UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
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`MYLAN PHARMACEUTICALS INC.,
`Petitioner
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`v.
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`QUALICAPS CO., LTD,
`Patent Owner
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`_____________
`
`Case IPR2017-00203
`Patent 6,649,180
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`PATENT OWNER’S IDENTIFICATION OF NEW
`ARGUMENTS IN PETITIONER’S REPLY
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`_____________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
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`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner
`
`v.
`
`QUALICAPS CO., LTD,
`Patent Owner
`
`_____________
`
`Case IPR2017-00203
`Patent 6,649,180
`_____________
`
`
`PATENT OWNER’S IDENTIFICATION OF NEW
`ARGUMENTS IN PETITIONER’S REPLY
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`As authorized by the Board (Ex. 2075), Patent Owner identifies Section III(B)
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`IPR2017-00203
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`of the Reply (p. 17, l. 1–p. 21, l. 14) as exceeding the scope permitted under 37
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`C.F.R. § 42.23(b), and provides a brief explanation for each contention.
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`I. New Argument: Whether the ’180 patent record shows that the cloud
`spotting defects in capsules were composed of gelling aid precipitates.
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`Petitioner argues that the inventors improperly inferred gelling aid
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`
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`precipitation to be the problem solved by the claimed invention, when the real
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`problem was instead residual salts in the HPMC or water. Reply, p. 18, l. 3–p. 19,
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`l. 13 (p. 18, l. 6: “Precipitation of residual salts may cause spotting”; p. 18, ll. 12-14
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`(arguing that the inventors admit inferring that gelling aid precipitation was the
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`problem); p. 19, ll. 4-9 (arguing that an unsupported inference is “insufficient” and
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`that “any reduction in spotting is due to a prior art feature – commercially available
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`HPMC or water with low residual salt content.”)).
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`This argument is new for at least the reason that it contradicts the Petition,
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`where Petitioner argued that the prior art inherently prevented the cloud spotting
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`problem. Petition, Section C., p. 51, l. 11–p. 55, l. 6; Petition, p. 52, ll. 5-8
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`(“Accordingly, the properties of the capsule shell that prevent [gelling aid]
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`precipitation are . . . inherent and foreseeable by one of ordinary skill in the art in
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`creating and selecting a desirable medicinal capsule shell.”). Petitioner’s new
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`causation argument was raised for the first time in the Reply, and is an improper new
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`issue not argued or explained in the Petition. See Arista Networks, Inc. v. Cisco Sys.,
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`- 1 -
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`Inc., IPR2016-00308, Paper 42 at 13–14 (May 25, 2017) (new theory in reply was a
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`IPR2017-00203
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`non-responsive attempt to fill petition gaps identified in patent owner response).
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`
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`Not only is this argument presented for the first time in the Reply, it is not
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`responsive to the Patent Owner Response, being premised on evidence available at
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`the time the Petition was filed: the ’180 patent and Tanjoh prosecution declaration.
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`Reply, p. 18, ll. 3-5 (discussing data in the ’180 patent and Tanjoh prosecution
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`declaration); id. at p. 20, l. 17–p. 21, l. 2 (same). The Reply cites nothing from the
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`Tanjoh deposition exhibits produced by Patent Owner in support of this argument
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`(production only “confirms” what inventor reported in the ‘180 patent). Reply, p.
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`18, l. 15–p. 19, 1. 3 (citing Ex. 1029 (Ex. 2064–2072)).
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`
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`II. New Argument: Whether, even if the cloud spotting defects were gelling
`aid precipitates, the claimed invention prevented these defects.
`Petitioner argues for the first time in the Reply that the claimed invention lacks
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`
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`nexus with the unexpected solution. Reply, p. 15, l. 11–p. 18, l. 2; p. 19, l. 14–p. 21,
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`l. 14 (p. 17, ll. 13-16: “Patent Owner possesses no evidence linking the optimization
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`of a single variable (substitution ranges) to the alleged benefit, which merely
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`reduces, but does not eliminate, the alleged cloud spotting”; p. 19, ll. 18-20: “[T]he
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`alleged unexpected benefit was to remove spots, but that is not what the claim
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`encompasses.”; p. 20, l. 17–p. 21, l. 5: “[A]ll that [the Table 1] data shows is between
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`38.1% and 36.4/36.7 there is some level of aesthetically acceptable spotting.”).
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`- 2 -
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`Like New Argument I, this argument also contradicts the Petition, where
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`IPR2017-00203
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`Petitioner instead assumed that the claimed invention, like the prior art, led to the
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`solution. Petition, Section C., p. 51, l. 11–p. 55, l. 6; Petition, pp. 55, ll. 3–6 (“[A
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`POSA] at the time of the invention would have recognized that a capsule with an
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`HPMC base and the claimed percentages of hydroxypropyl and methoxyl groups
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`result in the clarity and stability that is a purported object of the invention of the ’180
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`Patent.”).
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`This argument is not responsive to the Patent Owner Response. Petitioner had
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`all the data used in the Reply at the time the Petition was filed, and knew that
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`unexpected results had been at issue during prosecution. Patent Owner Response
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`(Paper 26), pp. 37–40. See Arista, IPR2016-00308, Paper 42 at 13–14.
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`III. New Argument: Whether an “acceptable amount” of spotting can be
`determined by a “subjective” assessment.
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`Petitioner newly argues that Patent Owner’s evidence of unexpected results is
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`entitled to little or no weight because it is based on a “subjective distinction between
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`acceptable spotting and unacceptable spotting.” Reply, p. 19, l. 14–p. 21, l. 14
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`(quotation at p. 21, ll. 11-12). This argument is new as it contradicts the position
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`Petitioner took at pages 54-55 of the Petition, where Petitioner relied on subjective
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`assessments of film quality (such as “Poor – very hazy, quite rough”) to support its
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`obviousness case.
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`- 3 -
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`Date: October 6, 2017
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`IPR2017-00203
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`Respectfully submitted,
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`
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`By /Andrea G. Reister/
`Jessica L. Parezo (Reg. No. 50,286)
`Andrea G. Reister (Reg. No. 36,253)
`Scott E. Kamholz (Reg. No. 48,543)
`Michael N. Kennedy (pro hac vice)
`Megan P. Keane (pro hac vice)
`COVINGTON & BURLING LLP
`One CityCenter, 850 Tenth Street, NW
`Washington, DC 20001
`(202) 662-6000
`
`MaryAnne Armstrong (Reg. No. 40,069)
`Lynde F. Herzbach (Reg. No. 74,886)
`BIRCH, STEWART, KOLASCH & BIRCH, LLP
`8110 Gatehouse Road, Suite 100 East
`Falls Church, VA 22042
`(703) 205-8000
`
` Attorneys for Patent Owner
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`- 4 -
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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 copy of
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`IPR2017-00203
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`Patent Owner’s Identification of New Arguments in Petitioner’s Reply was served
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`by electronic mail, by agreement of the parties, on the following counsel of record
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`for Petitioner.
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`Date: October 6, 2017
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`Mitchell G. Stockwell
`David C. Holloway
`Miranda C. Rogers
`Mylan-WC-IPR@kilpatricktownsend.com
`KILPATRICK TOWNSEND & STOCKTON LLP
`1100 Peachtree Street, Suite 2800
`Atlanta, GA 30309
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` /Andrea G. Reister/
`Andrea G. Reister, Esq.
`Reg. No.: 36,253
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