Full opinion text
MEMORANDUM GREGORY M. SLEET, Chief Judge. I.INTRODUCTION In this consolidated patent infringement action, plaintiffs Santarus, Inc. (“Santarus”) and the Curators of the University of Missouri (the “University”) (collectively, “the plaintiffs”) allege that defendant Par Pharmaceutical, Inc.’s (“Par”) proposed generic pharmaceutical product infringes the asserted claims of the patents-in-suit. (D.I. 1.) The court held a five-day bench trial in this matter on July 13 through July 17,2009. (D.I. 168-172.) After the fourth day of trial, the court ruled that Par’s proposed products infringed the asserted claims of the patents-in-suit. (See D.I. 171 at 936-941.) Presently before the court are the parties’ post-trial proposed findings of fact and conclusions of law concerning the validity and enforceability of the patents-in-suit. (D.I. 173-174.) Pursuant to Fed.R.Civ.P. 52(a), and after having considered the entire record in this case and the applicable law, the court concludes that: (A) the patents-in-suit are invalid due to obviousness; (B) the patents-in-suit are not unenforceable due to inequitable conduct; and (C) an award for attorneys’ fees and costs is not warranted in this case. The court further concludes that certain asserted claims of the patents-in-suit are invalid because they lack a written description, or are not entitled to the filing date of earlier applications because the disclosures in the prior applications do not meet the written description requirement. These findings of fact and conclusions of law are set forth in further detail below. II. FINDINGS OF FACT A. The Parties 1. Plaintiff Santarus, Inc. is a corporation organized and existing under the laws of Delaware, and has its principal place of business at 3721 Valley Centre Drive, San Diego, CA 92130. (D.I. 152, Tab 1 at ¶ 1.) 2. Plaintiff The Curators of the University of Missouri is the governing body of the University of Missouri, which is a public corporation and body politic having a principal place of business at 321 University Hall, Columbia, Missouri 65211. (Id. at ¶ 2.) 3. Defendant Par Pharmaceutical, Inc. (“Par”) is a corporation organized and existing under the laws of Delaware, having a principal place of business at 300 Tice Boulevard, Woodcliff Lake, New Jersey 07677. (Id. at ¶ 3.) B. The Patents In Suit i. Prosecution History 4. On January 4, 1996, Dr. Phillips filed U.S. Provisional Application No. 60/009,608 (hereinafter “the Provisional Application”). (See JTX-31.) 5. The Provisional Application describes a pharmaceutical composition “referred to as simplified omeprazole solution (SOS).” (Id. at 8.) 6. On July 15, 1996, Dr. Phillips filed U.S. patent application Ser. No. 08/680,376 (hereinafter, the “'737 Application”), which issued as U.S. Patent No. 5,840,737 (hereinafter, the “'737 patent”) on November 24,1998. (See JTX-33.) 7. On October 30, 1998, Dr. Phillips filed U.S. patent application Ser. No. 09/183,4^2 (hereinafter, the “'422 Application”). (See JTX-32.) 8. The Provisional Application, the '737 Application, and the '422 Application (collectively, “the priority applications”) share the following features: • Each application describes the invention as a “pharmaceutical composition” (JTX-31 at 8; JTX-32 at 16; JTX-33 at 21.) • The “DETAILED DESCRIPTION OF THE INVENTION” section of each application states that the pharmaceutical composition is prepared by mixing: • Omeprazole or other substituted proton pump inhibitors; and • A bicarbonate salt of a Group IA metal (JTX-31 at 8; JTX-32 at 17; JTX-33 at 21.) The preferred bicarbonate salt is sodium bicarbonate (JTX-31 at 9; JTX-32 at 17; JTX-33 at 22.) ii. The Patents 9. On December 3, 2002, the United States Patent and Trademark Office (“PTO”) issued U.S. Patent No. 6,489,346 (the “'346 Patent”), entitled “Substituted Benzimidazole Dosage Forms and Method of Using Same” to the University, the named assignee of the named inventor Jeffrey O. Phillips (“Dr. Philips”). (D.I. 152, Tab 1 at ¶ 4.) 10. The face of the '346 Patent states that “[t]his application is a continuation-in-part of U.S. patent application Ser. No. 09/183,422 filed on Oct. 30,1998, now abandoned, which is -a continuation-in-part of U.S. patent application Ser. No. 08/680,376 filed on Jul. 15, 1996, now U.S. Pat. No. 5,840,737, which claims priority to U.S. Provisional Application Serial No. 60/009,608 filed on Jan. 4, 1996. This application claims priority to all such previous applications, and such applications are hereby incorporated herein by reference.” The face of the '346 Patent states that it is subject to a terminal disclaimer. (Id. at ¶ 5.) 11. On November 11, 2003, the PTO issued U.S. Patent No. 6,645,988 (the “'988 Patent”), entitled “Substituted Benzimidazole Dosage Forms and Method of Using Same” to the University, the named assignee of the named inventor Dr. Phillips. (Id. at ¶ 6.) 12. The face of the '988 Patent states that “[tjhis application is a continuation-in-part of U.S. patent application Ser. No. 09/481,207, filed on Jan. 11, 2000, now U.S. Pat. No. 6,489,346 which is a continuation of U.S. patent application Ser. No. 09/183,-422, filed Oct. 30, 1998, now abandoned, which is a continuation-in-part of U.S. patent application Ser. No. 08/680,376, filed on Jul. 15, 1996, now U.S. Pat. No. 5,840,737, which claims priority to U.S. Provisional Application Ser. No. 60/009,608 filed on Jan. 4,1996. This application claims priority to all such previous applications, and such applications are hereby incorporated herein by reference to the extent permitted by law.” The face of the '988 Patent states that it is subject to a terminal disclaimer. (Id. at ¶ 7.) 13. On March 2, 2004, the PTO issued U.S. Patent No. 6,699,885 (the “'885 Patent”), entitled “Substituted Benzimidazole Dosage Forms and Methods of Using Same” to the University, the named assignee of the named inventor Dr. Phillips. (Id. at ¶ 8.) 14. The face of the '885 Patent states that “[tjhis application is a continuation-in-part of U.S. patent application Ser. No. 09/901,942, filed on Jul. 9, 2001, which is a continuation-in-part of U.S. patent application Ser. No. 09/481,207, filed on Jan. 11, 2000, now U.S. Pat. No. 6,489,346, which is a continuation-in-part of U.S. patent application Ser. No. 09/183,422, filed on Oct. 30, 1998, now abandoned, which is a continuation-in-part of U.S. patent application Ser. No. 08/680,376, filed on Jul. 15, 1996, now U.S. Pat. No. 5,840,737, which claims priority to U.S. Provisional Application Serial No. 60/009,608, filed on Jan. 4, 1996. This application claims priority to all such previous applications, and such applications are hereby incorporated herein by reference.” The face of the '885 Patent states that it is subject to a terminal disclaimer. (Id. at ¶ 9.) 15. On or about August 22, 2005, a third party requested that the PTO reexamine the '885 Patent. On September 18, 2007, after concluding reexamination proceedings, the PTO issued an Ex Parte Reexamination Certificate for the '885 Patent. (Id. at ¶ 10.) 16. On August 24, 2004, the PTO issued U.S. Patent No. 6,780,882 (the “ "882 Patent’ ”), entitled “Substituted Benzimidazole Dosage Forms and Methods of Using Same” to the University, the named assignee of the named inventor Dr. Phillips. (Id. at ¶ 11.) 