Paper No. 12
`
`Trials@uspto.gov
` Entered: July 20, 2016
`571-272-7822
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`GRAY SQUARE PHARMACEUTICALS, LLC,
`Petitioner,
`
`v.
`
`POZEN, INC.,
`Patent Owner.
`____________
`
`Case IPR2016-00191
`Patent 7,332,183 B2
`____________
`
`
`Before DONNA M. PRAISS, JO-ANNE M. KOKOSKI, and
`JEFFREY W. ABRAHAM, Administrative Patent Judges.
`
`ABRAHAM, Administrative Patent Judge.
`
`
`
`DECISION
`Denying Petitioner’s Request for Rehearing
`37 C.F.R. § 42.71(d)
`
`
`
`
`
`
`
`
`
`
`Trials@uspto.gov
` Entered: July 20, 2016
`571-272-7822
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`GRAY SQUARE PHARMACEUTICALS, LLC,
`Petitioner,
`
`v.
`
`POZEN, INC.,
`Patent Owner.
`____________
`
`Case IPR2016-00191
`Patent 7,332,183 B2
`____________
`
`
`Before DONNA M. PRAISS, JO-ANNE M. KOKOSKI, and
`JEFFREY W. ABRAHAM, Administrative Patent Judges.
`
`ABRAHAM, Administrative Patent Judge.
`
`
`
`DECISION
`Denying Petitioner’s Request for Rehearing
`37 C.F.R. § 42.71(d)
`
`
`
`
`
`
`
`
`
`
`IPR2016-00191
`Patent 7,332,183 B2
`
`
`I. INTRODUCTION
`Gray Square Pharmaceuticals, LLC (“Petitioner”) filed a Request for
`Rehearing of our Decision (Paper 10, “Dec.”) denying inter partes review of
`claims 1 and 2 of U.S. Patent No. 7,332,183 B2 (Ex. 1001, “the ’183
`patent”). Paper 11 (“Req. Reh’g”). In our Decision, we determined that
`Petitioner had not established a reasonable likelihood of prevailing with
`respect to any of the challenged claims of the ’183 patent. Dec. 2.
`For the reasons that follow, Petitioner’s Request for Rehearing is
`denied.
`
`II. STANDARD OF REVIEW
`The party challenging a decision in a request for rehearing bears the
`burden of showing the decision should be modified. 37 C.F.R. § 42.71(d).
`A request for rehearing “must specifically identify all matters the party
`believes the Board misapprehended or overlooked, and the place where each
`matter was previously addressed.” Id. Upon a request for rehearing, the
`decision on a petition will be reviewed for an abuse of discretion. 37 C.F.R.
`§ 42.71(c).
`
`
`III. DISCUSSION
`1. Construction of “dissolution of said naproxen occurs
`independently of said triptan”
`Claim 1 of the ’183 patent requires a multilayer tablet wherein “said
`first layer and said second layer are in a side by side arrangement such that
`the dissolution of said naproxen occurs independently of said triptan.” Ex.
`1001, 18:35–37. At page 8 of our Decision, we stated that
`the broadest reasonable interpretation of the phrase “dissolution
`of said naproxen occurs independently of said triptan” is a
`
`
`
`2
`
`
`
`IPR2016-00191
`Patent 7,332,183 B2
`
`
`dissolution profile such that complete dissolution of naproxen
`and triptan when the drugs are given in the combination tablet
`requires the same amount of time ± 10% as when the same
`amount of naproxen or triptan is given alone.
`Dec. 8. We based our construction on a specific portion of the Specification
`that we determined to be Patent Owner’s definition of “dissolve
`independently.” Id. at 6 (citing Ex. 1001, 2:46–54).
`Petitioner contends that the Board overlooked a “critical sentence” in
`the Specification when construing the phrase “dissolution of said naproxen
`occurs independently of said triptan” in claim 1 and, therefore,
`misapprehended the express definition of “dissolve independently.” Req.
`Reh’g 3. This “critical sentence” is shown in bold in the passage from the
`Specification reproduced below:
`The layers should be arranged such that the individual
`therapeutic agents dissolve independently of one another, i.e.,
`dissolution should occur at approximately the same rate as
`would occur if the drugs were given separately. In this context,
`“approximately the same rate” indicates that the time for
`complete dissolution of agent when drugs are given in the
`combination tablet should require the same amount of time ±
`10% as when the same amount of agent is given alone. This
`can be achieved by placing the individual layers in a side-
`by-side arrangement, as opposed, for example, in a single
`layer tablet matrix containing both agents or one layer forming
`a core surrounded by the other layer.
