UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`MYLAN PHARMACEUTICALS INC.
`Petitioner
`
`v.
`
`QUALICAPS CO. LTD.
`Patent Owner
`
`U.S. Patent No. 6,649,180
`Filing Date: April 13, 2000
`Issue Date: November 18, 2003
`Title: HARD CAPSULE FORMED OF CELLULOSE ETHER FILM WITH A
`SPECIFIC CONTENT OF METHOXYL AND HYDROXYPROPOXYL
`GROUPS
`________________
`
`Inter Partes Review No. Unassigned
`
`
`
`
`
`PETITION FOR INTER PARTES REVIEW
`
`UNDER 35 U.S.C. §§ 311-319 AND 37 C.F.R. § 42.100 ET SEQ.
`
`i
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`

`
`Petition for Inter Partes Review of U.S. Patent No. 6,649,180
`
`TABLE OF CONTENTS
`
`I.
`
`INTRODUCTION ...................................................................................... - 1 -
`
`II. MANDATORY NOTICES UNDER 37 C.F.R. § 42.8(B) ........................ - 1 -
`
`A.
`
`B.
`
`C.
`
`REAL PARTY IN INTEREST ........................................................ - 1 -
`
`RELATED MATTERS .................................................................... - 1 -
`
`PAYMENT OF FEES ...................................................................... - 2 -
`
`D. DESIGNATION OF LEAD COUNSEL ......................................... - 3 -
`
`E.
`
`F.
`
`SERVICE INFORMATION ............................................................ - 3 -
`
`POWER OF ATTORNEY ............................................................... - 4 -
`
`III. REQUIREMENTS FOR INTER PARTES REVIEW ................................. - 4 -
`
`A. GROUND FOR STANDING ........................................................... - 4 -
`
`B.
`
`IDENTIFICATION OF CHALLENGE ........................................... - 5 -
`
`1.
`
`2.
`
`3.
`
`Claims Challenged ................................................................. - 5 -
`
`Background of the Technology .............................................. - 5 -
`
`Prior Art ............................................................................... - 12 -
`
`C.
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED ......... - 13 -
`
`IV. OVERVIEW OF THE ’180 PATENT ..................................................... - 13 -
`
`PRIORITY DATE OF THE ’180 PATENT .................................. - 13 -
`
`SUMMARY OF THE ’180 PATENT ............................................ - 14 -
`
`PERSON OF ORDINARY SKILL IN THE ART ......................... - 15 -
`
`CLAIM CONSTRUCTION ........................................................... - 15 -
`
`1.
`
`2.
`
`“gelling agent” ..................................................................... - 17 -
`
`“gelling aid” ......................................................................... - 18 -
`
`i
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`A.
`
`B.
`
`C.
`
`D.
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`

`
`Petition for Inter Partes Review of U.S. Patent No. 6,649,180
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`V.
`
`LEGAL STANDARDS ............................................................................ - 19 -
`
`A. Obviousness .................................................................................... - 19 -
`
`VI. FULL STATEMENT OF THE REASONS FOR THE RELIEF
`REQUESTED ........................................................................................... - 21 -
`
`A. GROUND 1: CLAIMS 1 AND 4 ARE UNPATENTABLE AS
`OBVIOUS IN VIEW OF YAMAMOTO IN COMBINATION
`WITH JAPANESE PHARMACOPEIA ........................................ - 21 -
`
`1.
`
`2.
`
`3.
`
`4.
`
`Brief Summary of Yamamoto .............................................. - 21 -
`
`Brief Summary of Japanese Pharmacopeia ......................... - 22 -
`
`Claim 1 ................................................................................. - 22 -
`
`Claim 4 ................................................................................. - 33 -
`
`B.
`
`GROUND 2: CLAIMS 1 AND 4 ARE UNPATENTABLE AS
`OBVIOUS IN VIEW OF GREMINGER ...................................... - 41 -
`
`1.
`
`2.
`
`3.
`
`Brief Summary of Greminger .............................................. - 41 -
`
`Claim 1 ................................................................................. - 41 -
`
`Claim 4 ................................................................................. - 48 -
`
`C.
