Trials@uspto.gov
`571-272-7822
`
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`
`
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`
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`
`
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` Paper No. 10
`
`
` Entered: May 31, 2019
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MAIA PHARMACEUTICALS, INC.,
`Petitioner
`
`
`
`
`
`
`
`v.
`
`BRACCO DIAGNOSTICS INC.,
`Patent Owner.
`_______________
`Case IPR2019-00345
`U.S. Patent No. 6,803,046 B2
`_______________
`
`
`
`Before SHERIDAN K. SNEDDEN, ZHENYU YANG, and
`RICHARD J. SMITH, Administrative Patent Judges.
`
`SNEDDEN, Administrative Patent Judge.
`
`
`DECISION
`Denying Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
`
`
`
`
`
`
`
`
`571-272-7822
`
`
`
`
`
`
`
`
`
`
`
`
` Paper No. 10
`
`
` Entered: May 31, 2019
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MAIA PHARMACEUTICALS, INC.,
`Petitioner
`
`
`
`
`
`
`
`v.
`
`BRACCO DIAGNOSTICS INC.,
`Patent Owner.
`_______________
`Case IPR2019-00345
`U.S. Patent No. 6,803,046 B2
`_______________
`
`
`
`Before SHERIDAN K. SNEDDEN, ZHENYU YANG, and
`RICHARD J. SMITH, Administrative Patent Judges.
`
`SNEDDEN, Administrative Patent Judge.
`
`
`DECISION
`Denying Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
`
`
`
`
`
`
`
`
`
`I.
`
`IPR2019-00345
`U.S. Patent No. 6,803,046 B2
`
`INTRODUCTION
`Maia Pharmaceuticals, Inc. (“Petitioner”) filed a Petition requesting
`an inter partes review of claims 1–19, 21–38, 40–55, 77–102, and 104–105
`of U.S. Patent No. 6,803,046 B2 (Ex. 1001, “the ’046 patent”). Paper 2
`(“Pet.”). Bracco Diagnostics Inc. (“Patent Owner”) filed a Preliminary
`Response. Paper 9 (“Prelim. Resp.”).
`To institute an inter partes review, we must determine that the
`information presented in the Petition shows “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). After considering the evidence and
`arguments presented in the Petition and Preliminary Response, we determine
`that Petitioner has not satisfied its burden under § 314. Thus, we do not
`institute an inter partes review.
`
`A. Related Matters
`The parties identify the following litigation between the parties
`involving the ’046 patent: Bracco Diagnostics Inc. v. Maia
`Pharmaceuticals, Inc., Case No. 3:17-cv-13151-PGS-TJB, pending in the
`United States District Court for the District of New Jersey. Pet. 3; Paper 7.
`
`B. The ’046 patent
`The’046 patent discloses pharmaceutically acceptable formulations of
`sincalide. Ex. 1001, 1:5–6. Sincalide “is a synthetically prepared C-
`terminal octapeptide of cholecystokinin (CCK-8), with the following amino
`acid sequence: Asp-Tyr(SO3H)-Met-Gly-Trp-Met-Asp-Phe-NH2.” Id. at
`1:12–16.
`
`
`2
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`IPR2019-00345
`U.S. Patent No. 6,803,046 B2
`
`The disclosed formulations “include an effective amount of sincalide,
`a bulking agent/tonicity adjuster, a stabilizer, a surfactant, a chelator, and a
`buffer.” Id. at Abstract. The’046 patent also discloses “kits and methods for
`preparing improved sincalide formulations, as well as methods for treating,
`preventing, and diagnosing gall bladder-related disorders using sincalide
`formulations.” Id.
`
`C. Illustrative Claims
`Independent claims 1, 21, 40, 77 and 104, reproduced below, are
`illustrative of the challenged claims:
`1. A stabilized, physiologically acceptable formulation of sincalide
`comprising:
`(a) an effective amount of sincalide,
`(b) at least one stabilizer,
`(c) a surfactant/solubilizer
`(d) a chelator,
`(e) a bulking agent/tonicity adjuster, and
`(f) a buffer.
