Trials@uspto.gov
`571-272-7822
`
`Paper 66
`Date: July 16, 2021
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`GALDERMA S.A.; GALDERMA LABORATORIES, INC.; GALDERMA
`LABORATORIES LP; GALDERMA RESEARCH & DEVELOPMENT
`SNC; NESTLÉ SKIN HEALTH, INC.; NESTLÉ SKIN HEALTH S.A.; and
`NESTLÉ S.A.,
`Petitioner,
`
`v.
`
`MEDY-TOX, INC.,
`Patent Owner.
`
`PGR2019-00062
`Patent 10,143,728 B2
`
`
`
`
`
`Before ZHENYU YANG, CHRISTOPHER G. PAULRAJ, and
`TIMOTHY G. MAJORS, Administrative Patent Judges.
`
`PAULRAJ, Administrative Patent Judge.
`
`JUDGMENT
`Final Written Decision
`Cancelling Original Claims 1–10
`Denying Patent Owner’s Non-Contingent Revised Motion to Amend With
`Regard to Proposed Substitute Claims 19–27
`35 U.S.C. § 328(a)
`
`
`
`
`
`
`
`
`571-272-7822
`
`Paper 66
`Date: July 16, 2021
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`GALDERMA S.A.; GALDERMA LABORATORIES, INC.; GALDERMA
`LABORATORIES LP; GALDERMA RESEARCH & DEVELOPMENT
`SNC; NESTLÉ SKIN HEALTH, INC.; NESTLÉ SKIN HEALTH S.A.; and
`NESTLÉ S.A.,
`Petitioner,
`
`v.
`
`MEDY-TOX, INC.,
`Patent Owner.
`
`PGR2019-00062
`Patent 10,143,728 B2
`
`
`
`
`
`Before ZHENYU YANG, CHRISTOPHER G. PAULRAJ, and
`TIMOTHY G. MAJORS, Administrative Patent Judges.
`
`PAULRAJ, Administrative Patent Judge.
`
`JUDGMENT
`Final Written Decision
`Cancelling Original Claims 1–10
`Denying Patent Owner’s Non-Contingent Revised Motion to Amend With
`Regard to Proposed Substitute Claims 19–27
`35 U.S.C. § 328(a)
`
`
`
`
`
`
`
`
`
`PGR2019-00062
`Patent 10,143,728 B2
`
`I.
`
`INTRODUCTION
`
`This is our Final Written Decision pursuant to 35 U.S.C. § 328(a).
`
`For the reasons discussed below, we hereby deny Patent Owner’s non-
`
`contingent revised Motion to Amend with regard to proposed substitute
`
`claims 19–27. Paper 30 (“revised MTA” or “Rev. Mot.”). We do not
`
`address the patentability of original claims 1–10, each of which is cancelled
`
`by virtue of the non-contingent revised MTA.
`
`A.
`
`Procedural Background and Summary
`
`Galderma S.A., et al., (“Petitioner”) filed a Petition requesting post-
`
`grant review of claims 1–10 of U.S. Patent No. 10,143,728 B2 (Ex. 1001,
`
`“the ’728 patent”). Paper 2 (“Pet.”). Medy-Tox, Inc. (“Patent Owner”) filed
`
`a Preliminary Response to the Petition. Paper 11.
`
`We determined that the ’728 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 1–10 of the ’728 patent. Paper 14 (“Institution Decision”
`
`or “Dec.”).
`
`Following institution, Patent Owner did not file a Response to the
`
`Petition to contest the unpatentability arguments presented in the Petition
`
`with regard to the original claims, and instead chose to file a non-contingent
`
`Motion to Amend. Paper 21. In its Motion to Amend, Patent Owner
`
`requested that we provide Preliminary Guidance concerning the Motion to
`
`Amend in accordance with the Board’s pilot program concerning motion to
`
`amend practice and procedures. Mot. 3; see also Notice Regarding a New
`
`Pilot Program Concerning Motion to Amend Practice and Procedures in
`
`Trial Proceedings Under the America Invents Act Before the Patent Trial
`
`and Appeal Board, 84 Fed. Reg. 9,497 (Mar. 15, 2019) (providing a patent
`
`2
`
`
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`PGR2019-00062
`Patent 10,143,728 B2
`
`owner with the option to receive preliminary guidance from the Board on its
`
`motion to amend) (“Notice”). Petitioner filed an Opposition to the Motion
`
`to Amend. Paper 26.
