addition during the foodstuff
preparation process. For example, fish oil contains DHA which may
be mixed with one or more microbial oils containing another PUFA
(e.g. ARA).
(Van den Burg 7:33 to 8:2)
[FF8] Van den Burg discloses: “It is preferred that the source of the PUFA
is a microbial oil and/or a fish oil.” (Van den Burg 8:11-12)

Discussion
The Examiner found that it would have been obvious to have used Kyle
‘591’s polar lipid fraction, comprising PUFAs, in Van den Burg’s spray drying
method. Appellant contends that Van den Burg teaches that PUFA lipids (DHA
and ARA) should be added after spray drying (step d) listed above), not before as
Appeal 2011-011342
Reexamination 95/001,082
Patent 6,812,009

9 

in the claims (App. Br. 11). Appellant contends such disclosure is a teaching away
from the claimed invention because spray drying before addition of the PUFA can
cause degradation of the PUFAs (App. Br. 15).
We do not agree with Appellant’s reasoning. Van den Burg teaches that
PUFAs are “preferably” added after the drying step (FF6). However, Van den
Burg does not limit the addition of PUFA to after the spray drying step. Rather,
Van den Burg recognizes that damage to PUFA is incurred by heating, drying, and
homogenization, and expressly states that “PUFA may therefore be added after one
or more heating and/or drying stages” to minimize its degradation (FF6.) Van den
Burg teaches that heating can occur during homogenization and sterilization, steps
which precede drying (FF2 & FF3). Thus, while Van den Burg preferred adding
the PUFA after drying, Van den Burg did not limit its disclosure to adding it only
after the drying step, but indicated it could be added prior to drying but after
heating or homogenization.
Van den Burg also taught that prior art processes had utilized compositions
which had been prepared by spray drying emulsions comprising PUFAs (FF3).
While such compositions, and methods of making them, might have been inferior,
that alone does not by itself constitute a teaching away because it is not a teaching
away to use a prior art step or composition for its known purpose, even when such
step or composition was known to be inferior. See In re Gurley, 27 F.3d 551, 553
(Fed. Cir. 1994). A “finding that prior art as a whole suggests the desirability of a
particular combination need not be supported by a finding that the prior art
suggests that the combination claimed by the patent applicant is the preferred, or
most desirable, combination.” In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004).
Appellant also contends that Van den Burg’s PUFA composition lacks
Appeal 2011-011342
Reexamination 95/001,082
Patent 6,812,009

10 

proteins and phospholipids (App. Br. 12). This argument is not persuasive since
the Examiner relied upon the polar lipid fraction of Kyle ‘591 for its protein
content (RAN 7). The Examiner specifically found that Kyle ‘591’s polar fraction
would inherently comprise protein, citing paragraphs 18 and 24 of the Ward
declaration as support for this finding (RAN 7). Dr. Ward testified in his written
declaration that, since microbial cell membranes comprise proteins and polar
phospholipids, a polar lipid fraction would comprise these components (Ward
Decl. ¶¶ 18, 19, 21, & 24). Consistently, Mr. Gladue, an expert testifying on
behalf of the Appellant, acknowledged that Kyle ‘591’s DHA-enriched polar lipid
fraction contained protein: “In fact, the DHA-enriched polar lipid fraction of Kyle
‘591 was an impurity-laden material in that it contained unwanted microbial
proteins and phospholipids.” (2d Gladue Decl.,14 pp. 9-10, ¶¶ 21-2) [FF9].
.
Kyle ‘591
Findings of Fact
[FF10]
The present invention relates to the cultivation of microorganisms,
notably dinoflagellates, in a fermentor, induction of those
microorganisms to produce significant quantities of single cell oil
containing a high proportion of DHA and recovery of that oil. As used
herein, “single cell oil” refers to a lipid product of a unicellular
organism.
(Col. 2, ll. 37-43.)

14 Mr. Raymond M. Gladue Second Declaration, Sept. 14, 2009. 
Appeal 2011-011342
Reexamination 95/001,082
Patent 6,812,009

11 

[FF11]
The present invention also includes food products, such as infant
formulas and baby foods, as well as dietary supplements, which
contain the single-cell oil containing DHA of the present invention.
(Col. 6, ll. 55-58.)
[FF12]
After induction of oil production, the culture is grown for about 24
additional hours. During this period of oleosynthesis, the single cell oil
containing DHA is being synthesized and visible oil droplets become
apparent. . . .
From about 15 to 30% of the resultant biomass, using wild-type
C. cohnii, comprises extractable oil. . . . Preferably, the oil comprises
greater than about 70% triglycerides having, in general, the following
fatty acid composition.

15-20% myristic acid (C14:0)
20-25% palmitic acid (C16:0)
10-15% oleic acid (C18:1)
30-40% DHA (C22:6)
0-10% others
(Other oil components including polar lipids, such as phosphatidyl
choline, also may be enriched in DHA.) . . . Desirably, the oil
contains at least about 20% DHA by weight and most preferably at
least about 35% DHA by weight.
(Col. 5, l. 49 to col. 6, l. 9.)
[FF13]
The organisms are harvested by conventional means, known to those
of skill in the art, such as centrifugation, flocculation or filtration, and
can be processed immediately or dried for future processing. In either
Appeal 2011-011342
Reexamination 95/001,082
Patent 6,812,009

