BASF Plant Science Company GMBH

Patent Trials and Appeals Board

Oct 1, 2021

PGR2020-00057 (P.T.A.B. Oct. 1, 2021)

Trials@uspto.gov Paper 35
571-272-7822 Entered: October 1, 2021

UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE PATENT TRIAL AND APPEAL BOARD

COMMONWEALTH SCIENTIFIC AND INDUSTRIAL RESEARCH
ORGANISATION,
Petitioner,
v.
BASF PLANT SCIENCE COMPANY GMBH,
Patent Owner.

PGR2020-00057
Patent 10,351,870 B2

Before ULRIKE W. JENKS, JEFFREY W. ABRAHAM, and
ROBERT A. POLLOCK, Administrative Patent Judges.
POLLOCK, Administrative Patent Judge.

JUDGMENT
Final Written Decision
Determining All Challenged Claims Unpatentable
35 U.S.C. § 328(a)
Denying In Part Petitioner’s Motion to Exclude Evidence
37 C.F.R. § 42.64

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I. INTRODUCTION
A. Procedural Background and Summary
Commonwealth Scientific and Industrial Research Organisation
(“CSIRO” or “Petitioner”) filed a Petition requesting post-grant review of
claims 1–17 (“the challenged claims”) of U.S. Patent No. 10,351,870 B2
(Ex. 1001, “the ’870 patent”). Paper 1 (“Pet.”). BASF Plant Science
Company GMBH (“Patent Owner”) filed a Preliminary Response to the
Petition. Paper 7 (“Prelim. Resp.”).
We determined that the ’870 patent was eligible for post-grant review
and that Petitioner demonstrated that it is more likely than not that at least
one of the challenged claims was unpatentable. Accordingly, we instituted
trial as to claims 1–17 of the ’870 patent. Paper 9 (“Institution Decision” or
“Dec.”).
After institution, Patent Owner filed a Response to the Petition (Paper
14, “PO Resp.”), Petitioner filed a Reply to Patent Owner’s Response (Paper
20, “Reply”), and Patent Owner filed a Sur-reply (Paper 21, “Sur-reply”).
Patent Owner also filed a Motion to Exclude (Paper 27, “Mot.”); Petitioner
filed an Opposition to Patent Owner’s Motion to Exclude (Paper 28,
“Opp.”).
On July 8, 2021, the parties presented arguments at an oral hearing.
The transcript of the hearing has been entered into the record. Paper 34
(“Tr.”).
B. Real Parties-in-Interest
Petitioner identifies itself as the real party-in-interest. Pet. 4. Petitioner
further identifies Grains Research and Development Corporation, Nuseed
Pty Ltd., Nuseed Americas Inc. and its parent, Nufarm Limited, as
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“commercial partners of CSIRO, and co-owners with CSIRO of their own
patents in the field of polyunsaturated ω3-fatty acids,” but does not
expressly identify these entities as real parties-in-interest. Id. at 4–5. Patent
Owner identifies itself as the real party-in-interest. Paper 5, 1. The parties do
not dispute the identification of real parties-in-interest.
C. Related Matters
Petitioner and Patent Owner identify pending U.S. Application No.
16/502,970, filed July 3, 2019, which is a continuation of U.S. Application
No. 15/351,962, which issued as the ’870 patent. Pet. 5; Paper 5.
The parties report that the ’870 patent is not the subject of any other
judicial or administrative matter. Pet. 6; Paper 5. Petitioner notes, however,
that it “and related parties have been involved in judicial proceedings
relating to Petitioner’s patents in the field of ω-3 polyunsaturated fatty acid
synthesis,” including BASF Plant Science, LP et al. v. Commonwealth
Scientific and Industrial Research, United States District Court for the
Eastern District of Virginia Norfolk Division, Civil Action No. 2:17-cv-
00503-HCM-LRL (“the Virginia Litigation”). Pet. 6; see Prelim. Resp. 10–
15; Sur-reply 8.
D. The ’870 Patent (Ex. 1001) and Relevant Background
The Specification of the ’870 patent relates to the recombinant
manufacture of polyunsaturated fatty acids or “PUFAs” in a wide range of
non-human transgenic organisms, preferably “a plant, plant part, or plant
seed.” Ex. 1001, 1:26–27, 17:4–8, 21:65–22:5. The Specification explains
that “[f]atty acids can be divided into two groups: saturated fatty acids
formed of single carbon bonds and the unsaturated fatty acids which contain
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one or more carbon double bonds in cis-configuration.” Id. at 1:45–48. With
respect to the latter, the Specification defines PUFAs as comprising at least
two double bonds and, preferably, fatty acids chains of 18–24 carbon atoms.
Id. at 22:6–10. These include linoleic acid (18:2) and α-linoleic acid (18:3),
where 18 refers to the number of carbons in the fatty acid chain and 2 or 3
refers to the number of double bonds. Id. at 1:62–64; Ex. 1002 (Yadav
Declaration) ¶ 26; see also id. ¶¶ 31 for a fuller explanation of fatty acid
nomenclature.
The Specification further refers to long chain polyunsaturated fatty
acids having fatty acid chains of 20 to 24 carbon atoms as “LCPUFA.”
Ex. 1001, 22:10–12. These include arachidonic acid or ARA (20:4),
eicosapentaenoic acid or EPA (20:5), docosahexaenoic or DHA (22:6), and
docosapentaenoic acid or DPA (22:5). Id. at 22:13–20; Ex. 1002 ¶ 31.
According to the Specification, “beneficial health effects have been
shown for DHA or mixtures of EPA/DHA,” but “the major sources of DHA
are oils from fish and algae,” each of which has its disadvantages. Ex. 1001,
2:1–48, 65–66. Accordingly, the Specification discloses “an improved and
efficient method” for large-scale production of such preferred LCPUFAs in
transgenic plants “capable of synthesizing fatty acids, such as all
dicotyledonous or monocotyledonous plants, algae, or mosses.” Id. at 3:1–6,
17:8–12; see id. at 17:14–21:35 (enumerating preferred plants). In some
embodiments, the host plant is an oilseed crop such as rapeseed (Brassica
sp.), soybean, (Glycine sp.), or corn (Zea mays). Id. at 13:24–34; see also id.
at 71:44–51 (claim 3), and 72:43–50 (claim 11).
According to Patent Owner, “EPA and DHA are not naturally
produced in plants.” PO Resp. 7 (citing Ex. 2012 (Sederoff Declaration)
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¶ 22). To induce the production of EPA, DHA, and other LCPUFAs in a
host plant, the Specification discloses the introduction of heterologous
nucleic acids encoding various desaturases and elongases from various
organisms including the phytoplankton Emiliana huxleyi. See Ex. 1001, 3:1–
4:21, 7:62–8:6, 14:17–15:47 (listing preferred desaturases and elongases). In
this respect, Tables 2–4 disclose “[e]xemplary suitable combinations of
genes” favoring the production of ARA, EPA, and DHA, respectively. Id. at
28:23–29:8; see, e.g., PO Resp. 20 (highlighting E. huxleyi genes among the
desaturases and elongases of Table 4).
The underlying biology of PUFA synthesis in plants is discussed at
Pages 4–7 and 11–12 of the Patent Owner Response. Figure 1 of Exhibit
2018, reproduced below, provides particularly relevant background:
Figure 1 of Exhibit 2018 shows a general overview of lipid biosynthesis in
plants. “Fatty acid synthesis occurs in the plastid [aka chloroplast] through a
series of reaction that incorporates acyl moieties of acetyl-Coenzyme A
(-CoA) into acyl group of 16 or 18 carbon atoms.” Ex. 2018, 684, Fig. 1.
These products, C16:0-CoA, C18:0-CoA, and C18:1-CoA, are exported to
the cytosol and taken up by the endoplasmic reticulum where they can be
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converted into PUFAs, including linoleic acid (18:2) and α-linolenic acid
(18:3), via the eukaryotic biosynthetic pathway. Id.; Ex. 2012 ¶¶ 19–20;
Tr. 19:9–19.
In the endoplasmic reticulum, some portion of PUFAs and other fatty
acids are converted to triacylglycerides (“TAGs”). See Ex. 1002 ¶¶ 26–29;
2012 ¶¶ 19–21, 23.1 Some portion of these TAGs may be sequestered in oil
bodies, which comprise, among other things, the long term oil storage
compartments in mature seeds. Id.; see Ex. 2015, Abstract, Figs. 2, 3;
Ex. 2012 ¶ 21.
In the eukaryotic (aerobic) biosynthetic pathway relevant to the ’870
patent, PUFAs are synthesized in the endoplasmic reticulum via a series of
alternating steps of desaturation (the addition of a double bond/removal of
hydrogen atoms) and “elongation” (the addition of two carbon atoms by
desaturase and elongase enzymes, respectively). Pet. 12; Ex. 1002 ¶¶ 34–35.
Figure 1 of the ’870 patent, reproduced below, illustrates biochemical
pathways in which the enzymes of the aerobic pathway can lead to
production of ARA, EPA, DHA, and related compounds.2

1 As a matter of convenience, we will generally omit reference to
Coenzyme A and triacylglycerol moieties in discussing the synthesis of
various fatty acids.
2 Figure 1 distinguishes between “aerobic,” “PKS (anaerobic)” and
“Sprecher” pathways. We refer herein to the “aerobic pathway” of Figure 1,
unless otherwise specified.
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Figure 1 shows “the different enzymatic activities leading to the production
of ARA, EPA and DHA,” including seven enzymatic activities of the
aerobic pathway.3 Ex. 1001, 24:40–42; Tr. 16:8–13. Although Figure 1
shows nine steps in the aerobic pathway, several of these activities (e.g., Δ9-
elongase, Δ8-desaturase) appear at multiple points in the pathway.

3 For the purpose of this Decision, we consider Δ7-elongase as part of a
separate “Sprecher” pathway.
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Table 4 of the ’870 patent is reproduced below.
Table 4 recites eleven specific genes for ten enzyme activities, including two
Δ5 elongase genes, D5Elo(Eh) from Emilana huxleyi and D5Elo(Ot) from
Ostreococcus tauri. Ex. 1001, 7:62–66, 15:12–13; Pet. 16–17; Ex. 1002
¶ 14.4 The ten enzymatic activities of Table 4 include the seven listed in
Figure 1 (Δ5-, Δ6-, Δ9 elongases and Δ4-, Δ5-, Δ6-, Δ8-desaturases) plus

4 “Delta,” “Δ,” and occasionally “d” or “D” are used interchangeably in this
proceeding.
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three additional activities: omega 3 desaturase, Δ12 desaturase, and
Δ15 desaturase.5
The ’870 Specification contains nine Examples. Of these, Example 9
discloses the results of Arabidopsis thaliana plants transformed with various
combinations of desaturase and elongase genes. Ex. 1001, 29:9–30:51; see
also id. at 29:9–19 (disclosing transgene combinations AP2, OstELO5TcD4,
and OstELO5E5mD4, “[b]ased on gene combinations as described in Table
2, Table 3, or Table 4”); see also Ex. 1002 ¶¶ 42–43 and n.8 (identifying
typographical errors).
Figure 10 discloses seed oil profiles of thirty-two plant lines
transformed with the OstELO5E5mD4 combination, which encodes five of
the activities listed in Table 4, including the Δ4 desaturase from Emilana
huxleyi, encoded by d4Des(Eh). Ex. 1001, 24:66–25:3, 29:13–15, 30:5–14,
Fig 10; Ex. 2012 ¶ 41.
Figure 11 of the ’870 patent discloses “[g]as chromatographic analysis
of mature Arabidopsis seeds transformed with different constructs,”
including OstELO5E5mD4. Ex. 1001, Fig. 11.
According to the Specification, “[a]ll lines show the production of
DHA with levels of up to 4.7%. Of special interest is the ratio of DHA to

5 In the pathway to DHA, Δ12 desaturase can convert oleic acid (18:1) to
linoleic acid (18:2); Δ15 desaturase can convert linoleic acid (18:2) to alpha
linoleic acid (18:3). Ex. 1013, Fig. 1; Ex. 1016, 80:4–81:3; 89:18–22.
Evidence of record suggests that the omega 3 desaturase can convert omega
6 fatty acids to omega 3 fatty acids at several points within the aerobic
pathway. See Ex. 2030, 9780 (Figure 1), 9786 (“The availability of the ω 3-
desaturase gene from Thraustochytrium sp. may allow to merge the ω 6-
pathway with the ω 3-pathway at different stages to increase the proportion
of ω 3-PUFAs in transgenic oilseed plants, such as rapeseed, with high
proportions of linoleic acid.”).
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DPA.” Id. at 30:11–13. The Specification further states that “[a] high ratio of
DHA:DPA is for the commercial use of such oils of importance.” Id. at
30:20–21. In this respect, the Specification describes Figure 11 as “a
comparison between two d4-desaturases (Tc and Eh) showing that
d4Des(Eh) is different from known d4-desaturases in producing a high ratio
of DHA:DPA.” Id. at 25:4–7. More particularly, Figure 11 reports “[v]alues
. . . generated from the best individual Arabidopsis line,” wherein, “[t]he
construct with the d4Des(Eh) delivered the highest levels of DHA [4.7%]
and highest ratio of DHA:DPA (2.9).” Fig. 11; see also id. at 30:14–15
(“Surprisingly, the [DHA:DPA] ratio of d4Des(Eh) is much higher than in
d4-desaturases known in the art.”). As noted in the Petition, a comparison of
the reported fatty acid percentages in Figures 10 and 11, indicates that the
“best individual Arabidopsis line” reproduced in Figure 11 is
“OstELOEmD4_7,” and has reported seed oil levels of 3.8% EPA, 1.6%
DPA, and 4.7% DHA. Pet. 19 (citing Ex. 1002 ¶ 45).
In addition to the Arabidopsis data discussed above, Example 9
indicates that “[t]ransgenic rapeseed lines were generated” but specifies
neither the transgenes used nor the results obtained in any Brassica plant.
See Ex. 1001, 29:20–21.
E. Prosecution History
The ’870 patent issued on July 16, 2019, from Application
No. 15/351,962, filed November 15, 2016 (“the ’962 application”), which is
a continuation of Application No. 13/384,277 (“the ’277 application”), now
U.S. Patent No. 9,493,520. Ex. 1001, codes (21), (45), (63); 1:7–9. The ’277
application is a national stage application of PCT/EP2010/060178, filed July
15, 2010, which claims the benefit of U.S. Provisional Application No.
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61/226,301 and European Application No. 09165752.8, both filed on July
17, 2009. Id. at codes (30), (60); 1:10–13; Ex. 1004; Ex. 1005.
Patent Owner refers to PCT/EP2010/060178, which published as WO
2011/006948 (Ex. 1003), as its “2010 priority application.” PO Resp. 33. All
of the above-identified applications preceding the ’962 application are
referred to herein as the “Earlier Applications.” The parties agree that the
’962 application and the Earlier Applications contain the same disclosure as
pertinent to this case. See Pet. 21–22; Prelim. Resp. 5, 27–28, 27 n.2; PO
Resp. 33; Ex. 1002 ¶¶ 50–51.
Petitioner provides the following illustration of the various
applications and their filing dates, both before and after March 16, 2013.

