Case 2:16-cv-00528-RSP Document 64 Filed 05/17/17 Page 1 of 31 PageID #: 1001
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`THE UNITED STATES DISTRICT COURT
`FOR THE EASTERN DISTRICT OF TEXAS
`MARSHALL DIVISION
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`APOPHARMA, INC. ET AL.
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`v.
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`TARO PHARMACEUTICAL
`INDUSTRIES, LTD., ET AL.,
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`Plaintiffs,
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`Defendants.
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` CASE NO. 2:16-CV-528
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`CLAIM CONSTRUCTION OPINION AND ORDER
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`Before the Court is the opening claim construction brief of Plaintiffs ApoPharma Inc.,
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`ApoPharma USA, Inc. and Apotex Technologies Inc. (collectively, “ApoPharma” and/or
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`“Plaintiffs”) (Dkt. No. 55, filed on March 22, 2017), the response of Defendants Taro
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`Pharmaceutical Industries Ltd. and Taro Pharmaceuticals U.S.A., Inc. (collectively, “Taro” and/or
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`“Defendants”) (Dkt. No. 59, filed on April 5, 2017), and the reply of Plaintiffs (Dkt. No. 60, filed
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`on April 12, 2017). The Court held a claim construction hearing on May 5, 2017. Having
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`considered the arguments and evidence presented by the parties at the hearing and in their claim
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`construction briefing, the Court issues this Claim Construction Order.
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`Apotex Tech.
`Ex. 2010
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`Case 2:16-cv-00528-RSP Document 64 Filed 05/17/17 Page 2 of 31 PageID #: 1002
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`Table of Contents
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`I. BACKGROUND ....................................................................................................................... 3
`II. LEGAL PRINCIPLES ........................................................................................................... 4
`III. CONSTRUCTION OF AGREED TERMS ........................................................................ 6
`IV. CONSTRUCTION OF DISPUTED TERMS ..................................................................... 6
`A. Disputed Terms ..................................................................................................................... 6
`B. Plaintiffs’ Position ................................................................................................................ 7
`C. Defendants’ Position ............................................................................................................. 9
`D. Court’s Analysis ................................................................................................................. 10
`V. CONCLUSION...................................................................................................................... 30
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`Case 2:16-cv-00528-RSP Document 64 Filed 05/17/17 Page 3 of 31 PageID #: 1003
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`I. BACKGROUND
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`Plaintiffs brings suit alleging infringement of United States Patent No. 7,049,328 (“the
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`’328 patent” or “patent-in-suit”) by the Defendants. Defendants have filed an Abbreviated New
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`Drug Application (“ANDA”) seeking approval from the United States Food and Drug
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`Administration to market a generic version of Plaintiffs’ FERRIPROX® product prior to the
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`expiration of the ’328 patent.
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`The U.S. application leading to the ’328 patent was filed on April 4, 2003, and is based on
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`a PCT application filed on June 28, 2001, which claims priority to Canadian provisional patent
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`application 2313270, filed on June 30, 2000. The ’328 patent issued on May 23, 2006 and is
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`entitled “Use for Deferiprone.” In general, the ’328 patent is directed to a method of treating iron
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`induced cardiac disease by administering deferiprone to the patient (such as a patient with
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`thalassemia). The Abstract of the ’328 patent states:
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`A method of treating iron induced cardiac disease in a patient with iron overload,
`such as in thalassemia or the like comprising administering to the patient a
`therapeutically effective amount of deferiprone or a physiologically acceptable salt
`thereof sufficient to treat iron induced cardiac disease normally associated with iron
`overload.
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`Claims 2, 4, 5, 7, 8, 11, and 19 are asserted and contain the terms to be construed. Claim
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`2 of the ’328 patent recites:
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`2. A method of treating iron loading in the heart of a blood transfusion dependent
`patient experiencing an iron overload condition of the heart, said method
`comprising administering to the transfusion dependent patient a therapeutically
`effective amount of deferiprone or a physiologically acceptable salt thereof
`sufficient to reduce further iron overload in the heart normally associated with iron
`induced cardiac disease.
