Arbutus Biopharma Corporation v. Modernatx, Inc. ( 2023 )

Case: 20-1183 Document: 93 Page: 1 Filed: 04/11/2023
United States Court of Appeals
for the Federal Circuit
______________________
ARBUTUS BIOPHARMA CORPORATION, FKA
PROTIVA BIOTHERAPEUTICS, INC.,
Appellant
v.
MODERNATX, INC., FKA MODERNA
THERAPEUTICS, INC.,
Appellee
______________________
2020-1183
______________________
Appeal from the United States Patent and Trademark
Office, Patent Trial and Appeal Board in No. IPR2018-
00680.
______________________
Decided: April 11, 2023
______________________
DAVID I. BERL, Williams & Connolly LLP, Washington,
DC, argued for appellant. Also represented by JESSICA
PALMER RYEN; SONJA ROCHELLE GERRARD, MICHAEL T.
ROSATO, Wilson Sonsini Goodrich & Rosati, Seattle, WA;
LORA MARIE GREEN, Gemini Law LLP, Washington, DC.
AMY K. WIGMORE, Wilmer Cutler Pickering Hale and
Dorr LLP, Washington, DC, argued for appellee. Also rep-
resented by NORA N. XU; MARK CHRISTOPHER FLEMING,
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2 ARBUTUS BIOPHARMA CORPORATION v. MODERNATX, INC.
ANASTASIA GREENBERG, MADELEINE C. LAUPHEIMER, EMILY
R. WHELAN, Boston, MA.
______________________
Before REYNA, SCHALL, and CHEN, Circuit Judges.
REYNA, Circuit Judge.
Appellant Arbutus Biopharma Corporation appeals a
final written decision in an inter partes proceeding of the
Patent Trial and Appeal Board that found claims 1–22 of
U.S. Patent No. 9,404,127 invalid as anticipated. On ap-
peal, Arbutus Biopharma Corporation challenges the
Board’s anticipation finding. We affirm.
BACKGROUND
Protiva Biotherapeutics, once a wholly owned subsidi-
ary of—and is now amalgamated into—Appellant Arbutus
Biopharma Corporation (“Arbutus”), owned U.S. Patent
No. 9,404,127 (the “’127 patent”). See Moderna Therapeu-
tics, Inc. v. Protiva Biotherapeutics, Inc., No. IPR2018-
00680, 2019 WL 12447121, at *1 & n.2. (P.T.A.B. Sept. 10,
2019) (“Decision”). The ’127 patent was filed on March 9,
2015 and claims priority to Application No. 61/360,480 that
was filed on June 30, 2010. Id. at *1. The ’127 patent is-
sued on August 2, 2016, listing three co-inventors: Ed Ya-
worski, Lloyd B. Jeffs, and Lorne R. Palmer. Id. It is
directed to an invention that provides stable nucleic acid-
lipid particles (“SNALP”) that have a non-lamellar struc-
ture and “comprise a nucleic acid . . . methods of making
the SNALP, and methods of delivering and/or administer-
ing the SNALP.” Id. at *2 (quoting ’127 patent, Abstract).
The three-dimensional structure of SNALP is a physical
property that has one of two morphologies: lamellar or non-
lamellar. Appellee’s Br. 6–8.
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ARBUTUS BIOPHARMA CORPORATION v. MODERNATX, INC. 3
Id. A lamellar morphology is one in which sheets of lipid
bilayers are arranged in layers (shown above in the picture
on the left). Appellee’s Br. 6. A non-lamellar form refers
to a non-bilayer morphology of the particles, an example of
which is an inverse hexagonal structure (shown above in
the picture on the right). Id. at 7–8; Decision at *2 n.5.