`Ex. 1001, 2:46–58 (emphasis added).
`In our Decision, we considered Patent Owner’s definition of “dissolve
`independently” to include only the first two sentences of the passage
`reproduced above. Dec. 6. Petitioner, however, contends that the sentence
`shown in bold is part of Patent Owner’s definition of “dissolve
`independently” such that the proper construction of the phrase “dissolution
`
`
`
`3
`
`
`
`IPR2016-00191
`Patent 7,332,183 B2
`
`of said naproxen occurs independently of said triptan” includes the sentence
`“[t]his can be achieved by placing the individual layers in a side-by-side
`arrangement.” Req. Reh’g 4, 6.
`We are not persuaded by Petitioner’s argument that we
`misapprehended the express definition of “dissolve independently” by
`overlooking the alleged “critical sentence” identified by Petitioner. The
`sentence in question explains how one can achieve independent dissolution
`(as acknowledged by Petitioner (id. at 4)), not what it means to “dissolve
`independently.” To the contrary, the first two sentences in the passage
`reproduced above—the portion of the Specification we identified in our
`Decision as containing Patent Owner’s definition of “dissolve
`independently”—squarely addresses what that term means. Dec. 6; Ex.
`1001, 2:46–54.
`Further, we note that the sentence in question indicates independent
`dissolution “can be achieved by placing the individual layers in a side-by-
`side arrangement,” which is different from requiring that a person of
`ordinary skill in the art must achieve it that way. Ex. 1001, 2:54–55
`(emphasis added). Thus, because Patent Owner chose to describe the side-
`by-side configuration as an optional way to achieve independent dissolution
`in the Specification, we are not persuaded that the definition of “dissolve
`independently” should expressly include that configuration. This is
`especially true considering that claim 1, as Petitioner recognizes (Req. Reh’g
`6–7), separately requires that the multilayer tablet have a side-by-side
`configuration in addition to requiring that the naproxen and triptan dissolve
`independently.
`
`
`
`4
`
`
`
`IPR2016-00191
`Patent 7,332,183 B2
`
`
`Nor are we persuaded that the construction adopted in the Decision is
`inconsistent with the Patent Owner’s teaching in the Specification, or that it
`requires that the limitation that “dissolution . . . occurs independently”
`cannot be met by placing the individual layers in a side by side
`configuration. See Req. Reh’g. 7. To the contrary, in view of the optional
`language provided in the Specification, independent dissolution is not
`necessarily tied to any specific configuration. In order to establish
`unpatentability of claim 1 in view of prior art, however, Petitioner has the
`burden of demonstrating that the prior art discloses or suggests both
`independent dissolution and a side-by-side configuration, as required by
`claim 1.
`2. Whether the limitation “such that the dissolution . . . occurs
`independently” is a patentable distinction over the prior art
`Petitioner contends that the Board overlooked and misapprehended its
`argument that the limitation requiring ingredients to be arranged side-by-side
`“such that dissolution . . . occurs independently” is not a patentable
`distinction. Req. Reh’g 11. For the reasons set forth below, we disagree.
`In the Petition, Petitioner argued that the limitation requiring
`independent dissolution is not a patentable distinction because “[p]ersons of
`ordinary skill knew that ‘independent’ dissolution of the ingredients in the
`respective layers of a bilayer tablet was an inherent property of that
`formulation.” Pet. 38. As Petitioner acknowledges (Req. Reh’g 14), we
`addressed this argument directly in our Decision, noting that Petitioner failed
`to provide evidence sufficient to demonstrate that the property of
`independent dissolution is necessarily present in bilayer tablets. Dec. 11
`(citing Akamai Technologies, Inc. v. Cable & Wireless Internet Services, 344
`F.3d 1186, 1192 (Fed. Cir. 2003)). The lack of proof demonstrating that
`
`
`
`5
`
`
`
`IPR2016-00191
`Patent 7,332,183 B2
`
`independent dissolution was an inherent property of prior art tablets
`undermines Petitioner’s position.
