Trials@uspto.gov
`571-272-7822
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` Paper 28
`Date: October 23, 2020
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`NEW U LIFE CORPORATION,
`Petitioner,
`
`v.
`
`AXCESS GLOBAL SCIENCES, LLC,
`Patent Owner.
`____________
`
`IPR2019-01141
`Patent 6,613,356 B1
`____________
`
`
`Before GEORGIANNA W. BRADEN, JENNIFER MEYER CHAGNON,
`and MICHAEL A. VALEK, Administrative Patent Judges.
`
`VALEK, Administrative Patent Judge.
`
`
`
`
`JUDGMENT
`Final Written Decision
`Determining Some Challenged Claims Unpatentable
`35 U.S.C. § 318(a)
`
`
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`571-272-7822
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` Paper 28
`Date: October 23, 2020
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`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`NEW U LIFE CORPORATION,
`Petitioner,
`
`v.
`
`AXCESS GLOBAL SCIENCES, LLC,
`Patent Owner.
`____________
`
`IPR2019-01141
`Patent 6,613,356 B1
`____________
`
`
`Before GEORGIANNA W. BRADEN, JENNIFER MEYER CHAGNON,
`and MICHAEL A. VALEK, Administrative Patent Judges.
`
`VALEK, Administrative Patent Judge.
`
`
`
`
`JUDGMENT
`Final Written Decision
`Determining Some Challenged Claims Unpatentable
`35 U.S.C. § 318(a)
`
`
`
`
`
`
`
`
`
`
`
`IPR2019-01141
`Patent 6,613,356 B1
`
`
`INTRODUCTION
`I.
`New U Life Corporation (“Petitioner”) filed a Petition (Paper 1
`(“Pet.”)) seeking an inter partes review of claims 1–19 of U.S. Patent
`No. 6,613,356 B1 (“the ’356 patent,” Ex. 1001). We instituted trial to review
`the challenged claims. Paper 8 (“Dec.”). Thereafter, Axcess Global
`Sciences, LLC1 (“Patent Owner”) filed a Response to the Petition (Paper 11,
`“PO Resp.”), Petitioner filed a Reply (Paper 15, “Reply”), and Patent Owner
`filed a Sur-Reply (Paper 17, “Sur-Reply”). Patent Owner also filed a
`contingent Motion to Amend the challenged claims in the event any of the
`challenged claims were determined unpatentable (Paper 12, “MTA”),
`Petitioner filed an Opposition to Patent Owner’s MTA (Paper 14), and we
`provided Preliminary Guidance on the MTA (Paper 16). Patent Owner
`subsequently withdrew its MTA (Paper 18). Thus, there is no pending
`motion to amend and only the challenged claims are at issue in this
`proceeding. We held an oral hearing on September 1, 2020. A transcript of
`that hearing is of record (Paper 26, “Tr.”).
`We issue this final written decision pursuant to 35 U.S.C. § 318(a)
`and 37 C.F.R. § 42.73. For the reasons explained below, we conclude
`Petitioner has shown by a preponderance of evidence that claims 1, 2, 5, 8,
`11, 14, and 17 of the ’356 patent are unpatentable, but has failed to show by
`a preponderance of evidence that claims 3, 4, 6, 7, 9, 10, 12, 13, 15, 16, 18,
`and 19 are unpatentable on any ground raised in the Petition.
`
`
`1 The Petition identifies VND Butyrate, LLC as the Patent Owner. In its
`mandatory notice, Patent Owner represents that the “entire right, title and
`interest in and to” the ’356 patent was assigned to Axcess Global Sciences,
`LLC “on or about November 20, 2018.” Paper 5, 2.
`2
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`Related Proceedings
`A.
`Patent Owner informs us that the following actions involve the ’356
`patent: RK Solutions v. Equinox Nutraceuticals, No. 2:18-cv-00797-RJS-
`EJF (D. Utah) and RK Solutions, LLC v. Vitajoy USA Inc., No. 2:18-cv-
`06608-CAS-E (C.D. Cal.). Paper 5, 2.