The ’127 patent states that its purpose is to allow for
more efficient methods and compositions for introducing
nucleic acids into cells and methods of downregulating
gene expression. ’127 patent, col. 2 ll. 54–61. The inven-
tion is, in part, the “surprising discovery” of the Morphol-
ogy Limitation when one controls two factors: the lipid
compositions of a SNALP formulation and formation pro-
cess. ’127 patent, col. 2 ll. 64–col. 3 l. 1. Thus, the physical
property or morphology of the particles depends on two fac-
tors: (1) the lipids used for making the formulations and (2)
the process used to form the particles. Appellant’s Br. 5–6;
Appellee’s Br. 8–9. The ’127 patent identifies five formula-
tions of various compositions that can be prepared by ei-
ther Stepwise Dilution Method (“SDM”) or Direct Dilution
Method (“DDM”). Decision at *2; ’127 patent, Tables 1, 3;
col. 104 ll. 44–60; col. 105 ll. 53–64. These formulations are
1:62, 1:57, 2:40, 2:30, and 10:15, with the first two being
the most relevant to this case. Decision at *2. The
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4 ARBUTUS BIOPHARMA CORPORATION v. MODERNATX, INC.
numbers refer to molar percentages of the conjugated lipid
and cationic lipid, respectively. Decision at *2 n.6.
The ’127 patent incorporates by reference U.S. Patent
Publication No. 2007/0042031 (the “’031 publication”) to
describe DDM and the apparatuses for carrying out DDM.
’127 patent, col. 16 ll. 27–31, col. 93 ll. 14–18, col. 104 ll.
32–37. It also incorporates by reference Publication No.
2004/0142025 to describe SDM and the apparatuses for
carrying out for carrying out SDM. ’127 patent, col. 16
ll. 27–31, col. 93 ll. 47–50, col. 104 ll. 9–22. The disclosure
for each incorporated patent or publication is “in its en-
tirety for all purposes.” ’127 patent, col. 104 ll. 9–22, 32–
37. Independent Claim 1 is representative:
1. A composition comprising:
a plurality of nucleic acid-lipid particles, wherein
each particle in the plurality of particles comprises:
(a) a nucleic acid;
(b) a cationic lipid;
(c) a non-cationic lipid; and
(d) a conjugated lipid that inhibits aggregation of
particles, wherein at least about 95% of the parti-
cles in the plurality of particles have a non-lamel-
lar morphology. [Morphology Limitation]
’127 patent, col. 149 ll. 29–37.
PROCEDURAL HISTORY
Appellee Moderna Therapeutics (“Moderna”) filed a pe-
tition for inter partes review (“IPR”) challenging claims 1–
22 of the ’127 patent, and review was instituted on Septem-
ber 12, 2018. Decision at *1. Moderna argued that U.S.
Patent No. 8,058,069 (the “’069 patent”), which was filed on
April 15, 2009 and claims priority to Application No.
61/045,228 that was filed on April 15, 2008, anticipated
every claim. Id. at *7. The ’069 patent lists five inventors,
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three of which are listed on the ’127 patent. Id. The ’069
patent, its child patent (U.S. Patent No. 9,364,435 (the
“’435 patent”)), and the ’127 patent, are all commonly
owned by Arbutus. Id. While the ’127 patent was filed
during the pendency of the ’069 patent, it does not claim
priority to it. Id. at *7 n.16.
BOARD’S FINAL WRITTEN DECISION
The Patent Trial and Appeal Board (“Board”) insti-
tuted the IPR and issued a final written decision (“FWD”)
finding all 22 claims anticipated by the ’069 patent (“’069
patent” or “prior art patent”). Id. at *1. In doing so, it
found the ’069 patent to be prior art to the ’127 patent. 1 Id.
at *9, 12. The Board then found several of the same com-
ponents between the two patents. Both patents: are di-
rected to the same purpose (providing SNALP, methods of
making and delivering SNALP); disclose at least the 1:57
and 1:62 formulations; explain that SNALP can be formed
by any method in the art including direct dilution, and di-
rect the reader to rely on the ’031 publication for details on
using DDM. Id. at *7–8; ’069 patent, col. 57 ll. 50–55.
The Board’s FWD also addressed several incorporated
references. The ’031 publication is incorporated by refer-
ence in both the ’127 and ’069 patents. Decision at *2, 7–8.
Several other references—including U.S. Patent Publica-
tion No. 2006/0083780 (the “’780 publication”), U.S. Patent
Publication No. 2004/0142025 (the “’025 publication”), and
U.S. Patent No. 5,885,613 (the “’613 patent”)—were incor-
porated by reference in the ’069 patent, each “in its entirety
for all purposes.” ’069 patent, col. 11 ll. 62–64, col. 51 ll.