The illustration above shows a timeline including application numbers
and filing dates for each of the applications in the priority chain for the ’870
patent. Pet. 32.
During prosecution of the ’962 application, Patent Owner filed an
amendment that cancelled claim 1 and presented new claims 2–16 (the
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“December 2017 amendments”). Ex. 1006, 194–95. Those new claims
included the following limitations:
wherein the oil comprises at least 1% docosahexaenoic acid
(DHA) and at least 1% but not more than 7% eicosapentaenoic
acid (EPA);
wherein the oil has a ratio of DHA to docosapentaenoic acid
(DPA) of at least 2; and
wherein the oil has a conversion rate of docosapentaenoic acid
(DPA) to DHA of at least 75%.
Id. (see new claims 2 & 9).
Patent Owner also provided a statement of support for the December
2017 amendment. Id. at 196. In addition to citing exemplary page, line, and
figure numbers, the statement of support reads: “Applicant notes that the
amounts of docosahexaenoic acid (DHA), docosapentaenoic acid (DPA),
and eicosapentaenoic acid (EPA) produced in the transgenic Arabidopsis
lines listed in Figure 10 implicitly support the limitations recited in the
present claims in connection with the amounts of those fatty acids.” Id.
Patent Owner concluded that “Applicant submits herewith that no new
matter has been added in the present amendment.” Id.
On December 21, 2018, Patent Owner filed further amendments to the
pending claims that, as pertinent here, limited the amount of EPA to “at least
1% but not more than 6%” in challenged claims 1 and 9, and to “at least 1%
but not more than 5%” in challenged claims 7 and 16 (the “December 2018
amendment”). Id. at 251–262. Patent Owner cited no additional support for
the December 2018 amendment.
The pertinent claim limitations resulting from the December 2017 and
December 2018 amendments (the “December Limitations”) are as follows:
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wherein the oil comprises at least 1% docosahexaenoic acid
(DHA) and at least 1% but not more than 6% eicosapentaenoic
acid (EPA) (challenged claims 1 and 9);
wherein the oil has a ratio of DHA to docosapentaenoic acid
(DPA) of at least 2 (challenged claim 1); and
wherein the seeds of the transgenic plant have a conversion rate
of docosapentaenoic acid (DPA) to DHA of at least 75%
(challenged claim 9).
See id. at 259–60.
Relevant to Grounds 1–10 we credit Petitioner’s unopposed assertion
that “there is no record of the Examiner analyzing the Written Description or
Enablement of the presented claims during prosecution.” Pet. 26 (citing
Ex. 1006, 174–179, 214–227, 269–273).
F. Illustrative Claims
Claims 1 and 9 are the only independent claims. Patent Owner focuses
its arguments on claims 5 and 13, which are directed to the genus Brassica,
but ultimately depend from claims 1 and 9, respectively.
Claim 1 recites:
1. Plant seed oil obtained from seeds of a transgenic plant,
wherein the oil comprises at least 1% docosahexaenoic acid
(DHA) and at least 1% but not more than 6% eicosapentaenoic
acid (EPA), based on the total fatty acids of the transgenic seeds,
and wherein the oil has a ratio of DHA to docosapentaenoic acid
(DPA) of at least 2.
Ex. 1001, 71:37–42. Among the claims depending from claim 1, claim 5
depends from claim 2, which depends from claim 1. Claim 2 provides that
“the transgenic plant is a transgenic oilseed plant.” Id. at 71:43–44. Claim 5
further provides that “the oilseed plant is a Brassica plant.” Id. at 71:54–55.
Claim 9 recites:
9. Plant seed oil obtained from seeds of a transgenic plant,
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wherein the oil comprises at least 1% docosahexaenoic acid
(DHA) and at least 1% but not more than 6% eicosapentaenoic
acid (EPA), based on the total fatty acids of the transgenic seed,
and wherein the seeds of the transgenic plant have a conversion
rate of docosapentaenoic acid (DPA) to DHA of at least 75%.
Id. at 71:63–72:40. Claim 13 depends from claim 10, which depends from
claim 9. Claims 10 and 13 recite essentially the same limitations as claims 2
and 5, respectively.
G. Asserted Grounds of Unpatentability
Petitioner asserts that the challenged claims are unpatentable on the
following grounds. Pet. 26–28.
Ground
Claim(s)
Challenged

35 U.S.C. § Reference(s)/Basis
1 1–17 112(a) Written description
2 1–8, 14 112(a) Written description
3 9–17 112(a) Written description
4 1–17 112(a) Written description
5 1–17 112(a) Written description
6 6, 15 112(a) Written description
7 7, 16 112(a) Enablement
8 8, 17 112(a) Enablement
9 1–17 112(a) Enablement
10 1–5, 7, 8, 14 112(a) Enablement
11 9–14, 16, 17 112(a) Enablement
12 6, 15 112(a) Enablement
13 1–17 102(a)/103 Bauer6
14 1–4, 6–12, 14–17 102(a) Napier7

6 Bauer et al., PCT International Application Publication No.
WO2011/006948 A1, published Jan. 20, 2011 (“Bauer”). Ex. 1003.
7 Napier et al., PCT International Application Publication No. WO
2013/153404 A1, published Oct. 17, 2013 (“Napier”). Ex. 1010.
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15 1–5, 7–14, 16, 17 102(a) Petrie I8
16 1–17 103 Petrie II9
With respect to the 112(a) grounds, we note that the Petition asserts
that the challenged claims (1–17), as a group, lack written description
support under three separate grounds. Those grounds include the limitations
“seeds of a transgenic plant,” “at least 1%” DHA, “at least 1% but not more
than 6%” EPA, and the combination of those limitations plus either a ratio of
DHA to DPA of “at least 2” or a conversion rate of DPA to DHA of “at least
75%.” See Pet. 36–38, 45–48 (Grounds 1, 4, & 5). In contrast, only one
enablement ground, Ground 9, is directed to all 17 challenged claims,
whereas the remaining three enablement grounds are directed to different
sets of the challenged claims.
Petitioner relies on the Declaration of Narendra Yadav, Ph.D. in
support of its arguments. Ex. 1002; see also Ex. 2017 (transcript of
Dr. Yadav’s deposition); Ex. 2029 (transcript of Dr. Yadav’s deposition in
PGR2020-00033). Patent Owner relies on the Declaration of Heike Sederoff,
Ph.D. in support of its arguments. Ex. 2012; see also Ex. 1016 (transcript of
Dr. Sederoff’s deposition); Ex. 1017 (Dr. Sederoff’s declaration in
PGR2020-00033).

8 Petrie et al., PCT International Application Publication No. WO
2013/185184 A2, published Dec. 19, 2013 (“Petrie I”). Ex. 1008.
9 Petrie et al., PCT International Application Publication No. WO
2010/057246 A1, published May 27, 2010 (“Petrie II”). Ex. 1013.
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II. ANALYSIS
As indicated above, Petitioner challenges claims of the ’870 Patent as
unpatentable as lacking sufficient written description, as non-enabled, and as
obvious over and/or anticipated by the prior art. Pet. 26–28. As each of these
challenges is assessed from the perspective of the person of ordinary skill in
the relevant field, we begin with a consideration of the level of ordinary skill
in the art.
A. Level of Ordinary Skill in the Art
Relying on the testimony of Dr. Yadav, Petitioner contends that a
person of ordinary skill in the art “would have had at least a Ph.D. in
molecular biology, molecular genetics, biochemistry, or a related field and at
least 3–5 years of experience in molecular genetics or biology, plant
genetics, or recombinant DNA techniques.” Pet. 31; see Ex. 1002 ¶ 15.
Petitioner further asserts that the ordinarily skilled artisan “need not have
every qualification enumerated above and more experience, such as research
work on plant lipids, can compensate for less formal education.” Pet. 31
(citing Ex. 1002 ¶ 15). Although Patent Owner opposed this definition prior
to the institution stage, it did not then propose an alternative definition and
we adopted Petitioner’s definition solely for the purpose of institution. See
Dec. 8–9.
Patent Owner now argues that Petitioner’s definition is “too general”
given “the specificity with which the ’870 patent is focused on plant
genetics, transformation of plants, and the functional characteristics of plant
lipids and the capabilities of plants to produce those lipids.” PO Resp. 25
(citing Ex. 2012 ¶ 55). Patent Owner argues that Petitioner’s expert in the
Virginia Litigation provided a definition of one of ordinary skill in the art
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having, inter alia, “at least 3–5 years of research work on plant lipids” with
respect to an application “so sufficiently similar in field to the ’870 patent
that there is no reasonable basis for defining the POSA [person of ordinary
skill in the art] differently.” Id. at 26 (citing Ex. 2027 (Declaration of
Petitioner’s expert, Dr. Kunst, in the Virginia Litigation) ¶ 30); see also
Prelim. Resp. 11–12 (citing Ex. 2003, 5) (asserting that CSIRO (Petitioner)
characterized its patents in the Virginia Litigation as directed to “production
of EPA and DHA in plant cells,” which “enabled the production of LC-
PUFAs like DHA in canola plants [Brassica napus]”).10 Patent Owner thus
proposes that we apply Dr. Sederoff’s definition of one of ordinary skill in
the art as “someone with a Ph.D. in plant molecular biology, lipid
biochemistry, or lipid metabolism and at least three years of work
experience (excluding Ph.D. thesis studies) in lipid biochemistry, or lipid
metabolism.” PO Resp. 26 (citing Ex. 2012 ¶ 55).
Although the precise definition of the person of ordinary skill in the
art is not dispositive of Petitioner’s grounds, we find it useful in framing the
field of the invention. While we agree with Petitioner’s emphasis on plant
recombinant DNA techniques, Patent Owner’s focus on plant genetics and
plant lipids is well taken. As noted in the Patent Owner Response, the
challenged claims are “directed to plant seed oils produced by a transgenic

