UNITED STATES PATENT AND TRADEMARK OFFICE
`__________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________
`
`
`
`Lupin Ltd. and Lupin Pharmaceuticals Inc.
`
`Petitioners
`
`v.
`
`Pozen, Inc.
`
`Patent Owner
`
`___________
`
`Case IPR2015-01774
`
`U.S. Patent No. 8,852,636
`___________
`
`
`
`PETITIONER’S REQUEST FOR REHEARING
`
`PURSUANT TO 37 C.F.R. § 42.71(d)
`
`
`
`
`__________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________
`
`
`
`Lupin Ltd. and Lupin Pharmaceuticals Inc.
`
`Petitioners
`
`v.
`
`Pozen, Inc.
`
`Patent Owner
`
`___________
`
`Case IPR2015-01774
`
`U.S. Patent No. 8,852,636
`___________
`
`
`
`PETITIONER’S REQUEST FOR REHEARING
`
`PURSUANT TO 37 C.F.R. § 42.71(d)
`
`
`
`
`
`TABLE OF CONTENTS
`
`IPR2015-01174
`Patent No. 8,852,636 B2
`
`I.
`Introduction ...................................................................................................... 1
`Standard Of Law .............................................................................................. 2
`II.
`III. Background ...................................................................................................... 3
`IV. Petitioner Has Demonstrated A Reasonable Likelihood That
`Claims 1-6 And 13-15 Are Unpatentable Pursuant To Ground 2 Of
`The Petition ................................................................................................................ 4
`A.
`The Board Overlooked and Misunderstood The Common
`Knowledge That Would Motivate A POSA To Make The
`Claimed Formulation With A Reasonable Expectation Of
`Success ............................................................................................................. 4
`B.
`The Board Erroneously Found Dr. Banakar Relied On A
`“Conclusory Statement” .................................................................................. 5
`C.
`The Board Misunderstood The Teaching Of Pilbrant ........................... 7
`D.
`Petitioner Has Demonstrated A Reasonable Likelihood
`That Claims 1-6 And 13-15 Are Unpatentable Over The ’556
`Patent In View Of The ’225 Patent ................................................................. 9
`Petitioner Has Demonstrated A Reasonable Likelihood That
`V.
`Claims 1-6 And 13-15 Are Unpatentable Pursuant To Ground 5 Of
`The Petition ..............................................................................................................11
`VI. Conclusion .....................................................................................................15
`
`
`
`
`
`
`
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`TABLE OF AUTHORITIES
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`IPR2015-01174
`Patent No. 8,852,636 B2
`
`Cases
`Board of Trustees of Bay Med. Center v. Humana Military Healthcare Svcs., Inc.,
`
`447 F.3d 1370 (Fed. Cir. 2006) ............................................................................. 2
`
`Broadcom Corp. v. Emulex Corp., 732 F.3d 1325 (Fed. Cir. 2013) ......................... 2
`
`KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007) ..................................... 2, 4, 7, 9
`
`Randall Mfg. v. Rea, 733 F.3d 1355 (Fed. Cir. 2013) ...........................................4, 6
`
`PTAB Decisions
`Lupin Ltd. and Lupin Pharmaceuticals v. Pozen, Inc., IPR2015-01773, Paper 15
`
`(March 1, 2016) ....................................................................................................12
`
`Lupin Ltd. and Lupin Pharmaceuticals v. Pozen, Inc., IPR2015-01775, Paper 15
`
`(March 1, 2016) ....................................................................................................12
`
`Merial Ltd. v. Virbac, IPR2014-01279, Paper 18 (Jan. 22, 2015) ............................. 3
`
`
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`IPR2015-01174
`Patent No. 8,852,636 B2
`Pursuant to 37 C.F.R. § 42.71(d), Lupin Ltd. and Lupin Pharmaceuticals Inc.