58–61, col. 58 ll.18–21, col. 47 ll. 59–64. The Board found
that the disclosure of the ’069 patent thus includes the
1 Protiva did not dispute that the ’069 patent was
prior art under pre-AIA 35 U.S.C. § 102(e)(2). Decision at
*7 n.15.
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6 ARBUTUS BIOPHARMA CORPORATION v. MODERNATX, INC.
disclosures of the ’031 publication, the ’613 patent, the ’025
publication, and the ’780 patent publication. Decision at *8
(citing Advanced Display Sys., Inc. v. Kent State Univ., 212
F.3d 1272, 1282 (Fed. Cir. 2000) and Harari v. Lee, 656
F.3d 1331, 1335 (Fed. Cir. 2011)). Together, the ’069 patent
and its incorporated references detail several of the same
disclosures and experiments as the ’127 patent. Decision
at *16, 21. The specificity of the disclosure in the prior art
is the same as in the ’127 patent. The ’435 patent has the
same disclosures and experiments as the prior art patent
as well. Id.The main issue before the Board was whether claim
1(d) of the ’127 patent—wherein at least about 95% of the
particles in the plurality of particles have a non-lamellar
morphology (the “Morphology Limitation”)—is inherently
disclosed in the ’069 patent. Id. at *9. Moderna argued
that the Morphology Limitation, while not expressly men-
tioned in the prior art, is an “inherent natural property”
resulting from the lipid composition of the formulation and
formation process. Id. at *11. Arbutus disagreed, arguing
that there was no presumption of inherency and that there
was no evidence (such as testing or reasoning) showing
that the ’069 patent and its formulations would necessarily
have the same morphology as disclosed by the ’127 patent.
Id. at *12. Arbutus also submitted experimental evidence
from its expert, who prepared two 2:30 lipid formulations
from the ’069 patent, to demonstrate that the Morphology
Limitation was not met. Id. at *17. After weighing the
evidence, the Board found Arbutus’s arguments unavail-
ing.
Arbutus argued that DDM is not a specific formulation
process such that a person skilled in the art would under-
stand that many parameters could be varied from classes
of processes. Decision at *16. The Board noted—and relied
upon—Arbutus’s expert’s apparent concession that the ’435
patent, a continuation of the prior art patent, would also
disclose the Morphology Limitation. Id. at *13–14. Thus,
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the disclosure of the ’069 patent and its incorporated refer-
ences sufficiently demonstrate to a person skilled in the art
how to make and use the claimed compositions, processed
by DDM, that results in the Morphology Limitation. Id.
at *16. Accordingly, the Board found that all challenged
claims were invalid as anticipated. The Board found inde-
pendent claim 1, particularly, the Morphology Limitation,
to be inherently anticipated by the ’069 patent and its dis-
closures because the Morphology Limitation is an inherent
property or natural result of the disclosures. Id. at *21–22.
It also found the remaining claims invalid as anticipated.
Moderna appeals. We have jurisdiction pursuant to
28 U.S.C. § 1295(a)(4)(A).
STANDARD OF REVIEW
We review the Board’s legal conclusions de novo and its
factual findings for substantial evidence. ACCO Brands
Corp. v. Fellowes, Inc., 813 F.3d 1361, 1365 (Fed. Cir.
2016). Substantial evidence “means such relevant evi-
dence as a reasonable mind might accept as adequate to
support a conclusion.” In re Gartside, 203 F.3d 1305, 1312
(Fed. Cir. 2000) (citations omitted). Anticipation is a ques-
tion of fact reviewed for substantial evidence. In re Ram-
bus Inc., 694 F.3d 42, 46 (Fed. Cir. 2012). Whether a claim
limitation is inherent in a prior art reference is a question
of fact that we review for substantial evidence. Monsanto
Tech. LLC v. E.I. DuPont de Nemours & Co., 878 F.3d 1336,
1342 (Fed. Cir. 2018) (quoting Telemac Cellular Corp. v.