12 

event, the oil can be extracted readily with an effective amount of
solvent.
(Col. 6, ll. 10-15.)
[FF14]
The solvent then is removed from the oil by distillation techniques
known to those of skill in the art. Conventional oilseed processing
equipment is suitable to perform the filtering, separation and
distillation. Additional processing steps, known to those of skill in the
art, can be performed if required or desirable for a particular
application. These steps also will be similar to those involved in
conventional vegetable oil processing and allow the separation of
DHA-enriched polar lipid fractions.
(Col. 6, ll. 39-48.)
[FF15]
The culturing conditions are depicted graphically in FIG. 1. The
culture was then harvested by centrifugation with the cell pellet
retained. The harvested pellet of cells was frozen and dried
(lyophilized) to about a 4% moisture content. Hexane (2.8 liters) was
added to the dried biomass and stirred in a glass kettle for 1.5 hours at
50° C. A rotary evaporator was used to remove the hexane, producing
about 175 g of crude DHA-containing oil.
(Col. 7, ll. 60-68 (Example 1).)
Discussion
Does Kyle ‘591 describe using the DHA-enriched polar lipid fraction in a
food product?
The rejection is based on utilizing the DHA-enriched polar lipid fraction of
Kyle ‘591 in Van den Burg’s process. Appellant acknowledges that the DHA-
enriched polar lipid fraction described in Kyle ‘591 is “a polar lipid fraction of a
Appeal 2011-011342
Reexamination 95/001,082
Patent 6,812,009

13 

lipid extract” prepared from microbial cells as required by claim 1. (App. Br. 13).
However, Appellant contends that Kyle ‘591 describes extracting a microbial
biomass with hexane “followed by removal of hexane from the oil and separation
of DHA-enriched polar lipid fractions from the crude oil, thereby producing both
(i) a phospholipid fraction containing impurities and (ii) a refined oil that can be
used in infant formula. (Kyle ‘591, col. 6, ll. 19-48.).” (App Br. 12.) Appellant
contends that the (ii) “refined single-cell oil” is described by Kyle ‘591 as useful
for a food product, but “does not disclose any uses for the [(i)] ‘DHA-enriched
polar lipid fraction,’ and only discloses ‘separation’ of this fraction as part of the
refining process for single-cell microbial oil. . . . Second Gladue Declaration at ¶¶
21-22.)” (App Br. 13; id. at 15.) Appellant contends that the polar lipid fraction is
discarded by Kyle ‘591 and would not have been further processed to form a
spray-dried particulate material as required by the claim. Thus, the issue raised by
Appellant is whether the Examiner properly determined that the polar lipid fraction
of Kyle ‘591 was a suitable food product.
Kyle ‘591 describes culturing and extracting microorganisms to produce an
oil containing DHA (FF10-12). The oil is described by Kyle ‘591 as a “single cell
oil” and is defined as “a lipid product of a unicellular organism.” (FF10.) This
definition does not restrict the single cell oil to a particular form or to being a
product of a specific processing method.
Kyle’ 591 describes at least two products which contain DHA (FF10-11).
First, Kyle ‘591 describes a crude oil which is extracted from the microorganism
biomass with a solvent (FF12-14). The oil contains DHA (FF10-12). This oil is
specifically exemplified in Kyle ‘591 as being produced by a single solvent
extraction step (FF15). This is the first product described by Kyle ‘591.
Appeal 2011-011342
Reexamination 95/001,082
Patent 6,812,009

14 

Kyle ‘591 also discloses that “[a]dditional processing . . . can be performed
if required or desirable” on the extracted oil which “allow[s] the separation of
DHA-enriched polar lipid fractions.” (FF14.) This processing step is therefore
optional. The polar lipid fraction is a second product containing DHA which is
described by Kyle ‘591.
This “additional processing” step is also described in a declaration by
Raymond Gladue (2d Gladue Decl., p. 3), a scientist with a background in
fermentation techniques and operations (1st Gladue Decl.,15 pp. 1-2, dated Dec. 29,
2008) [FF16]. Mr. Gladue acknowledged that, when microbial material was
processed, two products are made: (i) a DHA-enriched polar lipid fraction
containing proteins, carbohydrates and ash (a polar lipid fraction of a lipid extract;
See Example 1 of the ‘009 patent, col. 6-7 and Table 1) and (ii) a refined single-
cell microbial oil (See e.g., col. 6, lines 10-48, of Kyle ‘591). (2d Gladue Decl., p.
4, ¶ 7; [FF17].) Mr. Gladue stated that the polar lipid fraction (i) was considered a
waste-by-product and testified that no use was disclosed for it in Kyle ‘591 (2d
Gladue Decl., p. 4, ¶ 22) [FF18]. On the other hand, Mr. Gladue testified that the
“refined single-cell microbial oil is taught [by Kyle ‘591] to be useful as a food
product, such as an additive to infant formula.” (2d Gladue Decl., p. 4, ¶ 21)
[FF19].
The relied-upon evidence does not support Mr. Gladue’s statement that the
“refined single-cell microbial oil” was the fraction utilized by Kyle ‘591 in its food
products (2d Gladue Decl., p. 4, ¶ 7 & p. 10, ¶ 22 [FF20]). To the contrary, as
discussed above, a single-cell oil extract from lysed cells, in which a single
extraction step is performed, is described and exemplified in Kyle ‘591 (FF14-15).