`
`THE PROPOSED GROUNDS FOR REJECTION ADDRESS
`PATENTEE’S ASSERTED UNEXPECTED BENEFIT OF
`SHELL CLARITY AND STABILITY .......................................... - 51 -
`
`VII. CONCLUSION ......................................................................................... - 55 -
`
`
`
`ii
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`

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`Petition for Inter Partes Review of U.S. Patent No. 6,649,180
`
`EXHIBIT LIST
`
`Exhibit No. Description
`
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`1013
`
`1014
`
`
`
`United States Patent No. 6,649,180
`
`Complaint, Warner Chilcott (US), LLC et al. v. Mylan
`Pharmaceuticals, Inc., et al., Case No. 2:15-cv-01740-JRG-RSP
`(E.D. Texas)
`
`Proof of Service of Complaint, Case No. 2:15-cv-01740-JRG-
`RSP (E.D. Texas)
`
`United States Patent No. 5,756,123 (“Yamamoto”)
`
`The Japanese Pharmacopeia (The Society of Japanese
`Pharmacopeia, 13th ed. 1996) (“Japanese Pharmacopeia”)
`
`United States Patent No. 3,493,407 (“Greminger”)
`
`21 C.F.R. § 172.874 (1998)
`
`National Formulary (American Pharmaceutical Association,
`12th ed. 1965)
`
`Handbook of Pharmaceutical Excipients (1986)
`
`File History of United States Patent No. 6,649,180
`
`Expert Declaration of Arthur H. Kibbe
`
`Shin-Etsu Chemical Co., Ltd. PHARMACOAT Technical
`Information
`Shin-Etsu Chemical Co., Ltd. TC-5 Technical Information
`
`Chichester, C.O., E.M. Mrak, and G.F. Stewart, “Utilization of
`Synthetic Gums in the Food Industry,” Advances in Food
`Research, Volume 12, Technical Center, General Foods
`Corporation, Tarrytown, N.Y., 1963.
`
`Deposition Transcript of Jason T. McConville, Ph.D., Case No.
`2:15-cv-1471-JRG-RSP (E.D. Tex.), July 8, 2016
`
`iii
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`

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`Petition for Inter Partes Review of U.S. Patent No. 6,649,180
`
`
`
`
`
`iv
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`

`
`Petition for Inter Partes Review of U.S. Patent No. 6,649,180
`
`I.
`
`INTRODUCTION
`
`Through counsel, real parties in interest Mylan Pharmaceuticals Inc.
`
`(“Mylan” or “Petitioner”) hereby respectfully petitions for institution of inter
`
`partes review of U.S. Patent No. 6,649,180 (the “’180 Patent”), titled “HARD
`
`CAPSULE FORMED OF CELLULOSE ETHER FILM WITH A SPECIFIC
`
`CONTENT OF METHOXYL AND HYDROXYPROPOXYL GROUPS.” Ex.
`
`1001. The ’180 Patent is currently asserted in a co-pending litigation, and this
`
`petition is being filed within one year of Petitioner being served with a complaint
`
`for infringement. See Ex. 1002. Thus, the ’180 Patent is eligible for inter partes
`
`review.
`
`II. MANDATORY NOTICES UNDER 37 C.F.R. § 42.8(B)
`
`A. REAL PARTY IN INTEREST
`
`The following real parties-in-interest are identified: Mylan Pharmaceuticals
`
`Inc., which is the Petitioner in this matter, and Mylan Laboratories Limited, both of
`
`which are wholly owned subsidiaries of Mylan Inc.; Mylan Inc., which is an
`
`indirectly wholly owned subsidiary of Mylan N.V.; and Mylan N.V.
`
`B. RELATED MATTERS
`
`The ‘180 Patent is the subject of a civil action filed by Warner Chilcott (US),
`
`LLC, Warner Chilcott Company, LLC, and Qualicaps Co., Ltd. against Mylan
`
`Pharmaceuticals, Inc., Mylan Laboratories Ltd., and Mylan, Inc. This lawsuit was
`
`
`
`- 1 -
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`

`
`Petition for Inter Partes Review of U.S. Patent No. 6,649,180
`
`filed in the United States District Court for the Eastern District of Texas on
`
`November 9, 2015. Warner Chilcott (US), LLC et al. v. Mylan Pharmaceuticals,
`
`Inc., et al., Case No. 2:15-cv-01740-JRG-RSP (consolidated for the purposes of
`
`claim construction and discovery with Case No. 2:15-cv-01471-JRG-RSP).