`
`
`
`(collectively and individually, “Petitioner”) hereby respectfully request rehearing
`
`of the portions of the Board’s Decision (Paper No. 15, March 1, 2016) regarding
`
`Statutory Ground 2 of the Petition1 asserting claims 1-6 and 13-15 are unpatentable
`
`under 35 U.S.C. § 103(a) as obvious over the ’556 patent2 in view of the ’225
`
`patent; and Statutory Ground 5 asserting claims 1-6 and 13-15 are obvious over the
`
`’225 patent3 in view of Chandramouli4 and WO ’1855.
`
`I.
`
`Introduction
`
`
`
`Concerning Ground 2, the Board’s Decision should be reconsidered and
`
`reversed because it failed to give appropriate weight to the knowledge and
`
`reasoning of a person or ordinary skill in the art, contrary to the legal standard for
`
`
`
`1 References and citations herein to “Petition” or “Pet.” are to Petitioner’s
`
`Corrected Petition, Paper No. 4, filed August 31, 2015.
`
`2 U.S. Patent No. 6,544,556, claiming priority date of Sept 11, 2000 (Exh. 1004).
`
`3 U.S. Patent No. 5,698,225, issued Dec. 16, 1997 (Exh. 1007).
`
`4 Chandramouli et al., Prevention and management of NSAID-Induced
`
`Gastropathy, Journal of Pharmaceutical Pain and Symptom Control, 8(4):27-40,
`
`2000, published February 23, 2001 (Exh. 1011).
`
`5 Published Patent Appl. WO/2000/026185, published May 11, 2000 (Exh. 1012).
`
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`IPR2015-01174
`Patent No. 8,852,636 B2
`obviousness set forth in KSR. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418
`
`(2007). Notably, the Board overlooked the reasoning set forth in the Petition and
`
`Dr. Banakar’s Declaration and erroneously found Dr. Banakar’s statements
`
`“conclusory.” Additionally, the Board’s evaluation of Pilbrant ignored the full
`
`disclosure as understood by a person or ordinary skill in the art and erroneously
`
`focused on one phrase of the publication.
`
`
`
`Concerning Ground 5, the Board misapprehended a statement in WO’185
`
`because it overlooked a distinction between sodium bicarbonate solid and solution
`
`and thus committed a clear error in its analysis.
`
`II. Standard Of Law
`The Board reviews requests for rehearing under an “abuse of discretion”
`
`
`
`standard. 37 C.F.R. § 42.71(c). “An abuse of discretion occurs when a district
`
`court exercises its discretion ‘based upon an error of law or clearly erroneous
`
`factual findings’ or commits ‘a clear error of judgment in weighing relevant
`
`factors.’” Broadcom Corp. v. Emulex Corp., 732 F.3d 1325, 1336 (Fed. Cir. 2013).
`
`“[C]ourts have recognized three grounds justifying reconsideration: 1) an
`
`intervening change in controlling law; 2) the availability of new evidence; and 3)
`
`the need to correct clear error or manifest injustice.” Board of Trustees of Bay
`
`Med. Center v. Humana Military Healthcare Svcs., Inc., 447 F.3d 1370, 1377 (Fed.
`
`Cir. 2006). For example, the Board has granted institution of claims where it
`
`-2-
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`IPR2015-01174
`Patent No. 8,852,636 B2
`previously overlooked disclosures in the prior art. See, e.g., Merial Ltd. v. Virbac,
`
`IPR2014-01279, Paper 18 at 14 (Jan. 22, 2015) (granting institution on two
`
`grounds where PTAB had overlooked significance of a disclosure in the prior art).