10 Petitioner does not contest Patent Owner’s assertions regarding the
similarities between the subject matter of the ’870 patent and the patents at
issue in the Virginia litigation but asserts that its arguments in the Virginia
litigation differed from those presented here, that those arguments were not
accepted by the judge, and that “CSIRO ended up giving BASF a covenant
not to sue on every single patent that had the language ‘at least a number
with no upper limit.’” See Ex. 2005, 5–16; Ex. 2003, 14–16; Tr. 75:25–
76:11.
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plant,” whereas the portions of the Specification most relevant to those
claims describe “genetically modified plants capable of producing certain
oils, lipids, and fatty acids, and the genetic techniques related thereto.”
PO Resp. 24–25 (citing Ex. 2012 ¶ 54); see also section I.D, above.
Considering the above, as well as the ’870 patent and cited art, we
view a person of ordinary skill in the relevant art as having a working
knowledge of plant recombinant DNA techniques, a Ph.D. in plant
molecular biology, lipid biochemistry, or lipid metabolism, and three years
of work experience (excluding Ph.D. thesis studies) in lipid biochemistry or
lipid metabolism as applied to plants.
B. Claim Construction
We interpret a claim “using the same claim construction standard that
would be used to construe the claim in a civil action under 35 U.S.C.
282(b).” 37 C.F.R. § 42.100(b) (2019). This standard requires that we
construe claims “in accordance with the ordinary and customary meaning of
such claim[s] as understood by one of ordinary skill in the art and the
prosecution history pertaining to the patent.” Id.; see also Phillips v. AWH
Corp., 415 F.3d 1303 (Fed. Cir. 2005). Only those terms that are in
controversy need be construed, and only to the extent necessary to resolve
the controversy. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795,
803 (Fed. Cir. 1999); see also Nidec Motor Corp. v. Zhongshan Broad
Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (applying Vivid
Techs. in the context of an AIA trial proceeding). In the matter before us,
this involves the construction of terms encompassing the words “at least.”
As an initial matter, Patent Owner implies that we should hold
Petitioner to positions it took in defending “nearly identical claim terms” in
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the Virginia Litigation. See, e.g., Sur-reply 8–9. We recognize that both
parties took essentially opposite positions in that proceeding compared to
those espoused here regarding the meaning of “at least [x]%” and, rather
than tie terms containing that language to some “inherent upper limit
enabled by the specification,” the district court in the Virginia Litigation
applied the plain and ordinary meaning. See Dec. 11–12; Ex. 2003, 14–16;
Ex. 2006, 10, 14; Ex. 2007, 11–12 n.2, 14; Sur-reply 8–10; see also PO
Resp. 39; Ex. 2008 (further indicating that the parties took opposite positions
the Virginia Litigation regarding the extent disclosure regarding Arabidopsis
supports Brassica claims). Although the two proceedings involve different
patents, the similarities of subject matter and claim language suggest efforts
to twist the claims, “like ‘a nose of wax,’” in “one way to avoid [invalidity]
and another to find infringement.” Amazon.com, Inc. v.
Barnesandnoble.com, Inc., 239 F.3d 1343, 1351 (Fed. Cir. 2001). But as
both parties engage in the same behavior, and for the reasons set forth in our
Institution Decision, we decline to hold either party to its prior position, or
import a construction from a different proceeding involving different
patents, claims, specifications, and prosecution histories. See Dec. 12 (citing
Phillips, 415 F.3d at 1315).
In the case before us, independent claims 1 and 9 are directed to plant
seed oil obtained from seeds of a transgenic plant, wherein the oil has “at
least 1% docosahexaenoic acid (DHA);” “at least 1% but not more than 6%
eicosapentaenoic acid (EPA);” “a ratio of DHA to docosapentaenoic acid
(DPA) of at least 2” (claim 1 only); and “a conversion rate of
docosapentaenoic acid (DPA) to DHA of at least 75%” (claim 9 only).
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Petitioner points out that while these phrases use the open-ended term
“at least” followed by a percentage value or a ratio value, none of them
recite an upper limit for the feature referenced. Pet. 30. Addressing these
upper limits, Petitioner contends that we should construe “at least” X% to
mean from X% up to 100% or “up to the highest mathematically possible
percentage after taking account of the other recited features in the claim.” Id.
Accordingly, Petitioner asserts, we should construe “at least 1%
docosahexaenoic acid (DHA)” “to cover amounts of DHA from 1% to 99%
(since the claims also require a minimum amount of 1% EPA).” Id.
Petitioner also contends we should construe the ratio of DHA to DPA
of “at least 2” specified in claim 1 to cover a ratio from 2 up to infinity, and
the conversion rate of DPA to DHA “of at least 75%” recited in claim 9 to
cover a conversion rate of 75% to 100%. Id. at 30–31 (citing Ex. 1002 ¶ 57).
In response, Patent Owner substantively addresses only the
construction of “at least 1% docosahexaenoic acid (DHA).” PO Resp. 27–
30; Sur-reply 3–10. In particular, Patent Owner proposes that we construe
this term to mean “from 1% docosahexaenoic acid (DHA) to the sum of the
percent of 18:2 (linoleic acid) and 18:3 (α-linolenic acid) in the transgenic
plant species.” PO Resp. 30; Ex. 2012 ¶ 64.
Referencing Figure 1 of the ’870 patent, Patent Owner contends that
(1) linoleic acid (18:2) and α-linolenic acid (18:3) are the sole starting
materials that can be converted in DHA and, (2) plants do not have a
feedback mechanism to make more linoleic acid (18:2) and α-linolenic acid
(18:3) if these starting materials are depleted. See generally PO Resp. 11–13,
27–30; Sur-reply 3–5 (citing Ex. 2012 ¶ 28). Accordingly, Patent Owner
contends, one of ordinary skill in the art would understand that the sum of
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the amount of linoleic acid (18:2) and α-linolenic acid (18:3) in a particular
plant “serves as a cap on the amount of DHA that could be produced in any
transgenic plant.” PO Resp. 28. Pointing to evidence that the amount of
linoleic acid (18:2) and α-linolenic acid (18:3) in various Brassica species
ranges from 23% to 39% of total seed oil, Patent Owner argues that the
“theoretical upper bound to ‘at least 1% DHA” for the entire genus of
Brassica recited in claims 5 and 13 is “about 40% DHA.” Id. (citing
Ex. 2012 ¶ 63); id. at 59 (“In the case of Brassica oilseed plants, the
maximum amount of 18:2 and 18:3 is about 40%.”) (citing Ex. 2012 ¶ 129).
Patent Owner relies on expert testimony indicating that there is no
known feedback mechanism for a plant to make more linoleic acid (18:2)
and α-linolenic acid (18:3) if these starting materials are depleted. Id. at 11
(citing Ex. 2017, 18:12–19:7; Ex. 2012 ¶ 26); Sur-reply 10. Patent Owner
further points to the following “admission” as evidence that Petitioner’s
expert, Dr. Yadev, agrees with its proposed construction:
Q. You . . . would agree with me that the maximum amount you
could make would be the amount of starting material that you
have to start with, that is the 18:2 and the 18:3, correct?
A. Yes.
Q. If you only start with a certain percentage of 18:2 and 18:3,
even if the enzymes were 100 percent efficient the only -- the
maximum amount you could make is the full conversion of
18:2 and 18:3 to DHA, correct?
A. Yes, generally speaking, yes.
Q. And, so, you would agree with me that that’s a theoretical
maximum of DHA that could be produced in plants?
A. In a given plant at a given time, yes.
PO Resp. 10 (quoting Ex. 2017, 18:12–19:7), 41; Sur-reply 10; Tr. 54:1–
55:25.
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We do not view Dr. Yadav’s testimony as the admission Patent Owner
proposes. As Petitioner points out, that portion of the deposition focused on
the biochemical pathway set forth in Figure 1 of the ’870 patent. Reply 7
(citing Ex. 2017, 17:20–18:3; 18:19–19:2). Taken in context, we understand
Dr. Yadav’s supposed “admission” as merely agreeing that: if you only start
with a certain percentage of 18:2 and 18:3—as shown in the scheme set forth
in Figure 1—the maximum amount you could make is the full conversion of
18:2 and 18:3 to DHA. This understanding comports with the preceding
testimony in which Dr. Yadav was expressly asked about the starting
materials for the process set forth in Figure 1. Ex. 2017, 13:19–14:9.
Dr. Yadav explained that Figure 1 represented “the tail end of the pathway
that makes ARA, EPA and DHA. And upstream of this is the biosynthesis of
the precursors of 18:2 and 18:3, which includes 18:0, 16:0, 18:1 and the
like.” Id. at 14:10–14.11 Accordingly, we read Dr. Yadav’s “admission” as
intentionally excluding potential upstream precursors because he understood
the context of the question to relate solely to the enzymatic reactions set
forth in Figure 1.
Consistent with our interpretation, Dr. Yadav qualified the passage
Patent Owner relies on as pertaining to “a given plant at a given time.” See
id. at 19:7. Taken in context, “at a given time” readily admits the possibility
that additional 18:2 (linoleic) and/or 18:3 (α-linoleic) can be made from, for
example, 18:0, 16:0, and 18:1 fatty acid precursors that he identified earlier
in the line of questioning. See id. at 14:10–14 (Dr. Yadav testifying that
“upstream of [the start of Figure 1] is the biosynthesis of the precursors of

11 The 18:0, 16:0, and 18:1 fatty acids are stearic, palmitic, and oleic,
respectively. See Ex. 1002 ¶ 20; Ex. 2012 ¶ 27.
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18:2 and 18:3, which includes 18:0, 16:0, 18:1 and the like”). Further
underscoring our interpretation, Patent Owner’s expert, Dr. Sederoff,
admitted that at least one of these fatty acids, 18:1 (oleic acid), can be used
as a substrate to make DHA. Ex. 1016, 89:18–22.
Patent Owner admits that a plant contains 18:1 (oleic acid) in its
endoplasmic reticulum, but argues that this pool is not available for
conversion into 18:2 or 18:3 because the maximum possible conversion in
the endoplasmic reticulum has already happened. PO Resp. 4; Ex. 2012
¶ 19; Tr. 48:14–49:17, 49:21–50:11, 51:8–53:24. While this may be correct
for a native plant, we are not persuaded that Patent Owner’s argument
applies to transgenic plants having exogenous enzymes designed to produce
higher levels of DHA.
The record makes clear, for example, that the inventors of the ’870
patent intended to take advantage of the availability of 18:1 (oleic acid) in
the endoplasmic reticulum to increase the synthesis of DHA and other
LCPUFAs in transgenic plants. See Tr. 73:17–74:2. In particular, Table 4 of
the ’870 patent (“Gene combinations for the production of DHA”) as well as
the OSTELOSEmD4-containing plants assayed in Figure 10, include the
gene D12Des(Ps), encoding a Δ12 desaturase from Phytophthora sojae.
Ex. 1001, 14:17–35, 28:55–29:7 (Table 4), 29:13–16, Table 10; Ex. 1016,
74:10–24, 75:15–18; Ex. 1002 ¶¶ 41–43. Dr. Sederoff admitted that Δ12
desaturase catalyzes the desaturation of 18:1 (oleic acid) to 18:2 (linoleic
acid) “further up in the pathway” shown in Figure 1. Ex. 1016, 77:8–22,
81:18–22, 89:7–22; see also id. at 73:17–22 (Dr. Sederoff indicating that
Δ12 desaturase was the “the most important enzyme” for producing high
ratios of DHA).
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Given Patent Owner’s position that increasing the activity of enzymes
shown in Figure 1 increases the production of DHA via the conversion of
18:2 and 18:3 and various intermediates, it seems reasonable that the
addition of Δ12 desaturase activity would similarly induce the pool of 18:1
oleic acid in the endoplasmic reticulum to enter the same pathway. Indeed,
Patent Owner itself asserts that a maximal level of DHA would be achieved
by using all eleven enzymes specified in Table 4 of the ’870 patent—which
include a Δ12 desaturase. See PO Resp. 59–60.
In this respect, Petrie I (Exhibit 1008) discloses the production of
LCPUFAs and, in particular, high levels of DHA, in transgenic plants. See
e.g., Ex. 1008, Abstract, 4:19–20. The disclosed process includes the use of
Δ12-desaturases (“Δ12-desaturase”) to convert 18:1 (oleic acid) to 18:2
(linoleic acid). Id. at 18:26–19:17, 58:11–21, 171:1–4 (“the Δ12-desaturase
converts oleic acid to linoleic acid in one or more cells of the plant”). And as
Dr. Sederoff explained, Petrie I’s Figure 1 illustrates the use of Δ12
desaturase to convert 18:1 (oleic acid) to 18:2 (linoleic acid) as the first step
in the production of DHA. Ex. 1016, 79:11–81:6; Ex. 1008, 40:19 (“Aerobic
DHA biosynthesis pathways”), Fig. 1.
With this background, we agree with and adopt Petitioner’s argument
that Patent Owner’s
asserted “theoretical maximum” amount of DHA is not a
theoretical maximum at all, but rather the maximum amount of
DHA that could theoretically be produced if a person of
ordinary skill in the art (“POSA”) arbitrarily used only the
enzymes listed in Figure 1 of the specification. PO has no basis
to read such a requirement into the claims. On the contrary,
Table 4 of the ’870 Patent and the exemplified OstELOEmD4
construct include a Δ12-desaturase not shown in Figure 1 (See
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Ex. 1016, 89:7-22), highlighting the logical inconsistency in
PO’s argument.
Reply 2, 5, 20 (citing Phillips, 415 F.3d 1303 (Fed. Cir. 2005); Amgen Inc.
v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1325 (Fed. Cir. 2003)); see
also SuperGuide Corp. v. DirecTV Enters., Inc., 358 F.3d 870, 875 (Fed.
Cir. 2004) (“Though understanding the claim language may be aided by the
explanations contained in the written description, it is important not to
import into a claim limitations that are not a part of the claim.”).
Petitioner hypothesizes that under Patent Owner’s theory, calculating
the maximal theoretical amount of DHA produced should take into account
the sum of 18:1, 18:2, and 18:3 in a plant because all of these fatty acids can
ultimately be converted into DHA. Reply 6. Asserting that “[o]leic acid is
present, for example, in Brassica napus seed in an amount of 63.8%,”
Petitioner calculates that the theoretical maximum of DHA under Patent
Owner’s proposed construction would be over 90%. Id. (citing Ex. 1016,
80:13–17; Ex. 1017 ¶ 41); Tr. 28:21–30:26. Petitioner admits that this
calculation fails to reach the 99% DHA evident from the plain words of the
claim and that even 90% is simply not possible given, for example, the
diversion of fatty acids in to TAGs.12 Tr. 28:24–30:26, 31:2–32:20.
Petitioner, however, argues that it raises this argument and calculation
merely to show that Patent Owner’s theoretical upper limit approach “is not
an appropriate construction.” Id. at 30:13–26.

12 In this respect, we note that Petitioner’s calculation does not address
Patent Owner’s arguments that much of a plant’s oleic acid may be in the
cytosol and unavailable for conversion in the endoplasmic reticulum, or that
a plant may not survive if its entire pool of oleic acid was depleted. See Tr.
51:8–16.
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At bottom, Patent Owner asks us to construe the upper limit of “at
least 1% docosahexaenoic acid (DHA)” as “at least 1% docosahexaenoic
acid (DHA)” to “the sum of the percent of 18:2 (linoleic acid) and 18:3 (α-
linolenic acid) in the transgenic plant species.” PO Resp. 30; Ex. 2012 ¶ 64.
This construction is flawed for at least the following reasons. Patent
Owner’s proposed construction for the upper limit of “at least 1%
docosahexaenoic acid (DHA)” is a theoretical abstraction that presumes that
all seven enzymatic activities shown in Figure 1 are 100% efficient in
converting linoleic acid (18:2) and α-linolenic acid (18:3) to DHA. See
Reply 22 (citing PO Resp. 9; Ex. 2012 ¶ 23). We find no basis for this
premise. To the contrary, Patent Owner admits that “[one of ordinary skill in
the art] would have readily understood that . . . no enzymatic process is
100% efficient.” PO Resp. 2; see also id. at 28 (citing Ex. 2017, 18:4–8);
Ex. 1016, 105:4–5; Tr. 63:12–13 (Patent Owner asserting in the context of
enablement: “We’re not saying that you have to be 100 percent efficient.”).
As such, one of ordinary skill in the art would have expected the final seed
oil content of a transgenic plant to contain some amount of unreacted
starting materials and intermediates.
Moreover, as Petitioner emphasizes: “We’re not talking about
converting just one step.” Tr. at 38:11–39:15. Although Patent Owner points
to the Δ4 desaturase from Emiliana huxleyi as efficiently promoting the
conversion of 22:5 (DPA) to 22:4 (DHA), we are not persuaded that one of
ordinary skill in the art would see this reaction—let alone the other six
enzymatic activities set forth in aerobic pathway of Figure 1 or all ten of the
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enzymatic activities recited in Table 4—proceeding to 100% efficiency.13
See, e.g., PO Resp. 21–22 (citing Ex. 1001, 30:10–21; Ex. 2012 ¶ 42); Sur-
reply 15–17 (arguing that increasing the copy number of E. huxleyi Δ4
desaturase in transgenic plants would increase the conversion of DPA to
DHA and, thus, provide support for “a ratio of DHA to DPA of at least 2”
and “a conversion rate of DPA to DHA of at least 75%”). In this respect, and
as further discussed below, we find unpersuasive Dr. Sederoff’s testimony
that, by increasing the copy number of the E. huxleyi Δ4 desaturase, “[n]o
technical limitation prevents reaching a conversion rate nearing 100% (i.e.,
an undetectable amount of DPA or 0% DPA)” for the conversion of DHA to
DPA, let alone for all steps in the pathway leading to the production of DHA
in transgenic plants. See Ex. 2012 ¶¶ 100, 113, 136, 142.
Moreover, Patent Owner admits, “as the biosynthetic pathway
proceeds to produce DHA, a series of intermediates are produced (i.e., EPA
and DPA), each of which can be incorporated into a TAG and further
removed from the endoplasmic reticulum into an oil body. That removal
further depletes the pool of substrates needed to produce DHA.” PO Resp. 9
(citing Ex. 2012 ¶ 23). Accordingly, we find that one of ordinary skill in the
art would understand that it would be impossible to achieve an amount of
DHA that is “the sum of the percent of 18:2 (linoleic acid) and 18:3 (α-
linolenic acid)” based solely on the conversion of those two fatty acids to
DHA as Patent Owner’s proposed construction requires.