`
`Ex. 1002. Qualicaps is the owner of the ’180 Patent. Warner Chilcott Company,
`
`LLC has an exclusive license to manufacture a drug called DELZICOL® under the
`
`’180 Patent. Rejection and cancellation of Claims 1 and 4 of the ’180 Patent will
`
`prevent Patent Owner from claiming technologies in the public domain as its own
`
`and prevent it from asserting these invalid claims to exclude others in commerce.
`
`The following pending actions also involve the ’180 Patent: Warner
`
`Chilcott (US), LLC et al. v. Teva Pharmaceuticals USA, Inc. et al., Case No. 2:15-
`
`cv-01471-JRG-RSP (consolidated with Case No. 2:15-cv-01740-JRG-RSP) (E.D.
`
`Tex.), Warner Chilcott (US), LLC et al. v. Zydus Pharmaceuticals (USA) Inc. et
`
`al., Case No. 2:16-cv-00323-JRG-RSP (E.D. Tex.), and Warner Chilcott (US),
`
`LLC et al. v. Teva Pharmaceuticals USA, Inc. et al., Case No. 1:15-cv-00761-GMS
`
`(D. Del.).
`
`C.
`
`PAYMENT OF FEES
`
` A payment of $23,000 may be charged against Deposit Account No. 20-
`
`1430. Thus, this Petition meets the fee requirements under 37 C.F.R. § 42.15 and
`
`35 U.S.C. § 312(a)(1).
`
`
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`Petition for Inter Partes Review of U.S. Patent No. 6,649,180
`
`D. DESIGNATION OF LEAD COUNSEL
`
`Lead Counsel for Petitioner is Mitchell G. Stockwell (Reg. No. 39,389), of
`
`Kilpatrick Townsend & Stockton LLP. David C. Holloway (Reg. No. 58,011),
`
`Miranda C. Rogers (Reg. No. 73,339), and Jonathan D. Olinger (pro hac vice to be
`
`filed) also of Kilpatrick Townsend & Stockton LLP are Backup Counsel for
`
`Petitioner.
`
`E.
`
`SERVICE INFORMATION
`
`As identified in the attached Certificate of Service, a copy of this Petition, in
`
`its entirety, is being served to the address of the attorney or agent of record in the
`
`Patent Office for the ’180 Patent, as well as counsel of record for the Patent Owner
`
`in the above-referenced litigation. Counsel for Petitioner may be contacted via the
`
`methods below:
`
`Mitchell G. Stockwell
`Registration No. 39,389
`Kilpatrick Townsend & Stockton LLP
`1100 Peachtree Street, Suite 2800
`Atlanta, GA 30309-4528
`(404) 815-6500 (telephone)
`(404) 541-3403 (facsimile)
`
`
`
`David C. Holloway
`Registration No. 58,011
`Kilpatrick Townsend & Stockton LLP
`1100 Peachtree Street, Suite 2800
`Atlanta, GA 30309-4528
`(404) 815-6500 (telephone)
`(404) 541-3403 (facsimile)
`
`Miranda C. Rogers
`Registration No. 73,339
`Kilpatrick Townsend & Stockton LLP
`1400 Wewatta Street, Suite 600
`Denver, CO 80202
`(303) 571-4000 (telephone)
`(303) 571-4321 (facsimile)
`
`- 3 -
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`

`
`Petition for Inter Partes Review of U.S. Patent No. 6,649,180
`
`Jonathan D. Olinger (pro hac vice to be
`filed)
`Kilpatrick, Townsend & Stockton LLP
`1100 Peachtree Street, Suite 2800
`Atlanta, GA 30309-4528
`(404) 815-6500 (telephone)
`(404) 541-3403 (facsimile)
`
`The following email address may be used for service and all
`
`communications to both Lead and Backup Counsel:
`
`Mylan-WC-IPR@kilpatricktownsend.com
`
`F.
`
`POWER OF ATTORNEY
`
`Pursuant to 37 C.F.R. § 42.10(b), a Power of Attorney executed by
`
`Petitioner for appointing the above designated counsel is concurrently filed.
`
`III. REQUIREMENTS FOR INTER PARTES REVIEW
`
`This Petition meets and complies with all requirements under 37 C.F.R.
`
`§ 42.104 for inter partes review of Claims 1 and 4 of the ’180 Patent.
