Citations
- 99 F. Supp. 3d 5
Full opinion text
OPINION
ROSEMARY M. COLLYER, United States District Judge
What does it take to disclose a protein sufficiently so that it can be patented? After 20 years of litigation, the parties are still arguing about it. Abbott GMBH & Co. KG and Yeda Research and Development Co. Ltd. claim competing U.S. patent applications, each based on an earlier-filed foreign patent application. Abbott's application to patent the TBP-II protein was filed in Germany on May 9, 1989. Yeda filed its application to patent the TBP-II protein nine days later, on May 18, 1989 in Israel. From that few days’ difference in time fortunes might be made. Yeda has been arguing since April 5, 1995 that Abbott’s application was incomplete and infirm, while its own application more fully identified the TBP-II protein and is entitled to priority and U.S. patent protection for the next 17 years. Abbott’s patent has since expired. Here, Yeda raises serious issues.
The current focus is a May 26, 2010 opinion by the Board of Patent Appeals and Interferences that granted Abbott the benefit of the earlier filing date of its first German application. After thorough consideration of the full administrative record, the parties’ briefs and accompanying exhibits, and with the benefit of excellent oral argument, the Court will grant Abbott’s motion for summary judgment and deny Yeda’s motions for summary judgment.
I. OVERVIEW
As stated by the Board of Patent Appeals and Interferences (Board) in 2010, “This is an old interference,” ie., a claim by one inventor that another has interfered with his invention and the claimant was the first to invent. Administrative Record (AR) [Dkt 89-4] (5/26/10 Board Decision) at 5961. The interference in this ease resulted when Yeda asserted that its inventors were the first to disclose a protein called the Tumor Necrosis Factor Binding Protein-II (TBP-II) claimed by Abbott in U.S. Patent No. 5,344,915 (the '915 Patent”). TBP-II was “isolated from the urine of individuals with a fever and from the ascites fluid of individuals with ovarian carcinomas.” Abbott III, 576 F.Supp.2d at 46. TBP-II “binds to, and thereby neutralizes, potentially harmful polypeptides.” Id. at 45.
To prove its priority before the Board and this Court, Abbott relies on application P39 15 072 (’072 Application) to patent TBP-II in Germany, filed on May 9, 1989 by Hans-George LeMaire and three co-inventors, Abbott’s predecessors. Thereafter, on July 15, 1989, Abbott filed application P39 22 089 (’089 Application) in Germany covering the same protein. On May 4, 1990, Abbott filed an International Patent Application (later designated as a U.S. patent application) claiming the benefit of the filing date of the '072 Application. On September 6,1994, the U.S. application matured into the '915 Patent. As described by the Board:
This proceeding had its genesis when Yeda requested an interference with Abbott’s ['915] patent. Application 07/930,-443, Miscellaneous Incoming Letter, filed April 5, 1995. An examiner requested Yeda to make a claim for the purpose of interference. Miscellaneous Office Action, mailed May 15, 1995. Yeda responded by submitting its Claim 67. Application 07/930,443, Amendment filed May 24, 1995. After some additional prosecution, the examiner recommended that an interference be declared. Form 850, attachment to Paper 1.
This interference was declared with Yeda designated as the senior party. Paper 2, p.l. Yeda was accorded the benefit of the filing dates of four earlier applications. The earliest was an Israeli application filed May 18, 1989. Paper 1, Appendix, numbered p.l. Abbott was accorded the benefit of the May 4, 1990, filing date of [the International Patent Application].
During the interference, Yeda filed a ... motiqn asserting that all of Abbott’s claims were unpatentable over certain prior art. Paper 21. Abbott opposed the motion arguing that its claimed subject matter was entitled to the benefit of the filing dates of two German applications under 35 U.S.C. § 119 — Applications P 39 22 089(089) and P 39 15 072(072). The filing dates of both applications preceded the date of [the prior art] reference. Abbott argued that because it was entitled to benefit [from the application dates for the ’072 Application and the ’089 Application], the reference was not prior art to its claims.
A panel of the Board held that Abbott had not established entitlement to the filing dates of the German applications and that its claims were unpatentable over the prior art. In particular, the panel held that the German applications do not have written descriptive support for the subject matter claimed. Since Abbott did not have any patentable claims, the panel entered judgment against Abbott. Paper 105. The other preliminary motions filed by the parties were considered moot and left undecided.
On July 21, 2000, Abbott sought judicial review of the board’s decision under 35 U.S.C. § 146. Paper 107. Abbott reasserted entitlement to the filing date of the 089 application. Entitlement to the filing date of the 072 application was apparently not asserted in the district court.
On September 15, 2008, the district court held that Abbott’s claimed subject matter was described in the 089 application, vacated the panel’s decision of un-patentability, and remanded the interference to the board. Paper 110. Yeda’s appeal to the Court of Appeals for the Federal Circuit was dismissed for lack of jurisdiction on May 29, 2009. Paper 115.
See 5/26/10 Board Decision [Dkt. 89-4] AR at 5961-62. After remand in 2008, the Board granted Abbott the benefit of the May 9,1989 filing date of German Application P 39 15 072 ('072 Application), giving it priority over Yeda. Id. at 5963.
This appeal followed. It has its own intricate history, which need not be detailed. During the course of the immediate proceedings, the parties have engaged in discovery, which has amplified the record from that before the Board. In the interim, the Federal Circuit determined that parties can introduce new evidence before the district court in a § 146 interference action, regardless of whether the issue or evidence was presented to the Board. See Troy v. Samson Mfg’g Corp., 758 F.3d 1322, 1325 (Fed.Cir.2014) (reh’g denied) (“We conclude that the Supreme Court’s decision in [Kappos v. Hyatt, — U.S. —, 132 S.Ct. 1690, 1694, 1700, 182 L.Ed.2d 704 (2012) ] permits new evidence to be admitted without regard to whether the issue was raised before the Board. The Supreme Court held, without qualification, that ‘there are no evidentiary restrictions beyond those already imposed by the Federal Rules of Evidence and the Federal Rules of Civil Procedure.’ ”) Yeda seeks to introduce evidence produced from Abbott in discovery in this case and to obtain a claim construction on a new term. With some legitimacy, Abbott argues that the Federal Rules of Procedure bar Yeda’s late evidence. Nonetheless, to provide a complete record for appeal, this Court has considered all of the evidence and arguments submitted by both parties.
II. PATENT AND INTERFERENCE BACKGROUND
Under long-standing U.S. patent law, the “first person to conceive the invention is the first inventor, ... provided that when the first to conceive the invention is the last to reduce it to practice, the person who was first to conceive must have exercised reasonable diligence to his own actual or constructive reduction to practice, ‘from a time prior to conception by the other.’ ” Hyatt v. Boone, 146 F.3d 1348, 1351 (Fed.Cir.1998) (quoting 35 U.S.C. § 102(g) prior to 2011 amendment; other citations omitted) (emphasis added).
