Full opinion text
MEMORANDUM AND ORDER YOUNG, Chief Judge. I. INTRODUCTION This patent infringement action concerns patents held by Amgen, Inc. (“Am-gen”), relating to the manufacture of a recombinant (genetically engineered) DNA product, known as epoietin alfa, that is similar to natural erythropoietin (“EPO”), a hormone that stimulates production of red blood cells, and is useful in, among other things, treating patients who need blood transfusions and suffer from blood composition disorders such as hemophilia, anemia, and sickle cell disease. This product and this case are not new to the public or to this Court. The ease began brewing in 1997, when Amgen filed a declaratory judgment in the United States District Court for the District of Massachusetts against Defendants Hoechst Marion Roussel, Inc. and Tran-skaryotic Therapies, Inc. (collectively “HMR/TKT”) claiming that three of its patents were infringed by HMR/TKT’s human EPO product, “HMR 4396,” produced from the R223 cell line grown in culture. See Amgen, Inc. v. Hoechst Marion Rous-sel, Inc., 3 F.Supp.2d 104, 106 (D.Mass.1998). In 1999, Amgen amended the complaint to include two other patents. Amgen, Inc. v. Hoechst Marion Roussel, Inc., 126 F.Supp.2d 69, 96-98 (D.Mass.2001) (“Amgen I ”). A lengthy jury-waived trial ensued. It commenced in May 2000 and lasted twenty-three days over the course of four months. Id. at 78. Not surprisingly, HMR/TKT appealed this Court’s decision, Amgen I, 126 F.Supp.2d 69. In Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313 (Fed.Cir.2003) (“Amgen II”), the Federal Circuit affirmed a majority of this Court’s findings and rulings but vacated and remanded a few issues to this Court. Id. at 1358. This memorandum and order addresses those issues on remand, some of which have already been decided by the Court and announced to the parties, thus requiring only a brief review. II. BACKGROUND: PROCEDURAL AND SUBSTANTIVE HISTORY A. The Patents, at Issue There were originally five patents at issue in this case. Only four, however, remain on remand. The patents and claims now at issue are: Claim 1 of U.S. Patent No. 5,955,422 (issued Sept. 21, 1999) (“ ’422 patent”); Claims 2-4 of U.S. Patent No. 5,621,080 (issued Apr. 15, 1997) (“ ’080 patent”); Claims 4-9 of U.S. Patent No. 5,618,698 (issued Apr. 8, 1997) (“ ’698 patent”); and Claims 1, 3, 4, 6, and 7 of U.S. Patent No. 5,756,349 (issued May 26, 1998) (“ ’349 patent”). Amgen I, 126 F.Supp.2d at 79; Amgen II, 314 F.3d at 1320. Although the patents vary, they all share a common disclosure and identical specifications. Amgen I, 126 F.Supp.2d at 79. For ease of reference, the Court cites to the specification found in the ’933 patent, which is identical to the specification of the patents in dispute on remand. ’933 Patent, Ex. I. B. The Technology As Amgen I set out the basics of the underlying technology in detail, only a brief summary is provided here. EPO is a naturally occurring hormone that controls erythropoiesis, the production of red blood cells in bone marrow. ’933 Patent, Ex. 1, col. 5: 39-67. Erythropoiesis occurs continuously to offset cell destruction. Id. It enables a sufficient (but not excessive) amount of red blood cells to be available in the blood to provide tissue oxygenation. Id. Hemoglobin is the protein in the red blood cells that actually transports the oxygen. Amgen I, 126 F.Supp.2d at 98. The amount of hemoglobin correlates to the amount of oxygen. Id. Hematocrit, which indicates the relative proportion of red blood cells to the total volume of blood, measures the ability of the blood to supply oxygen to the body. Id. Thus, generally an increase or decrease in hematocrit equates with an increase or decrease in the ability to supply oxygen to the body. Id. Under normal conditions, a person has a hematocrit of about forty-five to fifty, which means forty-five to fifty percent of the blood is made up of red blood cells. Id. EPO is produced in the kidney and liver. Therefore, patients with chronic renal failure lack normal levels of EPO and suffer from anemia. Amgen II, 314 F.3d at 1321. Introduction of additional EPO into the patient’s body can increase a patient’s he-matocrit level and sustain it at or near normal levels. Id. In other words, the blood is able to provide a steady supply of sufficient oxygen to the tissues. Id.; Amgen I, 126 F.Supp.2d at 99. Early attempts to obtain EPO from plasma or urine proved unsuccessful 'because the body only produces human EPO in very small amounts, ’933 Patent, Ex. 1, col. 5: 54-58, and the techniques were very complicated and resulted in the collection of very small amounts of impure and unstable amounts of EPO, id. at col. 6: 60-65. Amgen is recognized as the pioneer in the production of a therapeutically effective amount of EPO via recombinant EPO (“rEPO”) techniques. See, e.g., Molecular Biology and Biotechnology: A Comprehensive Desk Reference 108 (Robert A. Meyers ed., VCH Publishers 1995). Dr. Fu-Kuen Lin (“Lin”), the named inventor of all the patents in issue, isolated and characterized DNA sequences encoding EPO from humans and monkeys. ’933 Patent, Ex. 1, col. 13: 50-53. Lin determined the DNA sequence of human EPO and its predicted amino acid sequence. ’933 Patent, Ex. 1, col. 10: 65-11: 2. Lin then produced large amounts of EPO by using recombinant DNA technology. Id. at col. 14: 23-29. In the patent specification, many methods of producing EPO are described. EPOGEN® is produced by the method described in Example 10, wherein human EPO is produced by introducing exogenous DNA into host Chinese hamster ovary (“CHO”) cells. Id. at col. 25: 30-29: 7. The rEPO that is produced has the same or similar amino acid sequences or primary structural conformation as that of naturally-occurring EPO. Id. at col. 29: 1-7. As a result, it possesses one or more the biological properties of naturally-occurring EPO but differs from natural EPO in its “glycosylation,” that is, it has a different average carbohydrate composition. Id. at col. 10: 35-41. HMR/TKT, in producing its human er-ythropoietin, HMR 4396 (also called Gene-Activated EPO “GA-EPO”), also uses recombinant technology. HMR/TKT, however, does not use a host cell from a nonhuman species but manipulates the ordinarily unexpressed human EPO gene where it naturally resides. Amgen I, 126 F.Supp.2d at 102. In that way, the human EPO DNA material is endogenous to the human cell. Id. After introducing a promoter sequence, human EPO is expressed in a human rather than a hamster cell. Id. C. The Federal Circuit’s Decision A brief review of the key rulings and findings that were affirmed and remanded on appeal follows: 1. Claim Construction a. Affirmed The Federal Circuit upheld all of the Court’s claim constructions. Amgen II, 314 F.3d at 1320. Specifically, the Federal Circuit upheld this Court’s construction that Amgen’s claims do not limit the invention to using only exogenous DNA (as opposed to endogenous DNA). Id. at 1327. It also upheld this Court’s determinations that (1) non-naturally occurring means “ ‘not occurring in nature” ’; (2) vertebrates are anything with “ ‘a segmented bony or cartilaginous spinal cord’ which obviously includes humans”; and (3) humans are a subset of mammals and mammals are a subset of vertebrates. Id. at 1327-28 (quoting Amgen I, 126 F.Supp.2d at 85, 90-91). To that end, the Federal Circuit agreed that the specification indicates that the invention uses human DNA in human host cells in