`
`A. GROUND FOR STANDING
`
`Pursuant to 37 C.F.R. § 42.104(a), Petitioner certifies that the ’180 Patent is
`
`available for inter partes review, and further certifies that Petitioner is not barred
`
`or estopped from requesting an inter partes review challenging the ’180 Patent on
`
`the grounds identified herein. The ’180 Patent has not been subject to a previous
`
`estoppel-based proceeding of the AIA, and the Complaint served on Petitioner was
`
`
`
`- 4 -
`
`

`
`Petition for Inter Partes Review of U.S. Patent No. 6,649,180
`
`served within the last twelve months, on November 9, 2015. See Exs. 1002 and
`
`1003.
`
`B.
`
`IDENTIFICATION OF CHALLENGE
`
`Pursuant to 37 C.F.R. § 42.104(b), the precise relief requested by Petitioner
`
`is that the Patent Trial and Appeal Board invalidate Claims 1 and 4 of the ’180
`
`Patent.
`
`1.
`
`Claims Challenged
`
`Claims 1 and 4 of the ’180 are challenged in this Petition.
`
`2.
`
`Background of the Technology
`
`Medicinal capsules have been around for more than a century. Originally,
`
`the capsules were made out of gelatin, which is derived from collagen from animal
`
`by-products. It is essentially the same material used to make foods such as
`
`marshmallows and JELL-O. Ex. 1011 at ¶ 19.
`
`The manner in which gelatin was made into capsules is similar in many
`
`regards to processes used today, using other materials. Id. at ¶ 20. First, one
`
`makes a mixture of approximately 30% gelatin and 70% hot water. Id. This forms
`
`a viscous hot mixture. Id. For opaque and/or colored capsules an opacifying
`
`agent, dye, pigment, and other addenda are added. Id. Room temperature stainless
`
`steel pins then are dipped into the hot liquid. Id. Gelatin adheres to the surface of
`
`the pins forming a film for use as the hard capsule. Id. The film is dried to remove
`
`
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`Petition for Inter Partes Review of U.S. Patent No. 6,649,180
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`excess water and stripped off the pin, forming the cap and body of the capsule. Id.
`
`The body and cap of the capsule are filled with a pharmaceutical compound and
`
`joined together. Id.
`
`A temperature difference resulting from heating the mixture and then
`
`cooling the mixture by introducing the cooler, room temperature pins allows the
`
`gelatin molecules to cross-link and bind to one another. Id. at ¶ 21.
`
`There were several problems with the use of gelatin. One concern is that
`
`gelatin capsule were made from animal products. Id. at ¶ 22. The pharmaceutical
`
`industry identified cellulose ethers as one material that could replace gelatin
`
`capsules. Id. Cellulose ethers are derived from plant materials and can be
`
`manipulated into plastic films that make up capsule caps and bodies. Id. One such
`
`cellulose ether is hydroxypropylmethylcellulose (“HPMC”). Id. Two common,
`
`but vastly different, ways of creating HPMC capsules were developed: thermal
`
`gelling and additive gelling. Id.
`
`a.
`In this method, no additives are utilized to form capsule films. U.S. Patent
`
`Thermal Gelling
`
`No. 3,493,407 (“Greminger”), a prior art reference discussed in greater detail
`
`herein, discloses a method of thermal gelling in which pins are dipped into a
`
`warmed aqueous solution and transferred to an oven for several minutes until dry.
`
`Ex. 1006 at col. 3, line 60-col. 4, line 70.
`
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`Petition for Inter Partes Review of U.S. Patent No. 6,649,180
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`
`
`Likewise, in a method primarily utilized by Capsugel Belgium NV, the
`
`stainless steel pins used to form and shape the HPMC capsule films are preheated
`
`above HPMC’s gelation temperature. Id. at ¶ 23. The pins are dipped into a cooler
`
`solution of HPMC dispersed in the solvent water. Id. The pins are removed from
`
`the aqueous solution, with an HPMC film having formed on the surface of the pins.
`
`Id. The gel capsule pieces are dried at a particular temperature and humidity to
`
`allow the HPMC to gel and dry on the pin. Id. The HPMC capsule shells are then
`
`removed. Id.
`
`HPMC-only capsules form gels that can be made into capsule films when
`
`HPMC is dissolved in water and then heated. Id. at ¶ 24. No other chemicals or
`
`reagents are added to the system.1 Id. Water is present in the system as the solvent
`
`to disperse the HPMC. Id. The heat needed to cause the HPMC to gel is added to
`
`the system by dipping pins that are heated above the gelling temperature of the
`
`HPMC dispersed in the water solvent. Id. The energy around the pins then leads
`
`to the HPMC molecules exposing their hydrophobic units. Id. The HPMC
`
`molecules then organize by aligning their hydrophobic units. Id. This
`
`
`1 Nonetheless, Patent Owner’s exclusive licensee has accused the capsules made
`
`from this process as infringing in the underlying litigation.
