Case: 22-1165 Document: 61 Page: 1 Filed: 06/27/2023
`
`United States Court of Appeals
`for the Federal Circuit
`______________________
`
`MEDYTOX, INC.,
`Appellant
`
`v.
`
`GALDERMA S.A., GALDERMA LABORATORIES
`INC., GALDERMA LABORATORIES, L.P.,
`GALDERMA RESEARCH AND DEVELOPMENT,
`S.N.C., SHDS, INC., GALDERMA HOLDINGS S.A.,
`Appellees
`
`KATHERINE K. VIDAL, UNDER SECRETARY OF
`COMMERCE FOR INTELLECTUAL PROPERTY
`AND DIRECTOR OF THE UNITED STATES
`PATENT AND TRADEMARK OFFICE,
`Intervenor
`______________________
`
`2022-1165
`______________________
`
`Appeal from the United States Patent and Trademark
`Office, Patent Trial and Appeal Board in No. PGR2019-
`00062.
`
`______________________
`
`Decided: June 27, 2023
`______________________
`
`VISHAL C. GUPTA, Steptoe & Johnson LLP, New York,
`NY, argued for appellant. Also represented by TYLER DOH,
`JOHN J. MOLENDA; CHRISTOPHER ALAN SUAREZ,
`
`

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`MEDYTOX, INC. v. GALDERMA S.A.
`
`Washington, DC.
`
` JOSEPH A. MAHONEY, Mayer Brown, LLP, Charlotte,
`NC, argued for appellees. Also represented by AMANDA
`STREFF BONNER, ERICK J. PALMER, Chicago, IL.
`
` ROBERT MCBRIDE, Office of the Solicitor, United States
`Patent and Trademark Office, Alexandria, VA, argued for
`intervenor. Also represented by SARAH E. CRAVEN, THOMAS
`W. KRAUSE, FARHEENA YASMEEN RASHEED.
` ______________________
`
`Before DYK, REYNA, and STARK, Circuit Judges.
`REYNA, Circuit Judge.
`Appellant Medytox, Inc. appeals a final written deci-
`sion in a post-grant review proceeding of the Patent Trial
`and Appeal Board that denied Medytox’s revised motion to
`amend to substitute claims 19–27 of U.S. Patent No.
`10,143,728. On appeal, Medytox challenges the Board’s
`findings on claim construction, written description, and en-
`ablement. Medytox also challenges the Board’s Pilot Pro-
`gram concerning motion to amend practice and procedures
`under the Administrative Procedure Act. We affirm.
`BACKGROUND
`The patent-at-issue, U.S. Patent No. 10,143,728 (the
`“’728 patent”) issued from an application filed on October
`27, 2016, but claims priority from a provisional application
`filed on December 12, 2013. See Galderma S.A. v. Medy-
`tox, Inc., PGR2019-00062, 2021 WL 3039217, at *2
`(P.T.A.B. July 16, 2021) (“Decision”). The ’728 patent is di-
`rected to the use of an animal-protein-free botulinum toxin
`composition that exhibits a longer lasting effect in the pa-
`tient compared to an animal protein-containing botulinum
`toxin composition. ’728 Patent, col. 2 ll. 57–62.
`
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`According to the ’728 patent, the animal-protein-free
`botulinum toxin composition can be used to treat both cos-
`metic and non-cosmetic conditions, from glabellar lines and
`lateral canthal lines to chronic migraines. ’728 Patent, col.
`11 l. 5–col. 12 l. 47.