15 Mr. Raymond M. Gladue First Declaration, Dec. 29, 2008. 
Appeal 2011-011342
Reexamination 95/001,082
Patent 6,812,009

15 

There is no apparent disclosure in Kyle ‘591 that this extract requires further
extraction to be useful as a food supplement. Kyle ‘591 discloses additional
processing to produce a DHA polar lipid fraction (FF14), but Kyle ‘591 does not
disclose that this further processing step is necessary and the examples do not
perform it (FF15). It is an optional step.
Mr. Gladue cited column 6, lines 55-58, of Kyle ‘591 to support his
conclusion that it is “the refined single-cell microbial oil (not the DHA enriched
polar lipid fractions) that is used to make the infant formula.” (2d Gladue Decl., p.
10, ¶ 21). We reproduce that passage from Kyle ‘591 below (FF10):
The present invention also includes food products, such as infant
formulas and baby foods, as well as dietary supplements, which
contain the single-cell oil containing DHA of the present invention.
This passage does not use the term “refined oil,” nor does it describe the “single-
cell oil” as having been refined to remove the polar lipids.
Kyle ‘591 describes single-cell oil containing DHA as useful for its food
products (FF10-11). Kyle ‘591 specifically teaches that polar lipids comprise
DHA (FF12 & FF14). Consequently, the skilled worker would have recognized
the polar lipid fraction would be useful as well for Kyle ‘591’s food products
[FF21]. Mr. Gladue did not provide sufficient evidence that such fraction would
be discarded as waste product by Kyle ‘591 (2nd Gladue Decl., p. 3), when Kyle
specifically discloses that it contains the desired DHA lipid (FF14). In sum, the
preponderance of the evidence supports the Examiner’s determination that the
polar lipid fraction of Kyle ‘591 was a suitable food product.

Appeal 2011-011342
Reexamination 95/001,082
Patent 6,812,009

16 

Protein levels
Appellant contends that nothing in Kyle ‘591 would have suggested that the
DHA-enriched polar lipid fraction would comprise high protein levels suitable for
aquaculture feed (App. Br. 13).
Claim 1 and others recite a “polar lipid fraction” which comprises
“phospholipids and proteins of the microbes.” The claims do not require that the
polar lipid fraction have a specific content of protein. Any quantity of protein
would meet the limitations of the claim. Appellant’s argument about Kyle ‘591
not suggesting that the polar lipid fraction would comprise high amounts of protein
is therefore without merit since the claim does not require the fraction to contain
“high” protein levels.
As noted by the Examiner, Mr. Gladue acknowledged that Kyle ‘591’s
DHA-enriched polar lipid fraction contained protein: “In fact, the DHA-enriched
polar lipid fraction of Kyle ‘591 was an impurity-laden material in that it contained
unwanted microbial proteins and phospholipids.” (2nd Gladue Decl., pp. 9-10, ¶
21) [FF22]).
Durrani
The Examiner relied upon Durrani for its teaching of a spray-dried
composition comprising drug, phospholipids, and proteins (RAN 7). Appellant
disputes the Examiner’s finding about Durrani’s composition inherently
comprising protein and contends that it does not teach a polar lipid fraction as
recited in claim 1 (App. Br. 13-14). However, because Kyle ‘591 describes such a
polar lipid fraction with microbial protein, meeting the corresponding limitation of
claim 1, even were Appellant’s argument correct, that alone would not vitiate the
Examiner’s case of prima facie obviousness.
Appeal 2011-011342
Reexamination 95/001,082
Patent 6,812,009

17 

Appellant attempts to distinguish Durrani on the grounds that Durrani
describes a clear feed solution with a different composition that the claimed polar
lipid fraction and thus would not be expected to apply to a polar lipid fraction
(App. Br. 16). We have considered this argument, but do not find it persuasive.
Both Durrani and Van den Burg (FF6) provide evidence of the conventionality of
spray-drying of compositions. That the compositions are different establishes the
wide applicability and expected success of spray-drying, regardless of the
components and materials in the composition.

Combination of prior art publications
In setting forth the ground of the rejection, the Examiner found that it would
have been obvious to one of ordinary skill in the art to utilize a polar lipid fraction
described in Kyle ‘591 to create a spray dried product as taught by Van den Burg
(RAN 7). Appellant contends that “replacing the PUFA oil of Van den Burg with
the polar lipid fraction of Kyle ‘591 would be expected to render the composition
of Van den Burg unsuitable for its intended use as an infant formula” because of
the presence of allergenic microbial proteins (App. Br. 15). To support this
argument, Appellant provided a written declaration by Dr. Lien, a scientist
specializing in the area of pediatric nutrition and infant formula research (Lien
Decl.16 ¶¶ 1-2). Dr. Lien testified that the “problem of allergenicity due to the
protein content of infant formula is well recognized.” (Lien Decl. ¶ 12 [FF23].)
Dr. Lien testified:
even proteins that are commonplace in the diet of adults can raise
safety concerns when introduced into infant formula. Any infant
formula containing microbial proteins from the lcPUFA [long chain

