Case 2:14-cv-00384-JRG-RSP Document 65 Filed 03/13/15 Page 1 of 8 PageID #: 634
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE EASTERN DISTRICT OF TEXAS
`MARSHALL DIVISION
`
`HYPERION THERAPEUTICS, INC.,
`Plaintiff,
`
`v.
`
`Case No. 2:14-CV-384-JRG-RSP
`
`PAR PHARMACEUTICAL, INC.,
`Defendant.
`
`JOINT CLAIM CONSTRUCTION AND PREHEARING STATEMENT
`
`Pursuant to the Court’s Docket Control Order (D.I. 36) and Local Patent Rule 4-3,
`
`Plaintiff Hyperion Therapeutics, Inc. (“Hyperion”) and Defendant Par Pharmaceutical, Inc.
`
`(“Par”) hereby submit their Joint Claim Construction and Prehearing Statement concerning U.S.
`
`Patent Nos. 8,404,215 (“the ’215 patent”) and 8,642,012 (“the ’012 patent”).
`
`I.
`
`Construction of Claim Terms on which the Parties Agree (L. Pat. R. 4-3(a))
`
`In accordance with Local Patent Rule 4-3(a), the parties agree that the terms below
`
`should be construed as follows:
`
`U.S. Patent No. 8,404,215
`
`Term Identified for Construction
`“35 (cid:541)mol/L” (claim 10)
`
`Joint Proposed Construction
`plain and ordinary meaning
`
`“adjusting” (claims 1, 4, 5, 6, 8, 9, 10, 11)
`
`plain and ordinary meaning
`
`“administering” (claims 1-6, 8-11)
`
`plain and ordinary meaning
`
`“based on” (claim 11)
`
`plain and ordinary meaning
`
`1
`
`1
`
`PAR PHARMACEUTICAL, INC.
`EX. 1022
`
`

`
`Case 2:14-cv-00384-JRG-RSP Document 65 Filed 03/13/15 Page 2 of 8 PageID #: 635
`
`“blood ammonia level” (claims 1-6, 8-11)
`
`“ammonia level in blood”
`
`“combination of two or more” (claim 6)
`
`plain and ordinary meaning
`
`“comparing” (claims 1-6, 8-11)
`
`plain and ordinary meaning
`
`“effective dosage” (claim 11)
`
`“dosage administered in step (c) of claims 1–3,
`which is calculated to decrease the blood
`ammonia level”
`
`“excretion” (claim 11)
`
`plain and ordinary meaning
`
`“fasting blood ammonia level”
`(claims 1-6, 8-11)
`
`“ammonia in blood level measured after
`fasting”
`
`“greater than” (claims 1-6, 8-11)
`
`plain and ordinary meaning
`
`“hepatic encephalopathy” (claim 4)
`
`“a spectrum of neurologic signs and symptoms
`believed to result from hyperammonemia,
`which frequently occur in subjects with
`cirrhosis or certain other types of liver disease”
`
`“mean conversion” (claim 11)
`
`plain and ordinary meaning
`
`“measuring” (claims 1-6, 8-11)
`
`plain and ordinary meaning
`
`“nitrogen retention disorder” (claims 2-6, 8-11)
`
`“nitrogen scavenging drug” (claims 1-6, 8-11)
`
`“a condition associated with elevated blood
`nitrogen / ammonia levels”
`
`“drug that decreases blood nitrogen and/or
`ammonia levels”
`
`“previously been administered”
`(claims 1-6, 8-11)
`
`plain and ordinary meaning
`
`“PAA prodrug” (claims 5, 6, 11)
`
`plain and ordinary meaning
`
`“prior to step (b)” (claim 9)
`
`“prodrug” (claims 5, 6, 11)
`
`“produces” (claim 8)
`
`“subject” (claims 1-6, 8-11)
`
`“urinary” (claim 11)
`
`plain and ordinary meaning
`
`plain and ordinary meaning
`
`plain and ordinary meaning
`
`plain and ordinary meaning
`
`plain and ordinary meaning
`
`2
`
`2
`
`