13 Further highlighting the number of steps that must proceed at or near
100% efficiency under Patent Owner’s view, Figure 1 shows that delta 9
elongase and delta 8 desaturase each act on two different substrates.
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We are also persuaded on the record before us that one of ordinary
skill in the art would understand that the introduction of an exogenous Δ12
desaturase would convert some portion of the 18:1 (oleic acid) naturally
present in a plant’s endoplasmic reticulum into 18:2 (linoleic acid) and that
this additional oleic acid could be converted to DHA. See, e.g., Ex. 1008,
Abstract, 4:19–20, 18:26–19:17, 58:11–21, 171:1–4; Ex. 1016, 79:11–81:6;
Ex. 1008, 40:19. Under this scenario, Petitioner calculates a theoretical
maximum of 63.8% DHA for Brassica napus.
But again, such theoretical calculations do not account for enzyme
efficiency or the real-world expectation of the ordinarily skilled artisan as
the record provides no evidence that one of ordinary skill in the art would
understand how much oleic acid (18:1), linoleic acid (18:2) or α-linolenic
acid (18:3) would remain unreacted, be converted to one of the many
intermediates listed in Figure 1, or become sequestered (itself or as an
intermediate) in oil bodies and/or as TAGs prior to conversion to DHA. In
this respect, Dr. Sederoff testified that numerous factors, including
sequestration, limit DHA production. Ex. 2012 ¶ 23. For example,
as the biosynthetic pathway proceeds to produce DHA, a series
of intermediates are produced (i.e., EPA and DPA), each of
which can be incorporated into a TAG and further removed
from the [endoplasmic reticulum] into an oil body, which
would remove those intermediates from the pathway, thereby
further depleting the pool of substrates needed to produce
DHA.
Id.
We further find Patent Owner’s “feedback” argument irrelevant
because Petitioner’s critique of Patent Owner’s proposed construction does
not require synthesizing and/or importing additional 18:1, 18:2, and 18:3
fatty acids into the endoplasmic reticulum using a plant’s endogenous
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enzymes, and instead points to the conversion of oleic acid to the linoleic
acid shown as a starting material for the synthesis of DHA in Figure 1 using
an exogenous Δ12 desaturase. See, e.g., Tr. 20:12–22:26, 44:4–21; see
Ex. 2018, Fig. 1 showing transport of C18:1 (oleic acid) from the cytosol to
the endoplasmic reticulum in the form of C18:1-CoA.
Thus, even with respect to the genus Brassica recited in claims 5 and
13, Patent Owner does not persuade us that one of ordinary skill in the art
would understand that the upper limit of “at least 1% docosahexaenoic acid
(DHA)” is either 23% to 39% of total seed oil, or “about 40% DHA”
depending on the particular Brassica species. See PO Resp. 30 (citing
Ex. 2012 ¶ 63). That the sum of the variables discussed above might, in
certain circumstances, fortuitously result in an amount of DHA equivalent to
“the sum of the percent of 18:2 (linoleic acid) and 18:3 (α-linolenic acid) in
the transgenic plant species,” does not comport with the thrust of Patent
Owner’s position. Rather, and as Petitioner apparently intends, these issues
underscore the deficiency of Patent Owner’s approach. See, e.g., Tr. 20:21–
30:26. To the extent we consider only the starting materials shown in Figure
1, the maximal amount of DHA is less than the “cap” asserted by Patent
Owner whereas, to the extent we include the contribution of 18:1 (oleic acid)
as acted on by exogenously added Δ12 desaturase, the potential limit to
DHA production is potentially much higher. See PO Resp. 28. Accordingly,
the underlying variables and uncertainties in the record before us do not
reasonably permit us to calculate an inherent limit for the upper bound of “at
least 1% docosahexaenoic acid (DHA).”
In light of the above, the many variables affecting DHA production
render the functional upper bound of “at least 1% docosahexaenoic acid
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(DHA)” a moving target. We thus return to the intrinsic evidence and the
plain language of the independent claims. Applying the ordinary and
customary meaning in accord with Phillips, we adopt Petitioner’s proposed
construction of “at least 1% docosahexaenoic acid (DHA)” as covering
amounts of DHA from 1% to 99% (since the claims also require a minimum
amount of 1% EPA). See Pet. 30; Ex. 1002 ¶ 57.
For similar reasons, and because Patent Owner does not expressly
argue the meaning of the remaining terms, we further adopt Petitioner’s
proposed construction of “a ratio of DHA to [DPA] of at least 2,” as
covering a ratio from 2 up to infinity; and “a conversion rate of DPA to
DHA of at least 75%,” as covering a conversion rate of 75% to 100%. See
Pet. 30–31; Ex. 1002 ¶ 57; Dec. 13–14. We further adopt Petitioner’s
uncontested explanation that the “ratio of DHA to DPA of 2.9” recited in
claims 6 and 15 indicates “an implicit upper limit of 73.6% DHA.” See Pet.
56 n.15.
Applying these terms, we address Petitioner’s written description,
enablement, and prior art Grounds.
C. Written Description
“A description adequate to satisfy 35 U.S.C. § 112, first paragraph,
must ‘clearly allow persons of ordinary skill in the art to recognize that [the
inventor] invented what is claimed.’” Ariad Pharms., Inc. v. Eli Lilly & Co.,
598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc) (alteration in original). “The
essence of the written description requirement is that a patent applicant, as
part of the bargain with the public, must describe his or her invention so that
the public will know what it is and that he or she has truly made the claimed
invention.” AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc., 759
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F.3d 1285, 1298 (Fed. Cir. 2014). Accordingly, “[t]he purpose of the written
description requirement is to ‘ensure that the scope of the right to exclude, as
set forth in the claims, does not overreach the scope of the inventor’s
contribution to the field of art as described in the patent specification.’”
Ariad, 598 F.3d at 1353–54.
“[T]he hallmark of written description is disclosure,” and “the test [for
satisfaction of the written description requirement] requires an objective
inquiry into the four corners of the specification from the perspective of a
person of ordinary skill in the art.” Id. at 1351. Where the specification
“does not use precisely the same terms used in a claim, the question then is
whether the specification directs or guides one skilled in the art to the
subject matter claimed.” Union Oil Co. of California v. Atlantic Richfield
Co., 208 F.3d 989, 1003 (Fed. Cir. 2000). While the written description
requirement does not require that the specification recite the claimed
invention in any particular way, pointing to an “amalgam of disclosures”
from which an artisan could have created the claimed invention does not
satisfy this requirement. Novozymes A/S v. DuPont Nutrition Biosciences
APS, 723 F.3d 1336, 1349 (Fed. Cir. 2013).
“[I]t is the specification itself that must demonstrate possession. And
while the description requirement does not demand any particular form of
disclosure . . . or that the specification recite the claimed invention in haec
verba, a description that merely renders the invention obvious does not
satisfy the requirement.” Ariad, 598 F.3d at 1352; see also, e.g., Regents of
the Univ. of California v. Eli Lilly & Co., 119 F.3d 1559, 1567 (Fed. Cir.
1997) (“a description which renders obvious a claimed invention is not
sufficient to satisfy the written description requirement of that invention”).
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1. “Plant seed oil obtained from seeds of a transgenic plant wherein the
oil comprises at least 1% docosahexaenoic acid (DHA)” (Ground 1)
As Ground 1, Petitioner contends that claims 1–17 lack written
descriptive support for “[p]lant seed oil obtained from seeds of a transgenic
plant wherein the oil comprises at least 1% docosahexaenoic acid (DHA),”
as recited in claims 1 and 9, from which all remaining claims of the ’870
depend. Pet. 36–38; Ex. 1002 ¶ 100. Petitioner advances three arguments in
connection with this challenge. Petitioner argues first that the ’870 Patent
and the Earlier Applications14 do not convey the “concept” of plant seed oils
comprising “‘at least 1% docosahexaenoic acid (DHA)’ as broadly as
claimed,” nor is there any “description in the specification of the specific
range of ‘at least 1%’ DHA for Arabidopsis seed oil let alone for seed oil
generally.” Pet. 36–37 (citing Ex. 1002 ¶ 67).
In its second argument, Petitioner references Applicants’ statement of
support for the December 2017 amendments, wherein Applicants asserted
that “the amounts of docosahexaenoic acid (DHA), docosapentaenoic acid
(DPA), and eicosapentaenoic acid (EPA) produced in the transgenic
Arabidopsis lines listed in Figure 10 implicitly support the limitations
recited in the present claims.” Id. at 37 (quoting Ex. 1006, 196). Petitioner
contends “there is no basis for this assertion,” in part, because the
Specification lacks any statement or rationale connecting these results to the
production of DHA, DPA, or EPA in plant species other than Arabidopsis.
Id. at 37–38. Moreover, Petitioner argues, “there is no description in the

14 Because the ’870 patent shares substantially the same specification with
the earlier applications, we generally omit express reference to the earlier
applications in the remaining discussion of written description and
enablement.
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specification selecting from [Example 10] only the amounts of DHA, DPA
and EPA, and excluding the amounts of other fatty acids (for example
ARA), produced by the transgenic Arabidopsis plants. Id. at 37.
Finally, Petitioner asserts that the Specification discloses DHA
production only in Arabidopsis, with several lines expressing 1% DHA, and
one line expressing 4.7% DHA. Based on this disclosure, Petitioner contends
that one of ordinary skill in the art “would not reasonably conclude that
inventors had possession of the full scope of the claimed subject matter of
plant seed oil, from any plant, comprising 1%, all the way up to 99% DHA.”
Id. at 38 (citing Ex. 1002 ¶ 69).
Citing Lockwood v. American. Airlines, Inc., 107 F.3d 1565, 1572
(Fed. Cir. 1997), Patent Owner responds that the absence of the words “at
least 1% DHA” in the Specification is not dispositive because “[w]ritten
descriptive support can be established through the ‘words, structures,
figures, diagrams, formulas, etc., that fully set forth the claimed invention.’”
PO Resp. 34–35. In this respect, Patent Owner argues that the one of
ordinary skill in the art would have understood from the ’870 Specification
“that ‘the concept’ of the invention was the production of DHA beginning
from 1% to as high a level as possible.” Id. at 36 (citing Ex. 1002 ¶ 37).
Patent Owner points, in particular, to Figure 1’s “schematic
representation of the steps performed within the plant ‘leading to the
production of ARA, EPA, and DHA’”; Table 4’s disclosure of “Gene
combinations for the production of DHA”; and the Arabidopsis experiments
of Example 9, wherein “particular emphasis is placed on the ability of the
novel Δ4 desaturase from E. huxleyi to efficiently covert DPA to DHA,
highlighting the inventors’ goal to produce substantial quantities of DHA in
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seed oil.” Id. at 35–36 (citing Ex. 1001, 14:5–7, 24:40–42, 28:55–29:9,
30:5–21, Fig. 1, Table 4; Ex. 2012 ¶ 75); Ex. 2017, 29:5–18.
Patent Owner further points to Figure 10, reporting test results for 32
transgenic Arabidopsis seeds according to Example 9, which Patent Owner
contends, “show[s] at least 31 of which had from ‘at least 1%’ DHA,” with
one of these seeds having 4.7% DHA. PO Resp. 36 (citing Ex. 1001, Fig 10;
Ex. 2012 ¶ 76); Sur-reply 11–12. Patent Owner states that “[t]he inventors
reported that data by noting that ‘[a]ll lines show the production of DHA
with levels of up to 4.7%.’” PO Resp. 36 (citing Ex. 1001, 30:11–12)
(alteration in original); see also Ex. 1001, Fig. 11 (reporting “[v]alues []
generated from the best individual Arabidopsis line” and showing 4.7%
DHA for one line of OstELOEmD4).
Focusing its arguments on the Brassica limitation of claims 5 and 9,
Patent Owner argues that one of ordinary skill in the art reading the ’870
Specification would understand to “apply the constructs of the invention to
rapeseed (B[rassica] napus)” which, unlike the Arabidopsis used in Example
9, is a commercially valuable oilseed plant. PO Resp. 39–40 (citing
Ex. 1001, 17:23–54, 29:19–24, 30:20–21; Ex. 2012 ¶¶ 79–81). Citing
evidence that “Arabidopsis is a Reliable and Predictive Model for Brassica
napus,” Patent Owner contends that the Arabidopsis data of Example 9 can
be extrapolated to Brassica plants in such a manner as to provide equivalent
written descriptive support. See id. at 39–42 (citing Ex. 2008, 5; Ex. 2027,
¶ 61; Ex. 2029, 51:13–19, 52:4–9, 55:18–56:1).
Because attributing even the 4.7% DHA from Example 9 to Brassica
plants does not achieve the 23% to 39% DHA for various Brassica species
required under its proposed construction, Patent Owner asserts that one of
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ordinary skill in the art would have recognized that the Arabidopsis data did
not represent the “high water mark for DHA levels” because it was based on
a construct “limited to five enzymes from Table 4, only one of which was an
E. huxleyi enzyme.” PO Resp. 41 (citing Ex. 2017, 18:12–19:7, 53:3–54:11;
Ex. 2012 ¶¶ 30, 80, 86); Sur-reply 12–13. Rather, Patent Owner asserts, the
ordinarily skilled artisan would have known that “using the entire array of
eleven enzymes listed in Table 4 to make DHA would have resulted in a
much higher level of DHA than 4.7%.” PO Resp. at 42 (citing Ex. 2012
¶ 86); Sur-reply 14; see also PO Resp. 59–60 (“The teaching to achieve the
maximal level of DHA was included in the list of eleven enzymes in Table
4.”).15 Referencing this purportedly implied disclosure, Patent Owner
contends that “[n]othing more is needed to establish that the inventors had
possession of a generalized method for producing high levels of DHA.” Sur-
reply 14. We disagree.
We consider, first, the evidence of record under our construction of
“at least 1% docosahexaenoic acid (DHA)” as covering amounts of DHA
from 1% to 99% (since the claims also require a minimum amount of 1%
EPA). Patent Owner argues that such levels are “impossible” and does not
contest Petitioner’s assertion that the challenged claims are unpatentable for
lack of written description under this construction. PO Resp. 27, 28. Indeed,
Dr. Sederoff admitted that the ’870 patent neither describes nor enables one