`In addition, inter partes review of claims 1 and 2 of the ’356 patent
`was previously instituted based on a petition from a different petitioner in
`IPR2015-01798. That case was terminated pursuant to joint motion of the
`parties prior to the filing of a response by Patent Owner and before any final
`decision from the Board. See IPR2015-01798, Paper 16.
`Background of Technology and the ’356 Patent
`B.
`The ’356 patent relates to “a medication for weight loss by means of
`appetite suppression and a method for administering this medication” to
`humans. Ex. 1001, Abstr. This medication “comprises potassium butyrate
`and closely related chemical compounds, which reduce appetite in mammals
`when administered orally.” Id. at 2:18–22. According to the Specification,
`“[t]he anorexic effect of the butyrate ion is thought to be due to the fact that
`its presence is a signal to the stomach receptors that there are bacteria in the
`stomach contents,” which indicates the stomach is full or “stagnant.” Id.
`at 3:11–25. Thus, consuming butyrate ion before each meal makes the
`stomach feel as if more was eaten than was actually eaten, thereby
`suppressing the appetite. Id. at 3:35–37.
`Illustrative Claims
`C.
`Claims 1, 14, and 17 are independent claims. Claims 1–13 are
`method claims, and claims 14–19 are composition claims. Claim 1 is
`illustrative of the method claims and is reproduced below.
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`A process for causing weight loss, or avoidance of
`1.
`weight gain, in mammals, comprising oral administration to
`said mammals of butyric acid or one or more pharmaceutically
`effective and acceptable salts or derivatives of butyric acid
`selected from the group consisting of/butyric acid, sodium
`butyrate, calcium butyrate, potassium butyrate, magnesium
`butyrate, alphahydroxybutyric acid, sodium
`alphahydroxybutyrate, calcium alphahydroxybutyrate,
`potassium alphahydroxybutyrate, magnesium
`alphahydroxybutyrate, betahydroxybutyric acid, sodium
`betahydroxybutyrate, calcium betahydroxybutyrate, potassium
`betahydroxybutyrate, magnesium betahydroxybutyrate,
`isobutyric acid, sodium isobutyrate, calcium isobutyrate,
`potassium isobutyrate, and magnesium isobutyrate.
`Ex. 1001, 8:65–9:12. As shown above, claim 1 recites the oral
`administration of butyric acid as well as certain salts and derivatives of
`butyric acid specified in a Markush group. Adopting the parties’
`nomenclature, we refer to these compounds collectively as the “Markush
`Compounds.”
`Claims 14 and 17 are composition claims directed to a “capsule” and
`“tablet,” respectively, comprising one or more of the Markush Compounds
`in “an amount effective for weight loss or avoidance of weight gain.” Claim
`14 is illustrative of the composition claims and is reproduced below.
`14. A composition of matter comprising a capsule capable of
`dissolving in the stomach of a mammal, wherein said capsule
`contains, in an amount effective for weight loss or avoidance of
`weight gain in said mammal, one or more of the compounds
`selected from the group consisting of/butyric acid, sodium
`butyrate, calcium butyrate, potassium butyrate, magnesium
`butyrate, alphahydroxybutyric acid, sodium
`alphahydroxybutyrate, calcium alphahydroxybutyrate,
`potassium alphahydroxybutyrate, magnesium
`alphahydroxybutyrate, betahydroxybutyric acid, sodium
`betahydroxybutyrate, calcium betahydroxybutyrate, potassium
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`betahydroxybutyrate, magnesium betahydroxybutyrate,
`isobutyric acid, sodium isobutyrate, calcium isobutyrate,
`potassium isobutyrate, and magnesium isobutyrate.
`Ex. 1001, 10:7–22.
`Asserted Challenges to Patentability
`D.
`Petitioner asserts the following challenges to patentability: 2
`Claim(s)
`Challenged
`1, 2, 5–14, 17
`1
`2, 5–14, 17
`3, 4, 15, 16, 18, 19
`
`35 U.S.C. §
`102
`103
`103
`103
`
`Reference(s)
`Pawan3
`Pawan
`Pawan, Neesby,4 Moran5
`Pawan, Neesby, Moran,
`Strachan6
`Martin7
`Martin
`Martin, Neesby, Moran
`Martin, Neesby, Moran,
`Strachan
`
`1, 2, 5–14, 17
`1
`2, 5–14, 17
`3, 4, 15, 16, 18, 19
`
`102
`103
`103
`103
`
`
`2 In addition, the Petition presents alternative challenges asserting that
`Neesby and Moran anticipate claim 1 “[i]f . . . the Board construes claim 1
`so as to consider the preamble not limiting.” Pet. 59–60, 67. As explained
`below, we determine the preamble is limiting and, therefore, do not address
`these alternative challenges further.