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`Case 2:16-cv-00528-RSP Document 64 Filed 05/17/17 Page 4 of 31 PageID #: 1004
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`The parties’ dispute centers on the meaning of the italicized terms, namely whether the
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`italicized phrase is limiting. A similar dispute exists as to the similar claim terms in the other
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`asserted claims.
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`II. LEGAL PRINCIPLES
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`Claim construction is guided by the Federal Circuit’s decision in Phillips v. AWH
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`Corporation, 415 F.3d 1303 (Fed. Cir. 2005) (en banc). Phillips explained that “the claims of a
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`patent define the invention to which the patentee is entitled the right to exclude.” 415 F.3d at 1312
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`(quoting Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1115 (Fed.
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`Cir. 2004)). “The construction that stays true to the claim language and most naturally aligns with
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`the patent’s description of the invention will be, in the end, the correct construction.” Id. at 1316
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`(quoting Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1250 (Fed. Cir. 1998)).
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`Patent claims are generally given their ordinary and customary meaning, which “is the
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`meaning that the term would have to a person of ordinary skill in the art in question at the time of
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`the invention, i.e., as of the effective filing date of the patent application.” Id. at 1312-13. This
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`principle of patent law flows naturally from the recognition that inventors are usually persons who
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`are skilled in the field of the invention and that patents are addressed to, and intended to be read
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`by, others skilled in the particular art. Id.
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`Despite the importance of claim terms, Phillips made clear that “the person of ordinary
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`skill in the art is deemed to read the claim term not only in the context of the particular claim in
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`which the disputed term appears, but in the context of the entire patent, including the
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`specification.” Id. The written description set forth in the specification, for example, “may act as
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`a sort of dictionary, which explains the invention and may define terms used in the claims.”
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`Case 2:16-cv-00528-RSP Document 64 Filed 05/17/17 Page 5 of 31 PageID #: 1005
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`Markman, 52 F.3d at 979. Thus, as the Phillips court emphasized, the specification is “the primary
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`basis for construing the claims.” Phillips, 415 F.3d at 1314–17. However, it is the claims, not
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`the specification, which set forth the limits of the patentee’s invention. Otherwise, “there would
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`be no need for claims.” SRI Int’l v. Matsushita Elec. Corp., 775 F.2d 1107, 1121 (Fed. Cir. 1985)
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`(en banc).
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`The prosecution history plays an important role in claim interpretation as intrinsic evidence
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`that is relevant to the determination of how the inventor understood the invention and whether the
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`inventor limited the invention during prosecution by narrowing the scope of the claims. Phillips,
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`415 F.3d at 1314–17; see also Microsoft Corp. v. Multi-Tech Sys., Inc., 357 F.3d 1340, 1350 (Fed.
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`Cir. 2004) (noting that “a patentee’s statements during prosecution, whether relied on by the
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`examiner or not, are relevant to claim interpretation”). The prosecution history helps to
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`demonstrate how the inventor and the United States Patent and Trademark Office (“PTO”)
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`understood the patent. Id. at 1317. Because the prosecution history, however, “represents an
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`ongoing negotiation between the PTO and the applicant,” it may sometimes lack the clarity of the
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`specification and thus be less useful in claim construction. Id.
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`Courts are also permitted to rely on extrinsic evidence, such as “expert and inventor
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`testimony, dictionaries, and learned treatises,” id. (quoting Markman, 52 F.3d at 980), but Phillips
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`cautioned that claim construction should be consistent with the intrinsic record. Id. at 1319. “In
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`cases where . . . subsidiary facts are in dispute, courts will need to make subsidiary factual findings
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`about [the] extrinsic evidence. These are the ‘evidentiary underpinnings’ of claim construction
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`[discussed] in Markman, and this subsidiary factfinding must be reviewed for clear error on
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`appeal.” Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831, 841 (2015).
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`Case 2:16-cv-00528-RSP Document 64 Filed 05/17/17 Page 6 of 31 PageID #: 1006
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`III. CONSTRUCTION OF AGREED TERMS
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`The parties have agreed to the following meanings for the following terms. See, e.g., Dkt.
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`No. 61 (Joint Claim Construction Chart.)
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`The term “blood transfusion dependent patient(s),” as it appears in the preambles of
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`claims 2-5, 7, and 8, has a plain and ordinary meaning as understood by a person of ordinary skill
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`in the art and that person would understand that term to at least include a patient having
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`thalassemia.
