Trials@uspto.gov
`571.272.7822
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`
`
`
`
` Paper No. 11
`
` Entered: January 8, 2016
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`
`
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`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`PHARMACOSMOS A/S,
`Petitioner,
`
`v.
`
`LUITPOLD PHARMACEUTICALS, INC.,
`Patent Owner.
`____________
`
`Case IPR2015-01490
`Patent 7,754,702 B2
`____________
`
`
`Before TONI R. SCHEINER, LORA M. GREEN, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`GREEN, Administrative Patent Judge.
`
`
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`
`
`571.272.7822
`
`
`
`
`
` Paper No. 11
`
` Entered: January 8, 2016
`
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`PHARMACOSMOS A/S,
`Petitioner,
`
`v.
`
`LUITPOLD PHARMACEUTICALS, INC.,
`Patent Owner.
`____________
`
`Case IPR2015-01490
`Patent 7,754,702 B2
`____________
`
`
`Before TONI R. SCHEINER, LORA M. GREEN, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`GREEN, Administrative Patent Judge.
`
`
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`
`
`
`IPR2015-01490
`Patent 7,754,702 B2
`
`
`
`I.
`
`INTRODUCTION
`
`Pharmacosmos A/S (“Petitioner”) filed a Petition requesting an inter
`
`partes review of claims 1–3, 10–15, 17, 23, 25–28, 30, 34, 41–43, and 47 of
`
`U.S. Patent No. 7,754,702 B2 (Ex. 1001, “the ’702 patent”). Paper 1
`
`(“Pet.”). Luitpold Pharmaceuticals, Inc. (“Patent Owner”) filed a
`
`Preliminary Response to the Petition. Paper 7 (“Prelim. Resp.”).
`
`We have jurisdiction under 35 U.S.C. § 314, which provides that an
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`inter partes review may not be instituted “unless . . . there is a reasonable
`
`likelihood that the petitioner would prevail with respect to at least 1 of the
`
`claims challenged in the petition.” Upon considering the Petition and the
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`Preliminary Response, we determine that Petitioner has shown a reasonable
`
`likelihood that it would prevail in showing the unpatentability of claims 1–3,
`
`10–15, 17, 23, 25, 27, 28, 30, 41–43, and 47. Accordingly, we institute an
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`inter partes review of those claims.
`
`A.
`
`Related Proceedings
`
`Neither Petitioner nor Patent Owner identifies any related district
`
`court proceedings. See, e.g., Pet. 1 (“There are no existing judicial or
`
`administrative matters that would affect, or be affected by, a decision in this
`
`proceeding.”); Paper 6 (“Patent Owner’s U.S. Patent No. 7,754,702 . . . is
`
`not involved in litigation.”). In addition, Petitioner filed petitions for inter
`
`partes review of related patents U.S. Patent No. 8,431,549 B2 (IPR2015-
`
`01493) and U.S. Patent No. 8,895,612 B2 (IPR2015-01495). Pet. 1.
`
`B.
`
`The ’702 Patent (Ex. 1001)
`
`
`
`The ’702 patent issued on July 13, 2010, with Mary Jane Helenek,
`
`Marc L. Tokars, and Richard P. Lawrence as the listed co-inventors.
`
`Ex. 1001. The ’702 patent relates to “methods of treating a disease,
`
`2
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`IPR2015-01490
`Patent 7,754,702 B2
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`disorder, or condition characterized by iron deficiency or dysfunctional iron
`
`metabolism through the administration of at least 0.6 grams of elemental
`
`iron via a single unit dosage of an iron carbohydrate complex to a subject
`
`that is in need of such therapy.” Id. at 2:32–37.
`
`As taught by the ’702 patent, “the method treats anemia [such as] iron
`
`deficiency anemia.” Id. at 2:38–39. In addition, as taught by the ’702
`
`patent, the “iron carbohydrate complexes . . . can be administered
`
`parenterally at relatively high single unit dosages for the therapeutic
`
`treatment of a variety of iron-associated diseases, disorders, or conditions.”
`
`Id. at 5:24–27.
`
`In some embodiments of the ’702 patent, “the iron carbohydrate
`
`complex is [an] iron carboxymaltose complex, iron mannitol complex, iron
`
`polyisomaltose complex, iron polymaltose complex, iron gluconate
`
`complex, iron sorbitol complex, [ ] iron hydrogenated dextran complex [or]
`
`an iron polyglucose sorbitol carboxymethyl ether complex.” Id. at 3:33–39.