culture. Id. The Federal Circuit also upheld the Court’s determination that claim 1 of the ’422 patent, claims 2, 3, and 4 of the ’080 patent, and claims 1, 3, 4, and 6 of the ’349 patent are product claims (not process claims) and thus are not restricted or defined by any method of production or any particular source, other than what is specifically excluded. Amgen II, 314 F.3d at 1329-30. b. Remanded Although all the terms that this Court construed in Amgen I under the principles of Markman v. Westview Instruments, Inc., 517 U.S. 370, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996), were upheld, the Federal Circuit remanded to this Court the construction of the term “therapeutically effective.” Amgen II, 314 F.3d at 1354. This phrase was not considered by the Court to be in dispute during the first trial. In its written analysis, however, this Court interpreted the term. Amgen I, 126 F.Supp.2d at 112; see also id. at 99. While interpreting a term to provide context for the discussion is proper when the term is not in dispute, the Federal Circuit determined that the term “therapeutically effective” actually was in dispute “because it is central to whether Goldwasser is properly considered prior art.” Amgen II, 314 F.3d at 1353. Therefore, it remanded so this Court could construe “therapeutically effective” pursuant to Markman. Id. at 1358. Since claim construction is matter of law, Markman, 517 U.S. at 386, 116 S.Ct. 1384; but see Arthur R. Miller, The Pretrial Rush to Judgment: Are the “Litigation Explosion, ” “Liability Crisis, ” and Efficiency Cliches Eroding Our Day in Court and Jury Trial Commitments?, 78 N.Y.U. L.Rev. 982, 1087 (2003). (criticizing the decision in Markman), the Federal Circuit could have proceeded to construe the phrase itself. Where a word or phrase has not been first construed in the district court, the Federal Circuit follows the courteous and prudential path of first seeking claim construction below. Hon. Pauline Newman, Remarks at the American Law Inst. — Am. Bar Assoc. Panel on the Trial of a Patent Case (Sept. 18, 2003). 2. Infringement a. Affirmed The Federal Circuit affirmed this Court’s ruling on summary judgment that claim 1 of the ’422 patent is literally infringed. Amgen II, 314 F.3d at 1348. It also affirmed this Court’s ruling that the ’080 patent is not literally infringed by HMR/TKT’s HMR 4396, id. at 1344-45, but that claims 1, 3, 4, and 6 of the ’349 patent are literally infringed by it, id. at 1351-52. b. Remanded (1) The ’080 Patent After finding that HMR 4396 did not literally infringe claims 2, 3, and 4 of the ’080 patent because HMR 4396 comprised only 165 amino acids, Amgen I, 126 F.Supp.2d at 99-101, this Court held that HMR 4396 performed substantially the same function in substantially the same way to obtain substantially the same result as the EPO glycoprotein of claims 2 and 3 of the ’080 patent, id. at 133. Therefore, it ruled that Amgen’s ’080 patent was infringed by HMR/TKT’s product under the doctrine of equivalents. Id. In response to HMR/TKT’s argument that Amgen should be estopped from arguing equivalent infringement, this Court ruled that prosecution history estoppel did not apply because Amgen did not add the “mature amino acid sequence of Figure 6” limitation “in an attempt to overcome a rejection [or] to avoid prior art,” but, instead, to “demonstrate that ‘same invention’ type double patenting did not apply,” — that is, to distinguish the ’080 patent from the ’933 patent. Id. at 134-35. The Federal Circuit agreed that the amendment was made for this purpose but made clear that under Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki, 535 U.S. 722, 731, 122 S.Ct. 1831, 152 L.Ed.2d 944 (2002) (“Festo II ”), “ ‘a narrowing amendment to satisfy any requirement of the Patent Act may give rise to an estoppel.’ ” Amgen II, 314 F.3d at 1345 (quoting Festo II, 535 U.S. at 736), 122 S.Ct. 1831 (emphasis added). Therefore, it held that the presumption of prosecution history estop-pel applied. Id. at 1345. The Federal Circuit then vacated this Court’s finding of equivalent infringement and remanded for an analysis based on the “narrow ways of rebutting the Supreme Court’s presumption of estoppel” outlined in Festo II. Id. at 1345. (2) The ’698 Patent On appeal, the Federal Circuit vacated and remanded this Court’s ruling regarding infringement of the ’698 patent because this Court had compared the accused device to the preferred or commercial embodiments of the patent instead of to the properly construed claims themselves. Amgen II, 314 F.3d at 1347. Therefore, it remanded to this Court the question whether claims 4-9 of the ’698 patent are infringed. Id. (3) The ’349 patent Although this Court found that claims 1, 3, 4, and 6 of the ’349 patent are literally infringed by HMR/TKT’s 4396, it held that HMR/TKT did not literally or equivalently infringe claim 7, the process claim, of the ’349 patent. Amgen I, 126 F.Supp.2d at 122. The Court compared the accused process to the preferred embodiment in the claim and concluded that HMR/TKT’s “process for producing erythropoietin differs markedly from that disclosed by Am-gen’s specification.” Id. The Federal Circuit, as it did with the Court’s holding of infringement of the ’698 patent, vacated this ruling and remanded so that the Court could analyze infringement by comparing the accused process to the properly construed claims themselves. Amgen II, 314 F.3d at 1350-51. 3.Inequitable Conduct The Court’s determination that HMR/ TKT had not proven by clear and convincing evidence that the ’933, ’080, ’349 and ’422 patents were unenforceable due to inequitable conduct was affirmed on appeal. Amgen II, 314 F.3d at 1357-58. 4. Written Description, Definiteness, and Enablement a. Affirmed The Federal Circuit affirmed this Court’s rulings that the ’422, ’080, and ’349 patents are adequately described and enabled. Id. at 1337. In so ruling, the Federal Circuit explained that this Court “carefully considered these issues, finding in the end that HMR/TKT had not met its clear and convincing burden of proof.” Id. Because the Federal Circuit found “no clear error in these factual determinations,” and the parties did not allege any legal error, it reasoned that it would “not disturb [this Court’s] holding that the asserted patents are not invalid for failure to meet the enablement requirement of § 112 ¶ 1.” Id. As mentioned in an earlier footnote, see note 3, supra, this Court held and the Federal Circuit affirmed that the ’933 patent (specifically the claims requiring “gly-cosylation which differs”) was invalid for indefiniteness under section 112. Amgen I, 126 F.Supp.2d at 156-57. Therefore, the ’933 patent is not at issue on remand. 