Full opinion text
MEMORANDUM OPINION AND ORDER AMY J. ST. EVE, District Court Judge: In this patent infringement action, The Medicines Company (“TMC”) asserts that Defendants’ proposed generic bivalirudin drug product infringes United States Patent No. 7,582,727 (the “’727 patent”). Specifically, TMC claims that Defendants Mylan, Inc., Mylan Pharmaceuticals Inc. and Bioniche Pharma USA, LLC (collectively, “Mylan”) proposed generic bivaliru-din drug infringes claims 1-3, 7-10, and 17 of the ’727 patent. (See R.l, Compl.; PTX 397, Parties’ Statement of Uncontested Facts, ¶ 38.) Mylan disputes that its proposed drug infringes the ’727 patent and asserts that the ’727 patent is invalid on grounds of anticipation, obviousness, and non-enablement and unenforceable for inequitable conduct. The Court held a bench trial on TMC’s infringement claim and Mylan’s • counterclaims regarding the ’727 patent. Having considered the evidence and the parties’ arguments, the Court finds as follows: (1) Mylan failed to prove by clear and convincing evidence that claims 1-3, 7-10, and 17 of the ’727 patent are invalid or unenforceable; and (2) Mylan’s proposed bivalirudin drug product infringes claims 1-3, 7-10, and 17 of the ’727 patent. BACKGROUND I. The ’727 Patent The ’727 patent was filed with the United States Patent and Trademark Office (“PTO”) as U.S. Application No. 12/180,553 on July 27, 2008 and issued as the ’727 patent on September 1, 2009. (PTX 1. ’727 patent; see PTX 397, ¶ 6.) The ’727 patent is entitled “Pharmaceutical Formulations of Bivalirudin and Processes of Making the Same.” (Id.) Dr. Gary Musso and Dr. Gopal Krishna are the named inventors of the ’727 patent, but TMC owns all rights, title, and interest to the ’727 patent. (PTX 397, ¶¶ 8, 9.) The ’727 patent generally pertains to pharmaceutical formulations of bivalirudin, a reversible thrombin inhibitor used to temporarily prevent blood clotting during catherization procedures. (See id., at col. 1:21-56; PTX 397, ¶6.) The section of the ’727 patent entitled “Background of the Invention” states: “[o]ne class of anticoagulants is direct thrombin inhibitors that disrupt the activity of thrombin, an important protein in the coagulation cascade.” (Id., col. 1:49-51.) The ’727 further states: “[i]n particular, bivalirudin (ANGIOMAX®), which directly inhibits thrombin by specifically binding to both its catalytic site and to the anion-binding exo-site, is regarded as a highly effective anticoagulant for use during catherization [sic] procedures.” (Id., col. 1:52-56.) The medical and therapeutic applications of bivalirudin, make it “essential that the bivali-rudin formulation maintains a high level of purity.” (Id., col. 2:1-3.) The compounding process for the bivalirudin formulation may generate impurities, such as Asp-bivalirudin (from deamidation of aspara-gine at position 9 of bivalirudin to aspartic acid) and D-Phe impurities (from isomer-ization of L-phenylalanine at position 12 of bivalirudin to the D-isomer). (Id. at. col. 2:1-13.) The ’727 patent also relates to development of processes for synthesizing bivalirudin that minimize the generation of impurities and pharmaceutical batches produced by such processes. (Id. at col. 2:19-22.) By way of background, this compounding process involves three basic steps. (See DTX 1080, Compounding Instructions-Bivalirudin Formulation, at MEDMYL4509463, MEDMYL450971.) First, the active pharmaceutical ingredient (“API”), bivalirudin, is dissolved into a mannitol solution to form a bivalirudin solution. Second, the resulting bivalirudin solution is mixed with a pH-adjusting solution, such as sodium hydroxide, to raise the pH of the bivalirudin API to an acceptable level. Third, the mannitol solution and the pH-adjusting solution are removed from the mixture to form the final drug product. The asserted claims describe • pharmaceutical batches of bivalirudin. Specifically, - claim 1 of the ’727 patent teaches “pharmaceutical batches” of bivalirudin having a maximum Asp impurity level of 0.6%. (PTX 1, col. 25:56-64.) Dependent claims 2 and 3 contain even stricter limitations on Asp impurities, reducing the maximum allowable level of Asp impurities to 0.4% and 0.3%, respectively. (See id. at col. 25:65-26:56.) Dependent claims 7-10 and 17 contain all the limitations of claim 1 and additional limitations regarding the maximum level of D-Phe-bivali-rudin impurities (claim 7), the type of pharmaceutically acceptable carrier contained in the final drug product (claims 8-10), and the base used to adjust the pH of the final drug product (claim 17). (See id. at col. 27-28.) The asserted claims of the ’727 patent read as follows: 1. Pharmaceutical batches of a drug product comprising bivalirudin (SEQ ID No: 1) and a pharmaceutically acceptable carrier for use as an anticoagulant in a subject in need thereof, wherein the batches have a pH adjusted by a base, said pH is about 5-6 when reconstituted in an aqueous solution for injection, and wherein the batches have a maximum impurity level of Asp-bivliarudin of about 0.6% as measured by HPLC [high-performance liquid chromatography]. 2. The pharmaceutical batches of claim 1, wherein the maximum impurity level of Asp-bivalirudin does not exceed about 0.4% as measured by HPLC. 3. The pharmaceutical batches of claim 2, wherein the maximum impurity level of Asp-bivalirudin does not exceed about 0.3% as measured by HPLC. 7. The pharmaceutical batches of claim 1, wherein the batches have a maximum level of D-Phe-bivalirudin that does not exceed about 2.5% as measured by HPLC. 8. The pharmaceutical batches of claim 1, wherein the pharmaceutically acceptable carrier comprises one or more of a bulking agent or a stabilizing agent. 9. The pharmaceutical batches of claim 8, wherein the bulking agent is a sugar. 10.The pharmaceutical batches of claim 9, wherein the sugar is man-nitol. 17. The pharmaceutical batches of claim 1, wherein the base is sodium hydroxide. (PTX 1, col. 25:55-28:9.) During claim construction, the Court construed the term “pharmaceutical batches” as follows: “Pharmaceutical batches” may include a single batch, wherein the single batch is representative of all commercial batches (see generally, Manual of Policies and Procedures, Center for Drug Evaluation and Research, MAPP 5225.1, Guidance on the Packaging of Test Batches at 1) made by a compounding process, and wherein the levels of, for example, Asp-bivalirudin, total impurities, and largest unknown impurity, and the reconstitution time represent levels for all potential batches made by said process. “Batches” may also include all batches prepared by a same compounding process. (See R.119, Claim Construction Order.) The ’727 patent specification describes several experiments Dr. Musso and Dr. Krishna ran and provides the resulting Asp impurity levels for the batches produced in each experiment. Examples 4 and 5 in the specification provide a comparison of an old “inefficient” mixing process (Example 4) and a new “efficient” mixing process (Example 5), and Tables 6 and 7 report the impurity levels and reconstitution times for Original Angiomax® batches produced using inefficient mixing (Table 6) and Improved Angiomax® batches produced using efficient mixing (Table 7). (See PTX 397, ¶¶ 13-17.) Comparison of the results in Table 6 (“inefficient mixing”) and Table 7 (“efficient mixing”) reveals that the percentage of