Case 1:15-cv-01684-JBS-JS Document 47-1 Filed 09/28/15 Page 1 of 11 PageID: 460
`
`Exhibit A: Parties’ Proposed Constructions and Supporting Evidence
`
`Claim Term: “osmotic-adjusting agent1”
`Recited in ‘094 Patent, claims 1-9
`Recited in ‘540 Patent, claims 6, 12-16
`
`
`
`Defendants’ Supporting Evidence
`
`Intrinsic Evidence
`Specification and Claims
`
`‘094 Patent, Abstract
`’094 Patent Specification
`
`1:62-65
`
`2:27-37
`
`2:60-5:7, Examples 1-3
`
`‘094 Patent Claims
`
`Claim 1
`
`Claim 3
`
`Claim 4
`
`Claim 5
`
`‘540 Patent, Abstract
`‘540 Patent Specification
`
`1:61-67
`
`2:3-13
`
`Defendants’ Proposed
`Construction
`a component that adjusts the
`tonicity (osmotic pressure) of
`the composition
`
`Baxter’s Supporting Evidence
`
`Intrinsic Evidence
`
`‘094 Patent at Abstract, 1:24-2:14,
`2:27-37, 2:62-5:7
`
`‘540 Patent at Abstract, 1:21-67, 2:3-
`13, 3:11-25, 4:14-5:54
`
`Extrinsic Evidence
`
`U.S. Patent No. 4,857,552
`
` 7
`
` Pharmacy-Related General
`Chapters in USP Pharmacists’
`Pharmacopeia, 785, S5/37-39 (USP
`32-NF27) (BXBRV00336102-104)
`
`Remington: The Science and Practice
`of Pharmacy, Ch. 18 at 246-48
`
`Baxter’s Proposed
`Construction
`a discrete component added to
`the composition that adjusts
`the osmotic pressure of the
`composition
`
`
`1The parties note that the Court issued an opinion on September 23, 2015 in the Baxter v. HQ Specialty Pharma Case, wherein the
`court construed the term “osmotic adjusting-agent.” The parties are reviewing and considering the Court’s construction and shall
`advise the Court whether construction of the “osmotic adjusting-agent” remains at issue in the above-captioned cases.
`
`
`
`1
`
`
`
`Exhibit A: Parties’ Proposed Constructions and Supporting Evidence
`
`Claim Term: “osmotic-adjusting agent1”
`Recited in ‘094 Patent, claims 1-9
`Recited in ‘540 Patent, claims 6, 12-16
`
`
`
`Defendants’ Supporting Evidence
`
`Intrinsic Evidence
`Specification and Claims
`
`‘094 Patent, Abstract
`’094 Patent Specification
`
`1:62-65
`
`2:27-37
`
`2:60-5:7, Examples 1-3
`
`‘094 Patent Claims
`
`Claim 1
`
`Claim 3
`
`Claim 4
`
`Claim 5
`
`‘540 Patent, Abstract
`‘540 Patent Specification
`
`1:61-67
`
`2:3-13
`
`Defendants’ Proposed
`Construction
`a component that adjusts the
`tonicity (osmotic pressure) of
`the composition
`
`Baxter’s Supporting Evidence
`
`Intrinsic Evidence
`
`‘094 Patent at Abstract, 1:24-2:14,
`2:27-37, 2:62-5:7
`
`‘540 Patent at Abstract, 1:21-67, 2:3-
`13, 3:11-25, 4:14-5:54
`
`Extrinsic Evidence
`
`U.S. Patent No. 4,857,552
`
` 7
`
` Pharmacy-Related General
`Chapters in USP Pharmacists’
`Pharmacopeia, 785, S5/37-39 (USP
`32-NF27) (BXBRV00336102-104)
`
`Remington: The Science and Practice
`of Pharmacy, Ch. 18 at 246-48
`
`Baxter’s Proposed
`Construction
`a discrete component added to
`the composition that adjusts
`the osmotic pressure of the
`composition
`
`
`1The parties note that the Court issued an opinion on September 23, 2015 in the Baxter v. HQ Specialty Pharma Case, wherein the
`court construed the term “osmotic adjusting-agent.” The parties are reviewing and considering the Court’s construction and shall
`advise the Court whether construction of the “osmotic adjusting-agent” remains at issue in the above-captioned cases.
`
`
`
`1
`
`
`
`Case 1:15-cv-01684-JBS-JS Document 47-1 Filed 09/28/15 Page 2 of 11 PageID: 461
`
`Baxter’s Proposed
`Construction
`
`Baxter’s Supporting Evidence
`
`Defendants’ Proposed
`Construction
`
`Defendants’ Supporting Evidence
`
`(Alfonso R. Gennaro ed., 20th ed.