`
`
`21. A method for making a stabilized formulation of sincalide, said
`method comprising the step of mixing:
`(a) at least one stabilizer,
`(b) a surfactant/solubilizer,
`(c) a chelator,
`(d) a bulking agent/tonicity adjuster,
`(e) a buffer
`(f) an aqueous solution, and
`(g) sincalide.
`
`
`40. A kit, comprising:
`(i) a powder mixture comprising (a) sincalide, (b) at least one
`stabilizer, (c) a surfactant, (d) a chelator, (e) a bulking agent/tonicity
`adjuster, and (f) a buffer;
`(ii) a container to hold said powder mixture; and
`
`3
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`IPR2019-00345
`U.S. Patent No. 6,803,046 B2
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`
`(iii) optionally, a physiologically acceptable fluid.
`
`
`77. A method for imaging the hepatobiliary system of a subject, said
`method comprising:
`(a) administering a hepatobiliary imaging agent to said subject;
`(b) before or after step (a), administering to a subject a sincalide
`formulation comprising: (i) sincalide, (ii) at least one stabilizer, (iii) a
`surfactant, (iv) a chelator, (v) a bulking agent/tonicity adjuster, and
`(vi) a buffer; and
`(c) detecting said imaging agent in said subject with a detection
`device.
`
`104. A method for imaging the hepatobiliary system of a subject, said
`method comprising:
`a) administering to a subject a sincalide formulation
`comprising: (i) sincalide, (ii) at least one stabilizer, (iii) a surfactant,
`(iv) a chelator, (v) a bulking agent/tonicity adjuster, and (vi) a buffer;
`and
`
`b) scanning the subject using a diagnostic imaging modality.
`D. Evidence Relied Upon
`Petitioner relies upon the following prior art references:
`Ex. 1005, Physicians’ Desk Reference for Radiology and Nuclear
`Medicine, 1977/78 (1977) (“PDR”).
`Ex. 1006, PCT Publication No. WO 00/51629 to Sato (English
`Translation with affidavit) (“Sato”).
`Ex. 1017, Nema et al., “Excipients and Their Use in Injectable
`Products,” 51 PDA J. OF PHARMA. SCI. AND TECH. 166 (1997) (“Nema”).
`Ex. 1030, Essentials of Nuclear Medicine Science (Hladik, et al., eds.,
`1987) (“ENMS”).
`
`4
`
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`IPR2019-00345
`U.S. Patent No. 6,803,046 B2
`
`E. Asserted Grounds of Unpatentability
`Petitioner asserts the following grounds of unpatentability (Pet. 38):
`
`Ground
`
`1
`
`2
`
`3
`
`4
`
`Claims
`1–4, 6–11, 13, 15, 16, 19,
`21–24, 26-31, 33, 35, 36,
`40–42, 44–49, 51, 53, 55,
`and 104
`
`5, 12, 14, 17, 18, 25, 32, 34,
`37, 38, 43 50, 52, and 54
`
`77-88, 90-95, 97, 99, 100,
`and 105
`
`89, 96, 98, 101, and 102
`
`Basis
`
`References
`
`§ 103(a) PDR and Sato
`
`§ 103(a) PDR, Sato, and Nema
`
`§ 103(a) PDR, Sato, and ENMS
`§ 103(a) PDR, Sato, ENMS,
`and Nema
`
`
`In support of its patentability challenge, Petitioner relies on the
`Declaration of Christian Schöneich, Ph.D. Ex. 1003.
`
`II. DISCUSSION
`A. Claim Construction
`For petitions filed after November 13, 2018, such as the case here, we
`interpret the claims of a challenged patent using the same claim construction
`standard used in a civil action under 35 U.S.C. 282(b), which is the standard
`articulated in Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en
`banc).1 Under the Phillips standard, the “words of a claim are generally
`
`1 The claim construction standard used in an inter partes review changed.
`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) (amending 37 C.F.R. § 42.100(b) effective
`5
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`IPR2019-00345
`U.S. Patent No. 6,803,046 B2
`
`given their ordinary and customary meaning,” which is “the meaning that
`the term would have to a person of ordinary skill in the art in question at the
`time of the invention, i.e., as of the effective filing date of the patent
`application.” Id. at 1312–13. The specification is “the single best guide to
`the meaning of a disputed term and . . . acts as a dictionary when it expressly
`defines terms used in the claims or when it defines terms by implication.”