`
`Case 2:14-cv-00384-JRG-RSP Document 65 Filed 03/13/15 Page 3 of 8 PageID #: 636
`
`U.S. Patent No. 8,642,012
`
`Term Identified for Construction
`“about 60%” (claims 8, 11, 12)
`
`Joint Proposed Construction
`“approximately 60%”
`
`“administering” (claims 8, 11, 12)
`
`plain and ordinary meaning
`
`“based on” (claims 8, 11, 12)
`
`“concentration” (claim 9)
`
`plain and ordinary meaning
`
`plain and ordinary meaning
`
`“determining” (claims 8, 11, 12)
`
`plain and ordinary meaning
`
`“effective dosage” (claims 8, 11, 12)
`
`“dosage calculated to decrease the blood
`ammonia level”
`
`“following administration” (claims 8, 11, 12)
`
`plain and ordinary meaning
`
`“mean conversion of PAA prodrug to urinary
`PAGN” (claims 8, 11, 12)
`
`plain and ordinary meaning
`
`“patient” (claims 8, 11, 12)
`
`“pharmaceutically acceptable salt”
`(claims 8, 11, 12)
`
`“phenylacetic acid (PAA) prodrug”
`(claims 8, 11, 12)
`
`plain and ordinary meaning
`
`plain and ordinary meaning
`
`plain and ordinary meaning
`
`“phenylbutyric acid” (claims 8, 11, 12)
`
`plain and ordinary meaning
`
`“prodrug” (claims 8, 11, 12)
`
`“produces” (claim 12)
`
`plain and ordinary meaning
`
`plain and ordinary meaning
`
`“urinary PAGN excretion” (claims 8, 11, 12)
`
`plain and ordinary meaning
`
`II.
`
`Proposed Constructions of Disputed Claim Terms (L. Pat. R. 4-3(b))
`
`In accordance with Local Patent Rule 4-3(b), the parties propose the following
`
`constructions for the disputed claim terms identified below:
`
`3
`
`3
`
`

`
`Case 2:14-cv-00384-JRG-RSP Document 65 Filed 03/13/15 Page 4 of 8 PageID #: 637
`
`U.S. Patent No. 8,404,215
`
`Term Identified for
`Construction
`“adjusted dosage”
`(claims 1, 3-6, 8-11)
`
`Hyperion’s Proposed
`Construction
`“second dosage”
`
`Par’s Proposed Construction
`
`“a different dose than the
`initial dose”
`
`“determining an upper limit of
`normal” (claim 9)
`
`“determining the highest level
`in the range of normal values”
`
`indefinite
`
`“half the upper limit of
`normal” (claims 1-6, 8-11)
`
`“half the highest level in the
`range of normal values”
`
`indefinite
`
`“initial dosage”
`(claims 1, 3-6, 8-11)
`
`“normal average daily
`ammonia level” (claim 8)
`
`“first dosage”
`
`“starting dosage”
`
`indefinite
`
`plain and ordinary meaning
`To the extent additional
`construction is necessary: “an
`average daily blood ammonia
`level within the range of
`normal values”
`
`“treating” (claims 3-6, 8-11)
`
`plain and ordinary meaning
`
`“decreasing the blood nitrogen
`and/or ammonia level”
`
`“upper limit of normal”
`(claims 1-6, 8-11)
`
`“the highest level in the range
`of normal values”
`
`indefinite
`
`“urea cycle disorder” (claim 4)
`
`“urinary PAGN of 60-75%”
`(claim 11)
`
`“an inherited deficiency of an
`enzyme or transporter
`necessary for the synthesis of
`urea from ammonia, including
`enzymes involved in the urea
`cycle”
`
`plain and ordinary meaning
`
`“deficiency in the synthesis of
`urea from ammonia”
`
`“urinary PAGN about 60-75%
`This construction is informed
`by the prosecution history of
`the ’012 patent.
`
`4
`
`4
`
`