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`The “experiencing” and “having” terms, as they appear in the preambles of claims 2, 7,
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`and 8, are synonymous and would therefore be understood by a person of ordinary skill in the art
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`to have the same meaning.
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`The remaining terms that appear in the preambles of claims 2-5, 7, and 8 have a plain and
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`ordinary meaning that would be understood by a person of ordinary skill in the art.
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`IV. CONSTRUCTION OF DISPUTED TERMS
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`The parties’ positions and the Court’s analysis as to the disputed terms are presented below.
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`A. Disputed Terms
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`Claim
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`2
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`4
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`5
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`7
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`8
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` Disputed Term
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`“sufficient to reduce further iron overload in the heart normally
`associated with iron induced cardiac disease”
`“sufficient to treat the iron burden in the heart normally associated
`with iron induced cardiac disease”
`“sufficient to reduce the iron burden of the heart normally associated
`with iron induced cardiac disease”
`“to chelate the iron stores in the heart in preference to general iron
`stores in the body, such as found in the liver”
`“to reduce the iron stores in the heart in preference to general iron
`stores organs/tissue in the body, such as found in the liver”
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`Case 2:16-cv-00528-RSP Document 64 Filed 05/17/17 Page 7 of 31 PageID #: 1007
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`11
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`19
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`“for treating the risk of iron induced heart disease in patients having
`iron overload”
`“has a cardio preferred/selective function when compared to
`deferrioxamine or other alternative chelating agents utilized in
`patients suffering iron overload”
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`For each of the above disputed terms, the parties’ arguments are the same.
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`The Plaintiffs’ proposed construction is a plain and ordinary meaning as understood by a
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`person of ordinary skill in the art. In other words, the disputed phrases/terms are limiting and
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`do not merely recite intended results
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` The Defendants’ proposed construction is that the disputed claim phrases/terms are non-
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`limiting because they each merely recite an intended result of the claimed method and do not alter
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`the steps of the method.
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`The parties’ positions are explained in more detail in the following sections.
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`B. Plaintiffs’ Position
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`Plaintiffs argue that the disputed phrases are limiting and do not merely recite intended
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`results. Plaintiffs argue that the disputed phrases are directed to the inventive aspects of the claims.
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`See, e.g., Plaintiffs’ Opening Claim Construction Brief (Dkt. No. 55) at page 9. Plaintiffs argue
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`the fact that the disputed phrases appear in the body of the claim rather than the preamble support
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`a finding that they are limiting. Id. at 11. Further, the use of “sufficient to” in claims 2, 4, and 5
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`and “to ___” in claims 7 and 8 imply material limitations, and erasing those phrases would change
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`the way the methods are performed. Id. at 11. Further, for some of the claims, if the disputed
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`phrases were removed, any distinguishing features would be removed thereby making the claims
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`identical. Id. at 11-12.
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`Case 2:16-cv-00528-RSP Document 64 Filed 05/17/17 Page 8 of 31 PageID #: 1008
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`Plaintiffs argue that the specification verifies the disputed claim terms are essential
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`limitations of the claims. Id. at 13-14. In particular, the specification’s comments on the prior
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`art and the preferential chelation and removal of iron in the heart demonstrate that the disputed
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`terms were intended to be claim limitations. Id. Further, the Plaintiffs argue that the PTO relied
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`on the disputed claim terms to find the claimed methods patentable over the prior art, they were
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`used to meaningfully distinguish the claims from the prior art, and they recite the “primary
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`purpose” for which the claims must be performed. Id. at 14-17.
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`Plaintiffs argue that the Bristol-Myers case is distinguishable on many grounds. Id. at 17-
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`19. First, one of the disputed phrases in Bristol-Myers was found in the preamble, while the
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`disputed phrases in the ’328 patent are found in the body of the claim. Id. at 17. Second, the
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`disputed phrase in Bristol-Myers was unnecessary to patentability and was voluntarily added after
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`the Examiner allowed the claims, which is in direct contrast to the disputed phrases for the ’328
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`patent which were added to distinguish over the cited prior art. Id. at 17-18. Third, the claims in
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`the ’328 patent are directed to a “new use of a known process” (as opposed to a “new result of an
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`old use”), which the Bristol-Myers court concluded may be patentable. Id. at 18. Fourth,
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`Plaintiffs’ proposed construction is not violating the rule of consistency – Plaintiffs are construing
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`the disputed claim language the same for purposes of infringement and validity. Id. at 19.