`Substitute claim 19 is representative of the substitute
`claims:
`19. A method for treating glabellar lines a condition in
`a patient in need thereof, comprising:
`locally administering a first treatment of therapeuti-
`cally effective amount of a botulinum toxin composition
`comprising a serotype A botulinum toxin in an amount pre-
`sent in about 20 units of MT10109L, a first stabilizer com-
`prising a polysorbate, and at least one additional stabilizer,
`and that does not comprise an animal-derived product or
`recombinant human albumin;
`locally administering a second treatment of the botuli-
`num toxin composition at a time interval after the first
`treatment;
`wherein said time interval is the length of effect of the
`serotype A botulinum toxin composition as determined by
`physician’s live assessment at maximum frown;
`wherein said botulinum toxin composition has a
`greater length of effect compared to about 20 units of
`BOTOX®, when whereby the botulinum toxin composition
`exhibits a longer lasting effect in the patient when com-
`pared to treatment of the same condition with a botulinum
`toxin composition that contains an animal-derived product
`or recombinant human albumin dosed at a comparable
`amount and administered in the same manner for the
`treatment of glabellar lines and to the same locations(s) as
`that of the botulinum toxin composition; and
`wherein said greater length of effect is determined by
`physician’s live assessment at maximum frown and
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`MEDYTOX, INC. v. GALDERMA S.A.
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`requires a responder rate at 16 weeks after the first treat-
`ment of 50% or greater. that does not comprise an animal-
`derived product or recombinant human albumin, wherein
`the condition is selected from the group consisting of gla-
`bellar lines, marionette lines, brow furrows, lateral canthal
`lines, and any combination thereof.
`J.A. 2683.1
`The specification notes that two previous patent appli-
`cations, which are incorporated by reference in their entire-
`ties into the ’728 patent, disclose animal-protein-free
`botulinum toxin compositions. ’728 Patent, col. 2 l. 63–col.
`3 l. 14. The specification also describes the results of “ex-
`perimental examples,” i.e., two clinical trials, which com-
`pared animal-protein-free botulinum toxin composition
`with botulinum toxin stabilized with human serum albu-
`min. ’728 Patent, col. 13 l. 41–col. 31 l. 55. These examples
`were provided in “support of [the specification’s] conclusion
`regarding longer lasting efficacy.” Decision, at *3.
`The first example is a Phase III clinical study compar-
`ing an animal-protein-free composition of MT10109L to
`BOTOX® in managing moderate to severe glabellar frown
`lines. ’728 Patent, col. 13 l. 41–col. 22 l. 67. The results of
`example 1 demonstrated that “MT10109L treatment” led
`to “significant improvement” of frown line severity at week
`4 and week 16. ’728 Patent, col. 20 ll. 53–57.
`The second example is a Phase II clinical study com-
`paring MT10109 to BOTOX®. ’728 Patent, col. 23 l. 1–col.
`31 l. 55. The result of example 2 is that “lyophilized
`MT10109 dosed at 20 U” “displays an increased sustained
`
`
`1 Substitute claim 19 reflects Medytox’s amend-
`ments to original claim 1 through underlined text (text
`added to) and strikethrough text (text deleted from). Ap-
`pellant’s Br. 17 n.6; Decision, at *4.
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`effect compared to BOTOX®.” ’728 Patent, col. 31 ll. 48–
`52.
`
`PROCEDURAL HISTORY
`Appellee Galderma S.A., et. al., filed a petition request-
`ing post-grant review of claims 1–10 of the ’728 patent,
`which the Patent Trial and Appeal Board (“Board”) granted
`on all challenged claims. Decision, at *1. Medytox filed a
`non-contingent motion to amend seeking to cancel claims
`1–10 of the ’728 patent and substitute claims 11–18.2 J.A.
`2635. Medytox requested that the Board issue a Prelimi-
`nary Guidance in accordance with the pilot program con-
`cerning the motion to amend practice and procedures
`(“Pilot Program”). Id.3 Galderma opposed the motion. De-
`cision, at *1. Among other things, Galderma argued that
`the claims added new matter because the claims covered
`compounds with a 16-week responder rate between 50%
`
`
`2 The Board’s underlying decision refers to Appellant
`as “Medy-Tox” (J.A. 2), Galderma refers to Appellant as
`“MedyTox” (Appellee’s Br. 1), but, for this opinion, we fol-
`low Appellant’s spelling, that is, “Medytox” (Appellant’s Br.
`2).