`
`“In some preferred embodiments, the iron carboxymaltose complex is
`
`polynuclear iron (III)-hydroxide-4(R)-(poly-(1→4)-O-α-glucopyranosyl)-
`
`oxy-2(R),3(S),5(R),6-tetrahydroxy-hexanoate[,]” which is also known as
`
`“VIT-45”. Id. at 3:58–61; 5:16–18.
`
`C.
`
`Illustrative Claim
`
`Petitioner challenges claims 1–3, 10–15, 17, 23, 25–28, 30, 34, 41–43,
`
`and 47 of the ’702 patent. Claim 1 is the only independent claim, is
`
`illustrative, and is reproduced below:
`
`1. A method of treating a disease, disorder, or condition
`characterized by iron deficiency or dysfunctional iron
`metabolism resulting in reduced bioavailability of dietary
`iron, comprising
`
`3
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`
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`IPR2015-01490
`Patent 7,754,702 B2
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`administering to a subject in need thereof an iron
`carbohydrate complex in a single dosage unit of at least
`about 0.6 grams of elemental iron;
`
`wherein
`the iron carbohydrate complex is selected from the group
`consisting of an iron carboxymaltose complex, an iron
`mannitol complex, an iron polymaltose complex, an iron
`gluconate complex, and an iron sorbitol complex; and
`
`the iron carbohydrate complex has a substantially non-
`immunogenic carbohydrate component and substantially
`no cross reactivity with anti-dextran antibodies
`
`wherein said disease, disorder or condition is not Restless
`Leg Syndrome.
`
`
`
`D. The Asserted Grounds of Unpatentability
`
`
`
`
`
`Petitioner challenges the patentability of claims 1–3, 10–15, 17, 23,
`
`25–28, 30, 34, 41–43, and 47 of the ’702 patent on the following grounds
`
`(Pet. 3–4):
`
`Reference(s)
`
`Geisser1
`
`Groman2
`
`Basis
`
`§ 102(b)
`
`§ 102(b)
`
`Claim(s) Challenged
`
`1–3, 10–13, 23, 25–
`27, and 41–43
`28
`
`Geisser and Groman
`
`§ 103(a)
`
`17, 34, and 47
`
`
`1 Geisser et al. (“Geisser”), WO 2004/037865, published May 6, 2004 (Ex.
`1002). Note that Ex. 1003 is the English language translation of Ex. 1002,
`and that US Patent No. 7,612,109 (Ex. 1014) is the resulting patent of the
`US National Stage application of Ex. 1002.
`2 Groman et al. (“Groman”), US 2003/0232084, published Dec. 18, 2003
`(Ex. 1004).
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`4
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`Patent 7,754,702 B2
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`
`Reference(s)
`
`van Zyl-Smit3
`
`Basis
`
`§ 102(b)
`
`Claim(s) Challenged
`
`1, 14, and 154
`
`van Zyl-Smit and Funk5
`
`§ 103(a)
`
`30
`
`
`
`
`II.
`
`ANALYSIS
`
`A.
`
`Claim Construction
`
`In an inter partes review, claim terms in an unexpired patent are
`
`interpreted according to their broadest reasonable constructions in light of
`
`the Specification of the patent in which they appear. See 37 C.F.R.
`
`§ 42.100(b); In re Cuozzo Speed Techs., LLC, 793 F.3d 1268, 1275 (Fed.
`
`Cir. 2015). Under the broadest reasonable construction standard, claim
`
`terms are presumed to have their ordinary and customary meaning, as would
`
`be understood by one of ordinary skill in the art in the context of the entire
`
`disclosure. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir.
`
`2007).
`
`We determine that, for purposes of this Decision, none of the terms in
`
`the challenged claims require express construction at this time.
`
`
`3 R. van Zyl-Smit & J. A. Halkett (“van Zyl-Smit”), Experience with the
`Use of an Iron Polymaltose (Dexrin) Complex Given by Single Total Dose
`Infusion to Stable Chronic Haemodialysis Patients, 92 NEPHRON 316–323
`(2002) (Ex. 1006).
`4 For reasons discussed below, we treat this challenge as including claim 1,
`from which claims 14 and depend.
`5 F. Funk, G. J. Long, D. Hautot, R. Büchi, I. Christl & P. G. Weidler
`(“Funk”), Physical and Chemical Characterization of Therapeutic Iron
`Containing Materials: A Study of Several Superparamagnetic Drug
`Formulations with the ß-FeOOH or Ferrihydrite Structure, 136 HYPERFINE
`INTERACTIONS 73–95 (2001) (Ex. 1026).