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`In its Reply, Plaintiffs argue that (i) the disputed claims include no claim dosage and
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`therefore the disputed terms necessarily define the amount of deferiprone that is “therapeutically
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`effective” to practice the claimed methods, and (ii) the disputed claim limitations were relied upon
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`as being essential to the patentability of the claimed methods. See, e.g., Plaintiffs’ Reply Claim
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`Construction Brief (Dkt. No. 60) at pages 1, 4-6. Plaintiffs argue that both of these factors favor
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`a finding of material limitations and are opposite to the facts of Bristol-Myers. Id. Plaintiffs argue
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`that any reliance on Defendants’ expert declaration is improper, and the infringing product
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`(and related infringement contentions) are irrelevant. Id. at 2-3, 6-8. Plaintiffs also
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`argue that Defendants are improperly narrowing all the claims to the same claim scope. Id. at
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`8-10.
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`C. Defendants’ Position
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`Defendants argue that the disputed phrases are merely non-limiting, intended results of the
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`method because they do not alter the steps that someone practicing the claimed method must
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`perform. See, e.g., Defendants’ Responsive Claim Construction Brief (Dkt. No. 59) at page 6.
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`Defendants argue that the disputed phrases recite nothing more than the intended results of
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`administering a “therapeutically effective amount” of deferiprone. Id. The disputed language does
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`not provide any further guidance to the “therapeutically effective amount” of deferiprone needed.
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`Id. at 6-7. Defendants argue that if the disputed claim language was limiting, it would necessarily
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`alter the way a person of ordinary skill in the art would carry out the claimed method as compared
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`to the prior art, but by the patentees’ own admissions it does not. Id. at 8. Defendants argue that
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`the claimed methods recite the treatment of the same patient with the same dose as has been
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`practiced for the past 20 years. Id. at 9.
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`Defendants also argue that the Plaintiffs treat the disputed claim language as non-limiting
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`in their infringement contentions but limiting in their invalidity contentions, and that Plaintiffs
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`cannot have it both ways. Id. at 9. In particular, Plaintiffs’ infringement contentions allege that
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`the same method and dosage range infringes the asserted claims but do not identify any steps of
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`the accused method that are different when discussing infringement of the individual claims. Id.
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`at 9-10. Defendants argue that the doctrine of claim differentiation only creates a presumption that
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`the claims have different scope and does not mandate such a requirement. Id. at 10. Defendants
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`Case 2:16-cv-00528-RSP Document 64 Filed 05/17/17 Page 10 of 31 PageID #: 1010
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`argue that the patent office did not rely on the claim terms to find the claims patentable. Id. at 11-
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`15. In particular, the patentee overcame the obviousness rejections not by amending claims but
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`through attorney argument. Id. at 13. Defendants argue that the Examiner never placed any
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`substantive weight on the disputed claim language and it was therefore not necessary for
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`patentability. Id. at 14-15.
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`D. Court’s Analysis
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`In determining whether the disputed phrases are limitations, the Court focuses on the
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`intrinsic record of the ’328 patent.
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`Specification
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`The ’328 patent specification discusses details of the the prior art, including that it was well
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`known that deferiprone can be used to remove iron from patients who are iron loaded. See, e.g.,
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`’328 patent, cols. 1-9; col. 9, ll. 34-36. The patent admits the common usage of deferiprone as
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`75 mg/kg/day dosages. Id. at col. 7, ll. 1-10. In light of the state of the art, the ’328
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`patent specification focuses on the unique cardio selective/preferred function of deferiprone as the
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`alleged invention:
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`The
`the
`for
`the use of deferiprone
`to
`relates
`invention
`prevention/stabilization/reduction of the risk of heart disease, such as heart failure,
`…
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`Thus while a general review of literature reveals that deferiprone is effective
`in removing iron from patients who are iron loaded (not withstanding some
`dissenting views), it is not definitive and dear [sic] whether or not such activity
`would result in decreased iron-induced heart disease and in prolongation of life.