17. The face of the '882 Patent states that “[tjhis application is a continuation of U.S. patent application Ser. No. 09/481,207, filed on Jan. 11, 2000, now U.S. Pat. No. 6,489,346 which is a continuation of U.S. patent application Ser. No. 09/183,422, filed Oct. 30, 1998, now abandoned, which is a continuation-in-part of U.S. patent application Ser. No. 08/680,376, filed on Jul. 15, 1996, now U.S. Pat. No. 5,840,737, which claims priority to U.S. Provisional Application Ser. No. 60/009,608, filed on Jan. 4,1996. This application claims priority to all such previous applications, and such applications are hereby incorporated herein by reference.” The face of the '882 Patent states that it is subject to a terminal disclaimer. (Id. at ¶ 12.) 18. On July 15, 2008, the PTO issued U.S. Patent No. 7,399,772 (the “'772 Patent”), entitled “Substituted Benzimidazole Dosage Forms and Method of Using Same” to the University, the named assignee of the named inventor Dr. Phillips. (Id. at ¶ 13.) 19. The face of the '772 Patent states that “[tjhis application is a continuation of U.S. patent application Ser. No. 10/068,437 filed Feb. 5, 2002 now abandoned, which is a continuation of U.S. patent application Ser. No. 09/481,207 filed Jan. 11, 2000, now U.S. Pat. No. 6,489,346, which is a continuation-in-part of U.S. patent application Ser. No. 09/183,422 filed Oct. 30, 1998, now abandoned, which is a continuation-in-part of U.S. patent application Ser. No. 08/680,-376, filed Jul. 15, 1996, now U.S. Pat. No. 5,840,737, which claims priority to U.S. Provisional Patent Application No. 60/009,-608 filed Jan. 4, 1996. This application claims priority to all such previous applications, and such applications are hereby incorporated herein by reference.” (Id. at ¶ 14.) 20. On November 24, 1998, the PTO issued United States Patent No. 5,840,737 (“the'737 Patent”), entitled “Omeprazole Solution and Method for Using Same” to the University, the named assignee of the named inventor Dr. Phillips. (Id. at ¶ 15.) 21. The face of the '737 Patent states that “[t]his application is a continuation-in-part of U.S. Prov.App. Ser. No. 60/009,608 filed on Jan. 4,1996.” (Id. at ¶ 16.) 22. Santarus holds an approved New Drug Application (“NDA”) for NDA Nos. 21-706 (40mg Zegerid® Powder for Oral Suspension), 21-636 (20mg Zegerid® Powder for Oral Suspension), and 21-849 (20mg & 40mg Zegerid® Capsules). (Id. at ¶ 17.) 23. Zegerid® is sold by Santarus under an exclusive license to the patents-in-suit from the University of Missouri. (See JTX-8.) 24. Zegerid® is a non-enteric-coated drug containing omeprazole and sodium bicarbonate. (D.I. 152, Tab 1 at ¶ 18.) 25. The '885, '346, '988 and '772 Patents are listed in the United States Food and Drug Administration’s (the “FDA”) Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, in connection with Santarus’ Zegerid® (omeprazole/sodium bicarbonate) Capsules 20 mg and 40 mg products. (Id.) 26. The '737, '885, '346, '988, '882 and '772 Patents are listed in the FDA’s Orange Book in connection with Santarus’ Zegerid® (omeprazole/sodium bicarbonate) Powder for Oral Suspension 20 mg and 40 mg products. (Id. at ¶ 19.) 27. None of the patents-in-suit expire before July 16, 2016. (Id. at ¶ 20.) 28. Jeffery Owen Phillips is named as the inventor on each of the patents-in-suit. (Id. at ¶ 34.) C. The Accused Products 29. Par has submitted Abbreviated New Drug Application No. 78-966 (the “Capsule ANDA”) to the FDA under § 505(j) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 355©). The Capsule ANDA seeks approval to engage in the commercial manufacture, use and/or sale of generic omeprazole and sodium bicarbonate capsules. Zegerid® was named in the Capsule ANDA as the reference listed drug. (Id. at ¶ 21.) 30. Par’s proposed products in the Capsule ANDA have 20 mg omeprazole/1100 mg of sodium bicarbonate or 40 mg omeprazole/1100 mg sodium bicarbonate. (Id. at ¶ 22.) 31. Par has requested the FDA to approve the Capsule ANDA before the July 16, 2016 expiration of the '885, '346, '988, and '772 Patents. (Id. at ¶ 23.) 32. Par has submitted Abbreviated New Drug Application No. 79-182 (the “Powder ANDA”) to the FDA under § 505© of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 355©). The Powder ANDA seeks approval to engage in the commercial manufacture, use and/or sale of generic omeprazole and sodium bicarbonate powder for oral suspension. Zegerid® was named in the Powder ANDA as the reference listed drug. (Id. at ¶ 24.) 33. Par’s proposed products in the Powder ANDA have 20 mg omeprazole/1680 mg of sodium bicarbonate or 40 mg omeprazole/1680 mg sodium bicarbonate. (Id. at ¶ 25.) 34. Par has requested the FDA to approve the Powder ANDA before the July 16, 2016 expiration of the '885, '346, '988, '882, and '772 Patents. (Id. at ¶ 26.) 35. Plaintiffs received a letter dated August 2, 2007, from Par notifying them that Par’s Capsule ANDA includes a certification under 21 U.S.C. § 355(j)(2)(A)(vü)(IV) (the “First Capsule Paragraph IV Certification”) that, in Par’s opinion, the '885, '346, and '988 Patents are invalid, unenforceable or will not be infringed by the commercial manufacture, use or sale of the Proposed Capsules. (Id. at ¶ 27.) 36. Plaintiffs alleged that the filing of Par’s Capsule and Powder ANDAs constituted patent infringement pursuant to 35 U.S.C. § 271(e)(2) and that the commercial manufacture, use, sale, offer for sale and/or importation of Par’s proposed Capsule and Powder ANDA products would infringe one or more claims of the '885, '346, '988, '882, and/or '772 Patents. (Id. at ¶ 28.) 37. Plaintiffs received a letter dated November 13, 2007, from Par notifying them that Par’s Powder ANDA includes a certification under 21 U.S.C. § 355(j)(2)(A)(vü)(IV) that, in Par’s opinion, the '885, '346, '988, and '882 Patents are invalid, unenforceable or will not be infringed by the commercial manufacture, use or sale of the Proposed 20 mg Powder. (Id. at ¶ 30.) 38. Plaintiffs received a letter dated December 6, 2007, from Par notifying them that Par’s Powder ANDA includes a certification under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) that, in Par’s opinion, the '885, '346, '988, and '882 Patents are invalid, unenforceable or will not be infringed by the commercial manufacture, use or sale of the Proposed 20 mg and 40 mg Powder. (Id. at ¶ 31.) 39. Plaintiffs received a letter dated September 30, 2008, from Par notifying them that the Capsule and Powder ANDAs include a certification under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (the “'772 Patent Paragraph IV Certification”) that, in Par’s opinion, the '772 Patent is invalid, unenforceable or will not be infringed by the manufacture, use or sale of the Proposed 20 mg and 40 mg Powder and Capsule Products. (Id. at ¶ 33.) D. Procedural History 40. Plaintiffs filed a first complaint for patent infringement against Par on September 13, 2007, and a first amended complaint against Par on October 2, 2007. (Id. at ¶ 29.) 41. In a separately-captioned action, C.A. No. 07-827, Plaintiffs filed a second complaint for patent infringement against Par on December 20, 2007. The cases were consolidated on March 4, 2008. (Id. at ¶ 32; see also Minute Entry for March 4, 2008.) 42. Plaintiffs filed a second amended complaint for patent infringement against Par in the consolidated action on October 17, 2008. (D.1.152, Tab 1 at ¶ 34.) 