Overreaching in patent claims dooms Gevo in district court. No infringement because of estoppel and invalidity through lack of enablement.
A post at Biomass Mag on the latest Gevo/Butamax court decision includes the text:
According the SEC filing, the court ruling is not material to the business of Gevo and is not material to any of the company’s other pending litigation cases with Butamax.
A press release issued by Butamax notes that the court granted its summary judgment motion for invalidity of the [Gevo] ‘375 patent,
Hmmm, a ruling that claims of a U.S. patent to Gevo are invalid is "not material to the business of Gevo"? When the claims were obtained, did Gevo management tell stockholders that the allowed claims were "not material to the business of Gevo"?
The case in question is Civ. No. 13-576-SLR in the federal district court in Delaware and was decided on July 26, 2013. The Gevo patents in question were U.S. Patent Nos. 8,017,375 ("the '375 patent") and 8,017,376 ("the '376 patent").
As a first point, there was a ruling that Butamax did not infringe the claims. The argued points pertained to the "doctrine of equivalents" and Festo surrender. Gevo narrowed its claims during prosecution and thus lost out on doctrine of equivalents. As to a prosecution practice tip, initially claiming too broadly can hurt you later. The Gevo case is a poster child.
Of relevant law, the Delaware court noted:
For there to be infringement under the doctrine of equivalents, the accused product or process must embody every limitation of a claim, either literally or by an equivalent. Warner-Jenkinson, 520 U.S. at 41. An element is equivalent if the differences between the element [*22] and the claim limitation are "insubstantial." Zelinski v. Brunswick Corp., 185 F.3d 1311, 1316 (Fed. Cir. 1999). One test used to determine "insubstantiality" is whether the element performs substantially the same function in substantially the same way to obtain substantially the same result as the claim limitation. See Graver Tank & Mfg. Co. v. Linde Air Products Co., 339 U.S. 605, 608, 70 S. Ct. 854, 94 L. Ed. 1097, 1950 Dec. Comm'r Pat. 597 (1950). This test is commonly referred to as the "function-way-result" test. The mere showing that an accused device is equivalent overall to the claimed invention is insufficient to establish infringement under the doctrine of equivalents. The patent owner has the burden of proving infringement under the doctrine of equivalents and must meet its burden by a preponderance of the evidence. See SmithKline Diagnostics, Inc. v. Helena Lab. Corp., 859 F.2d 878, 889 (Fed. Cir. 1988) (citations omitted).
The doctrine of equivalents is limited by the doctrine of prosecution history estoppel. In Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., Ltd., 535 U.S. 722, 122 S. Ct. 1831, 152 L. Ed. 2d 944 (2002) ("Festo VII"), the Supreme Court stated:
Prosecution history estoppel ensures that the doctrine of equivalents remains tied to its underlying [*23] purpose. Where the original application once embraced the purported equivalent but the patentee narrowed his claims to obtain the patent or to protect its validity, the patentee cannot assert that he lacked the words to describe the subject matter in question. The doctrine of equivalents is premised on language's inability to capture the essence of innovation, but a prior application describing the precise element at issue undercuts that premise. In that instance the prosecution history has established that the inventor turned his attention to the subject matter in question, knew the words for both the broader and narrower claim, and affirmatively chose the latter.
Id. at 734-735. In other words, the prosecution history of a patent, as the public record of the patent proceedings, serves the important function of identifying the boundaries of the patentee's property rights. Once a patentee has narrowed the scope of a patent claim as a condition of receiving a patent, the patentee may not recapture the subject matter surrendered. In order for prosecution history estoppel to apply, however, there must be a deliberate and express surrender of subject matter. See Southwall Tech., Inc. v. Cardinal IG Co., 54 F.3d 1570, 1580 (Fed. Cir. 1995).
Once [*24] a court has determined that prosecution history estoppel applies, it must determine the scope of the estoppel. See id. This requires an objective examination into the reason for and nature of the surrendered subject matter. Id.; see also Augustine Med., Inc. v. Gaymar Indus., Inc., 181 F.3d 1291, 1299 (Fed. Cir. 1999). If one of ordinary skill in the art would consider the accused product to be surrendered subject matter, then the doctrine of equivalents cannot be used to claim infringement by the accused product; i.e., prosecution history estoppel necessarily applies. Augustine Med., 181 F.3d at 1298. In addition, a "patentee may not assert coverage of a 'trivial' variation of the distinguished prior art feature as an equivalent." Id. at 1299 (quoting Litton Sys., Inc. v. Honeywell, Inc., 140 F.3d 1449, 1454 (Fed. Cir. 1998)).
"[A] narrowing amendment made to satisfy any requirement of the Patent Act" creates a presumption that "the patentee surrendered all subject matter between the broader and the narrower language" and bars any equivalents. Festo VII., 535 U.S. at 736, 740; see also Honeywell Int'l, Inc. v. Hamilton Sundstrand, 370 F.3d 1131, 1139 (Fed. Cir. 2004) (prosecution history [*25] estoppel "bar[s] the patentee from asserting equivalents if the scope of the claims has been narrowed by an amendment during prosecution.").