Asp-bivalirudin impurities in the 24 reported batches of Improved Angiomax® (shown in Table 7, recreated below) has a lower mean, standard deviation, and a lower maximum level when compared to the 87 reported batches of Original Angio-max® (shown in Table 6, recreated below): _TABLE 6_ Characteristics of the batches generated by the compounding process that features rapid addition of a pH-adjusting solution and inefficient mixing rates. No. of batches Mean ± SD Maximum Asp-bivalirudin (%) 87 0.5 ± 0.4 3.6 Total Impurities (%) 63 1.4 ±0.5 3.0 Largest unknown impurity (%) 86 0.3 ±0.1 0.5 Reconstitution Time (seconds) 85 30 ± 12 72 (See PTX 1, col. 22:10-20.) TABLE 7 Characteristics of the batches generated by the compounding process that features addition of a pH-adjusting solution at a constant rate with efficient mixing. No. of batches Mean±SD Maximum Asp -bivalirudin (%) 24 0.3 ± 0.1 0.6 Total Impurities (%) 24 1.0 ± 0.4 2.0 Largest unknown impurity (%) 24 0.2 ±0.1 0.3 Reconstitution Time (seconds) 24 18 ± 6 42 (See id. at col. 23:1-13.) In addition to the 24 reported batches of Improved Angio-max®, the patent specification discloses that Table 7 did not include the results for one batch because “the method used to generate the batch was not compliant with the protocol established for this study.” (See id. at col. 23:14-16.) II. The Present Litigation TMC is the owner of New Drug Application (“NDA”) No. 20-873, which was approved by the U.S. Food and Drug Administration (“FDA”), on December 15, 2000, for the manufacture and sale of a bivaliru-din drug product for intravenous injection. (PTX 397, ¶ 19.) TMC’s bivalirudin dug product is marketed in the United States under the tradename Angiomax®. (Id., ¶ 20.) Bivalirudin is the active ingredient in TMC’s Angiomax® drug, which is indicated for use as an anticoagulant during coronary angioplasty and stenting procedures. (Id., ¶¶ 20-24.) Mylan submitted Abbreviated New Drug Application (“ANDA”) No. 202471 to the FDA, seeking approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of a generic equivalent to .Angiomax® prior to the expiration of the ’727 patent. (See PTX 133; PTX 397, ¶¶ 30-31, 34.) The product specification for Mylan’s proposed bivaliru-din product seeks approval for a bivaliru-din drug with Asp impurities of up to 2.0% (1.0% a-Asp and 1.0% J3-Asp). My-lan submitted an exhibit batch of its proposed bivalirudin product to the FDA in support of its ANDA. Mylan’s exhibit batch, CMB10001, had total Asp impurities of 0.194%. In November 2011, the FDA sent a deficiency letter to Mylan regarding, among other things, the Asp impurity levels provided in Mylan’s specification. Specifically, the FDA wrote, “[y]our drug product impurity release specification is wide, and not supported by the exhibit batch test results.” (See PTX 162.) To date, Mylan has not submitted a response to the FDA’s' deficiency letter. An internal draft .response prepared in January 2012, however, proposed changing the maximum Asp impurity level to 1.0% (0.5% a-Asp and 0.5% B-Asp). (See PTX 164.8.) On February 23, 2011, TMC filed this patent infringement action under the Hateh-Waxman Act, alleging that the manufacture, sale, and offer for sale of Mylan’s proposed bivalirudin drug will infringe the ’727 patent and United States Patent No. 7,598,343 (the “ ’343 patent”). (R.l.) Before trial, the Court granted summary judgment of non-infringement in favor of Mylan with respect to the ’343 patent. (See R.309.) The Court also granted Mylan summary judgment on TMC’s willfull infringement claim. (Id.) The parties proceeded to trial on TMC’s infringement claims and Mylan’s counterclaims regarding the ’727 patent. The bench trial on the parties’ claims regarding the ’727 patent lasted approximately six full days. During the trial, the parties admitted numerous exhibits, including the ’727 patent file, Mylan’s ANDA, and various e-mails and batch testing documents. Additionally, the following witnesses testified at trial: • Anthony Flammia, Vice President of New Business Ventures for TMC • Gary Musso, Co-inventor of the ’727 patent • Julie Simon, formerly the Senior Director of Business Development for Mylan • Daniel Hoch, an employee of Protocol Link, Inc., a consulting firm that assisted Mylan in preparing its biva-lirudin ANDA • Martina O’Sullivan (via videotaped deposition), Director of Regulatory Affairs for Mylan and Bioniche • Leena Selvaraj (via videotaped depo-. sition), formerly the Director of External Research and Development and Project Management for Bio-niche and Mylan • Malini Sen (via videotaped deposition), Senior Manager of Quality Assurance at Biocon, the drug manufacturer Mylan contracted with to produce Mylan’s ANDA exhibit batch. • Alexander Klibanov, TMC’s expert in the fields of chemistry and in pharmaceutical formulations containing peptides, including their stability • Wayne Taitón, Vice President of Global Regulatory Affairs for Mylan • Ian McKeague, Mylan’s expert in statistics • David Auslander, Mylan’s expert in the field of pharmaceutical formulation and process development • Rajeshwar Motheram, formerly TMC’s Manager of Technical Operations • Gopal Krishna, Co-inventor of the ’727 patent • Alan Salzberg, TMC’s expert in statistics • Nancy Linck, Mylan’s expert in patent prosecution and PTO procedures • Sandra Kuzmich, TMC’s patent prosecution attorney The parties also submitted deposition designations and videotape clips for the following witnesses: Angela Green; Daniel Robins; James Leary; Lisa-Sue Wood; Pamela Savoy; Russell Garman; Steve McKinnon; and Timothy Smith. During the course of the trial, the Court carefully evaluated the demeanor and credibility of each witness including, where applicable, the witnesses’ body language, tone of voice, facial expressions, mannerisms, and other indicative factors. Based on the evidence presented at trial, the Court makes the detailed findings of fact and conclusions of law set forth below. DISCUSSION I. Development of the Invention . A. Original Angiomax® TMC is the owner of NDA No. 20-873, which the FDA approved on December 15, 2000 for the manufacture and sale of a bivalirudin drug product for intravenous injection. (PTX 397, ¶ 19.) TMC’s bivali-rudin product is marketed under the trade name Angiomax® and among other things, is indicated for use as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty. (Id. ¶ 20.) Anticoagulants are substances that prevent blood from clotting and are commonly used during coronary procedures. (Id. ¶¶ 23-24.) Bivalirudin is the API in TMC’s Angio-max® product that exhibits anticoagulant activity. (Id. ¶¶ 21, 22.) Bivalirudin is a synthetic peptide made up of twenty amino acid residues that are linked in a specific sequence to form a peptide. (Id. ¶¶ 22, 25.) The bivalirudin peptide sequence in Angiomax® is: D-Phe-Pro-Arg-Pro-Gly-Gly-Gly-Gly-Asn-Gly-Asp-Phe-Glu-Glulle-Pro-Glu-Glu-Tyr-Leu. (PTX 397, ¶ 26 (emphasis added).) The ninth amino. acid of the chain, shown above in italics, is asparagine (abbreviated as Asn9 or Asn). (Id. ¶ 27.) Under certain conditions, an asparagine (Asn) may decompose (undergo deamidation) to form an aspartic acid (Asp). (Id. ¶ 28) The impurity “Asp-bivalirudin,” may form in Angiomax® (or a generic equivalent) when the Asn residue deamidates to an Asp residue. (Id. ¶ 29.) Before the inventions of the ’727 and ’343 patents, the compounding process