`3 Pawan et al., Effect of 3-Hydroxybutyrate in Obese Subjects on Very-Low-
`Energy Diets and During Therapeutic Starvation, The Lancet 15–17 (1983)
`(Ex. 1010) (“Pawan”).
`4 Neesby, U.S. Patent No. 4,721,716, issued Jan. 26, 1988 (Ex. 1014)
`(“Neesby”).
`5 Moran et al., U.S. Patent No. 5,962,523, issued Oct. 5, 1999 (Ex. 1015)
`(“Moran”).
`6 Christine Elizabeth Strachan, The Formulation Technology of Dispersible
`Tablets (Feb. 2000) (Ph.D. thesis, Liverpool John Moores University)
`(Ex. 1012) (“Strachan”).
`7 Martin et al., U.S. Patent No. 6,380,244 B2, filed July 22, 1999, issued
`Apr. 30, 2002 (Ex. 1017) (“Martin”).
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`Claim(s)
`Challenged
`14, 17
`15, 16, 18, 19
`14, 17
`15, 16, 18, 19
`
`35 U.S.C. §
`102
`103
`102
`103
`
`Reference(s)
`Neesby
`Neesby, Strachan
`Moran
`Moran, Strachan
`
`II. ANALYSIS
`Principles of Law
`A.
`To prevail on its challenge to Patent Owner’s claims, Petitioner must
`demonstrate by a preponderance of the evidence that the claims are
`unpatentable. 35 U.S.C. § 316(e) (2012); 37 C.F.R. § 42.1(d) (2018). The
`petitioner “has the burden from the onset to show with particularity why the
`patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc.,
`815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3)
`(requiring inter partes review petitions to identify “with particularity . . . the
`evidence that supports the grounds for the challenge to each claim”)). This
`burden never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l
`Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (citing Tech. Licensing
`Corp. v. Videotek, Inc., 545 F.3d 1316, 1326–27 (Fed. Cir. 2008))
`(discussing the burden of proof in inter partes review).
`To establish anticipation, each and every element in a claim, arranged
`as recited in the claim, must be found in a single prior art reference. Net
`MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008);
`Karsten Mfg. Corp. v. Cleveland Golf Co., 242 F.3d 1376, 1383 (Fed.
`Cir. 2001). While the elements must be arranged or combined in the same
`way as in the claim, “the reference need not satisfy an ipsissimis verbis test,”
`i.e., identity of terminology is not required. In re Gleave, 560 F.3d 1331,
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`1334 (Fed. Cir. 2009); In re Bond, 910 F.2d 831, 832 (Fed. Cir. 1990).
`Thus, the dispositive question “is whether one skilled in the art would
`reasonably understand or infer from a prior art reference that every claim
`element is disclosed in that reference.” Eli Lilly v. Los Angeles Biomedical
`Research Inst. at Harbor–UCLA Med. Ctr., 849 F.3d 1073, 1074–75 (Fed.
`Cir. 2017). Still further, “it is proper to take into account not only specific
`teachings of the reference but also the inferences which one skilled in the art
`would reasonably be expected to draw therefrom.” In re Preda, 401 F.2d
`825, 826 (CCPA 1968).
`A patent claim is unpatentable under 35 U.S.C. § 103(a) if the
`differences between the claimed subject matter and the prior art are such that
`the subject matter, as a whole, would have been obvious at the time the
`invention was made to a person having ordinary skill in the art to which said
`subject matter pertains. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406
`(2007). The question of obviousness is resolved on the basis of underlying
`factual determinations including (1) the scope and content of the prior art;
`(2) any differences between the claimed subject matter and the prior art;
`(3) the level of ordinary skill in the art; and (4) any secondary
`considerations, if in evidence. Graham v. John Deere Co., 383 U.S. 1, 17–
`18 (1966).