16 Dr. Eric Lien Declaration, Sept. 14, 2009.
Appeal 2011-011342
Reexamination 95/001,082
Patent 6,812,009

18 

polyunsaturated fatty acids] source organism would likewise raise
immediate safety concerns. Based on my experience and knowledge
of infant formula manufacturing, it would not even occur to those
involved in the development of infant formula to utilize a lipid source
that was known to have any detectable level of microbial proteins.
(Lien Decl. ¶ 13 [FF24].)
These arguments are not persuasive. First, although both Van den Burg and
Kyle ‘591 describe infant formula as preferred embodiments, each publication
describes food products more generally and without limitation (FF1, FF3, &
FF11). Thus, even were allergenicity an issue for infant formula, neither Van den
Burg nor Kyle ‘591 are limited to infant foods. Second, despite Dr. Lien’s
statements about the concerns with microbial proteins in infant formula, Van den
Burg identifies a microbial oil as a preferred source of PUFA (FF8). Likewise,
Kyle ‘591 describes preparing a DHA oil to be used in infant formula from a
microbial source (FF13-15). Thus, Dr. Lien’s opinion that “it would not even
occur to those involved in the development of infant formula to utilize a lipid
source that was known to have any detectable level of microbial proteins” is
contradicted by the factual evidence in this record that microbial sources of PUFAs
were expressly suggested for infant formula.
Furthermore, Appellant contends that no plausible reason has been identified
that would have led the ordinary skilled worker to have utilized “the microbial
protein-laden polar lipid faction of Kyle ‘591” in Van den Burg (App. Br. 15). We
do not agree. The Examiner explicitly stated that the reason to have utilized Kyle
‘591 would have been to increase DHA, ARA, and protein in a food stuff (RAN 7).
Moreover, Van den Burg expressly suggested using microbial oil in its food as a
source of PUFA (FF7), providing a direct reason to have used Kyle 591’s DHA
polar lipid fraction prepared from microbes in Van den Burg’s food product.
Appeal 2011-011342
Reexamination 95/001,082
Patent 6,812,009

19 

Claims 10 and 59
Appellant contends claims 10 and 59 are patentable over the cited prior art,
relying on the same arguments already addressed. For the reasons discussed
above, we affirm the Examiner’s obviousness rejection of claims 10 and 59.

Claims 17, 18-23, 43, 54, and dependent claims
Appellant contends claims 17, 18-23, 43, and 54 [claims 54 not rejected
under Ground 18] are patentable over the cited prior art (App. Br. 11 & 16),
relying on the same arguments already addressed. For the reasons discussed
above, we affirm the Examiner’s obviousness rejection of claims 17, 18-23, and
43.

Claim 46-49
Claim 46 depends on claim 1 and further recites that “the polar lipid fraction
comprises dry matter and at least two thirds of the dry matter in the polar lipid
fraction is material derived from the cells of the microorganisms.” Claims 47-49
further limit the quantity of dry matter. The Examiner found that Kyle 591’s
fraction would inherently comprise such amounts (RAN 8). Appellant contends
that such amounts would not have been utilized based on the teachings of Van den
Burg (App. Br. 17). Appellant also contends that it would have been unreasonable
to use such a high percentage of a polar lipid fraction in an infant formula (id.).
Appellant’s argument is not persuasive. As noted by the Requester, the
PUFA content of Van den Burg’s material is irrelevant because the concentration
limitation at issue is directed to the polar lipid fraction, not the overall PUFA
content of the particulate material. As stated by the Examiner (RAN 8), Kyle ‘591
Appeal 2011-011342
Reexamination 95/001,082
Patent 6,812,009

20 

discloses the polar lipid fraction, which is entirely derived from C. cohnii (i.e.,
100% of the dry matter in the polar lipid fraction is derived from DHA producing
microorganisms). We find that other values would not confer patentability since a
person of ordinary skill in the art could routinely adjust the amounts of the fraction
of Kyle ‘591 to achieve the desired amount of PUFA for its known nutritional
value.
Summary
For the foregoing reasons, after considering the evidence before us, we
conclude that the obviousness rejection based on Ground 18 is supported by
preponderance of the evidence. We affirm the rejection of claims 1-2, 6-10, 17-24,
27, 29, 44, 46-52, 54-55, 59, 81, 87-88, and 92-93.

GROUND 19
Ground 19 cites Barclay as the primary reference, rather than Van den Burg
as for Ground 18. The bases of Grounds 18 and 19 are similar, with the Examiner
citing Barclay for its teaching of a particulate feed prepared from a microorganism
which is made into a slurry and then spray-dried as required by the product-by-
process steps of claim 1 (RAN 19). The Examiner found that Barclay did not
describe a polar lipid fraction as required by claim 1, the same deficiency the
Examiner identified for the Van den Burg publication in Ground 18. However, the
Examiner found that Kyle ‘767 and Kyle ‘591 described the recited “polar lipid
fraction” (RAN 20).
Appellant contends that neither Kyle ‘767 nor Kyle ‘591 describe the
claimed polar lipid fraction as a component of infant food (App. Br. 20). We have
addressed this issue with respect to the Kyle ‘591 and concluded that Kyle ‘591
Appeal 2011-011342
Reexamination 95/001,082
Patent 6,812,009

21 

describes separating a polar lipid fraction as claimed. We also concluded, based on
the evidence, that persons of ordinary skill in the art would have had reason to use
the polar lipid fraction of Kyle ‘591 in a food.
Appellant also contends that Kyle ‘767 does not describe a polar lipid
fraction.
Kyle ‘767 describes microbes comprising the PUFA, arachidonic acid
(ARA), and manufacture of an oil comprising it (Kyle ‘767, col. 2, ll. 57-67; col. 3,
ll. 14-20; col. 8, ll. 3-34 & 57-65 [FF25]). Kyle ‘767 teaches that the oil can be
further processed (col. 9, ll. 11-18 [FF26]). Because both Kyle ‘591 and Kyle ‘767
involve the manufacture of microbial oils comprising PUFAs, the ordinary skilled
worker would have had reason to prepare a polar lipid extract from Kyle ‘767’s oil
to enrich for ARA as taught by Kyle ‘591 (FF14). The oil of Kyle ‘767 comprises
phospholipids as required by the claim (Kyle ‘767, col. 10, ll. 8-10 [FF27]). Thus,
while we considered Appellant’s arguments regarding the deficiencies of Kyle
‘767 with respect to the polar lipid fraction (App. Br. 19-20), we find them
addressed by Kyle ‘591’s teachings.
Appellant attempts to distinguish the claims over the cited prior art by
arguing that Barclay does not disclose a “polar lipid fraction of a lipid extract.”
(App. Br. 18-19.) This argument is not persuasive because Kyle ‘591 was cited by
the Examiner for describing this element of the claim.
Appellant contends that Barclay does not describe infant formula and
therefore it is “unclear” why it would be combined with Kyle ‘591 and Kyle ‘767
(App. Br. 20). This argument is not persuasive. Neither Kyle ‘591 nor Kyle ‘767
(col. 2, ll. 52-54; col. 9, ll. 1-4 [FF27]) are restricted to infant formula. It is true
that Barclay describes nutritional feeds for aquaculture (Barclay 314 [FF28]).
Appeal 2011-011342
Reexamination 95/001,082
Patent 6,812,009