As a consequence of the principle that the first to invent is granted the patent, “there must be a mechanism for determining who among multiple patent applicants ... was the first to invent the claimed subject matter.” Cytologic, Inc. v. Biopheresis GmbH, 682 F.Supp.2d 1, 4 (D.D.C.2010). For this purpose, 35 U.S.C. § 135 specifically provided for “Interferences,” a “proceeding [ ] principally declared to permit a determination of priority.” Minnesota Mining and Mfg. Co. v. Norton Co., 929 F.2d 670, 674 (Fed.Cir.1991). As is the case here, a patent applicant may suggest an interference. See 37 C.F.R. § 41.203. If the Director of the United States Patent and Trademark Office (USPTO) decides that an interference is warranted, i&, that “an application is made for a patent which ... would interfere with any pending application, or with any unexpired patent,” he may declare an interference. 35 U.S.C. § 135. The Board “determine”] questions of priority of the inventions.” Id.
In 2013, the United States moved to a “first to file” system. See 35 U.S.C. § 102; see also Leahy-Smith America Invents Act (AIA), Pub.L. No. 112-29, 125 Stat. 284 (2011). While not applicable to this longstanding dispute, the critical change to the rules of priority must be noted. The AIA obviated patent interferences. See AIA § 3(i). Pursuant to AIA § 3(n)(2)(A), this interference remains governed by the laws in effect at the relevant time.
III. FACTS
Plaintiff Yeda Research & Development Co., Ltd. (Yeda) is an Israeli company; Abbott GmbH & Co. KG (Abbott) is a German subsidiary of Abbott Laboratories, Inc., which is based in Illinois. Compl. [Dkt'. 1] ¶¶ 3, 6-7.
A. Abbott’s German Patent Applications and the '915 Patent
Abbott filed application P39' 15 072 on May 9, 1989 ('072 Application) in Germany to cover a “novel protein found in certain biological fluids.” Abbott Mot. for Summ. J. [Dkt. 70] (Abbott Mot.) at 5; id. Ex. M [Dkt. 70-16] ('072 Application). Abbott filed a second patent application in Germany, P39 22 089 ('089 Application) on July 15, 1989. See id., Ex. K [Dkt. 70-14] ('089 Application). On May 4,1990, Abbott filed an International Patent Application, “claiming the benefit of the filing date of [the '072 Application];” the International Patent Application was eventually designated as a U.S. Patent Application, and the USPTO issued U.S. Patent No. 5,344,915 ('915 Patent) to Abbott on September 6, 1994. Compl. ¶¶ 8- 10; see also Abbott Mot., Ex. A [Dkt. 70-4] ('915 Patent).
1. '072 Application
The '072 Application described a novel protein as having the following characteristics: (1) a molecular weight of about 42 kilodaltons (kDa); (2) the specific biological property of inhibiting the cytotoxicity of TNF alpha; (3) found in the urine of febrile patients; and (4) not digestible by trypsin. See '072 Application at 2. The '072 Application identified the following partial amino acid sequence at the N-terminus of the claimed protein: “XTX1YX2X3 EX4GSX5X6RLR where X is oxygen, a phenylalanine radical (Phe) or the amino acid sequence X7X8PheQX9X10.” Id. Each of Xx-X10 “denote[s] not yet determined amino acids.” Id. at 3. The '072 Application identified three main sequences; Sequence 1: F T X1 Y X2 X3 E X4 G S X5 X6 R L R; Sequence 2: X7 X8 F Q W9 X10 F T X1 Y X2 X3 E X4 G S X5 X6 R L R; and Sequence 3: T X1 Y X2 X3 E X4 G S X5 X6 R L R. Id. at 8. The '072 Application suggested probable identities for several of the amino acids that had not been definitely identified at the time of filing. Id.
Example 2 of the '072 Application described a protocol for isolating the protein from the urine of patients with fever, which included the following elements: (1) collecting 40 liters of urine from patients with fever by (a) filtering the urine through a “Hemoflow F60” cartridge, and then (b) subjecting the “reteníate” (what was retained on and then collected from the cartridge) to the following multi-step column-chromatography protocol: (i) “S-Sepharose” column chromatography; (ii) “TNF-affinity” column chromatography; and (iii) “Mono-Q” column chromatography. Id. at 4-5.
2. '915 Patent
The '915 Patent described a novel protein having the following characteristics: (1) a molecular weight of about 42 kilodal-tons (kDa); (2) the specific biological property of inhibiting the cytotoxicity of TNF alpha; (3) found in the urine of febrile patients; and (4) digestible by trypsin with difficulty or not at all. See '915 Patent at 2. Example 2 of the '915 Patent discloses the same protocol to isolate the protein as the '072 Application. Compare '915 Patent at 2-3 [Dkt. 70^1] with '072 Application at 4-5 [Dkt. 70-16].
The '915 Patent identified the following amino acid sequence at the N-terminus of the claimed protein:
Abbott Mot., Appendix I.
Below is a comparison of Sequence 1 of the '072 Application with Sequence 2 of the '915 Patent:
Abbott Mot. at 18; see also id., Appendix I.
B. Yeda’s Patent Applications
On May 18, 1989, Yeda filed application No. 90,339 ('339 Application) in Israel for a patent covering the TBP-II protein. See Abbott Mot., Ex. AA [Dkt. 70-30] ('339 Application). Yeda disclosed an N-terminal sequence consisting of 13 amino acids in its longest sequence. See Abbott Mot. at 10. Below is a comparison of the longest sequence disclosed in Yeda’s '339 Application with the nine amino acids disclosed in Abbott’s '072 Application:
Abbott Mot. at 10. Asserting the benefit of the '339 Application, Yeda filed U.S. Patent Application No. 07/930,443 ('443 Application) on August 19, 1992 to claim the TBP-II protein. Compl. ¶ 12; see also Abbott Mot., Ex. B [Dkt. 70-5] ('443 Application).
C. Engelmann Paper
On January 16, 1990, the Journal of Biological Chemistry published a paper by Dr. Hartmut Engelmann et al., titled, “Two Tumor Necrosis Factor-Binding Proteins Purified from Human Urine.” See Abbott Mot., Ex. C [Dkt. 70-6] (Engel-mann Reference). Dr. Engelmann is one of the named inventors on Yeda’s '443 Application. The Engelmann Reference described the identification of the TBP-II protein, including the identification of an N-terminal sequence consisting of five amino acids. Id. at 1. The authors relied on that short amino acid sequence along with other characteristics and data to identify the TBP-II protein. Id. 1, 4-6. There was agreement in the scientific community that the data cited in the Engel-mann Reference showing that the scientists had identified a new TNFa-binding protein. See, e.g., Heller et al, Proc. Natl. Acad. Sci. USA 87, 6151-6155 (1990) (“The result is compatible with the sequence Val-Ala-Phe-Thr-Pro found in the recently published urinary TNF-binding protein II, which was also reported to be variable at the amino terminus.”); Loetscher et al., J. Bio. Chem. 265:33, 20131, 20137 (1990) (“... a short amino acid sequence of a second TNF inhibitory protein has recently been reported”); Lewis et al., Proc. Natl. Acad. Sci. USA. 88: 2830-2834 (April 1991) (“Recently two immunologically distinct cell-surface-associated TNF-binding proteins of 55-kDa and 75-kDa were identified.”).
