Trials@uspto.gov
`571.272.7822
`
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`
`
`
`
`
`Paper No. 9
`
` Entered: May 4, 2016
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`FRESENIUS KABI USA, LLC,
`Petitioner,
`
`v.
`
`CEPHALON, INC.,
`Patent Owner.
`____________
`
`Case IPR2016-00111
`Patent 8,895,756 B2
`____________
`
`
`Before JACQUELINE WRIGHT BONILLA, ZHENYU YANG, and
`TINA E. HULSE, Administrative Patent Judges.
`
`HULSE, Administrative Patent Judge.
`
`
`
`
`
`
`
`
`
`
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`571.272.7822
`
`
`
`
`
`
`
`
`Paper No. 9
`
` Entered: May 4, 2016
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`FRESENIUS KABI USA, LLC,
`Petitioner,
`
`v.
`
`CEPHALON, INC.,
`Patent Owner.
`____________
`
`Case IPR2016-00111
`Patent 8,895,756 B2
`____________
`
`
`Before JACQUELINE WRIGHT BONILLA, ZHENYU YANG, and
`TINA E. HULSE, Administrative Patent Judges.
`
`HULSE, Administrative Patent Judge.
`
`
`
`
`
`
`
`
`
`
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`IPR2016-00111
`Patent 8,895,756 B2
`
`
`INTRODUCTION
`
`Fresenius Kabi USA, LLC (“Petitioner”) filed a Petition requesting an
`inter partes review of claims 1–4 of U.S. Patent No. 8,895,756 B2
`(Ex. 1001, “the ’756 patent”). Paper 2 (“Pet.”). Cephalon, 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
`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.” 35 U.S.C. § 314(a). Upon considering
`the Petition and Preliminary Response, we determine that Petitioner has
`established a reasonable likelihood that it would prevail in showing the
`unpatentability of claims 1–4. Accordingly, we institute an inter partes
`review of those claims.
`
`Related Proceedings
`A.
`The parties identify several copending district court proceedings as
`relating to the ’756 patent. Pet. 5; Paper 5, 1–2. Petitioner is not a party to
`any of the proceedings. Pet. 5.
`Petitioner also filed a Petition for inter partes review of related U.S.
`Patent No. 8,791,270 B2. Fresenius Kabi USA, LLC v. Cephalon, Inc.,
`IPR2016-00098, Paper 2 (PTAB Oct. 28, 2015). A decision instituting inter
`partes review has issued concurrently with this Decision. Id., Paper 10.
`The ’756 Patent
`B.
`The ’756 patent relates to pharmaceutical formulations of lyophilized
`bendamustine. Ex. 1001, 1:18–21. Bendamustine is a nitrogen mustard, and
`nitrogen mustards are difficult to formulate as pharmaceuticals because of
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`Patent 8,895,756 B2
`their high reactivity in aqueous solutions. Id. at 1:35–36. Nitrogen mustards
`are therefore often supplied in a lyophilized form that requires
`reconstitution, usually in water, before administration. Id. at 1:36–38.
`Because nitrogen mustards are subject to degradation by hydrolysis once in
`aqueous solution, the reconstituted product should be administered to the
`patient as soon as possible after reconstitution. Id. at 1:39–42.
`Bendamustine was first synthesized in 1964 in Germany and has been
`available in Germany under the names Cytostasan® or Ribomustin® since
`1971. Id. at 1:60–64. Bendamustine has been widely used in Germany to
`treat chronic lymphocytic leukemia, Hodgkin’s disease, non-Hodgkin’s
`lymophoma, multiple myeloma, and breast cancer. Id. at 1:64–67.
`Ribomustin® contains bendamustine hydrochloride and mannitol in a
`sterile lyophilized form. Id. at 2:3–5. Reconstitution of bendamustine
`lyophilized powder is difficult, taking at least fifteen to thirty minutes. Id. at
`2:29–32. Besides being burdensome and time-consuming for the health care
`professional, the lengthy exposure of bendamustine to water during the
`reconstitution process increases the potential for loss of potency and
`impurity formation due to the hydrolysis of the product by water. Id. at
`2:32–37. According to the Specification, “a need exists for lyophilized
`formulations of bendamustine that are easier to reconstitute and which have
`a better impurity profile than the current lyophilate (lyophilized powder)
`formulations of bendamustine.” Id. at 2:38–41.
`Illustrative Claim
`C.