43. At trial, the plaintiffs asserted the following claims were infringed by Par’s Capsule and Powder ANDA products: • '346 Patent: Claims 26, 37, 38, 49, 50, 58, 59, 60, 66, 68, 80, 81, 82 • '772 Patent: Claims 1, 4, 5, 8, 10, 12, 14,15, 20, 21 • '882 Patent: Claims 11,12, 15, 27 • '885 Patent: Claims 2, 9,11,15,16,17, 18, 41 • '988 Patent: Claim 29 (See D.I. 174 at viii (hereinafter the “asserted claims”).) 44. After the fourth day of trial, the court held that the Capsule and Powder ANDA products infringed the asserted claims of the patents-in-suit. (See D.I. 171 at 936-941.) III. CONCLUSIONS OF LAW The court has subject matter jurisdiction over this matter pursuant to 28 U.S.C. §§ 1331, 1338 and 2201. Venue is proper in this court under 28 U.S.C. §§ 1391 and 1400(b). After having considered the entire record in this case, the substantial evidence in the record, the parties’ post-trial submissions, and the applicable law, the court concludes that: (A) the patents-in-suit are invalid due to obviousness; (B) the patents-in-suit are not unenforceable due to inequitable conduct; and (C) an award for attorneys’ fees and costs is not warranted in this case. The court further concludes that certain asserted claims of the patents-in-suit are invalid because they lack a written description, or are not entitled to the filing date of earlier applications because the disclosures in prior applications do not meet the written description requirement. The court’s reasoning follows. A. Written Description and Priority Par argues that a number of the asserted claims of the patents-in-suit are invalid because they do not meet the written description requirement. (See D.I. 173 at 24-27.) Par further asserts that these claims and several other asserted claims are not entitled to the priority date of earlier-filed applications because the written descriptions of those applications do not support the asserted claims. (Id. at 2-7.) To meet the written description requirement, the applicant must “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.” Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64 (Fed.Cir.1991). One skilled in the art, reading the disclosure, “must immediately discern the limitation at issue in the claims.” Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1323 (Fed.Cir.2000). Thus, support in the written description must be based on what actually is disclosed, and not on an obvious variant of what is disclosed. Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1571 (Fed.Cir.1997). The party challenging the sufficiency of a written description must establish by clear and convincing evidence that the claim is invalid or not entitled to an asserted filing date. See Tech. Licensing Corp. v. Videotek, Inc., 545 F.3d 1316, 1329-30 (Fed.Cir.2008). Table 1 (see following page) summarizes the court’s findings as to the priority dates of the asserted claims of the patents-in-suit. Table 1 Asserted claims All asserted claims of the pat-entitled to filing date ents-in-suit not listed below of January 4,1996 (Provisional Application) Asserted claims '346 Patent entitled to filing date of July 15, 1996 ('737 Application) • Claim 81 (see § I II.A.ÍÜ) • Claims 37, 38, 49 (see § III.A.iv) • Claim 50 (see §§ IILAJii & III.AJv) '772 Patent: Claim 2 (see § IILAJii) '988 Patent: Claim 29 (see § III.A.ÍÜ) Asserted claims '346 Patent entitled to filing date of January 11, 2000 ('346 Application) • Claims 37, 38, 66, 68, 80, 81, 82 (see § III.A.Ü) • Claim 26 (see § III.A.V) • 5Claims 49, 50 (see §§ III.A.Ü & III.A.V) '772 Patent: All claims (see § III.A.vi) '885 Patent: All claims (see § III.A.VÜ) '988 Patent: Claim 29 (see §§ III.A.ÜÍ and III.A.v) i. Types of Proton Pump Inhibitors Claims 24 and 57 of the '346 Patent and claim 29 of the '988 Patent each claim a group of seven proton pump inhibitors (“PPIs”): omeprazole, lansoprazole, rabeprazole, esomeprazole, pantoprazole, panprazole, and leminoprazole. Par asserts that the priority applications do not support this limitation because the applications only disclose a subset of the claimed group. The court disagrees. The Provisional Application states that the pharmaceutical composition “can include ... omeprazole or other substituted benzimidazoles such as lansoprazole, and derivatives thereof....” (ProvApp. at 8.) Similarly, the '737 and '422 applications states that the composition “can include ... omeprazole or other substituted benzimidazoles which are proton pump inhibitors such as lansoprazole, pantoprazole, rabeprazole, dontroprazole, perprazole, habeprazole, and derivatives thereof----” (’422 App. at 16.) The court finds that a person of ordinary skill in the art would have understood from these disclosures that the inventor possessed the claimed PPIs. ii. Types of Buffers Par also contends that claims 24 and 57 of the '346 Patent cannot claim the filing dates of the priority applications because they claim types of buffers — specifically magnesium and calcium salts — that are not disclosed in the priority applications. (See Tr. 643-44; D.I. 173 at 3.) The section of Santarus’ post-trial brief discussing this issue is both devoid of citations to the transcript and unavailing. (See D.I. 174 at 25.) Santarus makes no argument that any portion of the provisional or '737 applications supports the claiming of magnesium or calcium salts. With respect to the '422 Application, Santarus asserts that two of the original claims in the '422 Application disclose calcium salts. However, the '422 Application claims cited by Santarus refer to “calcium,” not calcium salts, and Santarus presented no evidence that this reference to “calcium” refers to calcium salts rather than calcium ions. Furthermore, the claims cited recite calcium as an additive that acts not as a buffer, but as a chelating agent; there is no indication that this disclosure of calcium was meant to encompass the use of calcium salts as buffering agents in place of sodium bicarbonate, and Santarus certainly presented no evidence that the claim should be so construed. Moreover, the written description requirement cannot be satisfied by making reference to claims in the prior application, but rather must be satisfied by disclosure in the specification of the prior application. See, e.g., TurboCare Div. of Demag Delaval Turbomachinery Corp. v. General Electric Co., 264 F.3d 1111, 1119 (Fed.Cir.2001) (“When the applicant adds a claim or otherwise amends his specification after the original filing date ... the new claims or other added material must find support in the original specification.”) (emphasis added). Santarus’ other post-trial arguments with respect to the disclosure of calcium and magnesium salts in the '422 Application are also unsupported by transcript citations and, in any case, unavailing. The fact that the '422 Application indicates that the prior art included “salts of carbonic acid, which include carbonates” (see D.I. 174 at 25, citing '422 App. at 9:1-4) is not sufficient to indicate that the inventor contemplated or possessed a composition wherein non-Group IA salts were substituted. The final sentence of Santarus’ argument on this issue-that “given the small number of therapeutically relevant carbonate buffering agents, an artisan would understand that the inventor disclosed the claimed salts” — is not supported by citation to any source, much less evidence in the record of this case. In short, Santarus points to no source, and certainly no testimony, indicating that calcium or magnesium salts are properly disclosed in any of the priority applications. Consequently, claims 24 and 57 