`
`III. Background
`
`The ’636 patent is directed to drug dosage forms that comprise a naproxen
`
`core surrounded by an enteric coating and further surrounded by the proton pump
`
`inhibitor esomeprazole. The patent discloses eight examples of combination oral
`
`dosages, of which four (Examples 5-8) are generally related to a combination of a
`
`PPI and naproxen. Each of these examples discloses a naproxen core surrounded
`
`by a barrier coat, further surrounded by an enteric film coat; and further
`
`surrounded by an acid inhibitor coat. Figure 1 is generally illustrative of the
`
`disclosed dosage forms:
`
`Barrier Coat
`
`Enteric Film Coat
`
`Naproxen
`
`
`Acid Inhibitor Coat
`(PPI + Buffer)
`
` Figure 1: Claimed technology in Examples 5-8 of the ’636 patent
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`IPR2015-01174
`Patent No. 8,852,636 B2
`Each example discloses a buffer present in the PPI layer to raise the pH of
`
`
`
`the stomach. Examples 7 and 8 utilize omeprazole granules having the buffer
`
`sodium bicarbonate, an alkaline compound. (’636 Patent, Exh. 1001, 18:18;
`
`19:38.) Further, Examples 5 and 6 utilize ammonium hydroxide in the outer film
`
`coating to adjust the pH of the stomach upwards. (Id. at 14:58, 16:27.) In each
`
`embodiment, the role of the alkaline buffer is to solubilize and protect the PPI
`
`before degradation before its absorption by raising the pH of the stomach. (See id.
`
`at 17:50-52.)
`
`IV. Petitioner Has Demonstrated A Reasonable Likelihood That Claims 1-6
`And 13-15 Are Unpatentable Pursuant To Ground 2 Of The Petition
`A. The Board Overlooked and Misunderstood The Common
`Knowledge That Would Motivate A POSA To Make The Claimed
`Formulation With A Reasonable Expectation Of Success
`
`
`
`In the Decision, the Board failed to give appropriate weight to the commonly
`
`available knowledge to a person of ordinary skill in the art (“POSA”). As a
`
`consequence, the Board overlooked a rationale to modify or combine references
`
`that would have been applied by a POSA based on his or her educational
`
`background and experience. E.g., KSR v. Teleflex, 550 U.S. at 418 (holding the
`
`obviousness analysis includes consideration of “the inferences and creative steps a
`
`person of ordinary skill in the art would employ”); Randall Mfg. v. Rea, 733 F.3d
`
`1355, 1362 (Fed. Cir. 2013) (“obviousness inquiries include recourse to logic,
`
`judgment, and common sense available to the person of ordinary skill that do not
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`IPR2015-01174
`Patent No. 8,852,636 B2
`necessarily require explication in any reference.”). Thus, the Board committed
`
`clear error in the following instances where it overlooked reasoning that would
`
`have been readily available to a person of ordinary skill. Applying the correct
`
`analysis as described below, the Board should find Petitioner has demonstrated a
`
`reasonable likelihood that claims 1-6 and 13-15 are unpatentable as obvious over
`
`the ’556 patent in view of Chandramouli or the ’225 patent pursuant to 35 U.S.C. §
`
`103.
`
`B. The Board Erroneously Found Dr. Banakar Relied On A
`“Conclusory Statement”
`
`
`
`The claimed formulations comprise an enteric-coated naproxen core
`
`surrounded by a non-enteric coated esomeprazole layer, which allows for
`
`immediate release of esomeprazole and delayed release of naproxen until the
`
`surrounding environment reaches a pH of 3.5 or higher. (Exh. 1001 at 21:22–
`
`22:56.) The ’556 patent discloses at least the inverse of this invention. (Decision
`
`at 13.) Both the Petition and Dr. Banakar’s Declaration detail reasons why a
`
`POSA would have been motivated by commonly available knowledge to modify
`
`the disclosure of the ’556 patent to first release esomeprazole and then release the
`
`NSAID, as claimed in the ’636 patent. (Pet. at 13; Exh. 1002 at ¶38.) In the
`
`Decision, the Board clearly erred by dismissing Dr. Banakar’s testimony as a
`
`“conclusory statement” because it overlooks the reasoning and citations set forth in
`
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`Dr. Banakar’s declaration and improperly ignores common knowledge and logic
`
`available to a person of ordinary skill. (Decision at 16.)
`
`
`
`As of the time of invention, it was well known to a POSA that PPIs act in
`
`the duodenal region – the portion of the GI tract located immediately after the
`
`stomach. (Exh. 1002 at ¶ 30, 31, 33), and the Patent Owner does not dispute this
`
`fact. (PO Preliminary Response at 11.) It was also well known to a POSA that
`
`NSAIDs, including naproxen, could cause gastric injury when released in low pH
`
`environments like the stomach and regions of the GI tract closer to the stomach.
