Court Opinion

ID: 9386114
Source: CourtListenerOpinion
Date Created: 2023-04-11 15:01:12.19778+00
Date Added: 2024-06-11T17:17:54.271798
License: Public Domain

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,
Case: 20-1183    Document: 93     Page: 2     Filed: 04/11/2023

 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.
Case: 20-1183     Document: 93      Page: 3     Filed: 04/11/2023

 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
Case: 20-1183      Document: 93      Page: 4     Filed: 04/11/2023

 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,
Case: 20-1183     Document: 93      Page: 5    Filed: 04/11/2023

 ARBUTUS BIOPHARMA CORPORATION      v. MODERNATX, INC.        5

 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.
Case: 20-1183     Document: 93     Page: 6     Filed: 04/11/2023

 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,
Case: 20-1183    Document: 93      Page: 7    Filed: 04/11/2023

 ARBUTUS BIOPHARMA CORPORATION     v. MODERNATX, INC.       7

 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,
Case: 20-1183     Document: 93      Page: 8     Filed: 04/11/2023

 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.”
Case: 20-1183     Document: 93     Page: 9    Filed: 04/11/2023

 ARBUTUS BIOPHARMA CORPORATION     v. MODERNATX, INC.        9

 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
Case: 20-1183    Document: 93      Page: 10     Filed: 04/11/2023

 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
Case: 20-1183    Document: 93      Page: 11    Filed: 04/11/2023

 ARBUTUS BIOPHARMA CORPORATION     v. MODERNATX, INC.       11

 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.
Case: 20-1183     Document: 93      Page: 12    Filed: 04/11/2023

 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.
Case: 20-1183    Document: 93       Page: 13    Filed: 04/11/2023

 ARBUTUS BIOPHARMA CORPORATION      v. MODERNATX, INC.       13

                               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—
Case: 20-1183    Document: 93      Page: 14     Filed: 04/11/2023

 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
Case: 20-1183    Document: 93      Page: 15    Filed: 04/11/2023

 ARBUTUS BIOPHARMA CORPORATION     v. MODERNATX, INC.       15

 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.