`
`
`
`IPR2017-00412
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_______________
`
`
`MONOSOL RX, LLC
`Petitioner
`
`v.
`
`ICOS CORPORATION,
`Patent Owner
`
`_______________
`
`Case: IPR2017-00412
`Patent 6,943,166 B1
`_______________
`
`
`
`
`PETITIONER MONOSOL RX, LLC’S REPLY TO PATENT OWNER’S
`OPPOSITION TO REQUEST FOR REHEARING
`
`
`
`
`
`
`
`
`
`IPR2017-00412
`
`Petitioner’s Request for Rehearing (“Request”) was premised on a proper
`
`factual and legal basis. Thus, Patent Owner’s Opposition to the Request fails.
`
`Petitioner did identify where its arguments were previously raised in the
`
`Petition. See, e.g., Req. at 5, 8, 12 (citing Pet. 33-34, 44, and 22-24); Ex. 1010.1
`
`The Opposition mistakenly argues that the Williams Declaration2 was
`
`addressed by the Board. This is wrong. The only cite to this declaration (see Opp.
`
`1, citing Dec., p. 4, 8) refers to Petitioner’s arguments – not the Board’s Analysis:
`
`• Decision at p. 4: “In support of its patentability challenges, Petitioner
`relies on the Declaration of Dr. Roger Williams (Ex. 1010).”
`• Decision at p. 8. “Pet. 15, 22, 27, 38”
`
`The first cite is a background statement, before the Board’s Analysis begins.
`
`The second cite does not list or cite the Williams Declaration. Indeed, there is no
`
`reference to the Declaration anywhere on p. 8 of the Board’s Decision.3
`
`Patent Owner inaccurately contends that Petitioner’s obvious to try position
`
`was addressed. But Petitioner submitted that the Board overlooked its obvious to
`
`try position under currently applicable law. Req. at 10-11. The case cited by the
`
`Board and by Patent Owner, In re O’Farrell, referred to the “obvious to try”
`
`standard in 1988, when it was still “improper grounds for a § 103 rejection.” 853
`
`
`1 The Cutler reference was cited in Ex. 1010 and in p. 11 of the Petition.
`2 Patent Owner argues “improper incorporation” by reference (Opp. 3), but cites no
`legal authority – just its own Preliminary Response (“Paper 9”).
`3 The Velander and Daicel cases are inapposite because the Williams Declaration
`was not conclusory and may be evaluated with other factual evidence at trial.
`
`1
`
`
`
`
`
`
`
`IPR2017-00412
`
`F.2d 894, 902 (Fed. Cir. 1988). Under post-KSR law, “obvious to try” is no longer
`
`“improper” when there is a “finite number of identified, predictable solutions.”
`
`KSR Int'l Co. v. Teleflex, Inc., 550 U.S. 398, 421 (2007). Such is the case here.
`
`Ex. 1010, ¶¶ 158-167; Pet. at 22 (finite dose range to optimize). Moreover, the
`
`Petition did address “reasonable expectation of success.” (e.g., Pet. at 12), contrary
`
`to Patent Owner’s assertions (Opp. at 2).
`
` Patent Owner suggests that Petitioner’s reliance in common sense was
`
`insufficient. Opp. at 3. But Petitioner relied on the prior art, a POSA’s ability to
`
`optimize based on the prior art, market pressure, design need, and common sense.
`
`Patent Owner argues that Dr. Williams is distinct from a POSA. Opp. at 3
`
`¶6. But Dr. Williams is a POSA, and ¶175 of Declaration shows what he believed
`
`to be public FDA correspondence. Finally, the Patent Owner mistakenly argues
`
`that the “admitted prior art” is a ground “never raised.” This is not true. Dr.
`
`Williams specifically discussed the admitted prior art as acknowledged in ’166
`
`patent. Ex. 1010, ¶¶45-51 (known problems of sildenafil including side effects)
`
`(referring to Ex. 1001, col. 2, lines 58- 65), and Daugan, which is in cited in
`
`Grounds 1-3 (Pet. 6-7), is referred to as “admitted prior art” in Ex. 1010, ¶ 131.
`
`CONCLUSION
`
`Petitioner respectfully requests rehearing and reconsideration of the decision
`
`not to institute the IPR and institution of the IPR as requested.
`
`2
`
`
`
`
`
`
`
`IPR2017-00412
`
`
`
`
`
`
`Date: August 16, 2017
`
`Customer Number: 27890
`Steptoe & Johnson LLP
`1330 Connecticut Avenue, N.W.
`Washington, DC 20036-1795
`Telephone: (202) 429-3000
`Facsimile: (202) 429-3902
`
`Respectfully Submitted,
`
`
`
`
`
`By: /Harold H. Fox/
`
`Harold H. Fox
`Reg. No. 41,498
`
`
`3
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`
`The undersigned hereby certifies that a copy of the foregoing PETITIONER
`
`MONOSOL RX, LLC’S REPLY TO PATENT OWNER’S OPPOSITION TO
`REQUEST FOR REHEARING was served on August 16, 2017 by filing this
`document through the Patent Trial and Appeal Board End to End system as well as
`by delivering a copy via electronic email to the attorneys of record for the Patent
`Owner’s as follows:
`Mark J. Feldstein
`mark.feldstein@finnegan.com
`
`Joshua L. Goldberg
`joshua.goldberg@finnegan.com
`
`Yieyie Yang
`yieyie.yang@finnegan.com
`
`Maureen D. Queler
`maureen.queler@finnegan.com
`
`Mark J. Stewart
`stewart_mark@lilly.com
`
`Dan L. Wood
`wood_dan_l@lilly.com
`
`Gerald P. Keleher
`keleher_gerald@lilly.com
`
`
`
`
`
`
`
`
`
`Date: August 16, 2017
`
`
`
`
`
`
`
`
`By: /Harold H. Fox/
`
`Harold H. Fox
`
`Reg. No. 41,498
`
`Counsel for MonoSol Rx, LLC
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