Thus, a presumption of prosecution history estoppel is established by showing that the patentee made a narrowing amendment and that "the reason for that amendment was a substantial one relating to patentability." Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 344 F.3d 1359, 1366 (Fed. Cir. 2003) (en banc) ("Festo X"). There are three exceptions to this presumption: (1) the equivalent was "unforeseeable at the time of the narrowing amendment"; (2) the rationale for the amendment "bore no more than a tangential relation to the equivalent in question"; or (3) "some other reason suggested that the patentee could not reasonably have been expected to describe the alleged equivalent." Festo VII., 535 U.S. at 740-41.
Gevo did have a narrowing amendment:
Gevo initially had a broad claim covering the use of any enzyme to convert α-ketoisovalerate to isobutyraldehyde and a dependent claim specifying that the enzyme should be a 2-keto acid decarboxylase. 6 On March 28, 2011, the examiner rejected those claims as, inter alia, obvious over Donaldson and van Maris. 7 (11-54 [*27] D.I. 515 at GJA2525-27) Gevo argued in response that the L. lactis KIVD produced "unexpected results" and, on April 28, 2011, adopted the examiner's suggestion to narrow the claims to specifically recite an "α-ketoisovalerate decarboxylase from Lactococcus lactis." 8 (Id. at GJA2811-24) Gevo does not appear to dispute that it narrowed its claim through amendment, instead invoking the "unforseeability" exception to prosecution history estoppel. (D.I. 24 at 12) Indeed, the summary of Gevo's interview with the examiner on April 22, 2011, notes that Gevo "indicated that [it] would look into the possibility of broadening the scope of the genus of KIVDs. The [e]xaminer indicated that she would consider future amendments in that regard as well as arguments in support of a broader scope of the genus of KIVDs." (11-54 D.I. 515 at GJA2622)
Gevo lost on infringement of US '375 for a lot of reasons:
The court concludes that use of the L. grayi enzyme was not unforseeable. Therefore, Gevo cannot assert infringement of independent claim 1 through the application of the doctrine of equivalents for enzymes other than what it specifically claimed, i.e., an "α-ketoisovalerate decarboxylase from Lactococcus lactis." 14 Additionally, the court concludes that the doctrines of ensnarement and claim vitiation also preclude Gevo from asserting its equivalence argument. Although Gevo does not appear to concede the issue, Gevo does not argue that Butamax's use of the L. grayi enzyme literally infringes independent claim 1 of the '375 patent. For the foregoing reasons, the court grants Butamax's motion for summary judgment of non-infringement of the asserted claims 1-3 and 5-7 of the '375 patent.
Similarly, Gevo lost on infringement of US '376:
Similarly, the court concludes that Gevo's equivalence theory vitiates the claim limitation requiring overexpression of AFT, leading to the increase in Aft production. See Warner--Jenkinson, 520 U.S. at 39 n. 8 ("[I]f a theory of equivalence would entirely vitiate a particular claim element, partial or complete judgment should be rendered by the court."); see also Mirror Worlds, LLC v. Apple Inc., 692 F.3d 1351,1358 (Fed. Cir. 2012) ("an argument that the absence of a feature is equivalent to its presence" negates the doctrine of equivalents"); Planet Bingo, LLC v. GameTech Intern., Inc., 472 F.3d 1338, 1345 (Fed. Cir. 2006) (refusing to apply the doctrine of equivalents to change "before" to "after" in the claim limitation stating that it had "refused to apply the doctrine [of equivalents] in other cases where the accused device contained [*41] the antithesis of the claimed structure). Gevo concedes that the accused Butamax strains do not literally infringe the asserted claims of the '376 patent. (D.I. 24 at 36) Therefore, the court grants Butamax's motion for summary judgment of non-infringement of the asserted claims of the '376 patent.
Having lost on infringement, Gevo managed to get the claims of US '375 invalidated, so that the claims cannot be asserted against anyone.
As to the law:
The statutory basis for the enablement and written description requirements, 35 U.S.C. § 112 ¶1, provides in relevant part:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same . . . .
"The enablement requirement is met where one skilled in the art, having read the specification, could practice the invention without 'undue experimentation.'" Streck, Inc. v. Research & Diagnostic Systems, Inc., 665 F.3d 1269, 1288 (Fed. Cir. 2012) [*42] (citation omitted). "While every aspect of a generic claim certainly need not have been carried out by the inventor, or exemplified in the specification, reasonable detail must be provided in order to enable members of the public to understand and carry out the invention." Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1366 (Fed. Cir. 1997). The specification need not teach what is well known in the art. Id. (citing Hybritech v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1384 (Fed. Cir. 1986)). A reasonable amount of experimentation may be required, so long as such experimentation is not "undue." ALZA Corp. v. Andrx Pharms., Inc., 603 F.3d 935, 940 (Fed. Cir. 2010).
"Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations." Martek Biosciences Corp. v. Nutrinova, Inc., 579 F.3d 1363, 1378 (Fed. Cir. 2009) (citing In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988). The Federal Circuit has provided several factors that may be utilized in determining whether a disclosure would require undue experimentation: (1) the quantity of experimentation necessary; (2) the amount of direction [*43] or guidance disclosed in the patent; (3) the presence or absence of working examples in the patent; (4) the nature of the invention; (5) the state of the prior art; (6) the relative skill of those in the art; (7) the predictability of the art; and (8) the breadth of the claims. In re Wands, 858 F.2d at 737. These factors are sometimes referred to as the "Wands factors." A court need not consider every one of the Wands factors in its analysis, rather, a court is only required to consider those factors relevant to the facts of the case. See Streck, Inc., 665 F.3d at 1288 (citing Amgen, Inc. v. Chugai Pharm. Co., Ltd., 927 F.2d 1200, 1213 (Fed. Cir. 1991)).
A discrete, but related, inquiry considers the presence of inoperative embodiments and informs the enablement inquiry. National Recovery Techs. Inc. v. Magnetic Separation Sys., Inc., 166 F.3d 1190, 1196 (Fed. Cir. 1999). Pursuant to this inquiry, a claim is invalid for lack of enablement "if it reads on a significant number of inoperative embodiments." Crown Operations Int'l, Ltd. v. Solutia Inc., 289 F.3d 1367, 1381 (Fed. Cir. 2002) (internal citations omitted). The use of prophetic examples does not automatically make a patent non-enabling. [*44] The burden is on one challenging validity to show, by clear and convincing evidence, that the prophetic examples together with the other parts of the specification are not enabling. Atlas Powder Co. v. E.I. Du Pont de Nemours & Co., 750 F.2d 1569, 1577 (Fed. Cir. 1984).
The enablement requirement is a question of law based on underlying factual inquiries. See Green Edge Enters., LLC v. Rubber Mulch Etc., LLC, 620 F.3d 1287, 1298-99 (Fed. Cir. 2010) (citation omitted); Wands, 858 F.2d at 737. Enablement is determined as of the filing date of the patent application. In re '318 Patent Infringement Litigation, 583 F.3d 1317, 1323 (Fed. Cir. 2009) (citation omitted). The burden is on one challenging validity to show, by clear and convincing evidence, that the specification is not enabling. See Streck, Inc., 665 F.3d at 1288 (citation omitted).
A patent must also contain a written description of the invention. 35 U.S.C. § 112, ¶ 1. The written description requirement is separate and distinct from the enablement requirement. See Ariad Pharms., Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1351 (Fed. Cir. 2011). It ensures that "the patentee had possession of the claimed invention at the time of [*45] the application, i.e., that the patentee invented what is claimed." LizardTech, Inc. v. Earth Resource Mapping, Inc., 424 F.3d 1336, 1344-45 (Fed. Cir. 2005). The Federal Circuit has stated that the relevant inquiry -- "possession as shown in the disclosure" -- is an "objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art. Based on that inquiry, the specification must describe an invention understandable to that skilled artisan and show that the inventor actually invented the invention claimed." Ariad, 598 F.3d at 1351.
This inquiry is a question of fact: "the level of detail required to satisfy the written description requirement varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology." Id. (citation omitted). In this regard, Butamax must provide clear and convincing evidence that persons skilled in the art would not recognize in the disclosure a description of the claimed invention. See PowerOasis, Inc. v. T-Mobile USA, Inc., 522 F.3d 1299, 1306-07 (Fed. Cir. 2008) (citation omitted). While compliance with the written description requirement is a question of fact, the issue is "amenable to summary judgment in cases where no reasonable fact finder could return a verdict for the non-moving party." Id. at 1307 (citing Invitrogen Corp. v. Clontech Labs., Inc., 429 F.3d 1052, 1072-73 (Fed. Cir. 2005)).
The analysis by the district court:
The parties agree that the term "theoretical yield of . . . from glucose" in the '375 patent means "the maximum amount of product that can be produced from the total amount of glucose provided." Atsumi (2008) describes an experiment yielding 0.35 g isobutanol per g glucose, as 86% of theoretical maximum yield. 19 To calculate the theoretical yield, Atsumi (2008) divides the amount of glucose consumed by the cell by the theoretical maximum yield for isobutanol of 0.41 g isobutanol per g glucose. Id. at 87 & fig. 2. After reviewing the data provided in the patent application, the patent examiner suggested the amendments adding theoretical yield, based on calculations using the amount of glucose consumed by the cell. 20 (11-54 D.I. 515, GJA3018) Gevo's expert, Dr. Voigt, explains that yields are calculated in the art based on the amount of substrate consumed by the cell. (11-54 D.I. 620 at ¶¶ 20, 32) The court agrees. Consistent with the scientific literature cited in the '375 patent, the prosecution history, and Gevo's expert, "the total amount of glucose provided" is that consumed by the cell. 21 Based on this definition, the '375 patent specification provides examples of yields greater than 10%.
**Footnotes 19-21:
19 "Atsumi (2008)" is Shota Atsumi et. al, Non-Fermentative Pathways for Synthesis of Branched-Chain Higher Alcohols as Biofuels, 451 Nature, 86-89, 87, fig. 2 (2008). The theoretical maximum yield for isobutanol is 0.41 g isobutanol per g glucose. Id. at fig. 2.