5. Anticipation and Obviousness a. Affirmed The Court’s ruling that the asserted claims of the ’080, ’349, and ’933 patents are not anticipated under 35 U.S.C. § 102 by the Sugimoto reference was affirmed by the Federal Circuit. Id. at 1320, 1356. In affirming, however, the Federal Circuit made clear that the Court’s determination that Sugimoto was not enabled was an error, though harmless, because the Court put the burden of proving enablement of Sugimoto on HMR/TKT when the burden of proving non-enablement should have been put on Amgen. Id. at 1356. b. Remanded The Federal Circuit remanded, however, the Court’s findings that Sugimoto does not anticipate claim 1 of the ’422 patent stating that the “district court should consider whether claim 1 of the ’422 patent is novel over Sugimoto in light of the court’s new definition of ‘therapeutically effective’ ” and be “mindful of the principle that source limitations cannot impart novelty to old compositions.” Id. at 1356. Additionally, the Federal Circuit remanded this Court’s finding that the ’422, ’080, and ’349 patents were not obvious in light of Sugi-moto because this Court based its decision, in part, on the fact that it concluded that Sugimoto was not enabled. Id. at 1357. The Federal Circuit explained that under section 103, a reference need not be enabled to qualify as prior art. Id. In Amgen I, this Court found that the asserted claims of the ’080, ’422 and ’349 patents were not anticipated or rendered obvious by the Goldwasser reference. Amgen I, 126 F.Supp.2d at 112-17. The Federal Circuit remanded these findings for further proceedings given that “therapeutically effective” was not construed in accordance with Markman. Amgen II, 314 F.3d at 1354. As mentioned above, it directed the Court to construe the term and determine whether Goldwasser invalidates any of the asserted patents under 35 U.S.C. § 102(a) or § 103. in light of the Court’s construction. Id. at 1354. D. Procedural and Substantive History Since Amgen II The Federal Circuit’s decision issued on January 6, 2003. This Court received the action on remand on March 13, 2003 [Doc. No. 653], and it held a status conference on April 16, 2003 [Doc. No. 657]. On May 16, 2003, Amgen moved for: (1) judgment under Federal Rule of Civil Procedure 52(c) that claims 2-4 of the ’080 patent were infringed under the doctrine of equivalents [Doc. No. 659]; (2) summary judgment of infringement of claims 4-9 of the ’698 patent [Doc. No. 663]; (3) judgment pursuant to Rule 52(c) that claim 1 of the ’422 patent and claim 4 of the ’080 patent are valid [Doc. No. 670]; and (4) judgment pursuant to Rule 52(c) that claims 1, 3, 4, 6, and 7 of the ’349 patent are valid and that claim 7 of the ’349 patent is infringed [Doc. No. 674]. HMR/TKT simultaneously moved for: (1) judgment that Amgen is estopped from asserting infringement of the ’080 patent pursuant to the doctrine of equivalents [Doc. No. 678]; (2) judgment that claim 1 of the ’422 patent is invalid as anticipated [Doc. No. 682]; (3) judgment pursuant to Rule 52(c) that the asserted process claims of the ’698 patent and ’349 patents are not infringed [Doc. No. 686]; and (4) judgment that the ’422, ’080, and ’349 claims are invalid for obviousness [Doc. No. 690], The memoranda in support of and in opposition to these motions raised additional issues that are reviewed in this opinion. They are described briefly below. In its opposition to Amgen’s renewed motion for summary judgment of infringement of the ’698 patent, HMR/TKT argued, among other things, that Amgen’s proposed construction of the words “DNA encoding” found in claims 4 and 6 of the ’698 patent is incorrect. HMR/TKT’s Mem. in Opp’n re ’698 [Doc. No. 700] at 7-8. Second, HMR/TKT argued that in claims 4 and 6 of the ’698 patent, Amgen set forth a step-plus-function claim in referring to the “steps of ... growing, under suitable nutrient conditions” and that an assessment of whether HMR/TKT infringed this aspect of the claim must focus on a comparison between HMR/TKT’s process for growing and the process for growing described by Amgen in the specification. Id. at 9. Finally, HMR/TKT argued that even if there is literal infringement here, it can justifiably invoke the defense of the reverse doctrine of equivalents. Id. at 13. With regard to claim 7 of the ’349 patent, HMR/TKT made four “new” arguments, two of which are very similar to those made in conjunction with the ’698 patent. First, HMR/TKT contended that its process does not infringe claim 7 of the ’349 patent when considered in light of its proposed claim construction of “DNA encoding.” HMR/TKT’s Mem. in Support re ’698/’349 [Doc. No. 687] at 8-9. Second, HMR/TKT argued that its process does not infringe claim 7 of the ’349 patent because claim 7 is a step-plus-function limitation; and, as such, HMR/TKT’s process does not literally infringe the “step of culturing” found in claim 7 because it does not involve the culturing procedures set forth in Amgen’s specification. Id. at 12-15. Third, HMR/TKT claimed that its process does not infringe the process claim under the reverse doctrine of equivalents. Id. at 15-18. Fourth and lastly, HMR/ TKT argued that if the Court construes the term “DNA encoding” as Amgen urges, then the validity of the asserted claim of the ’349 patent is called into question. Id. at 12. Amgen, in response, did not dispute that “DNA encoding” needs to be construed by the Court. See, e.g., Amgen’s Reply re ’698 [Doc. No. 731] at 6-10. It did, however, assert that HMR/TKT should not be allowed to make its “new” arguments relating to step-plus-function and the reverse doctrine of equivalents given the procedural posture of the case. See, e.g., id. at 10-15. On July 29, 2003, this Court held a Markman hearing regarding those terms in dispute and in need of construction and considered other pending motions, including motions for summary judgment. At the end of the Markman portion of the hearing, the Court tentatively construed the terms “DNA encoding” and “therapeutically effective,” providing two constructions for the latter, one being an alternate. 7/29/03 Hr’g Tr. at 55: 1-56: 23. It then continued to hear argument. At the end of the day, the Court noted that it would determine whether the asserted claims of the ’698 and ’349 patents were step-plus-function claims at a later date. Id. at 176: 1-10. It then continued the motion hearing to July 31, 2003. Id. at 176: 11-15. During a hearing two days later, the Court retracted the alternative construction and reiterated its primary “working construction,” retaining its right to revise it after a more careful review of the claims, specification, and prosecution history. 7/31/03 Hr’g Tr. at 87: 5-88: 7. Additionally, it ruled that claims 4 and 6 of the ’698 patent and claim 7 of the ’349 patent were not step-plus-function claims pursuant to 35 U.S.C. § 112. Id. at 88: 8-89: 9. It then denied Amgen’s motion for summary judgment of infringement of the ’698 patent, citing Arthur Miller’s recent article, The Pretrial Rush to Judgment. Id. at 89: 23-90: 25; see Miller, supra. The Court took everything else under advisement and set the final pretrial conference for September 18, 2003. Id. at 91: 25-92: 2. On August 5, 2003, the Court entered an order regarding the pending motions. [Doc. No. 740], It denied HMR/TKT’s motions for summary judgment with respect to the validity of the asserted claims of the ’422, ’080 and ’349 patents. Order of 8/5/03 at 1. It denied in part and allowed in part Amgen’s motions, under Rule 52(c), for judgment that claim 1 of the ’422 patent and claim 4 of the ’080 patent are valid and that claims 1, 3, 4, 6, and 7 of the ’349 patent are valid. Id. Because HMR/TKT did not dispute that the ’080 and ’349 patents are not anticipated by Goldwasser and that the ’349 patent is not rendered obvious by Goldwasser, the Court allowed Amgen’s motions with respect to these matters. Id. at 1-2. Specifically, the Court held that claim 4 of the ’080 patent is not anticipated by Goldwasser and that claims 1, 3, 4, 6, and 7 of the ’349 patent are not anticipated or rendered obvious by Goldwasser. Id. at 2. Because Amgen did not have the opportunity to rebut HMR/ TKT’s remaining validity arguments concerning the ’422, ’080, and ’349 patents during trial in 2000, the Court stated that Amgen would have that opportunity at the October trial. Id. On September 18, 2003, the Court held a final pretrial conference. After explaining that this case will not “turn into a patent version of Penelope’s robe,” in other words, that the Court and the parties were “not going to unravel anything [that the Court has] woven thus far which has not been unraveled by a higher court,” the Court made the following findings and rulings. First, it ruled that it would hear and take evidence on the reverse doctrine of equivalents as it related to the ’698 patent and that HMR/TKT could address other patent defenses. 