Below is a comparison of the five amino acid sequence disclosed in the Engelmann Reference compared with the nine amino acid sequence disclosed in the '072 Application and the fifteen amino acid sequence disclosed in the '915 Patent:
Abbott Mot. at 11; see also id., Appendix III.
D. The 2003 Abbott Experiments
In response to Yeda’s claims, Abbott conducted a set of experiments in 2003 to demonstrate the validity of the protocol in the '072 Application (2003 Experiments). See Abbott Mot., Ex. F [Dkt. 70-9] (Bradshaw Report) ¶¶ 40-52. There were two stages to the 2003 Experiments. The first took place in Ludwigshafen, Germany, and the second took place in Abbott Park, Illinois. During the 2003 Experiments, Abbott scientists repeated the protocol in Example 2 of the '072 Application to demonstrate “that Abbott’s first patent application describes and enables the subject matter of the Count.” Abbott Mot. at 3. Yeda retained Dr. Engelmann to observe the first phase in Germany, and it retained Dr. Menachem Rubinstein (another of the inventors named on Yeda’s '448 Application) to observe the second phase in the United States. Bradshaw Report ¶¶ 41, 45.
During the first stage, in a laboratory in Germany on February 3 through 7, 2003, Andreas Striebinger, one of Abbott’s scientists, performed the protocol from Example 2 in the '072 Application. Id. ¶41. Present and observing the first phase were Dr. Bradshaw for Abbott and Dr. Engel-mann for Yeda. Id. The first phase yielded two fractions of “essentially homogenous protein,” which Abbott then sent to Abbott Park “for an analysis of the N-terminal amino acid sequence using automated Edman sequencing techniques.” Bradshaw Report. ¶¶ 42, 44. In lay terms, in Germany Abbott attempted to isolate the TBP-II protein; in the United States it sought to determine the composition of the sample.
The second stage of the 2003 Experiments took place on March 3 through 5, 2003, in Abbott Park, Illinois. Abbott scientist Dr. Thomas Holzman and his assistant, Sally Dorwin, performed the Edman degradation. Id. ¶ 45. Also present for the second phase were Dr. Bradshaw for Abbott and Dr. Rubinstein for Yeda. Id.
The parties characterize the results of the two phases differently. Abbott states that “the 2003 experiments resulted in a purified and isolated protein that could be definitively identified as the TBP-II protein based on (among other characteristics) its molecular weight, its method of purification, its biological activity, and its N-terminal sequence.” Abbott Mot. at 14. Yeda states that the 2003 Experiments “did not result in a purified and isolated TBP-II protein as defined by the Count ... [because] the data does not permit the identification of anything close to one of the complete amino-acid sequences recited in the Count.” Yeda Response to Abbott Statement of Undisputed Facts [Dkt. 81-2] (Response to Abbott Facts) at 36.
IV. PROCEDURAL HISTORY
A. Interference before the Board
On October 1, 1996, the Board declared Interference No. 103,625 ('625 Interference) between Abbott’s '915 Patent and Yeda’s '443 Application. Compl. ¶ 14. The subject matter of the Interference was set forth in subsections (b) and (c) of the re-declared Count 2 (Count), which correspond to claims in the '915 Patent:
(b) A purified and isolated TNFa-bind-ing protein which has a molecular weight of about 42,000 daltons and has at the N terminus the amino acid sequence
Xaa-Thr-Pro-Tyr-Ala-Pro-Glu-Pro-Gly-Ser-Thr-Cys-Arg-Leu-Arg-Glu
where Xaa is hydrogen, a phenylalanine residue (Phe) or the amino acid sequences
Ala Phe,
Val Ala Phe,
Gin Val Ala Phe,
Ala Gin Val Ala Phe,
Pro Ala Gin Val Ala Phe or
Leu Pro Ala Gin Val Ala Phe.
or
(c) A process for the preparation of a protein which has a molecular weight of about 42,000 daltons and has at the N terminus the amino acid sequence
Xaa Thr Pro Tyr Ala Pro Glu Pro Gly Set Thr Cys Arg Leu Arg Glu where Xaa is hydrogen, a phenylalanine residue (Phe) or the amino acid sequences
Ala-Phe,
Val-Al a-Phe,
Gln-Val-Ala-Phe,
Ala-Gln-Val-Ala-Phe,
Pro-Ala-Gln-Val-AIa-Phe or
Leu-Pro-Ala-GlnVal-Ala-Phe
which comprises concentration of the urine of patients with fever and subsequent purification of the reteníate obtained in this way by ion exchange and affinity chromatography.
AR at 6007-08 (Board Redeclaration). Parts (b) and (c) of the Count, which correspond to claims in Abbott’s '915 Patent, require that the protein contain one of the following N-terminal amino acid sequences:
Thr-Pro-Tyr-Ala-Pro-Glu-Pro-Gly-Ser-Thr-Cys-Arg-Leu-Arg-Glu
Phe-Thr-Pro-Tyr-Ala-Pro-Glu-Pro-Gly-Ser-Thr-Cys-Arg-Leu-Arg-Glu
Ala-Phe-Thr-Pro-Tyr-Ala-Pro-Glu-Pro-Gly-Ser-Thr-Cys-Arg-Leu-Arg-Glu
Val-Ala-Phe-Thr-Pro-Tyr-Ala-Pro-Glu-Pro-Gly-Ser-Thr-Cys-Arg-Leu-Arg-Glu
Gln-Val-Ala-Phe-Thr-Pro-Tyr-Ala-Pro-Glu-Pro-Gly-Ser-Thr-Cys-Arg-Leu-Arg-Glu
Ala-Gln-Val-Ala-Phe-Thr-Pro-Tyr-Ala-Pro-Glu-Pro-Gly-Ser-Thr-Cys-Arg-Leu-Arg-Glu
Pro-Ala-Gln-Val-Ala-Phe-Thr-Pro-Tyr-Ala-Pro-Glu-Pro-Gly-Ser-Thr-Cys-Arg-Leu-Arg-Glu
Leu-Pro-Ala-Gln-Val-Ala-Phe-Thr-Pro-Tyr-Ala-Pro-Glu-Pro-Gly-Ser-Thr-Cys-Arg-Leu-Arg-Glu
Id.