of the '346 Patent cannot claim the filing date of the priority applications. Since asserted dependent claims 37, 38, 49, 50, 66, 68, and 80-82 do not further limit this claim element, they also are not entitled to priority. iii. Types of Solid Dosage Forms Par also challenges whether the written descriptions in the priority applications support the types of solid dosage forms claimed in claims 50 and 81 of the '346 Patent, claim 29 of the '988 Patent, and claim 2 of the '772 Patent. Those claims read, in pertinent part, as follows: • '346 Patent claims 50 and 81 are dependent on claims 24 and 57, respectively, of the '346 Patent. Claims 24 and 57 both include a “solid pharmaceutical composition in a dosage form that is not enteric coated.” Claims 50 and 81 then specify the claimed dosage forms as “selected from the group consisting of a tablet, powder, suspension tablet, chewable tablet, capsule, effervescent powder, effervescent tablet, pellets, and granules.” • '988 Patent claim 29 is an independent claim that includes a “non-enteric coated solid oral pharmaceutical dosage form.” The possible dosage forms are specified as “a powder, tablet, suspension tablet, chewable tablet, capsule, two-part tablet, two-part capsule, effervescent powder, pellet, granule or effervescent tablet.” • '772 Patent claim 2 is dependent on claim 1 of the '772 Patent. Claim 1 includes “a solid pharmaceutical composition.” Claim 2 specifies the composition as “a solid dosage form selected from the group consisting of a tablet, a chewable tablet, a capsule, a troche, and a lozenge.” • '882 Patent claim 1 is an independent claim that includes a “powder for suspension.” In its claim construction order, the court construed the terms “solid pharmaceutical composition in a dosage form” and “solid oral pharmaceutical dosage form” identically. (See D.I. 82.) Under the court’s construction, both terms refer to “a solid dosage form that is pharmaceutically acceptable for storage, shipping, and administration, including a powder that can be combined with an aqueous medium then orally administered.” (Id.) The invention as described and claimed in the Provisional Application is an aqueous solution. The only reference to solid dosage forms in the Provisional Application is that “formulations of the present invention can be manufactured in a concentrated form, such as an effervescent tablet, so that upon reaction with water, the aqueous form of the solution would be produced for oral or enteral administration.” (ProvApp. at 12.) All other descriptions, examples, and claims in the Provisional Application refer exclusively to the aqueous solution. In other words, there is no indication in the Provisional Application that the inventor possessed or was even aware of the ability to convert the omeprazole/bicarbonate solution into the disputed solid dosage forms. Indeed, the background section of the application indicates that a major drawback of then-available formulation of omeprazole as compared to the claimed invention was that some patients were unable to swallow solid dosage forms such as capsules and tablets: [I]n its current form, (capsules containing an enteric-coated granule formulation of omeprazole), omeprazole can be difficult or impossible to administer to patients ... who are unwilling or unable to swallow tablets or capsules. Therefore, it would be desirable to formulate an omeprazole solution which can be enterally delivered to a patient thereby providing the benefits of omeprazole without the drawbacks of the current capsule dose form. (Prov.App. at 4.) The invention’s ability to deliver omeprazole enterally as well as orally is emphasized throughout the background and description sections of the Provisional Application as an advantage of the claimed invention over the prior art. (See id. at 5-6, 10, 11, 12.) In all examples provided in the application, the solution was administered through a nasogastric tube to most or all patients. (See id. at 1A-30.) The Provisional Application’s references to solid dosage forms besides effervescent tablets were disparaging. The court finds that a person of ordinary skill in the art reading the Provisional Application would not believe that the inventor possessed- — or even contemplated — the composition in a capsule, non-effervescent tablet, granule, chewable tablet, pellet, troche, or lozenge form, as listed in the disputed claims from the '346, '988, and '772 Patents. Since support for these dosage forms does not appear in the Provisional Application, claims 50 and 81 of the '346 Patent, claim 29 of the '988 Patent, and claim 2 of the '772 Patent cannot claim priority to the Provisional Application. While the '737 and '422 Applications also include statements emphasizing the importance of enteral administration capability, those applications include additional disclosures pertaining to solid forms of the composition. Both the '737 and '422 Applications contain a paragraph stating that it is possible to form the PPI/bicarbonate solution “into a tablet, capsules, or granules, by methods well known to those skilled in the art.” (’422 App. at 23-24; '737 App. at 28-29.) The disclosure of possible solid formulations in the '422 Application is even more expansive, stating that the invention “can include an aqueous solution/suspension, or dry formulation” ('422 App. at 16 (emphasis added)) and that “the composition includes dry formulations.” (Id. at 17.) Similarly, the summary of the '422 Application makes reference to “a dry formulation of’ the composition, whereas both the Provisional Application and the '737 Application describe only an “aqueous solution.” (Compare '422 App. at 15 with Prov.App. at 6-7 and '737 App. at 19.) The '422 Application’s written description of “dry” and “solid” formulations of the invention would indicate to a person of ordinary skill in the art that the inventor contemplated and possessed the ability to make a wide variety of solid dosage forms. The “other suitable solid dosage form” language further indicates that the inventor possessed the ability to make solid dosage forms beyond those specifically listed. Given these statements, the court finds that a person of ordinary skill in the art would have known from the description in the '422 Application that the inventor possessed the solid dosage forms listed in the disputed claims of the '346, '988, and '772 Patents. The '737 Application is intermediate with respect to the other priority applications in its disclosures of solid dosage forms. In addition to the effervescent tablets disclosed in the Provisional Application, the '737 Application discloses that it is possible to form the omeprazole/bicarbonate solution into some non-effervescent solid dosage forms, specifically tablets, capsules, or granules. ('737 App. at 28-29.) Unlike in the '422 Application, however, the '737 Application’s written description does not include an open-ended statement stating that the composition could be made into solid dosage forms other than those explicitly described. The '737 Application also does not include the references to dry formulations that appear in the summary and at the beginning of the description in the '422 Application. Furthermore, the '737 Application includes the statements in the background section of the Provisional Application describing the disadvantages of orally administering tablets, capsules, and granules. (’737 App. at 