`
`In response to Patent Owner’s request, we issued our Preliminary
`
`Guidance, indicating our initial, preliminary, non-binding views on whether
`
`Patent Owner had shown a reasonable likelihood that it had satisfied the
`
`statutory and regulatory requirements associated with filing a motion to
`
`amend in a post-grant review and whether Petitioner had established a
`
`reasonable likelihood that the substitute claims are unpatentable. Paper 28
`
`(“Prelim. Guid.); see 35 U.S.C. § 326(d); 37 C.F.R. § 42.221; see also
`
`Notice, 84 Fed. Reg. at 9,497 (“The preliminary guidance . . . provides
`
`preliminary, non binding guidance from the Board to the parties about the
`
`[motion to amend].”)
`
`Patent Owner thereafter filed the non-contingent revised MMTA
`
`seeking to expressly cancel original claim 6 and replace the other original
`
`claims with proposed substitute claims 19–27. See generally Rev. Mot.
`
`Petitioner filed an Opposition to the revised MTA. Paper 40 (“Opp.”).
`
`Patent Owner filed a Reply in support of its revised MTA, Paper 55
`
`(“Reply”),1 and Petitioner filed a Sur-Reply in opposition to the revised
`
`MTA, Paper 60.
`
`After Patent Owner filed its revised MTA, the Chief Administrative
`
`Patent Judge extended the time to complete this proceeding by six months
`
`for good cause. Papers 32, 33, 34, 35. Prior to the oral hearing, we notified
`
`the parties of a potential sua sponte ground of unpatentability for substitute
`
`
`1 This corrected Reply replaced Patent Owner’s originally filed Reply, Paper
`52.
`
`3
`
`
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`PGR2019-00062
`Patent 10,143,728 B2
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`independent claim 19 as proposed in the revised MTA. Paper 54; see Nike,
`
`Inc. v. Adidas AG, 955 F.3d 45, 51 (Fed. Cir. 2020) (holding that the Board
`
`may sua sponte identify a patentability issue for a proposed substitute
`
`claim); Hunting Titan, Inc. v. DynaEnergetics Europe GmbH, IPR2018-
`
`00600, Paper 67 at 13 (PTAB July 6, 2020) (precedential) (explaining that
`
`the Board may, in rare circumstances, raise a ground of unpatentability not
`
`raised by the parties). We held the oral hearing on March 19, 2021, and the
`
`transcript of that hearing has been entered into the record. Paper 65 (“Tr.”).
`
`B.
`
`Real Parties-in-Interest
`
`Petitioner initially identified Galderma S.A., Galderma Laboratories,
`
`Inc., Galderma Laboratories LP, Galderma Research & Development SNC,
`
`Nestlé Skin Health, Inc., Nestlé Skin Health S.A., and Nestlé S.A. as the real
`
`parties-in-interest for Petitioner. Pet. 4–5. Petitioner later updated its
`
`mandatory notices to indicate that Nestlé Skin Health S.A. was acquired by
`
`EQT Partners on October 2, 2019, and that Nestlé S.A. sold Galderma S.A.,
`
`Galderma Laboratories, Inc., Galderma Laboratories L.P., Galderma
`
`Research & Development SNC, Nestlé Skin Health, Inc. (now SHDS, Inc.),
`
`and Nestlé Skin Health S.A. to an investment consortium of the following:
`
`(i) EQT Partners AB; (ii) PSP Investments; and (iii) Luxinva, a wholly
`
`owned subsidiary of Abu Dhabi Investment Authority. Paper 4. Petitioner
`
`contends that the consortium of investment partners are not real parties-in-
`
`interest because they did not have any role in directing, preparing, or filing
`
`the Petition, or any role in directing or controlling this proceeding. Id.
`
`Patent Owner identifies Medy-Tox, Inc., Allergan Pharmaceuticals
`
`Ireland, Allergan Pharmaceuticals Holding (Ireland), and Allergan, Inc., as
`
`the real parties-in-interest for Patent Owner. Paper 5.
`
`4
`
`
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`PGR2019-00062
`Patent 10,143,728 B2
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`The parties do not dispute the identification of the real parties-in-
`
`interest.
`
`C.
`
`Related Matters
`
`Petitioner and Patent Owner report that the ’728 patent is not the
`
`subject of any other judicial or administrative matter. Pet. 5; Paper 5, 2.