`
`5
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`Patent 7,754,702 B2
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`B.
`
`Anticipation by Geisser (Ex. 1002)
`
`Petitioner asserts that claims 1–3, 10–13, 23, 25–27, and 41–43 are
`
`unpatentable as being anticipated by Geisser. Pet. 22–39.
`
`i.
`
`Overview of Geisser (Ex. 1002, 1003(as translated))
`
`
`
`Geisser discloses “a water-soluble iron-carbohydrate complex
`
`obtained from an aqueous iron (III)-salt solution and an aqueous solution of
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`the product obtained by oxidizing one or several maltodextrins with an
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`aqueous hypochlorite solution at an alkaline pH value” and “a method for
`
`the production of said complex and medicaments for the treatment and
`
`prophylaxis of iron deficiencies.” Ex. 1003, Abstract.
`
`As taught by Geisser, medications containing iron carbohydrate
`
`complexes “are suitable . . . in the prophylaxis or therapy of iron-deficiency
`
`anemia” and are “particularly suitable for parenteral use.” Id. at 1. Geisser
`
`discloses that such iron carbohydrate complexes have the advantage of “low
`
`toxicity and a reduced risk of anaphylactic shock.” Id. at 8. Geisser teaches
`
`also that, in view of the stability of the iron carbohydrate complexes, it is
`
`possible to administer medications containing the complexes as a single dose
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`of 500 mg to 1000 mg. Id.
`
`ii.
`
`Analysis
`
`a.
`
`Claims 1, 2, 3, 10, 11, 12, 13, 23, 25, 27, and 41–43
`
`Petitioner asserts that claims 1–3, 10–13, 23, 25, 27, and 41–43 are
`
`unpatentable as being anticipated by Geisser. Pet. 22–33, 35–39. Petitioner
`
`relies on the Declaration of Dr. Robert Linhardt (Ex. 1005) to support its
`
`anticipation challenge.
`
`One of the specific iron carbohydrate complexes recited in claim 1 is
`
`an “iron carboxymaltose complex.” Petitioner contends that this is disclosed
`
`by Geisser, but acknowledges that “the term ‘carboxymaltose’ is not used by
`
`6
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`Patent 7,754,702 B2
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`Geisser.” Pet. 17. Petitioner asserts that “Geisser teaches iron
`
`carboxymaltose as disclosed and claimed in the ’702 patent” because “the
`
`’702 patent describes, as a preferred embodiment, the preparation of iron
`
`carboxymaltose via oxidation of maltodextrins using language that tracks
`
`(almost verbatim) that of Geisser (without referencing Geisser).” Id. at 17–
`
`18. Petitioner notes further that the U.S. equivalent of Geisser, U.S. Patent
`
`No. 7,612,109 B2 (Ex. 1014), is cited along with the ’702 patent “in the
`
`F.D.A. Orange Book as covering Injectafer® (a.k.a. VIT-45).” Id. at 17
`
`(citing Ex. 1012).
`
`In his Declaration, Dr. Linhardt considers “an iron carboxymaltose
`
`complex to be a complex between carboxymaltose and iron.” Ex. 1005 ¶ 8.
`
`Dr. Linhardt further considers “the carboxymaltose as defined in the ’702
`
`patent [to be] a maltose or maltodextrin, comprised of maltose type units, in
`
`which the aldehyde group of the reducing sugar end has been oxidized to
`
`form a carboxylic acid group.” Id. Patent Owner agrees “with Petitioner’s
`
`expert [Dr. Linhardt] with regard to his description of carboxymaltose.”
`
`Prelim. Resp. 30.
`
`Patent Owner offers also claim constructions of various terms. Id. at
`
`19–31. In particular, with respect to the claim limitation “the iron
`
`carbohydrate complex [having] a substantially non-immunogenic
`
`carbohydrate component,” Patent Owner indicates
`
`a logical construction of “iron carbohydrate complex” requires
`that the carbohydrate must be substantially non-immunogenic
`in the context of its role as a component in the complex and not
`as an independent carbohydrate [as proposed by Petitioner].
`Hence, the immunogenicity is determined by the complex as a
`whole.
`
`7
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`Id. at 20. Patent Owner contends further that the “term ‘substantially no
`
`cross reactivity with anti-dextran antibodies’ is a characteristic of the whole
`
`‘iron carbohydrate complex’” and not “a property of a non-dextran
`
`polysaccharide . . . out of context of its complexation.” Id. at 27–28
`
`(citations omitted).