`Id. at 1321 (internal quotation marks omitted).
`Petitioner does not propose constructions for any claim terms and
`states that it “has considered the claim terms according to their plain and
`ordinary meanings, consistent with the specification.” Pet. 37. “Patent
`Owner also believes that no express claim constructions are necessary.”
`Prelim. Resp. 12.
`As there is no current dispute as to the meaning of any claim term, we
`determine that no claim terms need to be construed for purposes of our
`analysis in this Decision. See Nidec Motor Corp. v. Zhongshan Broad
`Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“we need only
`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)).
`
`B. Petitioner’s Obviousness Grounds
`Petitioner argues that (1) claims 1–4, 6–11, 13, 15, 16, 19, 21–24, 26–
`31, 33, 35, 36, 40–42, 44–49, 51, 53, 55, and 104 are unpatentable as
`obvious over the combination of PDR and Sato (Pet. 39–59); (2) claims 5,
`
`
`November 13, 2018).
`
`6
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`IPR2019-00345
`U.S. Patent No. 6,803,046 B2
`
`12, 14, 17, 18, 25, 32, 34, 37, 38, 43 50, 52, and 54 are unpatentable as
`obvious over the combination of PDR, Sato, and Nema (id. at 59–65);
`(3) claims 77–88, 90–95, 97, 99, 100, and 105 are unpatentable as obvious
`over the combination of PDR, Sato, and ENMS (id. at 65–71); and
`(4) claims 89, 96, 98, 101, and 102 are unpatentable as obvious over the
`combination of PDR, Sato, ENMS, and Nema (id. at 71–72).
`Based on this record, we determine Petitioner has not established a
`reasonable likelihood that it would prevail in any of these assertions.
`
`1. Summary of References Relied Upon
`a. PDR (Ex. 1005)
`PDR discloses sincalide formulated for injection as
`a diagnostic agent which may be used: (1) to provide a sample of
`gallbladder bile that may be aspirated from the duodenum for
`analysis of its composition, e.g., to determine the degree of
`cholesterol saturation, (2) in conjunction with secretin . . . to
`stimulate pancreatic secretion for analysis of its composition and
`examination of cytology, e.g., in suspected cancer of the
`pancreas, (3) for postevacuation cholecystography, where the
`physician deems this procedure indicated but wishes to avoid the
`fatty meal.
`Ex. 1005, 154. “When injected intravenously, sincalide produces a
`substantial reduction in gallbladder size by causing this organ to contract.”
`Id. “[Sincalide for injection] is a sterile, lyophilized, white powder of the
`synthetic C-terminal octapeptide of cholecystokinin.” Id. “Each
`vial provides 5 mcg. sincalide with 45 mg. sodium chloride as a carrier;
`sodium hydroxide or hydrochloric acid may be added during manufacture
`to adjust the pH to 5.5 to 6.5.” Id.
`
`7
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`IPR2019-00345
`U.S. Patent No. 6,803,046 B2
`
`
`b. Sato (Ex. 1007)
`Sato is a translation of a Japanese PCT Publication No. WO 00/5169.
`Ex. 1007; Pet. n.4. Sato relates to stable formulations for granulate colony-
`stimulating factor (“G-CSF”). Ex. 1007, 4. Sato describes the disclosed
`invention as follows:
`An object of the present invention is to provide a G-CSF
`formulation, which is more stable even during long-term storage
`and which has a low content of Met-oxidized G-CSF.
` As a result of careful studies to achieve the above object,
`we accomplished the present invention on the basis of the finding
`that a G-CSF formulation showing a high residual ratio of G-CSF
`and a low content of Met-oxidized G-CSF even after long-term
`storage can be obtained by adding a combination of specific
`amino acids as a stabilizer.
`. . .
`invention also provides said G-CSF
`The present
`formulation containing one or more amino acids selected from
`the group consisting of lysine, histidine, arginine, aspartic acid,
`glutamic acid, threonine and asparagine; one or more amino
`acids selected from hydrophobic amino acids; and methionine.