`Petitioner challenges claims 1–4 of the ’756 patent, of which
`claims 1 and 4 are independent claims and are reproduced below:
`1. A vial containing a reconstituted solution of
`bendamustine hydrochloride and mannitol in sterile water for
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`IPR2016-00111
`Patent 8,895,756 B2
`injection, wherein the ratio by weight of bendamustine
`hydrochloride to mannitol in the vial is 15:25.5, and wherein
`the bendamustine hydrochloride is present in the vial at a
`concentration of 100 mg per 20 mL.
`4. A 20 mL vial containing 100 mg of bendamustine
`hydrochloride and 170 mg of mannitol reconstituted in sterile
`water for injection.
`The Asserted Grounds of Unpatentability
`D.
`Petitioner challenges the patentability of claims 1–4 of the ’756 patent
`on the following grounds:
`Reference
`Ribomustin® Product
`Monograph1 in view of
`Alexander2 or Sauerbier3
`Ribomustin® Product
`Monograph in view of
`Alexander or Sauerbier and
`further in view of Teagarden4
`Ribomustin® Product
`Monograph in view of
`Alexander or Sauerbier and
`Teagarden, and further in view
`of DeLuca5
`
`Basis
`§ 103
`
`§ 103
`
`§ 103
`
`Claim(s) challenged
`1–4
`
`1–4
`
`1–4
`
`
`1 Ribomustin® Product Monograph, updated Jan. 2002 (Ex. 1005).
`2 Alexander et al., US 4,537,883, issued Aug. 27, 1985 (Ex. 1006).
`3 Sauerbier et al., US 5,204,335, issued Apr. 20, 1993 (Ex. 1007).
`4 Teagarden et al., Practice Aspects of Lyophilization Using Non-Aqueous
`Co-Solvent Systems, 15 EUR. J. PHARM. SCI. 115–33 (2002) (Ex. 1008).
`5 DeLuca, Formulation of Small Volume Parenterals, in Pharmaceutical
`Dosage Forms: Parenteral Medications, Vol. 1, Chapter 5 (Kenneth E. Avis
`et al. eds., 1992) (Ex. 1011).
`
`4
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`IPR2016-00111
`Patent 8,895,756 B2
`Reference
`Maas6 and Ribomustin®
`Product Monograph in view of
`Alexander or Sauerbier,
`Teagarden, and DeLuca
`
`Pet. 9, 14–58.
`
`Basis
`§ 103
`
`Claim(s) challenged
`1–4
`
`ANALYSIS
`
`Person of Ordinary Skill in the Art
`A.
`Petitioner asserts that a person of ordinary skill in the art would have a
`Ph.D. in pharmaceutics, pharmaceutical sciences, or a related field, with at
`least three years of practice experience in the pharmaceutical formulation,
`including the formulation of lyophilized products. Pet. 13 (citing Ex. 1012
`¶ 22). Patent Owner does not offer a definition of the level of ordinary skill
`at this time. Prelim. Resp. 12. At this stage of the proceeding, we adopt the
`level of ordinary skill set forth by Petitioner and note that the prior art itself
`also demonstrates the level of skill in the art at the time of the invention. See
`Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (holding the
`absence of specific findings on “level of skill in the art does not give rise to
`reversible error ‘where the prior art itself reflects an appropriate level and a
`need for testimony is not shown’”) (quoting Litton Indus. Prods., Inc. v.
`Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)).
`Claim Construction
`B.
`In an inter partes review, the Board interprets claim terms in an
`unexpired patent according to the broadest reasonable construction in light
`
`
`6 Maas et al., Stabilität von Bendamustinhydrochlorid in Infusionslösungen
`[Stability of Bendamustine Hydrochloride in Infusions], 49 PHARMAZIE 775–
`77 (1994) (Ex. 1009).
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`Patent 8,895,756 B2
`of the specification of the patent in which they appear. 37 C.F.R. § 100(b);
`In re Cuozzo Speed Techs., LLC, 793 F.3d 1268, 1278–79 (Fed. Cir. 2015),
`cert. granted sub nom. Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 890
`(mem.) (2016). Under that standard, and absent any special definitions, we
`give claim terms their ordinary and customary meaning, as would be
`understood by one of ordinary skill in the art at the time of the invention.
`See In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Any
`special definitions for claim terms must be set forth with reasonable clarity,
`deliberateness, and precision. See In re Paulsen, 30 F.3d 1475, 1480
`(Fed. Cir. 1994).
