Trials@uspto.gov
`571-272-7822
`
`
`
`
`
`
` Paper 16
`Entered: March 22, 2017
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`DR. REDDY’S LABORATORIES, LTD. AND DR. REDDY’S
`LABORATORIES, INC.,
`
`Petitioner,
`v.
`MONOSOL RX, LLC,
`Patent Owner.
`____________
`
`Case IPR2016-01112
`Patent 8,017,150 B2
`____________
`Before ERICA A. FRANKLIN, TINA E. HULSE, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`FRANKLIN, Administrative Patent Judge.
`
`
`
`DECISION
`Denying Petitioner’s Request for Rehearing
`37 C.F.R. § 42.71
`
`
`
`
`
`

`

`IPR2016-01112
`Patent 8,017,150 B2
`
`
`INTRODUCTION
`I.
`Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc.
`(collectively, “Petitioner”) request a rehearing of the Decision Denying
`Institution, entered on December 5, 2016 (Paper 14, “Dec.”). Paper 15
`(“Reh’g Req.”). As background, Petitioner filed a Petition to institute an
`inter partes review of claims 1, 3–10, and 12–18 of U.S. Patent No.
`8,017,150 B21 (Ex. 1001, “the ’150 patent”). Paper 1 (“Pet.”). In the
`Petition, Petitioner raised the following challenges to the claims:
`Claims Challenged
`Basis
`Reference(s)
`1, 3–10, 12–18
`§ 103 Chen,2 Schiraldi,3 and Chen II4
`
`1, 4–5, 8, 10, 12–14, and 17
`
`6–7, 9, 15–16, 18
`
`1, 4–10, and 13–18
`
`§ 103
`
`§ 103
`
`§ 103
`
`Schiraldi and Verma5
`
`Schiraldi, Verma, and Khan6
`
`Yang7
`
`
`
` 1
`
` Issued to Robert K. Yang et al., Sept. 13, 2011.
`2 Patent Application Publication No. WO 00/42992, published Jul. 27, 2000
`(Ex. 1021) (“Chen”).
`3 US Patent No. 4,713,243 issued to Michael T. Schiraldi et al., Dec. 15,
`1987 (Ex. 1004) (“Shiraldi”).
`4 Patent Application Publication No. US 2002/0147201 A1, issued Oct. 10,
`2002 (Ex. 1049) (“Chen II”).
`5 US Patent No. 6,322,811 issued to Surendra Kumar Verma et al., Nov. 27,
`2001 (Ex. 1005) (“Verma”).
`6 US Patent No. 5,656,296 issued to Sadath U. Khan et al, Aug. 12, 1997
`(Ex. 1046) (“Khan”).
`7 Patent Application Publication No. US 2005/0037055 A1, published Feb.
`17, 2005 (Ex. 1006) (“Yang”).
`
`2
`
`
`
`

`

`IPR2016-01112
`Patent 8,017,150 B2
`
`
`Petitioner also relied upon the Declaration of Russell J. Mumper,
`Ph.D. (Ex. 1003). MonoSol RX, LLC (“Patent Owner”) filed a Preliminary
`Response to the Petition. Paper 10 (“Prelim. Resp.”).
`Upon considering the Petition, Preliminary Response, and evidence of
`record, we determined that Petitioner failed to demonstrate a reasonable
`likelihood of prevailing in showing the unpatentability of the challenged
`claims. Dec. 1. In the Rehearing Request, Petitioner seeks reconsideration
`of our Decision only with respect to its contention that claims 1, 3–10, and
`12–18 would have been obvious over the combination of Chen, Schiraldi,
`and Chen II. Reh’g Req. 1.
`
`II. ANALYSIS
`“When rehearing a decision on petition, a panel will review the
`decision for an abuse of discretion.” 37 C.F.R. § 42.71(c). “The burden of
`showing a decision should be modified lies with the party challenging the
`decision. The request must specifically identify all matters the party
`believes the Board misapprehended or overlooked, and the place where each
`matter was previously addressed in a motion, an opposition, or a reply.” Id.
`§ 42.71(d). Because Petitioner has not met that burden, as discussed below,
`the Rehearing Request is denied.
`Petitioner asserts that “the Board overlooked key testimony of
`Petitioners’ expert, Dr. Russell J. Mumper, Ph.D.” Reh’g Req. 2. In
`particular, Petitioner asserts that the Board erroneously found that Dr.
`Mumper’s “opinion does not address a skilled artisan’s motivation, ability,
`or reasonable expectation of successfully achieving a film comprising the
`specific ranges and portions of low and high molecular weight polyethylene
`oxides required by the claims.” Id. at 1–2 (quoting Dec. 11). According to
`
`3
`
`
`
`

