`
`Paper 12
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_____________
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________
`
`
`
`COMPLEX INNOVATIONS, LLC,
`Petitioner,
`
`v.
`
`ASTRAZENECA AB,
`Patent Owner.
`
`____________
`
`IPR2017-00631
`
`Patent 7,759,328 B2
`____________
`
`
`PATENT OWNER’S SUR-REPLY TO PRELIMINARY RESPONSE
`
`
`
`
`
`
`
`
`
`
`
`IPR2017-00631
`Patent 7,759,328
`
`Patent Owner’s Sur-Reply
` to Preliminary Response
`
`Petitioner inconsistently assumes that (a) the canister is only partially filled
`
`with liquid when it proposes the 6–10 g fill weight, but that (b) the canister is
`
`completely filled with liquid when it proposes the 0.9 mg FFD mass. These two
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`assumptions cannot both be correct simultaneously. Thus Petitioner’s calculation of
`
`FFD weight percentage by dividing the FFD mass by the fill weight is erroneous.
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`Petitioner made assumption (a) when it argued that a canister having
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`Dr. Beasley’s 6–10 g fill weight would be filled with part liquid and part gas
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`HFA227. Reply 2. Petitioner presented no evidence to support the fill weight
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`(Prelim. Resp. 9–10) or to specify what fraction of the canister is filled with liquid.
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`Petitioner’s Reply argument highlights this gap in the petition.
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`Petitioner made assumption (b) when Dr. Beasley stated, again without
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`evidentiary support, that the canister volume is 10–19 mL (id.) and used the total
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`canister volume to calculate the FFD mass. Id. at 14. The total canister volume is
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`irrelevant to this calculation. Rather, the liquid HFA227 volume is what matters,
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`because it is the liquid phase that carries the drug. Id. at 15 n.16; Ex. 1004, 28:14–
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`15 (drug particles not adhered to internal canister surface “remain wetted in the
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`liquid”); Ex. 1005, 4:1–3 (drug suspended in liquid propellant); Ex. 1006, 6:23–25
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`(same); Ex. 1008, 1:23–24 (drug expelled from inhaler in droplets). Gas HFA227,
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`having a far lower density than liquid (Reply 2), does not count when figuring the
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`volume in which the FFD is suspended.
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`1
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`
`
`IPR2017-00631
`Patent 7,759,328
`
`Patent Owner’s Sur-Reply
` to Preliminary Response
`
`By multiplying the FFD concentration by the full canister weight, Dr. Beasley
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`assumed that no portion of the canister contained gas HFA227 and that it instead
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`was completely filled with liquid. This assumption is inconsistent with Petitioner’s
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`other assumption that the canister is only partly filled with liquid HFA227.
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`If Petitioner’s partial liquid fill assumption is correct, then Petitioner’s and
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`Dr. Beasley’s FFD mass calculation clearly is wrong, because it was calculated from
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`the full volume of the canister. Prelim. Resp. 15–16 & n.16. Moreover, Petitioner
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`presented no evidence or discussion of what fraction of the canister volume is
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`occupied by liquid, even though this parameter is critical to Petitioner’s case, leaving
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`a fatal gap in the petition. If instead Petitioner’s complete fill assumption is correct,
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`then Petitioner’s fill weight of 6–10 g clearly is wrong, because a 10 mL canister
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`filled with liquid HFA227 has a fill weight of about 14 g, not 6–10 g. Id. at 12.
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`In summary, either Petitioner’s FFD mass is wrong, or its fill weight is wrong.
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`Petitioner’s numbers for these two parameters cannot both be correct at the same
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`time, because the canister cannot be both partially and completely filled with liquid
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`at the same time. Therefore, Petitioner’s calculation of FFD weight percentage,
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`which depends on both the FFD mass and the fill weight, cannot be correct.
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`Petitioner’ Reply also does not diminish Patent Owner’s other critiques of the
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`petition, such as picking and choosing (id. at 2–8, 18–19), lack of evidence support-
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`ing the expert (id. at 9–10, 19), and failure to show inherency (id. at 11–13, 19).
`
`2
`
`
`
`'IPR2017-00631
`Patent 7,759,328
`
`.
`
`Patent Owner’s Sur—Reply
`to Preliminary Response
`
`Dated:
`
`June 16 2017
`
`
`
`Respectfully submitted,
`63M
`g. No. 39,837
`Christopher N. Sipes,
`Andrea G. Reister, Reg. No. 36,253
`Scott E. Kamholz, Reg. No. 48,543
`Covington & Burling LLP
`Counsel for Patent Owner
`
`
`
`IPR2017-0063]
`Patent 7,759,328
`
`Patent Owner’s Sur—Reply
`to Preliminary Response
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. §§ 42.6, I certify that on the date listed below, a
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`copy of this paper and every exhibit filed with this paper was served by
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`electronic mail, by agreement of the parties, on the following counsel of
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`record.
`
`Sharad K. Bijanki (sb@hkw~law.corn)
`Vivek Ganti (vg@hkw~law.c0m)
`Hill, Kertscher & Wharton, LLP
`3350 Riverwood Parkway SE
`Suite 800
`
`Atlanta GA 30339
`
`Dated:
`
`
`
`June 16 2017
`
`%;
`
`Scott E. Kamholz
`
`Reg. No. 48,543
`
`
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