15 The arguments and evidence adduced in this proceeding do not address
whether the conversion of 18:2 and 18:3 to DHA could be accomplished
using a subset of the enzyme activities shown in Figure 1 by omitting some
of the enzymes that permit formation of alternative intermediates. To the
extent this is possible, it would not alter the thrust of our reasoning
throughout this Decision.
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of ordinary skill in the art to make a transgenic Brassica plant (as recited in
claims 5 and 13) that produces more than 50% DHA. Ex. 1016, 64:23–66:2,
67:24–68:4. But although reaching the upper limit of “at least 1%
docosahexaenoic acid (DHA)” may be impossible under any of the
constructions considered herein, the Federal Circuit “repeatedly and
consistently has recognized that courts may not redraft claims, whether to
make them operable or to sustain their validity.” Chef Am., Inc. v. Lamb-
Weston, Inc., 358 F.3d 1371, 1374 (Fed. Cir. 2004) (collecting cases).
For the above reasons, we find that a preponderance of the evidence
supports Petitioner’s contention that claims 1–17 do not comply with the
written description requirement as set forth in Ground 1 under our
construction of “at least 1% docosahexaenoic acid (DHA),” with respect to
any plant including Arabidopsis. Considering claims 5 and 13, in particular,
the ’870 patent does not describe a transgenic Brassica plant that produces
more than 50% DHA.
For the reasons set forth in section II.B, above, we decline to adopt
Patent Owner’s proposed construction of “at least 1% docosahexaenoic acid
(DHA)” as encompassing “from 1% docosahexaenoic acid (DHA) to the
sum of the percent of 18:2 (linoleic acid) and 18:3 (α-linolenic acid) in the
transgenic plant species” and, more particularly with respect to claims 5 and
13, 23% to 39% (“about 40%”) DHA in various Brassica species. Had we
applied Patent Owner’s proposed construction, we likewise would find the
challenged claims unpatentable as lacking written description for many of
the same reasons we rejected this construction in section II.B. We,
nevertheless, address here arguments Patent Owner makes regarding written
description support under its proposed construction.
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We note, first, that Patent Owner’s theory requires that one of
ordinary skill in the art extrapolate DHA levels from Arabidopsis
(maximally 4.7% for the embodiment shown in Figures 9 and 10) to
transgenic plants of the genus of Brassica. While there is no dispute that
Arabidopsis is a close relative and model system for Brassica napus, we
accept Dr. Yadav’s explanation that while the model is qualitatively
predictive, results obtained in Arabidopsis cannot be quantitatively
extrapolated to Brassica napus. Ex. 2029, 53:14–56:24; see id. at 54:17–23
(“actual amount[s] may differ”); Reply 3; Tr. 74:20–75:24; see also
Ex. 1016, 19:5–9, 121:2–7 (Dr. Sederoff’s testimony that Arabidopsis is a
qualitative model). And though we recognize “that a claim may be broader
than the specific embodiment disclosed in a specification,” the range of 0–
4.7% DHA shown in Figure 10 for Arabidopsis is nowhere close to a
disclosure of up to “about 40%” upper limit for Brassica under Patent
Owner’s proposed construction. See Bilstad v. Wakalopulos, 386 F.3d 1116,
1123–24 (Fed. Cir. 2004) (quoting In re Rasmussen, 650 F.2d 1212, 1215
(CCPA 1981)).
According to Patent Owner’s theory, one of ordinary skill in the art
seeking to produce more than the 4.7% DHA shown in Table 10 would
derive transgenic plants “using the entire array of eleven enzymes listed in
Table 4,” which “would have resulted in a much higher level of DHA than
4.7%.” PO Resp. 42. As an initial matter, Patent Owner’s asserted “much
higher level,” is ambiguous and does not clearly support the levels of DHA
set forth in its proposed construction. And although, in the context of
enablement, Patent Owner proposes selective breeding and increased
transgene copy number as methods to promote additional DHA production,
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neither technique is disclosed in the ’870 Specification. To the contrary,
Dr. Sederoff admitted that the ’870 patent provides no guidance as to the
copy numbers to use. Ex. 1016, 133:7–9.
In seeking to establish written description, Patent Owner argues that
one of ordinary skill in the art would “us[e] the entire array of eleven
enzymes listed in Table 4.” PO Resp. 42. We do not find such disclosure in
the Specification. Moreover, Patent Owner does not address, for example,
why the ordinarily skilled artisan would use both versions of Δ4 desaturase
listed in Table 4. We find this omission curious given Patent Owner’s
emphasis on “the highly efficient” Δ4 desaturase from Emiliana huxleyi
D5Elo(Eh) among those listed in Table 4. Id. at 2–3; see Sur-reply 15; Tr.
61:17–20; 70:13–19; Ex. 1006, 57–58; Ex. 2012 ¶¶ 17, 41. Further, Table 4
is directed to “Gene combinations for the production of DHA,” suggesting
that the recited “combinations” (plural) do not necessarily contemplate a
plant comprising all eleven genes, but rather subsets of them, such as used in
the Arabidopsis plants described in Table 10. Ex. 1001, Table 4; see also
Sur-reply 21 (suggesting that one of ordinary skill in the art would “mix-
and-match the enzymes listed in Table 4 of the ’870 patent”). Sur-reply 21.
Accordingly, the record as a whole is not consistent with the purported
disclosure to use all eleven genes in a single transgenic plant.
Whatever their technical merits, for the purpose of establishing
written description we are not persuaded by the increased copy number,
selective breeding, and gene combination arguments advanced by Patent
Owner. To the contrary, we agree with Petitioner that: “It is not sufficient for
purposes of the written description requirement of § 112 that the disclosure,
when combined with the knowledge in the art, would lead one to speculate
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as to modifications that the inventor might have envisioned, but failed to
disclose.” Reply 15 (quoting Lockwood, 107 F.3d at 1571–1572).
While it may have been obvious to introduce transgenes encoding all
eleven enzymes into Brassica, we find no express or implied teaching to do
so in the Specification. The same is true of Patent Owner’s assertions that
one of ordinary skill in the art would further resort to high copy number
transformants and/or selective breeding in an effort to increase the amount
DHA produced. To the extent one or more of these non-disclosed steps may
be obvious, the Federal Circuit makes clear that “a description that merely
renders the invention obvious does not satisfy the [written description]
requirement.” See Ariad, 598 F.3d at 1352; see also ICU Medical, Inc. v.
Alaris Medical Sys., Inc., 558 F.3d 1368, 1377 (Fed. Cir. 2009) (The
specification “must do more than merely disclose that which would render
the claimed invention obvious.”).
Finally, as discussed in section II.B, above, Patent Owner’s proposed
construction fails to account for unreacted starting material and
intermediates, as well as the sequestration of these compounds in TAGs and
oil bodies, which is incompatible with conversion to DHA. See, e.g., PO
Resp. 7 (“In mature seeds, over 90% of fatty acids are stored as TAGs in oil
bodies. [] Oil bodies do not contain any desaturases, elongases or other fatty
acid modifying enzymes and only serve as storage compartments.”) (citation
omitted); Ex. 2012 ¶¶ 20–23. Accordingly, we would find the challenged
claims lacking in written description support under this construction
because, assuming the maximal amount of DHA is “the sum of the percent
of 18:2 (linoleic acid) and 18:3 (α-linolenic acid) in the transgenic plant
species,” one of ordinary skill in the art would understand that theoretical
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limit to be impossible in practice as it involves at least the series of
enzymatic steps shown in Table 1, where no step can be 100% efficient. See
section II.B (citing, e.g., PO Resp. 2, 9, 28; Ex. 2017, 18:4–8; Ex. 1016,
105:4–5; Ex. 2012 ¶ 23; Tr. 28:24–30:26, 31:2–32:20, 36:11–39:15, 63:12–
13).
In sum, we find that a preponderance of the evidence supports
Petitioner’s contention that claims 1–17 do not comply with the written
description requirement as set forth in Ground 1 under this panel’s
construction of the claims or under the construction proposed by Patent
Owner.
2. “Plant seed oil obtained from seeds of a transgenic plant . . . wherein
the oil has a ratio of DHA to docosapentaenoic acid (DPA) of at least 2”
(Ground 2)
As Ground 2, Petitioner contends that claims 1–8 and 14 lack written
descriptive support for “[p]lant seed oil obtained from seeds of a transgenic
plant . . . wherein the oil has a ratio of DHA to docosapentaenoic acid (DPA)
of at least 2,” as recited in independent claim 1. Pet. 39–42 (citing Ex. 1002
¶¶ 70–75). In challenging these claims, Petitioner makes similar arguments
as to those set forth above regarding Ground 1, albeit with respect to the
limitation that the oil has a ratio of DHA to DPA of at least 2. See id.
Petitioner argues, for example, that the ’870 patent and the Earlier
Applications are completely devoid of any disclosure that suggests
possession of, or any concept of, seed oil obtained from seeds of any
transgenic plant wherein the oil has a ratio of DHA to DPA of at least 2. Id.
at 39–40 (citing Ex. 1002 ¶¶ 70–72).
Petitioner also points to Purdue Pharma as involving facts similar to
the present case. Pet. 40 (citing Purdue Pharma L.P. v. Faulding Inc., 230
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F.3d 1320, 1326 (Fed. Cir. 2000)). Petitioner notes that the Purdue Pharma
court found that claims reciting a Cmax/C24 ratio of greater than 2 lacked
written description support. Id. And in so finding, the court stated that the
specification “discloses a multitude of pharmacokinetic parameters, with no
blaze marks directing the skilled artisan to the Cmax/C24 ratio or what value
that ratio should exceed.” Id. (citing Purdue Pharma, 230 F.3d at 1326)
(emphasis omitted).
As Petitioner explains, “[a]lthough Example 9 and Figures 10 and 11
of the ’870 Patent provide data from which one can derive ratios of DHA to
DPA, as in [Purdue Pharma], one can derive many ratio values of DHA to
DPA from the data and there is nothing directing the skilled artisan to ‘2’ as
the value that the ratio should exceed.” Id. Thus, according to Petitioner,
“[t]he specification provides no indication directing the skilled artisan to a
ratio of DHA to DPA of 2, let alone ‘at least 2,’ as being part of the
disclosed invention for any type of plant seed oil.” Id. (citing Ex. 1002 ¶ 73).
We find persuasive Petitioner’s discussion of Purdue Pharma and adopt it as
our own.
Petitioner further argues that a ratio of DHA to DPA of at least 2
means that there is no minimum amount of DPA, and that the maximum
amount of DPA is one half of the amount of DHA that is present, such that
the claims encompass “any plant seed oil with any amount of DHA between
1–99% and no minimum amount of DPA.” Id. at 41–42. Petitioner asserts
that, in the example of seed oil from only one species of plant (Arabidopsis),
the ratio of DHA to DPA in the “best Arabidopsis line” was 2.94, and the
specification lacks any description or example of any higher ratio of DHA to
DPA. Id. at 42. Thus, according to Petitioner, a person of ordinary skill in
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the art “would not reasonably conclude that [the] inventors had possession of
the full scope of the claimed subject matter of plant seed oil with ratios of
DHA to DPA from 2 to infinity.” Id. (citing Ex. 1002 ¶ 75). We agree with
and adopt Petitioner’s underlying facts and conclusion.
In arguing that the Specification supports the claim language “a ratio
of DHA to [DPA] of at least 2,” Patent Owner argues (1) that the
Specification emphasizes the importance of the ratio of DHA to DPA and
the efficiency of the E. huxleyi Δ4 desaturase; (2) that the information in
Figures 9 and 10 show that three of the Arabidopsis plants expressing this
gene have DHA:DPA ratios of 2, and one has a DHA:DPA ratio of 2.9; and
(3) that one of ordinary skill in the art would understand that these ratios
“could be further improved by introducing additional Δ4 desaturase from
Emiliana huxleyi.” PO Resp. 43–44 (citing Ex. 1001, 25:4–7, 30:13–21,
Figs. 10, 11, Ex. 2012 ¶ 91); Sur-reply 15–17 (further citing Ex. 2012 ¶ 100;
Ex. 2017, 29:5–13; Ex. 1016, 130:12–134:5).
As set forth in section II.B, above, we construe “a ratio of DHA to
[DPA] of at least 2” as covering a ratio from 2 up to infinity.16 Patent Owner
does not argue that the Specification provides written description support for
the upper end of this range. Applying our construction, we find that a
preponderance of the evidence supports Petitioner’s contention that claims
1–8 and 14 do not comply with the written description requirement as set