22 

However, as Barclay describes the same type of composition described in the Kyle
publications – microbial sources of PUFA – persons of ordinary skill in the art
would have considered Barclay’s teaching reasonably pertinent to preparing the
microbial oils of Kyle ‘591 and Kyle ‘767. “[I]f a technique has been used to
improve one device, and a person of ordinary skill in the art would recognize that it
would improve similar devices in the same way, using the technique is obvious
unless its actual application is beyond his or her skill.” KSR Int’l Co. v. Teleflex,
Inc., 550 U.S. 398, 417 (2007). Appellant has not provided sufficient evidence that
it was beyond the skill of the ordinary skilled worker to apply Barclay’s teaching
to the Kyle publications, and vice-versa.
Likewise, we do not consider Appellant’s argument persuasive that the
whole cells of Barclay would have not been combined with the biomass paste
describe in Kyle ‘591 (App. Br. 20-21). To the contrary, both publications
describe microbial oils with PUFAs that are useful feeds (col. 2, ll. 52-54; col. 9, ll.
1-4 (FF27); Barclay 314 (FF28)) and thus the ordinary skilled worker would have
combined them for these teachings. While each publication might also describe
additional products and by-products, such teachings would not impede the skilled
worker from seeing the benefit of applying Barclay’s slurry/spray drying method to
Kyle ‘591’s microbial oil.
Appellant also contends the compositions utilized in Barclay and Durrani are
different, and therefore persons of ordinary skill in the art would not have
combined their teachings about spray drying (App. Br. 21). This argument is not
persuasive. As already discussed above, the fact that spray drying techniques had
been applied to different types of compositions supports the Examiner’s position
Appeal 2011-011342
Reexamination 95/001,082
Patent 6,812,009

23 

that spray drying would have been expected to work, irrespective of the
components in the composition.
Appellant contends that Kyle ‘767 microbial oil would lack protein (App.
Br. 21). Appellant did not support this position with evidence. As already
discussed, the skilled worker would have had reason to apply Kyle ‘591’s teaching
about preparing a polar lipid fraction to the oil of Kyle ‘767. Appellant’s expert
acknowledged the polar lipid fraction contained microbial proteins (2d Gladue
Decl., p. 10, ¶ 22) (FF20). Thus, Appellant’s argument is not consistent with their
own expert testimony.
Appellant contends that claims 10, 11, 13-16, 52-53, 55, and 58-59 are
patentable over the prior art, but presented the same unpersuasive arguments as for
claim 1 and others (App. Br. 21).

Summary
For the foregoing reasons, after considering the evidence before us, we
conclude that the obviousness rejection based on Ground 19 is supported by
preponderance of the evidence. We affirm the obviousness rejection of claims 1-2,
4-11, 13-16, 24-25, 27, 29, 44-53, 55, 58-59, 73-77, 79-80, and 81-82.

GROUND 20
This ground of rejection differs from Grounds 18 and 19 by relying on
Kohn, rather than Kyle ‘591, for its teaching of a polar lipid fraction. Kohn was
cited by the Examiner for its teaching of a polar lipid fraction. The Examiner
concluded that it would have been obvious to add the polar lipid of Kohn to the
whole cell Schizochytrium extract of Barclay before spray drying the combined
Appeal 2011-011342
Reexamination 95/001,082
Patent 6,812,009

24 

material (RAN 31-32). By combining the references in this manner, the Examiner
stated the spray drying of Barclay would have been applied to the polar lipid
material of Kohn (RAN 31-32). Durrani was cited by the Examiner for its
disclosure of a process of spray drying a material (RAN 31-32). Henderson, Beach,
and Kendrick were cited as evidence of the composition of microbial cells (RAN
31).

Kohn
Appellant contends that the “claimed invention is readily distinguishable
from the refined phospholipids of Kohn, as [Kohn’s] refined phospholipids do not
include the claimed proteins of the polar lipid fraction of the present invention.
(Second Gladue Declaration at ¶¶ 23-26.)” (App. Br. 22.) Appellant also contends
that it “is well known that phospholipids are refined to remove ‘non-lipidic by-
products such as carbohydrates, proteins or other impurities.’ (Ex. F of the Ward
Declaration, Schneider, at 115.)” (App. Br. 23.)
Appellant’s argument, in a nutshell, is that Kohn teaches that its polar
phospholipid fraction must be refined before it is utilized in food and that such
refinement would necessarily include removing proteins. As the claims require
that the polar lipid fraction comprise protein, and Kohn’s polar lipid fraction
allegedly does not, Appellant contends the rejection does not satisfy all the
limitations of the claim. We therefore begin our analysis by examining Kohn’s
disclosure.
Kohn discloses a method of obtaining lipids with a high proportion of long
chain polyunsaturated fatty acids (LCPs) from algae (Kohn, col. 1, ll. 11-15 & 60-
62) [FF30]). The lipids “provide a foundation for producing foods, in particular
Appeal 2011-011342
Reexamination 95/001,082
Patent 6,812,009