Topp Telecom, Inc., 247 F.3d 1316, 1328 (Fed. Cir. 2001)).
DISCUSSION
On appeal, Arbutus challenges the Board’s finding of
inherent anticipation of the Morphology Limitation, and
both the inherent and express anticipation findings for de-
pendent claims 3, 8–12 of the ’127 patent.
A claim is anticipated if each and every element as set
forth in the claim is found, either expressly or inherently,
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8 ARBUTUS BIOPHARMA CORPORATION v. MODERNATX, INC.
in a single prior art reference. Trintec Indus., Inc. v. Top-
U.S.A. Corp., 295 F.3d 1292, 1295 (Fed. Cir. 2002). A find-
ing of anticipation “does not require the actual creation or
reduction to practice of the prior art subject matter; antic-
ipation requires only an enabling disclosure.” Schering
Corp. v. Geneva Pharms., 339 F.3d 1373, 1380 (Fed. Cir.
2003).
A limitation is inherent if it is the “natural result flow-
ing from” the prior art’s explicit disclosure. Id. at 1379. A
patent “can be invalid based on inherency when the patent
itself makes clear that a limitation is ‘not an additional re-
quirement imposed by the claims . . . but rather a property
necessarily present’.” Hospira, Inc. v. Fresenius Kabi USA,
LLC, 946 F.3d 1322, 1332 (Fed. Cir. 2020) (quoting In re
Kubin, 561 F.3d 1351, 1357 (Fed. Cir. 2009)). Thus, inher-
ent anticipation requires “merely that the disclosure of the
prior art is sufficient to show that the natural result flow-
ing from the operation as taught in the prior art would re-
sult in the claimed product.” SmithKline Beecham Corp. v.
Apotex Corp., 403 F.3d 1331, 1343–44 (Fed. Cir. 2005) (in-
ternal quotation marks omitted) (modifications in the orig-
inal). We have also explained that “[n]ewly discovered
results of known processes directed to the same purpose
are not patentable because such results are inherent.”
Bristol–Myers Squibb Co. v. Ben Venue Labs, Inc., 246 F.3d
1368, 1376 (Fed. Cir. 2001). “Insufficient prior under-
standing of the inherent properties of a known composition
does not defeat a finding of anticipation.” Atlas Powder Co.
v. Ireco, Inc., 190 F.3d 1342, 1349 (Fed. Cir. 1999).
This court has also discussed the effect of incorporated
references. When a reference or material from various doc-
uments is incorporated, they are “effectively part of the
host document as if [they] were explicitly contained
therein.” Advanced Display Sys., Inc., 212 F.3d at 1282.
While looking at the reference as a whole, the court will
“conclude whether or not that reference discloses all ele-
ments of the claimed invention arranged as in the claim.”
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Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369
n.5 (Fed. Cir. 2008). While “[a]rtisans of ordinary skill may
not recognize the inherent characteristics or functioning of
the prior art,” whether a reference anticipates is assessed
from the perspective of one skilled in the art. Atlas Powder,
190 F.3d at 1347; see also Dayco Prods., Inc. v. Total Con-
tainment, Inc., 329 F.3d 1358, 1368–69 (Fed. Cir. 2003).
I
With this backdrop in mind, we first address whether
the Morphology Limitation of claim 1 of the ’127 patent is
met, or inherently anticipated.
There is no dispute that the ’069 patent does not explic-
itly teach the Morphology Limitation. Decision at *11; Ap-
pellee’s Br. 15; Appellant’s Br. 1. Moderna argues that the
Morphology Limitation is inherently anticipated because it
is a “natural result” and “inherent property” of the varia-
bles identified and claimed in the ’127 patent such that one
skilled in the art would necessarily produce the limitation
after controlling the two factors of the invention: the lipid
composition of the SNALP formulation and using the for-
mation process of DDM to prepare it. ’127 Patent, col. 2
l. 64–col. 3 l. 10; Appellee’s Br. 3, 15. Arbutus argues that,
even if one skilled in the art could have met the Morphol-
ogy Limitation, the legal test requires that the embodi-
ment(s) must necessarily yield the limitation. Appellant’s
Br. 2–3. Additionally, while Arbutus does not dispute that
the references were properly incorporated, it takes issue
with the Board’s understanding of DDM as a particular
process as opposed to a “broad genus” or a “generic cate-
gory” of formation methods. Appellant’s Br. 3, 11, 40. Ar-
butus has not shown that the Board erred in finding the
Morphology Limitation inherently met by the disclosures.