used to manufacture TMC’s Angiomax® drug resulted in variable and sometimes' high levels of Asp impurities in the final drug product. At least two batches of Angiomax® manufactured using the original compounding process (“Original Angio-max®”) failed to meet the specification requiring a 1.5% maximum Asp impurity level applicable to Original Angiomax® batches. Lot 716184, which TMC’s drug manufacturer Ben Venue Laboratories (“Ben Venue” or “BVL”) produced on June 8, 2005, had an Asp impurity level of 3.6%. (See PTX 223.) Ben Venue investigated the failure of Lot 716184 and determined that laboratory error- did not cause the failure. In an attempt to avoid future lot failures, Ben Venue and TMC reviewed and implemented changes to its manufacturing instructions, e.g., instructions for adding the pH-adjusting solution to the bivalirudin solution in aliquots. (Tr. 61:22-62:12 (Flammia); Tr. 207:9-208:3 (Musso); PTX 223.15; DTX 1211; DTX 1207; PTX 218 at MEDMYL4399135-36.) Less than a year later, however, Ben Venue produced a second lot with Asp impurity levels that again exceeded the 1.5% specification. (See PTX 218; Tr. 1399:23-1402:22 (Klibanov); Tr. .207:9-2008:25 (Musso); Tr. 62:17-64:22 (Flammia).) The second failed lot, Lot 896002, had an Asp impurity level of 2.3%. (See id.) Ben Venue could not definitively determine the root cause of either lot failure. Following this second lot failure, TMC decided to become involved with Ben Venue’s investigation into the underlying cause of the high Asp impurity levels for the failed lot. The co-inventors of the ’727 patent, Dr. Gopal Krishna and Dr. Gary Musso, led the investigation for TMC. Dr. Krishna was a TMC employee at the time, and TMC hired Dr. Musso as a consultant to assist in the investigation. On July 14, 2006, Dr. Musso and two TMC employees, Anthony Flammia and Angie Green, met with several Ben Venue employees involved in the production of Original Angiomax® to discuss the lot failures. Dr. Krishna was on vacation and did not attend the July 14, 2006 meeting. Discussions at the meeting addressed the taffy or marshmallow-like precipitate formed during the compounding process and suggestions on how to improve the process were made. First, variations in the heights of the two stirrers in the tank were proposed so that one stirrer mixes the upper part of the solution and the other mixes the lower part of the solution. (See PTX 7.) The second proposal involved increasing the stirring speed prior to the addition of the base. (See id.) Finally, a proposal regarding addition of the base through a dip tube was made, so that the base dispersed at the bottom of the tank where mixing is still possible. (See id.) After the operators left the meeting, senior Ben Venue staff and TMC discounted the suggestions. The first suggestion — to vary the stirrer heights — was already part of the Original Angiomax® manufacturing instructions, and Ben Venue had used the third suggestion — adding the base through a dip tube — -in manufacturing the first failed lot in 2005. With respect to the second suggestion — increasing the stirring speed before addition of the base — Dr. Musso testified that Ben Venue staff expressed concern that this may lead to foaming. B. Improved Angiomax® Following the July 14, 2006 meeting, Dr. Musso and Dr. Krishna observed the compounding process used to manufacture Original Angiomax® and developed a set of experiments designed to identify improvements to reduce the formation of Asp impurities during the compounding process. Dr. Musso and Dr. Krishna then supervised and directed the Ben Venue employees who performed the experiments. Ultimately, through these experiments, Dr. Musso and Dr. Krishna developed an “efficient mixing” process that resulted in lower and more consistent Asp impurity levels in the bivalirudin final drug product. Under the direction of Dr. Musso and Dr. Krishna, Ben Venue manufactured 26 batches of Angiomax® using the improved compounding process (“Improved Angio-max®”). Twenty-four of those batches had a maximum Asp impurity level of about 0.6% or less, but the remaining two batches had an Asp impurity level of 12.4% (Lot 116050) and 1.5% (Lot 1344985). Ben Venue conducted investigations into both failed lots. With respect to Lot 116050, Ben Venue concluded after its investigation that operator error had caused the batch failure. With respect to Lot 1344985, however, Ben Venue found no operator error in the manufacturing process and closed its investigation without identifying the root cause of the failure. TMC and the co-inventors challenged Ben Venue’s conclusion that the high Asp impurity level in Lot 1344985 was not due to operator error. Ultimately, Ben Venue agreed to destroy the lot and provide a credit to TMC’s account for the batch failure. To date, however, neither TMC nor Ben Venue has definitively identified the root cause of the failure. II. Invalidity The Court first turns to Mylan’s counterclaims that the ’727 patent is invalid due to anticipation, obviousness, and non-enablement. Because patents are presumed valid, the party seeking to invalidate a patent — in this case, Mylan — bears the burden of proving the patent’s invalidity by clear and convincing evidence. See Microsoft Corp. v. i4i Ltd. P’ship, — U.S. -, 131 S.Ct. 2238, 2242, 180 L.Ed.2d 131 (2011) (citing 35 U.S.C. § 282). The presumption of validity creates “ ‘a heavy burden of persuasion,’ requiring proof of the defense by clear and convincing evidence .... [T]he presumption encompassed not only an allocation of the burden of proof but also an imposition of a heightened standard of proof.” Id., 131 S.Ct. at 2246; see also AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1297-98 (Fed.Cir.2014) (“[P]at-ents are presumed to be valid, and overcoming this presumption requires clear and convincing evidence.”). New evidence supporting an invalidity defense that the PTO did not consider before issuing the patent-in-suit may “carry more weight” in an infringement action than evidence that the PTO previously considered. See Microsoft Corp., 131 S.Ct. at 2251. The introduction of new evidence not previously considered by the PTO, however, does not lessen the burden of the party seeking invalidity to prove that the patent is invalid by clear and convincing evidence. Id. at 2250-51. A. Anticipation Under 35 U.S.C. § 102 Mylan alleges that claims 1-3, 7-10, and 17 of the ’727 patent are invalid as anticipated under 35 U.S.C. § 102(b). (See R.553, Mylan’s Posh-Trial Brief, at 2-11.) 1. Legal Standard Section 102(b) provides in relevant part: “A person shall be entitled to a patent unless ..'