`
`3 Patent owners can partake in the Pilot Program
`concerning motion to amend practice for motions filed in
`inter partes reviews, post-grant reviews, and covered busi-
`ness method patent reviews (i.e., AIA trials) before the Pa-
`tent Trial and Appeal Board. 84 Fed. Reg. 9,497. After
`receiving the petitioner’s opposition to its motion to amend,
`the Pilot Program allows a patent owner to receive a Pre-
`liminary Guidance from the Board regarding its motion or
`to file a revised motion to amend. Id. The Preliminary
`Guidance is an initial discussion about whether there is a
`reasonable likelihood that the motion to amend meets the
`statutory and regulatory requirements. Id.
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`MEDYTOX, INC. v. GALDERMA S.A.
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`and 100% but the specification only disclosed responder
`rates of up to 62%. J.A. 2638.
`The Board issued a Preliminary Guidance, which fo-
`cused on the substitute claims and amendments proposed
`in Medytox’s motion. J.A. 2635. The Board found that, “at
`this stage of the proceeding, and based on the current rec-
`ord,” Medytox had not shown a reasonable likelihood that
`it satisfied the statutory and regulatory requirements un-
`der 35 U.S.C. § 326(d) and 37 C.F.R. § 42.221(a) for filing a
`motion to amend. Id. at 2636. The Board gave its “prelim-
`inary view” that Medytox’s proposed responder-rate limi-
`tation did not add new matter, and that it should not
`“necessarily be interpreted as a range of 50–100%” as op-
`posed to simply 50% or greater. J.A. 2638–39.
`In addition, the Board stated:
`We emphasize that the views expressed in
`this Preliminary Guidance are subject to
`change upon consideration of the complete
`record, including any revision to the Mo-
`tion filed by Patent Owner. Thus, this Pre-
`liminary Guidance is not binding on the
`Board when rendering a final written deci-
`sion.
`J.A. 2636.
`Medytox then filed a non-contingent revised motion to
`amend (“revised motion”) seeking to cancel original claim 6
`and replace the other original claims with substitute
`claims 19–27, which Galderma opposed. Decision, at *1.
`Galderma’s opposition to Medytox’s revised motion chal-
`lenged the “50% or greater” language in the claim, the “re-
`sponder rate limitation,”4 as not sufficiently enabled or
`
`
`4 The responder rate, in the context of the ’728 pa-
`tent, is “the proportion of patients who responded
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`described in the specification. Appellant’s Br. 19 (citing
`J.A. 3463–66). Medytox replied that the rate was a clini-
`cally meaningful threshold such that the claims were nar-
`rower in scope, should not be treated as a range, and were
`adequately described, enabled, and not indefinite. Id. (cit-
`ing J.A. 4221). Galderma reiterated its arguments in a sur-
`reply. Id. at 19–20 (citing J.A. 4662–63).
`The oral hearing was held on March 19, 2021. Deci-
`sion, at *2. Prior to the hearing, the Board notified the par-
`ties of a “potential sua sponte ground of unpatentability”
`for substitute claim 19 from the revised motion to amend,
`raising an indefiniteness issue from Medytox’s use of the
`term BOTOX®. Id. During the hearing, the Board asked
`the parties to discuss how the responder rate limitation
`should be construed and to identify specific examples from
`the specification that would satisfy the written description
`requirement for the dose claims. J.A. 4487–89, 4924.
`Medytox’s response pointed to its expert’s testimony, clini-
`cal trial design, and case law, including In re Wertheim, 541
`F.2d 257 (CCPA 1976) and In re Fisher, 427 F.2d 833
`(CCPA 1970). J.A. 4924–49.