First, we look at the disclosures of the formulations. As
Moderna explains, the ’127 and ’069 patents disclose the
same formulations with “almost identical wording.” Appel-
lee’s Br. 28. Both patents disclose identical lipid
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10 ARBUTUS BIOPHARMA CORPORATION v. MODERNATX, INC.
compositions for the 1:57 and 1:62 formulations. Decision
at *19–20. For the other formulations (2:30, 2:40, 10:15),
Arbutus’s expert explained that the parameters such as en-
capsulation efficiency, particle size, and polydispersity, can
be substituted without impacting the Morphology Limita-
tion. Appellee’s Br. 31. The specificity of the disclosure in
the ’069 patent is the same as in the ’127 patent. See King
Pharms., Inc. v. Eon Labs, Inc., 616 F.3d 1267, 1276 (Fed.
Cir. 2010). Thus, substantial evidence supports the
Board’s finding that the formulations “are the same or es-
sentially the same” across the patents.
Second, we look at the disclosures of the processes. The
inquiry involves assessing how the ’127 and ’069 patents
refer to the process parameter, DDM. Contrary to Arbu-
tus’s argument, this does not involve a disclosure of an an-
ticipating genus of a process. Appellee’s Br. 24; Oral Arg.
at 17:30–18:52, 19:39–20:03, https://oralargu-
ments.cafc.uscourts.gov/default.aspx?fl=20-1183_1104202
2.mp3 (Moderna’s counsel explaining how the ’127 patent
defines DDM); contra Appellant’s Br. 23 (arguing that
DDM is a genus method). The ’069 patent states that “[the]
processes and the apparatuses for carrying out these direct
dilution processes are described in detail in [the ’031 pub-
lication].” ’069 patent, col. 59 ll. 11–16. The ’127 patent
explains that the non-lamellar morphology can be “readily
determined using techniques known to and used by those
of skill in the art.” ’127 patent, col. 9 ll. 29–31. The ’127
patent—although it provides details that are not included
in the ’069 patent—continually references “the Direct Di-
lution Method” and incorporates the ’031 publication to
provide details for carrying out this process. ‘127 patent,
col. 104 ll. 33–37 (“The Direct Dilution Method (‘DDM’), . . .
as well as the apparatuses for carrying out the DDM are
described in detail in [the ’031 publication], the disclosure
of which is herein incorporated by reference in its entirety
for all purposes.”). The Board’s finding that the references
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disclose and describe DDM the same way is thus supported
by substantial evidence. 2 Decision at *21.
Finally, the inherent anticipation analysis involves un-
derstanding whether, by making the formulations (1:57 or
1:62) by the DDM process, which are similarly disclosed in
both the ’127 and ’069 patents with the disclosures of the
incorporated references, would naturally result in a com-
position having the Morphology Limitation. The Board
found that making the disclosed formulations according to
the disclosed process would “naturally result in a composi-
tion having the claimed morphological property.” 3 Id. at
*21.
We have explained that the “critical question” for in-
herent anticipation is “whether the [prior art] patent suffi-
ciently describes and enables one or more embodiments—
whatever the settings of their operational features—that
necessarily include or result in the subject matter of [the]
limitation. . . .” See Toro Co. v. Deere & Co., 355 F.3d 1313,
1321 (Fed. Cir. 2004). Here, because there is no error in
the Board’s determinations that the prior art teaches the
2 Moderna argues that the prior art patent discloses
the same SDM parameters as the ’127 patent, which would
also result in the Morphology Limitation. Appellee’s Br.
12, 21, 51, 60 n.12. Because DDM used with at least two
formulations renders the limitation inherent, we need not
further address this method.