25 

baby foods, among others” (Kohn, col. 2, ll. 58-59) [FF31]. To produce the lipids,
Kohn describes extracting the algae with solvent to produce an extract containing
the desired lipids (Kohn, col. 3, ll. 7-10; col. 4, ll. 24-26) [FF32]).
Kohn teaches the lipid extract can be further processed by additional
extraction steps:
From the miscella obtained with the aid of an organic solvent or from
the extract obtained from that and freed completely or partially of
solvent, extraction can be done once again with a compressed gas,
preferably carbon dioxide. In this preferred embodiment, the extract
obtained with the aid of the organic solvent was fractionated into a
nonpolar high triglyceride-containing fraction and a polar
phospholipid-containing fraction, which optionally after suitable
refinement can be used for manifold purposes.
(Kohn, col. 5, ll. 48-57 [FF33].)
The “polar phospholipid-containing fraction” of Kohn is produced from
algae through two solvent extraction steps. The resulting fraction corresponds to
the “polar lipid fraction” of the claims. The dispute in this rejection centers on
Kohn’s statements about further refining the polar phospholipid fraction:
• “a polar phospholipid-containing fraction, which optionally after suitable
refinement can be used for manifold purposes.” (Kohn, col. 2, ll. 55-57 (FF33).)
• “The LCP-containing lipid extracts or individual lipid fractions
(triglycerides, glycolipids, phospholipids, etc., or mixtures of both) according to
the invention may, optionally after conventional refinement and stabilization, be
used as an additive to the fat content of infant formulas.” (Kohn, col. 6, ll. 19-23
[FF34].)
• “Because of the characteristic proportions of LCP and their emulsifying
properties, phospholipid-containing fractions from algae raw materials in
particular, after suitable refinement and stabilization, can also be used as an
Appeal 2011-011342
Reexamination 95/001,082
Patent 6,812,009

26 

additive in fat emulsions for parenteral nutrition.” (Kohn, col. 6, ll. 28-32
(emphasis added) [FF35].)
Appellant’s position is that not only is refinement necessary for the
phospholipid fraction to be used in food, but refinement requires removal of
protein, since protein would be allergenic when present in foods. Appellant
supports this position with expert written testimony and a publication. Pertinent
evidence is as follows:
• Not all compositions containing phospholipids also contain proteins
of the source organism. Phospholipid extracts are typically purified to
remove nonlipidic byproducts such as carbohydrates, proteins or other
impurities. Schneider, Exhibit F of the Ward Declaration, at 115-116.
Further, removal of the proteins is required for a number of
sophisticated applications such as emulsifiers for parenteral
administration and infant formula. Schneider, Exhibit F of the Ward
Declaration, at 116. In certain applications, removal of even trace
proteins is required where allergenicity is a concern. (Id.) Thus
disclosure of phospholipids in a reference does not necessarily equate
to disclosure of a composition containing proteins of the source
organism.
(2d Gladue Decl. p. 5, ¶ 10 (emphasis added) [FF36].)
• As noted above, Kohn specifically discloses that lipids, such as the
polar phospholipid-containing fraction, can be used “after suitable
refinement.” (Kohn, col. 5, ll. 53-57). Refining of phospholipids
typically includes removal of non-lipophilic components such as
carbohydrates and proteins. Schneider, Exhibit F of the Ward
Declaration, at 115-116. Therefore, the phospholipids disclosed by
Kohn do not necessarily include proteins, even though Kohn discloses
obtaining a polar lipid fraction of a lipid extract.
(2d Gladue Decl. p. 10, ¶ 24 (emphasis added) [FF39].) [This decision does
not contain FF37 and FF38.]
Appeal 2011-011342
Reexamination 95/001,082
Patent 6,812,009

27 

The Schneider publication,17 referred to in Mr. Gladue’s second declaration,
is a book chapter describing the fractionation and purification of lecithin, a mixture
which comprises phospholipids (Schneider, p. 109 [FF40]). Schneider describes
obtaining lecithin from vegetable oil by solvent extraction (Schneider, p. 115
[FF41]), similar to the extraction procedure of Kohn. Pertinent disclosure of
Schneider is as follows:
Lecithin purification is the removal nonlipidic by-products such as
carbohydrates, proteins or other impurities.
(Schneider, p. 115) [FF42].)
In some cases, separation or nonlipidic contaminants is essential,
especially when the lecithin is used for sophisticated applications.
Examples are deoiled and fractionated lecithins such as emulsifiers for
intraveneous fat emulsions. Here especially, even slight traces of
proteins must be removed since they are of uncertain allergenic
potential to patients who are already suffering from severe illnesses.
(Schneider, p. 116) [FF43].)
Appellant also cited a written declaration by Dr. Lien, a scientist specializing
in the area of pediatric nutrition and infant formula research about the “problem of
allergenicity due to the protein content of infant formula is well recognized.” (Lien
Decl. ¶ 12 (FF23); (Lien Decl. ¶ 13 (FF24).)
Kohn refers to refinement and stabilization steps as optional, but the optional
steps appear to be included when the LCP is to be used in infant and parenteral
foods. The evidence introduced by Appellant supports this conclusion (Kohn, col.
6, ll. 19-23 (FF34); (Kohn, col. 6, ll. 28-32 (FF35); (2d Gladue Decl. p. 5, ¶ 10
(FF36); (Schneider, p. 116) (FF43). However, the preponderance of the evidence