`Id. at 5.
`
`Sato also discloses that “[t]he present invention also provides a
`method for inhibiting a physiologically active protein containing a
`methionine residue from producing a variant oxidized at the methionine
`residue, comprising adding methionine to a composition containing said
`protein.” Id. at 6. Sato discloses that “physiologically active proteins”
`include the following:
`cytokines such as interleukins (e.g., IL-1 ~ IL-13), colony-
`stimulating factors (e.g., granulocyte colony-stimulating factor
`(G-CSF), macrophage colony-stimulating factor (M-CSF),
`granulocyte/macrophage colony-stimulating factor (GM-CSF),
`
`8
`
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`IPR2019-00345
`U.S. Patent No. 6,803,046 B2
`
`erythropoietin (EPO)), interferons (e.g., IFN-α, β, γ), tumor
`necrosis factors (e.g., TNF-α, TNF-β), transforming growth
`factor (TGF), platelet-derived growth factor (PDGF), LIF
`(leukemia inhibitory factor), oncostatin M (OSM), migration
`inhibitory factor (MIF), chemokines (e.g., IL-8, LD78, MCP-1);
`physiologically active peptides such as insulin, glucagon,
`parathyroid hormone (PTH), gastrin, selectin, cholecystokinin,
`gastric inhibitory polypeptides, substance P, motilin, spleen
`polypeptides, neurotensin, enteroglucagon, gastrin-releasing
`peptides,
`somatostatin-28, dynorphin, galanin, balenin,
`pancreostatin and zeopsin; bioenzymes such as enzymes having
`a methionine residue at the active center (e.g., malate
`dehydrogenase); or variants thereof.”
`Id. at 11 (emphasis added).
`
`c. ENMS (Ex. 1030)
`Petitioner relies on ENMS for its disclosure of a method for
`“administering a hepatobiliary imaging agent to a patient in conjunction with
`administering sincalide.” Ex. 1030, 126–127; Pet. 67; Ex. 1001, Claims 77–
`88, 90–95, 97, 99, 100, and 105. ENMS discloses, in one approach, that
`“patients are premedicated with sincalide prior to injection of the
`radiopharmaceutical.” Id. at 127. In another approach, patients are
`administered sincalide “followed by another injection of 99mTc-IDA,” a
`radiopharmaceutical imaging agent. Id. Thus, sincalide may be
`administered before or after administering the hepatobiliary imaging agent.
`Id.; Ex. 1003 ¶ 167.
`
`d. Nema (Ex. 1017)
`Nema discloses lists of the functional classes of excipients suitable for
`use in in injectable formulations, which include, for example, 1) solvents,
`2) solublizing, wetting, suspending, emulsifying or thickening agents,
`
`9
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`IPR2019-00345
`U.S. Patent No. 6,803,046 B2
`
`3) chelating agents, 4) antioxidants, 5) buffers, and 6) bulking agent/tonicity
`adjusters. Ex. 1017, Abstract. For example, Nema discloses that “[s]ulfite,
`bisulfite, and metabisulfite constitute the majority of antioxidants used in
`parenteral products,” with sodium metabisulfite being one of the most
`commonly used antioxidants. Id. at 168.
`NEMA further discloses that
`Generally, a knowledge of which excipients have been deemed
`safe by the FDA or are already present in a marketed product
`provides increased assurance to the formulator that these
`excipients will probably be safe for their new drug product.
`However, there is no guarantee that the new drug product will be
`safe as excipients are combined with other additives and/or with
`a new drug, creating unforeseen potentiation or synergistic toxic
`effects.
`Id. at 166.
`
`2. Analysis
`For all of its asserted obviousness grounds, Petitioner relies on the
`same arguments to explain why one of ordinary skill in the art would have
`had a reason to combine the teachings of PDR and Sato. Pet. 39–59
`(analysis for Ground I based on PDR and Sato), 59 (Ground 2 adds Nema to
`the combination of PDR and Sato for Nema’s alleged disclosure of
`limitations found in dependent claims), 66 (“For the reasons explained [in
`Ground 1] with respect to claim 1, it would have been obvious to a POSA to
`develop a sincalide formulation containing the claimed classes of
`excipient”), 71 (“For the reasons explained in Ground 2, claims 89, 96, 98,
`101, and 102 are also unpatentable as obvious over the PDR, Sato, ENMS,
`and Nema . . . .”). Thus, we focus our analysis on the combination of PDR
`and Sato.