20 While the court may accord some deference to an examiner's reasoning, that the examiner proposed the language of the claim is not dispositive of the validity issue. Microsoft Corp. v. i4i Ltd. P'ship, ___ U.S. ___, 131 S. Ct. 2238, 2251-52, 180 L. Ed. 2d 131 (2011). Here, the examiner's reasoning does not clarify that the factual issues underlying Butamax's defense were considered, therefore, the court independently evaluates the invalidity arguments without deference.
21 Butamax argues that "the total amount of glucose provided" is that provided to the system or media. (D.I. 16 at 11-12) Dr. Henry calculates the yield based on the media used in the examples, which contain 20 g/L [*48] of glucose. Dr. Henry notes that, at a certain growth, "glucose was added to a concentration of 5%," which serves to increase "the total amount of glucose provided and renders the reported isobutanol yields even further from the claimed 10% theoretical yields." (11-54 D.I. 594, ex. 3 at ¶¶ 79-80, n.10) Using the amount of glucose provided to the media renders this measurement arbitrary, as this amount could be increased or decreased as needed to achieve desired yields.
***
Butamax argues that the patent is invalid for lack of written description and enablement as it does not support the claimed high yields of greater than 50% up to greater than 97.5%, asserting that "undue experimentation" would be required to achieve these high theoretical yields. 22 (D.I. 16 at 14-16; '375 patent, 24:21-45) These yields are far beyond the inventor's highest actual obtained yield of 12.8%. 23 (D.I. 16 at 15; '375 patent, tbl. EX8A-2) Gevo's expert, Dr. Voigt, opines that a person of ordinary skill in the art would look to the specification and examples, which provide a path for achieving the higher yields. (11-54 D.I. 620 at ¶¶ 84-91) Dr. Papoutsakis also testified that one could optimize the process to potentially achieve the higher yields. (11-54 D.I. 619, ex. 110 at 109:11-110:24) On the other hand, Butamax's expert, Dr. Henry, avers that the application fails to teach one of ordinary skill in the art how to obtain recombinant yeast microorganisms capable of producing isobutanol at the upper end of the theoretical yields. (11-54 D.I. 594 at ¶ 87) Additionally, there have been no reports before or after the issuance of the '375 patent of yeast organisms producing isobutanol at theoretical yields of up to 90%. (Id. at ¶ 88, 92)
The bottom line:
As to written description, the court concludes that Butamax has shown, by clear and convincing evidence, that persons skilled in the art would not recognize in the disclosure a description of the higher yields of the claimed invention. The parties' experts agree that the technology at issue is both complex and unpredictable. (See e.g., 11-54 D.I. 619, ex. 110 at 109:24-110:7, 127:2-128:12; 11-54 D.I. 594, ex. 3 at ¶ 87) The specification provides no detail on how to practice claim 1 to achieve higher yields.
As to the validity challenge to US '376, although Butamax did not get summary judgment, Gevo lost a key point on priority:
Turning to the '376 patent, Gevo argues that the disclosure of U.S. Provisional Application No. 61/263,952 ("the '952 application") provides support for the claims of the later issued '376 patent. (D.I. 20 at 29) The parties do not dispute that the '952 application discloses only recombinant yeast microorganisms overexpressing cytosolically localized DHAD. (11-54 D.I. 643, ex 67 at ¶ 31; see also D.I. 594, ex. 8 at ¶ 87; D.I. 26 at 8; 11-54 D.I. 618 at ¶ 28 & ex. B) The parties apparently disagree over whether the disclosures of the '376 patent are commensurate, thus allowing the '376 patent to claim priority to the '952 application. The '376 patent specification references both "cytosolically localized DHAD enzyme" and "mitochondrially localized DHAD enzyme" throughout. (See e.g. '376 patent, abstract, 21:10-14, 24:40-45) Of the asserted claims, only dependent claim 9 recites a location for DHAD in the cytosol. 27 Given the above, the court concludes that the '952 application lacks written description to support the claims of the '376 patent. This precludes the '376 patent from claiming priority to the '952 application.
IPBiz had seen this one coming. From the IPBiz post titled Re-examination of Gevo's US Patent 8,017,376 :
As to the re-examination of Gevo's US Patent, 8,017,376 [inter partes re-exam 95/001,870 ], there was an Action on March 23, 2012. Therein, claims 1-8, 10-15, and 17-20 were rejected. One basis of rejection was 102(e) over the disclosure within WO 2011/103300 ("Flint"). This document was NOT of record during the prosecution of Gevo's '376 patent. The Flint application (PCT/US2011/025258, rights assigned to Butamax) claims priority to US provisional 61/305,333, filed 17 Feb. 2010. However, Gevo's '376 patent claims priority to U.S. Provisional Application Ser. No. 61/263,952, filed Nov. 24, 2009, and U.S. Provisional Application Ser. No. 61/350,209, filed Jun. 1, 2010. Among other things, the contents of provisional 61/263,952 will be important to this re-exam, and that analysis involves simply reading the provisional application.
On April 12, 2012, Gevo requested an extension of time to respond by June 25, 2012, primarily because of time obligations of one of the inventors, Andrew Hawkins. The time extension request was granted. The request brought up the possibility of swearing behind the 102(e) rejection.