`Neither party proposes any claim constructions at this time. Pet. 13;
`Prelim. Resp. 12. At this stage of the proceeding, we determine that it is
`unnecessary to expressly construe any claim terms for purposes of this
`Decision. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361
`(Fed. Cir. 2011) (“[C]laim terms need only be construed ‘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)).
`C. Obviousness over Maas, Ribomustin® Product Monograph,
`Alexander, Teagarden, and DeLuca
`Relying on the testimony of Michael J. Akers, Ph.D. (Ex. 1012),
`Petitioner asserts that claims 1–4 are unpatentable as obvious over Maas,
`Ribomustin® Product Monograph, Alexander, Teagarden, and DeLuca.
`Pet. 46–56. Patent Owner opposes Petitioner’s assertion. Prelim. Resp. 36–
`37. Based on the current record, we determine that Petitioner has
`established a reasonable likelihood that it would prevail in showing claims
`1–4 are unpatentable over that cited art.
`
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`Patent 8,895,756 B2
`
`1. Maas (Ex. 1009)
`Maas describes a study of the stability of bendamustine hydrochloride
`in 0.9% sodium chloride after storage at different temperatures for different
`lengths of time. Ex. 1009, Abstract. According to Maas, the stability of
`lyophilized bendamustine hydrochloride is known, but data is still lacking on
`the stability of bendamustine infusions. Id. at 4.7 Maas states that
`“[b]endamustine is very unstable in an aqueous solution.” Id.
`Ribomustin® Product Monograph (Ex. 1005)
`2.
`Ribomustin® Product Monograph discloses various properties of
`Ribomustin®. For example, Ribomustin® is offered in vials with two
`different amounts of bendamustine hydrochloride and mannitol: one vial
`with 25 mg bendamustine hydrochloride and 30 mg mannitol, and another
`vial with 100 mg bendamustine hydrochloride and 120 mg mannitol.
`Ex. 1005, § 2.3. The 25 mg bendamustine is dissolved in 10 ml of sterile
`water, whereas the 100 mg bendamustine vial is dissolved in 40 ml of sterile
`water. Id. § 2.6. A clear solution is usually obtained by shaking for five to
`ten minutes. Id.
`
`Alexander (Ex. 1006)
`3.
`Alexander relates to a lyophilized cyclophosphamide, which is a
`widely used antineoplastic drug chemically related to the nitrogen mustards.
`Ex. 1006, 1:10–13. The main objective of Alexander is “to provide a
`cyclophosphamide dosage form with improved solubility characteristics and
`enhanced appearance, while maintaining stability comparable to the dry pre-
`
`
`7 We cite the certified translation on pages 4–6 of Exhibit 1009 (page
`numbers refer to those provided by Petitioner under 37 C.F.R.
`§ 42.63(d)(2)(i)).
`
`7
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`IPR2016-00111
`Patent 8,895,756 B2
`mix composition.” Id. at 2:16–21. Alexander states that the lyophilized
`cyclophosphamide-mannitol solid composition has improved thermal
`stability when it contains an amount of water approximately equimolar to the
`cyclophosphamide content taken as the anhydride. Id. at 3:45–51. “Of
`equal importance is the discovery that the desirable physical properties of
`the solid composition appear to be achieved only by using mannitol as the
`major excipient.” Id. at 3:51–54.
`Teagarden (Ex. 1008)
`4.
`Teagarden describes the use of non-aqueous co-solvent systems in the
`lyophilization of pharmaceutical products. Ex. 1008, Abstract. According
`to Teagarden, the advantages of using such systems include increased drug
`wetting or solubility, increased sublimation rates, increased pre-dried bulk
`solution or dried product stability, decreased reconstitution time, and
`enhancement of sterility assurance of the pre-dried bulk solution. Id.
`Teagarden notes that the co-solvent system that has been most extensively
`evaluated is the tert-butanol (“TBA”)/water combination. Id. Teagarden
`teaches that the use of TBA in certain drugs produced an increase in
`solubility and slowed degradation of the drug in the presence of water. Id.,
`3, 4.
`
`DeLuca (Ex. 1011)
`5.