9/18/03 Final Pretrial Conf. Tr. at 6: 4-16. Second, it ruled that Amgen had met its burden (outlined in Festo II) of proving that the prosecution history does not estop it from arguing equivalent infringement with regard to the ’080 patent and it affirmed its earlier finding that HMR/TKT infringes claims 2-4 of the ’080 patent. Id. at 7: 17-8: 5. It explained that it would issue a full opinion at a later date but that it might have to revisit the Festo issue due to the rapidly-developing law in that area. Id. at 7: 19-25. The Court then turned to the ’349 patent and explained that it would allow Amgen to put on rebuttal evidence as to the matter of obviousness and Sugimoto only and it made clear that the Court would not accept other evidence from HMR/TKT regarding the ’349 patent. Id. at 8: 12-19, 16: 5-6 (“As far as evidence goes, ’349 is in the can and I’m done with it.”). The Court then issued a revised claim construction of “therapeutically effective” based on a more thorough analysis of the claims, specification, and prosecution history. Id. at 9: 3-10: 25. The Court mentioned, however, that this revision may have made the third sentence of the construction unnecessary and, therefore, reserved its right to further consider the proper construction. Id. at 10: 21-25. It directed the parties to try the case based on the construction it had just issued along with a construction that eliminated the third sentence. Id. at 11: 1-5. The pretrial conference was continued until September 24, 2003. Id. at 30: 22-23. During the further pretrial conference, the Court reviewed the issues to be tried and outlined the procedure for trial and the parameters for the introduction of evidence and expert testimony. See 9/24/03 Final Pretrial Conf. Tr. After the Court provided both parties with an opportunity to be heard on the subject, pursuant to Federal Rule of Civil Procedure 53(b)(1), the Court appointed Michele D. Beardslee as Special Master, beginning January 1, 2004, to assist the Court in research, analysis, and drafting of the forthcoming opinion. Order re Special Master [Doc. No. 801]; see also 11/07/03 Beardslee Aff. [Doc. No. 799]. The trial on remand was set to commence on October 7, 2003. 9/24/03 Final Pretrial Conf. Tr. at 40: 23. On October 30, 2003, the Court issued an opinion supporting its ruling that Am-gen had successfully rebutted the presumption of prosecution history estoppel as outlined in Festo II and, therefore, was not estopped from asserting equivalent infringement of the ’080 patent. Amgen, Inc. v. Hoechst Manon Roussel, Inc., 287 F.Supp.2d 126 (D.Mass.2003) (“Amgen III”). The remanded trial lasted nine days over the course of four and a half weeks. All the remaining issues — those remanded to the Court from the Federal Circuit and those raised by the parties in the course of this remanded trial — are addressed herein. III. CLAIM CONSTRUCTION As expounded in great detail in Amgen I, this Court strongly believes in the importance of construing patent claims without regard to the alleged infringement issues. Amgen I, 126 F.Supp.2d at 80-81; MediaCom Corp. v. Rates Tech., Inc., 4 F.Supp.2d 17, 21-24 (D.Mass.1998); see also Anthony R. Zeuli & Rachel Clark Hughey, Avoiding Patent Claim Construction Errors: Determining the Ordinary and Customary Meaning Before Reading the Written Description, Fed. Law., June 2004, at 29. One way to avoid conflating issues of fact and law and to ensure division between the fact finding and law explaining roles in a patent case is to hold the Markman hearing prior to and separate from the summary judgment motion hearing. Although (as mentioned above) this Court held the Markman hearing for the trial on remand on the same day as the summary judgment motions hearing, it kept the hearings independent of one another by separating the hearing into two parts. The first part dealt with claim construction. Then the Court held a recess, issued its preliminary constructions, and moved on to the summary judgment motions hearing. The Court followed its usual procedure in conducting the Markman hearing. The Court entertained oral argument from counsel for each party. Counsel referred the Court to the relevant portions of the patent, specification, and prosecution history. Demonstrative exhibits were presented and references were made to certain expert testimony, but extrinsic evidence was not admitted. At the conclusion of the Markman portion of the hearing the Court interpreted “therapeutically effective” and “DNA encoding”' — cautioning that they were “working constructions” — and held off deciding whether the asserted claims of the ’349 and ’698 patent were step-plus-function claims. The Court then announced during the July 31, 2003 hearing that it did not construe the asserted claims of the ’349 and ’698 patents as step-plus-function claims. During the pretrial conference on September 18, 2003, after the Court had engaged in a more careful review of the patents, specification, and prosecution history, the Court issued a revised claim construction for “therapeutically effective.” The final claim constructions are reproduced and explained below. A. “Therapeutically Effective” 1. Background The term “therapeutically effective” is contained in claim 1 of the ’422 patent and claim 4 of the ’080 patent. As mentioned above, although this phrase was not construed during the first trial, in determining whether prior art anticipated the ’422 and ’080 patents, the Court interpreted the term to mean an increase in hematocrit: Such evidence [of e.g., increased eryth-roid marrow stimulation] should be outweighed by the fact that the actual production of mature red blood cells was not achieved and, as a result, hematocrit levels were unchanged. Because an increase in hematocrit and hemoglobin levels is the true mark of therapeutic effectiveness, Dr. Goldwasser’s study, which revealed only inchoate indicators of red blood cell production, falls far short of anticipating claims requiring a therapeutic amount of human EPO. Amgen I, 126 F.Supp.2d at 112; see also id. at 99 (“The therapeutic effectiveness or benefit of an erythropoietin preparation is shown by demonstrating a correction in anemia by increasing and maintaining the hematocrit of a patient to normal or near normal levels.”). The Federal Circuit, in addition to remanding so that the Court could construe the term pursuant to Markman, provided some guidance. It agreed that the “endgame in the treatment of chronically anemic patients is to increase the hematocrit,” but pointed out that the term should be construed in light of the specification. Amgen II, 314 F.3d at 1353. It stated, however, that the “specification appears to teach that results in addition to simply