`BOARD’S FINAL WRITTEN DECISION
`The Board issued its final written decision (“FWD”) on
`July 16, 2021. First, the Board cancelled original claims 1–
`5 and 7–10 because “a non-contingent [motion to amend] is
`one in which ‘the Board provides a final decision on the pa-
`tentability of substitute claims in place of determining the
`patentability of corresponding original claims.’” Decision,
`at *3 (italics in original). Second, the Board addressed the
`parties’ dispute regarding whether the responder rate
`
`
`favorably” to the treatment with Medytox’s MT10109L, a
`botulinum toxin composition, out of all patients to receive
`it, multiplied by 100 to generate a percentage. Appellant’s
`Br. 6.
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`MEDYTOX, INC. v. GALDERMA S.A.
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`limitation should be construed as a range of 50–100% (as
`argued by Galderma) or a minimum threshold of 50% (as
`argued by Medytox). Id. at *6, 8–9. The Board analyzed
`whether Medytox’s substitute claims were a reasonable
`number under 37 C.F.R. § 42.221(a)(3); responsive to
`grounds of unpatentability involved in the trial under 37
`C.F.R. § 42.221(a)(2)(i); improperly broader than the origi-
`nal claims under 35 U.S.C. § 326(d)(3) and 37 C.F.R. §
`42.221(a)(2)(ii); and introduced new matter under 35
`U.S.C. § 326(d)(3) and 37 C.F.R. § 42.221(a)(2)(ii). Id. at
`*6–12. Third, the Board addressed section 112 concerns
`regarding a lack of written description and lack of enable-
`ment. Id. at *12–14.
`Ultimately, the Board found that the substitute claims
`impermissibly introduced new matter with the inclusion of
`the responder rate limitation and thus, failed to meet the
`requirements for revised motions to amend. Id. In light of
`that finding, the Board found that the proposed substitute
`claims were unpatentable for a lack of written description.
`Id. After assessing Galderma’s expert testimony and evi-
`dence for the factors from In re Wands, 858 F.2d 731, 737
`(Fed. Cir. 1998) (“Wands factors”),5 the Board found that,
`by a preponderance of the evidence, the full scope of the
`claims was not enabled, particularly because a skilled arti-
`san would not have been able to achieve higher than 62%
`for the responder rate limitation when reading the
`
`
`5 There are eight Wands factors that the Board con-
`sidered in assessing whether the substitute claims satis-
`fied the enablement requirement of 35 U.S.C. § 112(a): (1)
`the quantity of experimentation necessary, (2) the amount
`of direction or guidance presented, (3) the presence or ab-
`sence 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. Decision, at *12.
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`specification. Id. at *12−14. Recognizing that it had inter-
`preted the claim differently in its Preliminary Guidance,
`the Board now rejected Medytox’s argument that the re-
`sponder rate limitation only requires a threshold of 50%,
`instead interpreting the limitation as a range with an up-
`per limit of 100%. Id. at *9, 14. Accordingly, the Board
`found that a skilled artisan would not have been able to
`achieve higher responder rates under the guidance pro-
`vided in the specification without undue experimentation.
`Id. Based on the foregoing, the Board thus denied
`Medytox’s revised motion to amend. Id. Medytox appeals.
`We have jurisdiction pursuant to 28 U.S.C. § 1295(a)(4)(A).
`STANDARD OF REVIEW
`We review Board decisions using the standards set
`forth in the Administrative Procedure Act. 5 U.S.C. § 706;
`see also In re Sullivan, 362 F.3d 1324, 1326 (Fed. Cir.
`2004). 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). Whether a claim amendment satisfies the written
`description requirement or improperly adds new matter
`are both questions of fact reviewed for substantial evi-
`dence. Knowles Elecs. LLC v. Cirrus Logic, Inc., 883 F.3d
`1358, 1365 (Fed. Cir. 2018); see also In re Lew, 257 F. App’x
`281, 285 (Fed. Cir. 2007) (referencing Vas-Cath Inc. v. Ma-
`hurkar, 935 F.2d 1555, 1563 (Fed. Cir. 1991)). Substantial
`evidence “means such relevant evidence 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).
`Claim construction is an issue of law that may involve
`underlying factual findings. See Teva Pharms. USA, Inc.