`
`Patent Owner does not explain, however, how its proffered claim
`
`constructions would render the challenged claims patentable over a reference
`
`that discloses one of the claimed iron carbohydrate complexes. It is well-
`
`settled that “[p]roducts of identical chemical composition can not have
`
`mutually exclusive properties.” In re Spada, 911 F.2d 705, 708 (Fed. Cir.
`
`1990); see In re Papesch, 315 F.2d 381, 391 (CCPA 1963) (a chemical
`
`compound and its properties are inseparable). Thus, a disclosure of a
`
`specific iron carbohydrate complex is likewise a disclosure of its inherent
`
`properties, regardless of whether the immunogenicity or reactivity of a given
`
`complex should be determined on the basis of the carbohydrate component
`
`individually or the complex as a whole.
`
`Petitioner presents claim charts demonstrating where each limitation
`
`of the challenged claims may be found in Geisser. We have reviewed the
`
`claim charts and the Geisser reference, as well as the supporting Declaration.
`
`Based on the record currently before us, we conclude Petitioner has shown a
`
`reasonable likelihood that it would prevail in showing that independent
`
`claim 1 is unpatentable as being anticipated by Geisser. In addition, based
`
`on the record currently before us, we also conclude that Petitioner has shown
`
`a reasonable likelihood that dependent claims 2, 3, 10–13, 23, 25, 27, and
`
`41–43 are unpatentable as being anticipated by Geisser.
`
`
`
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`8
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`
`b. Claim 26
`
`Petitioner asserts also that claim 26 is unpatentable as being
`
`anticipated by Geisser. Pet. 33–35. Petitioner notes that claim 26
`
`depends from claims 1 and 23 and further requires that the iron
`carboxymaltose
`complex
`has
`the
`chemical
`formula
`[FeOx(OH)y(H2O)z]n[{(C6H10O5)m(C6H12O7)}l]k, where n
`is
`about 103[], m is about 8, l is about 11, and k is about 4,
`contains about 28% elemental iron and has a molecular weight
`of about 150,000 Da.
`
`Id. at 33 (quoting Ex. 1001 at 28:18–24). Petitioner notes further with
`
`respect to the value of n, that “[p]resumably, ‘103’ is intended to mean
`
`‘103.’” Id. n. 12.
`
`Patent Owner responds by stating “Petitioner is correct that the value
`
`of ‘n’ in the structure recited . . . [in] claim 26 [] should be about 103 not
`
`about 103. . . . This value of ‘n’ is what a [person of ordinary skill in the
`
`art] would conclude is the correct value.” Prelim. Resp. 30.
`
`On October 14, 2015, we issued an Order authorizing Patent Owner to
`
`file a motion requesting authorization to file a request for a certificate of
`
`correction to change “103” to “103” in claim 26 of the ’702 patent. Paper 8,
`
`3. However, in their Notice of Response in lieu of Motion filed October 20,
`
`2015, Patent Owner elected not to file a motion requesting such
`
`authorization, noting that “Petitioner is [] not prejudiced by the Board
`
`agreeing that ‘n’ is correctly about ‘103’” and trusting “that the Board will so
`
`construe the value of ‘n’”. Paper 9, 1.
`
`We decline to construe the value of “n” in claim 26 of the ’702 patent
`
`as “103.” The Federal Circuit “repeatedly and consistently has recognized
`
`that claims should not be redrafted to make them operable or to sustain their
`
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`Patent 7,754,702 B2
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`validity.” Chef Am., Inc. v. Lamb-Weston, Inc., 358 F.3d 1371, 1374 (Fed.
`
`Cir. 2004) (noting that “courts may not redraft claims, whether to make them
`
`operable or to sustain their validity”). Rather, in the absence of a certificate
`
`of correction, the claim may only be corrected “if (1) the correction is not
`
`subject to reasonable debate based on consideration of the claim language
`
`and the specification and (2) the prosecution history does not suggest a
`
`different interpretation of the claims.” Novo Industries, L.P. v. Micro Molds
`
`Corp., 350 F.3d 1348, 1357 (Fed. Cir. 2003).
`
`Here, although Patent Owner indicates that the correct value of n
`
`should be “103” and not “103” as written in claim 26, and Petitioner has
`
`proceeded upon that assumption, there is no evidence identified in either the
`
`’702 patent Specification or its prosecution history that suggests the value of
`
`“n” should be a value other than “103” as written. In addition, we note the
`
`value of “n” is given consistently as “103” in the ’702 patent at col. 3, ll. 54–
`
`55 and col. 11, ll. 66–67. The difference between “103” and “103” is an
`
`order of magnitude, and thus not insignificant. In the absence of evidence
`
`demonstrating that the value of “n” as recited in claim 26 is a clear error that
`
`would require us to construe claim 26 in any manner other than how it is
`
`written, we decline to do so.