`
`Level of Ordinary Skill in the Art
`B.
`The Petition does not specifically address the level of skill of a person
`of ordinary skill in the art. Patent Owner asserts:
`The correct level of ordinary skill in the field of the effects of
`chemicals on the human body is a person having a bachelor’s
`degree in biochemistry or a similar discipline, or equivalent
`work experience. This level of ordinary skill reflects the
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`educational level of workers in the field and the sophistication
`of the technology.
`PO Resp. 7. Petitioner does not dispute Patent Owner’s description in its
`Reply.
`Patent Owner’s description is consistent with the level of skill
`reflected in the prior art of record and in the disclosure of the ’356 patent.
`Accordingly, we agree with Patent Owner’s description of the level of
`ordinary skill in the art and adopt it for our analysis herein.
`Claim Construction
`C.
`In an inter partes review based on a petition filed on or after
`November 13, 2018 (as in this proceeding), a claim term “shall be construed
`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).” See Changes to the
`Claim Construction Standard for Interpreting Claims in Trial Proceedings
`Before the Patent Trial and Appeal Board, 83 Fed. Reg. 51,340 (Oct. 11,
`2018) (codified at 37 C.F.R. pt. 42 (2019)) (amending 37 C.F.R.
`§ 42.100(b) effective November 13, 2018). Under this standard, claim terms
`are given their ordinary and customary meaning as would have been
`understood by a person of ordinary skill in the art at the time of the invention
`and in the context of the entire patent disclosure. Philips v. AWH Corp.,
`415 F.3d 1303, 1312–14 (Fed. Cir. 2005) (en banc). If the specification
`“reveal[s] a special definition given to a claim term by the patentee that
`differs from the meaning it would otherwise possess[,] . . . the inventor’s
`lexicography governs.” Id. at 1316.
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`1. Markush Compounds
`As discussed above, each of the claims is limited to a list of
`pharmaceutically effective and acceptable salts or derivatives of butyric acid
`recited in the form of a Markush group. In our Institution Decision, we
`agreed with the Board’s prior determination that the claims are drafted in
`Markush form. Dec. 7 (citing Ex. 1008 (IPR2015-01798, Paper 11), 6). In
`particular, we applied the Board’s determination from IPR2015-01798 “that
`the claims are limited to the specific salts and derivatives identified in the
`Markush group.” Ex. 1008, 6. The parties in the present proceeding do not
`dispute that the claims are so limited (see Pet. 15; PO Resp. 7–8). We
`maintain this construction for this Final Written Decision.
`
`Preamble language (claim 1)
`2.
`The preamble of independent claim 1 recites a process “for causing
`weight loss, or avoidance of weight gain, in mammals.” Ex. 1001, 8:65–66.
`Petitioner argues that the preamble is limiting because the patent applicant
`relied on it to distinguish prior art during prosecution. See Pet. 17.
`Moreover, Petitioner contends the applicant’s arguments during prosecution
`“foreclos[e] any claim scope beyond express use for appetite suppression.”
`Id. at 13. In its Preliminary Response to the Petition, Patent Owner urged
`that the claims are not limited to appetite suppression because they more
`broadly “recite ‘weight loss, or avoidance of weight gain’” and there is no
`clear and unmistakable disclaimer limiting them to weight management via
`appetite suppression. Paper 7, 10–11.
`We offered a preliminary construction in our Institution Decision,
`determining that the preamble is limiting and that it “encompasses appetite
`suppression as a means for ‘causing weight loss or avoidance of weight
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`gain,’ as claimed,” but “does not exclude other mechanisms for achieving
`such.” Dec. 10. Patent Owner does not dispute that construction. PO
`Resp. 7–8. Nor does Petitioner specifically address it in its Reply. We now
`reiterate our prior rationale and adopt the same construction for this
`decision.
`The preamble of claim 1 is limiting because the patent applicant relied
`on it to distinguish the prior art during prosecution. See Catalina Mktg.
`Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002)
`(“[C]lear reliance on the preamble during prosecution to distinguish the
`claimed invention from the prior art transforms the preamble into a claim
`limitation because such reliance indicates use of the preamble to define, in
`part, the claimed invention.”). During prosecution, the claims of the ’356
`patent were rejected over Lammerant,8 which the examiner found taught “a
`pharmaceutical composition containing a pharmaceutically acceptable salt of
`butyric acid . . . to prevent metabolic disorders.” Ex. 1002 (’356 patent file
`history), 52. The applicant responded, urging that “Lammerant relates to
`problems of the heart, not obesity, and is therefore not relevant to the
`Application,” and submitted a declaration from Dr. Ghulam Ahmad Shakeel
`Ansari (“Ansari Decl.”) exhorting the same. Id. at 56; see also id. at 59–64
`(Ansari Decl.). The applicant later amended claim 1 to add the preamble
`language and to incorporate the Markush group of claim 2 such that the
`amended claim was limited to administration of the Markush Compounds
`for the express purpose of “causing weight loss, or avoidance of weight
`gain.” Id. at 153. Thus, the applicant clearly relied on the preamble––first
`
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`8 Lammerant et al., U.S. Patent No. 4,771,074, issued Sept. 13, 1988.
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`by arguing that its invention was directed to problems of obesity to
`distinguish the prior art, and second by amending claim 1 to add the
`preamble language in response to the examiner’s rejections. See In re
`Cruciferous Sprout Litig., 301 F.3d 1343, 1347–48 (Fed. Cir. 2002)
`(determining that preamble was limiting where patentee relied on such “to
`persuade the Patent Office that the claimed invention is not anticipated by
`the prior art”).
`While claim 1 is limited by the preamble to “causing weight loss or
`avoidance of weight gain,” it does not require that the weight loss or
`avoidance of weight gain occur by a particular mechanism. According to the
`Specification, “[t]he presence of exogenously administered butyric acid or
`butyrate ions apparently . . . causes stomach receptors to react as though
`there were stagnant food in the stomach, and causes the receptors to signal to
`the brain through the vagus nerve, thus suppressing the appetite.” Ex. 1001,
`3:27–32; see also id. at Abstr. (“The invention involves a medication for
`weight loss by means of appetite suppression”). The language of the claim
`preamble, however, is more general and does not recite appetite suppression
`or any other mechanism by which the claimed weight loss or avoidance of
`weight gain must be achieved. Petitioner urges, without identifying any
`particular statement or support, that the applicant’s arguments in response to
`the Lammerant rejection “foreclose[d] any claim scope beyond express use
`for appetite suppression.” Pet. 13 (citing Ex. 1002, 50–54 (applicant’s
`response), 55–91 (Ansari Decl.)). But we see no “clear and unmistakable
`disclaimer” in those arguments that would foreclose the administration of
`the Markush Compounds to cause weight loss or avoid weight gain by
`means other than appetite suppression. See Omega Eng’g, Inc. v. Raytek
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`Corp., 334 F.3d 1314, 1326 (Fed. Cir. 2003). Thus, while the Specification
`makes clear that appetite suppression is one way by which the Markush
`Compounds can cause weight loss or avoid weight gain (and, therefore,
`claim 1 encompasses appetite suppression as a means for “causing weight
`loss or avoidance of weight gain,” as claimed), the preamble language does
`not exclude other mechanisms for achieving such.
`
`“an amount effective for weight loss or avoidance of
`3.
`weight gain” (claims 14 and 17)
`Patent Owner argues “the Board should construe ‘an amount effective
`for weight loss or avoidance of weight gain’” as recited in claims 14 and 17
`to mean “an amount ranging from 90 milligrams to 7.5 grams.” Sur-reply 3.
`According to Patent Owner, this construction “is consistent with the claims,
`specification, and how Petitioner itself construed this term in the Petition.”
`Id. Petitioner disagrees. Reply 18, 27–28. According to Petitioner, claims
`14 and 17 “do not recite dosage ranges” and there “is no sound reason for
`importing any specific dosage information into Claims 14 and 17.” Id.