`Nowhere is there taught the cardio selective/preferred function of deferiprone in
`relation to desferrioxamine and/or other chelating agents when administered to
`patients having iron overload.
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`Case 2:16-cv-00528-RSP Document 64 Filed 05/17/17 Page 11 of 31 PageID #: 1011
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`Id. at col. 1, ll. 8-10; col. 9, ll. 34-43; see also col. 25, ll. 17-32. The patent specification then goes
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`on to state the objects of the invention:
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`It is therefore an object of this invention to use deferiprone or a
`physiologically acceptable salt thereof for treating and/or preventing iron induced
`cardiac disease or cardiac complications in a patient with iron overload, such as
`thalassemia or the like.
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`It is a further object of the invention to provide a method of reversing and
`or preventing iron induced cardiac disease in a patient with iron overload, such as
`thalassemia or the like.
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`Id. at col. 9, ll. 44-52. These objects of the invention – which are characterized as that lacking in
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`the prior art – are substantially similar to the disputed phrases. In other words, the allegedly unique
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`feature of the patent is that which is contained within the disputed phrases. Thus, by itself, the
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`specification demonstrates that the disputed phrases were not just a description of the intended
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`results but are central aspects of the claimed invention.
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`Claims
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`The claims are also instructive, in addition to the the prosecution history leading up to the
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`issued claims.
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`As a representative example, claim 2 recites:
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`2. A method of treating iron loading in the heart of a blood transfusion
`dependent patient experiencing an iron overload condition of the heart, said method
`comprising administering to the transfusion dependent patient a therapeutically
`effective amount of deferiprone or a physiologically acceptable salt thereof
`sufficient to reduce further iron overload in the heart normally associated with iron
`induced cardiac disease.
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`(emphasis added and disputed phrase underlined). The phrase disputed in claim 2 (like each of
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`the other claims) appears in the body of the claim and not in the preamble. On its face, the disputed
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`phrase appears to give meaning to the previously recited “therapeutically effective amount” of
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`deferiprone. If the disputed phrase was not limiting, then the “therapeutically effective amount”
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`of deferiprone would be unknown from the face of the claim or at least not as precisely defined.
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`In other words, the disputed phrase is material to and gives meaning to the “therapeutically
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`effective amount” limitation.
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`A similar analysis exists for the other independent claims, recited below:
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`4. A method of stabilizing iron induced heart disease in blood transfusion dependent
`patients having iron overload, comprising the administration of a therapeutically
`effective amount of deferiprone or a physiologically acceptable salt thereof
`sufficient to treat the iron burden in the heart normally associated with iron induced
`cardiac disease.
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`5. A method of reducing the iron burden in the heart associated with iron induced
`heart disease in blood transfusion dependent patients having iron overload,
`comprising the administration of a therapeutically effective amount of deferiprone
`or a physiologically acceptable salt thereof sufficient to reduce the iron burden of
`the heart normally associated with iron induced cardiac disease.
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`7. A method of treating iron loading in the heart of blood transfusion dependent
`patient having an iron overload condition of the heart comprising administering to
`the patient a therapeutically effective amount of deferiprone or a physiologically
`acceptable salt thereof to chelate the iron stores in the heart in preference to general
`iron stores in the body, such as found in the liver.
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`8. A method of treating iron loading in the heart of blood transfusion dependent
`patient having an iron overload condition of the heart comprising administering to
`the patient a therapeutically effective amount of deferiprone or a physiologically
`acceptable salt thereof to reduce the iron stores in the heart in preference to general
`iron stores organs/tissue in the body, such as found in the liver.
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`(emphasis added.) Thus, for each of the independent claims, the disputed phrases are recited in
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`the body of the claims and provide meaning to the previously recited “therapeutically effective
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`amount” limitation. While there is some dispute between the parties as to the extent of the meaning
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`(e.g., the Defendants argue the disputed phrases give no meaning or guidance to the amount of
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`deferiprone needed and the Plaintiffs disagree), on its face, the claim language appears to treat the
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`disputed phrases as material limitations for the independent claims and does give some guidance
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`to the meaning of “therapeutically effective amount.”