an increase in hematocrit can provide effective therapy.” Id. (citing ’933 Patent, col. 33: 19-31). It pointed out that Amgen was arguing that one skilled in the art would construe “therapeutically effective” as “increasing and maintaining the patient’s hematocrit to normal or near normal levels,” but that “the relevant question is not whether one of ordinary skill would so understand the term, but whether that term should be limited based upon the express disclosure in the specification.” Id. at 1353-54 (citing CCS Fitness v. Brunswick Corp., 288 F.3d 1359, 1367 (Fed.Cir.2002) (“[A] claim term will not carry its ordinary meaning if the intrinsic evidence shows that the patentee distinguished that term from prior art on the basis of a particular embodiment, expressly disclaimed subject matter, or described a particular embodiment as important to the invention.”)). The Federal Circuit stated that it appeared that the term “therapeutically effective” encompassed the list of effects described in the specification and noted that if the Court also held this to be true, then the Goldwasser study may indeed invalidate some of the claims at issue in this case under 35 U.S.C. § 102(a) or § 103. Id. at 1354 (“If the claim term ‘therapeutically effective’ encompasses the patient responses described in the specification, as it appears to us it does, then the Goldwasser study may constitute invalidating prior art under § 102(a) or § 103 even if he did not achieve his intended result.”) (emphasis added). Therefore, it vacated this Court’s determination that Goldwasser did not constitute prior art and ordered this Court to construe the term and thereafter determine whether Goldwasser invalidates any of the asserted patents. Id. 2. The Claims at Issue The actual words of the claims are as follows: ’422 Claim 1: A pharmaceutical composition comprising a therapeutically effective amount of human erythropoietin and a pharmaceutically acceptable diluent, adjuvant or carrier, where insaid erythropoietin is purified from mammalian cells grown in culture. ’422 Patent, Ex. 1, col. 88: 36-41 (emphasis added). ’080 Claim 4: A pharmaceutical composition comprising a therapeutically effective amount of an erythropoietin gly-coprotein product according to Claim 1, 2, or 3. ’080 Patent, Ex. 1, col. 38: 51-53 (emphasis added). 3. Summary of the Parties’ Arguments Amgen urges adoption of the ordinary meaning of “therapeutically effective” given by those skilled in the art. Amgen’s Mem. in Support re ’422/’080 [Doc. No. 671] at 7. Specifically, it argues that (1) expert testimony shows that the ordinary meaning of “therapeutically effective” is “sufficient to produce a sustained increase in hematocrit,” and that the term requires a therapeutic — not merely biological — effect; (2) the other effects listed in the specification, to which the Federal Circuit referred, are known biological effects of EPO, not the intended therapeutic effects; (3) the specification taken as a whole supports the plain meaning of “therapeutically effective,” and that no special meaning was given to the term; (4) the prosecution history shows that Amgen specifically noted that its invention shares the same in vivo biological activity as naturally occurring human EPO, but differentiated its invention from prior art by pointing out that human recombinant EPO (unlike naturally-occurring human EPO) is not a viable, effective human therapeutic product; and (5) the doctrine of claim differentiation requires that this term have a different meaning than the recitation of EPO’s biological activities. Id. at 8-17. In its reply memorandum, Amgen also argues that the dictionary definition of the term supports its asserted meaning. Amgen’s Reply re ’422/’080 [Doc. No. 730] at 5-6. HMR/TKT, on the other hand, argues that the Federal Circuit made clear that it believed that the term “therapeutically effective” encompasses all of the effects set forth in the specification described. HMR/ TKT’s Mem. in Opp’n re ’422/’080 [Doc. No. 702] at 5. Thus, it argues, the term encompasses those effects observed in the Goldwasser study. Id. at 6. Moreover, it asserts that Amgen is trying to import limitations from the specification to make the claims require an increase in the he-matocrit levels when the claims contain no language indicating such a requirement and the specification language itself is actually inconsistent with such a requirement. HMR/TKT points to the same section of the specification as did the Federal Circuit did to make its point: [T]o the extent that polypeptide products of the invention share the in vivo activity of natural EPO isolates they are conspicuously suitable for use in erythropoietin therapy procedures practiced on mammals, including humans, to develop any or all of the effects herefore attributed in vivo to EPO, e.g., stimulation of reticulocyte response, development of ferrokinetic effects ... erythrocyte mass changes, stimulation of hemoglobin C syntheses ... and, as indicated in Example 10, increasing he-matocrit levels in mammals. Id. at 13 (quoting ’933 Patent, Ex. 1, col. 33: 19-31). This, HMR/TKT asserts, makes clear that “erythropoietin therapy procedures” include procedures that “develop any or all of the effects heretofore attributed in vivo to EPO,” and, therefore, “therapeutically effective amount” includes any or all of the effects listed in this portion of the specification — which, HMR/ TKT argues, are defined in terms of biological effects. Id. at 14. HMR/TKT further argues that Amgen is trying to rely on isolated references of the specification to restrict the term meaning when these restrictions are not apparent in the plain language, and when the intrinsic record, as a whole, supports a broader interpretation. Id. at 16. 4. Discussion While the Federal Circuit indeed mentioned that the term “therapeutically effective” appeared to encompass the biological effects listed within lines 19-31 of column 33, the Court notes that the Federal Circuit did not, in Amgen II, actually construe the term “therapeutically effective.” See Amgen II, 314 F.3d at 1324 (noting that the Federal Circuit considers claim construction “afresh” on appellate review); Bayer AG. v. Biovail Corp., 279 F.3d 1340, 1349 (Fed.Cir.2002) (noting that, notwithstanding its de novo review, “it would be premature for this court to engage in its own claim construction without ... evidence of the meaning of the terms to one of skill in the art at the time of the invention”). On the contrary, the Federal Circuit remanded that task to this Court. To perform it properly, however, the Court must consider the prosecution history in addition to the claims and the specification — something that the Federal Circuit did not do. See Amgen II, 314 F.3d at 1324 (“To properly construe the claims, a court must examine the claims, the rest of the specification, and if in evidence, the prosecution history.”); Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed.Cir.1996) (“[I]t is well-settled that, in interpreting an asserted claim, the court should look first to the intrinsic evidence of record, i.e., the patent itself, including the claims, the specification and, if in evidence, the prosecution history.”); SRI Int’l v. Matsushita Elec. Corp. of Am., 775 F.2d 1107, 1118 (Fed.Cir.1985) (noting that a claim is construed in light of its language, the specification, and the prosecution history). Moreover, the Court must begin by determining what the plain