Yeda prevailed in the '625 Interference, arguing that the Engelmann Reference was a prior art publication that invalidated the claims of the '915 Patent because Abbott had not established entitlement to the filing dates of the '072 and '089 Applications. The Board invalidated Abbott’s '915 Patent and found that Abbott was not entitled to priority. See Abbott III, 576 F.Supp.2d at 47. The Board reasoned that the '072 and '089 Applications did not, “as originally filed,” sufficiently describe the TBP-II protein, id. and that Abbott “failed to effectively remove Engelmann as prior art,” Abbott Mot., Ex. D [Dkt. 70-7] (First '625 Interference Decision) at 19. Abbott sought review of the Board’s decision in this Court under 85 U.S.C. § 146, in case Civil No. 00-1720.
B. Initial District Court Litigation
The case was assigned to the Honorable Ricardo Urbina. In 2005, Judge Urbina denied Yeda’s motion for summary judgment, rejecting its argument that Abbott’s '089 Application did not adequately describe the '915 Patent as a matter of law. See Abbott I at *7. Two years later, Judge Urbina construed the '915 Patent, adopting Abbott’s proposed construction, and concluding that the “['915] Patent covers only the TBP-II protein” but not its “naturally occurring muteins.” See Abbott II, 516 F.Supp.2d at 6. After construing the single term in the '915 Patent requested by the parties, Judge Urbina found the evidence underlying the Board’s decision in the '625 Interference “wholly unsup-portive” of the Board’s conclusion. See Abbott III, 576 F.Supp.2d at 51. He found that the Board had committed clear error in invalidating the '915 Patent. Id. at 46. Specifically, Judge Urbina rejected the Board’s conclusions that the '089 application did not inherently disclose the TBP-II protein and that the '089 application did not provide an adequate written description because it could describe either the TBP-I or TBP-II protein. Id. at 50-51. Judge Urbina found that (a) the '089 application, '915 Patent, and Engelmann Reference “provide entirely consistent descriptions of the TBP-II protein albeit with varying levels of specificity;” and (b) the “majority of the known amino acids set forth in the 072 application match the amino acids designated in the 089 application” and '915 Patent. Id. at 50. Judge Urbina granted summary judgment to Abbott and remanded the case to the Board for further proceedings. See Order, Civ. No. 00-1720(RMU) (D.D.C. Sept. 15, 2008) (Dkt. 117). Yeda appealed to the Federal Circuit, which dismissed the appeal. See Abbott IV, 333 Fed.Appx. at 525 (“Since the district court remanded the case for the Board to determine priority, the case is not final; the issue of patentability can be reviewed on appeal from a final judgment resolving all issues.”).
C. On Remand
On remand, the primary issue was whether Abbott’s '072 Application was a constructive reduction to practice of the Count, which required Abbott to prove by a preponderance of the evidence that the '072 Application “describes and enables at least an embodiment meeting all the limitations of the [C]ount.” 5/26/10 Board Decision at 5968-89, 5971 (citing Frazer v. Schlegel, 498 F.3d 1283 (Fed.Cir.2007)). Before the Board, Abbott argued that the “N-terminal sequences are inherent in the proteins obtained as described in the '072” Application so that it did not need to identify a full sequence to recognize the TBP-II protein. Id. at 5965. Yeda maintained that Abbott did not submit sufficient evidence of discovery. The Board noted that Abbott’s burden was to “show that it is more likely true than not that the necessary and only reasonable construction of the 072 application is that the proteins are the same.” Id. at 5970. The Board compared the disclosures contained in the '072 Application with the '915 Patent and found that
they describe (1) the same source of the protein-urine from patients with a fever, (2) the same method of isolating and purifying the protein from the urine— the use of a TNF affinity column, (3) the same amount of protein obtained ... per liter of urine, (4) the use of the same technique to determine the molecular weight and purity of the protein — 15% SDS gel electrophoresis, (5) obtaining a protein that has a molecular weight of about 42,000 daltons with a purity of about 90%, (6) recovered a protein that does not degrade when exposed to tryp-sin and (7) a protein that binds TNFa. Additionally, the N-terminal sequences of the protein of 072 [Application] are consistent with the N-terminal sequences disclosed in the 915 patent.
Id. In light of these similarities, the Board concluded that the '072 Application and the '915 Patent “describe the same proteins.” Id.
The Board evaluated Yeda’s central argument that the '072 Application did not meet the written description or enablement requirements of 85 U.S.C. § 112. Id. at 5971. Yeda argued that “a correct sequence, at least at the N-terminal, is critical in order to adequately identify and fingerprint the [TBP-II] protein as being something different from other proteins of about the same molecular weight and activity, and obtained from the same source.” Id. at 5973. The Board rejected Yeda’s argument because “Abbott’s motion [was] not based on the disclosure of 072 [Application] alone. Abbott relies upon a comparison of the 072 and 915 disclosures to show that the proteins are the same.” Id. The Board reiterated its prior finding that the protein described in both applications is the same. Id. at 5973-74. The Board rejected Yeda’s argument that an enabling' disclosure would have had to enable a skilled person to “immediately ascertain the N-terminal sequence of the protein at the time the 072 application was filed.” Id. at 5975. Because amino acid sequencing is not the only way to identify a protein, the Board was satisfied that the '072 Application provided “sufficient information to enable the protein” because it “describes the protein by partial N-terminal sequences, its source, the method of making and purifying it, its molecular weight, amount recovered, purity, degradation characteristics in trypsin and its ability to bind TNFot.” Id. Accordingly, on May 26, 2010, the Board granted judgment in the '625 Interference to Abbott, giving Abbott the benefit of the filing date of the '072 Application. Id. at 5980.
D. The Instant Litigation
Yeda filed a Complaint in the Northern District of Illinois on September 8, 2010 to obtain review of the May 26, 2010 Board Decision. That Court granted Abbott’s motion to transfer the case to this District, where it was docketed as Civil No. 10-1836, before Judge Urbina. While discovery was under way, Judge Urbina retired and the case was reassigned to the undersigned.
Y. LEGAL STANDARDS
A. Review of Board Decision under 35 U.S.C. § 146
A district court has authority to review a decision by the Board under 35 U.S.C. § 146. Questions of law are reviewed de novo and the Board’s underlying factual determinations are reviewed for clear error. See Winner Int’l Royalty Corp. v. Wang, 202 F.3d 1340, 1348 (Fed.Cir.2000). If a district court accepts new evidence not previously before the Board, the proceedings become “a hybrid of an appeal and a trial de novo.” Estee Lauder Inc. v. L’Oreal, S.A., 129 F.3d 588, 592 (Fed.Cir.1997). In a hybrid case, the court is a de novo factfinder for issues on which the court accepts new evidence. See Winner, 202 F.3d at 1347-48.