. the invention was ... in public use or on sale in this country, more than one year prior to the date of the application for patent in the United States.... ” 35 U.S.C. § 102(b); see also ResQNet.com, Inc. v. Lansa, Inc., 594 F.3d 860, 866 (Fed.Cir.2010) (“An offer for sale, sale, or public use, if more than one year before the patent application was filed, will bar patenting of the product.”). “The on-sale bar applies when two conditions are satisfied before the critical date [i.e. more than one year before the patent was filed]: (1) the claimed invention must be the subject of a commercial offer for sale; and (2) the invention must be ready for patenting.” Hamilton Beach Brands, Inc. v. Sunbeam Prods., Inc., 726 F.3d 1370, 1374 (Fed.Cir.2013) (citing Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 67, 119 S.Ct. 304, 142 L.Ed.2d 261 (1998)). In determining whether claims are invalid due to an on-sale bar, courts should determine “whether the subject of the barring activity met each of the limitations of the claim, and thus was an embodiment of the claimed invention.” Netscape Commc’ns Corp. v. Konrad, 295 F.3d 1315, 1323 (Fed.Cir.2002) (citations omitted). In addition, “[o]nly an offer which rises to the level of a commercial offer for sale, one which the other party could make into a binding contract by simple acceptance (assuming consideration), constitutes an offer for .sale under [section] 102(b).” Id. (citations omitted). “To determine if the offer is sufficiently definite, one must examine the language of the proposal in accordance with the principles of general contract law.” Id. at 1323-24. 2. Analysis The critical date for the ’727 patent is July 27, 2007. {See PTX 1.) Mylan relies on five Original Angiomax® batches sold in the United States between 2002 and 2004, prior to the critical date, for its § 102(b) argument. Mylan, for example, submitted evidence alleging TMC sold Lot No. 273786 in the United States to Ameri-Source Bergen Drug Corp. in Louisville, Kentucky (sold on 12/17/02), and to Morris & Dickson Co., LLC in Shreveport, Louisiana (sold on 12/17/02). {See DTX 1658 at MEDMYL4580643-44; see also JTX 3028 (McKinnon Dep. 126:13-127:10).) Mylan argues that the sales of these batches satisfy the requirements for an on-sale bar, namely, that TMC made the sales before the critical date, and: (1) the sales constitute the claimed invention as a subject of the commercial offer for sale; and (2) the claimed invention was ready for patenting as of that date. TMC argues that the batches to which Mylan refers represent only a subset of the multiple batches of Original Angiomax® and that the Court would have to consider all the batches in its analysis of whether the subject of the commercial offer for sale was in fact the claimed invention. a. TMC Sold Original Angiomax® Batches Prior to the Critical Date As an initial matter, TMC does not dispute that the sale of Original Angiomax® batches constitutes a commercial offer for sale and the evidence at trial established the same. During prosecution of Application No. 12/180,553, which issued as the ’727 patent, TMC admitted the Original Angiomax® batches referenced in Table 6 were sold, stating “[t]he drug products generated from the old compounding process, which were sold/marketed/offered for sale for more than, one (1) year prior to the filing date of the accompanying application, comprised a maximum Asp-bivali-rudin level of about 3.6%, a maximum reconstitution time of about 72 seconds, and a maximum amount of total impurities of about 3.0%.” (PTX 3.145 (emphasis added); PTX 3.708-709; see also R.560, TMC’s Responsive Posh-Trial Br., at 17 (“[T]he file history demonstrates that the PTO was made aware that these Original Angiomax® batches were sold ....”); see also R.418, Pretrial Order, Exhibit M, My-lan’s Proposed Findings of Fact and Con-elusions of Law on Invalidity and Unen-forceability and TMC’s Responses, TMC’s Response to FF.9, stating “[i]n 2001, TMC only sold pharmaceutical batches of Original Angiomax®.”) The evidence at trial also demonstrated that TMC sold Original Angiomax®, through its distributor — Integrated Commercialization Solutions (“ICS”) — to various customers in the United States prior to July 27, 2007. (See DTX 1658; DTX 1775; Tr. 150:24-154:9 (Flammia); JTX3028 (McKinnon Dep. 126:18:5-14:17.). The Court, therefore, finds that the Original Angiomax® batches constitute a commercial offer for sale, b. Original Angiomax® Batches Sold Are Not the Claimed Invention The Court now turns to whether the commercial offers for sale were of the claimed invention. At their core, Mylan’s and TMC’s arguments regarding the batches of Original Angiomax® focus on whether a single batch can be used to meet the “pharmaceutical batches” requirement of the ’727 patent claims. During claim construction, the Court construed the term “pharmaceutical batches” as follows: “Pharmaceutical batches” may include a single batch, wherein the single batch is representative of all commercial batches (see generally, Manual of Policies and Procedures, Center for Drug Evaluation and Research, MAPP 5225.1, Guidance on the Packaging of Test Batches at 1) made by a compounding process, and wherein the levels of, for example, Asp-bivalirudin, total impurities, and largest unknown impurity, and the reconstitution time represent levels for all potential batches made by said process. “Batches” may also include all batches prepared by a same compounding process. (See R.119.) Although the parties agreed to this construction during the claim construction hearing, they now disagree on its meaning. TMC argues that the Court’s construction consists of two parts: (1) the first part, regarding a “single batch,” refers only to an ANDA test batch, as evidenced by the parenthetical citation to MAPP 5225.1 regarding the packaging of test batches, and (2) the second part, regarding “all batches,” refers to prior art like Original Angiomax® in which TMC. produced multiple batches. Mylan, on the other hand, argues that the first part of the Court’s construction regarding a “single batch” may apply to single batches other than ANDA test batches and that the Court should consider whether individual batches of Original Angiomax® on sale before July 27, 2007 anticipate the asserted claims. The Court need not resolve this dispute, however, because even if the Court accepts Mylan’s interpretation, Mylan failed to establish that the individual Original Angiomax® batches on which it relies meet “each of the limitations of the claim, and thus [are] an embodiment of the claimed invention.” See Netscape Commc’ns, 295 F.3d at 1323 (citations omitted). Namely, Mylan failed to prove that any of the cited Original Angiomax® batches are “representative” as required by the claim. Namely, that the cited Original Angiomax® batches are: (1) “representative of all commercial batches ... made by a compounding process,” and (2) “wherein the levels of ... Asp-bivalirudin ... represent levels for all potential batches made by said process.” (PTX 1, claim 1; see also R.119.) i. TMC Batches 339257 and 515495 Are Not “Representative” of All Commercial Batches Mylan contends that two of its five cited batches — batches 339257 and 515495 — satisfy the “single batch” prong of the Court’s “pharmaceutical batches” construction because the batches are “representative.” Specifically, Mylan argues that TMC’s selection of batches 339257 and 515495 as “stability batches” for use in FDA-required testing on the stability, or shelf-life, of its Original Angiomax® drug product demonstrates their “representative” nature. While TMC does not dispute that the batches are from “a compounding process”, it argues that the batches are not “representative” as required by the ’727 patent claims. TMC contends that any “representative” nature of the single stability batches identified by Mylan pertains only to their stability, not to the general nature of the batch (which would include being representative of properties other than stability, such as level of impurities.) Both parties, however, seem to ignore the fact that the use of “representative” in the claims of the ’727 patent