`
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`Petition for Inter Partes Review of U.S. Patent No. 6,649,180
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`organization leads to the gelling of HPMC. Id. The HPMC-only capsules formed
`
`from this thermal gelation process possess many advantages over gelatin capsules.
`
`Id. at ¶ 25. Because they are derived from vegetable sources, they may be more
`
`widely accepted by customers, including those in cultures that rely primarily on
`
`vegetable sources for nutrition or that have strict regulations on materials from
`
`animal sources. Id.
`
`b.
`As discussed above, capsule films made from gelatin include animal
`
`Additive Gelling
`
`products and there was a desire to remove animal products from capsule films. Id.
`
`at ¶ 27. However, the thermal gelling process used for pure-HPMC films requires
`
`modification to the existing capsule forming equipment, such as the use of heated
`
`dipping pins versus the room temperature pins used for gelatin based capsules. Id.
`
`As described in the ’180 Patent, the capsule films made using the described
`
`additive gelling process made use of existing equipment. See Ex. 1001 at col. 4,
`
`lines 54-59 (“for example, the film can be prepared in the form of capsule shells by
`
`a well-known dipping method as in the manufacture of conventional gelatin
`
`capsules.”); see also Ex. 1011 at ¶ 28.
`
`Unlike the pure HPMC capsule films described above, the capsule film of
`
`the ’180 patent comprises three main ingredients: a specific HPMC base, a gelling
`
`agent, and a gelling aid. Ex. 1001 at col. 2, lines 54-57; see also Ex. 1011 at ¶ 29.
`
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`Petition for Inter Partes Review of U.S. Patent No. 6,649,180
`
`As the patent describes, a composition of these ingredients “prevents the gelling
`
`aid from precipitating out and maintains a favorable outer appearance during long-
`
`term storage.” Ex. 1001 at col. 2, lines 13-15; see also Ex. 1011 at ¶ 29. The
`
`specific HPMC base (made up of specified functional substitutions of
`
`hydroxyproypl and methoxy groups), which gels via promotion by the gelling
`
`agent, ensures that the gelling aid stays in ion form in the film to keep it from
`
`precipitating out. Ex. 1001 at col. 2, lines 46-49; see also Ex. 1011 at ¶ 29.
`
`Unlike the pure HPMC capsule film where the film solution is roughly at
`
`room temperature and the pins dipped into the solution are heated, the films
`
`formed according to the ’180 Patent involve dipping room temperature pins into a
`
`heated dispersion of the necessary ingredients. Ex. 1011 at ¶ 30. The ’180 Patent
`
`states “the cellulose ether [HPMC base], gelling agent, gelling aid[,] and optional
`
`additives are dissolved in water in appropriate amounts . . . to form a dipping
`
`solution, capsule-forming pins are dipped in the dipping solution, then drawn out
`
`of the solution.” Ex. 1001 at col. 4, lines 59-64; see also Ex. 1011 at ¶ 30. The
`
`’180 Patent does not describe thermal gelling films. See generally Ex. 1001; see
`
`also Ex. 1011 at ¶ 31. The described films instead make use of the gelling
`
`mechanism akin to that of gelatin through the use of gelling agents that enhance
`
`the gelling properties of HPMC. Ex. 1011 at ¶ 31.
`
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`Petition for Inter Partes Review of U.S. Patent No. 6,649,180
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`The method described in the ’180 Patent begins with dissolving HPMC in
`
`the solvent water at about room temperature. Id. at ¶ 32. To that aqueous solution,
`
`a gelling agent, such as the family of compounds listed in the ’180 Patent,
`
`including carrageenan, is added. Id. Also added to the aqueous solution are
`
`potassium ions in the form of potassium chloride. Id. The potassium ions serve as
`
`the gelling aid as described in the specification. Id. The temperature of the
`
`solution is raised, just as it is for gelatin. Id. Then, cooler, room-temperature pins
`
`are lowered into the solution. Id. The film solution adheres to the outside of the
`
`pins and, as the solution cools, the carrageenan molecules associate –association
`
`that is facilitated by the potassium ions – and serve as the lattice on which the
`
`HPMC solution gels and forms a film. Id.