B. Written Description, Enablement, and Best Mode under 35 U.S.C. § 112
“The filing of a patent application serves as conception and constructive reduction to practice of the subject matter described in the application.” Hyatt v. Boone, 146 F.3d 1348, 1352 (Fed.Cir.1998). As is argued here, “when the priority claim is based on subject matter disclosed in a foreign patent application whose filing date is properly claimed, ... the foreign application has the same effect as if filed in the United States.” Frazer v. Schlegel, 498 F.3d 1283, 1287 (Fed.Cir.2007) (citing 35 U.S.C. § 119(a), (e)(1)). Therefore, the invention disclosed in a foreign patent application “must be disclosed in the manner provided by the first paragraph of [35 U.S.C.] section 112.” Id.
35 U.S.C. § 112 codifies the written description, enablement, and best mode requirements of a patent:
[t]he specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
A written description of the invention “is separate and distinct from the enablement requirement.” Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64 (Fed.Cir.1991). To satisfy the written description requirement, “the applicant must also convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention.”' Id. (emphasis in the original).
Enablement requires that “the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation.’ ” ALZA Corp. v. Andrx Pharm. LLC, 603 F.3d 935, 946 (Fed.Cir.2010) (citing Genentech Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1365 (Fed.Cir.1997)) (emphasis added). “En-ablement is not precluded where a ‘reasonable’ amount of routine experimentation is required to practice a claimed invention, however, such experimentation must not be ‘undue.’ ” Id. at 940 (citations omitted). “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations.” In re Wands, 858 F.2d 731, 737 (Fed.Cir.1988). In Wands, the Federal Circuit set forth the factors that a district court may consider when determining if a disclosure requires undue experimentation:
(1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.
The test for best mode is whether ■the “invention possessed a better mode than was described in the patent and ... such better mode was intentionally' concealed.” Ateliers de la Haute-Garonne v. Broetje Automation USA, Inc., 717 F.3d 1351, 1356-57 (Fed.Cir.2013). In the context of a priority claim, “one looks to the foreign application and its filing date to determine the adequacy of the best mode disclosure and not the filing date of the corresponding U.S. application.” Transco Prods. Inc. v. Performance Contracting, Inc., 38 F.3d 551, 558 (Fed.Cir.1994).
C. Summary Judgment
Under Rule 56 of the Federal Rules of Civil Procedure, summary judgment shall be granted “if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.” Fed.R.Civ.P. 56(a); accord Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). Moreover, summary judgment is properly granted against a party who “after adequate time for discovery and upon motion ... fails to make a showing sufficient to establish the existence of an element essential to that party’s case, and on which that party will bear the burden of proof at trial.” Celotex Corp. v. Catrett, 477 U.S. 317, 322, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986).
The moving party bears the initial burden of “identifying those portions of ‘the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any,’ which it believes demonstrate the absence of a genuine issue of material fact.” Celotex Corp., 477 U.S. at 323, 106 S.Ct. 2548. In ruling on a motion for 'summary judgment, the court must draw all justifiable inferences in the nonmoving party’s favor. Anderson, 477 U.S. at 255, 106 S.Ct. 2505. A nonmoving party, however, must establish more than “the mere existence of a scintilla of evidence” in support of its position. Id. at 252, 106 S.Ct. 2505. In addition, the non-moving party may not rely solely on allegations or eonclusory statements. Greene v. Dalton, 164 F.3d 671, 675 (D.C.Cir.1999). If the evidence “is merely color-able, or is not significantly probative, summary judgment may be granted.” Anderson, 477 U.S. at 249-50, 106 S.Ct. 2505 (citations omitted). Summary judgment is properly granted against a party who “after adequate time for discovery and upon motion ... fails to make a showing sufficient to establish the existence of an element essential to that party’s case, and on which that party will bear the burden of proof at trial.” Celotex, 477 U.S. at 322, 106 S.Ct. 2548.
VI. ANALYSIS
Abbott filed for summary judgment, Dkt. 70, on the grounds that the Board of Patent Appeals and Interferences correctly determined that the '072 Application met the written description and enablement requirements in 35 U.S.C. § 112. Yeda filed three separate motions for summary judgment, contending that the '072 Application did not contain an adequate written description, Dkt. 71; that the '072 Application did not enable the invention defined by the Count in the '915 Patent, Dkt 73; and that the '072 Application did not disclose Abbott’s best mode of carrying out the invention, Dkt. 72.
Although somewhat reframed to support each of its motions for summary judgment, Yeda rests on the same alleged frailties of the '072 Application: (1) the '072 Application failed to disclose a complete amino acid sequence identified in the Count; (2) just before the '072 Application was filed, Abbott scientists used different processes that were not disclosed in the '072 Application to discover some of the TBP-II amino acids claimed in the '072 Application; and (3) the '072 Application failed to describe a process that would result in a “purified and isolated” TBP-II protein, as required by the Count. These arguments challenge the legitimacy of the '072 Application as the parent of the '915 Patent.
A. Written Description in '072 Application
Yeda has repeatedly argued that Abbott’s '072 Application is infirm because it did not disclose any of the “complete N terminal amino acid sequences recited in the [C]ount.” See, e.g., Yeda Mot. for Summ. J. on Written Description [Dkt. 71] (Yeda Mot. re: Description) at 10; see also 5/26/10 Board Decision at 5972-73 (“Yeda argues that the 072 application neither provides a written description nor enables the subject matter of the count. Yeda’s argument focuses on the failure of 072 [Application] to disclose the complete N-terminal sequences of the count.”). The facts are not in contention: the '072 Application correctly identified nine amino acids at the N-terminal of the TBP-II protein. Parts (b) and (c) of the Count (from the '915 Patent) disclose eight complete N-terminal amino acid sequences, the shortest of which contains 15 amino acids and the longest of which contains 22 amino acids. The real question is whether Abbott’s admitted failure to identify any of the complete amino acid sequences recited in the Count is fatal.
Yeda advances three arguments concerning the amino acid sequences disclosed in the '072 Application: first, that the '072 Application does not satisfy the express limitations of the Count because it does not explicitly include at least one of the complete N-terminal amino acid sequences recited in the Count; second, that Abbott cannot rely on the doctrine of inherent disclosure because all of the amino-acid-sequence limitations in the Count are material to the patentability of Abbott’s claims; and third, that a person of ordinary skill would not have understood, at the time the '072 Application was filed, that the specification disclosed any complete amino acid sequence disclosed in the Count.
Yeda quotes Hyatt v. Boone, 146 F.3d 1348, 1354-55 (Fed.Cir.1998), as its basic support: “the written description must include all of the limitations of the interference count, or the applicant must show that any absent text is necessarily comprehended in the description provided and would have been so understood at the time the patent was filed.” Hyatt also instructs that “when an explicit limitation in an interference count is not present in the written description whose benefit is sought it must be shown that a person of ordinary skill would have understood, at the time the patent application was filed, that the description requires that limitation.” Id. at 1353. See also Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1323 (Fed.Cir.2000) (“Put another way, one skilled in the art, reading the original disclosure, must immediately discern the limitation at issue in the claims.”).