`Petitioner further argues that the limitation requiring independent
`dissolution is not a patentable distinction “because it is a property of a tablet
`formulation that previously existed.” Req. Reh’g. 11–12; Pet. 39.
`Specifically, Petitioner argues that “[t]he general principle that a newly-
`discovered property of the prior art cannot support a patent on that same art
`is not avoided if the patentee explicitly claims that property.” Req. Reh’g
`12; Pet. 39 (quoting Abbott Labs. V. Baxter Pharm. Prods., 471 F.3d 1363,
`1367 (Fed. Cir. 2006)). Petitioner contends that “the Board overlooked the
`same argument made by Petitioner in its petition as made in Abbott Labs.”
`Req. Reh’g. 14.
`In the Request for Rehearing, Petitioner asserts that “the Abbott Labs
`rule does not require a finding of inherency to apply.”1 Id. Additionally,
`although not referenced in the Petition, Petitioner cites Titanium Metals
`Corp. v. Banner, 778 F.2d 775 (Fed. Cir. 1985), in support of its argument in
`the Request for Rehearing, noting “the Court in Titanium Metals held ‘it is
`immaterial, on the issue of their novelty, what inherent properties the alloys
`have or whether these applicants discovered certain inherent properties.’”
`Req. Reh’g 14.
`
`
`1 In contrast to Petitioner’s argument, we note that in Abbott Labs., the
`Federal Circuit stated that a prior art reference “may anticipate without
`disclosing a feature of the claimed invention if that missing characteristic is
`necessarily present, or inherent, in the single anticipating reference.” Abbott
`Labs., 471 F.3d at 1368 (quoting Schering Corp. v. Geneva Pharms., 339
`F.3d 1373, 1377 (Fed. Cir. 2003)) (emphasis added).
`
`
`
`
`6
`
`
`
`IPR2016-00191
`Patent 7,332,183 B2
`
`
`Petitioner’s arguments are unpersuasive. In Abbott Labs., the Federal
`Circuit stated:
`Abbott’s objection here is merely that at the time of the [prior
`art] patent, nobody knew that the water-saturated sevoflurane
`that patent disclosed had the property of resisting the Lewis
`acid degradation reaction. Just as in Titanium Metals, that lack
`of knowledge is wholly irrelevant to the question of whether the
`[challenged] patent claims something “new” over the disclosure
`of the [prior art] patent; the claimed property of resistance to
`degradation is found inherently in the disclosure.
`Abbott Labs., 471 F.3d at 1368. Thus, in Abbott Labs., the Federal Circuit
`found that the claimed property was an inherent property of the prior art. Id.
`In view of this, the Federal Circuit held that the prior art anticipated the
`claimed invention, even though there was no indication that persons of
`ordinary skill in the art appreciated that the prior art possessed the inherent
`property. Id.
`Here, Petitioner has failed to provide evidence sufficient to
`demonstrate that independent dissolution is an inherent property of prior art
`tablets. Nor has Petitioner provided evidence demonstrating that any prior
`art tablets possessed the claimed property at all. See, e.g., Dec. 10. In view
`of this, and in contrast to the findings in Abbott Labs., there is insufficient
`evidence of record for us to conclude that prior art tablets possessed the
`claimed property, or that the claims of the ’183 patent simply recite a newly
`discovered, but inherent, property. Thus, although Petitioner mirrors the
`arguments made in Abbott Labs., the evidence and information of record do
`not warrant a similar outcome.
`
`
`
`
`7
`
`
`
`IPR2016-00191
`Patent 7,332,183 B2
`
`
` ORDER
`IV.
`For the reasons given, it is hereby
`ORDERED that the Request for Rehearing is denied.
`
`
`
`
`
`
`
`8
`
`
`
`IPR2016-00191
`Patent 7,332,183 B2
`
`
`PETITIONER:
`Zachary Silbersher
`Sergey Kolmykov
`Kroub, Sibersher & Kolmykov PLLC
`zsilbersher@kskiplaw.com
`skolmykov@kskiplaw.com
`
`PATENT OWNER:
`Dominick A. Conde
`Brendan M. O’Malley
`FITZPATRICK CELLA, HARPER & SCINTO
`PozenIPR@fchs.com
`
`Stephen M. Hash
`Jeffrey S. Gritton
`BAKER BOTTS LLP
`PozenIPR@bakerbotts.com
`
`
`
`9
`
`
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