`
`10
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`IPR2019-00345
`U.S. Patent No. 6,803,046 B2
`
`Petitioner contends that “a POSA would have relied on Sato and a
`POSA’s general knowledge of the art to develop a sincalide formulation that
`solves sincalide’s known stability problems.” Pet. 40. In particular,
`Petitioner contends that “Sato successfully solved the same stability
`problems in G-CSF, and also expressly applied the teachings to
`cholecystokinin peptides, such as sincalide.” Id. (citing Ex. 1003 ¶¶ 33–35,
`98). For example, Petitioner argues that it would have been obvious to use a
`surfactant to produce an improved sincalide formation, and that
`A POSA would have been motivated to include a surfactant in
`the sincalide formulation to prevent surface adsorption, such as
`adherence to the walls of a glass vial, and the resulting loss of
`biological activity. [Ex. 1013], 162 (describing loss of protein’s
`biological activity due to adsorption); [Ex. 1020], 504 (reporting
`an ‘unpredictable loss of material’ due to CCK and secretin
`surface adsorption); [Ex. 1003], ¶70.
`Id. at 23–24, 45.
`For the reasons set forth on pages 16–21 and 27–32 of the Preliminary
`Response, which we adopt, we are not persuaded by Petitioner’s arguments
`and evidence attempting to show obviousness of the challenged claims.
`Briefly, we are persuaded that “Sato contains no data or teachings specific to
`CCK-8.” Prelim. Resp. 21. Rather, “Sato relates to G-CSF, which contains
`174 or 178 amino acids.” Id. at n.11; Ex. 2009, 2:2–7. Although Sato
`discloses “cholecystokinin” as one of the possible “[p]hysiologically active
`proteins of the present invention” (Ex. 1007, 11), we are not persuaded, on
`the current record, that this one-time reference to the family of
`cholecystokinin proteins and peptides is sufficient to support Petitioner’s
`“conclusion that a POSITA would have found it beneficial to use methionine
`plus the numerous potential excipients recited by Sato with sincalide (CCK-
`
`11
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`IPR2019-00345
`U.S. Patent No. 6,803,046 B2
`
`8) to produce a stable formulation of sincalide.” Prelim. Resp. 21, 27–32.
`Specifically, we are not persuaded that the current record supports a
`conclusion that a person of ordinary skill in the art would have been motived
`to add a surfactant as an excipient for the reason articulated by Petitioner.
`In particular, we are not persuaded that the current record sufficiently
`supports a finding that instability due to surface adsorption was a commonly
`understood problem to be solved for sincalide. As Patent Owner notes,
`Wünsch2 (Ex. 1020) does not support Petitioner’s contention “that peptides
`in the secretin and CCK families, including sincalide (“CCK-PZ-octa-
`[]peptide”), were observed to undergo surface adsorption on glassware” (Pet.
`14), because “Wünsch does not teach that CCK-8 has surface adsorption
`issues” (Prelim. Resp. 16–17). Rather, Wünsch discloses as follows:
`The CCK-PZ-octa- [CCK-8] and decapeptides were long
`believed to possess higher activity than CCK-PZ-33 or its variant
`39. It is now known that this difference is mainly attributable to
`adsorption on laboratory glassware.”
`Ex. 1020, 503. Thus, as noted by Patent Owner,
`
`if CCK-8 (sincalide) has higher activity than the longer peptides,
`it is not being adsorbed on glassware. Instead, it is the CCK-33
`or CCK-39 that are being adsorbed. This is because Wünsch’s
`reference to “higher activity” is a reference to activity in the
`body. (Ex. 1010 at 1:9 to 2:10 (explaining how CCK interacts
`with type A or B receptors in the body).) Accordingly, because
`CCK-8 has “higher activity” than CCK-33 and CCK-39, it is not
`being adsorbed onto glassware. Rather, as Wünsch makes clear,
`it is the CCK-33 and the CCK-39 that have the glassware
`adsorption issues.