Yeda’s “first step” in furtherance of the Hyatt analysis is its contention that “you can’t really define the invention properly without [identifying] all 22 [amino acids.]”' Oral Arg. Tr. I [Dkt. 94] at 18-19. In the alternative, Yeda argues that the '072 Application is fatally flawed because it failed to identify, at the least, “the shortest [sequence] at the top, which I believe is 15 amino acids.” Id. at 19.
Despite Yeda’s adherence to its argument, it is clear that the identification of every amino acid in a sequence is not always necessary before it can be determined that a new protein has been identified. The Federal Circuit most recently made this point clear when it adopted the Board’s findings in Sanofi-Aventis v. Pfizer Inc., 733 F.3d 1364 (Fed.Cir.2013). Sa-nofi-Aventis was an interference in which Pfizer claimed priority of invention of a “DNA polynucleotide that encodes the protein binding chain of the IL-13 receptor.” Id. at 1366. The Circuit noted the unremarkable fact that, under “applicable law [pre-AIA], the patent is awarded to the first party to conceive and reduce to practice the invention represented by the interference count.” Id. The Board awarded priority to Pfizer because Pfizer “had established conception of the subject matter of the count when it selected, isolated, and obtained the desired IL-13be full-length polynucleotide and verified that it was the desired product, regardless of whether the fully correct sequencing of the polynucleo-tide was complete.” Id. On appeal, Sano-fi continued to argue that “conception of the claimed cDNA could not be established for priority purposes until the fully correct nucleotide sequence was determined, because the interference count was directed to the isolated polynucleotide.”. Id. In sharp contrast, the Board had concluded that, “ ‘[f]or proteins and polynucleotide species, a sequence is the gold standard for identifying a species with precision.... It does not, however, thereby follow that a sequence is the only way to identify the composition precisely.’ ” Id. at 1369. Because the Board’s findings were based on substantial evidence and it had “applied the correct law,” the Circuit sustained the award of priority to Pfizer, even though Pfizer had not identified all of the polynu-cleotides. Id.
This should come as no surprise to Yeda. Indeed, Yeda’s own '339 Application disclosed an N-terminal sequence consisting of 13 amino acids in the longest sequence, and therefore did not disclose any of the complete amino acid sequences identified in the Count. The Engelmann Reference, written by Yeda’s chief scientist, reported that an N-terminal sequence of five amino acids, together with other biological data, was sufficient to identify a novel TNFa-binding protein. See Engel-mann Reference at 1, 4-6. When prosecuting its U.S. Patent Application No. 08/485,129 (claiming priority for Yeda’s '339 Application), Yeda assured the U.S. Patent Examiner that a novel protein can be “adequately defined and fingerprinted by a partial amino acid sequence with disclosures of certain biological properties.” Abbott Mot., Ex. E [Dkt. 70-8] (Amendment to Yeda Application) at 16 (emphasis added). The Examiner agreed and concluded that the amino acid sequence of the TBP-II protein is an “inherent property” of that protein. Id., Ex. I [Dkt. 70-12] (Examiner’s Answer) at 8, 12. In fact, despite its argument before this Court, Yeda conceded at oral argument that a full recitation of all the amino acids identified in any of the sequences in the Count is not necessary for its identification. Oral Arg. Tr. I at 25-26 (“The Court: And it seems to me that once I have 13 of 15 [amino acids in the sequence], I got it because there’s nothing else that’s going to result — that we know of to date, that’s going to result, except this particular protein. [Yeda Counsel]: Correct.”). More critically, the parties agree that “the only normal protein containing the N-terminal sequence set forth in the '072 Application is the normal TBP-II protein — ie., the same protein claimed in the '915 Patent and recited in the Count.” Abbott Mot. at 8; Oral Arg. Tr. I at 18 (Yeda Counsel: “[I]f you look at the amino acids which were ... identified correctly in the 072 Application at the correct positions, we don’t know of a protein today, other than TBP-II, that actually has ... those amino acids there.”).
Yeda attempts to avoid this evidence and its concessions by challenging Abbott’s reliance on the doctrine of inherent disclosure. That doctrine holds that the requirement of Section 112 for a written description can be satisfied by showing that the first-filed application inherently discloses a property of the later-claimed subject matter. Kennecott Corp. v. Kyocera Int’l Inc., 835 F.2d 1419, 1422-23 (Fed.Cir.1987). The doctrine stands on the recognition that a “compound and all of its properties are inseparable; they are one and the same thing.” Regents of the Univ. of New Mexico v. Knight, 321 F.3d 1111, 1122 (Fed.Cir.2003). Thus, “the disclosure in a subsequent patent application of an inherent property does not deprive the product of the benefit of an earlier filing date. Nor does the inclusion of a description of that property in later-filed claims change this reasonable result.” Kennecott, 835 F.2d at 1423; see also Therma-Tru Corp. v. Peachtree Doors, Inc., 44 F.3d 988, 993 (Fed.Cir.1995). It is not necessary for skilled artisans to possess actual knowledge of an inherent property so long as the initial filing provides an adequate description of the claimed invention. See Hitzeman v. Rutter, 243 F.3d 1345, 1354 (Fed.Cir.2001) (“Where the balance of the claim fully identifies the compound ... and the property is inherent, we fail to see that such statements add anything to the claim definition of the named compound.”); Silvestri v. Grant, 496 F.2d 593, 599 (CCPA 1974).
Yeda stresses that “in the context of priority determination, the allegedly inherent limitation cannot be material to the patentability of the invention.” Hitzeman, 243 F.3d at 1355 (rejecting “conception” of invention based on later-discovered inherent property). Yeda contends that Abbott relied exclusively on amino acid sequences to distinguish prior art, ie., the Engel-mann Reference, and to persuade the Patent Office to issue the '915 Patent. Yeda therefore urges the Court to disregard Abbott’s reliance on inherency to prove Abbott’s invention of the TBP-II protein based only on nine amino acids at the N-terminal.
