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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
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`BIODELIVERY SCIENCES INTERNATIONAL, INC.
`Petitioner
`
`v.
`
`RB PHARMACEUTICALS LIMITED
`Patent Owner
`
`
`Case No. IPR2014-00325
`Patent 8,475,832
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`
`
`PETITIONER’S OBJECTIONS UNDER 37 CFR § 42.64(b)(1)
`TO EVIDENCE SUBMITTED IN CONNECTION WITH
`PATENT OWNER RESPONSE
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`
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`ME1 19245918v.1
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`Page 1
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`Pursuant to 37 CFR § 42.64(b)(1), Petitioner BioDelivery Sciences
`
`International, Inc. (“BDSI”), objects to evidence submitted in connection with
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`Patent Owner RB Pharmaceutical Limited’s (“Patent Owner”) Patent Owner
`
`Response filed on November 7, 2014 as follows:
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`Exhibit
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`Objection(s)
`
`Ex. 2003
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`1. Failure to comply with FRE 702. Dr. Johnston does not meet
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`the definition of a person of ordinary skill in the art that he
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`himself sets out in his declaration.
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`2. Failure to comply with FRE 702. Dr. Johnston’s declaration
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`improperly relies on irrelevant or incomplete documents,
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`unreliable evidence, and hearsay. See, e.g., objections to Exs.
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`2005, 2008, 2024, 2030, 2031, 2035, 2039, 2040, and 2051
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`below.
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`Ex. 2005
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`3. Lack of relevance; Exhibit 2005 does not support the
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`proposition for which it is cited. See Ex. 2003, Johnston Decl.,
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`at ¶42.
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`Ex. 2008
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`1. Hearsay without exception under FRE 801-803. See also 77
`
`Fed. Reg. 486121, 48645 (Aug. 14, 2012) (“United States
`
`patents present hearsay issues when offered to prove the truth of
`
`the matters they disclose.”)
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`ME1 19245918v.1
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`2
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`Page 2
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`Exhibit
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`Objection(s)
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`Ex. 2024
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`1. Hearsay without exception under FRE 801-803.
`
`2. Lack of authentication under FRE 901-902.
`
`3. Lack of relevance. Exhibit 2024 is cited in the “Background
`
`Regarding Buprenorphine Dosages and Pharmacokinetics”
`
`section of the Johnston Declaration. However, on its face,
`
`Exhibit 2024 is dated 2011, after the asserted priority date of the
`
`‘832 patent.
`
`Ex. 2030
`
`1. Lack of relevance. Exhibit 2030 is cited in the Johnston
`
`Declaration for the proposition “[a]s of 2009, the POSITA
`
`would be informed . . . .” Ex. 2003, Johnston Decl., at ¶62. On
`
`its face, Exhibit 2030 purports to have been updated in 2013.
`
`See Ex. 2030 at 1.
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`2. Hearsay without exception under FRE 801-803.
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`3. Lack of authentication under FRE 901-902.
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`ME1 19245918v.1
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`3
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`Page 3
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`
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`Exhibit
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`Objection(s)
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`Ex. 2031
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`1. Lack of relevance; Exhibit 2031 does not support the
`
`proposition for which it is cited. With respect to Exhibit 2031,
`
`the Johnston Declaration states “as of 2009 (indeed, long before
`
`then), peroral administration of buprenorphine would have been
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`regarded by the person of ordinary skill in the art as
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`therapeutically inappropriate and unacceptable.” See Ex. 2003,
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`Johnston Decl., at ¶63. On its face, Exhibit 2031 is dated 2013.
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`2. Hearsay without exception under FRE 801-803.
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`3. Lack of authentication under FRE 901-902.
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`Ex. 2035
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`1. Hearsay without exception under FRE 801-803.
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`2. Lack of relevance under FRE 401-403. Ex. 2035 does not
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`support the proposition for which it is cited in the Patent Owner
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`Response. And on its face, Ex. 2035 is dated 2011.
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`Ex. 2039
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`1. Hearsay without exception under FRE 801-803.
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`2. Lack of authentication under FRE 901-902.
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`Ex. 2040
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`1. This document is heavily redacted and so is not the original
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`document. See FRE 1001-1002.
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`2. Hearsay without exception under FRE 801-803.
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`3. Lack of authentication under FRE 901-902.
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`ME1 19245918v.1
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`4
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`Page 4
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`Exhibit
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`Objection(s)
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`Ex. 2042
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`1. Lack of relevance under FRE 401-403.
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`Ex. 2043
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`2. Lack of relevance under FRE 401-403.
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`3. Patent Owner mischaracterizes the contents of this document.
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`See, e.g., Patent Owner Response, at 50.
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`Ex. 2044
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`1. This document is incomplete.
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`Ex. 2045
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`2. Lack of relevance; Exhibit 2045 does not support the
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`proposition for which it is cited. See, e.g., Patent Owner
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`Response, at 55 and 56.
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`Ex. 2046
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`1. Lack of relevance; Exhibit 2045 does not support the
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`proposition for which it is cited. See, e.g., Patent Owner
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`Response, at 55-56.
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`Ex. 2047
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`1. Lack of relevance; Exhibit 2031 does not support the
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`proposition for which it is cited. See, e.g., Patent Owner
`
`Response, 55-56.
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`2. Lack of authentication under FRE 901-902.
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`3. Ex. 2047 contains highlighting, which is evidently not part of
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`the original document, and accordingly this exhibit is not the
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`original evidence per FRE 1001-1002.
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`ME1 19245918v.1
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`5
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`Page 5
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`Exhibit
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`Objection(s)
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`Ex. 2048
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`1. Lack of relevance; Exhibit 2031 does not support the
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`proposition for which it is cited. See, e.g., Patent Owner
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`Response at 56.
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`2. Lack of authentication under FRE 901-902.
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`3. Exhibit 2048 contains highlighting, which is evidently not part
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`of the original document, and accordingly this exhibit is not the
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`original evidence per FRE 1001-1002.
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`Ex. 2051
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`1. Patent Owner improperly characterizes this document. In its
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`Response, the Patent Owner characterizes Exhibit 2051 as a
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`“BDSI Poster Presentation, 2010.” However, there is no date on
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`the face of the document.
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`
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`These objections have been made within five business days of the November
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`7, 2014 deadline for Patent Owner’s Response.
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`
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`Respectfully submitted,
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`Date: November 14, 2014
`
`
`
`/s/ Danielle Herritt
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`Danielle L. Herritt (Reg. No. 43,670)
`Kia L. Freeman (Reg. No. 47,577)
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`ME1 19245918v.1
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`6
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`Page 6
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a copy of the foregoing Petitioner’s
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`Objections under 37 CFR § 42.64(b)(1) to Evidence Submitted in connection with
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`Patent Owner Response was electronically served on November 14, 2014, by
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`transmitting a copy to lead counsel James Bollinger at
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`james.bollinger@troutmansanders.com and to backup counsel Daniel Ladow at
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`daniel.ladow@troutmansanders.com in accordance with the consent set forth in
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`Patent Owner Second Amended Mandatory Notice Information.
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`By:
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`
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`/Danielle L. Herritt/
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`Danielle L. Herritt
`Registration No. 43,670
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`
`
`Attorney for Petitioner
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`ME1 19245918v.1
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`Page 7
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