and ordinary meaning of “therapeutically effective” is in order to determine whether Amgen has become its own lexicographer. Intellectual Prop. Dev., Inc. v. UA-Columbia Cablevision of Westchester, Inc., 336 F.3d 1308, 1315 (Fed.Cir.2003) (“Consulting the written description and prosecution history as a threshold step in the claim construction process, before any effort is made to discern the ordinary and customary meanings attributed to the words themselves, invites a violation of our precedent counseling against importing limitations into the claims.” (quoting Texas Digital Systems, Inc. v. Telegenix, Inc., 308 F.3d 1193, 1204 (Fed.Cir.2002)) (internal quotation marks omitted)). a. The Plain and Ordinary Meaning Generally, it is the plain and ordinary meaning of the words — as defined by one skilled in the relevant art — that governs. Vitronics, 90 F.3d at 1582; Erik Paul Belt, Federal Circuit Stresses Ordinary Meaning, Nat’l L.J., Sept. 22, 2003, at SI. Amgen argues that the plain and ordinary meaning of the term “therapeutically effective” is “sufficient to produce a sustained increase in hematocrit.” HMR/ TKT argues, on the other hand, that the plain and ordinary meaning of “therapeutically effective” is not so restricted. Interestingly, HMR/TKT never states what it believes the plain and ordinary meaning of the term to be — it only discusses the meaning of the term with reference to how it believes Amgen has so defined it in the specification and prosecution history. Amgen, on the other hand, grounds its assertion of the plain and customary meaning of the disputed term upon expert testimony. This, however, is extrinsic evidence to which resort ought be had only “if necessary.” Vitronics, 90 F.3d at 1583 (quoting Hormone Research Foundation, Inc. v. Genentech, Inc., 904 F.2d 1558, 1562 (Fed.Cir.1990)). Therefore, the Court does not begin by considering this evidence. Instead, it turns first to the dictionary and to technical treatises to decipher the plain and ordinary meaning of “therapeutically effective.” See id. at 1584 & n. 6 (noting that judges are free to consult technical treatises and dictionaries in order to gain a better understanding of the claims and to interpret them, “so long as the dictionary definition does not contradict any definition found in or ascertained by a reading of the patent documents.”). The dictionary definition of “therapeutic” is “[h]aving healing or curative powers,” or “[o]f or relating to the treatment of disease or disorders by remedial agents or methods.” The American Heritage Dictionary 1260 (2d college ed.1985); Webster’s Ninth New Collegiate Dictionary 1223 (1984), attached as Tab X to Supp.App. [Doc. No. 735] to Amgen’s Reply re ’422/’080; see also Chamber’s Technical Dictionary 844 (3d ed.1961), attached as Tab W to Supp.App. to Amgen’s Reply re ’422/’080 (“Of, or pertaining to, the medical treatment of disease: remedial: curative”). The definition of therapeutics is “[t]he medical treatment of disease.” The American Heritage Dictionary, supra, at 1260. The dictionary definition of “effective” is “[h]aving an intended or expected effect” or “[pjroducing or designed to produce the desired impression or response.” Id. at 439. Based on these definitions alone, one would surmise that a “therapeutically effective” amount is one that produces healing or curing as it relates to medical treatment of disease. This is, in essence, consistent with the definition that Amgen proposes. See Amgen’s Mem. in Support re ’422/’080 [Doc. No. 671] at 14 (arguing that the ordinary meaning is an amount sufficient to “cure or relieve a disease state” and “require[s] a meaningful benefit to the health of patients”). Amgen, however, goes further, asserting that the plain and ordinary meaning of “therapeutically effective amount,” to one skilled in the art, taken in the context of this patent, is an amount that provides more than the biological effects of EPO and “produce[s] a sustained increase in hematocrit,” because only this result provides a meaningful benefit to the health of patients suffering from anemia. Id. at 7-8, 14. Neither the claims, the specification, nor the prosecution history, however, demonstrate clearly that the plain and ordinary meaning of the term to one skilled in the art involves an increase in hematocrit. Therefore, the Court begins with the assumption that the plain and ordinary meaning of “therapeutically effective amount” is one in line with that found in the dictionaries and treatises noted above — i.e., one that heals or cures as it relates to medical treatment of disease. The next step is to look to the claims, specification, and prosecution history to see if Amgen redefined the term in the file wrapper. In addition, the Court will look to these sources to determine whether the file wrapper indicates clearly the types of patients for which this product is “therapeutically effective” and thus infuses the term with real meaning. Indeed, this is the elephant in the room. Without tackling this question, the term “therapeutically effective” or “therapeutically effective amount” is vague and meaningless. The public must know upon reading the patent what disease state is cured or healed by the product. As the Federal Circuit pointed out, “indiscriminate reliance on definitions found in dictionaries can often produce absurd results.... One need not arbitrarily pick and choose from the various accepted definitions of a word to decide which meaning was intended .... The subject matter, the context, etc., will more often than not lead to the correct conclusion.” Renishaw PLC v. Marposs Societa’ per Azioni, 158 F.3d 1243, 1250 (Fed.Cir.1998) (quoting Liebscher v. Boothroyd, 258 F.2d 948, 46 C.C.P.A. 701 (1958)) (first alteration in original). Thus, the Court, in addition to determining whether Amgen has expanded or confined the meaning of the disputed term, will look to the file wrapper to clarify this ambiguity. b. The Claims “The name of the game is the claim.” Amgen I, 126 F.Supp.2d at 80 (quoting Giles S. Rich, Extent of Protection and Interpretation of Claims — American Perspectives, 21 Int’l Rev. Indus. Prop. & Copyright L. 497, 499 (1990)) (internal quotation marks omitted). Thus, the first step in claim construction is to look to the plain and ordinary meaning of the words of the patent claim to determine the meaning of a term. Vitronics, 90 F.3d at 1582; Bell Communications Research, Inc. v. Vitalink Communications Corp., 55 F.3d 615, 619-20 (Fed.Cir.1995); Renishaw, 158 F.3d at 1248 (“[T]he claim construction inquiry, therefore, begins and ends in all cases with the actual words of the claim_[T]he resulting claim interpretation must, in the end, accord with the words chosen by the patentee to stake out the boundary of the claimed property.”). Do the claims redefine the plain and ordinary meaning of the terms used? Am-gen asserts that the claims do not support HMR/TKT’s argument that it has redefined the term to include the biological effects of EPO. Amgen asserts that because claim terms are construed to give each term meaning, Lantech, Inc. v. Keip Mack Co., 32 F.3d 542, 546 (Fed.Cir.1994), the patent claims themselves distinguish between biological and therapeutic effects. Amgen’s Reply re ’422/’080 at 10. To make its point, it refers to claims 4 and 2 of the ’080 patent. ’080 Claim, 4: A pharmaceutical composition comprising a therapeutically effective amount of an erythropoietin gly-coprotein product