`
`“[A]nticipation requires that all of the elements and limitations of the
`
`claim are found within a single prior art reference.” Scripps Clinic &
`
`Research Found. v. Genentech, Inc., 927 F.2d 1565, 1576 (Fed. Cir. 1991).
`
`Petitioner has not identified where Geisser discloses all of the elements and
`
`limitations of claim 26. Specifically, Petitioner did not address the
`
`limitation n is about 103, rather addressing the limitation as n is about 103.
`
`10
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`Thus, we determine that Petitioner has failed to demonstrate a reasonable
`
`likelihood that challenged claim 26 is anticipated by Geisser.
`
`iii. Conclusion
`
`
`
`For the reasons set forth above, we conclude that Petitioner has
`
`established a reasonable likelihood that claims 1–3, 10–13, 23, 25, 27, and
`
`41–43 are anticipated by Geisser. However, Petitioner has not established a
`
`reasonable likelihood that claim 26 is anticipated by Geisser.
`
`C.
`
`Anticipation by Groman (Ex. 1004)
`
`Petitioner contends that claim 28 is unpatentable as anticipated by
`
`Groman. Pet. 39–44.
`
`i.
`
`Overview of Groman (Ex. 1004)
`
`Groman is drawn to a method of administering a composition
`
`containing “an iron oxide complex with a polyol, [such as] for example
`
`dextran.” Ex. 1004 ¶ 8. Such compositions “can serve as an iron
`
`supplement for patients suffering from anemia.” Id. ¶ 82.
`
`As taught by Groman:
`
`reduced
`invention provides a
`the
`An embodiment of
`polysaccharide iron oxide complex, wherein the reduced
`polysaccharide
`is derivatized, for example,
`the reduced
`derivatized polysaccharide is a carboxyalkyl polysaccharide.
`The carboxyalkyl is selected from the group consisting of
`carboxymethyl, carboxyethyl and carboxypropyl. Further, the
`reduced polysaccharide can be a reduced dextran, for example,
`the reduced dextran can be a reduced carboxymethyl dextran.
`
`Id. at ¶ 31.
`
`
`
`Groman teaches that “[i]n a more particular embodiment, the reduced
`
`derivatized polysaccharide is an ether polysaccharide, more particularly a
`
`carboxyalkylether polysaccharide selected from the group consisting of
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`carboxymethylether, carboxyethylether, and carboxypropylether
`
`polysaccharide.” Id. at ¶ 38.
`
`ii.
`
`Analysis
`
`Petitioner asserts that claim 28 is anticipated by Groman. Pet. 39–44.
`
`Petitioner relies on the Declaration of Dr. Linhardt (Ex. 1005) to support its
`
`anticipation challenge.
`
`Claim 28 depends from claim 1.6 Petitioner contends that, instead of
`
`using the same “nomenclature to refer to iron-polyglucose sorbitol
`
`carboxymethyl ether” recited in claim 28, Groman instead “uses the term
`
`‘carboxymethyl reduced dextran’ and its abbreviation ‘CMRD,’ which is an
`
`example of a polyglucose sorbitol carboxymethyl ether.” Pet. 40. Petitioner
`
`argues, therefore, that Groman discloses the claimed “polyglucose sorbitol
`
`carboxymethyl ether” by reciting its chemical equivalent carboxymethyl
`
`reduced dextran (“CMRD”). Id. Petitioner further asserts that the other
`
`limitations of claim 28 are also present in Groman. Id. at 42–44.
`
`Patent Owner does not dispute of any of Petitioner’s contentions
`
`regarding Groman’s disclosure. Rather, regarding Petitioner’s allegation
`
`that claim 28 is improperly dependent on claim 1, Patent Owner states that
`
`“[i]f the Board adopts Petitioner’s construction for claim 28, then the Board
`
`should not institute trial on Ground 2’s claim 28.”
`
`Although Petitioner and Patent Owner seem to agree that claim 28 is
`
`not properly dependent from claim 1, for purposes of this Decision, it is
`
`clear what the claim means. Specifically, Petitioner presents a claim chart
`
`
`6 Petitioner asserts that claim 28 is not properly dependent from claim 1.
`Pet. 12, 39; see Dec. ¶ 14. In a conference call with the panel on October 6,
`2015, Patent Owner stated that it wished to rewrite dependent claim 28 in
`independent form. Paper 9, 2.