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`Dependent claims 11 and 19 are reproduced below, each which contain separate disputed
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`claim terms:
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`11. The method of claims 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10 wherein deferiprone or a
`physiologically acceptable salt thereof is administered orally for treating the risk of
`iron induced heart disease in patients having iron overload.
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`19. The method of claims 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10 wherein deferiprone has a
`cardio preferred/selective function when compared to desferrioxamine or other
`alternative chelating agents utilized in patients suffering iron overload.
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`(emphasis added.) On balance, the disputed phrases provide meaning to the claims. For example,
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`claim 11 specifies that deferiprone is “administered orally for treating the risk of iron induced heart
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`disease in patients having iron overload.” The disputed phrase provides efficacy and/or meaning
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`to the “administered orally” limitation and is not superfluous to that limitation. Regarding claim
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`19, elimination of the disputed phrase (as Defendants propose) effectively eliminates all of the
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`language in the claim. Further, claim 19 recites that deferiprone has a cardio preferred/selective
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`function as compared to desferrioxamine. The disputed phrase provides material limitations that
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`are not otherwise present in that claim.
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`Prosecution History
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`In general, all of the claims with the disputed phrases were rejected on various grounds,
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`including under 35 U.S.C. § 112 for indefinite/enablement issues and as being obvious under 35
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`U.S.C. § 103(a) in view of the prior art. (See, e.g., February 17, 2004 Office Action, at pages 3-
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`6.) During prosecution, the Applicant amended the claims to respond to the Examiner’s rejections.
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`(See, e.g., July 28, 2004 Response to Office Action dated February 17, 2004 at pages 3-8.) For
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`some of the asserted claims, the disputed phrase was added during prosecution. For other asserted
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`claims, the disputed phrase was already included with the original claim.
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`In response to the Examiner’s initial prior art rejections in the first Office Action, the
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`Applicant argued against a finding of obviousness. (See, e.g., July 28, 2004 Response to Office
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`Action dated February 17, 2004, pages 15-20.) In general, these arguments accompanied claim
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`amendments. (See id. at 3-8.) The Applicant’s arguments were directly related to the disputed
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`phrases, whether they were added to the claims or already present in the claims. In general, the
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`Applicant argued that a person of ordinary skill in the art would not understand the prior art as
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`teaching the invention with respect to the unique cardio-preferential action of deferiprone. For
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`example, as to the cited prior art references, the Applicant argued that the prior art does not disclose
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`or suggest the “therapeutic value of deferiprone with respect to preventing iron accumulation and
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`further iron accumulation in the heart associated with iron induced cardiac disease.” (See id. at
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`page 17.) As another example, the Applicant argued that the patent application teaches the fact
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`that deferiprone has a preferential effect on the heart than other organs and overall body iron,
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`which is not taught in the prior art:
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`Case 2:16-cv-00528-RSP Document 64 Filed 05/17/17 Page 15 of 31 PageID #: 1015
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`(Id. at 19.) As still another example, the Applicant further argued that the prior art does not teach
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`the unexpected result that deferiprone can remove iron from the iron overloaded heart:
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`Case 2:16-cv-00528-RSP Document 64 Filed 05/17/17 Page 16 of 31 PageID #: 1016
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`(Id. at 26.) In response to the amendments and arguments, the Examiner removed the prior art
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`rejections as to the method claims, which included all of the asserted claims with the disputed
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`terms/phrases. (See, e.g., Office Action dated September 8, 2004.) In other words, based on the
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`arguments and claim amendments to the Examiner, the prior art rejections were removed.
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`The relevant individual claims and amendments thereto during prosecution are discussed
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`briefly below.
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`Issued Claim 2
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`16
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`Case 2:16-cv-00528-RSP Document 64 Filed 05/17/17 Page 17 of 31 PageID #: 1017
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`Issued claim 2 corresponds to original claim 2 in the patent application. Claim 2 was
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`rejected on various grounds in the first Office Action, including under 35 U.S.C. § 112 for
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`indefinite issues (“such as in thalassemia or the like”) and as being obvious under 35 U.S.C.