`DeLuca generally describes the lyophilization of pharmaceutical
`products. DeLuca explains that an optimal freeze-dried formulation permits
`the overall cycle to be carried out in the least amount of time, while
`providing a stable and efficacious product that contains a low moisture
`content, undergoes rapid reconstitution, and possesses the desired
`appearance. Ex. 1011, 6. Because relatively small amounts of
`pharmaceutical agents are required for the lyophilized dosage form, a
`
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`IPR2016-00111
`Patent 8,895,756 B2
`suitable filler or bulking agent is often needed. Id. According to DeLuca,
`the percentage of solids in the frozen plug varies depending on the dosage
`and nature of the active ingredient. Id. Generally, the formulation should
`have 5% to 30% solids, with 10–15% being optimum. Id. DeLuca identifies
`mannitol as a material to choose from to add to the solution to improve the
`physical characteristics of the finished cake. Id. Moreover, DeLuca states
`that the depth of fill in a container is critical, with a rule of thumb of 1 to 2
`cm in depth, but never exceeding one-half the capacity of the container. Id.
`Analysis
`6.
`a.
`Claims 1–3
`Petitioner argues that claim 1 is unpatentable as obvious over Maas,
`Ribomustin® Product Monograph, Alexander, Teagarden, and DeLuca.
`Petitioner asserts that the Ribomustin® Product Monograph teaches each
`limitation of claims 1–3, except the claimed weight ratio of bendamustine
`hydrochloride to mannitol of 15:25.5 (or 1:1.7) and the concentration of
`bendamustine of 100 mg per 20 mL (or 5 mg/mL). Pet. 15–16; Ex. 1012
`¶¶ 68–69. The Ribomustin® Product Monograph discloses a weight ratio of
`1:1.2 and a bendamustine hydrochloride concentration of 2.5 mg/mL
`(dissolving 25 mg in 10 mL or 100 mg in 40 mL). Pet. 15–16; Ex. 1012
`¶¶ 67–69; Ex. 1005 §§ 2.3, 2.6.
`Petitioner offers several arguments regarding the obviousness of the
`weight ratio and drug concentration limitations. For example, Petitioner
`argues that a person of ordinary skill in the art would have been motivated to
`reduce the reconstitution time of Ribomustin® in order to lower the amount
`of bendamustine degradation, for the reasons discussed in Maas. Pet. 16. In
`particular, a person of ordinary skill in the art would have understood from
`Maas that bendamustine was “very unstable in aqueous solution.” Id. at 46
`
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`IPR2016-00111
`Patent 8,895,756 B2
`(citing Ex. 1009, 4). Moreover, Petitioner argues that a skilled artisan
`reading Teagarden would have used the TBA/water co-solvent system to
`obtain a lyophilized formulation with less impurities and more desirable
`cake characteristics than Ribomustin®. Id. at 46–47 (citing Ex. 1012 ¶ 120).
`Because the use of a TBA/water co-solvent system could increase the
`surface area of the lyophilized cake, Petitioner asserts that a person of
`ordinary skill in the art would have understood that increasing the amount of
`mannitol might be needed to support a cake with a larger surface. Id. at 47–
`48 (citing Ex. 1012 ¶¶ 121–122).
`To determine how much additional mannitol would be needed,
`Petitioner relies on Alexander’s teaching of improved lyophilized cake
`characteristics with respect to cyclophosphamide, which is another nitrogen
`mustard used as an antineoplastic drug. Id. at 17–18; Ex. 1006, 3:53–55; Ex.
`1012 ¶¶ 35–37. Alexander teaches that the preferred weight ratio of
`cyclophosphamide to mannitol is 1:0.5 to 1:2.0. Pet. 18; Ex. 1006, 7:18–27;
`Ex. 1012 ¶ 38. Petitioner argues that a skilled artisan would have had a
`reason to alter the bendamustine hydrochloride and mannitol amounts of
`Ribomustin® to the weight ratio recited in challenged claim 1 to obtain a
`lyophilized formulation with more desirable cake characteristics, such as
`faster reconstitution time. Pet. 19 (citing Ex. 1012 ¶ 78). According to
`Petitioner and its declarant, doing so would have “involved routine
`experimentation with a finite number of predictable solutions.” Pet. 19–20
`(citing Ex. 1012 ¶¶ 78–81).
`Petitioner also argues that DeLuca offers specific teachings about the
`solids content and the depth of fill in a container. Id. at 37–38 (citing Ex.
`1012 ¶ 105; Ex. 1011, 6). Petitioner asserts that a skilled artisan reading
`DeLuca would have been motivated to modify the amount of mannitol in
`
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`IPR2016-00111
`Patent 8,895,756 B2
`Ribomustin® to obtain a desirable lyophilized cake, and would have had a
`reasonable expectation of success in doing so given the guidance in DeLuca.
`Pet. 38 (citing Ex. 1012 ¶ 106).