10.) Nonetheless, the court finds that Par has not shown by clear and convincing evidence that the written description of the '737 Application is insufficient to support the dosage forms recited in the disputed claims of the patents-in-suit. The '737 Application’s disclosure that the composition “can be formed into a tablet, capsules, or granules” is sufficient to convey with reasonable clarity to those skilled in the art that, as of the filing date of the '737 Application, Dr. Phillips was in possession of solid dosage forms. Vas-Cath, 935 F.2d at 1563-64. This specific disclosure more than counterbalances the concerns expressed in the background section regarding the oral administration of solid dosage forms, and a person of ordinary skill in the art would conclude that Dr. Phillips possessed the ability to form the composition into solid dosage beyond those specifically listed. Under these circumstances, the court finds that a person of ordinary skill in the art would know from the disclosures in the '737 Application that the inventor was in possession of the solid dosage forms recited in the disputed claims. iv. Amount of Buffer Par also asserts that several asserted claims of the patents-in-suit include limitations regarding the amount of buffer in the composition that are not supported by the priority applications. (See D.I. 173 at 4-5.) Par further asserts that the originally-filed application for the '346 Patent does not support these limitations, thus rendering the claims invalid for lack of written description. (See D.I. 173 at 24-25.) Specifically, Par argues that the following claim limitations are not disclosed: • '346 Patent • Claim 24: “a buffering agent in an amount of approximately 1.0 mEq to approximately 150 mEq” • Claim 57: “a buffering agent ... in an amount more than about 40 times the amount of’ the PPI • '772 Patent • Claim 1: “sodium bicarbonate in an amount of 0.2 mEq to 5 mEq per 2mg omeprazole” • '882 Patent • Claim 1: “buffering agents in an amount of about 0.1 mEq to about 2.5 mEq per mg of’ the PPI • '885 Patent • Claim 1: “buffering agents in an amount of about 0.1 mEq to about 2.5 mEq per mg of’ the PPI and “a total buffering agent to total [PPI] weight ratio of greater than 20:1” • Claim 26: “buffering agents in an amount of about 0.1 mEq to about 2.5 mEq per mg of’ the PPI • '988 Patent • Claim 1: “at least one Primary Essential Buffer and at least one optional Secondary Essential Buffer in a total amount of approximately 0.1 mEq to approximately 2.5 mEq per mg of’ PPI Each of the priority applications and the '846 Patent disclose that “[t]he concentration of the bicarbonate salt of the Group 1A metal in the composition generally ranges from approximately 5.0% to approximately 60.0%.” (Prov.App. at 9; '737 App. at 22; '422 App. at 17; '346 Patent col. 14:18-21.) The same documents also disclose a preferred range of 7.5% to 10%, and a preferred embodiment of 8.4%. (Prov.App. at 9; '737 App. at 22; '422 App. at 17; '346 Patent col. 14:21-26.) Other portions of these documents list the amount of buffer in terms of mEq or mEq per mg of PPI rather than in percentage concentration. It is undisputed that 1 mEq of sodium bicarbonate weighs 84mg (see, e.g., D.I. 153, Ex. 12 at 177), and the court finds that a person of ordinary skill in the art would know this equivalence. Once that equivalence is established, simple arithmetic confirms that the priority applications disclose most of the buffer amount recited in the asserted claims. For instance, as noted above, the priority applications all disclose a sodium bicarbonate concentration as low as “approximately 5%.” The priority applications and '346 Patent also disclose a 10 mL solution. (E.g., ‘Prov.App. at 19; '737 App. at 25:4; '422 App. at 20:8; '346 Patent col. 25:61-64 & col. 32:64-67.) A 5% sodium bicarbonate solution would contain 5 g of sodium bicarbonate per 100 mL of water, or 500 mg per 10 mL. Furthermore, the priority applications disclose an omeprazole concentration as high as “approximately 6 mg/ml.” (ProvApp. at 8:19; '737 App. at 21:21; '422 App. at 17:12.) Thus, 10 mL of a 5% sodium bicarbonate solution with this concentration of omeprazole would contain 5.95 mEq (500 / 84) sodium bicarbonate and 60 mg of omeprazole. This, in turn, would translate to 0.099 mEq of sodium bicarbonate per mg of omeprazole — almost exactly the lower end (0.1 mEq/mg) of the claimed range in claim 1 of the '882, claim 1 of the '772 Patent, claims 1 and 26 of the '885 Patent, and claim 1 of the '988 Patent. Similarly, using the same 10 mL volume of solution, a 10% sodium bicarbonate concentration (ProvApp. at 9; '737 App. at 22; '422 App. at 17) and a 0.5 mg/ml concentration of omeprazole (ProvApp. at 8:19; '737 App. at 21:21; '422 App. at 17:12) would yield 2.38 mEq of buffering agent per mg of omeprazole— just below the higher end (2.5 mEq/mg) of the claimed range in those claims. The court thus finds that the priority applications support the claimed mEq/mg ranges mEq/mg in claim 1 of the '882, claim 1 of the '772 Patent, claims 1 and 26 of the '885 Patent, and claim 1 of the '988 Patent. Claim 24 of the '346 Patent calls for “a buffering agent in an amount of approximately 1.0 mEq to approximately 150 mEq.” For the upper limit, the priority applications and '346 Patent disclose a 20 mL solution (ProvApp. at 19; '737 App. at 35; '422 App. at 29; '346 Patent col. 32:64-67) with a 60% concentration of sodium bicarbonate (ProvApp. at 9; '737 App. at 22; '422 App. at 17; '346 Patent col. 14:18-21), which would yield 12000 mg — or 142 mEq — of sodium bicarbonate. The court finds that this is within the “approximately 150 mEq” upper limit specified in claim 24 of the '346 Patent. In claim 57 of the '346 Patent and claim 1 of the '885 Patent, the amount of buffer is provided in relation to the relative weight of buffer and PPI in the composition. Support for the 40:1 ratio provided in claim 57 of the '346 Patent can be found by dividing the preferred concentration of sodium bicarbonate (an 8.4% solution, which yields 84 mg/ml of sodium bicarbonate) by the 2 mg/ml standard concentration of omeprazole in the solution, both of which are provided in the priority applications and the '346 Patent. The resulting ratio— 42:1 — is sufficient to support a limitation of “more than about” 40:1. Similarly, using the upper end of the preferred concentration of omeprazole — 4 mg/ml (Prov.App. at 8; '737 App. at 22; '422 App at 17) — yields a weight ratio of 21:1, which is sufficient to support the “ratio of greater than 20:1” limitation in claim 1 of the '885 Patent. The only claimed buffer amount for which there does not appear to be numerical support in each of the priority applications is the lower end of the claimed range in claim 24 of the '346 Patent, which specifies a lower limit of “approximately 1.0 mEq” of buffering agent. The '737 and '422 Applications both state that “[t]he dosage range of omeprazole or other substituted benzimidazoles and derivatives thereof can range from approximately 2 mg/day to approximately 100 mg/day.” ('737 App. at 24; '422 App. at 20.) The '346 Patent discloses a range of “approximately <2 mg/day to approximately 300 mg/day” of PPI ('346 Patent col. 12:65-13:1) and later mentions a concentration of 100 mg/day of IV-administered omeprazole as the lower limit of typical adult dosage. (Id. col. 10:65-67.) These documents also state that “[t]he amount