**As a separate matter, a patentee's arguments "for" enablement can have adverse consequences in defending against obviousness.
According the SEC filing, the court ruling is not material to the business of Gevo and is not material to any of the company’s other pending litigation cases with Butamax.
A press release issued by Butamax notes that the court granted its summary judgment motion for invalidity of the [Gevo] ‘375 patent,
Hmmm, a ruling that claims of a U.S. patent to Gevo are invalid is "not material to the business of Gevo"? When the claims were obtained, did Gevo management tell stockholders that the allowed claims were "not material to the business of Gevo"?
The case in question is Civ. No. 13-576-SLR in the federal district court in Delaware and was decided on July 26, 2013. The Gevo patents in question were U.S. Patent Nos. 8,017,375 ("the '375 patent") and 8,017,376 ("the '376 patent").
As a first point, there was a ruling that Butamax did not infringe the claims. The argued points pertained to the "doctrine of equivalents" and Festo surrender. Gevo narrowed its claims during prosecution and thus lost out on doctrine of equivalents. As to a prosecution practice tip, initially claiming too broadly can hurt you later. The Gevo case is a poster child.
Of relevant law, the Delaware court noted:
For there to be infringement under the doctrine of equivalents, the accused product or process must embody every limitation of a claim, either literally or by an equivalent. Warner-Jenkinson, 520 U.S. at 41. An element is equivalent if the differences between the element [*22] and the claim limitation are "insubstantial." Zelinski v. Brunswick Corp., 185 F.3d 1311, 1316 (Fed. Cir. 1999). One test used to determine "insubstantiality" is whether the element performs substantially the same function in substantially the same way to obtain substantially the same result as the claim limitation. See Graver Tank & Mfg. Co. v. Linde Air Products Co., 339 U.S. 605, 608, 70 S. Ct. 854, 94 L. Ed. 1097, 1950 Dec. Comm'r Pat. 597 (1950). This test is commonly referred to as the "function-way-result" test. The mere showing that an accused device is equivalent overall to the claimed invention is insufficient to establish infringement under the doctrine of equivalents. The patent owner has the burden of proving infringement under the doctrine of equivalents and must meet its burden by a preponderance of the evidence. See SmithKline Diagnostics, Inc. v. Helena Lab. Corp., 859 F.2d 878, 889 (Fed. Cir. 1988) (citations omitted).
The doctrine of equivalents is limited by the doctrine of prosecution history estoppel. In Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., Ltd., 535 U.S. 722, 122 S. Ct. 1831, 152 L. Ed. 2d 944 (2002) ("Festo VII"), the Supreme Court stated:
Prosecution history estoppel ensures that the doctrine of equivalents remains tied to its underlying [*23] purpose. Where the original application once embraced the purported equivalent but the patentee narrowed his claims to obtain the patent or to protect its validity, the patentee cannot assert that he lacked the words to describe the subject matter in question. The doctrine of equivalents is premised on language's inability to capture the essence of innovation, but a prior application describing the precise element at issue undercuts that premise. In that instance the prosecution history has established that the inventor turned his attention to the subject matter in question, knew the words for both the broader and narrower claim, and affirmatively chose the latter.
Id. at 734-735. In other words, the prosecution history of a patent, as the public record of the patent proceedings, serves the important function of identifying the boundaries of the patentee's property rights. Once a patentee has narrowed the scope of a patent claim as a condition of receiving a patent, the patentee may not recapture the subject matter surrendered. In order for prosecution history estoppel to apply, however, there must be a deliberate and express surrender of subject matter. See Southwall Tech., Inc. v. Cardinal IG Co., 54 F.3d 1570, 1580 (Fed. Cir. 1995).
Once [*24] a court has determined that prosecution history estoppel applies, it must determine the scope of the estoppel. See id. This requires an objective examination into the reason for and nature of the surrendered subject matter. Id.; see also Augustine Med., Inc. v. Gaymar Indus., Inc., 181 F.3d 1291, 1299 (Fed. Cir. 1999). If one of ordinary skill in the art would consider the accused product to be surrendered subject matter, then the doctrine of equivalents cannot be used to claim infringement by the accused product; i.e., prosecution history estoppel necessarily applies. Augustine Med., 181 F.3d at 1298. In addition, a "patentee may not assert coverage of a 'trivial' variation of the distinguished prior art feature as an equivalent." Id. at 1299 (quoting Litton Sys., Inc. v. Honeywell, Inc., 140 F.3d 1449, 1454 (Fed. Cir. 1998)).
"[A] narrowing amendment made to satisfy any requirement of the Patent Act" creates a presumption that "the patentee surrendered all subject matter between the broader and the narrower language" and bars any equivalents. Festo VII., 535 U.S. at 736, 740; see also Honeywell Int'l, Inc. v. Hamilton Sundstrand, 370 F.3d 1131, 1139 (Fed. Cir. 2004) (prosecution history [*25] estoppel "bar[s] the patentee from asserting equivalents if the scope of the claims has been narrowed by an amendment during prosecution.").