`v. Sandoz, Inc., 574 U.S. 318, 325 (2015). Whether the
`scope of the claims has been enlarged is “a matter of claim
`construction” that is subject to de novo review. Quantum
`Corp. v. Rodime, PLC, 65 F.3d 1577, 1580 (Fed. Cir. 1995).
`
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`Whether a claim satisfies the enablement requirement is a
`question of law that may be based on underlying factual
`findings. Alcon Rsch. Ltd. v. Barr Lab’ys, Inc., 745 F.3d
`1180, 1188, 1190 (Fed. Cir. 2014).
`DISCUSSION
`On appeal, Medytox challenges the Board’s findings on
`claim construction, new matter, written description, and
`enablement, as well as the Board’s Pilot Program concern-
`ing motion to amend practice and procedures under the Ad-
`ministrative Procedure Act. Medytox also raises a due
`process claim. We address each issue in turn.
`I
`With this backdrop in mind, we first address the
`Board’s claim construction of the responder rate limitation
`as a range. Medytox argues that the responder rate limi-
`tation should be construed as a “yes-or-no inquiry” such
`that it is a “threshold” for determining whether the animal-
`protein-free composition has a “greater length of effect”
`than BOTOX®. Appellant’s Br. 28–29.
`Galderma asserts that Medytox’s claim construction
`argument that is based on the intrinsic record is forfeited
`because Medytox did not specifically point out the intrinsic
`evidence it now relies on before the Board issued its FWD.
`Appellee’s Br. 25–27; Oral Arg. at 20:34–21:03. Medytox
`does not substantively rebut Galderma’s assertion that
`Medytox relies on intrinsic evidence for the first time on
`appeal. Medytox does not point to anywhere prior to its
`petition for rehearing that it directed the Board’s attention
`to intrinsic evidence in support of its claim construction.
`Medytox instead asserts that it relied on extrinsic evidence
`to support its claim construction before the Board so the
`Board did not address intrinsic evidence. Appellant’s Br.
`34 n.9; Reply Br. 14 (“Medytox relied on extrinsic evidence
`below in support of its claim construction argument, in-
`cluding evidence cited and relied on by both Medytox’s and
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`Galderma’s experts, and admissions from Galderma’s ex-
`perts.”).
`Typically, intrinsic evidence, such as the specification,
`is the most important consideration in a claim construction
`analysis. See, e.g., Phillips v. AWH Corp., 415 F.3d 1303,
`1317 (Fed. Cir. 2005) (en banc) (“[W]e have emphasized the
`importance of intrinsic evidence in claim construction . . .
`.”); see also Ericsson, Inc. v. D-Link Sys., Inc., 773 F.3d
`1201, 1217–18 (Fed. Cir. 2014) (“[In] ascertain[ing] the
`scope and meaning of the asserted claims, . . . [our] inquiry
`typically begins and ends with the intrinsic evidence.”). We
`have held that “arguments that are based on a specification
`in evidence and that are in support of an existing claim
`construction are not barred by the doctrine of waiver for
`the sole reason that they were not first presented to the
`trial court.” Interactive Gift Express, Inc. v. Compuserve
`Inc., 256 F.3d 1323, 1347 (Fed. Cir. 2001); see also Seabed
`Geosolutions (US) Inc. v. Magseis FF LLC, 8 F.4th 1285,
`1289 (Fed. Cir. 2021) (“The doctrine of waiver does not pre-
`clude a party from supporting its original claim construc-
`tion with new citations to intrinsic evidence of record.”).
`Medytox acknowledges that the Board did not, in the first
`instance, address the intrinsic record in its claim construc-
`tion analysis of the responder rate limitation. Appellant’s
`Br. 34 n.9. We note, however, that even if we agreed to
`analyze the intrinsic record for the first time on appeal, it
`would not change our holding on claim construction be-
`cause the parties’ constructions do not substantively differ.
`We, therefore, decline to decide the forfeiture issue.