`
`(Pet. at 20; Exh. 1002 at ¶ 31, 45; Exh. 1011, 32.) Thus, a POSA would want the
`
`naproxen to be released in the gastrointestinal tract and not earlier in the stomach.
`
`(Pet. at 17; Exh. 1002 at ¶45.) In turn, a POSA would have known that the use of
`
`enteric-coated naproxen was a well-known strategy for releasing the drug after
`
`passing through the stomach, which is the embodiment taught by the ’225 patent.
`
`(Exh. 1007, 2:46-49) Thus, the Petition and Dr. Banakar set forth a sound logical
`
`rationale supporting an ordinary artisan’s motivation to release the PPI first and the
`
`NSAID second.
`
`In its decision, the Board overlooked this clear motivation and failed to
`
`apply the appropriate legal standard because it did not give appropriate weight to
`
`the rationale of a person of ordinary skill based on commonly available knowledge.
`
`See, e.g., Randall v. Rea, 733 F.3d at 1362 (finding PTAB analysis did not
`
`-6-
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`IPR2015-01174
`Patent No. 8,852,636 B2
`correctly apply the KSR standard because it focused narrowly on prior art
`
`references and ignored evidence cited to demonstrate the knowledge and
`
`perspective of one of ordinary skill in the art).
`
`C. The Board Misunderstood The Teaching Of Pilbrant
`The Board overlooked reasoning that would have been readily available to a
`
`
`
`POSA as it dismissed Pilbrant based on a single phrase in the publication. This is
`
`clear error because the Board mistakes a POSA for an automaton without
`
`understanding of pharmaceutical formulations and the bioavailability of drugs.
`
`This analysis is contrary to the educational background and experience of a POSA
`
`for the ’190 patent and is inconsistent with the law of obviousness. See KSR v.
`
`Teleflex, 550 U.S. at 418.
`
`
`
`Recognizing that a significant amount of omeprazole was likely to degrade
`
`upon first administration without an enteric coating, Pilbrant set out to evaluate
`
`how much omeprazole would degrade. (Pet. at 19; Exh. 1010, 116-117.) The
`
`statement that “more than half” of the solid non-enteric coated omeprazole is
`
`degraded means that a very substantial amount (but less than half) is not degraded.
`
`(Exh. 1010 at 114.) Pilbrant does not teach bioavailability of a non-enteric coated
`
`PPI depends on whether it is delivered as a solid or in unbuffered solution. For
`
`example, Pilbrant discloses both that 44% of uncoated, unbuffered omeprazole was
`
`not lost to degradation in the acidic stomach and suggested less than half of the
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`IPR2015-01174
`Patent No. 8,852,636 B2
`solid non-enteric coated esomeprazole was not lost. (See Exh. 1010 at 114,
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`117.) Thus, a POSA would look to the data disclosed in the studies for his or her
`
`own analysis. (E.g., Pet. at 21; Exh. 1002 at ¶ 68.)
`
`
`
`Pilbrant does state an immediate release oral dosage form was “ruled out in a
`
`pilot bioavailability study (see below), where it was shown that more than half of
`
`the omeprazole in a rapidly dissolving dosage form degrades in the stomach”.
`
`(Exh. 1010 at 114.) This does not foreclose the matter at hand because the data
`
`teaches a POSA that non-enteric coated esomeprazole would be bioavailable
`
`because a substantial amount of omeprazole does not degrade. (Pet. at 19.) Based
`
`on this data, a POSA would know how much uncoated omeprazole to administer in
`
`order to obtain the desired therapeutic amount claimed in the ’636 patent.
`
`
`
`The Board’s Decision focused heavily on the phrase “ruled out” and
`
`overlooked all data disclosed in the publication. This is improper because, as
`
`stated in the Petition and supported by Banakar, “a POSA would read and evaluate
`
`the entire disclosure of a reference” — not the phrase “ruled out”. (E.g., Pet. at 21;
`
`Exh. 1002 at ¶ 68.) The phrase “ruled out” has no concrete meaning to a POSA.