of the sodium bicarbonate used in the solution/suspension of the present invention is approximately 1 mEq (or mmole) sodium bicarbonate per 2 mg omeprazole.” ('737 App. at 28; '422 App. at 23; '346 Patent col. 14:27-31.) The court concludes from these two disclosures that a person of ordinary skill in the art would understand from the ’737 and '422 Applications that Dr. Phillips was in possession of buffer amounts as low as approximately 1 mEq. The Provisional Application, however, does not appear to include comparable disclosures of the dosage range of omeprazole or the approximate amount of sodium bicarbonate relative to omeprazole used in the invention, and Santarus does not assert in its post-trial brief that such a disclosure is present in the Provisional Application or that a person of skill in the art could deduce from the Provisional Application that Dr. Phillips possessed buffer amounts as low as 1 mEq in his invention. Consequently, the court finds that Provisional Application does not support the lower end of the range of buffer amount claimed in claim 24 of the '346 Patent. This claim thus is not entitled to the priority date of the Provisional Application. Dependent asserted claims 37, 38, 49, and 50 of the '346 Patent thus can claim priority only to the filing date of the '737 Application. v. Amount of PPI Par also asserts that the priority applications do not support limitations relating to the amount of PPI provided in claim 24 of the '346 Patent and claim 29 of the '988 Patent. Specifically, the disputed claims provide for “approximately 5 mg to approximately 300 mg” of a PPI in the claimed composition. Par’s challenge appears to relate primarily to the upper end of the claimed range. (See D.I. 173 at 3-4.) Santarus asserts that the 300 mg figure can be found by taking 6.0 mg/ml — the upper limit of PPI concentration recited in the priority application (Prov.App. at 8:19; '737 App. at 21:21; '422 App. at 17:12)— and multiplying it by 50 ml. The court finds, however, that the priority applications do not support a claim limitation based on the administration of a 50 ml volume of solution that could contain up to 300 mg of omeprazole, and is not aware of any other basis for the “300 mg” limitation. The pages of the '422 Application that Par cites to support its claim do not describe a 50 ml solution being used to administer Dr. Phillips’ invention in a way that allows for PPI amounts as high as 300 mg. For instance, one of the cited pages describes a study that administered divided doses of 20 ml, 20 ml, and 10 ml of the claimed composition spaced several hours apart, and even the total amount of omeprazole (lOOmg) in the divided doses was well below 300 mg. (See '422 App at 29.) Another page states that the total drug cost for the composition as used in one study was calculated using “the average institutional cost[ ] of ... 50 ml sodium bicarbonate vials” (id. at 35), but the amount of solution actually administered to patients was either 10 ml or 20 ml. (Id. at 32.) Furthermore, the description of the invention in the '737 and '422 Applications specifically disclose a much lower upper limit of PPI amount (100 mg/day). (See id. at 20; '737 App. at 25.) Thus, the court finds that the priority applications do not support the claimed range. Consequently, claim 29 of the '988 Patent, claim 24 of the '346 Patent, and asserted dependent claims 26, 49, and 50 of the '346 Patent are not entitled to the filing date of the priority applications. vi. “No sucralfate” Par further asserts that the negative limitation “wherein the composition contains no sucralfate” included in claim 1 of the '772 Patent is not supported by the priority applications or by the written description of the '772 Patent. (D.I. 173 at 6; Tr. 653:24-654:4.) In response, Santarus asserts that the specification of the patents-in-suit and the priority applications “teach [] an artisan that sucralfate has adverse effects and that avoiding sucralfate is desirable.” (D.I. 174 at 22 (citing Tr. 949:20-951:20, 953:19-955:4).) Consequently, Santarus argues that “[a]n artisan would understand that sucralfate is contraindicated” with regard to Dr. Phillips’ inventions. (Id.) The Provisional Application states that “H2 antagonists, antacids, and sucralfate ... have certain disadvantages associated with their use .... Omeprazole represents an advantageous alternative to the use of H2 antagonists, antacids, and sucralfate .... ” (Prov.App. at 3-4.) While this indicates that omeprazole is preferable to sucralfate, the same statements indicate with no less force that omeprazole is preferable to antacids such as sodium bicarbonate. Nonetheless, sodium bicarbonate, an antacid, is listed as the preferred carrier or buffer in the disclosed invention. Thus, it cannot be true that the priority applications’ disclosure of the disadvantages of sucralfate, by itself, implies that its use in the invention is contraindicated. Santarus further notes that the background sections of the '737 and '422 applications and the '772 Patent include additional information regarding the potentially serious adverse effects of sucralfate. (See '737 app. 8:1-13; '422 app. 6:1-11; '772 Patent col. 11:1-5.) These documents also included, however, a paragraph discussing the increased risk of pneumonia associated with antacids. (’737 app. 13:4-14:2; '422 app. 10:5-11:2; '772 Patent col. 5:37-6:15.) Santarus asserts, citing the testimony of Dr. Gilbert Banker, that a person of ordinary skill in the art would understand from these disclosures regarding the adverse effects of sucralfate that its use was contraindicated in Dr. Phillips’ invention. (See D.I. 174 at 22; Tr. 949:20-951:20, 965:11-968:12.) The court did not find this testimony persuasive. Neither the priority applications nor Dr. Banker provided information regarding the frequency of the adverse effects associated with sucralfate relative to other therapies. One of the adverse incidents cited by Santarus consists of a single patient in a single study. Dr. Banker also testified that the adverse effects associated with sucralfate — such as “diarrhea, flatulence, [and] GI disease” — are “pretty socially unacceptable.” (Tr. 951:6-9.) Again, however, neither the priority applications nor Dr. Banker indicated the frequency of these effects. In addition, Dr. Banker did not explain why the “social unacceptability” of sucralfate’s side effects should be considered more troublesome than pneumonia or the other adverse affects associated with antacids. Certainly, no evidence was presented as to why a person of ordinary skill in the art reading the application would believe that sucralfate was “contraindicated” in the claimed composition. Consequently, the court finds that neither the priority applications nor the specification of the '772 Patent support the “no sucralfate” limitation. Since this limitation is not supported and claim 1 is the only independent claim of the '772 Patent, the asserted claims of the '772 Patent are only entitled to the filing date of the '346 application, and are also invalid for lack of written description. vii. Initial serum concentration Claims 1, 2, and 26 of the '885 Patent include limitations that identify minimum serum concentrations of the PPI that must be obtained “within about 30 minutes of administration.” Specifically, claims 1 and 26, the only independent claims of the '885 Patent provide that “an initial