3 The Board considered, but did not credit, the exper-
imental evidence submitted by Arbutus because the Board
found that the testing suffered from a myriad of problems
that affected its reliability, including the involvement of
Arbutus’s counsel, the fact that the expert was an inter-
ested party, and the expert’s apparent lack of experience in
characterizing morphology. Decision at *19. This was not
error, because the Board’s finding was supported by sub-
stantial evidence.
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12 ARBUTUS BIOPHARMA CORPORATION v. MODERNATX, INC.
same formulations and the same DDM as the ’127 patent,
we see no error in the Board’s conclusion that the ’069 pa-
tent inherently anticipates the Morphology Limitation. To
anticipate, the prior art need only meet the inherently dis-
closed limitation to the same extent as the patented inven-
tion. King Pharms., 616 F.3d at 1276 (rejecting the
argument that a prior art method did not “necessarily re-
sult” in a claimed limitation when the prior art described
using the same method as the patent). The Board reason-
ably found that the ’127 patent itself teaches making the
formulations disclosed, such as the 1:62 formulation, with
the DDM process described by the ’031 publication, and
would naturally result in a composition having the claimed
morphological property. Decision at *21 (citing ’127 patent,
col. 8 ll. 51–62, col. 104 ll. 32–37, col. 109 l. 11–col. 110 l.
21).
We are also not persuaded that this a case where there
is only a probability that the Morphology Limitation would
result from controlling several variations of formulations
and processes. Appellant’s Br. 24; contra Continental Can
Co. USA, Inc. v. Monsanto Co., 948 F.2d 1264, 1269 (Fed.
Cir. 1991) (citing Hansgirg v. Kremmer, 102 F.2d 212, 214
(C.C.P.A. 1939) (“The mere fact that a certain thing may
result from a given set of circumstances is not sufficient.”)
(emphasis in original). This is a case where there are a
“limited number of tools”—five formulations and two pro-
cesses—that a person skilled in the art would have to fol-
low. Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331,
1344 (Fed. Cir. 2016). The Board reasonably found that a
person skilled in the art would follow these disclosures re-
sulting in a composition with the inherent morphological
property. The Board did not err in its determination that
the Morphology Limitation of claim 1 is inherently antici-
pated by the ’069 patent in that its determination is sup-
ported by substantial evidence. Id. at *21–22.
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II
We next address whether dependent claims 3 and 8–12
of the ’127 patent are anticipated. The Board found that
Moderna demonstrated that each of the challenged depend-
ent claims were anticipated by the ’069 patent and its in-
corporated references.
Dependent claim 3 recites “[t]he composition of claim
1, wherein the nucleic acid is mRNA.” ’127 patent, col. 149
ll. 40–41. The Board found that the ’069 patent explicitly
discloses that the nucleic acid can be mRNA. See ’069 pa-
tent col. 10 ll. 16–26; Decision at *22. Claim 8 recites “[t]he
composition of claim 1, wherein the nucleic acid is fully en-
capsulated in the particles.” ’127 patent, col. 149 ll. 60–61.
The Board found that the prior art patent explicitly dis-
closes that the nucleic acid may be fully encapsulated
within the lipid portion of the particle. Decision at *24 (cit-
ing ’069 patent (claim 17)); see also ’069 patent, col. 22 ll.
43–63. The Board’s finding of anticipation for dependent
claims 3 and 8 is, therefore, supported by substantial evi-
dence.
Claim 9 recites “[t]he composition of claim 1, wherein
the non-lamellar morphology of the particles comprises an
inverse hexagonal (HII) or cubic phase structure.” ’127 pa-
tent, col. 149 ll. 62–64. As compared to independent claim
1, the additional limitation for dependent claim 9 is the in-
verse hexagonal structure. Decision at *24. The Board
found that the structures recited in claim 9 were inherent
properties of the non-lamellar Morphology Limitation that
is, in turn, inherently anticipated in claim 1. Id. While
Moderna identified various three-dimensional structures
for nucleic acid-lipid particles that were well-known in the
art, the Board stated that Arbutus only offered “one con-
clusory comment” that anticipation was not met. Id. (citing
PO Resp. 40). Based on the “trial record as a whole,” the
Board found this property to be disclosed by the prior art
’069 patent through incorporation of another reference—
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14 ARBUTUS BIOPHARMA CORPORATION v. MODERNATX, INC.
the ’613 patent. Id. We agree that dependent claim 9 is
inherently anticipated by the references.