`We agree with Petitioner that claims 14 and 17 are not limited to a
`particular dosage range. Claims 14 and 17 recite “[a] composition of
`matter” comprising either a “capsule” (claim 14) or a “tablet” (claim 17) that
`“contains, in an amount effective for weight loss or avoidance of weight
`gain” one or more of the Markush Compounds. Ex. 1001, 10:7–11,
`10:37–40. There is no particular dosage range recited in the claim language
`itself.
`The Specification of the ’356 patent does not define “an amount
`effective for weight loss or avoidance of weight gain” so as to restrict that
`term to a particular range. Rather, the Specification generally describes
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`exemplary dosages in terms of the amount in a single dose or capsule. See,
`e.g., Ex. 1001, 3:45–57 (“[t]he upper range of the preferred dose is
`about 1.15 grams of potassium butyrate or 5 of the size #0 filled capsules
`(described in this Application) taken three times a day”); 4:16–28
`(describing tests on human volunteers who were administered “a dosage
`of 3–5 capsules” multiple times per day with each capsule “typically
`contain[ing] 231 to 287 mg of potassium butyrate” along with excipients in
`a “920 to 1 100 mg Size 0 Lilly gelatin capsule”). The Specification also
`describes these exemplary dosages in terms of total daily dosage, i.e., the
`aggregate amount administered in multiple capsules or tablets over the
`course of a day. See, e.g., id. at 4:9–10 (stating that “even 10 doses a day
`or 36 capsules would probably be well tolerated”).
`The statement in the Specification that “[t]he maximum safe dose is
`probably 2.5 grams (2,500 mg) before meals” (Ex. 1001, 3:59–60) is not a
`sufficient basis to import Patent Owner’s proposed dosage range into
`claims 14 and 17. Patent Owner appears to derive the upper end of its
`proposed range, i.e., 7.5 grams, by assuming that three doses of 2.5 grams
`each could be administered over the course of a day. See Tr. 54:14–23
`(acknowledging that the range in Patent Owner’s proposed construction
`comes from the specification’s description of the total daily dosage). But the
`Specification also states that even as many as “10 doses a day,” i.e.,
`2.5 x 10 = 25 grams, could be “well tolerated.” Id. at 4:9–10. In addition,
`the Specification refers to alternative embodiments in which “[o]ther ranges
`of dosage of potassium butyrate and frequency of administration to
`mammals might be used.” Id. at 6:50–57. We, therefore, decline Patent
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`Owner’s invitation to import a dosage range that is not recited in claim
`language and that would exclude these other embodiments.
`We also note Patent Owner’s proposed construction is inconsistent
`with the surrounding claim language, which recites a capsule or tablet
`“wherein said capsule [or tablet in claim 17] contains, in an amount
`effective for weight loss or avoidance of weight gain” one or more Markush
`Compounds. See Ex. 1001, 10:7–11 (emphasis added). The emphasized
`text evidences that the term “amount effective” refers to the amount
`contained in a capsule or tablet––not the aggregate amount administered in
`multiple capsules or tablets over the course of a day. Thus, there is a
`disconnect between Patent Owner’s proposed construction, which Patent
`Owner acknowledges is derived from the Specification’s description of the
`total daily dosage (see Tr. 54:14–23), and the text of claims 14 and 17.
`Nevertheless, Patent Owner argues we should adopt its construction
`because Petitioner proposed the same construction in the Petition. See
`Sur-reply 2–3 (asserting “Petitioner is judicially estopped from now
`disavowing its prior claim construction position.”) We disagree.
`Petitioner did not propose a construction for this term in the Petition.
`Rather, in its argument that the compositions of claims 14 and 17 are
`anticipated, Petitioner urged that the amounts taught in the prior art
`compositions were inherently “effective for weight loss or avoidance of
`weight gain” because the prior art taught the administration of capsules and
`tablets to provide daily dosages that overlap with those in the ’356 patent.