`
`In Pilbrant, for example, it refers to whether a design is practical — not whether it
`
`is viable. A POSA looking at the Pilbrant data would have understood that non-
`
`enteric coated omeprazole is bioavailable, and therefore a viable and obvious
`
`solution.
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`IPR2015-01174
`Patent No. 8,852,636 B2
`Contrary to the obviousness standard set forth in KSR, the Board focused on
`
`
`
`the phrase “ruled out” without proper attention to context. Specifically, the
`
`Decision did not consider “the inferences and creative steps a person of ordinary
`
`skill in the art would employ”. See KSR v. Teleflex, 550 U.S. at 418. The decision
`
`should be reconsidered because the Board relied on a clearly erroneous finding of
`
`fact—that a POSA would overlook the data in Pilbrant--to support its conclusion.
`
`D. Petitioner Has Demonstrated A Reasonable Likelihood That
`Claims 1-6 And 13-15 Are Unpatentable Over The ’556 Patent In
`View Of The ’225 Patent
`
`
`
`In the Decision, the Board found the ’556 patent teaches enteric coated
`
`esomeprazole surrounded by non-enteric coated naproxen and declined to find an
`
`ordinary artisan would be motivated to create the inverse with a reasonable
`
`expectation of success. (Decision at 22.) The Board misapplied the law to the
`
`extent it overlooked common knowledge and reasoning available to an ordinary
`
`artisan that would have provided both motivation and a reasonable expectation of
`
`success to create tablet forms using the process described in claims 1-6 and 13-15.
`
`
`
`Applying the correct legal standard as described above, the Board should
`
`find Petitioner has demonstrated a reasonable likelihood that claims 1-6 and 13-15
`
`are obvious over the ’556 patent in view of the ’225 patent. Specifically, both Dr.
`
`Banakar and the ’225 patent show that naproxen was known to cause gastric injury
`
`when released in low pH environments such as the stomach and early portion of
`
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`IPR2015-01174
`Patent No. 8,852,636 B2
`the GI tract. (Exh. 1002 at ¶ 31, 45; Exh. 1007 at 1:24-27, 6:55-57.) Further, as
`
`described above, Dr. Banakar discloses it was common knowledge that PPIs such
`
`as esomeprazole act in the duodenum – early in the GI tract. (Exh. 1002 at ¶ 30,
`
`31, 33.) This knowledge, when taken into consideration, provides the teaching and
`
`motivation to a POSA to use a tablet of the form disclosed in the ’556 patent that
`
`first releases the PPI and second releases the NSAID. (Pet. at 28.) Further, as
`
`described above, a POSA having knowledge about bioavailability, would not have
`
`dismissed Pilbrant as summarily as a lay person may have on the sole basis of the
`
`phrase “ruled out”. (Pet. 17-18.) Instead, a POSA would have understood from
`
`the data that uncoated omeprazole has substantial bioavailability and that a
`
`formulation employing uncoated omeprazole would be a viable and obvious
`
`choice. Further, a POSA would know to add a buffer to reduce degradation of
`
`esomeprazole. (Pet. at 20.) WO’185, for example, reflects this awareness by
`
`teaching use of a bicarbonate salt buffer for this purpose. (Id. at 40.)
`
`
`
`Applying this knowledge and the reasoning available to an ordinary artisan
`
`at the time, Petitioner demonstrated through Dr. Banakar a reasonable likelihood
`
`that claims 1-6 and 13-15 of the ’636 patent are unpatentable on the basis of
`
`Ground 2. Thus, the Board should reconsider its Decision and institute review on
`
`the basis of this Ground.