`2000) (BXBRV00336083-101)
`
`Patent Owner Response, EP 1,368,019
`B1 (BXBRV00000371-93)
`
`Patent Owner Further Submission, EP
`1,368,019 B1 (BXBRV00000425-
`440)
`
`EPO Decision, EP 1,368,019 B1
`(BXBRV00000541-587)
`
`Baxter may also rely on expert
`opinion testimony concerning the
`level of skill possessed by a person of
`ordinary skill in the art and the
`meaning of the term “osmotic-
`adjusting agent” to a person of
`ordinary skill in the art, in view of the
`teachings of the specifications of the
`‘094 and ‘540 patents
`
`
`
`2
`
`3:11-25
`4:13-5:53, Examples 1-3
`
`
`
`
`‘540 Patent Claims
`
`Claim 1
`
`Claim 4
`
`Claim 5
`
`Claim 6
`
`Claim 7
`
`Claim 11
`
`Claim 12
`
`Claim 13
`
`References Cited in Specification
`U.S. Pat. No. 4,857,552 (‘094 Patent,
`1:44, ‘540 Patent, 1:42)
`
`U.S. Pat. No. 5,107,609 (‘540 Patent,
`1:42)
`
`Extrinsic Evidence
`
`Mahesh V. Chaubal Witness
`Statement, Exhibit A1, Opposition to
`EP-B-1,368,019 (2009)
`(BXBRV00000441-462)
`
`Expert Testimony
`Defendants may rely on expert opinion
`and testimony as to the level of skill of
`one of ordinary skill in the art, and
`
`
`
`Case 1:15-cv-01684-JBS-JS Document 47-1 Filed 09/28/15 Page 3 of 11 PageID: 462
`
`Baxter’s Proposed
`Construction
`
`Baxter’s Supporting Evidence
`
`Defendants’ Proposed
`Construction
`
`Defendants’ Supporting Evidence
`
`further that one of ordinary skill in the
`art (1) would have understood the
`claim term “osmotic-adjusting agent”
`to mean “a component that adjusts the
`tonicity (osmotic pressure) of the
`composition,” and (2) would not have
`understood the claim term “osmotic-
`adjusting agent” to mean “a discrete
`component added to the composition
`that adjusts the osmotic pressure of the
`composition.”
`
`
`
`
`
`
`
`
`
`3
`
`
`
`Case 1:15-cv-01684-JBS-JS Document 47-1 Filed 09/28/15 Page 4 of 11 PageID: 463
`
`Claim Term: “aqueous”
`Recited in ‘094 Patent, claims 1-9
`Recited in ‘540 Patent, claims 6, 12-16
`
`
`Baxter’s Proposed Construction
`
`Baxter’s Supporting Evidence
`
`an “aqueous” composition is a solution in
`which water is the solvent
`
`
`
`
`Intrinsic Evidence
`
`‘094 Patent at Abstract, 1:5-11,
`1:25-48, 1:63-2:14, 2:60-5:8
`
`‘540 Patent at Abstract, 1:22-52,
`1:61-67, 2:3-14, 4:13-5:54
`
`Extrinsic Evidence
`
`McGraw-Hill Dictionary of
`Scientific and Technical Terms
`(5th ed. 1994) at 120
`
`Remington: The Science and
`Practice of Pharmacy, Ch. 39
`(Alfonso R. Gennaro ed., 2000)
`
`Robert Shrewsbury, Applied
`Pharmaceutics in Contemporary
`Compounding (2001) at 48-51
`
`De Luca and Boylan,
`Pharmaceutical Dosage Forms:
`Parenteral Medications, vol. 1,
`ch. 5 (1992)
`
`
`4
`
`Defendants’ Proposed
`Construction
`Plain and ordinary meaning
`
`Alternatively, “containing
`water”
`
`Defendants’ Supporting Evidence
`
`Intrinsic Evidence
`Specification and Claims
`
`‘094 Patent, Abstract
`‘094 Patent Specification
`
`1:24-40
`
`1:48-58
`
`1:62-65
`
`2:60-5:7, Examples 1-3
`
`‘094 Patent Claims
`
`Claim 1
`
`Claim 4
`
`‘540 Patent, Abstract
`‘540 Patent Specification
`
`1:22-52
`
`1:61-67
`
`2:3-13
`
`2:30-49
`
`4:13-5:53, Examples 1-3
`
`‘540 Patent Claims
`
`Claim 1
`
`Claim 4
`
`Claim 5
`
`
`
`Case 1:15-cv-01684-JBS-JS Document 47-1 Filed 09/28/15 Page 5 of 11 PageID: 464
`
`Baxter’s Proposed Construction
`
`Baxter’s Supporting Evidence
`
`Defendants’ Proposed
`Construction
`
`Defendants’ Supporting Evidence
`
`Baxter may also rely on expert
`opinion testimony concerning the
`level of skill possessed by a
`person of ordinary skill in the art
`and the meaning of the term
`“aqueous” to a person of ordinary
`skill in the art, in view of the
`teachings of the specifications of
`the ‘094 and ‘540 patents
`
`
`Claim 6
`Claim 7
`Claim 11
`Claim 12
`Claim 13
`
`
`
`
`
`
`
`References Cited in Specification
`U.S. Pat. No. 4,857,552 (‘094 Patent,
`1:44, ‘540 Patent, 1:42)
`
`U.S. Pat. No. 5,107,609 (‘540 Patent,
`1:42)
`
`Extrinsic Evidence
`
`McGraw Hill Dictionary of Chemistry
`(5th ed., 1994), at 28 (produced at
`AGILA_002653 – AGILA_002655).