`
`The underlying chemistry in the shell of the ’180 Patent differs from a pure-
`
`HPMC base film. Id. at Ex. 33. As detailed above, in the pure-HPMC base film,
`
`the HPMC molecules cross-link to form the gel. Id. In the ’180 Patent, the
`
`carrageenan molecules begin to gel as the temperature of the solution drops just as
`
`gelatin does, and, in doing so, forms a substrate that orients and constrains the
`
`HPMC molecules so that the film as a whole can gel. Id. The ’180 Patent explains
`
`that the gel is easier to control because of the action of the gelling agent and
`
`gelling aid. See Ex. 1001 at col. 3, lines 62-66; see also Ex. 1011 at ¶ 33.
`
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`Petition for Inter Partes Review of U.S. Patent No. 6,649,180
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`The resulting film is dried and used as a hard capsule film to contain an
`
`active ingredient in a pharmaceutical dosage form. Ex. 1011 at ¶ 34. The ’180
`
`Patent makes this clear. Id. at col. 4, line 67-col. 5, line 4 (“The shells are then cut
`
`. . . and mated to construct hard capsules of the cellulose ether film according to
`
`the invention.”); col. 6, lines 26-28; see also Ex. 1011 at ¶ 34. The claims of the
`
`’180 Patent further confirm that the described invention is a composition that
`
`makes up the final hard capsule. Ex. 1001 at Claim 1 (“[a] hard capsule formed of
`
`a film composition comprising . . . .”); see also Ex. 1011 at ¶ 35. The presence of
`
`the gelling agent in the finished capsule is important because the ’180 Patent
`
`makes clear that too little gelling agent “may achieve a lower degree of gelation
`
`and fail to produce a film of sufficient thickness to enable shell formation by the
`
`dipping method.” Ex. 1001 at col. 4, lines 11-14; see also Ex. 1011 at ¶ 36.
`
`Similarly, the presence of the gelling aid in the finished capsule is important in
`
`that, if too little gelling aid is used, the gelling aid “may promote gelation of the
`
`gelling agent to a less extent and fail to produce a film of a sufficient thickness to
`
`enable shell formation by the dipping method.” Ex. 1001 at col. 4, lines 40-43; see
`
`also Ex. 1011 at ¶ 36. And while the amount of the “gelling agent” and “gelling
`
`aid” is stated as “not critical”, the ’180 Patent makes clear that both have important
`
`and necessary purposes in the composition. Ex. 1001 at col. 4, lines 4-48; see also
`
`Ex. 1011 at ¶ 36.
`
`
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`Petition for Inter Partes Review of U.S. Patent No. 6,649,180
`
`3.
`
`Prior Art
`
`The prior art references relied on are:
`
`• United States Patent No. 5,756,123 (“Yamamoto”);
`
`• United States Patent No. 3,493,407 (“Greminger”); and
`
`• The Japanese Pharmacopeia (The Society of Japanese Pharmacopeia,
`
`13th ed. 1996) (“Japanese Pharmacopeia”)
`
`a.
`
`Yamamoto as Prior Art Under 35 U.S.C. § 102(a) and
`§ 102(e).
`
`Yamamoto was issued on May 26, 1998. See Ex. 1004. Yamamoto is thus
`
`prior art to the ’180 Patent pursuant to § 102(a) and § 102(e).
`
`b.
`
`Japanese Pharmacopeia as Prior Art Under 35 U.S.C.
`§ 102(a) and § 102(b).
`Japanese Pharmacopeia was published on April 1, 1996. See Ex. 1005.
`
`Japanese Pharmacopeia is thus prior art to the ’180 Patent pursuant to § 102(a) and
`
`§ 102(b).
`
`c.
`
`Greminger as Prior Art Under 35 U.S.C. § 102(a) and
`§ 102(b).
`Greminger was issued on February 3, 1970. See Ex. 1006. Greminger is
`
`thus prior art to the ’180 Patent pursuant to § 102(a) and § 102(b).
`
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`Petition for Inter Partes Review of U.S. Patent No. 6,649,180
`
`C.
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED
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`Pursuant to 35 U.S.C. § 311, this Petition requests cancellation of Claims 1
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`and 4 of the ’180 Patent in accordance with one or more of the following grounds,
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`as indicated in the discussion below.