according to claim 1, 2, or 3. ’080 Claim 2: An isolated erythro-poietin glycoprotein having the in vivo biological activity of causing bone marrow cells to increase production of reti-culocytes and red blood cells, wherein said erythropoietin glycoprotein comprises the mature erythropoietin amino acid sequence of FIG. 6 and is not isolated from human urine. Amgen asserts that under the doctrine of claim differentiation, claim 4 of the ’080 patent must not include any or all of the effects listed in the specification because otherwise claim 4 would be identical to that of claim 2. Specifically, it points out that claim 4 of the ’080 patent requires “[a] pharmaceutical composition comprising a therapeutically effective amount” of EPO according to claim 1, 2, or 3. Amgen’s Mem. re ’422/’080 at 15-16. It then asserts that the claim 2 requires the “in vivo biological activity of causing bone marrow cells to increase production of reticulocytes and red blood cells.” Therefore, if “therapeutically effective” included the effects listed in the specification to which the Federal Circuit pointed, Amgen argues, it would include the in vivo biological activity cited by claims 1, 2, or 3 of the ’080 patent and render claim 4 of the ’080 patent superfluous. Id. at 16. As HMR/TKT urges, however, this argument is flawed because claim 4 concerns a pharmaceutical composition comprising a “therapeutically effective amount” of an EPO that happens to have the qualities described in claim 2. HMR/TKT’s Opp’s re ’422/’080 at 22. HMR/TKT correctly points out that claim 2 recites an isolated EPO glycoprotein and therefore refers to biological effects whereas claim 4 recites a pharmaceutical composition and involves therapeutic effects. Id. at 21-22. Hence, claim 2 would not be rendered superfluous if this Court construed “therapeutically effective” to include the biological effects listed in the specification. Id. at 22. Another equally flawed argument is that claim 4, by encompassing claim 2 (in referring to a “therapeutically effective” amount of the product claimed in claim 2), indicates that a “therapeutically effective amount” is one that does more than cause the in vivo biological activities described in claim 2. After a careful review of the technology and its history, it is clear that this is not a correct reading of the claims. This review relied on extrinsic evidence, as is permissible under Federal Circuit precedent. Vitronics, 90 F.3d at 1584 (noting that a court may resort to extrinsic evidence and expert testimony to help it understand the technology); Altiris, Inc. v. Symantec Corp., 318 F.3d 1363, 1371 (Fed.Cir.2003) (“In this regard, the expert testimony serves the permissible purposes of aiding our understanding of the technology and in helping us view the patent through the eyes of the skilled artisan.”). Before Amgen’s invention, human EPO was known to elicit certain biological effects, but it was impossible to extract an efficient amount of it for use in treatment of patients with anemias and other low red blood cell disorders. Amgen invented a product, recombinant EPO, that had the same in vivo biological effects as natural EPO but differed in its carbohydrate composition and was capable of manufacture in quantities large enough to provide effective treatment. With this understanding of the technology, it is clear that claims 2 and 4 of the ’080 patent, by themselves, do not define “therapeutically effective” beyond its plain and ordinary meaning, nor do they indicate that a “therapeutically effective amount” of EPO is one that does more than elicit the biological effects noted in claim 2. Instead, claim 2 stakes out Am-gen’s novel recombinant EPO that has the same in vivo biological activities of natural EPO (causing bone marrow cells to increase production of reticulocytes and red blood cells). Claim 4 sets out a pharmaceutical composition that has a novel amount of the EPO — an amount that can actually treat or cure patients. Notably, these claims do not indicate whether biological effects are themselves sufficient to treat or cure patients. Similarly, the claims of the ’422 patent do not define a “therapeutically effective amount” as one that does something above and beyond eliciting the biological effects of EPO listed in the specification. The next question is whether the claims themselves indicate for what types of patients this product is “therapeutically effective.” Amgen contends that its EPO is specifically designed for those suffering from anemias and thus only an increase in hematocrit is “therapeutically effective.” Indeed, the record shows that Amgen’s product can be used to increase levels of hematocrit, in other words, it can be used to “cure” or “relieve” the diseased state brought on by anemia. Amgen I, 126 F.Supp.2d at 99 (“The therapeutic effectiveness or benefit of an erythropoietin preparation is shown by demonstrating a correction in anemia by increasing and maintaining the hematocrit of a patient to normal or near normal levels.”). Dr. Er-slev testified at the first trial that a sustained increase in hematocrit and hemoglobin is required to determine whether or not anemia has been corrected. Erslev Test., Trial Tr. at 1688: 14-1689: 4; Means Test., Trial Tr. at 1905: 17-20; 1910: 9-13. Dr. Erslev also testified that the other effects listed in the specification such as an increase in reticulocyte count or an increase in iron uptake cannot — each standing alone — correct anemia. Erslev Test., Trial Tr. at 1688: 14-1689: 4. The problem with Amgen’s argument, however, is that the claims that contain the disputed term do not themselves include a limitation directed to the specific clinical benefit of correcting anemia. Therefore, the plain and ordinary meaning of “therapeutically effective” cannot be limited to curing anemia, i.e., producing an increase in hematocrit levels based on the claims alone. The claim language simply does not allow for such a specific interpretation. This conclusion is further supported by the fact that claim 6 of the ’080 patent (unlike claim 4) does indeed specify the type of treatment (kidney dialysis) for which the EPO should be used and calls out, in that context, that an effective amount is one that increases hematocrit: ’080 Claim 6: A method for treating a kidney dialysis patient which comprises administering a pharmaceutical composition of claim 4 in an amount effective to increase the hematocrit level of said patient. ’080 Patent, Ex. 1, col. 38: 57-60. Had Amgen used similar claim language in claim 4 — that is, had it referred specifically to anemia — then its argument would have merit. Based on the non-specific language of claim 4, however, this argument fails. In sum, the claim language supports only the plain and ordinary definition of “therapeutically effective” — an amount that produces a result that, in and of itself, helps to heal or cure. The language of the claims at issue does not delineate the type of disease for which the EPO is “therapeutically effective.” Therefore, the Court must now turn to the specification and the prosecution history to determine whether Amgen has limited or altered the plain meaning of the term either by defining the term or specifying the disease states for which the product is intended. c. The Specification The second step in claim construction is to review the specification to determine whether the patentee has used terms in a manner inconsistent with the ordinary meaning or