`See, e.g., Pet. 53 (“Since the dose amounts taught by Neesby . . . correspond
`generally to the amounts taught in the ‘356 Patent (that is, between 96 mg
`and 7.5 grams per day), it is inherent that taking butyrates as, and in the
`
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`amounts, taught by Neesby [] would be effective in suppressing appetite
`as taught by the ‘356 Patent.”). Thus, the Petition cites the description of
`some of the exemplary dosages in the Specification as evidence the
`limitation is inherently met in the prior art. Petitioner did not, however, seek
`to limit claims 14 and 17 to only those exemplary dosages. Moreover, even
`if Petitioner had proposed the same claim construction Patent Owner now
`advances, the intrinsic record of the ’356 patent does not support and,
`therefore, we do not accept that claim construction as explained above.
`In sum, we reject Patent Owner’s proposed construction. Claims 14
`and 17 are not limited to a particular daily dosage range. The term “an
`amount effective for weight loss or avoidance of weight gain” includes, but
`is not limited to, the amounts in the exemplary, standard–sized capsules
`described in the Specification. See Ex. 1001, 4:16–28. Further claim
`construction of this term is unnecessary to resolve the issues presented in
`this proceeding. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor
`Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (explaining that it is only
`necessary to “construe terms ‘that are in controversy, and only to the extent
`necessary to resolve the controversy’” (quoting Vivid Techs., Inc. v. Am. Sci.
`& Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).
`
`Remaining claim terms
`4.
`The parties do not propose constructions for any other claim terms
`and we determine that it is unnecessary to expressly construe any other
`claim terms to resolve the issues presented. See Nidec, 868 F.3d at 1017.
`
`15
`
`
`
`IPR2019-01141
`Patent 6,613,356 B1
`
`
`References Relied Upon
`D.
`Pawan (Ex. 1010)
`1.
`Pawan describes a study in which “[s]odium DL-3-hydroxybutyrate
`was administered to obese subjects . . . who were either receiving a 2 · 5 MJ
`(600 kcal) diet . . . one day with a total fast (water and vitamins only) on the
`next day . . . or were undergoing therapeutic starvation.” Ex. 1010, 1. The
`subjects on the energy restricted diet received 18 g/day of sodium DL-3-
`hydroxybutyrate either in a “slow intravenous infusion” or orally in a
`flavored aqueous solution in four doses “taken at 8, 12, 16 and 20 hours
`daily.” Id. The therapeutic starvation subjects received 18 g/day orally. Id.
`Pawan reports all of the subjects lost weight, but there was no
`significant difference in the rate of weight loss for those subjects given
`3-hydroxybutyrate as compared to control subjects on the same energy
`restricted or therapeutic starvation diets. Id. at 2. For the cohort of subjects
`on the energy restricted diet, Pawan reports that “[b]oth intravenous and oral
`3-hydroxybutyrate was well tolerated and significantly reduced net body
`protein loss.” Id. Moreover, “none [of the subjects in Pawan’s study]
`complained of hunger while receiving 3-hydroxybutyrate” and, even for
`those subjects undergoing therapeutic starvation, “[g]enerally the patients
`reported feeling less hungry when receiving hydroxybutyrate.” Id. at 1–2.
`
`2. Martin (Ex. 1017)
`Martin relates to nutritional or therapeutic compositions for increasing
`ketone body levels in the blood of mammals by providing a source of ketone
`bodies in the form of linear or cyclic oligomers or derivatives of
`3-hydroxyacids. Ex. 1017, Abstr. According to Martin, increasing blood
`
`16
`
`
`
`IPR2019-01141
`Patent 6,613,356 B1
`
`ketone levels is desirable for appetite suppression during weight loss. Id.
`at 1:12–17. Martin cites Pawan and explains it “has been reported that
`3-hydroxybutyrate beneficially suppresses the appetite.” Id. at 1:63–67.
`Martin teaches that 3-hydroxybutyrate is a preferred 3-hydroxyacid
`for its compositions. Id. at Abstr., 3:47–48. Martin teaches formulations of
`such compounds can be administered “alone, in dry or powdered form, in
`solution in a carrier . . . or mixed with other materials which will elevate
`blood ketones.” Id. at 7:21–24; see also id. at 9:15–17 (Example 2)
`(describing administration of a 3-hydroxyacid compound in gelatin to dogs).
`
`Neesby (Ex. 1014)
`3.
`Neesby discloses a method for treating food allergies by desensitizing
`the gastrointestinal tract with oral ingestion of an effective amount of butyric
`acid or a salt thereof. Ex. 1014, Abstr., 1:47–52. Neesby teaches that
`butyrate may be “administered orally in either tablet or capsule form.” Id.