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`§ 103(a) in view of the prior art. (See, e.g., February 17, 2004 Office Action, at pages 3, 6.) In
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`response to prior art rejections and other claims rejections, original claim 2 was amended as
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`follows:
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`(See, e.g., July 28, 2004 Response to Office Action dated February 17, 2004 at page 3.) In
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`particular, the term “treat” was replaced with the disputed phrase “prevent further iron
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`accumulation in the heart normally associated with...” (See id.) The Office Action prior to the
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`amendment rejected the claim based (among other items) on a finding of obviousness over the
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`prior art, but after the amendment and Applicant’s arguments, the subsequent Office Action
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`removed the prior art rejections. (See, e.g., February 17, 2004 Office Action and September 8,
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`2004 Office Action.) Later during prosecution in response to “indefinite” rejections, the Applicant
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`made the following amendments:
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`17
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`Case 2:16-cv-00528-RSP Document 64 Filed 05/17/17 Page 18 of 31 PageID #: 1018
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`(See, e.g., December 6, 2004 Response to Office Action dated September 8, 2004 at page 2.) Later
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`during prosecution in response to “enablement” rejections, the Applicant made the following
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`amendments:
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`(See, e.g., September 29, 2005 Response to Office Action dated March 29, 2005 at page 2.) In
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`sum, the “preventing” language (both in the preamble and the body) was replaced with “treating”
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`language based on enablement rejections by the Examiner. No other material changes were made
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`to the claim during prosecution.
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`Issued Claim 4
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`Issued claim 4 corresponds to original claim 12 in the patent application. Claim 12 was
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`rejected on various grounds in the first Office Action, including under 35 U.S.C. § 112 for
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`indefinite issues (“such as in thalassemia or the like”) and as being obvious under 35 U.S.C.
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`§ 103(a) in view of the prior art. (See, e.g., February 17, 2004 Office Action, at pages 3, 6.) In
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`18
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`Case 2:16-cv-00528-RSP Document 64 Filed 05/17/17 Page 19 of 31 PageID #: 1019
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`response to prior art rejections and other claims rejections, original claim 12 was amended as
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`follows:
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`(See, e.g., July 28, 2004 Response to Office Action dated February 17, 2004 at page 4.) In
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`particular, the phrase iron “burden in the heart” was inserted as an additional limitation in the
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`claim. (See id.) The Office Action prior to the amendment rejected the claim based (among other
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`items) on a finding of obviousness over the prior art, but after the amendment and Applicant’s
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`arguments the subsequent Office Action removed the prior art rejections. (See, e.g., February 17,
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`2004 office action and September 8, 2004 office action.) Later during prosecution in response to
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`“indefinite” and “enablement” rejections, the Applicant made the following amendments:
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`(See, e.g., December 6, 2004 Response to Office Action dated September 8, 2004 at page 2.) No
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`other material changes were made to the claim during prosecution.
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`Issued Claim 5
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`Issued claim 5 corresponds to original claim 13 in the patent application. Claim 13 was
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`rejected on various grounds in the first Office Action, including under 35 U.S.C. § 112 for
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`19
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`Case 2:16-cv-00528-RSP Document 64 Filed 05/17/17 Page 20 of 31 PageID #: 1020
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`indefinite issues (“such as in thalassemia or the like”) and as being obvious under 35 U.S.C.
`
`§ 103(a) in view of the prior art. (See, e.g., February 17, 2004 Office Action, at pages 3, 6.) In
`
`response to prior art rejections and other claims rejections, original claim 13 was amended as
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`follows:
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`(See, e.g., July 28, 2004 Response to Office Action dated February 17, 2004 at page 4.) In
`
`particular, the term “treat” was replaced with the disputed phrase “reduce the iron burden of the
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`heart normally associated with...” (See id.) The Office Action prior to the amendment rejected
`
`the claim based (among other items) on a finding of obviousness over the prior art, but after the
`
`amendment and Applicant’s arguments the subsequent Office Action removed the prior art
`
`rejections. (See, e.g., February 17, 2004 Office Action and September 8, 2004 Office Action.)
`
`Later during prosecution in response to “enablement” and “indefinite” rejections, the Applicant
`
`made the following amendments:
`
`(See, e.g., December 6, 2004 Response to Office Action dated September 8, 2004 at page 3.) No
`
`other material changes were made to the claim during prosecution.
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`20
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`Case 2:16-cv-00528-RSP Document 64 Filed 05/17/17 Page 21 of 31 PageID #: 102