`Regarding the claimed concentration of 5 mg/mL (i.e., “100 mg per
`20 mL,” as recited in claim 1), Petitioner asserts that a person of ordinary
`skill in the art would have understood that the concentration of
`bendamustine hydrochloride in the vial could be, and should be, adjusted
`and optimized. Pet. 24 (citing Ex. 1012 ¶ 85; Ex. 1005, 9). Because
`Ribomustin® has no standard dosage, Petitioner argues that a person of
`ordinary skill in the art would not have considered the bendamustine
`hydrochloride concentration recited in claim 1 to be essentially different
`from the 2.5 mg/mL concentration taught by the Ribomustin® Product
`Monograph. Pet. 25 (citing Ex. 1012 ¶ 86).
`In opposition, Patent Owner argues that Petitioner cites no prior art
`reporting degradant problems with Ribomustin® and that the inventors were
`the first to recognize the problem. Prelim. Resp. 14. At this stage of the
`proceeding, however, we are persuaded that Maas’s statement that
`bendamustine “is very unstable in an aqueous solution” suggests a
`recognized problem in the art with the stability of bendamustine. See Ex.
`1009, 4.
`Patent Owner also argues that Alexander is inapposite because
`cyclophosphamide is structurally very different from bendamustine. Prelim.
`Resp. 18–19. On this record, we are persuaded that a person of ordinary
`skill in the art would have looked to Alexander because both
`cyclophosphamide and bendamustine are nitrogen mustards used for treating
`neoplastic diseases. Indeed, the specification of the ’756 patent states in the
`Field of the Invention that the invention “relates to pharmaceutical
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`IPR2016-00111
`Patent 8,895,756 B2
`formulations comprising nitrogen mustards” (Ex. 1001, 1:16–20) and in the
`Summary of the Invention that the “present invention is directed to stable
`pharmaceutical compositions of nitrogen mustards” (id. at 3:7–8).
`Patent Owner also argues that because the weight ratio of
`Ribomustin® already falls within the preferred weight ratio range disclosed
`in Alexander, a person of ordinary skill in the art would not have had a
`reason to modify the formulation of Ribomustin®. Prelim. Resp. 26. At this
`stage of the proceeding, we are not persuaded by Patent Owner’s argument.
`“[I]t is not inventive to discover the optimum or workable ranges by routine
`experimentation.” In re Aller, 220 F.2d 454, 456 (CCPA 1955). Moreover,
`only if the results of optimizing a variable are “unexpectedly good” can a
`patent be obtained for a critical range. In re Geisler, 116 F.3d 1465, 1470
`(Fed. Cir. 1997) (quoting In re Antonie, 559 F.2d 618, 620 (CCPA 1977)).
`On this record, Petitioner has offered the testimony of Dr. Akers, who states
`that altering the bendamustine hydrochloride and mannitol amounts would
`involve routine experimentation with a finite number of predictable
`solutions. Ex. 1012 ¶ 78. Similarly, Dr. Akers states that a person of
`ordinary skill in the art would not have considered the claimed concentration
`different from that taught by Ribomustin® Product Monograph. Id. ¶ 86.
`At this stage of the proceeding, based on the record before us, we determine
`that Petitioner has shown a reasonable likelihood that it would prevail in
`showing that these limitations would have been obvious over the cited art.
`We have considered Patent Owner’s remaining arguments and do not
`find them persuasive at this time. Thus, on this record, we determine that
`Petitioner has established a reasonable likelihood that it would prevail in its
`assertion that claims 1–3 would have been obvious over Maas, Ribomustin®
`Product Monograph, Alexander, Teagarden, and DeLuca.
`
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`
`Claim 4
`b.
`Independent claim 4 requires a 20 mL vial containing 100 mg of
`bendamustine hydrochloride and 170 mg of mannitol reconstituted in sterile
`water for injection. Regarding the specific amounts of bendamustine
`hydrochloride and mannitol recited in claim 4, Petitioner makes the same
`points regarding “routine experimentation” discussed above in relation to the
`weight ratio limitation of claim 1. Pet. 46–49; see id. at 48 (referring to
`“routine experimentation”). Regarding the 20 mL vial limitation of claim 4,
`Petitioner asserts that the Ribomustin® Product Monograph discloses a 50
`mL vial with 100 mg of bendamustine hydrochloride, but 120 mg of
`mannitol instead of 170 mg. Pet. 55 (citing Ex. 1005 §§ 2.3–2.6; Ex. 1001,
`2:13–19). Petitioner argues that a skilled artisan would have been motivated
`to repackage Ribomustin® in a smaller vial size to allow more vials to be
`processed in a lyophilizer during each cycle and, therefore, increase the
`overall lyophilization efficiency and reduce manufacturing cost. Pet. 35
`(citing Ex. 1012 ¶ 103).