`
`
`2 Ex. 1020, Wünsch, E., “Peptide Factors as Pharmaceuticals: Criteria for
`Application,” 22 BIOPOLYMERS 493 (1983) (“Wünsch”).
`
`12
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`IPR2019-00345
`U.S. Patent No. 6,803,046 B2
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`Prelim. Resp. 17.
`
`Petitioner cites two additional references in its attempt to support its
`conclusion that instability due to surface adsorption was a commonly
`understood problem for sincalide. Pet. 14 (citing Liddle III3 and Konturek4).
`Liddle III discloses the intravenous administration of CCK-8 to five male
`humans for gallbladder testing. Ex. 1042, 1146. In describing its test
`procedure, Liddle III discloses that:
`The actual infusion rate was determined by measuring the CCK
`concentration of the infusate taken from the delivery system.
`This measurement corrects for losses of CCK by adsorption to
`syringes and intravenous tubing.
`Id. Similarly, Konturek discloses the intravenous administration of
`CCK-8 to dogs for pancreas testing. Ex. 1043, 1014–15. In describing
`its test procedure, Konturek discloses that:
`
`In all tests involving administration of CCK, gasttin, serretin, or
`neurotensin, a solution of 0.5% albumin (Sigma) was used to
`dissolve these peptides to prevent their degradation and
`adsorption into the plastic tubes during intravenous infusion.
`Id. at 1015. Although Liddle III and Konturek describe precautionary
`measures taken to account for any possible surface adsorption, neither
`reference clearly identifies surface adsorption as a problem particular for the
`CCK-8 peptide. When we weight the evidence presented in Wünsch, Liddle
`III, and Konturek, we find that the evidence of record does not support a
`
`3 Ex. 1042, Liddle, et al., “Cholecystokinin Bioactivity in Human Plasma,”
`75 J. CLIN. INVEST. 1144 (1985) (“Liddle III”).
`4 Ex. 1043, Konturek, et al., “Effect of Cholecystokinin Receptor Antagonist
`on Pancreatic Responses to Exogenous Gastrin and Cholecystokinin and to
`Meal Stimuli,” 94 GASTROENTEROLOGY 1014 (1988) (“Konturek”).
`
`13
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`IPR2019-00345
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`
`finding that sincalide suffered from surface adsorption issues, and therefore
`does not support a determination that a “POSA would have been motivated
`to include a surfactant in the sincalide formulation to prevent surface
`adsorption,” as argued by Petitioner. Pet. 23; see also id. at 13 (“A POSA
`would have been motivated to develop a sincalide product formulated to
`address these instability issues.”).
`Accordingly, we are not persuaded that the combination of PDR and
`Sato would have rendered obvious the subject matter of the challenged
`claims. As each of Petitioner’s Grounds 1 to 4 rely on the combination of
`PDR and Sato, and because neither ENMS nor Nema cure the deficiency in
`the combination of PDR and Sato discussed above, we are not persuaded
`that Petitioner will prevail in showing that any of the challenged claims
`would have been obvious under any of Petitioner’s Grounds 1 to 4. See
`supra, Section I.E.
`
`III. CONCLUSION
`For the foregoing reasons, Petitioner does not establish a reasonable
`likelihood that it will prevail in showing that at least one claim of the ’046
`patent is unpatentable.
`
`IV. ORDER
`Accordingly, it is
`ORDERED that the Petition is denied, and no trial is instituted.
`
`
`
`
`
`
`14
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`IPR2019-00345
`U.S. Patent No. 6,803,046 B2
`
`For PETITIONER:
`Benjamin Anger
`Peter Law
`KNOBBE, MARTENS, OLSON & BEAR LLP
`2bba@knobbe.com
`peter.law@knobbe.com
`
`For PATENT OWNER:
`
`Barry Schindler
`Heath Briggs
`GREENBERG TRAURIG, LLP
`schindlerb@gtlaw.com
`briggsh@gtlaw.com
`
`
`
`
`
`
`
`
`15
`
`
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