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`Ground 1: Claims 1 and 4 of the ’180 Patent are not patentable as obvious
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`in view Yamamoto in combination with Japanese Pharmacopeia.
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`Ground 2: Claims 1 and 4 of the ’180 Patent are not patentable as obvious
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`in view of Greminger and its inherent disclosures.
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`These two grounds are not redundant for at least the following reason.
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`Yamamoto discloses capsules manufactured through additive gelling process.
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`Ex. 1004 at col. 5, lines 6-19. Greminger, on the other hand, discloses prior art
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`capsules manufactured through the thermal gelling process – without additives and
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`instead uses an HPMC-only base for the capsule film. Ex. 1006 at col. 1, lines 62-
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`col. 2, line 1. Thus, both Ground 1 and Ground 2, as discussed in greater detail
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`herein, invalidate as obvious Claims 1 and 4 of the ‘180 Patent using either method
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`of medicinal capsule manufacture.
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`IV. OVERVIEW OF THE ’180 PATENT
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`A.
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`PRIORITY DATE OF THE ’180 PATENT
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`The ’180 Patent was filed on April 13, 2000, and claims priority to an
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`application filed in Japan, JP 11-106689, filed on April 14, 1999. Ex. 1001. For
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`Petition for Inter Partes Review of U.S. Patent No. 6,649,180
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`purposes of this Petition only, Petitioner assumes the earliest priority date for the
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`’180 Patent is April 14, 1999.
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`B.
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`SUMMARY OF THE ’180 PATENT
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`The ’180 Patent describes a cellulose ether film suited for use in forming
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`pharmaceutical and food hard capsules. Ex. 1011 at ¶ 38. The Abstract of the ’180
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`Patent describes the cellulose ether film as “formed of a composition comprising a
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`cellulose ether as a base in which some of the hydrogen atoms of cellulosic
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`hydroxyl groups are replaced by alkyl groups and/or hydroxyalkyl groups, a
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`gelling agent, and a gelling aid.” Ex. 1001 at Abstract; see also Ex. 1011 at ¶ 38.
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`The Abstract, moreover, describes the “the total content of alkoxyl and
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`hydroxyalkoxyl groups in the cellulose ether [as] limited to 23-37.6% by weight,
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`which is effective for preventing the gelling aid from precipitating out and
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`maintaining a favorable outer appearance during long-term storage.” Ex. 1001 at
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`Abstract; see also Ex. 1011 at ¶ 38.
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`Claim 1 of the ’180 Patent describes the claimed composition, and is
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`reproduced below:
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`A hard capsule formed of a film composition
`comprising a hydroxypropyl methyl cellulose as a base,
`a gelling agent,
`and a gelling aid,
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`Petition for Inter Partes Review of U.S. Patent No. 6,649,180
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`wherein said hydroxypropyl methyl cellulose has a
`content of hydroxypropoxyl groups of at least 4% by
`weight of the hydroxypropyl methyl cellulose and a
`content of methoxyl gropus and hydroxypropoxyl groups
`combined of 23 to 37.6% by weight of the hydroxypropyl
`methyl cellulose.
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`Ex. 1001 at 6:38-45. Claim 4 of the ’180 Patent recites a variation of the film,
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`“wherein the content of methoxyl and hydroxypropoxyl groups combined is 29 to
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`37% by weight of the hydroxypropyl methyl cellulose.” Id. at 6:55-58.
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`C.
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`PERSON OF ORDINARY SKILL IN THE ART
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`One of ordinary skill in the art at time of the earliest effective filing date of
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`the ’180 Patent would have been someone with at least a bachelor’s degree in
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`chemistry, chemical engineering, material engineering, pharmacy, or the
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`equivalent technical degree, and at least two years of industry experience in
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`pharmaceutical formulation. Ex. 1011 at ¶ 41.
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`D. CLAIM CONSTRUCTION
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`Pursuant to 37 C.F.R. § 42.100(b), the claim terms of an unexpired patent
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`subject to inter partes review shall receive the “broadest reasonable construction in
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`light of the specification of the patent in which [they] appear[].” See Cuozzo Speed
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`Tech., LLC v .Lee, 136 S.Ct. 2131, 2142-2146 (2016). In compliance with 37
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`C.F.R. § 42.104(b)(4), Petitioner states that, in general, the “claim terms are
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`presumed to take on their ordinary and customary meaning.” See Changes to
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`Implement Inter Partes Review Proceedings, Post-Grant Review Proceedings, and
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`Transitional Program for Covered Business Method Patents, 77 Fed. Reg. 48699
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`(2012), Response to Comment 35. Where, however, as here, a definition is
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`provided by a patent applicant for a specific claim term, that definition will control
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`interpretation of the term as it is used in the claim. See, e.g., Toro Co. v. White
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`Consolidated Indus., Inc., 199 F.3d 1295, 1301 (Fed. Cir. 1999).