16 Of the claims challenged under Ground 2, dependent claim 6 is further
limited to “[t]he oil of claim 1, wherein the oil has a ratio of DHA to DPA of
2.9.” Ex. 1001, 71:56–57. For essentially the same reasons, and as further
discussed in section II.C.6, below, we construe this limitation as covering a
ratio from 2.9 up to infinity and apply the same written description analysis
to the upper limit of this claim term.
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forth in Ground 2 because the ’870 patent and the Earlier Applications are
devoid of any disclosure that suggests possession of, or any concept of, seed
oil obtained from seeds of any transgenic plant wherein the oil has “a ratio
of DHA to DPA of at least 2.”
Patent Owner’s arguments, however, appear to apply its proposed pre-
institution construction of “at least [X]%” such that the claim is construed to
cover only that portion of “at least” that is enabled by the Specification. See
Prelim. Resp. 16. We reject this approach for the same reasons set forth on
pages 11–14 of our Institution Decision.
Patent Owner argues that Petitioner’s reliance on Purdue Pharma is
unavailing because the specification before the court never indicated that the
claimed ratio was “an important defining quality of the formulation” that
was “not discussed even in passing in the disclosure.” PO Resp. 45 (quoting
Purdue Pharma, 230 F.3d at 1327, 1329). In contrast, Patent Owner argues,
the instant Specification makes clear that “[a] high ratio of DHA:DPA is for
the commercial use of such oils of importance;” touts the efficiency of
E. huxleyi Δ4 desaturase in converting DPA to DHA; and discloses that a
construct containing this enzyme “delivered the highest levels of DHA and
the highest ratio of DHA:DPA (2,9).” Id. at 45–46 (citing Ex. 1001, 30:20–
21, Fig. 11; Ex. 2012 ¶ 92).
We do not, however, agree that the cited portions of the Specification
shows the importance of the claimed ratio, let alone that it was a “defining
quality” of the disclosed invention. Nor does this evidence, or any evidence
of record, suggest an upper limit to any limitation in the form of “at least
[X]%” short of 100% or the highest level permitted according to the plain
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meaning of any claim term. In this respect, we find that Petitioner has the
better argument:
Emphasizing the importance of achieving a “high ratio” of
DHA to DPA is not equivalent to describing a ratio of “at least
2” or of a conversion of “at least 75%.” Further, a table
describing experimental Arabidopsis seed oil with various
ratios of DHA to DPA is not a description of Brassica seed oil
with a ratio of DHA to DPA of “at least 2,” much less a
description of a ratio of 2 up to infinity.
Reply 11.
Patent Owner also points us to Ralston Purina Co. v. Far-Mar-Co,
Inc., 772 F.2d 1570 (Fed. Cir. 1985). In Ralston, the Federal Circuit
determined that the trial court did not clearly err in finding, in light of
extrinsic evidence showing “that soybean meal of 44%, 50%, 70%, and 90%
protein were standard, available commodities,” that the claim language
“protein content of at least about that of solvent extracted soybean meal,”
was supported by the specification. Ralston at 1575–76. In Ralston, the court
pointed to, inter alia, disclosure that “[s]oybean meal having a protein
content of approximately 50% . . . is preferred,” and when “meal has a
protein content of substantially less than 50%, it may be mixed with a high
protein component which will increase the protein content of the
combination to the preferred 50%.” Id. (first alteration in original).
Although Patent Owner argues that it is similarly well-known “to
increase the number of copies of the Δ4 desaturase from Emiliana huxleyi
that catalyzes the conversion of DPA to DHA,” such methods are not
disclosed in the ’870 Specification as are the pertinent methods in the patent
at issue in Ralston. See id. (disclosing mixing low protein meal with high
protein content meal (known in the art as having at least up to 90% protein)
to reach a preferred level of 50%). Rather, Patent Owner’s proposed
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manipulations of copy number are, at best, obvious from the disclosure of
the ’870 patent. See section II.C.1, above. Moreover, the record before us
insufficiently defines the extent these manipulations can be expected to
increase DHA production. Id. Accordingly, Patent Owner’s evidence does
not “allow[] one skilled in the art to visualize or recognize the identity of the
subject matter purportedly described.” See PO Resp. 45 (citing Enzo
Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 968 (Fed. Cir. 2002)).
In sum, we find that a preponderance of the evidence supports
Petitioner’s contention that claims 1–8 and 14 do not comply with the
written description requirement as set forth in Ground 2 under this panel’s
construction of the claims or under the construction proposed by Patent
Owner.
3. “Plant seed oil obtained from seeds of a transgenic plant . . . wherein
the seeds of the transgenic plant have a conversion rate of
docosapentaenoic acid (DPA) to DHA of at least 75%” (Ground 3)
As Ground 3, Petitioner contends that claims 9–17 lack written
descriptive support for “a conversion rate of docosapentaenoic acid (DPA)
to DHA of at least 75%,” as recited in independent claim 9. Pet. 42–45
(citing Ex. 1002 ¶¶ 76–79); Reply 11–12. Patent Owner opposes. PO Resp.
49–53; Sur-reply 15–17. The parties’ arguments and evidence substantially
overlap or parallel those set forth with respect to Ground 2 and need not be
repeated in detail here.
Specific to Ground 3, Patent Owner additionally asserts that one of the
32 Arabidopsis lines of Figure 11 “had less than 0.X% DPA and more than
3% DHA, which would translate to a minimum conversion rate of 3%/3.9%,
or 77%”, and that, with this additional information, “[one of ordinary skill in
the art] would have understood that the recited ratio was disclosed in the
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specification.” PO Resp. 51 (citing Ex. 2012 ¶¶ 104–105). Referencing a
lack of blaze marks, however, Petitioner argues that although Example 9 and
Figure 11 provide data
from which one can derive a conversion rate of
docosapentaenoic acid (DPA) to DHA of 74.6%, as in [Purdue
Pharma] one can derive many other values as well and the
specification provides no indication directing the skilled artisan
to the conversion rate of ‘at least 75%’ as part of the disclosed
invention.
Pet. 43–44 (citing Ex. 1002 ¶ 79). As in section II.C.1, Petitioner has the
better argument, which we adopt here.
As with other claim elements in the “at least [X]%” format, we
consider written description under the panel’s construction, as well as that
implicitly argued by Patent Owner. In either scenario, considering the record
as a whole and our analysis with respect to Ground 2, we find that a
preponderance of the evidence supports Petitioner’s contention that claims
9–17 do not comply with the written description requirement as set forth in
Ground 3.
4. “wherein the oil comprises at least 1% but not more than 6%
eicosapentaenoic acid (EPA)” (Ground 4)
As Ground 4, Petitioner contends that claims 1–17 lack written
descriptive support for “wherein the oil comprises [...] at least 1% but not
more than 6% eicosapentaenoic acid (EPA)” as recited in independent
claims 1 and 9. Pet. 45–47; Reply 12. In response, Patent Owner points to
Figure 10 of the ’870 patent, which discloses that 30 of the 32 Arabidopsis
lines fell within the range of 1% to 6% EPA. Accordingly, Patent Owner
asserts, “‘[t]he concept of seed oil having ‘at least 1% but not more than 6%
eicosapentaenoic acid (EPA)” was disclosed in the ’870 patent and “[one of
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ordinary skill in the art] would have understood that the recited range was
disclosed in the specification.” PO Resp. 54–55 (citing Ex. 1001, Fig. 10;
Ex. 2012 ¶ 117); see also Sur-reply 17 (arguing “that the data in Figure 10
shows a consistent theme”).
In its Reply, Petitioner asserts:
The data in Figure 10 describes Arabidopsis seed oil with
amounts of EPA falling below 1% and exceeding 6%. This
description is not a description of Brassica seed oil with “at
least 1% but not more than 6% eicosapentaenoic acid (EPA).”
See Lockwood, 1572. There is no description in the
specification that supports a floor of “at least 1%” or a cap of
“not more than 6%” for the amount of EPA in Brassica seed
oil. Indeed, Dr. Sederoff admitted that the ‘870 Patent includes
no reason for setting a minimum of 1% EPA and that Figure 10
shows that the EPA levels exceed 6% and reached up to 7%.
(Ex. 1016, 69:18–70:5.)
Reply 12; see generally Ex. 1016, 69:18–71:7. We further note that in
testifying about Figure 10, Dr. Sederoff stated that he “[did not] see a reason
why .9 percent EPA would be significantly different from 1 percent . . . But
you have to set the boundary somewhere.” Ex. 1016, 69:18–24. Dr. Sederoff
further testified that while “[t]he range is between – the lowest one is less
than 1, and the highest one is more than 7,” he didn’t calculate the mean but
based his observation on “a visual impression.” Id. at 70:20–71:7.
Considering the evidence of record, we agree with and adopt
Petitioner’s argument.
Further, as with Grounds 1–3, Patent Owner contends that one of
ordinary skill in the art would extrapolate the results from Arabidopsis to
other plants, most particularly, to the genus of Brassica recited in dependent
claims 5 and 13. PO Resp. 56 (citing Ex. 2012 ¶¶ 118–121); Sur-reply 17.
For the reasons discussed previously, we find that one of ordinary skill in the
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art would understand that results obtained in Arabidopsis cannot be
quantitatively extrapolated to Brassica napus or any other Brassica species.
See, e.g., section II.C.1, above. Accordingly, even if the claimed range had
been sufficiently described by the Arabidopsis data of Figure 10, we find
that one of ordinary skill in the art could not, with a sufficient degree of
precision, have quantitatively extrapolated that data to any other species,
including the Brassica species encompassed by claims 5 and 13.
In light of the above, and considering all the evidence of record, we
find that a preponderance of the evidence supports Petitioner’s contention
that claims 1–17 do not comply with the written description requirement as
set forth in Ground 4.
5. “at least 1%” DHA, “at least 1% but not more than 6%” EPA, and
either a ratio of DHA to DPA of “at least 2” or a conversion rate of
DPA to DHA of “at least 75%” (Ground 5)
As Ground 5, Petitioner contends that claims 1–17 lack written
descriptive support for various combinations of the above claim elements.
Pet. 48 (citing Ex. 1002 ¶¶ 86–87). Patent Owner opposes. PO Resp. 57;
Ex. 2012 ¶ 124. As set forth in sections II.C.1–4, above, we find each of the
individual elements lacking written descriptive support and, thus, agree with
Petitioner that the same elements in claims 1–14 also lack written descriptive
support as set forth in Ground 5.
6. “wherein the oil has a ratio of DHA to DPA of 2.9” (Ground 6)
As Ground 6, Petitioner contends that claims 6 and 15 lack written
descriptive support for “wherein the oil has a ratio of DHA to DPA of 2.9.”
Pet. 49–50 (citing Ex. 1002 ¶¶ 89–90). According to Petitioner:
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The only possible description of this specific ratio of DHA to
DPA is from a single Arabidopsis plant which comprised 4.7%
DHA and 1.6% DPA. . . . [T]he specification lacks any
statement connecting the amounts of DHA and DPA in seed oil
produced by transgenic Arabidopsis to amounts produced in all
other plants. Without even a statement that, much less a
rationale for why, an example of a particular composition of
fatty acids in Arabidopsis seed oil reflects possession of a
composition of fatty acids with a ratio of DHA to DPA of 2.9 in
other plant species, a POSITA could not understand that the
inventors had possession of seed oil from other plants with a
ratio of DHA to DPA of 2.9. Ex. 1002, ¶90.
Id. (emphasis removed).
Patent Owner does not substantively address Petitioner’s contentions
regarding this element.
Petitioner’s argument is reasonable and sufficiently supported in the
record as a whole. Accordingly, we find that a preponderance of the
evidence supports Petitioner’s contention that claims 6 and 15 do not comply
with the written description requirement as set forth in Ground 6.
7. “wherein the oil comprises at least 1% but not more than 5% EPA”
(Ground 7)
As Ground 7, Petitioner contends that claims 7 and 16 lack written
descriptive support for “wherein the oil comprises at least 1% but not more
than 5% EPA.” Pet. 50 (citing Ex. 1002 ¶ 92).
Petitioner reasonably relies on Dr. Yadav’s testimony that the ’870
patent lacks sufficient disclosure to “allow a POSITA to reasonably
conclude that the inventors had possession of seed oil produced by any other
transgenic plant comprising ‘at least 1% but not more than 5%’ EPA.” Id.
Patent Owner does not substantively address Petitioner’s contentions
regarding this element.
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Considering all the evidence of record, we find that a preponderance
of the evidence supports Petitioner’s contention that claims 7 and 16 do not
comply with the written description requirement as set forth in Ground 7.
8. “wherein the DHA, EPA and DPA are triglyceride esters” (Ground 8)
As Ground 8, Petitioner contends that claims 8 and 17 lack written
descriptive support for the plant seed oil obtained from seeds of a transgenic
plant comprising the amounts of DHA, EPA, and DPA recited in claims 1 or
9, “wherein the DHA, EPA and DPA are triglyceride esters.” Pet. 27, 51
(citing Ex. 1002 ¶¶ 93–94).17 Patent Owner does not substantively address
Petitioner’s contentions regarding this element.
Petitioner asserts that the ’870 Specification fails to describe the
amounts of DHA, EPA or DPA in the form of triglyceride esters. Id.
Petitioner explains that:
the total fatty acids in a plant seed include those in triglycerides
as well as free fatty acids, phospholipids and glycolipids.
Because Figures 10 and 11 do not describe the amounts of
DHA, EPA, and DPA which are triglyceride esters,[18] the
amounts of fatty acids described in these Figures for
Arabidopsis cannot be relied upon as a description of DHA,
EPA, and DPA as triglyceride esters even for Arabidopsis,
much less all plants as recited in claims 8 and 17.
Id. at 51 (citing Ex. 1002 ¶ 94).
Petitioner’s argument is reasonable and sufficiently supported in the
record as a whole. Accordingly, we find that a preponderance of the

17 Page 51 of the Petition incorrectly identifies claims 7 and 16, which we
consider a typographical error of no consequence.
18 Petitioner further notes that the seed oil triglycerides of Figures 10 and 11
“describe the total fatty acids in Arabidopsis seed, not the amount of fatty
acids in triglyceride esters.” Pet. 51 (citing id. at 14–15).
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evidence supports Petitioner’s contention that claims 7 and 16 do not comply
with the written description requirement as set forth in Ground 8.
D. Enablement
To be enabling, “the specification of a patent must teach those skilled in
the art how to make and use the full scope of the claimed invention without
‘undue experimentation.’” MagSil Corp. v. Hitachi Global Storage Techs.,
Inc., 687 F.3d 1377, 1380–81 (Fed. Cir. 2012).
The enablement requirement ensures that the public knowledge
is enriched by the patent specification to a degree at least
commensurate with the scope of the claims. The scope of the
claims must be less than or equal to the scope of the enablement.
The scope of enablement, in turn, is that which is disclosed in the
specification plus the scope of what would be known to one of
ordinary skill in the art without undue experimentation.
National Recovery Techs. Inc. v. Magnetic Separation Sys., Inc., 166 F.3d
1190, 1195–96 (Fed Cir. 1999).
Some experimentation, even a considerable amount, is not “undue” if,
e.g., it is merely routine, or if the specification provides a reasonable amount
of guidance as to the direction in which the experimentation should proceed.
In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988).
Factors to be considered in determining whether a disclosure
would require undue experimentation . . . . include (1) the
quantity of experimentation necessary, (2) the amount of
direction or guidance presented, (3) the presence or absence of
working examples, (4) the nature of the invention, (5) the state
of the prior art, (6) the relative skill of those in the art, (7) the
predictability or unpredictability of the art, and (8) the breadth of
the claims.
Id.
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The above “Wands factors” are illustrative, rather than mandatory, and
therefore “all of the factors need not be reviewed when determining whether
a disclosure is enabling.” Enzo Biochem, Inc. v. Calgene, Inc., 188 F.3d
1362, 1371 (Fed. Cir. 1999). What matters for the purpose of the enablement
inquiry are the particular facts being considered. Amgen, Inc. v. Chugai
Pharm. Co., 927 F.2d 1200, 1213 (Fed. Cir. 1991).
1. Ground 9
As Ground 9, Petitioner argues that claims 1–17 are unpatentable for
lack of enablement because the ’870 patent does not teach a person of
ordinary skill in the art how to make the full scope of “at least 1%” DHA in
any plant seed oil obtained from seeds of a transgenic plant without undue
experimentation. Pet. 54 (citing Ex. 1002 ¶ 97) (emphasis omitted).
Petitioner states that the challenged claims encompass seed oils having from
1 to 99% DHA, whereas “the ‘870 Patent Specification discloses only a
single example in transgenic Arabidopsis achieving at most 4.7% DHA.” Id.
at 56. Citing the testimony of Dr. Yadav, Petitioner argues that the ’870
patent provides “no description of the steps a POSITA would need to take to
achieve seed oil having 25%, 50% or 75% DHA, and higher even in
Arabidopsis.” Ex. 1002 ¶100. Consequently, Petitioner argues, the ’870
patent does reasonably enable the full scope of the claimed range “in any
plant,” including Brassica species. Pet. 56–57 & fn.15–16 (citing Ex. 1002
¶¶ 100–101).
As an initial matter, Patent Owner does not contest that, under our
construction of “at least 1%” DHA as covering amounts of DHA from 1% to
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99%, the challenged claims are unpatentable for lack of enablement.19 To
the contrary, Patent Owner admits that an upper limit of 99% is
“impossible.” PO Resp. 27, 28 (citing Ex. 2017 18:4–8). Rather, Patent
Owner contends, the theoretical maximum amount of DHA that could be
produced by a given plant is the percent of the sum of 18:2 (linoleic acid)
and 18:3 (α-linolenic acid) in the plant, which “sets the ceiling” of “about
40%” for plants of the genus Brassica. See, e.g., id. at 59 (citing Ex. 2012 ¶
129); Sur-reply 5; see also Ex. 1016, 64:23–66:2, 67:24–68:4 (testifying that
in some Brassica species the theoretical maximum amount of DHA may be
as much as 50% DHA).
We find the MagSil case to be instructive. See MagSil, 687 F.3d 1377.
In MagSil, the court held that the claims were not enabled with respect to a
limitation reciting “a change in the resistance by at least 10% at room
temperature” when the specification only taught that the inventors were able
to achieve a maximum change in resistance of 11.8%. MagSil, 687 F.3d at
1379–85. The court explained that the specification only enabled an
ordinarily skilled artisan to achieve a small subset of the claimed range, and
“[t]he open claim language chosen by the inventors does not grant them any
forgiveness on the scope of required enablement.” Id. at 1383–84; see id. at
1381 (holding the claim limitation of “a change in resistance of at least
10%” was not enabled by specification teaching that the inventors’ “best
efforts achieved a maximum change in resistance of only 11.8% at room
temperature”).