has a specialized meaning. In order for a single batch to be a “pharmaceutical batch” of the ’727 patent claims, the single batch must be “representative.” The “representative” concept shows up in two portions of the claim language. A single batch is “representative” if it is: “[1] representative of all commercial batches ... made by a compounding process, and [2] wherein the levels of, for example, Asp-bivalirudin, total impurities, and largest unknown impurity, and the reconstitution time represent levels for all potential batches made by said process.” (See PTX 1, claim 1 (emphasis added); see also R.119.) Mylan claims that TMC’s chemistry expert’s (Dr. Klibanov’s) reliance on FDA compliance documents that expressly state that lots placed on stability must be “representative of the marketed product,” further demonstrates the representative nature of TMC’s stability batches. (See PTX 108.24 (emphasis added); Tr. 1458:5-15 (Klibanov).) The FDA compliance documents use of “representative,” however, does not contemplate the use of that term in the ’727 patent. As such, the explicit recitation of “representative” in the FDA compliance document does not bear on whether TMC’s stability batches meet the “pharmaceutical batches” limitation as used in the ’727 patent claims. See Rembrandt Vision Techs., L.P. v. Johnson & Johnson Vision Care, Inc., 725 F.3d 1377, 1379, 1382-83 (Fed.Cir.2013) (citing Fed. R. Evid. 403) (affirming the district court’s exclusion of plaintiffs circumstantial evidence as potentially confusing and non-probative of infringement where the evidence described the accused infringing product as “soft” and “soft gas permeable contact lens” was a claim term the court construed as requiring the lens to have a Short D Hardness less than five). Mylan also argues that the ICH Harmonized Stability Guidelines support its position that TMC’s stability batches are “representative.” This argument, however, views the “representative” limitation of the claim with a myopic focus on the “representative of all commercial batches” portion of the limitation. TMC’s Annual Product Review for Original Angiomax® identified the stability batches, stating: The bivalirudin drug product stability program is performed by BVL, on behalf of MDCO. Per agreement with MDCO, BVL conducts an active bivali-rudin drug product stability program with specified lot samples stored at temperatures and conditions in keeping, testing, and reporting within the ICH Harmonization Stability Guidelines and in keeping with FDA and EMEA commitments. (DTX 1698 at MEDMYL4115027 (emphasis added); see DTX 1744 (FDA Guidance adopting the ICH Guidelines).) The ICH Harmonized Stability Guidelines § 1.3 states: The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, and to establish a retest period for the drug substance or a shelf life for the drug product and recommended storage conditions. (DTX 1087 at MEDMYL4054113.) The ICH Harmonized Stability Guidelines § 2.2.3 regarding the selection of stability batches state that “[t]he manufacturing process used for primary batches should simulate that to be applied to production batches and should provide product of the same quality and meeting the same specification as that intended for marketing (See DTX 1087 at MEDMYL4054114 (emphasis added).) In an effort to address the “representative” claim limitation, Mylan relies on the ICH Harmonized Stability Guidelines’ reference to stability batches as being the same as that intended for marketing. TMC’s Vice President of Pharmaceutical Development, Dr. Rajeshwar Motheram, however, testified at trial that TMC generally followed ICH guidelines in choosing stability lots and selected stability lots that were “representative” of the stability of their commercial batches (as opposed to representative of the batches generally). (See Tr.. 1101:6-10, 1104:2-10.) While the ICH Harmonized Stability Guidelines may address use of a batch for stability testing that mimics “that intended for marketing,” the ’727 patent claims require more from a pharmaceutical batch than it simply being “representative of all commercial batches.” Namely, in order for a single batch to be “representative” in the ’727 patent claims, it must also have “levels of, for example, Asp-bivalirudin, ... [that] represent levels for all potential batches made by said process.” ii. TMC Batches 339257 and 515495 Do Not “Represent” the Asp-Bivalirudin Levels For All Potential Batches Mylan also has not proven by clear and convincing evidence that the two asserted stability batches are “representative” in the sense that “the levels of, for example, Asp-bivalirudin, ... represent levels for all potential batches made by said process.” (PTX 1, claim 1.) Mylan asserts that Original Angiomax® batches 273786, 273787, 335834, 339257, and 515495, which TMC sold through its distributor ICS in 2002-2004 (see DTX 1658), render the asserted claims invalid under § 102(b). Two . of the batches have Asp impurities of 0.5% or less with three of the batches (Lot Nos. 273786, 273787, and 335834) having Asp impurities of 0.3% or less. Several Original Angiomax® batches made by “said process” (ie., the compounding process of the cited batches), however, have Asp impurity levels above 0.6%. Lot Number 896002, for example, has Asp levels of 2.3% (PTX 218.2) and Lot No. 716184 has Asp levels of 3.6% (PTX 223.2). Both levels exceeded an Asp level of about 0.6%. Even Mylan’s expert, Dr. Auslander, admitted that Original Angio-max®, considered as a whole, fails to meet the Asp impurity level limitations in the asserted claims. (See Tr. 1022:2-23.) Because the claims require the representative batch to not only be representative of all commercial batches, but also represent levels for all potential batches made by said process, the “stability” batches — Lot Nos. 339257 and 515495 — do not meet the “representative” claim limitation. TMC’s action in selecting and designating batches 339257 and 515495 as stability batches is insufficient to establish that the Asp impurity levels in those batches represent the impurity levels for all potential Original Angiomax® batches made by the same process, as required by the claim. This is especially true in light of the other evidence at trial which showed just the opposite — ie., that some batches of Original Angiomax® contained Asp impurities well above the impurity levels observed in batches 339257 and 515495. Accordingly, Mylan has failed to prove that the Original Angiomax® batches alleged by it to meet the on-sale bar under § 102(b) meet each and every limitation of the claim, and thus Mylan has not established that the claimed invention was the subject of a commercial offer for sale by clear and convincing evidence and therefore cannot establish invalidity of the ’727 patent claims due to an on-sale bar. See Netscape Commc’ns, 295 F.3d at 1323 (explaining that in making a determination as to whether claims are invalid due to an on-sale bar, the court should determine “whether the subject of'the barring activity met each of the limitations of the claim, and thus was an embodiment of the claimed invention.”). Because Mylan failed to satisfy the first element of the on-sale bar, the Court does not address the second element, namely, whether the invention of the ’727 patent was ready for patenting. See Hamilton Beach, 726 F.3d at 1374. B. Obviousness Mylan next contends that Claims 1-3, 7-10, and 17 of the ’727 patent are invalid as obvious under 35 U.S.C. § 103. (See R.553 at 12-24.) 