`There is no dispute that the responder rate limitation
`has an inherent upper limit. Appellant’s Br. 50; Appellee’s
`Br. 21. Medytox’s expert acknowledged that a minimum
`threshold responder rate of 50%, 80%, and 90%, would
`meet the responder rate limitation. J.A. 21, 3489. The
`same expert also acknowledged that the responder rate
`limitation cannot exceed 100%. Id. at 3489. Accordingly,
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`we agree that the responder rate limitation has a natural
`upper limit of 100%.
`The parties do not meaningfully dispute that there is
`not a substantive difference between a “threshold” or
`“range” construction of the responder rate limitation. Dur-
`ing oral argument, Medytox explained that a minimum
`threshold responder rate of 95% would fall within the scope
`of the claims, and that any responder rate above 50% “is
`essentially the same.” Oral Arg. 0:30–0:44, 1:21–1:38.
`Medytox conceded that a 95% responder rate would fall
`within the scope of the claims under either Medytox’s
`“threshold” construction or Galderma’s “range” construc-
`tion. Id. at 2:05–2:20. Galderma similarly acknowledged
`during oral argument that there is no difference between
`the two constructions of the responder rate limitation. Id.
`at 16:19–58. We agree that there appears to be no substan-
`tive difference in the claim construction proposed by the
`parties for the responder rate limitation. Id. at 3:34–4:07.
`We thus affirm the Board’s construction of the responder
`rate limitation as a range.
`
`II
`The Board evaluated the parties’ evidence regarding
`the Wands factors and expert testimony and found that the
`full scope of the claims was not enabled. Decision, at *12–
`14.
`Medytox argues that the specification does not need to
`include a working example of “every possible embodiment
`to enable the full scope of the claims.” Appellant’s Br. 46–
`47 (citing Bayer Healthcare LLC v. Baxalta Inc., 989 F.3d
`964, 982 (Fed Cir. 2021)). Medytox cites to its expert’s tes-
`timony that there would not have been undue experimen-
`tation to practice the claims because it is “routine to
`clinically confirm” that similar compositions meet the du-
`ration limitation. Id. at 47 (citing J.A. 4313–14, 4465–66).
`Medytox asserts that the Board failed to provide an analy-
`sis or factual findings with respect to the Wands factors.
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`Appellant’s Br. 47–48. Finally, Medytox asserts that, even
`under the Board’s claim construction of the responder rate
`limitation, the claims are enabled. Appellant’s Br. 46.
`Addressing the Wands factors, Galderma asserts that
`Medytox needed to provide a clinical study for each formu-
`lation because clinical trials are not routine for “determin-
`ing whether pharmaceutical compositions fall within the
`scope of a patent claim.” Appellee’s Br. 48. Galderma ar-
`gues that the specification fails to disclose how one would
`modify the named formulations (MT10109L and MT10109)
`to achieve the claimed range. Id. at 49–51. Galderma
`points to how the Board credited its expert’s testimony and
`analyzed the factual findings before concluding that undue
`experimentation would be required to practice the claims.
`Id. at 63 (citing J.A. 32, 4056–66).
`To be sure, our caselaw may not require disclosure of
`every possible working example of responder rates, but
`here, there are at most three examples of responder rates
`above 50% at 16 weeks: 52%, 61%, and 62%. Decision, at
`*11; see also Wyeth & Cordis Corp. v. Abbott Lab’ys, 720
`F.3d 1380, 1385–86 (Fed. Cir. 2013) (holding that undue
`experimentation was required to practice the full scope of
`the claims where the specification “disclose[d] only a start-
`ing point for further iterative research in an unpredictable
`and poorly understood field”); see MagSil Corp. v. Hitachi
`Global Storage Techs., Inc., 687 F.3d 1377, 1381 (Fed. Cir.