17 Michael Schneider, Fractionation and Purification of Lechithin, in
LECHITHINS: Sources, Manufacture & Uses, 109-130 (Bernard F. Szuhaj ed.,
American Oil Chemists’ Society 1989).
Appeal 2011-011342
Reexamination 95/001,082
Patent 6,812,009

28 

does not establish that protein would necessarily be removed from the
phospholipid fraction before being incorporated into a food.
Schneider, which is relied upon by Appellant, describes removal of
“carbohydrates, proteins or other impurities” from the phospholipid fraction
(Schneider, p. 115; (FF42)). Schneider thus teaches three different components
that may be removed from the phospholipid fraction during purification, and states
this in the alternative (“or”), indicating that not all three must be removed.
Purification, as described by Schneider, would therefore reasonably be understood
to mean removal of just one component, but not all three, and not necessarily
protein.
Mr. Gladue cited the same disclosure in Schneider which described
removing “carbohydrates, proteins or other impurities” (Schneider, p. 115;
(FF42)), but misstated it in stating: “Refining of phospholipids typically includes
removal of non-lipophilic components such as carbohydrates and proteins.” ((2d
Gladue Decl. p. 10, ¶ 24 (FF39).) Schneider did not describe removing
carbohydrates and proteins, but rather made this statement in the alternative
(Schneider, p. 115; (FF42)).
There is evidence when the polar lipid fraction is used for certain purposes,
protein would typically be removed. When used in a food for infants and for
intravenous fat emulsions, Appellant provided evidence that protein would be
removed from the phospholipid fraction (see above). However, there is
countervailing evidence to the contrary, as discussed on page 18 above.
Nonetheless, Kohn’s teachings are not restricted to these purposes, but were more
broadly stated to be for “producing foods” (Kohn, col. 2, ll. 58-59 (FF31)). Thus,
even were true that protein was removed from foods intended for infants and
Appeal 2011-011342
Reexamination 95/001,082
Patent 6,812,009

29 

persons with severe illnesses, there is insufficient evidence that protein would be
removed when the fraction was used in other food products. Mr. Gladue, in his
written testimony, did not provide adequate evidence to the contrary. In sum,
Appellant’s argument that Kohn teaches that its polar phospholipid fraction would
lack proteins is not supported by the preponderance of the evidence before.

Combination
Appellant contends that the skilled worker would not have had reason to
combine Barclay, Kohn, and Kyle ‘767. Appellant contends that Barclay only
discloses an aquaculture feed and that Kohn describes the production of refined
lipids for “human nutrition” and fails to disclose any aquaculture uses whatsoever
(App. Br. 24). Appellant also argues that to the extent a person having ordinary
skill in the art would have thought the materials of Kohn useful for aquaculture,
they would have focused on the extracted biomass as suggested by Kyle ‘591,
which would fail to meet the recited limitation of a “polar lipid fraction.” (App. Br.
24.)
In making an obviousness determination, the first step is to ascertain the
prior art. Graham v. John Deere Co., 383 U.S. 1, 17-18 (1966). Prior art which is
pertinent to the claimed invention is referred to as “analogous” prior art.
Two criteria are relevant in determining whether prior art is
analogous: “(1) whether the art is from the same field of endeavor,
regardless of the problem addressed, and (2) if the reference is not
within the field of the inventor’s endeavor, whether the reference still
is reasonably pertinent to the particular problem with which the
inventor is involved.” Comaper Corp. v. Antec, Inc., 596 F.3d 1343,
1351 (Fed. Cir. 2010) (quoting In re Clay, 966 F.2d 656, 658-59 (Fed.
Cir. 1992)).
Wyers et al. v. Master Lock Co., 616 F.3d 1231, 1237 (Fed. Cir. 2010).
Appeal 2011-011342
Reexamination 95/001,082
Patent 6,812,009

30 

All three publications, like the claimed invention, involve similar microbial
compositions comprising polyunsaturated fatty acids and are therefore within the
same field of endeavor:
• “A docosahexaenoic acid (DHA), 22:6(n-3), rich strain of Schizochytrium
sp. was used in spray-dried form to evaluate the enhancement of highly unsaturated
fatty acids (HUFAs) in” Artemia and rotifers (Barclay 314) [FF44]
• “In the method of the invention to obtain lipids with a high proportion of
long-chain polyunsaturated fatty acids (LCPs) with 20 to 22 carbon atoms by
extraction from a raw material of animal or vegetable origin, unicellular algae
(microalgae), macroalgae from the families of the brown, red and green algae.”
(Kohn, Abstract [FF45].)
• “This invention relates to the production and use of arachidonic acid [a
polyunsaturated fatty acid] containing fungal oil (ARASCO) and to compositions
containing such oils. The oil can be referred to as a single cell oil. Fungi are
cultivated under oil-producing conditions, harvested and the oil extracted and
recovered.” (Kyle ‘767, col. 2, ll. 57-61) [FF46].)
Even if the publications do not describe exactly the same purposes for their
microbial extracts, they all involve utilizing the extract for food or dietary
supplements. They are therefore reasonably pertinent to the question of how to
prepare a microbial extract with a polyunsaturated fatty acid for producing food or
dietary supplement as in the claimed invention
A person of ordinary skill in the art would have found it obvious to apply
Barclay’s slurry and spray drying steps to Kohn’s microbial oil for their known and
expected advantages in making a particulate material in a convenient, easy to use
form (“Furthermore, spray-dried microalgae in their naturally encapsulated form
Appeal 2011-011342
Reexamination 95/001,082
Patent 6,812,009

31 

provide a dry source of HUFAs which may be easier to use than emulsified oil
products and minimizes the contamination of enrichment media with bacteria that
often occurs with emulsified oils.” Barclay 321, col. 1 [FF47]). KSR, 550 U.S. at
417 (“When a work is available in one field of endeavor, design incentives and
other market forces can prompt variations of it, either in the same field or a
different one. If a person of ordinary skill can implement a predictable variation, §
103 likely bars its patentability.”).
Appellant also contends that “combining the refined lipid products of Kohn
with the microbial material of Barclay fails to meet the claim limitation of a “polar
lipid fraction of a lipid extract comprising phospholipids and proteins.” (App. Br.
24.) However, as we have already discussed above that Kohn is not limited to a
refined lipid product, but also describes a polar lipid fraction.