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`All claim terms not specifically addressed below have been accorded their
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`broadest reasonable interpretation in light of the patent specification, including
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`their plain and ordinary meaning, to the extent such a meaning could be
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`determined by a skilled artisan. And, because the standards of claim interpretation
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`used by the courts in patent litigation and by the Board in post-grant proceedings
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`are different, Petitioner expressly reserves the right to present other interpretations
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`at a later time in the district court litigation.2 The interpretation of the claims
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`2 Petitioner notes that, in the co-pending district court litigation, Petitioner
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`advocated for a construction of the terms “gelling agent” and “gelling aid” that
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`could require means-plus-function treatment under 35 U.S.C. § 112, ¶ 6. The
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`potential need for that treatment is brought about by the functional nature of those
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`terms as used in the claims and specification and the potential indefiniteness issues
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`presented herein, either implicitly or explicitly, should not be viewed as
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`constituting, in whole or in part, Petitioner’s own interpretation and/or construction
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`of such claims for the purposes of the underlying litigation. Instead, such
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`constructions in this proceeding should be viewed only as constituting an
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`interpretation of the claims under the “broadest reasonable construction” standard.
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`1.
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`“gelling agent”
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`This claim term is found in claim 1 of the ’180 Patent. The proper
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`construction of this term under the broadest reasonable construction standard is “a
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`substance that increases the amount of gelation.”3 Ex. 1011 at ¶ 50. The ’180
`
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`created by functional claiming. Because Petitioner’s position that the terms may
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`need means-plus-function treatment is brought about because of indefiniteness
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`issues under 35 U.S.C. § 112, and those issues are not properly before the Patent
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`Trial and Appeal Board in an IPR proceeding, Petitioner relies on constructions
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`under the broadest reasonable interpretation and do not contest the definiteness of
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`those terms in this proceeding; instead, those issues are properly left to the district
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`court.
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`3 In the co-pending litigation, Petitioner advocated a construction of “gelling
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`agent” to be “a substance that increases the amount of gelation, as compared to
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`water.”
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`Patent discloses that the function or purpose of the gelling agent is to improve the
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`amount of gelation above and beyond the impact that the solvent has on HPMC’s
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`inherent gelling properties. See Ex. 1001 at col. 3, lines 60-66 (“[C]arrageenan is
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`especially preferred because it has a high gel strength and exhibits good gelling
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`properties in the co-presence of a specific ion so that it may achieve effective
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`gelation even when added in small amounts.”); col. 4, lines 7-17 (“When capsule
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`shells are formed by the well-known dipping method, for example, it is
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`recommended to use about 0.05 to 25 parts, and especially about 0.25 to 15 parts
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`by weight of the gelling agent per 100 parts by weight of the cellulose ether. Less
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`than 0.05 part of the gelling agent may achieve a lower degree of gelation and fail
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`to produce a film of a sufficient thickness to enable shell formation by the dipping
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`method. More than 25 parts of the gelling agent may achieve a too high degree of
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`gelation and provide a dipping solution with a viscosity higher than necessity,
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`making it difficult to form a uniform coat or film.”) (emphasis added); see also Ex.
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`1011 at ¶ 49.
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`2.
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` “gelling aid”
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`This claim term is found in claim 1 of the ’180 Patent. The proper
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`construction of this term under the broadest reasonable construction standard is “a
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`substance that promotes gelation by the gelling agent.” Ex. 1011 at ¶ 51. The
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`patent applicant acted as his own lexicographer in stating that the “gelling aid” is
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`“any substance that can promote gelation by the gelling agent.” See Ex. 1001 at
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`col. 4, lines 18-20; see also Ex. 1011 at ¶ 51.
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`V. LEGAL STANDARDS
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`A. Obviousness
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`A patent is invalid for obviousness “if the differences between the subject
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`matter sought to be patented and the prior art are such that the subject matter as a
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`whole would have been obvious at the time the invention was made to a person
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`having ordinar