serum concentration of the [PPI] greater than about 0.1 (xg/ml [be] obtained at any time within about 30 minutes after administration of the composition.” Claim 2, which is dependent on claim 1, further limits the initial serum concentration to “greater than about 0.15 (xg/ml.” Par asserts that these limitations are not supported by the priority applications (see D.I. 173 at 6), or the specification of the '885 Patent itself. (See id. at 24-25.) A Santarus witness did testify at trial that these serum concentrations were sufficiently disclosed in the written description of the '885 Patent itself. Nevertheless, Santarus does not cite any evidence presented at trial that would support a finding that information regarding initial serum concentrations was disclosed in any of the three priority applications. Furthermore, in its post-trial brief, Santarus does not contend that these concentrations were disclosed prior to the '885 Patent application. The specification of the '885 Patent does contain tables disclosing the initial PPI serum concentrations of patients using the claimed composition, so the disputed claims themselves are not invalid for lack of written description. '885 Patent col. 54-55. These tables do not, however, appear in the priority applications’ written descriptions, and Santarus does not contend that any tables or paragraphs disclosing initial serum concentrations are present in the priority applications. Consequently, the court finds that the priority applications do not support the initial serum concentration limitations. As a result, none of the asserted claims of the '885 Patent are entitled to the filing dates of the priority applications. viii. “A commercially stable powder for suspension” Lastly, Par asserts that the priority applications and the written description of the '882 Patent do not support the “commercially stable powder for suspension” limitation in claim 1 of the '882 Patent. (D.I. 173 at 6; Tr. 654:8-14.) To the extent that Par’s objection is to the “powder for suspension” portion of this limitation, the court finds that the priority applications support this dosage form limitation for the reasons stated in section Ill.a.iii, supra. As for the “commercially stable” portion of this limitation, the court finds that a person of ordinary skill in the art reading the priority applications and the '882 Patent would recognize that the inventor contemplated and possessed a commercially stable formulation. Consequently, the priority applications support this limitation in claim 1 of the '882 Patent. B. Obviousness Par challenges the validity of each of the asserted claims as anticipated by or obvious in light of the prior art. The court finds that Par has established by clear and convincing evidence that the patents-in-suit are, indeed, obvious. This is true regardless of which filing date is used for the asserted claims, because even at the time that the Provisional Application was filed, the available prior art rendered the patents-in-suit obvious. i. Legal Standard 35 U.S.C. § 103(a) provides that a patent may not be obtained “if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious to a person having ordinary skill in the art.” Obviousness is a question of law that is predicated upon several factual inquiries. Richardson-Vicks v. Upjohn Co., 122 F.3d 1476, 1479 (Fed.Cir.1997). Specifically, the trier of fact must consider four issues: (1) the scope and content of the prior art; (2) the level of ordinary skill in the art; (3) the differences between the claimed subject matter and the prior art; and (4) secondary considerations of non-obviousness, such as commercial success, long felt but unsolved need, failure of others, and acquiescence of others in the industry that the patent is valid, and unexpected results. Graham v. John Deere Co., 383 U.S. 1, 17-18, 86 S.Ct. 684, 15 L.Ed.2d 545 (1966). A party seeking to challenge the validity of a patent based on obviousness must also demonstrate by “clear and convincing evidence” that the invention described in the patent would have been obvious to a person of ordinary skill in the art at the time the invention was made. Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1359-60 (Fed.Cir.2007). However, in determining what would have been obvious to one of ordinary skill in the art at the time of invention, the use of hindsight is not permitted. See KSR Intern. Co. v. Teleflex, Inc., 550 U.S. 398, 421, 127 S.Ct. 1727, 1742, 167 L.Ed.2d 705, 724 (2007) (cautioning against “the distortion caused by hindsight bias” and “arguments reliant upon ex post reasoning” in determining obviousness) (emphasis added). In KSR, the Supreme Court rejected a rigid application of the principle that there should be an explicit “teaching, suggestion, or motivation” in the prior art, the nature of the problem, or the knowledge of a person having ordinary skill in the art, in order to find obviousness. See KSR Intern. Co. v. Teleflex, Inc., 550 U.S. at 415, 127 S.Ct. 1727. The KSR Court acknowledged, however, the importance of identifying ' “a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does’ in an obviousness determination.” Takeda Chem. Indus. v. Alphapharm Pty., Ltd., 492 F.3d 1350, 1356-57 (Fed.Cir.2007) (quoting KSR, 550 U.S. at 418, 127 S.Ct. 1727). ii. The Level of Ordinary Skill in the Art A person with an ordinary level of skill in the art to which the patents in suit pertain would be (i) a person with, for example, at least a bachelors degree in pharmacy, chemistry, biochemistry, biology, pharmaceutics, or a comparable field and multiple years of relevant work experience; or (ii) a person with an advanced degree in pharmacy, chemistry, biochemistry, biology, pharmaceutics, or a comparable field. iii. Scope and Content of Prior Art and Differences Between Claimed Subject Matter and Prior Art a. Published Studies Using Omeprazole! Sodium Bicarbonate Solutions The prior art at the time of the filing of the Provisional Application includes buffered, non-enteric-coated solutions or suspensions containing omeprazole and sodium bicarbonate. One such reference is an abstract by Lamers et al. that was presented at the annual meeting of the British Society of Gastroenterology in 1985 and published in the peer-reviewed Gut journal the same year. See JTX-93; pdf available at http://www.ncbi.nlm.nih. gov/pmc/articles/PMC1432933/pdf/ gut00383-0136.pdf (scroll to page A1134). The Lamers abstract briefly describes a study that used two different preparations containing 80 mg omeprazole and sodium bicarbonate: “an enteric-coated preparation together with 250 ml (40 mmol) sodium bicarbonate [and an] uncoated preparation with sodium bicarbonate.” (JTX-93 at A1134.) A third formulation used in the study consisted of enteric-coated omeprazole administered with 250 ml saline. (Id.) The abstract revealed that: There was wide variation in omeprazole absorption with the enteric-coated preparation and saline. Ingestion of entericcoated omeprazole with sodium bicarbonate resulted in significantly greater absorption. Omeprazole absorption after uncoated omeprazole with sodium bicarabonate was slightly greater than that with the enteric-coated preparation and saline, but not significantly different from that with enteric-coated omeprazole and sodium bicarbonate.... We therefore conclude that addition of alkali accelerates absorption of omeprazole in patients with Zollinger-Ellison syndrome