`at 2:51–52. According to Neesby, “[t]he normal dosage [for desensitizing
`the gastrointestinal tract] is in an amount of one to two grams of butyrate for
`each dose to be administered,” but the dosage may vary. Id. at 2:52–55. In
`Example 1, Neesby describes the preparation of “a size 00 gelatin capsule
`accommodating 500 to 600 mg. sodium butyrate.” Id. at 2:65–3:7. Neesby
`discloses that a dose should be taken “at each meal for a total daily intake of
`about 3 to about 10 grams butyrate.” Id. at 2:56–57.
`
`4. Moran (Ex. 1015)
`Moran discloses “methods of protecting against injury to hair follicles
`in a mammal by administering an effective amount of butyric acid or a
`biologically active butyric acid derivative.” Ex. 1015, Abstr. Moran teaches
`
`17
`
`
`
`IPR2019-01141
`Patent 6,613,356 B1
`
`that a daily dose of the active ingredient “can be expected to be about 0.05
`to 50 grams per kilogram of body weight.” Id. at 8:23–26. Moran discloses
`that the “active ingredient can be administered orally in solid or semi-solid
`dosages forms, such as hard or soft-gelatin capsules” or “tablets,” containing
`“10–500 milligrams of the active ingredient.” Id. at 8:38–40, 9:45–60.
`Moran also teaches that “tablets can be . . . enteric-coated for selective
`disintegration in the gastrointestinal tract.” Id. at 8:52–55.
`
`Strachan (Ex. 1012)
`5.
`Strachan discloses various “[a]pproaches to formulating a solid
`dosage form which rapidly disintegrates.” Ex. 1012, 8–12. One of the
`approaches described in Strachan is formulation in “[e]ffervescent tablets”
`that “depend on the reaction of bicarbonate or carbonate with an acid or
`other excipient with the capacity to evolve a gas after contact with water”
`causing the tablet to “rapidly disintegrate[] to produce a solution or
`suspension.” Id. at 8. According to Strachan, production of such tablets “is
`expensive and demanding and requires manufacturing at low relative
`humidity” and is “unsuitable” for drugs that are “incompatible with
`bicarbonate and acids.” Id.
`Alleged Anticipation by Pawan and/or Obviousness over Pawan
`E.
`Alone or in Combination with Other References
`Petitioner asserts claims 1–19 are unpatentable as anticipated by
`Pawan and/or obvious over Pawan, alone or in combination with other
`references. See Pet. 19–36. Patent Owner disputes Petitioner’s contentions.
`See PO Resp. 12–15, 24–27. As explained below, we determine Petitioner
`has shown by a preponderance of the evidence that claims 1, 2, 5, 8, 11, 14
`and 17 are unpatentable based on one or more of its grounds relying on
`
`18
`
`
`
`IPR2019-01141
`Patent 6,613,356 B1
`
`Pawan. We determine, however, Petitioner has not met that burden for
`claims 3, 4, 6, 7, 9, 10, 12, 13, 15, 16, 18, and 19.
`
`Claim 1
`1.
`Petitioner argues claim 1 is anticipated by Pawan and/or obvious over
`Pawan. Pet. 20–22. Specifically, Petitioner argues that Pawan teaches the
`oral administration of one of the Markush Compounds, sodium
`3-hydroxybutyrate,9 “as part of a therapy specifically aimed at weight loss”
`and that “the amounts given by Pawan were pharmaceutically effective (at
`least because they reduced hunger in severely fasting patients) and
`pharmaceutically acceptable (at least because the administration of
`hydroxybutyrate was known to be and shown to be safe).” Id. at 20.
`Patent Owner contends Pawan “does not disclose a Markush
`Compound used for ‘Causing Weight Loss or Avoidance of Weight Gain,’
`as recited in claims 1–13” because “there was no finding in Pawan of any
`causal relationship between weight loss and ingestion of hydroxybutyrate.”
`PO Resp. 13. In particular, Patent Owner urges that: (1) “the express
`disclosures of Pawan teach that there is
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