1. Legal Standard Section 103 forbids issuance of a patent when “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 at the time the invention was made to a person having ordinary skill.” See U.S.C. § 103(a) (2006); see also KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 406, 127 S.Ct. 1727, 167 L.Ed.2d 705 (2007). The party seeking to invalidate a patent as obvious must prove by clear and convincing evidence that “a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success from doing so.” Bristol-Myers Squib Co. v. Teva Pharms. USA, Inc., 752 F.3d 967, 973 (Fed.Cir.2014) (quoting Procter & Gamble Co. v. Teva Pharms. USA, Inc., 566 F.3d 989, 994 (Fed.Cir.2009)); see also Amgen, Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340, 1362 (Fed.Cir.2009) (“An obviousness determination requires that a skilled artisan would have perceived a reasonable expectation of success in making the invention in light of the prior art.”). Obviousness is a question of law based on underlying factual findings: (1) the scope and content of the prior art; (2) the differences between the claims and the prior art; (3) the level of ordinary skill in the art; and (4) objective considerations of nonobviousness. See InTouch Techs., Inc. v. VGO Comm’cns, Inc., 751 F.3d 1327, 1347 (Fed.Cir.2014) (citing Graham v. John Deere, 383 U.S. 1, 17-18, 86 S.Ct. 684, 15 L.Ed.2d 545 (1966)). If, after assessing these factors, a court concludes that the claimed invention was obvious, the claim is invalid under § 103. See KSR, 550 U.S. at 407, 127 S.Ct. 1727. The Supreme Court has warned, however, that, while an analysis of any teaching, suggestion, or motivation to combine known elements is useful to an obviousness analysis, the overall obviousness inquiry must be expansive and flexible. See KSR, 550 U.S. at 415, 419, 127 S.Ct. 1727; see also In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litig., 676 F.3d 1063, 1068-69 (Fed.Cir.2012). 2. Analysis Mylan identified the references below as alleged prior art, along with the testimony of its expert, Dr. Auslander, on the state of the pharmaceutical industry formulation and mixing arts, in support of its obviousness contentions: • The Original Angiomax® product and processes; • The 2005 Original Angiomax® product insert (DTX '1498 at MED-MYL0001916-1919); and/or U.S. Patent No. 5,196,404 (PTX 277); • Dr. Musso’s July 15, 2006 Trip Summary Report (“Musso Trip Summary”) (PTX 007; DTX 1246); • KL Amsberry, et al., Compatibility and Stability of Bivalirudin in IV Admixtures, AAPS Pharm. Sci. (1999) (“Amsberry Abstract”) (DTX 1498 at MEDMYL0001916-1919); • R. Bischoff & H. Kolbe, Deamidation of Asparagine and Glutamine Residues in Proteins and Peptides: Structural Determinants and Analytical Methodology, 662 J. Chromatography 261-78 (1994) (“Bischoff’) (DTX 1021); and • The 2005 European Medicines Agency (“EMEA”) publication (DTX 1498 at MEDMYL000123 9-1270). {See R.553 at 12.) a. The Scope and Content of the Prior Art In order for prior art to be used in combination to determine obviousness under 35 U.S.C. § 103, the alleged prior art must first qualify as prior art under § 102(a), (b), (e), (f), or (g). See OddzOn Prods., Inc. v. Just Toys, Inc., 122 F.3d 1396, 1402 (1997); see also Panduit Corp. v. Dennison Mfg. Co., 810 F.2d 1561, 1568 (Fed.Cir.1987) (“Before answering Graham’s ‘content’ inquiry [under the § 103 obviousness analysis], it must be known whether a patent or publication is in the prior art under 35 U.S.C. § 102 — a legal question.”). In this case, the parties do not dispute that the 2005 Original Angio-max® product insert, U.S. Patent No. 5,196,404, Amsberry Abstract, Bis-choff, and the 2005 EMEA publication qualify as prior art under § 102(b). (See R.553 at 12; R.560 at 6-8.) The parties do, however, dispute whether the Original Angiomax® product and the process used to produce it qualify as prior art under § 102(b). (See id.) The parties also dispute whether the Musso Trip Summary qualifies as prior art under § 102(f). (See id.) The Court first addresses the teachings of the agreed prior art followed by those references in dispute. i. The Undisputed Prior Art The person of ordinary skill in the art knew that Original Angiomax® was a product manufactured by Ben Venue, distributed by ICS, and marketed by TMC, indicated for use as an anticoagulant and contained bivalirudin as its API. (See DTX 1498 at MEDMYL0001916-1919.) The “Description” of the Original Angio-max® product states: Angiomax® (bivalirudin) is a specific and reversible direct thrombin inhibitor. The active substance is a synthetic, 20 amino acid peptide. The chemical name id D-phenylalanyl-L-prolyl-L-arginyl-L-prolyl-glycyl-glycyl-glycyl-glycyl-Lasparagyl-glycyl-L-aspartyl-L-phe-nylalanyl-L-ghitamyl-L-glutamyl-L-isoleucylL-prolyl-L-glutamyl-L-gluta-myl-L-tyrosyl-L-leucinetrifluoroacetate (salt) hydrate (Figure 1). The molecular weight of Angiomax is 2180 daltons (anhydrous free base peptide). Angio-max is supplied in single-use vials as a white lyophilized cake, which is sterile. Each vial contains 250 mg bivalirudin, 125 mg mannitol, and sodium hydroxide to adjust the pH to 5-6 (equivalent to approximately 12.5 mg sodium). When reconstituted with Sterile Water for injection the product yields a clear to opalescent, colorless to slightly yellow solution, pH 5-6. (Id. at MEDMYL0001916.) Based on Original Angiomax®, the person of ordinary skill knew that thrombin inhibitors may be formulated using conventional methods to prepare pharmaceu-tically useful compositions with pharma-ceutically acceptable carriers and with suitable fillers or bulking agents, such as mannitol. (DTX 1498 at MED-MYL0001916; id. at MEDMYL0001855; see also id. at MEDMYL0001239.) Regarding the pH of the reconstituted bivali-rudin product (for injection), .the person of ordinary skill also knew that the pH could be adjusted by a base to achieve a desired pH range of 5-6. (DTX 1498 at MED-MYL0001916.) In addition, the person of ordinary skill knew that bivalirudin was composed of 20 amino acids, and that the ninth position of the 20-mer peptide chain was an aspara-gine (Asn). (Id. at MEDMYL0001916; see also id. at MEDMYL0001240; PTX 277, U.S. Patent No. 5,196,404 (disclosing structure of bivalirudin as a thrombin inhibitor).) The person of ordinary skill also knew that Asn deamidates to Asp, and more specifically that “[a] known degradation product of bivalirudin involves the deamidation of asparagine in position 9 to asp9-bivalirudin.” (Amsberry Abstract, DTX 1498 at MEDMYL0001675, 1677; see also Bischoff, DTX 1021 (“[n]on-enzymatic deamidation of asparagine (Asn) ... residues in peptides and proteins is a well-documented phenomenon which may occur under physiological conditions ...).) ii. The Disputed Prior Art a) Original Angiomax® Process is Prior Art Under § 102(b) Mylan argues that sales of the Original Angiomax® product prior to the critical date render the process used to make it a public process. (See R.553 at 16.) Mylan further argues that because the process was public, knowledge of the high Asp9 impurity levels and of TMC’s internal efforts to avoid high Asp9 levels by adjusting the compounding process were also public. (Id., at 17 (referencing TMC’s internal documents amending its compounding instructions for