Thus, a presumption of prosecution history estoppel is established by showing that the patentee made a narrowing amendment and that "the reason for that amendment was a substantial one relating to patentability." Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 344 F.3d 1359, 1366 (Fed. Cir. 2003) (en banc) ("Festo X"). There are three exceptions to this presumption: (1) the equivalent was "unforeseeable at the time of the narrowing amendment"; (2) the rationale for the amendment "bore no more than a tangential relation to the equivalent in question"; or (3) "some other reason suggested that the patentee could not reasonably have been expected to describe the alleged equivalent." Festo VII., 535 U.S. at 740-41.
Gevo did have a narrowing amendment:
Gevo initially had a broad claim covering the use of any enzyme to convert α-ketoisovalerate to isobutyraldehyde and a dependent claim specifying that the enzyme should be a 2-keto acid decarboxylase. 6 On March 28, 2011, the examiner rejected those claims as, inter alia, obvious over Donaldson and van Maris. 7 (11-54 [*27] D.I. 515 at GJA2525-27) Gevo argued in response that the L. lactis KIVD produced "unexpected results" and, on April 28, 2011, adopted the examiner's suggestion to narrow the claims to specifically recite an "α-ketoisovalerate decarboxylase from Lactococcus lactis." 8 (Id. at GJA2811-24) Gevo does not appear to dispute that it narrowed its claim through amendment, instead invoking the "unforseeability" exception to prosecution history estoppel. (D.I. 24 at 12) Indeed, the summary of Gevo's interview with the examiner on April 22, 2011, notes that Gevo "indicated that [it] would look into the possibility of broadening the scope of the genus of KIVDs. The [e]xaminer indicated that she would consider future amendments in that regard as well as arguments in support of a broader scope of the genus of KIVDs." (11-54 D.I. 515 at GJA2622)
Gevo lost on infringement of US '375 for a lot of reasons:
The court concludes that use of the L. grayi enzyme was not unforseeable. Therefore, Gevo cannot assert infringement of independent claim 1 through the application of the doctrine of equivalents for enzymes other than what it specifically claimed, i.e., an "α-ketoisovalerate decarboxylase from Lactococcus lactis." 14 Additionally, the court concludes that the doctrines of ensnarement and claim vitiation also preclude Gevo from asserting its equivalence argument. Although Gevo does not appear to concede the issue, Gevo does not argue that Butamax's use of the L. grayi enzyme literally infringes independent claim 1 of the '375 patent. For the foregoing reasons, the court grants Butamax's motion for summary judgment of non-infringement of the asserted claims 1-3 and 5-7 of the '375 patent.
Similarly, Gevo lost on infringement of US '376:
Similarly, the court concludes that Gevo's equivalence theory vitiates the claim limitation requiring overexpression of AFT, leading to the increase in Aft production. See Warner--Jenkinson, 520 U.S. at 39 n. 8 ("[I]f a theory of equivalence would entirely vitiate a particular claim element, partial or complete judgment should be rendered by the court."); see also Mirror Worlds, LLC v. Apple Inc., 692 F.3d 1351,1358 (Fed. Cir. 2012) ("an argument that the absence of a feature is equivalent to its presence" negates the doctrine of equivalents"); Planet Bingo, LLC v. GameTech Intern., Inc., 472 F.3d 1338, 1345 (Fed. Cir. 2006) (refusing to apply the doctrine of equivalents to change "before" to "after" in the claim limitation stating that it had "refused to apply the doctrine [of equivalents] in other cases where the accused device contained [*41] the antithesis of the claimed structure). Gevo concedes that the accused Butamax strains do not literally infringe the asserted claims of the '376 patent. (D.I. 24 at 36) Therefore, the court grants Butamax's motion for summary judgment of non-infringement of the asserted claims of the '376 patent.
Having lost on infringement, Gevo managed to get the claims of US '375 invalidated, so that the claims cannot be asserted against anyone.
As to the law:
The statutory basis for the enablement and written description requirements, 35 U.S.C. § 112 ¶1, provides in relevant part:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same . . . .
"The enablement requirement is met where one skilled in the art, having read the specification, could practice the invention without 'undue experimentation.'" Streck, Inc. v. Research & Diagnostic Systems, Inc., 665 F.3d 1269, 1288 (Fed. Cir. 2012) [*42] (citation omitted). "While every aspect of a generic claim certainly need not have been carried out by the inventor, or exemplified in the specification, reasonable detail must be provided in order to enable members of the public to understand and carry out the invention." Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1366 (Fed. Cir. 1997). The specification need not teach what is well known in the art. Id. (citing Hybritech v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1384 (Fed. Cir. 1986)). A reasonable amount of experimentation may be required, so long as such experimentation is not "undue." ALZA Corp. v. Andrx Pharms., Inc., 603 F.3d 935, 940 (Fed. Cir. 2010).
"Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations." Martek Biosciences Corp. v. Nutrinova, Inc., 579 F.3d 1363, 1378 (Fed. Cir. 2009) (citing In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988). The Federal Circuit has provided several factors that may be utilized in determining whether a disclosure would require undue experimentation: (1) the quantity of experimentation necessary; (2) the amount of direction [*43] or guidance disclosed in the patent; (3) the presence or absence of working examples in the patent; (4) the nature of the invention; (5) the state of the prior art; (6) the relative skill of those in the art; (7) the predictability of the art; and (8) the breadth of the claims. In re Wands, 858 F.2d at 737. These factors are sometimes referred to as the "Wands factors." A court need not consider every one of the Wands factors in its analysis, rather, a court is only required to consider those factors relevant to the facts of the case. See Streck, Inc., 665 F.3d at 1288 (citing Amgen, Inc. v. Chugai Pharm. Co., Ltd., 927 F.2d 1200, 1213 (Fed. Cir. 1991)).