`2012) (holding that “a patentee chooses broad claim lan-
`guage at the peril of losing any claim that cannot be ena-
`bled across its full scope of coverage”). And, as the
`Supreme Court recently explained in Amgen Inc. v. Sanofi,
`143 S. Ct. 1243, 1254 (2023), “[t]he more one claims, the
`more one must enable.” Though a specification need not
`always “describe with particularity how to make and use
`every single embodiment within a claimed class,” it must
`nevertheless “enable the full scope of the invention as de-
`fined by its claims,” for example by “disclosing [a] general
`quality” of the class that may “reliably enable a person
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`skilled in the art to make and use all of what is claimed.”
`Id. at 1254–55.
`Here, the Board found that the arguments and evi-
`dence were insufficient to demonstrate enablement to a
`skilled artisan because said artisan “would not have been
`able to achieve” responder rates higher than the limited ex-
`amples provided in the specification. Decision, at *14. Sub-
`stantial evidence supports that finding. The Board
`provided adequate explanation and reasoning for its ena-
`blement finding. We see no error in the Board’s factual
`findings and discern no legal error in its determination of
`lack of enablement for the substitute claims.6
`III
`Medytox asserts that the Board’s revision of its claim
`construction of the responder rate limitation made between
`its Preliminary Guidance and FWD violated the Adminis-
`trative Procedure Act (“APA”) because it was arbitrary and
`capricious and deprived it of a full and fair opportunity to
`litigate. Appellant’s Br. 51 (citing 5 U.S.C. § 706(2)(A)).
`A
`Medytox argues that the portion of the FWD regarding
`claim construction failed to analyze “key intrinsic evi-
`dence,” and the Board relied on “irrelevant” caselaw that
`did not fix the “fundamentally flawed nature” of its “bare,
`conclusory” construction. Id. at 52. Medytox claims that
`
`
`6 Another issue on appeal is whether the ’728 patent
`
`specification supports Medytox’s claim that it possessed
`the entire claim range of 50%–100%. Appellant’s Br. 42–
`48. This issue was briefed and argued by the parties and
`the Board made related findings. In light of our decision to
`affirm the Board’s claim construction of the responder rate
`limitation as a range and our holding with respect to ena-
`blement, we do not address the written description issue.
`
`

`

`Case: 22-1165 Document: 61 Page: 15 Filed: 06/27/2023
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`MEDYTOX, INC. v. GALDERMA S.A.
`
`15
`
`the evidence cited by the Board in changing its claim con-
`struction was not new, such that the Board’s “inconsistent
`conclusions on a nearly identical record” renders its deci-
`sion arbitrary and capricious. Id. at 53 (citing BASF Corp.
`v. Enthone, Inc., 749 F. App’x 978, 985 (Fed. Cir. 2018);
`Robert Bosch, LLC v. Iancu, 778 F. App’x 871, 875 (Fed.
`Cir. 2019)).
`Galderma asserts that Medytox’s claims of “various vi-
`olations of the APA” lack merit. Appellee’s Br. 59. Gal-
`derma maintains that Medytox never cited intrinsic
`evidence to support its proposed claim construction and
`that, after the Preliminary Guidance was issued, the rec-
`ord was “significantly developed” with new evidence and
`arguments. Id. at 59–60. Galderma argues that Medytox
`did not even propose its “minimum threshold” construction
`of the responder rate limitation until after the Preliminary
`Guidance. Id. at 60.
`The Director of the Patent and Trademark Office (the
`“Director”) intervened in this appeal primarily to respond
`to Medytox’s APA challenges. The Director asserts that the
`Board’s Preliminary Guidance is exactly as its name sug-
`gests: preliminary. Intervenor Br. 8–9. Further, the Pre-
`liminary Guidance includes a statement that the views are
`“initial, preliminary, [and] non-binding” on whether the pa-
`tent owner has demonstrated a reasonable likelihood that
`it met the requirements for filing a motion to amend. Id.
`at 9. The Director contends that the difference in the
`standard in the burden of persuasion on Medytox for the
`Board’s FWD (preponderance of the evidence) from the
`standard for the Preliminary Guidance (reasonable likeli-
`hood) is indicative of the nature of the determinations
`reached in the Preliminary Guidance. Id. at 9–10; see also
`Trivascular, Inc. v. Samuels, 812 F.3d 1056, 1068 (Fed. Cir.