`
`D.
`
`The ’728 Patent
`
`The ’728 patent, titled “Long Lasting Effect of New Botulinum Toxin
`
`Formulation,” discloses the use of an animal-protein-free botulinum toxin
`
`composition that exhibits a longer lasting effect compared to an animal-
`
`protein-containing botulinum toxin composition. Ex. 1001, codes (54), (57).
`
`The patent issued from an application (No. 15/336,119) filed October 27,
`
`2016, but claims earliest priority to a provisional application (No.
`
`61/915,476) filed December 12, 2013. Id. at codes (60), (63).
`
`The specification explains that commercially available botulinum
`
`toxin A (BoNT/A) compositions, including BOTOX® (ona-BoNT/A), all
`
`contain animal proteins such as albumin and have a duration effect of
`
`approximately 3 months for treating conditions such as crow’s feet lines or
`
`glabellar lines. Id. at 1:40–44. In contrast, the ’728 patent claims methods
`
`of “locally administering a therapeutically effective amount of a botulinum
`
`toxin composition that does not comprise an animal-derived product or
`
`recombinant human albumin.” Id. at 32:4–7.
`
`As noted in the specification, animal-protein-free botulinum toxin
`
`compositions were previously disclosed in the inventors’ prior patent
`
`applications, U.S. Application Publication No. 2010/0291136, now U.S.
`
`Patent No. 8,617,568 (“Jung I”) (Exhibit 1006), and PCT/KR10–2012–
`
`0112248 (“Jung II”) (Exhibit 1007), which are both incorporated by
`
`5
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`PGR2019-00062
`Patent 10,143,728 B2
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`reference in their entirety into the ’728 patent. Id. at 2:63–3:20.2 The
`
`specification notes that the use of polysorbate 20, methionine, and optionally
`
`isoleucine, instead of an animal-derived protein such as albumin or gelatin,
`
`as stabilizers for botulinum toxin eliminates the potential risk of infecting
`
`the recipient with serum-derived pathogens or microorganisms. Id. at 6:4–9.
`
`Furthermore, the specification indicates that an animal-protein-free
`
`botulinum toxin composition exhibits a longer lasting effectiveness
`
`compared to an animal-protein-containing botulinum toxin composition. Id.
`
`at 5:47–56.
`
`In support of its conclusion regarding longer lasting efficacy, the
`
`specification describes the results of two clinical trials comparing an animal-
`
`protein-free botulinum toxin composition with botulinum toxin stabilized
`
`with human serum albumin. See id. at 13:60–31:55. Example 1 describes a
`
`Phase III clinical study that compared the efficacy of 20 units (U) liquid
`
`BoNTA/A (MT10109L), an animal-protein-free botulinum toxin
`
`composition, to 20 U BOTOX® in managing moderate to severe glabellar
`
`frown lines. Id. at 13:60–22:67. The specification indicates that the results
`
`presented from the Phase III study “demonstrate that MT10109L is not
`
`inferior to ona-BoNT/A in the improvement of glabellar lines and is
`
`relatively similar in safety,” and “[w]ith its longer maintaining period of the
`
`glabellar line improvement, convenience without the additional dilution step,
`
`easy storage and re-usage, and animal derived protein-free constituents,
`
`
`2 Petitioner relies upon Jung I and Jung II for its anticipation and
`obviousness challenges presented in the Petition. Pet. 36–87. Petitioner
`does not, however, argue in this proceeding that the proposed substitute
`claims are anticipated or obvious. See generally Opp.
`
`6
`
`
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`PGR2019-00062
`Patent 10,143,728 B2
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`MT10109L is a desirable substitute for the conventional powder formulation
`
`of BoNT/A.” Id. at 22:58–67.
`
`Example 2 describes a Phase II clinical study that compared the
`
`efficacy of a lyophilized formulation of MT10109 versus BOTOX®, both
`
`administered at a 20 U dose. Id. at 23:1–31:55. Based on the data from the
`
`Phase II study, the specification concludes that “lyophilized MT10109 dosed
`
`at 20 U demonstrates similarity to BOTOX® at early time points (e.g. day
`
`30),” and “[f]urther, it is demonstrated that MT10109 dosed at 20 U displays
`
`an increased sustained effect compared to BOTOX®, as the response of
`
`treatment was seen to be increased in the MT10109 20 U group compared to
`
`BOTOX® 20 U group at 120 days post treatment.” Id. at 31:48–55.