Original Angiomax® relating to equal addition of base).) Finally, Mylan contends that the person of ordinary skill would have been motivated to combine the attempt made by TMC to adjust its compounding process with the other prior art to arrive at the claimed invention. (Id. at 17.) Mylan relies on TorPharm, Inc. v. Ranbaxy Pharms., Inc., 336 F.3d 1322, 1326 (Fed.Cir.2003) and Dippin’ Dots, Inc. v. Mosey, 476 F.3d 1337, 1344-45 (Fed.Cir.2007) to assert that because TMC sold Original Angiomax® product one year before the ’727 patent was filed, the process by which Original Angiomax® was produced is public and, hence prior art under § 102(b). In both cases, the claims-at-issue were process claims and the Federal Circuit found because the product made by the claimed process was sold more than one year before the filing of the patent-in-suit, that sale rendered the process prior art under § 102(b), regardless of whether it was disclosed to the public or not. See TorPharm, 336 F.3d at 1326; Dippin’ Dots, 476 F.3d 1337, 1344-45 (Fed.Cir.2007) (emphasis added) (stating “[t]he public sale of goods produced by a process more than one year before a patent is filed places that process in the § 102(b) prior art”); see also D.L. Auld. Co. v. Chroma Graphics Corp., 714 F.2d 1144, 1147-48 (Fed.Cir.1983) (holding that “a party’s placing of a product of the method invention on sale more than a year before that party’s application filing date must act as a forfeiture of any right to the grant of a valid patent on the method to that party if circumvention of the policy animating § 102(b) is to be avoided in respect of patents on method inventions.”). The Court agrees with Mylan that the Original Angiomax® product, and the process by which it was made are prior art under § 102(b). The TorPharm case supports the Original Angiomax® product as “a reference under section 103 against the claimed invention” because it was sold before the ’727 patent’s critical date. See id., 336 F.3d at 1327 (explaining that the obviousness inquiry requires the district court to determine whether the Form 1 ranitidine of uncertain genesis sold in 1992, in conjunction with the prior art, rendered obvious TorPharm’s claimed process of crystallizing improved Form 1 ranitidine from a three- or four-carbon alcohol solvent.”). Because the Court has found that Original Angiomax® was sold before the ’727 patent’s critical date (see supra Discussion, II.A.2.a.), the Original Angio-max® product becomes a reference under § 103 against the claimed invention. The Dippin’ Dots case supports the premise that because the Original Angiomax® product was sold before the ’727 patent’s critical date, not only is the Original An-giomax® product prior art, but the process by which Original Angiomax® product was made is also prior art under the § 102(b) on-sale bar and “is also prior art for the purposes of obviousness under § 103.” See id., 476 F.3d at 1344. These cases, however, do not reach as far as Mylan contends. Namely, these cases do not stand for the proposition that everything TMC internally knew about the Original Angiomax® product and the process used to make it amounts to prior art under § 102(b). The claims at issue are directed to pharmaceutical batches of a product made by a compounding process that differs from the process used to make the Original Angiomax® product. In other words, the claims at issue in this case are not the process claims for production of Original Angiomax® like the claims presented in TorPharm. Nor are the claims at issue in this ease the exact process for production of Original Angiomax®, with additional steps recited, like the claims presented in Dippin’ Dots. Rather, the claims at issue here are directed to pharmaceutical batches of bivalirudin with maximum impurity levels of Asp9-bivaliru-din impurity of 0.5%. As such, the Court finds consistent with TorPharm and Dip-pin’ Dots, that the Original Angiomax® product and the process used to produce Original Angiomax® qualify as prior art for the purposes of obviousness under § 103. The Court does not find, however, that all of TMC’s internal efforts to avoid high Asp9 levels by adjusting the Angio-max® compounding process also become prior art, absent a showing that this knowledge was disclosed to the public. (See infra Discussion, II.B.2.a.ii.c).) The Court finds, therefore, that the person of ordinary skill in the art being aware of the Original Angiomax® product, knew bivalirudin to be a 20 amino acid peptide with an asparagine residue at the ninth position, and knew it was used as an anticoagulant. The Original Angiomax® product also taught that bivalirudin drug product was formulated as a dry, lyophilized cake and when reconstituted, the pH was adjusted with base (sodium hydroxide) to reach a pH of 5-6. The Original Angio-max® product was also known to be produced by a compounding process. The compounding process creates the final pharmaceutical product and involves three basic steps. First, the bivalirudin API is dissolved into a mannitol solution to form a bivalirudin solution. Second, the resulting bivalirudin solution is mixed with a pH-adjusting solution, such as sodium hydroxide, to raise the pH of the bivalirudin API to an acceptable level. Third, the mannitol solution and the pH-adjusting solution are removed from the mixture to form the final drug product. More specifically, the original manufacturing process for commercial batches of Original Angiomax® was disclosed in the ’727 patent as Example 4. (See PTX 1, col. 21:44-col. 22:27; Tr. 211:8-11; 285:6-14; 269:23 (Musso).) b) Portions of the Musso Trip Summary Are Prior Art Under § 102(f) Section 102(f) is a derivation provision which provides that a person shall be entitled to a patent unless “he did not himself invent the subject matter sought to be patented.” 35 U.S.C. § 102(f). Thus, § 102(f) “requires that the patentee be the actual inventor of the subject matter patented.” See New England Braiding Co., Inc. v. AW. Chesterton Co., 970 F.2d 878, 883 (Fed.Cir.1992). Mylan argues that “the July 14, 2006 communication from BVL employees to named inventor Musso” is prior art under 35 U.S.C. § 102(f).- (See R.553 at 17.) The Musso Trip Summary is an internal report prepared by Dr. Musso on July 15, 2006, summarizing a meeting that occurred at Ben Venue on July 14, 2006 “to followup on a recent failure of a bivalirudin batch due to high Asp9 levels (Limit NMT 1.5%).” (PTX 7.) TMC responds that in order to find-the Musso Trip Summary prior art under § 102(f), Mylan must prove by clear and convincing evidence “both prior conception of the invention by another and communication of the conception to the patentee.... ” (See R.560 at 6 (emphasis original).) TMC further argues that “[t]he communication must be sufficient to enable one of ordinary skill in the art to make the patented invention.” (Id.) TMC’s recited requirements, however, apply when a party is attempting to prove invalidity by derivation under § 102(f), not when a party is attempting to use the disclosure as prior art under § 102(f) in an obviousness analysis. See Creative Compounds, LLC v. Starmark Labs., 651 F.3d 1303, 1313 (Fed.Cir.2011) (citing Eaton Corp. v. Rockwell Int’l Corp., 323 F.3d 1332, 1344 (Fed.Cir.2003) (explaining that to prove derivation under § 102(f), a patent challenger must prove both prior conception of the invention by another and communication of that conception to the patentee by clear and convincing evidence); Galderma Labs, LP v. Paddock Labs, Inc., No. 2:09cv002Y, 2011 WL1119700, at *7 (N.D.Tex. March 28, 2011); see also Gambro Lundia AB v. Baxter Healthcare Corp., 110 F.3d 1573, 1577 (Fed.Cir.1997) (explaining the requirements of a showing of prior conception and an enabling disclosure for an anticipation argument of derivation under § 102(f) and emphasizing there is not a determination of obviousness in a § 102(f) analysis). Mylan relies on OddzOn Products, Inc. v. Just Toys, Inc., and its holding that “subject matter derived from another not only is itself unpatentable to the party who derived it under § 102(f), but, when combined with other prior art, may make a resulting obvious invention unpatentable to that party under a combination of §§ 102(f) and 103.” 