`
`Concise Chemical and Technical
`Dictionary (Fourth Enlarged Edition,
`1986), at 126 (produced at
`AGILA_002656-AGILA_002658)
`
`Academic Press Dictionary of Science
`and Technology (1996) , at 142
`(produced at AGILA_002659-
`AGILA_002661)
`
`Bailliere’s Nurses’ Dictionary (23rd ed.,
`2002), at 31 (produced at
`
`
`
`5
`
`
`
`Case 1:15-cv-01684-JBS-JS Document 47-1 Filed 09/28/15 Page 6 of 11 PageID: 465
`
`Baxter’s Proposed Construction
`
`Baxter’s Supporting Evidence
`
`Defendants’ Proposed
`Construction
`
`Defendants’ Supporting Evidence
`
`AGILA_002662-AGILA_002664)
`
`Expert Testimony
`Defendants may rely on expert opinion
`and testimony as to the level of skill of
`one of ordinary skill in the art, and further
`that if the claim term “aqueous” is not
`given its plain and ordinary meaning, one
`of ordinary skill in the art (1) would have
`understood the claim term “aqueous” to
`mean “containing water,” and (2) would
`not have understood the claim term
`“aqueous” to mean an ‘aqueous’
`composition is a solution in which water
`is the solvent.”
`
`
`
`
`
`
`
`
`6
`
`
`
`Case 1:15-cv-01684-JBS-JS Document 47-1 Filed 09/28/15 Page 7 of 11 PageID: 466
`
`Baxter’s Proposed Construction
`
`a stable, ready-to-use aqueous parenteral
`solution which has been subjected to
`autoclaving
`
`Claim Term: “injectable, aqueous pharmaceutical composition”
`Recited in ‘094 Patent, claims 1-9
`
`Baxter’s Supporting Evidence
`
`Defendants’ Proposed
`Construction
`Plain and ordinary meaning
`
`Alternatively, “injectable
`pharmaceutical composition
`containing water”
`
`Intrinsic Evidence
`
`‘094 Patent at Abstract, 1:24-59,
`1:62-2:14, 2:38-58, 2:64-5:7
`
`Extrinsic Evidence
`
`Baxter may rely on expert
`opinion testimony concerning the
`level of skill possessed by a
`person of ordinary skill in the art
`and the meaning of the phrase
`“injectable, aqueous
`pharmaceutical compound” to a
`person of ordinary skill in the art,
`in view of the teachings of the
`specification of the ‘094 patent
`
`Defendants’ Supporting Evidence
`
`Intrinsic Evidence
`Specification and Claims
`
`‘094 Patent, Abstract
`‘094 Patent Specification
`
`1:24-58
`
`1:62-2:14
`
`2:38-58
`
`2:60-5:7, Examples 1-3
`
`‘094 Patent Claims
`
`Claim 1
`
`Claim 4
`
`‘540 Patent, Abstract
`‘540 Patent Specification
`
`1:40-52
`
`1:61-67
`
`2:3-13
`
`2:30-49
`
`4:13-5:53, Examples 1-3
`
`‘540 Patent Claims
`
`Claim 1
`
`Claim 4
`
`Claim 5
`
`Claim 6
`
`
`
`7
`
`
`
`Case 1:15-cv-01684-JBS-JS Document 47-1 Filed 09/28/15 Page 8 of 11 PageID: 467
`
`Baxter’s Proposed Construction
`
`Baxter’s Supporting Evidence
`
`Defendants’ Proposed
`Construction
`
`Defendants’ Supporting Evidence
`
`Claim 7
`Claim 11
`Claim 12
`Claim 13
`
`
`
`
`
`
`References Cited in Specification
`U.S. Pat. No. 4,857,552 (‘094 Patent,
`1;44, ‘540 Patent, 1:42)
`
`U.S. Pat. No. 5,107,609 (‘540 Patent,
`1:42)
`
`Extrinsic Evidence
`Expert Testimony
`Defendants may rely on expert opinion
`and testimony as to the level of skill of
`one of ordinary skill in the art, and further
`that if the claim term “injectable, aqueous
`pharmaceutical composition” is not given
`its plain and ordinary meaning, one of
`ordinary skill in the art (1) would have
`understood the claim term “injectable,
`aqueous pharmaceutical composition” to
`mean “injectable pharmaceutical
`composition containing water,” and (2)
`would not have understood the claim
`term “injectable, aqueous pharmaceutical
`composition” to mean “a stable, ready-to-
`use aqueous parenteral solution which has
`been subjected to autoclaving”
`
`
`
`
`
`8
`
`
`
`Case 1:15-cv-01684-JBS-JS Document 47-1 Filed 09/28/15 Page 9 of 11 PageID: 468
`
`Claim Term: “sterile”
`Recited in ‘094 Patent, claims 4-9
`Recited in ‘540 Patent, claims 6, 12-16
`
`Baxter’s Supporting Evidence
`
`Defendants’ Proposed
`Construction
`Plain and ordinary meaning
`
`Alternatively, “having a
`reduced microbial burden
`(can be achieved through
`aseptic processing,
`autoclaving, etc.)”