Finally, claims 10 through 12 recite percentage ranges
for a lipid component of claim 1. Id. at *52; ’127 patent, col.
149 l. 64–col. 150 l. 34. Claim 10 recites “[t]he composition
of claim 1, wherein the cationic lipid comprises from about
10 mol % to about 50 mol % of the total lipid present in the
particle.” ’127 patent, col. 149 ll. 64–67. Claim 11 recites
“[t]he composition of claim 1, wherein the cationic lipid
comprises from about 20 mol % to about 50 mol % of the
total lipid present in the particle.” ’127 patent, col. 150 ll.
29–31. Claim 12 recites “[t]he composition of claim 1,
wherein the cationic lipid comprises from about 20 mol %
to about 40 mol % of the total lipid present in the particle.”
’127 patent, col. 150 ll. 32–34. Arbutus argues that using
different references to arrive at the limitations of the
claimed ranges is error because the Board did not evaluate
the claims as a whole. Appellant’s Br. 54–55. We disagree.
When a patent claims a chemical composition in terms
of ranges and a single prior art reference discloses a com-
position that falls within each of the ranges, the range is
anticipated. Titanium Metals Corp. of Am. v. Banner, 778
F.2d 775, 782 (Fed. Cir. 1985). This court has found that
where a prior art reference’s range “entirely encompasses,
and does not significantly deviate from” the claimed
ranges, the range is anticipated. Perricone v. Medicis
Pharm. Corp., 432 F.3d 1368, 1377 (Fed. Cir. 2005).
The Board reviewed Moderna’s citations to several dis-
closures in the prior art patent, through incorporation by
reference, to find the disclosure of cationic lipid amounts:
25% in the ’025 publication; 30% in the ’031 publication;
and, in the ’025 publication, about 10% to about 45%, from
about 20% to about 40%, or about 30% of the total lipid pre-
sent in the particle. Decision at *25. The 2:40 formulation
of the prior art patent includes a 36.4 mol % cationic lipid.
Id. at *26. The ’780 publication, incorporated by reference
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into the prior art patent, discloses the lipid amount “from
about 2% to about 60%.” ’780 Pub. ¶ 51. The Board then
found that the prior art patent and its incorporated refer-
ences disclose each of the claimed ranges. Decision at *25–
26. More specifically, the Board found that Moderna had
demonstrated, “by a preponderance of the evidence[,]” that
the 25% and 30% disclosures fall within the ranges of and
anticipate claims 10 and 11, while the disclosures of the
’069 patent with the incorporated disclosures anticipate
claim 12. Id. The Board also found that the ranges are
described with sufficient specificity such that a reasonable
fact finder could conclude that there is no reasonable dif-
ference in how the invention operates over the ranges. Id.
at *25 (citing Ineos USA LLC v. Berry Plastics Corp., 783
F.3d 865, 869 (Fed. Cir. 2015)).
Substantial evidence supports the Board’s finding that
the ’069 patent and its incorporated references describe nu-
cleic acid-lipid particles and disclose these amounts as an
inherent property of the formulations. Id. at *25–26. Ac-
cordingly, we agree that dependent claims 10–12 are antic-
ipated. Because Arbutus chose to incorporate several
references into both the prior art patent and ’127 patent,
that material became incorporated into the host document.
Those disclosures, when reviewed as a whole, sufficiently
disclose and describe claims 10–12, rendering each antici-
pated.
CONCLUSION
We hold that the Board’s finding that independent
claim 1 and its morphological property are inherently an-
ticipated by the disclosures of the ’069 patent and its incor-
porated references is supported by substantial evidence,
and that the Board properly found dependent claims 3 and
8–12 anticipated. Thus, we affirm the Board’s final written
decision concluding that claims 1, 3, and 8–12 of the ’127
patent are invalid as anticipated.
AFFIRMED
Case: 20-1183 Document: 93 Page: 16 Filed: 04/11/2023
16 ARBUTUS BIOPHARMA CORPORATION v. MODERNATX, INC.
COSTS
No costs.