has become his own lexicographer. Vitronics, 90 F.3d at 1582. In essence, “[t]he specification acts as a dictionary when it expressly defines terms used in the claims or when it defines terms by implication.” Id. (noting that the specification is “the single best guide to the meaning of a disputed term”). The Federal Circuit has stated that “a claim must be read in view of the specification of which it is part,” and therefore, a court can use the written description to define a term that is already in a claim limitation. Renishaw, 158 F.3d at 1248; SciMed Life Sys. v. Advanced Cardiovascular Sys., 242 F.3d 1337, 1341 (Fed.Cir.2001) (noting that claims can be given a narrow construction in light of the written description and explaining that one reason to look to the specification is “to determine if the paten-tee has limited the scope of the claims” (quoting Watts v. XL Systems, Inc., 232 F.3d 877, 882 (Fed.Cir.2000))). The part of the specification to which the Federal Circuit in Amgen II pointed is as follows: Similarly, to the extent that polypeptide products of the invention share the in vivo activity of natural EPO isolates they are conspicuously suitable for use in erythropoietin therapy procedures practiced on mammals, including humans, to develop any or all of the effects herefore attributed in vivo to EPO, e.g., stimulation of reticulocyte response, development of ferrokinetie effects (such as plasma iron turnover effects and marrow transit time effects), erythrocyte mass changes, stimulation of hemoglobin C synthesis (see, Eschbach, et al., supra) and, as indicated in Example 10, increasing hematocrit levels in mammals. ’933 Patent, Ex. 1, col. 33: 19-31 (emphases added). The Court begins by analyzing whether this section defines therapeutically effective to include the effects listed above. It is undisputed that this section declares that Amgen’s recombinant EPO is similar to natural EPO in that it shares some of the same in vivo activity. Id. at col. 33: 19-22. “[T]o the extent ” that it does so— to the extent that it is similar to natural EPO — Amgen’s EPO are “conspicuously suitable for use in erythropoeitin therapy procedures” to develop any or all of the effects that were “herefore” (before) attributed in vivo to EPO, such as the stimulation of reticulocyte response, development of ferrokinectic effects, erythrocyte mass changes, and stimulation of hemoglobin C synthesis. What is unclear and disputed, however, is whether the section that begins with “and, as indicated in Example 10, increasing hematocrit levels in mammals” is part of the laundry list of effects previously attributed in vivo to EPO or a separate suitable use for the product. In other words, this portion of the specification can be interpreted one of the following two ways: 1) Amgen’s EPO is “conspicuously suitable for use in erythropoietin therapy procedures practiced on mammals, including humans, to develop any or all of the effects herefore attributed in vivo to EPO, e.g., stimulation of reticulocyte response, ... and, as indicated in Example 10, increasing hematocrit levels in mammals.” 2) Amgen’s EPO is “conspicuously suitable for” (a) “use in erythropoietin therapy procedures practiced on mammals, including humans, to develop any or all of the effects herefore attributed in vivo to EPO, e.g., stimulation of reticulocyte response, ...” and, (b) “as indicated in Example 10, increasing hematocrit levels in mammals.” The former interpretation — a direct quote of the specification — suggests that an increase in hematocrit level was an effect previously attributed to natural EPO and that it, along with the biological effects, are a type of effective therapy. In other words, it includes “increasing the hematocrit levels” as one of the many effects of EPO that were previously identified and that are now produced by this product and useful in “erythropoietin therapy procedures.” The problem with this reading is that the intrinsic evidence (the claims, the specification, and the prosecution history) and extrinsic evidence suggest that an increase in hematocrit levels was not previously attributed to natural EPO. In remarks following an amendment made during prosecution of the ’080 patent, Amgen explained to the Patent, and Trademark Office (“PTO”) that Example 10 is novel in that it is the first therapeutic procedure ever practiced with EPO to demonstrate that EPO has the capacity to generate an increase in hematocrit in vivo. Amgen’s ’422/’080 App., Tab G (Ex. 2), at Tab 6, at 179. The extrinsic record also suggests that an increase in hematocrit was not previously attributed to natural EPO. Vitronics, 90 F.3d at 1583 (“Included within an analysis of the file history may be an examination of the prior art cited therein.”). Therefore, the first reading implies a factually incorrect conclusion. The latter interpretation — and the one that the Court adopts — suggests that an increase in hematocrit is independent or different from the in vivo effects previously attributed to natural EPO. In other words, in this section, Amgen calls out that its recombinant EPO can elicit “any or all” of the effects that natural EPO does — and more. Admittedly, the use of the words “therapy procedures” supports the interpretation that a “therapeutically effective amount” encompasses an amount that would result in the biological effects because it implies that the effects are a part of therapy. That being said, however, the way in which the increase in hematocrit is set off from the rest of the language suggests that this product elicits something in addition to what the prior art elicited, something more than the biological effects. Moreover, it makes clear that “any or all” only modifies those effects previously attributed to natural EPO — not the increase in hematocrit. Indeed, if the phrase “as indicated in Example 10, increasing hemat-ocrit levels in mammals” were merely an item in the list of “any or all of the effects herefore attributed in vivo to EPO,” then the words “in mammals” would be redundant. The list of items refers to “effects herefore attributed in vivo to EPO” for “use in erythropoietin therapy procedures practiced on mammals ”, so “increasing hematocrit levels in mammals ” must be a second end for which Amgen’s EPO is “conspicuously suitable.” This interpretation comports with the Court’s understanding — developed over the course of two intensive trials — of what hematocrit actually measures. Hematocrit measures the ability of the blood to supply oxygen to the body. It indicates the relative proportion of red blood cells to the total volume of blood. By introducing additional EPO into the patient’s body, a patient’s hematocrit level can be increased to and sustained at or near normal levels. In other words, the blood is able to provide a steady supply of sufficient oxygen to the tissues. It is the Court’s understanding that, in most cases, an increase in hemato-crit is accompanied, if not preceded, by “any or all” of the biological effects listed in the specification. In other words, this portion of the specification explains what happens when a “therapeutically effective amount” of EPO is used — that is, it produces an increase in hematocrit — along with any or all of the biological affects previously attributed to natural EPO. As will be discussed below, this reading is further supported by other parts of the specification and the prosecution history. Therefore, while this Court agre