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`12
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`demonstrating where each limitation of challenged claim 28 may be found in
`
`Groman, including claim 1 from which it depends. Pet. 42–44.
`
`We have reviewed the claim chart, the Groman reference, as well as
`
`the supporting Declaration. Based on the record currently before us, we
`
`conclude Petitioner has shown a reasonable likelihood that it would prevail
`
`in showing that claim 28 is unpatentable as being anticipated by Groman.
`
`D. Obviousness over the Combination of Geisser (Ex. 1002, Ex. 1003 as
`translated) and Groman (Ex. 1004)
`
`Petitioner contends that claims 17, 34, and 47 are unpatentable as
`
`obvious over the combination of Geisser and Groman. Pet. 44–50.
`
`Petitioner relies on the Declaration of Dr. Linhardt (Ex. 1005) to support its
`
`obviousness challenge.
`
`i.
`
`Analysis
`
`a.
`
`Claim 34
`
`Claim 34 depends from claim 1 and requires the iron carbohydrate
`
`complex to have a mean particle size of “no greater than about 35 nm.” Pet.
`
`47. Petitioner notes that “Groman discloses iron polyglucose sorbitol
`
`carboxymethyl ether complexes that have mean volume diameters less than
`
`15 [nm],” such as 12 nm. Id. at 48 (citing Ex. 1004 ¶¶ 270, 271, 280–282,
`
`and Tables 8 and 10).
`
`According to Petitioner, “[b]ecause of the structural similarities
`
`between carboxymaltose and carboxymethylated reduced dextran, it would
`
`have been obvious to one of ordinary skill in the art that the iron
`
`carboxymaltose complex of Geisser could have the particle size disclosed in
`
`Groman.” Id. But even if the complex of Geisser could have the same
`
`particle size as that disclosed in Groman, Petitioner has failed to articulate
`
`why a person of ordinary skill in the art would be motivated to alter the
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`particle size of the iron carboxymaltose complex disclosed by Geisser to
`
`have the particle size of a different iron carbohydrate complex as taught by
`
`Groman.
`
`An invention “composed of several elements is not proved obvious
`
`merely by demonstrating that each of its elements was, independently,
`
`known in the prior art.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418
`
`(2007). Moreover, a determination of unpatentability on the ground of
`
`obviousness must include “articulated reasoning with some rational
`
`underpinning to support the legal conclusion of obviousness.” In re Kahn,
`
`441 F.3d 977, 988 (Fed. Cir. 2006). The obviousness analysis “should be
`
`made explicit” and it “can be important to identify a reason that would have
`
`prompted a person of ordinary skill in the relevant field to combine the
`
`elements in the way the claimed new invention does.” KSR, 550 U.S. at 418.
`
`After review of the challenge as presented by Petitioner, as well as the
`
`references as relied upon by Petitioner, we conclude that Petitioner has not
`
`demonstrated a reasonable likelihood that the combination of Geisser and
`
`Groman renders claim 34 of the ’702 patent unpatentable.
`
`b.
`
`Claims 17 and 47
`
`Claim 47 depends ultimately from claim 1 and requires the iron
`
`carbohydrate complex to be “intravenously injected as a bolus.” Pet. 49.
`
`Petitioner notes that “in view of the alleged improved safety of the
`
`compounds of both Geisser and Groman, it would have been obvious to one
`
`of ordinary skill in the art that the iron carboxymaltose complex of Geisser
`
`could be administered as a bolus.” Id. Petitioner points to Groman’s
`
`Example 7 wherein parenteral administration of an iron complex by bolus
`
`injection “results in minimal anaphylactic response.” Id. at 49 (citing Ex.
`
`14
`
`
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`IPR2015-01490
`Patent 7,754,702 B2
`
`1004 ¶ 169). Patent Owner provides no argument as to the challenge of
`
`claim 47 at this stage of the proceeding.
`
`After review of the challenge as presented by Petitioner, as well as the
`
`references as relied upon by Petitioner, we conclude that Petitioner has
`
`demonstrated a reasonable likelihood that the combination of Geisser and
`
`Groman renders claim 47 of the ’702 patent unpatentable.
`
`Claim 17 depends from claim 1 and further requires the administration
`
`of the single dosage unit of elemental iron in 15 minutes or less. Pet. 45.