resulting in early inhibition of acid secretion. (Id. at A1135 (parenthetical statistical data omitted).) Lamers therefore teaches that the use of a sodium bicarbonate buffer is effective in preventing omeprazole from being deactivated by gastric acid, even in the absence of enteric coating. Another reference that disclosed buffered omeprazole/sodium bicarbonate suspensions was a study by Pilbrant et al. published in the Scandanavian Journal of Gastroenterology in 1985. See DTX-167; Aring Pilbrant et al., Development of an oral formulation of omeprazole, 20 Scand. J. Gastroenterology 113 (1985). Santarus attempts to distinguish Pilbrant from the patents-in-suit by asserting that Pilbrant involved the administration of “multiple, additional large doses of sodium bicarbonate solution” along with omeprazole as opposed to the single dose of sodium bicarbonate buffered omeprazole, as in Dr. Phillips’ invention. (See, e.g. D.I. 153, Ex. 12 at 116.) However, Santarus’ focus on the volume of liquid consumed is somewhat misleading. It is sodium bicarbonate, and not water, that neutralizes gastric acid and acts as a pH buffer in the various pharmaceutical compositions at issue. Santarus does not explain why a person of ordinary skill in the art would view the amount of liquid used in a preparation as taking such paramount importance. The court finds, based on the evidence presented at trial, that a person of ordinary skill in the art would find the amount of sodium bicarbonate rather than the amount of water or other liquid to be most relevant when examining the use of buffers in the prior art. In this regard, the amount of sodium bicarbonate administered in Pilbrant is well within the range of with the amounts specified in the asserted claims of the patents in suit. Each dose of sodium bicarbonate solution administered in Pilbrant contained 8 mmol of sodium bicarbonate, and five doses of this solution were given over the course of approximately 40 minutes. This total of 40 mmol — which translates to 40 mEq or 3360 mg — of sodium bicarbonate administered along with 60 mg omeprazole in the Pilbrant study is within the range of buffer specified in the asserted claims of the patents-in-suit. Under these circumstances, the fact that the sodium bicarbonate is provided in divided doses rather than a single dose is not such a significant difference as to render the Pilbrant reference irrelevant. On the contrary, the court finds that a skilled artisan would find Pilbrant highly relevant to the subject matter of the patents-in-suit. Santarus also attempts to persuade the court that a person of ordinary skill in the art would view Pilbrant as teaching away from Dr. Phillips’ invention because Figure 5 in the Pilbrant publication indicates that there may be a “rapid washout” of omeprazole in buffered solutions. (See D.I. 153, Ex. 12 at 118.) The court, however, is more persuaded by Dr. Roy Charles Orlando’s testimony that for the purposes of inhibiting acid production, the serum concentration of omeprazole at any given time is less important than the total amount of omeprazole reaching general circulation. (See Tr. 815-817.) In mathematical terms, on a graph indicating the blood concentration of omeprazole over time, the shape of the curve is less important than the area under the curve (“AUC”). (See id) Indeed, the Pilbrant reference explicitly states: The effect of omeprazole is long lasting. The effect is not a direct function of blood concentration of omeprazole at any time, but is rather a function of the total amount of omeprazole reaching the general circulation, i.e., directly proportional to the AUC. This means that the pharmacological effect is achieved with dosage forms of omeprazole producing equal AUCs. The shape of the plasma concentration-time curves are of no importance. (DTX-167 at 118; see also Tr. 817:1-818:10.) The Pilbrant reference therefore does not teach away from the use of sodium bicarbonate buffers on this basis. On the contrary, the court finds that the Pilbrant reference as a whole strongly indicates that buffering omeprazole with sodium bicarbonate is a possible alternative approach to enteric coating for the administration of omeprazole. The Pilbrant and Lamers references described aqueous solutions, in contrast to the solid compositions claimed in the patents-in-suit. But while this distinction is sufficient to render the Pilbrant and Lamers references non-anticipatory with respect to the patents-in-suit, it does not render them irrelevant to the obviousness analysis. The prosecution history of the patents-in-suit begins with applications that described and claimed aqueous solutions. The '737 and '422 Applications both state that the described composition could “be formed into a tablet, capsules, or granules, by methods well known to those skilled in the art.” '737 App. at 28-29; '422 App. at 23-34. Thus, Dr. Phillips himself recognized that the transition from liquid to solid dosage forms was well within the knowledge and capacity of persons of ordinary skill in the art. The Lamers and Pilbrant references teach that uncoated omeprazole formulations containing a sodium bicarbonate buffer could be used as an alternative to enteric coating in order to protect omeprazole from degrading in the stomach. For the reasons stated above, a person of skill would consider these references highly relevant to the subject matter of the patents-in-suit. As Santarus itself stated in a 505(b)(2) filing in connection with Zegerid’s NDA: “Pilbrant published the first study of sodium bicarbonate as an API protectant for omeprazole in 1985. This technology was then patented by Phillips in 1996 for all proton pump inhibitors.” (Tr. 145:9-12; D.I. 17 at Santarus0000216 (internal citations omitted).) The court finds that even in isolation, these references render the patents-in-suit obvious. Additional prior art references at the time of the filing of the Provisional Application confirm this finding. b. The Makino and Yamasaka Patents The prior art also includes references disclosing solid pharmaceutical compositions containing both sodium bicarbonate and benzimidazole compounds such as the PPIs included in the patents in suit. Two such references are United States Patent No. 5,093,132 (hereinafter, the “Makino Patent”), issued on March 3, 1992; and United States Patent No. 5,294,-439 (hereinafter, the “Yamasaka Patent”), issued on March 15, 1994. Both of these patents are prior art with respect to all claims of the patents-in-suit because they were issued more than one year prior to the filing of the Provisional Application. The Makino Patent describes solid oral pharmaceutical compositions containing both alkali inorganic salts such as sodium bicarbonate and benzimidazole compounds such as omeprazole that “exhibit[ ] excellent gastric antisecretory, gastric mucosa-producing, and antiulcer activities.” Makino Patent col. 11:38-41. The Makino Patent states that the resulting mixture: can be made up into dosage forms suited for oral administration, such as tablets, capsules, powders, granules, and fine granules, by per se known means. Tablets, granules and fine granules may be coated by a per se known method for the purpose of masking of the taste or providing them with enteric or sustained release property. Makino Patent col. 11:1-8. The Yamasaka patent describes solid oral pharmaceutical compositions containing both alkali salts such as s