`
`E. Originally Challenged Claims and Asserted Grounds in
`Petition
`
`Petitioner originally challenged claims 1–10 of the ’728 patent, of
`
`which claim 1 is the only independent claim. In the Petition, Petitioner
`
`advanced five grounds of unpatentability in relation to these original claims.
`
`See Pet. 1. The grounds are summarized in the table below:
`
`Claims Challenged 35 U.S.C. § Reference(s)/Basis
`
`1–10
`
`1–10
`
`1–10
`
`1–3, 8
`
`1–8, 10
`
`
`
`112
`
`112
`
`112
`
`102
`
`103
`
`Indefiniteness
`
`Written Description
`
`Enablement
`
`Jung I
`
`Jung I, Jung II, Allergan (ELN
`1145), BOTOX® COSMETIC
`(Botulinum Toxin Type A) (2002)
`(“2002 Label”)
`
`7
`
`
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`PGR2019-00062
`Patent 10,143,728 B2
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`In view of Patent Owner’s election to file a non-contingent motion to
`
`amend, none of the originally challenged claims remain at issue in this
`
`proceeding. In particular, Patent Owner’s non-contingent revised MTA
`
`expressly requests that we cancel original claim 6 and replace the remaining
`
`claims with revised substitute claims 19–27. Rev. Mot. 1. Although not
`
`expressly requested to be cancelled, we hereby also cancel original claims
`
`1–5 and 7–10 because a non-contingent MTA is one in which “the Board
`
`provides a final decision on the patentability of substitute claims in place of
`
`determining the patentability of corresponding original claims.” See Notice,
`
`84 Fed. Reg. at 9,505 (emphasis added). Accordingly, we do not address the
`
`patentability of original claims 1–10 in this Final Written Decision insofar as
`
`all those claims are deemed cancelled by virtue of the non-contingent
`
`revised MTA and only address the patentability of proposed substitute
`
`claims 19–27.
`
`II. ANALYSIS FOR MOTION TO AMEND
`
`A. Legal Standards for Motions to Amend
`
`In a post-grant review, amended claims are not added to a patent as of
`
`right, but rather must be proposed as part of a motion to amend. 35 U.S.C. §
`
`326(d). The Board must assess the patentability of the proposed substitute
`
`claims “without placing the burden of persuasion on the patent owner.” See
`
`Aqua Prods., Inc. v. Matal, 872 F.3d 1290, 1328 (Fed. Cir. 2017) (en banc);
`
`see also Lectrosonics, Inc. v. Zaxcom, Inc., IPR2018-01129, Paper 15 at 3–4
`
`(PTAB Feb. 25, 2019) (precedential). Ordinarily, “the petitioner bears the
`
`burden of proving that the proposed amended claims are unpatentable by a
`
`preponderance of the evidence.” Bosch Auto. Serv. Sols., LLC v. Matal, 878
`
`F.3d 1027, 1040 (Fed. Cir. 2017) (as amended on rehearing); see also
`
`Lectrosonics, Paper 15 at 3–4.
`
`8
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`Patent 10,143,728 B2
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`In determining whether a petitioner has proven unpatentability of the
`
`proposed substitute claims, the Board focuses on “arguments and theories
`
`raised by the petitioner in its petition or opposition to the motion to amend.”
`
`Nike, 955 F.3d at 51. The Board itself also may justify any finding of
`
`unpatentability by reference to evidence of record in the proceeding.
`
`Lectrosonics, Paper 15 at 4 (citing Aqua Products, 872 F.3d at 1311
`
`(O’Malley, J.)). “[O]nly under rare circumstances should the need arise for
`
`the Board to advance grounds of unpatentability to address proposed
`
`substitute claims that the petitioner did not advance, or insufficiently
`
`developed, in its opposition to the motion.” Hunting Titan, Paper 67 at 9.