`
`Petitioner notes that “Groman discloses administering the iron-polyglucose
`
`sorbitol carboxymethyl ether complexes, i.e., carboxymethylated reduced
`
`dextran complexes, in a single dose of up to 0.6 grams, in a time interval that
`
`includes about 15 minutes or less.” Id. According to Petitioner, it would
`
`have been obvious to administer the carboxymaltose complexes of Geisser at
`
`rates disclosed by Groman because “[t]he carboxymethylated dextran
`
`disclosed in Groman is structurally analogous to the carboxymaltose
`
`disclosed in Geisser, and used for essentially the same purpose (treatment of
`
`iron deficiency).” Id. at 46 (citing Ex. 1005 ¶¶ 20–22). Patent Owner
`
`provides no argument as to the challenge of claim 17 at this stage of the
`
`proceeding.
`
`After review of the challenge as presented by Petitioner, as well as the
`
`references as relied upon by Petitioner, we conclude that Petitioner has
`
`demonstrated a reasonable likelihood that the combination of Geisser and
`
`Groman renders claim 17 of the ’702 patent unpatentable.
`
`ii.
`
`Conclusion
`
`
`
`For the reasons set forth above, we conclude that Petitioner has
`
`established a reasonable likelihood that claims 17 and 47 would have been
`
`15
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`IPR2015-01490
`Patent 7,754,702 B2
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`rendered obvious by the combination of Geisser and Groman. However,
`
`Petitioner has not established a reasonable likelihood that claim 34 would
`
`have been rendered obvious by the combination of Geisser and Groman.
`
`E.
`
`Anticipation by van Zyl-Smit (Ex. 1006)
`
`Petitioner contends that claims 14 and 15 are unpatentable as
`
`anticipated by van Zyl-Smit. Pet. 50–54.
`
`i.
`
`Overview of van Zyl-Smit (Ex. 1006)
`
`Van Zyl-Smit discloses the administration of an iron polymaltose
`
`complex for the treatment of iron deficiency anemia. Ex. 1006, Abstract.
`
`The iron complex was administered at a total dose infusion (TDI) of 900–
`
`3,200 mg of iron. Id. at 317. According to van Zyl-Smit, “TDI with iron
`
`polymaltose (dextrin) is a safe and effective way of correcting iron
`
`deficiency.” Id. at 323.
`
`ii.
`
`Analysis
`
`Petitioner asserts that claims 14 and 15 are anticipated by van Zyl-
`
`Smit. Pet. 50–54. Petitioner relies on the Declaration of Dr. Linhardt (Ex.
`
`1005) to support its anticipation challenge.
`
`
`
`Claims 14 and 15 ultimately depend from claim 1 and, according to
`
`Petitioner, “modify only the amount of elemental iron provided by the single
`
`dosage unit.” Pet. 51. Thus, Petitioner contends that van Zyl-Smit discloses
`
`every limitation of claims 14 and 15, and notes that the administration of van
`
`Zyl-Smit’s “iron polymaltose at a total dose infusion of 900–3,200 mg [of
`
`iron] . . . does not result in anaphylactoid and delayed reactions such as
`
`pyrexia, arthralgia or myalgia” and thus “should be considered to be
`
`substantially non-immunogenic.” Id. at 51–52. Petitioner further notes that
`
`“the iron polymaltose complex disclosed in van Zyl-Smit is iron complexed
`
`16
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`IPR2015-01490
`Patent 7,754,702 B2
`
`with dextrin” and thus “has substantially no cross reactivity with anti-
`
`dextran antibodies as it is not iron dextran.” Id. at 52 (emphasis omitted).
`
`
`
`Patent Owner offers no dispute of any of Petitioner’s contentions
`
`regarding van Zyl-Smit’s disclosure. Rather, Patent Owner argues that,
`
`when determining the immunogenicity of the claimed iron carbohydrate
`
`complex, “the iron polymaltose complex must be assessed as a whole –
`
`considering both the iron and carbohydrate components in the context of
`
`their presence in the iron carbohydrate complex.” Prelim. Resp. 31.
`
`Similar to Patent Owner’s proffered claim construction discussed
`
`above in the anticipation challenge over Geisser, Patent Owner again does
`
`not explain how assessing the immunogenicity of the iron complex as a
`
`whole, rather than that of the carbohydrate component alone, would render
`
`the challenged claims patentable over an anticipatory reference. As we
`
`noted in our analysis of that challenge, a disclosure of a specific iron
`
`carbohydrate complex is likewise a disclosure of its inherent properties.
`
`Petitioner presents claim charts demonstrating where each limitation
`
`of the challenged claims, along with the limitations of claim 1, may be found
`
`in van Zyl-Smit. Pet. 52–54. Because the challenged claims depend from
`
`claim 1, and Petitioner understands all the limitations of claim 1 are also
`
`disclosed by van Zyl-Smit, this challenge likewise necessarily includes
`
`independent claim 1. See In re Cuozzo Speed Techs., LLC, 793 F.3d at 1275.