`
`Case 2:14-cv-00384-JRG-RSP Document 65 Filed 03/13/15 Page 5 of 8 PageID #: 638
`
`U.S. Patent No. 8,642,012
`
`Term Identified for
`Construction
`“first dosage”
`(claims 8, 11, 12)
`
`“normal plasma ammonia
`level” (claim 12)
`
`“urea cycle disorder”
`(claims 8, 11, 12)
`
`Hyperion’s Proposed
`Construction
`plain and ordinary meaning
`
`Par’s Proposed Construction
`
`indefinite
`
`plain and ordinary meaning
`
`indefinite
`
`“deficiency in the synthesis of
`urea from ammonia”
`
`“an inherited deficiency of an
`enzyme or transporter
`necessary for the synthesis of
`urea from ammonia, including
`enzymes involved in the urea
`cycle.”
`
`As required by Local Patent Rule 4-3(b), Exhibit A provides Hyperion’s proposed
`
`constructions for each of these terms and identifies the intrinsic and extrinsic evidence on which
`
`Hyperion intends to rely to support its proposed constructions or to oppose Par’s proposed
`
`constructions. In addition to the documentary evidence listed in Exhibit A, Hyperion intends to
`
`rely on a written declaration by its expert witness, Dr. Gregory Enns, as described in section IV,
`
`below.
`
`As required by Local Patent Rule 4-3(b), Exhibit B provides Par’s proposed constructions
`
`for each of these terms and identifies the intrinsic and extrinsic evidence on which Par intends to
`
`rely to support its proposed constructions or to oppose Hyperion’s proposed constructions. In
`
`addition to the documentary evidenced listed in Exhibit B, Par may rely on a written declaration
`
`by its expert witness, Dr. V. Reid Sutton, as described in section IV, below.
`
`III.
`
`Anticipated Time Needed for the Claim Construction Hearing (L. Pat. R. 4-3(c))
`
`The parties estimate that the claim construction hearing will require approximately 3
`
`hours, divided equally between Par (1.5 hours) and Hyperion (1.5 hours).
`
`5
`
`5
`
`

`
`Case 2:14-cv-00384-JRG-RSP Document 65 Filed 03/13/15 Page 6 of 8 PageID #: 639
`
`IV.
`
`Identification of Witnesses for the Claim Construction Hearing (L. Pat. R. 4-3(d))
`
`Hyperion does not intend to call any witnesses at the Claim Construction Hearing.
`
`However, Hyperion intends to rely on a written declaration by its expert witness, Dr. Gregory
`
`Enns, in support of its constructions. Dr. Enns’s declaration will address: background
`
`information on urea cycle disorders and other nitrogen retention disorders; the definition of a
`
`person of ordinary skill in the art for the ’215 and ’012 patents; the knowledge of a person of
`
`ordinary skill in the art as to treatment options and practices for urea cycle and other nitrogen
`
`retention disorders; and how a person of ordinary skill in the art would understand the proposed
`
`claim terms. Dr. Enns will opine on each of the disputed claim terms. Dr. Enns may also
`
`respond to any opinions offered by Par’s experts.
`
`Par does not intend to call any witnesses at the Claim Construction Hearing. However,
`
`Par may rely on a written declaration by its expert witness, Dr. V. Reid Sutton, in support of its
`
`constructions. Dr. Sutton’s declaration may address: background information on urea cycle
`
`disorders and other nitrogen retention disorders; the definition of a person of ordinary skill in the
`
`art for the ’215 and ’012 patents; the knowledge of a person of ordinary skill in the art as to
`
`treatment options and practices for urea cycle and other nitrogen retention disorders; and how a
`
`person of ordinary skill in the art would understand the proposed claim terms. Dr. Sutton may
`
`opine on each of the disputed claim terms. Dr. Sutton may also respond to any opinions offered
`
`by Hyperion’s experts.
`
`V.
`
`Other Issues for Prehearing Conference and Proposed Dates for Prehearing
`Conference (L. Pat. R. 4-3(e))
`
`Hyperion is unaware of any other issues which might appropriately be taken up at a
`
`prehearing conference prior to the claim construction hearing. Therefore, Hyperion does not
`
`believe that a prehearing conference is required.
`
`6
`
`6
`
`