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`V. Petitioner Has Demonstrated A Reasonable Likelihood That Claims 1-6
`And 13-15 Are Unpatentable Pursuant To Ground 5 Of The Petition
`
`
`
`The Board denied institution of Ground 5, which states that claims 1-6 and
`
`13-15 would have been obvious over the ’225 patent in view of Chandramouli and
`
`WO’185. The Board does not dispute the combination may render obvious a
`
`combination tablet comprising an enteric-coated NSAID core with a layer of non-
`
`enteric coated esomeprazole. (Decision at 29.) However, it denied institution of
`
`the claims because the ’636 patent claims require naproxen surrounded by a
`
`coating that “does not release naproxen until the pH of the surrounding medium is
`
`3.5 or higher”, and the Board read WO’185 to teach “a sodium bicarbonate
`
`solution is capable of dissolving an enteric coating.” (Id.) This reliance is clear
`
`error because the cited statement of WO’185 has no bearing on the obviousness
`
`analysis. Regardless of whether enteric coatings dissolve in a sodium bicarbonate
`
`solution, Petitioner has demonstrated the ’225 patent, Chandramouli, and WO’185
`
`would provide an ordinary artisan with motivation and a reasonable expectation of
`
`success of creating the alleged invention of the ’636 patent.
`
`
`
`The ’225 patent discloses a tablet that is similar to the composition recited in
`
`claims 1-6 and 13-15 of the ’636 patent, except that the ’225 patent uses
`
`misoprostol in place of a PPI. (Pet. at 27; see also IPR2015-01773, Institution
`
`Decision, Paper 15 at 34-35; IPR2015-01775, Institution Decision, Paper 15 at 32-
`
`33.) Thus, the primary question is whether an ordinary artisan would have had
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`IPR2015-01174
`Patent No. 8,852,636 B2
`reason to replace the misoprostol layer of the ’225 patent with a PPI such as
`
`esomeprazole. (See id.) The answer is plainly yes. This Board has held that
`
`WO’185, in combination with the ’225 patent, provides teaching and motivation to
`
`create combination drug tablet form in which the misoprostol layer is replaced with
`
`a non-enteric coated PPI. (IPR2015-01773, Paper 15 at 34; IPR2015-01775, Paper
`
`15 at 33.) For this reason, the Board granted inter partes review of claims similar
`
`to those in the ’636 patent. (IPR2015-01773, Paper 15 at 38; IPR2015-01775,
`
`Paper 15 at 37.) The alleged distinction between the instituted claims and the
`
`present claims is that the instituted claims allow for partial release of coated
`
`naproxen while the claims of the ’636 patent require all of the naproxen to be
`
`prevented from release.6 (See id.) Here, the Board’s denial of the present petition
`
`is based on a clear misunderstanding of WO’185. (See Decision at 29.)
`
`
`
`WO’185 teaches that bicarbonate salt can prevent degradation of omeprazole
`
`prior to absorption. (Decision at 26-27.) Specifically, WO’185 teaches solid
`
`granules containing both omeprazole and sodium bicarbonate salt, and further
`
`suggests such granules may be enteric-coated. (See Exh. 1015 at 17:1-7, 26:1-4.)
`
`The cited passage in WO’185 reads: “The coated omeprazole particles are mixed
`
`
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`6 As set forth in the related proceedings, Petitioner respectfully disagrees with the
`
`Board’s claim construction in the ’996 and ’190 patent proceedings.
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`IPR2015-01174
`Patent No. 8,852,636 B2
`with a sodium bicarbonate (NaHCO3) solution which dissolves the enteric coating
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`. . . .” (Exh. 1012 at 19:19-23.) This cited statement teaches nothing more than the
`
`primary characteristic of an enteric coating. An enteric coating, by definition,
`
`dissolves above a particular pH. (See, e.g., Decision at 15; PO Preliminary
`
`Response at 12-14; Pet. at 1). It is fundamental knowledge that a bicarbonate salt
`
`solution is a basic solution – meaning, it has a pH well above 3.5. In fact, this
`
`knowledge is commonly provided in high school chemistry courses.
`
`
`
`The Board clearly erred in giving weight to Patent Owner’s argument
`
`because the cited statement in WO’185 has no impact on the motivation or
`
`expectations of an ordinary artisan to combine a solid dosage of non-enteric coated
`
`esomeprazole and enteric-coated naproxen. Even if WO’185 teaches that enteric
`
`coating will dissolve in a sodium bicarbonate solution, the disclosure provides no
`
`suggestion that a solid salt form will impact the enteric coating. To the contrary,
`
`the referenced statement expressly teaches granules containing sodium bicarbonate
`
`salt may be enteric-coated. In other words, WO’185 teaches sodium bicarbonate
`
`salt can be used in a solid composition that concurrently contains an enteric
`
`coating. In any event, the enteric coating will dissolve only when the surrounding
`
`environment reaches the target pH. Further, a POSA would be aware of many
`
`ways to form a tablet including film barrier layers to isolate the compositions.