`
`Before reaching the patentability issues that Petitioner argues,
`
`however, we first consider whether Patent Owner’s revised MTA meets the
`
`statutory and regulatory requirements of 35 U.S.C. § 316(d) and 37 C.F.R. §
`
`42.121. Lectrosonics, Paper 15 at 4. Patent Owner bears the burden of
`
`meeting these statutory and regulatory requirements. See “Guidance on
`
`Motions to Amend in view of Aqua Products” (2017), available at
`
`https://www.uspto.gov/sites/default/files/documents/guidance_on_
`
`motions_to_amend_11_2017.pdf. Accordingly, Patent Owner must
`
`demonstrate that: (1) the amendment proposes a reasonable number of
`
`substitute claims; (2) the amendment does not seek to enlarge the scope of
`
`the claims of the patent or introduce new subject matter; (3) the amendment
`
`responds to a ground of unpatentability involved in the trial; and (4) the
`
`original disclosure sets forth written description support for each proposed
`
`claim. See 35 U.S.C. § 326(d); 37 C.F.R. § 42.221.
`
`B. Proposed Substitute Claims
`
`In its revised MTA, Patent Owner requests that we cancel original
`
`claim 6 and replace original claims 1–5 and 7–10 with revised substitute
`
`9
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`PGR2019-00062
`Patent 10,143,728 B2
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`claims 19–27. Rev. Mot. 1–2. Proposed substitute claim 19, which would
`
`replace claim 1, recites (with underlining and strikethroughs representing,
`
`respectively, text added to and deleted from claim 1, and added bracketed
`
`letters (e.g., [a], [b], etc.) correlating to Patent Owner’s indication of specific
`
`claim limitations):
`
`19. A method for treating glabellar lines a condition in a
`patient in need thereof, comprising:
`
`
`
`[a] locally administering a first treatment of therapeutically
`effective amount of a botulinum toxin composition
`comprising a serotype A botulinum toxin in an amount
`present in about 20 units of MT10109L, a first stabilizer
`comprising a polysorbate, and at least one additional
`stabilizer, and that does not comprise an animal-derived
`product or recombinant human albumin;
`
`
` [b] locally administering a second treatment of the
`botulinum toxin composition at a time interval after the
`first treatment;
`
`
` [c] wherein said time interval is the length of effect of the
`botulinum toxin composition as determined by
`physician’s live assessment at maximum frown;
`
`
` [d] 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 compared 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 location(s) as
`that of the botulinum toxin composition; and
`
`
` [e] wherein said greater length of effect is determined by
`physician’s live assessment at maximum frown and
`
`10
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`PGR2019-00062
`Patent 10,143,728 B2
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`requires a responder rate at 16 weeks after the first
`treatment 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 glabellar lines, marionette lines, brow
`furrows, lateral canthal lines, and any combination
`thereof.
`
`C.
`
`Level of Ordinary Skill in the Art
`
`In the Petition, Petitioner proposes that a person of ordinary skill in
`
`the art (“POSA”) “would have an advanced degree in biochemistry or
`
`molecular biology with at least 5 years of experience in formulations
`
`involving botulinum toxin and clinical studies involving such formulations.”
`
`Pet. 10 (citing Ex. 1004 ¶ 14).
`
`Patent Owner asserts that a POSA for the ’728 patent should include:
`
`A person having a medical degree who practices dermatology,
`aesthetic medicine, cosmetic surgery or other related
`disciplines, and has been trained in and has experience with
`administering botulinum toxin injections, including at least five
`years of experience with injecting botulinum toxin formulations
`and evaluating results of those treatments in patients or a person
`with an advanced degree in biochemistry, molecular biology or
`other related discipline with at least 5 years of experience in
`protein compositions, such as botulinum toxins, and/or clinical
`studies involving such compositions.
`
`Rev. Mot. 2 (citing Ex. 2032 ¶ 62).
`
`Patent Owner contends that the definition of a POSA must include
`
`physicians “because the claims are primarily directed to physicians, whom
`
`utilize the claimed methods of treatment, and have the most knowledge
`
`regarding the prior art.” Id. Patent Owner notes that its expert Dr. Singh is a
`
`physician “who has years of experience in administering neurotoxins [and]
`
`understands the clinical significance of the claims and prior art,” whereas
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`11
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`Patent 10,143,728 B2
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`“Petitioner’s expert, Dr. Ramzan, is not a physician and has never treated
`
`any patients with such toxins.” Id. at 2–3.
`
`In our Institution Decision, we determined, based on the record at the
`
`time, that a POSA would encompass the definition asserted by Petitioner.
`
`Dec. 8. We maintain that determination based on the full evidence of record
`
`adduced in this proceeding.