`
`Case 2:14-cv-00384-JRG-RSP Document 65 Filed 03/13/15 Page 7 of 8 PageID #: 640
`
`Par believes a prehearing conference would be premature at this time given the pending
`
`Par’s Motion To Dismiss Plaintiff’s Complaint Due To Lack of Personal Jurisdiction, Or In The
`
`Alternative, Motion To Transfer Venue (Dkt. No. 18).
`
`Dated: March 13, 2015
`
`/s/ Matthew Kudzin
`
`Melissa R. Smith
`State Bar No. 24001351
`melissa@gillamsmithlaw.com
`Harry L. Gillam, Jr.
`State Bar No. 07921800
`gil@gillamsmithlaw.com
`Gillam & Smith, LLP
`303 S. Washington Ave.
`Marshall, Texas 75670
`Telephone: (903) 934-8450
`Facsimile: (903) 934-9257
`
`George F. Pappas
`gpappas@cov.com
`Christopher N. Sipes
`csipes@cov.com
`Matthew Kudzin
`mkudzin@cov.com
`COVINGTON & BURLING LLP
`850 Tenth St., N.W.
`Washington, D.C. 20001
`Tel: (202) 662-6000
`
`Attorneys for Plaintiff
`
`/s/ Peter Giunta with permission by
`Michael E. Jones
`
`Michael E Jones
`mikejones@potterminton.com
`Patrick Colbert Clutter, IV
`patrickclutter@potterminton.com
`POTTER MINTON, a Professional
`Corporation
`110 N College Avenue, Suite 500
`Tyler, TX 75702
`
`Michael J. Freno (pro hac admitted)
`Harold M. Storey (pro hac admitted)
`michael.freno@klgates.com
`harold.storey@klgates.com
`K&L GATES LLP
`925 Fourth Avenue
`Suite 2900
`Seattle, Washington 98104
`206.623.7580 (tel)
`
`Peter Giunta (pro hac admitted)
`peter.giunta@klgates.com
`K&L GATES LLP
`599 Lexington Avenue
`New York, New York 10022
`
`Attorneys for Defendant
`
`7
`
`7
`
`

`
`Case 2:14-cv-00384-JRG-RSP Document 65 Filed 03/13/15 Page 8 of 8 PageID #: 641
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that all counsel of record who are deemed to have
`
`consented to electronic service are being served with a copy of this document via the Court’s
`
`CM/ECF system per Local Rule CV-5(a)(3) this 13th day of March, 2015.
`
`/s/ Melissa R. Smith
`Melissa R. Smith
`
`8
`
`8
`
`

`
`Exhibit A
`
`9
`
`Case 2:14-cv-00384-JRG-RSP Document 65-1 Filed 03/13/15 Page 1 of 7 PageID #: 642
`
`