Summary
For the foregoing reasons, after considering the evidence before us, we
conclude that the obviousness rejection based on Ground 20 is supported by
preponderance of the evidence. We affirm the rejection of claims 1-2, 4-7, 11, 50-
51, 53, 55, 73-77, 79-82 and 86-91.

GROUND 21
Claims 26, 78, and 83 are dependent claims which further recite that the
microbial cells from which the polar lipid fraction is prepared are Chlorella.
Kitagawa was cited by the Examiner for teaching that Chlorella, a unicellular
algae, comprises polyunsaturated fatty acids, such as EPA and DHA, and are
useful “feedstuffs” for Artemia (Kitagawa, col. 1, ll. 40-50; col. 1, 68 to col. 2, l.
Appeal 2011-011342
Reexamination 95/001,082
Patent 6,812,009

32 

17 [FF48]). The algae are lysed and spray dried (Kitagawa, col. 2, ll. 35-55
[FF49]. The Examiner found that it would have been obvious to have used
chlorella in the methods of Barclay and Kyle ‘767 methods since “since all three
are natural DHA producers (see Kitagawa at col. 6, lines 10-21).” (RAN 39.)
Appellant contends that Kitagawa’s disclosure is similar to Barclay’s in
using whole cells (App. Br. 25). Appellant argues, as they did for Ground 19, that
the combined publications do not describe a polar lipid fraction. As we have
addressed this argument, and found it unpersuasive, we affirm the rejection for the
reasons set forth by the Examiner.

GROUND 22
Claims 28 and 85 are dependent claims which further recite that the
microbial cells from which the polar lipid fraction is prepared are yeast. The
Examiner relied upon Herbert and Ratledge as teaching yeast as a source of fatty
acids and determined it would have been obvious to have used them as taught by
Barclay and Kyle ‘767. Appellant contends the claims are patentable for the
reasons as argued under Ground 19 (App. Br. 25). As we did not find these
arguments persuasive, we affirm the rejection for the reasons set forth by the
Examiner.

GROUND 24
Claim 43 is a dependent claim that recites that the microbial cells from
which the polar lipid fraction is prepared are Schizochytrium or Thraustochytrium.
Using the same rationale as for Grounds 21 and 22, the Examiner found it would
have been obvious to one of ordinary skill in the art to utilize Schizochytrium or
Appeal 2011-011342
Reexamination 95/001,082
Patent 6,812,009

33 

Thraustochytrium as taught by Barclay as the source of PUFAs. Appellant
contends the claims are patentable for the reasons as argued under Ground 18
(App. Br. 26). As we did not find these arguments persuasive, we affirm the
rejection for the reasons set forth by the Examiner.
SUMMARY
We affirm the rejection of all pending claims under Grounds 18-24 for the
reasons stated above and those of the Examiner.

CROSS-APPEAL
Requester contends that claims 1, 2, 4-11, 13-29, and 37-72 (corresponding
to present claims 1, 2, 4-11, 13-29, 43-55, 58,59 and 73-93) lack a written
description and enablement in compliance with 35 U.S.C. § 112, first paragraph, as
to the “polar lipid fraction comprises phospholipids and proteins” limitation. This
rejection was proposed by Requester on March 30, 2009, but was not adopted by
the Examiner (Action Closing Prosecution (“ACP” 22)). Requester cross-appeals
the Examiner’s decision not to adopt the rejection, but identifies the appeal as
“contingent” on the Board’s decision to reverse one of more rejections under 35
U.S.C. § 103(a). (Requester App. Br. 6.)
We have held all the pending claims to be unpatentable. Therefore, it is not
necessary for us to reach the additional grounds proposed. However, because
Requester filed a timely Notice of Appeal and subsequent Appeal Brief, we have
jurisdiction to decide the cross-appeal. Thus, although Requester characterizes the
appeal as contingent, we decline to treat it as so and exercise our discretion to
decide the matter. After reviewing all the evidence before, including the
declarations present by both sides, we find that the Examiner’s decision not to
Appeal 2011-011342
Reexamination 95/001,082
Patent 6,812,009

34 

adopt the rejection as set forth on pages 20-22 in the Action Closing Prosecution is
supported by a preponderance of evidence. We there affirm the Examiner’s
decision for the reasons stated therein.

TIME PERIOD FOR RESPONSE
Requests for extensions of time in this inter partes reexamination
proceeding are governed by 37 C.F.R. § 1.956. See also 37 C.F.R. § 41.79.

AFFIRMED

KMF

For Patent Owner:
STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C
100 New York Avenue, N.W.
Washington, DC 20005

For Third Party Requester
BAKER, DONELSON, BEARMAN, CALDWELL & BERKOWITZ
920 Massachusetts Avenue, N.W., Suite 900
Washington, DC 20001