`
`Factors that may be considered in determining level of ordinary skill
`
`in the art include: (1) the educational level of the inventor; (2) type of
`
`problems encountered in the art; (3) prior art solutions to those problems;
`
`(4) rapidity with which innovations are made; (5) sophistication of the
`
`technology; and (6) educational level of active workers in the field.
`
`Orthopedic Equip. Co. v. All Orthopedic Appliances, Inc., 707 F.2d 1376 at
`
`1381–82 (Fed. Cir. 1983).
`
`We recognize that the claims are directed to methods of treatment, and
`
`agree that a “clinician” or a “physician” may indeed have some relevant
`
`experience implementing the claimed methods. But we are not persuaded
`
`that the POSA must necessarily have a medical degree (M.D.) or be a
`
`medical doctor to the extent that Patent Owner seeks to impose such
`
`requirements on the POSA. In this regard, we note that none of the
`
`inventors are physicians themselves. See Ex. 1059 ¶ 7 (recounting that
`
`inventors Chang-Hoon Rhee and Gi-Hyeok Yang have PhDs, and inventor
`
`Hyun Jee Kim has a Master’s degree in Pharmacy); Ex. 1050, 1; Ex. 1051,
`
`1; Ex. 1052, 3. And although some of the publications of record appear to
`
`be authored by individuals with medical degrees, we do not find that the
`
`record suggests that being a physician is a prerequisite to working in the
`
`field of botulinum toxins relevant to the claims. As such, even though
`
`Petitioner’s expert, Dr. Ramzan, does not have a medical degree, we find
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`12
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`that he is qualified to provide an opinion from the perspective of a POSA in
`
`this proceeding based on his education and prior work experience in the field
`
`and credit his testimony accordingly. See Ex. 1004 ¶ 5 (identifying
`
`experience working on C. botulinum toxins, including work on
`
`“approximately 6 products at various stages of clinical and commercial
`
`development in the United States, Europe, and South Korea”).
`
`D. 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.
`
`Patent Owner did not propose any claim constructions for the
`
`substitute claims in its revised Motion. In its Opposition to the revised
`
`Motion, Petitioner contends that “[t]he term ‘a serotype A botulinum toxin’
`
`should be construed to mean ‘any serotype A botulinum neurotoxin,’
`
`irrespective of whether it is in complexed or purified form and irrespective
`
`of the size of the complex.” Opp. 1. Petitioner relies upon the definition for
`
`“botulinum toxin” set forth in the ’728 patent as “a botulinum neurotoxin as
`
`either pure toxin or complex, native, recombinant, or modified, and includes
`
`botulinum toxin type A[.]” Id. (citing Ex. 1001, 4:21–23). Thus, Petitioner
`
`contends that “the substitute claims encompass any serotype A botulinum
`
`neurotoxin, including the 900 kDa complex known as onabotulinumtoxinA,
`
`the mixture of 600 and 300 kDa complexes known as abobotulinumtoxinA,
`
`and the purified, uncomplexed 150 kDa toxin known as
`
`incobotulinumtoxinA.” Id. (citing Ex. 1094, 14:3–15). Patent Owner
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`responds that “no construction is necessary as this term has a plain and
`
`ordinary meaning that a POSA would understand, which both parties have
`
`previously acknowledged.” Reply 1.
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`Upon review of the parties’ contentions, we determine that we need
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`not expressly construe “serotype A botulinum toxin” to resolve any disputed
`
`issues of patentability for the proposed substitute claims. See Vivid Techs.,
`
`Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly
`
`those terms need to be construed that are in controversy, and only to the
`
`extent necessary to resolve the controversy.”); see also Nidec Motor Corp. v.
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`Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017)
`
`(applying Vivid Techs. in the context of an inter partes review).
`
`The parties also dispute whether the limitation requiring a responder
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`rate of “50 or greater” should be interpreted as a range of 50–100% (as
`
`argued by Petitioner) or merely a minimum threshold of 50% (as argued by
`
`Patent Owner). We address this issue as part of our analysis below.
`
`E.
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`Statutory and Regulatory Requirements
`
`1.
`
`Reasonable Number of Substitute Claims
`
`“There is a rebuttable presumption that a reasonable number of
`
`substitute claims per challenged claim is one (1) substitute claim.”