`
`We have reviewed the claim charts and the van Zyl-Smit reference, as
`
`well as the supporting Declaration. Based on the record currently before us,
`
`we conclude Petitioner has shown a reasonable likelihood that it would
`
`prevail in showing that claims 1, 14 and 15 are unpatentable as being
`
`anticipated by van Zyl-Smit.
`
`17
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`
`
`F.
`
`Obviousness over the Combination of van Zyl-Smit (Ex. 1006) and
`Funk (Ex. 1026)
`
`Petitioner contends that claim 30 is unpatentable as obvious over the
`
`combination of van Zyl-Smit and Funk. Pet. 55–57. Petitioner relies on the
`
`Declaration of Dr. Linhardt (Ex. 1005) to support its obviousness challenge.
`
`i.
`
`Analysis
`
`Claim 30 depends from claim 1, and adds the limitation that the iron
`
`carbohydrate complex has a mean iron core size of no greater than about 9
`
`nm. Pet. 55. Petitioner essentially relies on the van Zyl-Smit reference as
`
`discussed above, but notes that “van Zyl-Smit does not explicitly disclose
`
`the physical characteristics of the iron polymaltose complex.” Id.
`
`According to Petitioner, “Funk discloses iron polymaltose and iron dextrin
`
`complexes that can be used for the treatment of iron deficiency . . . [and]
`
`teaches that iron dextrin, i.e., iron polymaltose, with an iron core size of 4.1
`
`nm, demonstrated the greatest stability (e.g., stronger resistance to
`
`dissolution) and least lability.” Id.
`
`Petitioner contends “it would have been obvious to one of ordinary
`
`skill in the art to use the iron dextrin having a particle size of 4.1 nm
`
`disclosed in Funk for the treatment of iron deficiency as disclosed in van
`
`Zyl-Smit.” Id. at 56. Patent Owner provides no argument as to the
`
`challenge of claim 30 at this stage of the proceeding.
`
`After review of the challenge as presented by Petitioner, as well as the
`
`references and Declaration as relied upon by Petitioner, we conclude that
`
`Petitioner has demonstrated a reasonable likelihood that the combination of
`
`van Zyl-Smit and Funk renders claim 30 of the ’702 patent unpatentable.
`
`
`
`
`
`
`
`18
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`
`
`III.
`
`CONCLUSION
`
`For the foregoing reasons, we are persuaded that the Petition
`
`establishes a reasonable likelihood that Petitioner would prevail in showing
`
`claims 1–3, 10–15, 23, 25, 27, 28, and 41–43 of the ’702 patent are
`
`unpatentable under 35 U.S.C. § 102(b), and that claims 17, 30, and 47 of the
`
`’702 patent are unpatentable under 35 U.S.C. §103(a).
`
`
`
`At this stage of the proceeding, the Board has not made a final
`
`determination as to the patentability of any challenged claim or any
`
`underlying factual and legal issues.
`
`IV.
`
`
`
`ORDER
`
`In consideration of the foregoing, it is hereby:
`
`ORDERED that pursuant to 35 U.S.C. §314(a), an inter partes review
`
`is hereby instituted on the following grounds:
`
`Claims 1–3, 10–13, 23–25, 27, and 41–43 as anticipated by Geisser;
`
`Claim 28 as anticipated by Groman;
`
`Claims 1, 14, and 15 as anticipated by van Zyl-Smit;
`
`Claims 17 and 47 as obvious over Geisser and Groman; and
`
`Claim 30 as obvious over van Zyl-Smit and Funk.
`
`FURTHER ORDERED that no other proposed grounds of
`
`unpatentability are authorized; and
`
`FURTHER ORDERED that pursuant to 35 U.S.C. § 314(c) and
`
`37 C.F.R. § 42.4, notice is hereby given of the institution of a trial
`
`commencing on the entry date of this decision.
`
`
`
`
`
`
`
`19
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`IPR2015-01490
`Patent 7,754,702 B2
`
`PETITIONER:
`
`Lisa Kole
`lisa.kole@bakerbotts.com
`
`Steven Lendaris
`steven.lendaris@bakerbotts.com
`
`Paul Ragusa
`paul.ragusa@bakerbotts.com
`
`
`
`
`
`PATENT OWNER:
`George Quillin
`gquillin@foley.com
`
`Michael Kaminski
`mkaminski@foley.com
`
`
`
`20
`
`
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