`
`1
`
`Mol. Genet. Metab. 323 (2011).
`Sodium Phenylbutyrate and Glycerol Phenylbutyrate, 103
`Urea Cycle Disorders (UCDs); Phase 2 Comparison of
`Lichter-Konecki et al., Ammonia Control in Children with
`Ammonia Control, 100 Mol. Genet. Metab. 221 (2010).
`with Urea Cycle Disorders: Safety, Pharmacokinetics and
`Scavenging Agent with Sodium Phenylbutyrate in Patients
`Lee et al., Phase 2 Comparison of a Novel Ammonia
`Disease in Children.
`Geraghty & Brusilow, Disorders of the Urea Cycle, in Liver
`12:18–56,15:34–36, 16:26–32, Fig. 1.
`’215 patent, 1:14–3:5, 3:21–22, 3:47–48, 4:10–11, 4:48–53,
`
`Webster’s Unabridged Dictionary585 (2nd ed. 2001).
`10:26–31,15:1–19:14, Figs. 1–3.
`7:27–58, 8:46–59, 8:60–9:7, 9:2–20, 9:21–36, 9:37–54,
`’215 patent, 1:14–3:5, 4:39–5:27, 5:63–6:9, 6:55–67, 7:1–13,
`
`10
`
`range of normal values”
`“determining the highest level in the
`
`(claim 9)
`of normal”
`“determining an upper limit
`
`“second dosage”
`
`(claims 1, 3-6, 8-11)
`“adjusted dosage”
`
`Supporting Evidence
`
`Hyperion’sProposed Construction
`
`Claim Term
`
`U.S. Patent No. 8,404,215
`
`Case 2:14-cv-00384-JRG-RSP Document 65-1 Filed 03/13/15 Page 2 of 7 PageID #: 643
`
`

`
`2
`
`Webster’s Unabridged Dictionary585 (2nd ed. 2001).
`8:60–9:7, 9:21–36, 10:26–31, Fig 1.
`’215 patent, 1:14–3:5, 4:39–5:27, 5:63–6:9, 7:27–40, 7:41–58,
`
`Mol. Genet. Metab. 323 (2011).
`Sodium Phenylbutyrate and Glycerol Phenylbutyrate, 103
`Urea Cycle Disorders (UCDs); Phase 2 Comparison of
`Lichter-Koneck et al., Ammonia Control in Children with
`Ammonia Control, 100 Mol. Genet. Metab. 221 (2010).
`with Urea Cycle Disorders: Safety, Pharmacokinetics and
`Scavenging Agent with Sodium Phenylbutyrate in Patients
`Lee et al., Phase 2 Comparison of a Novel Ammonia
`Disease in Children.
`Geraghty & Brusilow, Disorders of the Urea Cycle, in Liver
`12:18–56, 15:34–36, 16:26–32, Fig. 1.
`’215 patent, 1:14–3:5, 3:21–22, 3:47–48, 4:10–11, 4:48–53,
`
`“first dosage”
`
`(claims 1, 3-6, 8-11)
`“initial dosage”
`
`11
`
`normal values”
`“half the highest level in the range of
`
`(claims 1-6, 8-11)
`normal”
`“half the upper limit of
`
`Supporting Evidence
`
`Hyperion’sProposed Construction
`
`Claim Term
`
`Case 2:14-cv-00384-JRG-RSP Document 65-1 Filed 03/13/15 Page 3 of 7 PageID #: 644
`
`