`
`(Exh. 1002 at ¶ 34; Exh. 1001 at 8:14-19.) Thus, the cited statement has no
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`Patent No. 8,852,636 B2
`bearing on a reasonable expectation of success of the invention envisioned by an
`
`ordinary artisan with knowledge of the ’225 patent, Chandramouli, and WO’185.
`
`
`
` To the extent Patent Owner argues exposure of enteric-coated naproxen to a
`
`basic solution would trigger dissolution of the enteric coating, such a tablet
`
`formulation is still well within the challenged claims of the ’636 patent. In fact,
`
`the ’636 patent describes use of solid bicarbonate salt in a PPI layer – not use in a
`
`solution. As described in Section III, the examples of the ’636 patent itself are
`
`directed to the same disclosure that would have been rendered obvious by the ’225
`
`patent, in light of Chandramouli and WO’185. (See also Pet. at 52.) These
`
`examples each include sodium bicarbonate or another pH buffer in a dry PPI layer.
`
`The ’636 patent itself informs the known purpose of a buffer in the outer layer is to
`
`raise the pH of the environment. (E.g., Exh. 1001 at 14:53, 16:27.) In turn, raising
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`the pH of the environment will trigger dissolution of the enteric coating. (E.g., id.
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`at 14:31-34.) Further, at least claims 14 and 17 expressly claim compositions that
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`include buffers. (Id. at 22:43, 53.) Thus, the WO’185 disclosure only motivates –
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`and does not teach away from the alleged invention of the ’636 patent.
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`For these reasons, Petitioner has demonstrated a reasonable likelihood that
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`claims 1-6 and 13-15 of the ’636 patent are unpatentable on the basis of Ground 5.
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`Thus, the Board should reconsider its Decision and institute review on the basis of
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`this Ground.
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`-14-
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`IPR2015-01174
`Patent No. 8,852,636 B2
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`VI. Conclusion
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`In light of the foregoing, Petitioner respectfully requests the Board rehear
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`and reconsider its Decision and institute Trial for Claims 1-6 and 13-15 of the ’636
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`patent pursuant to Statutory Grounds 2 and 5.
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`RESPECTFULLY SUBMITTED
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`SCHIFF HARDIN LLP
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`/ Sailesh K. Patel
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` /
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`Sailesh K. Patel (Reg. No. 46,982)
`John K. Hsu (Reg. No. 45,563)
`Attorneys for Petitioners
`233 S. Wacker Dr., Suite 6600
`Chicago, IL 60606
`(312) 258-5600
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`Date: April 5, 2016
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`-15-
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`IPR2015-01174
`Patent No. 8,852,636 B2
`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. §§ 42.6(e) and 42.105, I certify that, on April 5, 2016,
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`I caused to be served a true and correct copy of the foregoing via email to the
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`following:
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`Margaret J. Sampson, Ph. D.
`BAKER BOTTS LLP
`98 San Jacinto Blvd. Suite 1500
`Austin, TX 78701-4078
`margaret.sampson@bakerbotts.com
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`Jeffrey S. Gritton
`VINSON & ELKINS LLP
`2801 Via Fortuna Suite 100
`Austin, TX 78746-7568
`jgritton@velaw.com
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`
`Stephen M. Hash, Ph.D.
`BAKER BOTTS LLP
`98 San Jacinto Blvd.
`Suite 1500 Austin,
`TX 78701-4078
`stephen.hash@bakerbotts.com
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`Respectfully submitted,
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`/ Sailesh K. Patel
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`Sailesh K. Patel
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`USPTO Reg. No. 46,982
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`Attorney for Petitioners
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`-16-
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`Dated: April 5, 2016
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