`
`Lectrosonics, Paper 15 at 4–5; 37 C.F.R. § 42.221(a)(3). Here, Patent
`
`Owner’s revised MTA proposes nine substitute claims for nine of the
`
`originally challenged claims. See Rev. Mot., App’x A. Thus, the revised
`
`MTA complies with the requirement that the amendment propose a
`
`reasonable number of substitute claims.
`
`2.
`
`Responsive to Ground of Unpatentability
`
`Patent Owner’s revised MTA responds to a ground of unpatentability
`
`involved in this trial. See 37 C.F.R. § 42.221(a)(2)(i). In particular, Patent
`
`14
`
`
`
`PGR2019-00062
`Patent 10,143,728 B2
`
`Owner’s claim amendments add features in an attempt to distinguish the
`
`proposed substitute claims from the references as well as to address one or
`
`more of the § 112 grounds asserted by Petitioner and/or addressed in our
`
`Preliminary Guidance. Rev. Mot. 10–11; see Notice, 84 Fed. Reg. at 9,501
`
`(“A revised MTA must provide amendments, arguments, and/or evidence in
`
`a manner that is responsive to issues raised in the preliminary guidance (if
`
`requested) or the petitioner’s opposition to the MTA.”).
`
`3.
`
`No Enlargement of Claim Scope
`
`“A motion to amend may not present substitute claims that enlarge the
`
`scope of the claims of the challenged patent.” Lectrosonics, Paper 15 at 6–7;
`
`35 U.S.C. § 326(d)(3); 37 C.F.R. § 41.221(a)(2)(ii).
`
`Petitioner argues that proposed substitute claims 19 and 21–27
`
`improperly broaden the claims beyond the original scope by eliminating the
`
`phrase “dosed at a comparable amount” and introducing two new
`
`requirements, namely that the botulinum toxin composition (1) contains the
`
`same amount of neurotoxin as in about 20U MT10109L and (2) has a greater
`
`length of effect compared to about 20U of BOTOX® (claim 19[a], [d]).
`
`Opp. 2.
`
`Petitioner contends that the “‘dosed at a comparable amount’
`
`limitation in the original claims refers to a unit dose,” whereas “the
`
`substitute claims have been rewritten to require the botulinum toxin be
`
`administered in the same amount by weight of neurotoxin as is in 20U of
`
`MT10109L, eliminating comparable unit doses and fundamentally
`
`transforming the substitute claims.” Id. at 3–4.
`
`To illustrate this point, Dr. Ramzan provides a comparison of three
`
`botulinum neurotoxin products that were commercially available in the U.S.
`
`(i.e., BOTOX®, DYSPORT®, and XEOMIN®). Ex. 1106 ¶¶ 31–38. Based
`
`15
`
`
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`PGR2019-00062
`Patent 10,143,728 B2
`
`on dose equivalency studies, Dr. Ramzan indicates that comparable unit
`
`doses between the products are 50U of DYSPORT® to 20U of BOTOX®
`
`and 20U of XEOMIN® to 20U of BOTOX®. Id. ¶ 27. And based on
`
`published data from a peer-reviewed scientific journal measuring the mass
`
`of 150 kDa neurotoxin in each of the products and an assumption that 20U
`
`of MT10109L contains 0.17 ng of the 150 kDa neurotoxin protein, Dr.
`
`Ramzan asserts that “to administer 0.17 ng of the neurotoxin in XEOMIN®,
`
`one would need to inject 39U into a patient (or 0.17 ng multiplied by
`
`100U/0.44 ng).” Id. ¶ 34. Thus, Dr. Ramzan opines, the 39U derived
`
`applying a “by weight” calculation (like allegedly required in the substitute
`
`claims) “is significantly higher than 20U of XEOMIN®, the dose equivalent
`
`of 20U of BOTOX®” (like allegedly required applying the original claim
`
`language). Id. Likewise, Dr. Ramzan asserts that “to administer 0.17 ng of
`
`DYSPORT®, one would need to inject 26U into the patient (or 0.17 ng
`
`multiplied by 100U/0.65,” which “is significantly lower than 50U of
`
`DYSPORT®, the dose equivalent of 20U of BOTOX®.” Id. Dr. Ramzan
`
`summarizes the comparison in the following chart:
`
`Chart comparing “Comparable Dose” and “Same Amount By Weight”
`for the products XEOMIN® and DYSPORT®
`
`
`
`16
`
`
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`PGR2019-00062
`Patent 10,143,728 B2
`
`The chart above indicates a +19U (+95%) dosing variance for
`
`XEOMIN® and a -24U (-48%) dosing variance for DYSPORT® depending
`
`on whether a “Comparable Dose” or “By Weight” methodology is used.