19 In this respect, Patent Owner does not contest Petitioner’s reasoned
assertion that claims 6 and 15 have an implicit upper limit of about 73.6%
DHA, and are not enabled under this construction for substantially the same
reasons. See Pet. 56–57, fn.15–16.
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Similar to MagSil, the “best” example shown in the ’870 patent
contained only 4.7% DHA. See Ex. 1001, Fig. 11; see also In re Fisher, 427
F.2d 833, 839 (CCPA 1970) (“appellant has not enabled the preparation of
ACTHs having potencies much greater than 2.3, and the claim recitations of
potency of ‘at least 1’ render the claims insufficiently supported under the
first paragraph of 35 U.S.C. § 112”). More to the point, the plain language of
claims 1–17 recite an upper limit that is admittedly “impossible” to achieve.
See PO Resp. 27, 28 (citing Ex. 2017, 18:4–8).
In light of the above, a preponderance of the evidence supports
Petitioner’s contention that the ’870 Specification does not reasonably
enable claims 1–17 as set forth in Ground 9.
Patent Owner does not address the enablement arguments made with
regard to the full scope of the “at least 1%” DHA limitation when it is
interpreted to be a range of from 1 to 99% DHA. Rather, Patent Owner’s
arguments are based on the assumption that this limitation has an upper limit
of “about 40%” in Brassica, which we rejected for the reasons stated in
section II.B, above.
Had we applied Patent Owner’s proposed construction of “at least 1%
docosahexaenoic acid (DHA)” as encompassing “from 1% docosahexaenoic
acid (DHA) to the sum of the percent of 18:2 (linoleic acid) and 18:3 (α-
linolenic acid) in the transgenic plant species” and, more particularly with
respect to claims 5 and 13, 23% to 39% (“about 40%”) DHA in various
Brassica species, we likewise would find the challenged claims unpatentable
as lacking enablement for many of the same reasons we rejected its proposed
construction. See section II.B, above. In the interest of completeness, we
address here arguments Patent Owner makes in applying its proposed
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construction to claims 5 and 13. See generally PO Resp. 57–60; Sur-reply
17–23.
Referencing the 4.7% DHA achieved by the “best individual
Arabidopsis line” shown in Figure 11, Patent Owner argues that one of
ordinary skill in the art would understand that this exemplification was not
the “high-water mark for DHA production” and “would try additional
enzymes, or mix-and-match the enzymes listed in Table 4 of the ’870
patent” in an effort to increase the amount of DHA produced. PO Resp. 59–
60; Ex. 2012 ¶ 130; Sur-reply 21. Having thereby “obtained the optimal set
of enzymes,” Patent Owner asserts that the ordinarily skilled artisan would
employ routine techniques to increase the copy number of those genes to
maximize DHA production in Brassica. Sur-reply 21 (citing Ex. 2012
¶¶ 130, 136, 142); see also id. at 17 (citing Ex. 1001, 17:23–54, 29:19–24;
Ex. 2012 ¶¶ 119–120) (statement in Specification regarding transgenic
Brassica plants); Ex. 1016, 130:7–19, 131:22–132:7 (Dr. Sederoff testifying
about methods of increasing copy number). According to Dr. Sederoff,
increasing copy number is “a good way to try and increase the . . .
quantitative effect” of the added transgenes. Ex. 1016, 133:24–134:5.
As noted in Petitioner’s Reply, Patent Owner and Dr. Sederoff’s
proposed construction “assumes a ‘100% efficient LC-PUFA production
system’ where all 18:2 and 18:3 is converted through to DHA.” Reply 22
(citing PO Resp. 9; Ex. 2012 ¶ 23). Referencing the final step in the pathway
illustrated in Figure 1 (conversion of DPA (22:5) to DHA (22:6) by a Δ4
desaturase), Dr. Sederoff repeatedly asserts that “[n]o technical limitation
prevents reaching a ratio nearing infinity,” i.e., 100% conversion of DPA to
DHA. Ex. 2012 ¶¶ 100, 113, 136, 142. But this statement is at odds with
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Patent Owner and Dr. Sederoff’s admission that “[one of ordinary skill in the
art] would have readily understood that . . . no enzymatic process is 100%
efficient.” PO Resp. 2; 28; Ex. 2017, 18:4–8; Ex. 1016, 105:4–5; Tr. 36:11–
39:15. And to the extent 100% conversion of DPA to DHA were possible,
such an achievement alone, would not establish enablement because Patent
Owner’s proposed construction requires that each step of the pathway
illustrated in Figure 1 proceed with (or at least near) 100% efficiency, Patent
Owner’s suggestion otherwise, notwithstanding. See Sur-reply 22; Tr.
38:11–39:15, 63:12–13, 78:9–25.
In this respect, Patent Owner admits “it is well known that a variety of
factors prevent the complete conversion of linoleic acid (18:2), and α-
linolenic acid (18:3) to DHA.” PO Resp. 9; Ex. 2012 ¶ 23. Among these
limitations on DHA production, Dr. Sederoff explained that, “as the
biosynthetic pathway proceeds to produce DHA, a series of intermediates
are produced (i.e., EPA and DPA), each of which can be incorporated into a
TAG and further removed from the [endoplasmic reticulum] into an oil
body, which would remove those intermediates from the pathway, thereby
further depleting the pool of substrates needed to produce DHA.” Ex. 2012
¶ 23; PO Resp. 9 (same). And as Petitioner aptly points out, the
sequestration of intermediates is inconsistent with the essentially complete
conversion of 18:2 and 18:3 to DHA as required under Patent Owner’s
proposed construction. Reply 23.
Further, in support of the proposition that one of ordinary skill in the
art knew how to increase transgene expression and, thus, enzymatic
conversion rates leading to DHA production in Brassica, Patent Owner
relies on Dr. Sederoff’s discussion of Voelker (Ex. 2031), which examines
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the relationship between copy number of a particular thioesterase (Uc Fat81)
transgene (“a tandem, direct-repeat array of two identical, chimeric genes”)
and the accumulation of the medium-chain fatty acid, laurate (12:0), in
Brassica napus. See Sur-reply 19–21 (citing Ex. 2031, 230 (Fig. 1);
Ex. 1016, 131:22–132:7, 158:8–159:21, 161:15–173:8, 165:13–166:18,
169:8–172:10); Ex. 2031, 231.
As discussed in Petitioner’s Motion to Exclude, Patent Owner first
introduced Voelker (Ex. 2031) during its re-direct deposition of
Dr. Sederoff, whereupon it elicited the cited testimony from its own expert
witness. Mot. 2–6. Although Patent Owner focuses on Voelker’s Figure 1,
and Dr. Sederoff’s associated testimony in its Sur-reply,20 we are not
constrained to consider only those portions of Voelker that Patent Owner
and Dr. Sederoff direct us to. See Rovalma, S.A. v. Bohler–Edelstahl GMBH
& Co. KG, 856 F.3d, 1019, 1027 (Fed. Cir. 2017) (holding that the Board is
not precluded “from relying on arguments made by a party and doing its job,
as adjudicator, of drawing its own inferences and conclusions from those
arguments, even when the result is use of the party’s submissions against
it—subject, of course, to the provision of adequate notice and opportunity to
be heard”); id. at 1028 (“a tribunal may use a party’s own submissions
against it, even if the opposing party bears the burden of persuasion”).