`
`Intrinsic Evidence
`
`‘094 Patent at 1:48-58, 1:62-2:14,
`2:49-59, 4:4-7
`
`‘540 Patent at 1:53-58, 2:3-14,
`2:20-28, 3:45-56, 4:56-59
`
`Extrinsic Evidence
`
`The American Heritage
`Dictionary, 3rd Ed. (1997) at
`1332
`
`Webster’s Third New
`International Dictionary (2002) at
`2238
`
`Remington: The Science and
`Practice of Pharmacy, ch. 40 at
`753-758 (Alfonso R. Gennaro
`ed., 2000)
`
`Baxter may also rely on expert
`opinion testimony concerning the
`level of skill possessed by a
`person of ordinary skill in the art
`
`9
`
`Baxter’s Proposed Construction
`
`a composition that has been brought to a
`state of sterility and has not been
`subsequently exposed to microbiological
`contamination (i.e. the container holding
`the sterile composition has not been
`compromised)
`
`sterility is freedom from live bacteria or
`other microorganisms
`
`
`
`Defendants’ Supporting Evidence
`
`Intrinsic Evidence
`Specification and Claims
`‘094 Patent Specification
`
`1:14-23
`
`1:39-2:14
`
`2:49-59
`
`2:62-3:1
`
`2:60-5:7, Examples 1-3
`
`‘094 Patent Claims
`
`Claim 4
`
`‘540 Patent, Abstract
`‘540 Patent Specification
`
`1:10-21
`
`1:53-58
`
`1:61-67
`
`2:3-14
`
`2:20-40
`
`3:45-56
`
`3:66-4;8
`
`4:13-5;53, Examples 1-3
`
`‘540 Patent Claims
`
`Claim 1
`
`Claim 8
`
`
`
`Case 1:15-cv-01684-JBS-JS Document 47-1 Filed 09/28/15 Page 10 of 11 PageID: 469
`
`Baxter’s Proposed Construction
`
`Baxter’s Supporting Evidence
`
`Defendants’ Proposed
`Construction
`
`Defendants’ Supporting Evidence
`
`and the meaning of the term
`“sterile” to a person of ordinary
`skill in the art, in view of the
`teachings of the specifications of
`the ‘094 and ‘540 patents
`
`
`Claim 12
`Claim 13
`
`
`
`
`References Cited in Specification
`U.S. Pat. No. 4,857,552 (‘094 Patent,
`1:44, ‘540 Patent, 1:42)
`U.S. Pat. No. 5,107,609 (‘540 Patent,
`1:42)
`
`
`Extrinsic Evidence
`Expert Testimony
`Defendants may rely on expert opinion
`and testimony as to the level of skill of
`one of ordinary skill in the art, and further
`that if the claim term “sterile” is not
`given its plain and ordinary meaning, one
`of ordinary skill in the art (1) would have
`understood the claim term “sterile” to
`mean “having a reduced microbial burden
`below the threshold for safe
`administration (can be achieved through
`aseptic processing, autoclaving, etc.),” (2)
`would not have understood the term
`“sterile” to mean “a composition that has
`been brought to a state of sterility and has
`not been subsequently exposed to
`microbiological contamination (i.e. the
`container holding the sterile composition
`has not been compromised),” and (3)
`would not have understood the term
`“sterile” to mean “sterility is freedom
`
`
`
`10
`
`
`
`Case 1:15-cv-01684-JBS-JS Document 47-1 Filed 09/28/15 Page 11 of 11 PageID: 470
`
`Baxter’s Proposed Construction
`
`Baxter’s Supporting Evidence
`
`Defendants’ Proposed
`Construction
`
`Defendants’ Supporting Evidence
`
`from live bacteria or microorganisms.”
`
`
`
`
`
`
`11
`
`
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