A discrete, but related, inquiry considers the presence of inoperative embodiments and informs the enablement inquiry. National Recovery Techs. Inc. v. Magnetic Separation Sys., Inc., 166 F.3d 1190, 1196 (Fed. Cir. 1999). Pursuant to this inquiry, a claim is invalid for lack of enablement "if it reads on a significant number of inoperative embodiments." Crown Operations Int'l, Ltd. v. Solutia Inc., 289 F.3d 1367, 1381 (Fed. Cir. 2002) (internal citations omitted). The use of prophetic examples does not automatically make a patent non-enabling. [*44] The burden is on one challenging validity to show, by clear and convincing evidence, that the prophetic examples together with the other parts of the specification are not enabling. Atlas Powder Co. v. E.I. Du Pont de Nemours & Co., 750 F.2d 1569, 1577 (Fed. Cir. 1984).
The enablement requirement is a question of law based on underlying factual inquiries. See Green Edge Enters., LLC v. Rubber Mulch Etc., LLC, 620 F.3d 1287, 1298-99 (Fed. Cir. 2010) (citation omitted); Wands, 858 F.2d at 737. Enablement is determined as of the filing date of the patent application. In re '318 Patent Infringement Litigation, 583 F.3d 1317, 1323 (Fed. Cir. 2009) (citation omitted). The burden is on one challenging validity to show, by clear and convincing evidence, that the specification is not enabling. See Streck, Inc., 665 F.3d at 1288 (citation omitted).
A patent must also contain a written description of the invention. 35 U.S.C. § 112, ¶ 1. The written description requirement is separate and distinct from the enablement requirement. See Ariad Pharms., Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1351 (Fed. Cir. 2011). It ensures that "the patentee had possession of the claimed invention at the time of [*45] the application, i.e., that the patentee invented what is claimed." LizardTech, Inc. v. Earth Resource Mapping, Inc., 424 F.3d 1336, 1344-45 (Fed. Cir. 2005). The Federal Circuit has stated that the relevant inquiry -- "possession as shown in the disclosure" -- is an "objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art. Based on that inquiry, the specification must describe an invention understandable to that skilled artisan and show that the inventor actually invented the invention claimed." Ariad, 598 F.3d at 1351.
This inquiry is a question of fact: "the level of detail required to satisfy the written description requirement varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology." Id. (citation omitted). In this regard, Butamax must provide clear and convincing evidence that persons skilled in the art would not recognize in the disclosure a description of the claimed invention. See PowerOasis, Inc. v. T-Mobile USA, Inc., 522 F.3d 1299, 1306-07 (Fed. Cir. 2008) (citation omitted). While compliance with the written description requirement is a question of fact, the issue is "amenable to summary judgment in cases where no reasonable fact finder could return a verdict for the non-moving party." Id. at 1307 (citing Invitrogen Corp. v. Clontech Labs., Inc., 429 F.3d 1052, 1072-73 (Fed. Cir. 2005)).
The analysis by the district court:
The parties agree that the term "theoretical yield of . . . from glucose" in the '375 patent means "the maximum amount of product that can be produced from the total amount of glucose provided." Atsumi (2008) describes an experiment yielding 0.35 g isobutanol per g glucose, as 86% of theoretical maximum yield. 19 To calculate the theoretical yield, Atsumi (2008) divides the amount of glucose consumed by the cell by the theoretical maximum yield for isobutanol of 0.41 g isobutanol per g glucose. Id. at 87 & fig. 2. After reviewing the data provided in the patent application, the patent examiner suggested the amendments adding theoretical yield, based on calculations using the amount of glucose consumed by the cell. 20 (11-54 D.I. 515, GJA3018) Gevo's expert, Dr. Voigt, explains that yields are calculated in the art based on the amount of substrate consumed by the cell. (11-54 D.I. 620 at ¶¶ 20, 32) The court agrees. Consistent with the scientific literature cited in the '375 patent, the prosecution history, and Gevo's expert, "the total amount of glucose provided" is that consumed by the cell. 21 Based on this definition, the '375 patent specification provides examples of yields greater than 10%.
**Footnotes 19-21:
19 "Atsumi (2008)" is Shota Atsumi et. al, Non-Fermentative Pathways for Synthesis of Branched-Chain Higher Alcohols as Biofuels, 451 Nature, 86-89, 87, fig. 2 (2008). The theoretical maximum yield for isobutanol is 0.41 g isobutanol per g glucose. Id. at fig. 2.
20 While the court may accord some deference to an examiner's reasoning, that the examiner proposed the language of the claim is not dispositive of the validity issue. Microsoft Corp. v. i4i Ltd. P'ship, ___ U.S. ___, 131 S. Ct. 2238, 2251-52, 180 L. Ed. 2d 131 (2011). Here, the examiner's reasoning does not clarify that the factual issues underlying Butamax's defense were considered, therefore, the court independently evaluates the invalidity arguments without deference.