Yeda, however, has misread the prosecution record. Reviewing the '915 Patent, the Patent Examiner first concluded that prior art relating to the TBP-I protein invalidated the claimed TBP-II protein. Decl. in Support of Yeda Motions for Summ. J. (Yeda Exhibits) [Dkt. 74] Ex. K (Office Action dated 6/1/93) at 5. To overcome this rejection, Abbott convinced the Patent Examiner that Dr. Engelmann conclusively distinguished TBP-II from TBP-I based on variations of five contiguous amino acids at the N-terminal. Id. Ex. N [Dkt. 74-4] (Abbott Response dated 10/7/93) at 3. In response, the Patent Examiner withdrew its prior-art-based rejection because it agreed with Abbott that the “prior art protein was in fact different from the protein of the applied reference” and issued the '915 Patent. Id., Ex. 0 [Dkt. 74-4] (Office Action dated 10/22/93) at 2-3. Thus, Abbott demonstrated that TBP-II was different from TBP-I and patentable based, in part, on Dr. Engel-mann’s description of a new protein after he had identified only five amino acids. Abbott distinguished prior art (articles on TBP-I) by embracing (not distinguishing) the Engelmann Reference to show that a second TBP protein existed. In making its argument to the Patent Examiner, Abbott did not rely on any of the additional amino acids identified in the '915 Patent. The peculiar nature of Abbott’s reliance on the Engelmann Reference to support the fact of the separate existence of the TBP-II protein undercuts Yeda’s argument here. The Court concludes that Abbott can rely on the doctrine of inherent disclosure because the additional amino acids identified in the Count, but not disclosed in the '072 Application, are not material to the patentability of the TBP-II protein.
Next, Yeda maintains that one of ordinary skill in the art must have been able to deduce each of the additional amino acids identified in the Count based on those disclosed in the '072 Application. See Yeda Mot. re: Description at 23 (citing Agilent Techs., Inc. v. Affymetrix, Inc., 567 F.3d 1366, 1383 (Fed.Cir.2009) (“The very essence of inherency is that one of ordinary skill in the art would recognize that a reference unavoidably teaches the property in question.”)). Yeda argues that “there is no dispute here by Abbott that one of ordinary skill, back in 1989, looking at the 072 Application could not have discerned ... that the missing amino acids ... are inherent, inherently disclosed or inherently described.” Oral Arg. Tr. I at 31. Without doubt, the '072 Application did not disclose any of the complete amino acid sequences set forth in the Count; it erred in one identified amino acid, inserted an X in the sequence for amino acids not yet identified, and suggested probable amino acids (not always correctly) when uncertain. Abbott’s experts acknowledge that the unknown amino acids could not have been predicted or otherwise identified as of the date of filing of the '072 Application. See Yeda Exhibits, Ex. G [Dkt. 74-3] (Dep. Of Dr. Heinz. Hillen) at 63-64.
Nonetheless, the Court is persuaded that Yeda’s test for inherent disclosure is not scientifically or legally required when the claimed subject matter is a protein and the limitation at issue is the protein’s amino acid sequence. Yeda’s position ignores that “ ‘[ijnherent’ properties ... are the rare exceptions to the rule that a party must show possession of ‘every feature’ recited in the count and that ‘every limitation’ of the count must have been known to the inventor at the time of the alleged conception.” Hitzeman v. Rutter, 243 F.3d 1345, 1354-55 (Fed.Cir.2001). The purpose of the written description requirement of 35 U.S.C. § 112 is “to ensure that the inventor had possession, as of the filing date of the application relied on, of the specific subject matter later claimed by him.” Hyatt, 146 F.3d at 1354. Sanofi-Aventis confirms, under “In re Wallach, 378 F.3d 1330, 1333 (Fed.Cir.2004), ... when a protein was described by a partial amino acid sequence in addition to other characteristics sufficient to identify it, the inventors were in possession of the protein.”
This Court has no difficulty concluding that the Board’s findings here are supported by substantial evidence. The '072 Application correctly identified nine of 15 amino acids in the top line of the full N-terminal sequences recited in the Count. The '072 Application also identified certain biological characteristics of the novel protein: (1) a molecular weight of about 42 kilodaltons (kDa); (2) the specific biological property of inhibiting the cytotoxicity of TNFa; (3) found in the urine of febrile patients; and (4) not (usually) digestible trypsin. See '072 Application. Yeda’s argument that “those other limitations ... did not distinguish what Abbott had in its test tube” fails to read the Board’s decisions or Abbott’s argument correctly. Oral Arg. Tr. I at 24. As the Board held and Abbott argues, a partial amino acid sequence and the other biologic characteristics distinguished the TBP-II protein in the '072 Application. Yeda argued:
What distinguished TBP-II, in fact, when Yeda scientists actually purified and isolated it and actually got the entire N-terminal sequence correct, was the sequence. So the — that’s why the sequence is so critical here is because it’s that sequence that, in combination with the other characteristics, distinguished what had come before. And so once you have the complete sequence here, you can distinguish what came before, in combination with the other limitations in the count, of course.
Id. Yeda is incorrect that the entire sequence for TBP-II is necessary to distinguish it from TBP-I. Yeda’s own reliance in multiple fora on fewer than 15 amino acids to identify the TBP-II protein imposes judicial estoppel against its contrary position here. See, e.g., Comcast Corp. v. FCC, 600 F.3d 642, 647 (D.C.Cir.2010). Even if judicial estoppel did not bar Yeda’s argument, it is without merit. With identification of other biologic characteristics, a partial amino acid sequence for a protein may be sufficient to distinguish the novel protein from a known protein. The Engelmann Reference relied on biologic characteristics, in addition to only five identified amino acids. See Engel-mann Reference at 1, 4-6 (“TBPII can be clearly differentiated from TBPI by its lack of immunological cross-reactivity, different NH2-terminal amino sequences, and a difference in chromatographic properties .... ”). Yeda itself argued to the Patent Examiner that biologic references with an incomplete amino acid sequence were sufficient to identify the novel TBP-II protein. See Amendment to Yeda Application at 16 (stating that a novel protein can be “adequately defined and fingerprinted by a partial amino acid sequence with disclosures of certain biological properties”); Abbott Mot., Ex. BB [Dkt. 70-31] (Technical Paper Explaining [Yeda]’s Invention to the Board) at 8 (“The claims of [Yeda] which have been designated as corresponding to the count in the declaration of [the '625 Interference] are drawn to the substantially purified TBP-II protein identified by a partial amino acid sequence of 10 amino acid residues and by the functional property of being able to inhibit the cytotoxic effect of TNF and/or to maintain the prolonged benefit effects of TNF.”). The Board’s reliance on biologic characteristics in addition to specified amino acids adopted the very same approach. See 5/26/10 Board Decision at 5970.
Having found that the '072 Application adequately described the invention of the TBP-II protein, the Court agrees with Abbott that the additional amino acids of the TBP-II protein disclosed in the '915 Patent are inherent properties of the TBP-II protein. Abbott cites Wallach for the proposition that “a protein’s amino acid sequence is an inherent property of that protein.” Wallach, 378 F.3d at 1334. Yeda objects, pointing out that the Federal Circuit adds that “the fact that Appellants may have isolated and thus physically possessed TBP-II does not amount to knowledge of that protein’s sequence or possession of any of its other descriptive properties.” Id. at 1334-35. The Federal Circuit, however, has previously said that an applicant need not demonstrate knowledge of an inherent property at the time of filing. See Hitzeman, 243 F.3d at 1354. The additional amino acids “add[ ] nothing to the count beyond the other recited limitations and [are] redundant to the count.” Id.