20 When asked “is there a figure or data in [Voelker] that you could point to
that essentially tells you what you were thinking of this reference was
relevant to?,” Dr. Sederoff replied: “Well, Figure 1 is good.” Ex. 1016,
167:25–168:4; see also id. at 168:17–172:20 (summarizing that “[Figure 1]
says that [Voelker] achieved at least one plant that made 40 percent
laurate”).
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Here, Patent Owner submitted into evidence the entirety of Voelker,
and Dr. Sederoff’s testimony regarding Voelker. Having relied on that
evidence in its Sur-reply, Patent Owner cannot complain that it would be
denied due process if we consider the entirety of Voelker and all of
Dr. Sederoff’s testimony thereon. In this respect, Voelker’s broader
teachings are not entirely supportive of Patent Owner’s argument.
Voelker examined copy number and laurate production in over 100
independent Brassica napus transformants. Ex. 2031, 230. “Most
transformants contained 5-20 mol% laurate. Very few had significantly
higher proportions, the maximum being almost 40 mol%.” Id.; see also id. at
Figure 1. Moreover, “[t]ransformants having the highest laurate proportions
all had multiple copies of the transgene (up to approximately 15) . . .
illustrating the positive correlation between transgene copy number and
phenotype.” Id. at 230.
Elaborating on this correlation, Voelker discloses that the relationship
between the enzymatic activity programmed by the transgene and the extent
of laurate accumulation was approximately linear to about 30% laurate, but
above 35% laurate “the linear relationship is lost even though thioesterase
activity can still be increased (Figure 4).” Id. at 232. Voelker notes that
“higher laurate proportions were only achieved with increasingly
disproportionate thioesterase activities,” indicating that “thioesterase activity
eventually ceases to be the limiting factor in laurate accumulation, and a new
limitation takes effect.” Id. at 232, 238, Abstract (“Above 40 mol% laurate
other factors apparently limit the phenotype.”). In addition to these
observations, Voelker considered a number of factors which may have
limited the maximum laurate content, including “non-ideal timing” of
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transgene expression, “the specificity of Kennedy pathway enzymes,” and
“kinetics of thioesterase action on a dwindling 12:0-ACP pool.” Id. at 233,
237–238.
Voelker reports that “[a]fter selfing the T1 plants, the next generation
(T 2) was found to contain up to 56 mol% laurate in their seed (T 3) oils.
This represents about a three-fold higher accumulation level than we had
obtained earlier with the same construct in the crucifer Arabidopsis (Voelker
et al., 1992),” and, thus, suggests that the unidentified limiting factor(s) may
vary between species. See id. at 230, 232; see also id. at 232 (contrasting a
maximum efficiency of Uc FatB1 thioesterase in Brassica, with earlier work
showing up to 98% substrate conversion in bacteria). Voelker concludes
“that the tandem construction improved the frequency with which the
highest laurate events could be obtained, but that it did not lead to an
increase in the maximum laurate content of the oil.” Id. at 231.
As we read Voelker, the reference shows that although additional
copies of the Uc Fat81 transgene produced higher levels of thioesterase, one
of ordinary skill in the art would not necessarily expect that even high levels
of enzyme would result in complete (or even substantial) conversion of its
particular substrate in the context of a living plant. See also Ex. 2012 ¶ 15
(“no enzymatic process is 100% efficient”). Voelker’s description of
limiting factors comports with Patent Owner and Dr. Sederoff’s admission
that, in the case of DHA production, “it is well known that a variety of
factors prevent the complete conversion of linoleic acid (18:2) and α-
linolenic acid (18:3) to DHA.” PO Resp. 9. The factors include “differences
in enzyme activities and substrate specificities, feedback regulation of
enzyme activities and overall efficiency of a given enzyme.” PO Resp. 9;
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Ex. 2012 ¶ 23. Voelker, therefore, underscores the unpredictability of
achieving high levels of enzymatic conversion in plants.
In addition to the unpredictability in enzyme efficiency apparent from
Voelker, we also note Dr. Sederoff’s testimony indicating that the
methodology of increasing transgene copy number as shown in Voelker is
“unpredictable,” producing results that “depend on the plant and on the
gene.” Ex. 1016, 176:12–178:19; see also Ex. 1016, 178:20–179:13
(Dr. Sederoff testifying that increasing transgene copy number “is not a
guaranteed mechanism” for increasing fatty acid production). This too, is
reflected in Voelker, which cites reports in the literature “correlating copy
numbers and expression levels positively, negatively, and indeterminately
with phenotype.” Ex. 2031, 236.
As Petitioner notes, one of ordinary skill in the art recognized that
gene silencing is one of the factors that can reduce the amount of enzyme
produced from a transgene, and consequently the amount of fatty acid
converted by the enzyme. Reply 23–24 (citing Ex. 1016, 34:19–40:24,
133:7–134:20, 138:5–139:24, 175:14–179:13; 178:8–19; Ex. 1015, 6). In
this respect, Dr. Sederoff admitted that while increased copy number can
lead to gene silencing, the process is “complicated” and she did not know if
the underlying mechanism linking copy number to gene silencing was
known. See Ex. 1016, 35:20–37:16; see also Ex. 1015, 6 (paper listing
Dr. Sederoff as an author stating: “we cannot exclude the possibility that
partial transgene silencing took place in Lines 4 and 20 due to multiple
transgene copies”); Ex. 1016, 38:23–39:11; Mot. 3–4 (citing Ex. 1016,
158:8–159:25).
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In response, Patent Owner characterizes gene silencing when gene
copy number increases as “a potential impediment,” noting Dr. Sederoff’s
testimony that ‘[s]ilencing can be a problem, but doesn’t have [] to be.’”
Sur-reply 23 (quoting Ex. 1016, 133:10–14) (italics added) (first alteration in
original). As Dr. Sederoff admitted, however, the ’870 patent does not teach
how to “prevent” or “navigate around” the gene silencing problem – nor has
such evidence been adduced at trial. See Ex. 1016, 134:18–20; 138:16–20.
In view of the above, we find that one of ordinary skill in the art
would have understood that even in high copy number lines, unpredictable
effects such as gene silencing could prevent the accumulation of high levels
of enzymes such as those listed in Table 4 of the ’870 patent. Moreover,
even if high enzyme levels were achieved, the extent to which those
enzymes would catalyze the desired reactions would have been unknown.
Accordingly, from a quantitative standpoint, the evidence adduced points to
a high level of unpredictability in the art.
Focusing on the last step of the pathway illustrated in Figure 1 of the
’870 patent, Patent Owner also asserts that the ordinarily skilled artisan
“knew how to introduce multiple additional copies of the key enzyme
responsible for the rapid and efficient conversion of DPA to DHA, the Δ4
desaturase from Emiliana huxleyi, to achieve ratios of DHA to DPA
approaching infinity, and conversion rates approaching 100%.” Sur-reply 21
(citing Ex. 2021 ¶¶ 136, 142 (stating that “no technical limitation prevents
reaching a ratio nearing infinity,” i.e., 100% conversion of DPA to DHA)).
Ex. 2012 ¶¶ 100, 113, 136, 142. Although we accept that the ordinarily
skilled artisan could understand how and why to carry out those steps, the
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evidence discussed above persuades us that achieving the stated conversion
efficiency for this step alone would have entailed undue experimentation.
Considering that Patent Owner’s proposed construction requires, not
just one, but every step of the pathway illustrated in Figure 1 proceed with
(or at least near) 100% efficiency, the evidence of record persuades us that it
would have required undue experimentation to achieve the claimed
invention under any construction of “at least 1%” DHA advanced in this
proceeding.
In light of the above, and considering all the evidence, we find that a
preponderance of the evidence supports Petitioner’s contention that claims
1–17 are unpatentable for lack of enablement as set forth in Ground 9.
2. Grounds 10–12
As Ground 10, Petitioner argues that claims 1–5, 7–8, and 14 are
unpatentable for lack of enablement because the ’870 patent does not teach a
person of ordinary skill in the art how to make the full scope of plant seed
oil obtained from seeds of a transgenic plant having “a ratio of DHA to DPA
of at least 2,” without undue experimentation where “’at least 2’
encompasses ratios from 2 all the way to infinity.” Pet. 57–59; Ex. 1002
¶¶ 102–106.
As Ground 11, Petitioner contends that claims 9–14, 16, and 17 are
unpatentable for lack of enablement because the ’870 patent does not teach a
person of ordinary skill in the art how to make the full scope of plant seed
oil obtained from seeds of a transgenic plant “wherein the seeds of the
transgenic plant have a conversion rate of docosapentaenoic acid (DPA) to
DHA of at least 75%,” without undue experimentation. Pet. 59–61; Ex. 1002
¶¶ 100, 107–110. Petitioner reasonably notes that although the claimed
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conversion rate encompasses 75–100%, “[t]he specification does not provide
a single example based on non-truncated data, of seed oil reflecting a
conversion rate of DPA to DHA above 75%.” Id. at 60–61 (citing Ex. 1002
¶ 109).
As Ground 12, Petitioner contends that claims 6 and 15 are
unpatentable for lack of enablement because the ’870 patent does not teach a
person of ordinary skill in the art how to make the full scope of plant seed
oil obtained from seeds of a transgenic plant “wherein the ratio of DHA to
DPA is 2.9,” where the claim “encompasses seed oil produced in all plants”
but the ’870 Patent’s closest example is based on a single Arabidopsis plant.
Pet. 61–62; Ex. 1002 ¶¶ 111–113.
As with Ground 9, Patent Owner does not address Petitioner’s
contentions in Grounds 10–12 under our construction of the key terms. See
PO Resp. 57–66; Sur-reply 18–23; section II.B, above. For the reasons set
forth in section II.D.1, above, and as set forth at pages 57–62 of the Petition,
the ’870 Specification does not reasonably enable claims 1–17 as challenged
in Grounds 10–12.
Further, with respect to Ground 10, claim 5, and Ground 11, claim 13,
Patent Owner reiterates arguments as to why one of ordinary skill in the art
would extrapolate the results disclosed for Arabidopsis to the claimed genus
of Brassica such that we “should conclude that the data in the specification
would have been understood by a POSA as enabling the same results in
Brassica oilseed plants.” See PO Resp. 61–62, 64–65. For the reasons
discussed herein, we do not find Patent Owner’s position availing. See e.g.,
section II.C.1, above.
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Also with respect to Ground 10, claim 5, and Ground 11, claim 13,
Patent Owner contends that one of ordinary skill in the art would have
understood
that one could lower the levels of DPA, and increase the levels
of DHA by simply introducing more copies of the Δ4
desaturase from Emiliana huxleyi. That step, which was well
within the capabilities of a POSA, the inevitable result would
be the more robust conversion of DPA to DHA, and much
higher ratio that reported as the “best” in the ’870 patent. No
technical limitation prevents reaching a ratio nearing infinity
(i.e., an undetectable amount of DPA or 0% DPA).
PO Resp. 62–63, 65–66 (citations omitted); see Sur-reply 18–23. We find
this argument unpersuasive for essentially the same reasons as discussed
with respect to Ground 9. See section II.D.1, above.
Patent Owner does not separately address Ground 12.
For the reasons presented in II.D.1 above, the ’870 Specification does
not reasonably enable claims 1–17 as challenged in Grounds 10–12.
In light of the above, and considering all the evidence, we find that a
preponderance of the evidence supports Petitioner’s contention claims 1–17
are unpatentable for lack of enablement as set forth in Grounds 10–12.
E. Anticipation and Obviousness
1. Grounds 13–15
As Ground 13, Petitioner contends that claims 1–17 are anticipated by
and/or would have been obvious over Bauer. Pet. 64–67. Petitioner submits
a detailed claim chart comparing elements of the challenged claims to
disclosure of Bauer, and further relies on the testimony of Dr. Yadav. Id. at
65–67; Ex. 1002 ¶¶ 114–116.
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As Ground 14, Petitioner contends that claims 1–4, 6–12, 14–17 are
anticipated by Napier. Pet. 67–71. Petitioner submits a detailed claim chart
comparing elements of the challenged claims to disclosure of Napier, and
further relies on the testimony of Dr. Yadav. Id. at 68–71; Ex. 1002 ¶¶ 117–
119.
As Ground 15, Petitioner contends that claims 1–5, 7–14, 16, 17 are
anticipated by Petrie I. Pet. 72–75. Petitioner submits a detailed claim chart
comparing elements of the challenged claims to disclosure of Petrie I, and
further relies on the testimony of Dr. Yadav. Id. at 72–75; Ex. 1002 ¶¶ 120–
122.
Other than its blanket assertions regarding burden of proof, Patent
Owner does not address Petitioner’s contentions regarding Ground 14. See
Pet. 71–72, Sur-reply 23–24. Patent Owner further contends that claims 5
and 13 are not unpatentable under Grounds 13 and 15 because neither Bauer
nor Petrie I qualifies as prior art. PO Resp. 66–68. In particular, Patent
Owner argues that the ’870 patent is entitled to the benefit of its 2010
priority application, which has substantially the same specification. Id. As
such, Patent Owner contends that the effective filing date of the ’870 patent
predates both Bauer and Petrie I “because CSIRO has not demonstrated that
claims 5 and 13 lack written description and enablement support in the
common specification.” Id. at 68. Patent Owner’s premise fails for the
reasons set forth in Sections II.C and D, above.
Having considered Petitioner’s substantively unopposed arguments
and evidence with respect to Grounds 13–15, which we adopt, we find that
Petitioner has established by a preponderance of the evidence that the
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challenged claims are unpatentable under 35 U.S.C § 102 and/or 103 in view
of Bauer, Napier, and Petrie I.
2. Ground 16
As Ground 16, Petitioner contends that claims 1–17 are obvious over
Petrie II. Pet. 75–79. Petitioner submits a detailed claim chart comparing
elements of the challenged claims to disclosure of Petrie II, and further relies
on the testimony of Dr. Yadav. Id. at 76–79; Ex. 1002 ¶¶ 123–125.
Patent Owner, relying on the testimony of Dr. Sederoff, argues that
Petitioner’s contentions are flawed insofar as they “pick and choose”
between disparate passages and embodiments of Petrie II to support the three
limitations of the independent claims ((a) at least 1%” DHA; (b) from 1% to
6% EPA; and (c) the oil has “a ratio of DHA to docosapentaenoic acid
(DPA) of at least 2” (claim 1), or “a conversion rate of docosapentaenoic
acid (DPA) to DHA of at least 75%” (claim 9)) “[w]ithout any explanation
for how or why a POSA would choose between the various disparate
portions of [Petrie II] to arrive at the claimed invention.” PO Resp. 68–71;
Ex. 2012 ¶¶ 148–152.
Consistent with Patent Owner’s position, we note that, aside from the
bare recitation of elements and passages from Petrie II, the only overt
reasoning supporting Ground 13 is Petitioner’s quotation of In re Peterson:
“[A] prior art reference that discloses a range encompassing a somewhat
narrower claimed range is sufficient to establish a prima facie case of
obviousness.” Pet. 77 (citing In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir.
2003)) (alteration in original); see also Ex. 1002 ¶ 71 (Dr. Yadav
paraphrasing same). But this passage does not address the deficiencies
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argued by Patent Owner. Nor does Petitioner address Patent Owner’s
arguments in its Reply.
On this record, we find Patent Owner has the better position.
Accordingly, Petitioner has not established by a preponderance of the
evidence that claims 1–17 are unpatentable as obvious in view of Petrie II.
F. Petitioner’s Motion to Exclude
Petitioner requests that we exclude Voelker (Ex. 2031) and the
associated redirect testimony of Dr. Sederoff cited at pages 19–20 of Patent
Owner’s Sur-reply. Mot. 1. In the alternative, Petitioner requests that we
consider an additional passage from Dr. Sederoff’s deposition testimony
regarding the same subject matter. Id. (citing Ex. 1016, 173:21–181:13). At
core, Petitioner argues that the contested material relied on in the Sur-reply
should be excluded pursuant to 37 C.F.R. § 42.23(b) because it “is new
evidence . . . which is not a deposition transcript of the cross-examination of
Petitioner’s reply witness.” Id. at 9.
In response, Patent Owner argues that Dr. Sederoff’s redirect
examination only became necessary when Petitioner elicited her testimony
regarding the disclosure of Hu (Exhibit 1015) relating to the effect of
transgene copy number on the expression of fatty acids in plants. Opp. 1–2.
Patent Owner contends that, in response to Petitioner’s questioning
regarding the importance of transgene number, Dr. Sederoff referenced Hu’s
citation to Voekler. Id. at 3. Patent Owner further notes that Hu cites to
Voelker as supporting three statements potentially relevant to Petitioner’s
line of questioning. Id.
In support of its position, Patent Owner draws our attention to Taskett
v. Dentlinger, 344 F.3d 1337 (Fed. Cir. 2003). In Taskett, Patent Owner
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argues, the Board had found that, even if the scope of re-direct exceeded that
of the cross-examination, the elicited testimony “was proper because its
purpose was ‘to bring out omitted facts and circumstances concerning the
invention.’” Opp. 5 (citing Taskett, 344 F.3d at 1339). Patent Owner further
contends that the Federal Circuit
agreed, “conclud[ing] that the Board did not abuse its
discretion’ in denying Taskett’s motion and further noting that
‘[t]he Board has ample authority and discretion to admit
relevant testimony of the kind” obtained on redirect
examination, especially where it helps ‘clarify facts that were
not made sufficiently clear by either cross examination or direct
examination, as the Federal Rules of Evidence, and thus the
Board’s rules, so permit.
Id. (citing Taskett, 344 F.3d at 1343) (alterations in original).
Drawing a parallel to Taskett, Patent Owner takes the position that
Petitioner’s initial cross-examination regarding Hu and interplay of
multicopy transgenes and gene silencing was “confusing.” Id. at 6–7.
Accordingly, it merely sought “[t]o ensure a clear record and to ensure that
the factfinder (here, the Board) understands basic plant-breeding science,”
via the introduction of Voelker and its redirect examination of Dr. Sederoff.
Id. at 7.
We find Patent Owner’s argument reasonable. Moreover, taken in its
entirety, this panel finds the substance of Voelker and Dr. Sederoff’s
testimony on the disputed subject matter illuminating and useful to the
disposition of this proceeding. See section II.D.1, above. Accordingly, we
deny Petitioner’s request to exclude Voelker and the related testimony cited
in Patent Owner’s Sur-reply. In the interest of fairness, we also grant
Petitioner’s alternative request to affirmatively consider portions of
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Dr. Sederoff’s testimony on these issues that Patent Owner did not rely on.
See section II.D.1, above.
III. CONCLUSION
For the foregoing reasons, Petitioner has shown by a preponderance of
the evidence that the challenged claims of the ’870 patent are unpatentable,
as summarized in the following table:
Claims 35 U.S.C § Reference(s) / Basis
Claims
Shown
Unpatentable
Claims Not
Shown
Unpatentable
1–17 112(a) Written description 1–17
1–8, 14 112(a) Written description 1–8, 14
9–17 112(a) Written description 9–17
1–17 112(a) Written description 1–17
1–17 112(a) Written description 1–17
6, 15 112(a) Written description 6, 15
7, 16 112(a) Enablement 7, 16
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8, 17 112(a) Enablement 8, 17
1–17 112(a) Enablement 1–17
1–5, 7, 8,
14 112(a) Enablement 1–5, 7, 8, 14
9–14, 16,
17 112(a) Enablement 9–14, 16, 17
6, 15 112(a) Enablement 6, 15
1–17 102(a)/103 Bauer 1–17
1–4, 6–12,
14–17 102(a) Napier
1–4, 6–12,
14–17
1–5, 7–14,
16, 17 102(a) Petrie I
1–5, 7–14, 16,
17
1–17 103 Petrie II 1–17
Overall
Outcome 1–17

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IV. ORDER
In consideration of the foregoing, it is hereby:
ORDERED that claims 1–17 of U.S. Patent No. 10,351,870 B2 have
been shown to be unpatentable;
FURTHER ORDERED that, with respect to Paper 27, Petitioner’s
request to exclude Exhibit 2031 and associated testimony is denied;
Petitioner’s alternative request to consider certain portions of Dr. Sederoff’s
deposition testimony not cited in the Sur-reply is granted;
FURTHER ORDERED that, because this is a final written decision,
parties to the proceeding seeking judicial review of the decision must
comply with the notice and service requirements of 37 C.F.R. § 90.2.

For PETITIONER:

Gary J. Gershik
John P. White
COOPER & DUNHAM LLP
ggershik@cooperdunham.com
jwhite@cooperdunham.com

For PATENT OWNER:
Sandip H. Patel
Mark H. Izraelewicz
MARSHALL GERSTEIN & BORUN LLP
spatel@marshallip.com
mizraelewicz@marshallip.com