`2016) (discussing the “significant difference” and “qualita-
`tively different standard” between the burden to establish
`a reasonable likelihood of success and the burden of proof
`by a preponderance of the evidence).
`
`

`

`Case: 22-1165 Document: 61 Page: 16 Filed: 06/27/2023
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`16
`
`MEDYTOX, INC. v. GALDERMA S.A.
`
`Our review of the record indicates that the extrinsic
`record was developed between the Board’s issuance of its
`Preliminary Guidance and the FWD. Medytox’s expert tes-
`tified about the responder rate limitation, discussing which
`response rates (e.g., up to 100%) would fall within the scope
`of the claim. Intervenor Br. 13–15. Medytox explained at
`the oral hearing that the Board’s construction of the re-
`sponder rate limitation as a range would not affect its ar-
`guments. Id. at 15 (citing J.A. 4931 at 50:16–24). The
`Board was within its discretion to find this evidence rele-
`vant to its decision on claim construction for the responder
`rate limitation. The Board’s concerns about the substitute
`claims were also made clear during oral argument. For ex-
`ample, the Board asked counsel for both written descrip-
`tion support on the responder rate limitation, J.A. 4929,
`and examples of support in the specification about the var-
`iance in the response rate, J.A. 4930.
`This court has explained that “the Board has an obli-
`gation to assess the question anew after trial based on the
`totality of the record,” particularly where the standard
`changes. In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364,
`1377 (Fed. Cir. 2016). We have encouraged the Board to
`“change its view of the merits after further development of
`the record” if necessary, such as when a holding otherwise
`would “collapse” the two analyses and standards into one.
`Trivascular, Inc., 812 F.3d at 1068. Relatedly, this court
`has addressed an argument about the “Board chang[ing]
`theories” between an institution decision and a FWD and
`held that, given the “different standards of proof” between
`the two points in a proceeding, the Board is not first re-
`quired to notify parties to the possibility of changing its po-
`sition. Fanduel, Inc. v. Interactive Games LLC, 966 F.3d
`1334, 1340–41 (Fed. Cir. 2020). The court has further
`noted that such change “happens with some frequency.”
`Id.
`The Board here provided a reasoned analysis for its ul-
`timate claim construction, a construction that we approve
`
`

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`Case: 22-1165 Document: 61 Page: 17 Filed: 06/27/2023
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`MEDYTOX, INC. v. GALDERMA S.A.
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`17
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`under de novo review. The extrinsic record relied on by the
`Board was developed after the Board’s Preliminary Guid-
`ance was issued. We thus hold that the Board’s decision to
`change its claim construction for the responder rate limita-
`tion was not arbitrary and capricious.
`B
`Medytox argues that it was prevented from a full and
`fair opportunity to litigate the case because the Board’s re-
`versal was “solely based on the Board’s about-face on the
`responder rate limitation.”7 Appellant’s Br. 53. Medytox
`asserts that it was “penalized for its good faith efforts” to
`comply with the Pilot Program and that the Preliminary
`Guidance provided “no reason or explanation” suggesting
`that the Board might later rule differently. Id. at 54.
`Galderma counters, arguing that “it was not reasona-
`ble” for Medytox to rely on the Preliminary Guidance due
`to its preliminary nature and because it was Medytox’s “ob-
`ligation” to fully address the claim construction dispute,
`which it ultimately failed to do. Appellee’s Br. 61.
`The Director points to the Federal Register, where the
`notice on the Pilot Program was published, which reiter-
`ates the “preliminary, non-binding” nature of the guidance.
`Intervenor Br. 9 (citing 84 Fed. Reg. 9,497). During oral
`argument, counsel for the Director explained that the Pre-
`liminary Guidance was “designed to be an initial discus-
`sion.” Oral Arg. at 28:22–29:14. The Director asserts that
`49% of patent owners