`
`3
`
`Mol. Genet. Metab. 323 (2011).
`Sodium Phenylbutyrate and Glycerol Phenylbutyrate, 103
`Urea Cycle Disorders (UCDs); Phase 2 Comparison of
`Lichter-Konecki et al., Ammonia Control in Children with
`Ammonia Control, 100 Mol. Genet. Metab. 221 (2010).
`with Urea Cycle Disorders: Safety, Pharmacokinetics and
`Scavenging Agent with Sodium Phenylbutyrate in Patients
`Lee et al., Phase 2 Comparison of a Novel Ammonia
`Disease in Children.
`Geraghty & Brusilow, Disorders of the Urea Cycle, in Liver
`12:18–56, 15:34–36, 16:26–32, Fig. 1.
`’215 patent, 1:14–3:5, 3:21–22, 3:47–48, 4:10–11, 4:48–53,
`
`21:21–22:21, Fig. 1.
`’215 patent, 1:14–3:5, 4:39–53, 7:41–58, 9:21–36, 13:32–59,
`
`Mol. Genet. Metab. 323 (2011).
`Sodium Phenylbutyrate and Glycerol Phenylbutyrate, 103
`Urea Cycle Disorders (UCDs); Phase 2 Comparison of
`Lichter-Koneck et al., Ammonia Control in Children with
`Ammonia Control, 100 Mol. Genet. Metab. 221 (2010).
`with Urea Cycle Disorders: Safety, Pharmacokinetics and
`Scavenging Agent with Sodium Phenylbutyrate in Patients
`Lee et al., Phase 2 Comparison of a Novel Ammonia
`Disease in Children.
`Geraghty & Brusilow, Disorders of the Urea Cycle, in Liver
`12:18–56, 12:57–13:31, 15:34–36, 16:26–32, Fig. 1.
`’215 patent, 1:14–3:5, 3:21–22, 3:47–48, 4:48–53, 4:54–5:6,
`
`normal values”
`“the highest level in the range of
`
`(claims 1-6, 8-11)
`“upper limit of normal”
`
`plain and ordinary meaning
`
`(claims 3-6, 8-11)
`“treating”
`
`12
`
`normal values”
`ammonia level within the range of
`is necessary: “an average daily blood
`To the extent additional construction
`plain and ordinary meaning
`
`(claim 8)
`ammonia level”
`“normal average daily
`
`Supporting Evidence
`
`Hyperion’sProposed Construction
`
`Claim Term
`
`Case 2:14-cv-00384-JRG-RSP Document 65-1 Filed 03/13/15 Page 4 of 7 PageID #: 645
`
`

`
`4
`
`40:61–67, Fig. 5, claims 1, 8.
`30, 25:40–67, 26:1–16, 31:7–35:5 (Example 3), 40:33–47,
`13:7–14, 13:60–14:36, 15:39–43, 17:2–9, 23:13–18, 24:27–
`U.S. Patent No. 8,642,012, 1:28–3:5, 3:10–8:14, 9:21–35,
`’215 patent, 1:14–3:5, 3:27–34, 3:52–61,13:60–14:34, Fig. 1.
`
`Childhood, 134 J. Nutrition 1605S (2004).
`Urea Cycle and Related Metabolic Disorders During
`Endo et al., Clinical Manifestations of Inborn Errors of the
`Mol. Genet. Metab. 323 (2011).
`Sodium Phenylbutyrate and Glycerol Phenylbutyrate, 103
`Urea Cycle Disorders (UCDs); Phase 2 Comparison of
`Lichter-Konecki et al., Ammonia Control in Children with
`Ammonia Control, 100 Mol. Genet. Metab. 221 (2010).
`with Urea Cycle Disorders: Safety, Pharmacokinetics and
`Scavenging Agent with Sodium Phenylbutyrate in Patients
`Lee et al., Phase 2 Comparison of a Novel Ammonia
`39:66–40:5, Fig. 1.
`’012 patent 1:18–25, 1:28–3:5, 8:16–46, 8:53–58, 21:42–46,
`’215 patent, 1:14–3:5, 4:22–23, Fig. 1.
`
`plain and ordinary meaning
`
`(claim 11)
`“urinary PAGN of 60-75%”
`
`13
`
`urea cycle”
`including enzymes involved in the
`synthesis of urea from ammonia,
`or transporter necessary for the
`“an inherited deficiency of an enzyme
`
`(claim 4)
`“urea cycle disorder”
`
`Supporting Evidence
`
`Hyperion’sProposed Construction
`
`Claim Term
`
`Case 2:14-cv-00384-JRG-RSP Document 65-1 Filed 03/13/15 Page 5 of 7 PageID #: 646
`
`