Yeda’s argument that the '072 Application was required to identify all 22 amino acids, or alternatively, the 15 amino acids in the first sequence, contradicts its own application, its own admissions and Federal Circuit law. The full record demonstrates that the '072 Application satisfies the written description requirements of 35 U.S.C. § 112. A complete sequence of 15 amino acids in the first sequence is not needed to identify and distinguish the TBP-II protein. Yeda’s argument that one of ordinary skill would not have understood the '072 Application to disclose a full sequence of amino acids is merely a variant of the argument that the '072 Application was infirm because it did not identify a full sequence of amino acids. It fares no better on the second try. For the foregoing reasons, the Court will grant summary judgment to Abbott on the issue of written description.
B. Enablement: Claim Construction and Practicing the '072 Application and the 2003 Experiments
Yeda’s argument on enablement has two parts: First, Yeda argues that Abbott “failed to successfully practice its 072 Application protocol in 1989” because the procedure that is reported in the '072 Application did not yield a sample that was “purified and isolated” when practiced just before the '072 Application was submitted. Oral Arg. Tr. I. at 32, 35. Second, Yeda argues that to obtain the sample reported in the '072 Application, Abbott “worked out a materially different protocol that involved different column chromatography methods,” which “they didn’t disclose in the 072 Application.” Oral arg. Tr. I. at 35. Yeda asks this Court, years after Judge Urbina issued his Markman opinion, to construe the term “purified and isolated” in the '915 Patent and the '072 Application. Abbott responds that Yeda failed to raise its proposed claims construction at any prior time in decades of litigation and is woefully late, after discovery in this specific lawsuit has closed, to the severe prejudice of Abbott, which had no opportunity to develop opposing evidence. However, it appears that Yeda proposed approximately the same construction to the Board and Abbott proposes a competing construction. Therefore, the Court will address the argument.
1. Construction of “Purified and Isolated”
The Court begins with Yeda’s request that the Court construe “purified and isolated” to mean “sufficiently purified and isolated to permit identification of one of the complete amino-acid sequences in the Count.” Yeda Mot. for Summ. J. on En-ablement [Dkt. 73] (Yeda Mot. re: Enablement) at 13. Yeda argues that the need for a purified and isolated sample is the
principle [that] is at the heart of what Yeda’s experts have explained in this case, which is that the sample is dirty, it’s contaminated, and ... one can’t discern anything that even comes close to a complete 15 to 22 amino acid sequence, and if the sample had been purified and isolated, then that would be clear from the sequence data, but it’s just not.
Oral Arg. Tr. II [Dkt. 96] at 9. Abbott opposes on the grounds that Yeda’s proposed construction is the product of attorney argument and that a person of ordinary skill in the art in 1989 would not know that “purified and isolated” required the specification of either 22 or 15 amino acids in sequence. See id. at 39-40. Abbott proposes that a protein is “purified and isolated” when “you’re able to make a definitive identification of the protein.” Oral Arg. Tr. II at 40.
The words of a patent claim “are generally given their ordinary and customary meaning.” Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed.Cir.2005) (en banc) (citation omitted). “[T]he ordinary and customary meaning of a claim term is the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention, ie., as of the effective filing date of the patent application.” Id. at 1313. “Importantly, the person of ordinary skill in the art is deemed to read the claim term not only in the context of the particular claim in which the disputed term appears, but in the context of the entire patent, including the specification.” Id. “[I]n interpreting an asserted claim, the court should look first to the intrinsic evidence of record, ie., the patent itself, including the claims, the specification and, if in evidence, the prosecution history. Such intrinsic evidence is the most significant source of the legally operative meaning of disputed claim language.” Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed.Cir.1996) (internal citation omitted). “In most situations, an analysis of the intrinsic evidence alone will resolve any ambiguity in a disputed claim term.” Id. at 1583. “In some cases, however, the district court will need to look beyond the patent’s intrinsic evidence and to consult extrinsic evidence in order to understand, for example, the background science or the meaning of a term in the relevant art during the relevant time period.” Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., — U.S. —, 135 S.Ct. 831, 841, — L.Ed.2d — (2015).
In arguing that it proposed a construction of “purified and isolated” to the Board, Yeda adopts and re-argues points made on enablement in its earlier brief. See Yeda Reply [Dkt. 85] at 21-21. As now, Yeda argued:
Furthermore, the enablement requirement of 35 U.S.C. § 112 is not satisfied by the '072 Application as there is no evidence of record that those of ordinary skill in the art repeating Example 2 of this application would be able to obtain a protein of sufficient purity to allow an unambiguous N-terminal amino acid sequence to be determined.... Accordingly, the only conclusion that could be reached by one of ordinary skill ... is that there is no guarantee that the process for obtaining the protein from urine as disclosed in Example 2 of the '072 Application would ever yield an unambiguous protein pure enough to obtain an unambiguous N-terminal amino acid sequence.
Abbott Opp’n, Ex. PP [Dkt. 82-5] (Wallach Opp. to LeMaire Preliminary Mot. No. 1) at 21-23 (emphasis added). Before this Court, Yeda asks that “purified and isolated” be defined as “sufficiently purified and isolated to permit identification of one of the complete amino-acid sequences in the Count.” Yeda Mot. re: Enablement at 13. Yeda claims that the language of the Count, the specification of the '915 Patent, and the prosecution history of the '915 Patent support this construction. Id. at 13-16.
Yeda’s proposed definition of “purified ánd isolated” is merely a lawyer’s repeat of the failed argument that a full sequence of the TBP-II amino acids must have been “unambiguously]” revealed. Given the long history of this litigation and Yeda’s own repeated admissions, the argument is a non-starter. In other fora, as well as before this Court, Yeda has admitted that it is not necessary to identify a complete amino acid sequence, and the Court has rejected this argument as unsound. See Sanofi-Aventis, 733 F.3d at 1369 (a protein can be adequately described based on a partial amino acid sequence and other biological data). It is now clear, as a matter of law, that identification of a full amino acid sequence is not required when a patent applicant has additionally disclosed sufficient biological characteristics of a protein to “distinguish it from other materials, and to define how to obtain it.” Id. (quoting Amgen, Inc. v. Chugai Pharmaceutical Co., Ltd., 927 F.2d 1200, 1206 (Fed.Cir.1991)).
Furthermore, the intrinsic evidence does not support Yeda’s proposed construction. First, Yeda admits that the '915 specification “does not define or indicate that any special meaning was meant for ‘purified and isolated.’ ” Yeda Mot. re: Enablement at 15. The specification of the '915 Patent identifies characteristics of the TBP-II protein in addition to amino acid sequences, i.e., the protein’s molecular weight, its ability to inhibit the cytotoxicity of TNFa, its source, and its digestibility by trypsin. The specification uses “purified” and isolated” in reference to sources and techniques used to obtain the protein. For example, the specification states that “[t]he novel pro