`
`According to Petitioner and Dr. Ramzan, the large variances in the chart
`
`above show that “there is no correlation between (i) the dose required to
`
`administer the same amount by weight of neurotoxin in 20U of MT10109L
`
`and (ii) the equivalent dose to 20U of BOTOX®.” Id. ¶ 35; Opp. 5–6.
`
`Patent Owner responds that the amendment to remove the “dosed at a
`
`comparable amount” was to address the Board’s concerns in the Preliminary
`
`Guidance that the claims lack written description support in view of the fact
`
`that the claims are not limited to administration of a 20 Units dose. Reply 2.
`
`Patent Owner also contends that the amendment also addressed Petitioner’s
`
`prior argument that “comparable amount” broadly covered “any animal
`
`protein-free composition when dosed at any comparable amount of any
`
`animal-protein containing composition.” Id. at 2–3. According to Patent
`
`Owner, the claims now recite botulinum toxin compositions comprising a
`
`specific amount—the amount of toxin present in about 20 units of
`
`MT10109L—which is not broader than “any comparable amount.” Id. at 3.
`
`We do not agree with Petitioner’s argument that the proposed
`
`amendments are broader in scope than the original claims. Original claim 1
`
`recites that “the botulinum toxin composition exhibits a longer lasting effect
`
`in the patient when compared 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.” Ex. 1001,
`
`32:8–13. As noted by Petitioner, the comparison required by the original
`
`claims was based on unit doses of an animal protein-containing botulinum
`
`toxin composition and an animal-protein-free botulinum toxin composition
`
`17
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`PGR2019-00062
`Patent 10,143,728 B2
`
`as determined using an LD50 assay. Opp. 3. This was problematic
`
`according to Petitioner insofar as each manufacturer uses its own proprietary
`
`LD50 assay, and thus there was no uniform method by which those skilled in
`
`the art could make the required comparison. Id. Proposed substitute
`
`claim 19 now removes this ambiguity by reciting a composition with
`
`serotype A botulinum toxin in an amount present in about 20 units of
`
`MT10109L, and requiring a comparison of the length of effect of such a
`
`composition with 20 units of BOTOX®.
`
`Although the basis for the comparison has shifted from unit doses to
`
`weight, we do not agree with Petitioner’s argument that this amendment
`
`improperly broadens the claims’ scope. To the contrary, based on the record
`
`here, Patent Owner persuades us that the amendment in question now
`
`indicates a more specific amount of neurotoxin that falls within the scope of
`
`the original claims—addressing Petitioner’s past criticisms and responding
`
`to our concerns about unit dosing language of the earlier claims as explained
`
`in the Preliminary Guidance. See Prelim. Guid. 6–7; Ex. 2072 ¶ 19 (noting 1
`
`ng of a 900 kDa toxin complex, which includes the 150kDa toxin); Ex. 1106
`
`¶ 34 (noting a 0.17 ng weight for the 150kDa serotype A toxin protein); Tr.
`
`42:22–48:17 (discussing calculations to arrive at 0.17–0.18 nanograms of the
`
`serotype A toxin). We find no sufficient and persuasive evidence of record
`
`suggesting that the proposed substitute claims encompass a larger number of
`
`compositions than the original claims.
`
`Accordingly, we determine that the scope of each of the proposed
`
`substitute claims is not improperly broader than the claim for which it is a
`
`substitute.
`
`18
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`PGR2019-00062
`Patent 10,143,728 B2
`
`4.
`
`No New Matter
`
`“A motion to amend may not present substitute claims that . . .
`
`introduce new subject matter.” Lectrosonics, Paper 15 at 6–7; 35 U.S.C.
`
`§ 326(d)(3); 37 C.F.R. § 41.221(a)(2)(ii). To evaluate compliance with the
`
`prohibition on amendments that add new matter,
`
`the Board requires that a motion to amend set forth written
`description support in the originally filed disclosure of the
`subject patent for each proposed substitute claim, and also set
`forth support in an earlier filed disclosure for each claim for
`which benefit of the filing date of the earlier filed disclosure is
`sought.
`
`Lectrosonics, Paper 15 at 7.
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