`
`5
`
`Mol. Genet. Metab. 323 (2011).
`Sodium Phenylbutyrate and Glycerol Phenylbutyrate, 103
`Urea Cycle Disorders (UCDs); Phase 2 Comparison of
`Lichter-Koneckiet al., Ammonia Control in Children with
`Ammonia Control, 100 Mol. Genet. Metab. 221 (2010).
`with Urea Cycle Disorders: Safety, Pharmacokinetics and
`Scavenging Agent with Sodium Phenylbutyrate in Patients
`Lee et al., Phase 2 Comparison of a Novel Ammonia
`Disease in Children.
`Geraghty & Brusilow, Disorders of the Urea Cycle, in Liver
`41:1–7, Figs. 1, 12, 13.\
`40, 24:49–51, 25:26–39, 27:43–51, 32:53–67, 34:55–35:5,
`’012 patent 1:28–3:5, 12:1–4, 14:64–15:11, 18:32–35, 20:31–
`
`25:3–18, 25:25–39, 40:6–47, Figs. 1, 4
`52, 16:51–17:15, 18:65–19:6, 19:37–40, 20:41–21:6, 23:8–10,
`9:27–35, 9:42–49, 11:24–30, 12:12–16, 12:59–13:14, 15:39–
`’012 patent Abstract, 1:28–3:5, 2:48–3:31, 5:1–7:3, 8:47–53,
`
`plain and ordinary meaning
`
`Supporting Evidence
`
`Hyperion’sProposed Construction
`
`U.S. Patent No. 8,642,012
`
`14
`
`plain and ordinary meaning
`
`(claim 12)
`level”
`“normal plasma ammonia
`
`(claims 8, 11, 12)
`“first dosage”
`
`Claim Term
`
`Case 2:14-cv-00384-JRG-RSP Document 65-1 Filed 03/13/15 Page 6 of 7 PageID #: 647
`
`

`
`6
`
`Childhood, 134 J. Nutrition 1605S (2004).
`Urea Cycle and Related Metabolic Disorders During
`Endo et al., Clinical Manifestations of Inborn Errors of the
`Mol. Genet. Metab. 323 (2011).
`Sodium Phenylbutyrate and Glycerol Phenylbutyrate, 103
`Urea Cycle Disorders (UCDs); Phase 2 Comparison of
`Lichter-Konecki et al., Ammonia Control in Children with
`Ammonia Control, 100 Mol. Genet. Metab. 221 (2010).
`with Urea Cycle Disorders: Safety, Pharmacokinetics and
`Scavenging Agent with Sodium Phenylbutyrate in Patients
`Lee et al., Phase 2 Comparison of a Novel Ammonia
`’215 patent, 1:14–3:5, 4:22–23, Fig. 1.
`39:66–40:5, Fig. 1.
`’012 patent 1:18–25, 1:28–3:5, 8:16–46, 8:53–58, 21:42–46,
`
`urea cycle.”
`including enzymes involved in the
`synthesis of urea from ammonia,
`or transporter necessary for the
`“an inherited deficiency of an enzyme
`
`(claims 8, 11, 12)
`“urea cycle disorder”
`
`15
`
`Supporting Evidence
`
`Hyperion’sProposed Construction
`
`Claim Term
`
`Case 2:14-cv-00384-JRG-RSP Document 65-1 Filed 03/13/15 Page 7 of 7 PageID #: 648
`
`

`
`Exhibit B
`
`16
`
`Case 2:14-cv-00384-JRG-RSP Document 65-2 Filed 03/13/15 Page 1 of 4 PageID #: 649
`
`