`Petitioner also argues that a person of ordinary skill in the art would
`have had a reasonable expectation of success in preparing a
`prelyophilization solution of bendamustine and mannitol according to
`Teagarden to obtain a lyophilized formulation that reconstitutes faster and
`that could be packaged as 100 mg bendamustine hydrochloride in a 20 mL
`vial. Pet. 34 (citing Ex. 1012 ¶ 89).
`Finally, Petitioner argues that DeLuca’s teachings would have
`motivated a skilled artisan to modify the amount of mannitol in
`Ribomustin® to obtain a desirable lyophilized cake in a smaller vial size and
`would have had a reasonable expectation of success in doing so. Pet. 38
`(citing Ex. 1012 ¶ 106).
`
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`IPR2016-00111
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`In response, Patent Owner argues that Petitioner fails to establish that
`a person of ordinary skill in the art would have reasonably expected that
`using TBA as a co-solvent would have the same effect on bendamustine as it
`does on the drugs disclosed in Teagarden. Prelim. Resp. 30–31. Petitioner
`also argues that DeLuca makes no reference to bendamustine and that there
`was no reason for a person of ordinary skill in the art to increase the amount
`of mannitol while reducing the vial size. Prelim. Resp. 33–34.
`At this stage of the proceeding, we are persuaded that Petitioner has
`offered sufficient evidence to institute trial, including evidence from its
`declarant that a skilled artisan would have had reason to modify the amount
`of mannitol to improve the characteristics of the lyophilized cake, and that
`modifying the size of the vial would have amounted to a design choice. KSR
`Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007) (“When a work is
`available in one field of endeavor, design incentives and other market forces
`can prompt variations of it, either in the same field or a different one.”).
`Thus Petitioner has offered “some articulated reasoning with some rational
`underpinning to support the legal conclusion of obviousness.” Id. at 418.
`Thus, on this record, we determine that Petitioner has established a
`reasonable likelihood that it would prevail in showing claim 4 is
`unpatentable over Maas, Ribomustin® Product Monograph, Alexander,
`Teagarden, and DeLuca.
`
`Remaining Grounds
`D.
`Petitioner also asserts that claims 1–4 are unpatentable as obvious
`over: (1) Ribomustin® Product Monograph in view of Alexander or
`Sauerbier; (2) Ribomustin® Product Monograph in view of Alexander or
`Sauerbier and further in view of Teagarden; and (3) Ribomustin® Product
`
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`IPR2016-00111
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`Monograph in view of Alexander or Sauerbier and Teagarden, and further in
`view of DeLuca.
`In light of our findings above, we note that each remaining ground
`asserts a subset of the prior art upon which we are instituting an inter partes
`review. Accordingly, each remaining ground is encompassed within the
`ground upon which we are going forward.
`The patent rules promulgated for AIA post-grant proceedings,
`including those pertaining to institution, are “construed to secure the just,
`speedy, and inexpensive resolution of every proceeding.” 37 C.F.R.
`§ 42.1(b); see also 35 U.S.C. § 316(b) (regulations for AIA post-grant
`proceedings take into account “the efficient administration of the Office”
`and “the ability of the Office to timely complete [instituted] proceedings”).
`Therefore, we exercise our discretion and, for reasons of administrative
`necessity to ensure timely completion of the instituted proceeding, do not
`institute a review on any ground other than that specifically instituted in the
`Order below. See 37 C.F.R. § 42.108(a).
`CONCLUSION
`
`We conclude that Petitioner has established a reasonable likelihood of
`prevailing on its assertion that claims 1–4 of the ’756 patent are
`unpatentable.
`At this stage of the proceeding, the Board has not made a final
`determination as to the patentability of any challenged claim or the
`construction of any claim term.
`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 ground:
`
`15
`
`
`
`IPR2016-00111
`Patent 8,895,756 B2
`Claims 1–4 are unpatentable as obvious over Maas, Ribomustin®
`Product Monograph, Alexander, Teagarden, and DeLuca.
`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.
`
`
`
`PETITIONER:
`Lawrence Sung
`lsung@wileyrein.com
`Neal Seth
`nseth@wileyrein.com
`
`
`PATENT OWNER:
`Soumitra Deka
`Soumitra.deka@kayescholer.com
`
`
`16
`
`
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