21 Butamax argues that "the total amount of glucose provided" is that provided to the system or media. (D.I. 16 at 11-12) Dr. Henry calculates the yield based on the media used in the examples, which contain 20 g/L [*48] of glucose. Dr. Henry notes that, at a certain growth, "glucose was added to a concentration of 5%," which serves to increase "the total amount of glucose provided and renders the reported isobutanol yields even further from the claimed 10% theoretical yields." (11-54 D.I. 594, ex. 3 at ¶¶ 79-80, n.10) Using the amount of glucose provided to the media renders this measurement arbitrary, as this amount could be increased or decreased as needed to achieve desired yields.
***
Butamax argues that the patent is invalid for lack of written description and enablement as it does not support the claimed high yields of greater than 50% up to greater than 97.5%, asserting that "undue experimentation" would be required to achieve these high theoretical yields. 22 (D.I. 16 at 14-16; '375 patent, 24:21-45) These yields are far beyond the inventor's highest actual obtained yield of 12.8%. 23 (D.I. 16 at 15; '375 patent, tbl. EX8A-2) Gevo's expert, Dr. Voigt, opines that a person of ordinary skill in the art would look to the specification and examples, which provide a path for achieving the higher yields. (11-54 D.I. 620 at ¶¶ 84-91) Dr. Papoutsakis also testified that one could optimize the process to potentially achieve the higher yields. (11-54 D.I. 619, ex. 110 at 109:11-110:24) On the other hand, Butamax's expert, Dr. Henry, avers that the application fails to teach one of ordinary skill in the art how to obtain recombinant yeast microorganisms capable of producing isobutanol at the upper end of the theoretical yields. (11-54 D.I. 594 at ¶ 87) Additionally, there have been no reports before or after the issuance of the '375 patent of yeast organisms producing isobutanol at theoretical yields of up to 90%. (Id. at ¶ 88, 92)
The bottom line:
As to written description, the court concludes that Butamax has shown, by clear and convincing evidence, that persons skilled in the art would not recognize in the disclosure a description of the higher yields of the claimed invention. The parties' experts agree that the technology at issue is both complex and unpredictable. (See e.g., 11-54 D.I. 619, ex. 110 at 109:24-110:7, 127:2-128:12; 11-54 D.I. 594, ex. 3 at ¶ 87) The specification provides no detail on how to practice claim 1 to achieve higher yields.
As to the validity challenge to US '376, although Butamax did not get summary judgment, Gevo lost a key point on priority:
Turning to the '376 patent, Gevo argues that the disclosure of U.S. Provisional Application No. 61/263,952 ("the '952 application") provides support for the claims of the later issued '376 patent. (D.I. 20 at 29) The parties do not dispute that the '952 application discloses only recombinant yeast microorganisms overexpressing cytosolically localized DHAD. (11-54 D.I. 643, ex 67 at ¶ 31; see also D.I. 594, ex. 8 at ¶ 87; D.I. 26 at 8; 11-54 D.I. 618 at ¶ 28 & ex. B) The parties apparently disagree over whether the disclosures of the '376 patent are commensurate, thus allowing the '376 patent to claim priority to the '952 application. The '376 patent specification references both "cytosolically localized DHAD enzyme" and "mitochondrially localized DHAD enzyme" throughout. (See e.g. '376 patent, abstract, 21:10-14, 24:40-45) Of the asserted claims, only dependent claim 9 recites a location for DHAD in the cytosol. 27 Given the above, the court concludes that the '952 application lacks written description to support the claims of the '376 patent. This precludes the '376 patent from claiming priority to the '952 application.
IPBiz had seen this one coming. From the IPBiz post titled Re-examination of Gevo's US Patent 8,017,376 :
As to the re-examination of Gevo's US Patent, 8,017,376 [inter partes re-exam 95/001,870 ], there was an Action on March 23, 2012. Therein, claims 1-8, 10-15, and 17-20 were rejected. One basis of rejection was 102(e) over the disclosure within WO 2011/103300 ("Flint"). This document was NOT of record during the prosecution of Gevo's '376 patent. The Flint application (PCT/US2011/025258, rights assigned to Butamax) claims priority to US provisional 61/305,333, filed 17 Feb. 2010. However, Gevo's '376 patent claims priority to U.S. Provisional Application Ser. No. 61/263,952, filed Nov. 24, 2009, and U.S. Provisional Application Ser. No. 61/350,209, filed Jun. 1, 2010. Among other things, the contents of provisional 61/263,952 will be important to this re-exam, and that analysis involves simply reading the provisional application.
On April 12, 2012, Gevo requested an extension of time to respond by June 25, 2012, primarily because of time obligations of one of the inventors, Andrew Hawkins. The time extension request was granted. The request brought up the possibility of swearing behind the 102(e) rejection.
**As a separate matter, a patentee's arguments "for" enablement can have adverse consequences in defending against obviousness.
posted by Lawrence B. Ebert at 8:36 AM
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