`
`1
`
`is definite.
`patent to rebut any of Plaintiff’s arguments alleging the term
`Par reserves the right to use theintrinsic evidence of the ’215
`
`Notice of Allowability dated January 2, 2013, at 2.
`’215 patent at Examples 2–4;
`
`is definite.
`patent to rebut any of Plaintiff’s arguments alleging the term
`Par reserves the right to use the intrinsic evidence of the ’215
`
`is definite.
`patent to rebut any of Plaintiff’s arguments alleging the term
`Par reserves the right to use the intrinsic evidence of the ’215
`
`Notice of Allowability dated January 2, 2013, at 2.
`59, 14:29–33, Examples 2–4;
`’215 patent at 3:63–4:16, 5:15–22, 5:63–8:2, 9:55–65, 13:32–
`
`indefinite
`
`“starting dosage”
`
`indefinite
`
`(claim 8)
`ammonia level”
`“normal average daily
`
`(claims 1, 3-6, 8-11)
`“initial dosage”
`
`(claims 1-6, 8-11)
`normal”
`“half the upper limit of
`
`indefinite
`
`(claim 9)
`of normal”
`“determining an upper limit
`
`17
`
`“a different dose than the initial dose”
`
`(claims 1, 3-6, 8-11)
`“adjusted dosage”
`
`Supporting Intrinsic Evidence
`
`Par’s Proposed Construction
`
`Claim Term
`
`U.S. Patent No. 8,404,215 [Asserted claims: 1–6 and 8–11]
`
`rely upon the intrinsic and extrinsic evidence cited by Hyperion to rebut any arguments advanced by Hyperion.
`also reserves the right to rely upon expert testimony to rebut expert testimony presented by Hyperion. Par also reserves theright to
`proposed constructions up to and including the claim construction discovery deadline should this case proceed in this jurisdiction. Par
`construction brief. Moreover, Par reserves the right to amend and/or supplement the intrinsic and extrinsic evidence supporting its
`
`Par reserves the right to amend its proposed claim constructions up to and including the due date of its responsive claim
`
`Exhibit B: Par’s Proposed Constructions
`
`Case 2:14-cv-00384-JRG-RSP Document 65-2 Filed 03/13/15 Page 2 of 4 PageID #: 650
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`

`
`2
`
`18
`
`Amendment and Response dated December 7, 2012, at 6.
`’215 patent at 13:32–14:20;
`
`prosecution history of the ’012 patent.
`This construction is informed by the
`“urinary PAGN about 60-75%
`
`(claim 11)
`75%”
`“urinary PAGN of 60-
`
`’215 patent at 1:14–43.
`
`from ammonia”
`“deficiency in the synthesis of urea
`
`(claim 4)
`“urea cycle disorder”
`
`is definite.
`patent to rebut any of Plaintiff’s arguments alleging the term
`Par reserves the right to use the intrinsic evidence of the ’215
`
`indefinite
`
`(claims 1-6, 8-11)
`“upper limit of normal”
`
`’215 patent at 1:50–56, 1:60–65, 8:46–9:54, 10:4–19.
`
`ammonia level”
`“decreasing the blood nitrogen and/or
`
`Supporting Intrinsic Evidence
`
`Par’s Proposed Construction
`
`(claims 3-6, 8-11)
`“treating”
`
`Claim Term
`
`Case 2:14-cv-00384-JRG-RSP Document 65-2 Filed 03/13/15 Page 3 of 4 PageID #: 651
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`

`
`3
`
`19
`
`’012 patent at 1:29–59.
`
`from ammonia”
`“deficiency in the synthesis of urea
`
`(claims 8, 11, 12)
`“urea cycle disorder”
`
`is definite.
`patent to rebut any of Plaintiff’s arguments alleging the term
`Par reserves the right to use the intrinsic evidence of the ’012
`
`is definite.
`patent to rebutany of Plaintiff’s arguments alleging the term
`Par reserves the right to use the intrinsic evidence of the ’012
`
`indefinite
`
`indefinite
`
`Supporting Evidence
`
`Par’s Proposed Construction
`
`U.S. Patent No. 8,642,012 [Asserted claims: 8, 11, and 12]
`
`(claim 12)
`level”
`“normal plasma ammonia
`
`(claims 8, 11, 12)
`“first dosage”
`
`Claim Term
`
`Case 2:14-cv-00384-JRG-RSP Document 65-2 Filed 03/13/15 Page 4 of 4 PageID #: 652