`

`IPR2016-01112
`Patent 8,017,150 B2
`
`Petitioner, Dr. Mumper addressed those issues at paragraphs 148–154 of his
`declaration. Reh’g Req. 6 (citing Ex. 1003 ¶¶ 148–154). Further, Petitioner
`asserts that those paragraphs were referenced in the Petition. Id. (citing Pet.
`30). The remainder of the rehearing request discusses the testimony of Dr.
`Mumper in those paragraphs of his declaration. Reh’g Req. 6–9.
`We begin by noting that the contents of Dr. Mumper’s testimony
`relied upon and discussed by the Petitioner in the Rehearing Request was not
`discussed in the Petition. Indeed, in the Rehearing Request, Petitioner
`confirms that its discussion of how the prior art “would have particularly
`motivated a person of ordinary skill to test different ratios of polyethylene
`oxides, and thereby arrive at the claimed [invention]” is found at pages 32–
`33 of the Petition. Reh’g Req. 3 (citing Pet. 32–33). That portion of the
`Petition does not reference paragraphs 148–151 of Dr. Mumper’s
`declaration, or describe the contents thereof now relied upon by Petitioner.
`Pet. 32–33. Rather, as discussed in the Decision, that portion of Petitioner’s
`argument references paragraph 30 of Dr. Mumper’s declaration. Dec. 11,
`see also Pet. 33 (citing Ex. 1003 ¶ 30). Further, we explained in the
`Decision why that portion of the declaration did not support Petitioner’s
`contention. Specifically, we stated:
`
` The portions of Dr. Mumper’s declaration cited by
`Petitioner do not provide any further support for Petitioner’s
`position. We note that Dr. Mumper does not explain why the
`polyethylene oxides molecular weights limitation would have
`been obvious to a person of ordinary skill over the combined
`teachings of the prior art. Instead, Dr. Mumper opines only that
`the skilled artisan “would be highly motivated to vary the
`amounts of the low and high molecular weight polyethylene
`oxide to achieve the desired effects including, but not limited to
`drug solubility, mucoadhesion and drug release rate.” Ex. 1003
`
`4
`
`
`
`

`

`IPR2016-01112
`Patent 8,017,150 B2
`
`
`¶ 30. That opinion does not address a skilled artisan’s
`motivation, ability, or reasonable expectation of successfully
`achieving a film comprising the specific ranges and proportion
`of low and high molecular weight polyethylene oxides required
`by the claims. See In re Fine, 837 F.2d at 1074 (a showing of
`obviousness must be supported by evidence, as shown by some
`objective teaching in the prior art or by knowledge generally
`available to one of ordinary skill in the art that would have led
`that individual to combine the relevant teachings of the
`references to arrive at the claimed invention).
`
`Dec. 11.
`Petitioner’s assertion in the Rehearing Request that paragraphs 148–
`151 of Mr. Mumper’s declaration were referenced in a different portion of
`the Petition is unavailing, as that reference was only provided to support
`Petitioner’s contention that the prior art teaches a specific element of the
`challenged claims. Reh’g Req. 6 (citing Pet. 30). The Petition states:
`
` As of the earliest possible priority date (2003) of the ’150
`patent, the prior art taught the major elements of the challenged
`claims:
`
`Mucoadhesive films. (Ex. 1003, Mumper Decl. at ¶¶
`102-126, 131-132, 141-156.) Schiraldi, for example, described
`mucosally-adhesive, thin-film delivery systems that could
`provide controlled-release medications within the oral cavity of
`a patient. (Ex. 1004, Schiraldi at Abstract, 2:56-60; Ex. 1003,
`Mumper Decl. ¶¶ 119-126, 131.) Chen also described mucosally
`adhesive films containing a pharmaceutical agent. (Ex. 1021, Chen
`at 3:30-32). A film made according to Schiraldi’s teachings is
`“so thin and flexible when wet as to be unobtrusive to the patient
`when properly positioned and placed in the patients [sic] mouth.”
`(Ex. 1004, Schiraldi at 9:52-55, claim 2.)
`
`As seen, that portion of the Petition citing to paragraphs 141–156 of Dr.
`Mumper’s declaration is not in connection with any discussion regarding the
`alleged motivation, skill in the art, or a reasonable expectation of success in
`
`5
`
`
`
`

`

`IPR2016-01112
`Patent 8,017,150 B2
`
`combining the teachings of the prior art in a manner that yields the claimed
`invention.
`Because Petitioner has not identified in the Petition where Petitioner
`has discussed Dr. Mumper’s opinion allegedly addressing “a skilled artisan’s
`motivation, ability, or reasonable expectation of successfully achieving a film
`comprising the specific ranges and proportion of low and high molecular
`weight polyethylene oxides required by the claims,” or where Petitioner has
`referenced such testimony as support for Petitioner’s argument relating to
`those issues, Petitioner has not established persuasively that we
`misapprehended or overlooked such testimony when assessing whether
`Petitioner explained adequately why a person of skill in the art at the time of
`the invention would have had a reason to combine the teachings of the cited
`prior8 art in a manner that yields the claimed invention, or a reasonable
`expectation of successfully doing so. For that reason, we determine that
`Petitioner has not shown that the Board abused its discretion in denying
`institution of claims 1, 3–10, and 12–18 over the combination of Chen,
`Schiraldi, and Chen II. See 37 C.F.R. § 42.71(d).
`
`
` ORDER
`III.
`In consideration of the foregoing, it is hereby ordered that the
`Petitioner’s Rehearing Request is denied.
`
`
`
`
`
` 8
`
` Moreover, we disagree with Petitioner’s assertion that the Board “did not
`address Chen II” when denying institution of the challenged claims over the
`combination of Chen, Schiraldi, and Chen II. We address the teachings of
`Chen II and then explain that those teachings do not cure the deficiency of
`Chen and Schiraldi. Dec. 8, 10.
`
`6
`
`
`
`

`

`IPR2016-01112
`Patent 8,017,150 B2
`
`FOR PETITIONER:
`
`Jeffrey Arnold
`Peter Hagerty
`Leslie-Anne Maxwell
`Andrew Ryan
`CANTOR COLBURN LLP
`jarnold@cantorcolburn.com
`phagerty@cantorcolburn.com
`amaxwell@cantorcolburn.com
`ryan@cantorcolburn.com
`
`
`FOR PATENT OWNER:
`
`Harold Fox
`John Abramic
`STEPTOE & JOHNSON LLP
`hfox@steptoe.com
`jabramic@steptoe.com
`
`
`7
`
`
`
`