122 F.3d 1396, 1403-04 (Fed.Cir.1997). In OddzOn, the Federal Circuit found that the district court did not err by considering confidential disclosures known to the inventor to be prior art under the combination of §§ 102(f) and 103. See id. at 1404; see also IGT v. Bally Gaming Int’l., Inc., 610 F.Supp.2d 288, 321 n. 24 (D.Del.2009) (referencing OddzOn’s holding that “§ 102(f) non-public subject matter can be used to reject a claim of invention by another in possession of the § 102(f) subject matter under a combination of § 102(f) and § 103”). The confidential disclosures in OddzOn were two design references provided to the inventor by another. 122 F.3d at 1403-04. The July 15, 2006 Musso Trip Summary, however, is not the same as the confidential disclosures in OddzOn, because it is not a disclosure provided to Dr. Musso from another. Instead, Dr. Musso prepared the report himself to memorialize the meeting with Ben Venue, and dated it the following day. (PTX 7; DTX 1246; Tr. 199:21-201:7 (Musso).) Mylan’s request that the “July 14, 2006 communication from BVL employees to named inventor Musso is prior art under § 102(f),” when the report is actually dated as prepared by Dr. Musso on July 15, 2006 is not a mistake on Mylan’s part, but rather reflects the complex nature of Mylan’s request. The Musso Trip Summary contains Dr. Musso’s recollection of discussions he had on July 14, 2006 with Ben Venue employees working with the bivalirudin batches for Original Angiomax® and TMC, discussions that addressed the recent failure of bivalirudin batches due to high Asp9 levels (i.e. levels beyond the 1.5% allowed for in the product specification). {See PTX 7.1.) As such, the report contains both summaries of information Ben Venue employees allegedly provided to Dr. Musso on July 14, 2006, as well as Dr. Musso’s own thoughts, reactions, and proposals experienced during and after that meeting. My-lan specifically advocates for consideration of the “July lk, 2006 communication from Ben Venue employees, to named inventor Musso” as prior art under § 102(f), and not consideration of the Musso Trip Summary in its entirety created on July 15, 2006. Employees of both TMC and Ben Venue, along with the inventor Dr. Musso, attended the July 14, 2006 meeting. (PTX 7; DTX 1245; Tr. 67:19-68:18 (Flammia); Tr. 200:6-202:19 (Musso); Smith Dep. 71:06-71:18, June 10, 2014.) Dr. Musso testified that the Musso Trip Summary was an accurate memorialization of what happened during the meeting. {See Tr. 200:6-201:11 (Musso).) Dr. Musso further testified that Ben Venue operators shared their experiences regarding the compounding process, and referred to the section of three bullet points in the report, shown below, which states: The operators shared their experience based comments which included: • Vary the stirrer heights so that one mixed the upper and one mixed the lower level of the tank • Increase the stir speed prior to base addition • Add base through a dip tube so that it is dispersed in the bottom of the tank where mixing is still possible (the marshmallow solid was suggested to be more on the top portion of the formulation). (PTX 7.2; Tr. 202:17-204:7 (Musso).) Dr. Musso also testified about the operators insights regarding the compounding process, and referred to the section of five bullet points in the report as referring to the Original Angiomax® compounding process, also described in Example 4 of the ’727 patent. (Tr. 261:263:8 (Musso).) The portion of the Musso Trip Summary that Dr. Musso testified contained the comments from the Ben Venue operators is shown below, and states: The two operators provided some interesting insights such as: • There is no safety issue with base addition, so stirring could be rapid in the base addition • They had no problem adding all the base at once (both operators appeared physically strong) • They do not recall shutting off the stirrers during base addition • They also commented that with the low speed stir, the mixture is like a “marshmallow” after 3/4 of the base addition and the stirrer is ineffective at low speed. • Under low speed mixing, the formulation is generally not stirred at the end of the addition as the solid mass is too thick. In a discussion of portion-wise addtion [sic] the operators also indicated that the last base addition just sat on top of the marshmallow and did not mix — similar to the comments related to viscosity discussion held previously. (PTX 7.2; Tr. 261:263:8 (Musso).) The evidence revealed that at some point later in the meeting when the participants were still discussing the issues, Ben Venue operators were no longer present. (Tr. 68:9-10 (Flammia); Tr. 264:10 (Musso).) Timothy Smith, Director of Product and Process Development at Ben Venue at the relevant time, also testified that he attended the meeting with TMC on July 14, 2006. (Smith Dep. 71:06-71:18; see Gezzar Dep. 89:14-89:25, January 18, 2013.) Mr. Smith testified that Ben Venue operators were asked to join the .meeting, identifying one of the operators by name. (Smith Dep. 73:08-73:19.) In response to questions from Mylan’s counsel regarding the Musso Trip Summary, Mr. Smith testified that he “presumed” what the document was referring to, but provided no testimony regarding whether the Ben Venue operators provided the recited information to Musso and TMC or whether the meeting participants discussed the recited information, and My-lan never asked. (See Smith Dep. 74:04-79:11.) Mylan’s scientific expert, Dr. Aus-lander, provided a eonclusory opinion regarding the Musso Trip Summary, but later conceded that without having attended the meeting, it was not possible for him to tell who had led the discussion, what dialogue took place, or the dynamic of the discussion (e.g., who asked who what), and that it would be speculation to attempt to know. (Tr. 1013:6-1017:13 (Auslander).) In fact, Dr. Musso testified that the cause of the high Asp9 failure was not identified at the meeting. (Tr. 201:19-21.) Dr. Mus-so farther stated that he and Dr. Krishna “came up with the ideas on how to fix and make the improved product. Ben Venue did not contribute to those inventions.” (Tr. 205:19-21.) Based on this record, and in particular on Dr. Musso’s testimony and the Musso Trip Summary itself (a document created by Dr. Musso very close to the date of communication with Ben Venue), Mylan has established by clear and convincing evidence that the two bulleted portions from the Musso Trip Summary cited above qualify as prior art under § 102(f) in a § 103 obviousness analysis. M