Fresh From the Bench: Precedential Patent Cases From the Federal Circuit
By Peter E. Heuser, Devon Zastrow Newman and Micah Stolowitz
Columbia University – The panel affirms the claim construction and the judgment of noninfringement as to several Columbia patents directed to detecting malicious executable email attachments. However, the panel reverses the district court's construction as to other patents in suit and remands for a determination of infringement under the proper construction, giving Columbia another chance to prevail on its claim against Symantec, with whom it had been collaborating to develop such systems.
What is most interesting about the opinion is the language noting that the patent specification is often the best guide to the meaning of a disputed claim term, instead of using the plain meaning of the terms in the claims. In so holding, the panel rejects Columbia's argument that the plain meaning of the term must be used unless the patentee expressly redefined the term or expressly disavowed some aspect of its scope. Instead, the panel holds that district courts need only look for any implication of redefinition or disavowal. This opinion, written by Chief Judge Prost, is difficult to reconcile with recent decisions holding that disavowal must be "both clear and unmistakable" in order to be limiting. See, for example , Avid Technology, Inc. v. Harmonic, Inc., 2016 U.S. App. LEXIS 1439 (Fed. Cir. Jan. 29, 2016) by a different panel of the court.
Purdue – This appeal arises from ANDA filings involving reformulated versions of the pain reliever OxyContin®, which, in 2012, made up almost one-third of the U.S. market for prescription painkillers. Purdue Pharma and Grunenthal GmbH asserted a number of patents against Teva and other pharma companies that had filed ANDAs seeking to sell generic versions of OxyContin. The S.D.N.Y. conducted a bench trial in the Teva case and found all of the asserted claims invalid. It then dismissed the cases against the other defendants based on collateral estoppel. This appeal followed and the Circuit affirms, noting that "the manner in which the invention was made" is, by statute, not relevant, and the objective indicia fail to support nonobviousness. In affirming the case, the panel holds that the district court did not err in disregarding process limitations in product-by-process claims since the focus of such claims must be the product, not the process of making it. Finally the panel rejects the argument that it was impermissible for the district court to pick and choose among the teachings of a reference since the examples within the reference are all "directly related" to one another.
TriVascular – The panel affirms a determination of nonobviousness in an appeal of an IPR involving a patent directed to a vascular stent. After instituting the IPR, the Board concluded in its final decision that TriVascular had failed to prove the claims invalid. On appeal, TriVascular argued that the construction of the claim term "circumferential ridges" was incorrect but the panel disagrees, concluding that the plain meaning, specification and a general purpose dictionary all support the Board's construction. The panel rejects TriVascular's dictionary definition making reference to the Blue Ridge Mountains as being unrelated to the claimed topic, and rules that there was not a "clear and unmistakable" disclaimer in the prosecution history that would have been evident to one skilled in the art.
As to obviousness, TriVascular argued that one skilled in the art would have been motivated to replace the barbs of one reference with the gripping protuberances of another but the panel disagrees, ruling that the proposed substitution would destroy the basic purpose for the barbs. TriVascular also argued that the Board should not have changed its institution position as to obviousness without clearly explaining why it had done so. But the panel notes that there is a significant difference between a petitioner's burden to establish "a reasonable likelihood of success" at institution, and actually proving invalidity by a preponderance of the evidence at trial.
TriReme – The Circuit reverses dismissal for lack of standing a suit to add an inventor under Section 256, and remands to resolve factual issues. TriReme claimed to have rights in the patents by assignment from an unnamed inventor, Dr. Lotan, and AngioScore defended that it had acquired all of Dr. Lotan's rights under a Consulting Agreement prior to the assignment to TriReme.
Trustees of Columbia University v. Symantec Corp. , Fed. Cir. Case 2015-1146 (February 2, 2016)
Columbia appeals from a claim construction order and subsequent partial final judgment of non-infringement and invalidity with respect to claims of six of its patents. The district court correctly construed the terms "byte sequence feature" and "probabilistic model of normal computer system usage" and therefore affirms the district court's judgment of non-infringement as to four of the patents. We also affirm the judgment of the district court finding claims 1 and 16 of the '544 patent indefinite. However, we find that the court incorrectly construed the term "anomalous" by requiring the model of normal computer usage be built only with "typical, attack free data." Because we reverse claim construction as to two of the patents, we remand for further proceedings with respect to the asserted claims of those patents.
The Panel Rejects the Contention That There Is a Heavy Presumption That Claim Terms Carry Their Accustomed Meaning, Only to Be Overcome If the Patentee Has Expressly Defined or Disavowed
Claim construction requires a determination as to how a person of ordinary skill in the art would understand a claim term "in the context of the entire patent, including the specification." Phillips v. AWH Corp. , 415 F.3d 1303 (Fed. Cir. 2005) (en banc). We begin a claim construction analysis by considering the language of the claims themselves. Id . However, "claims must be read in view of the specification, of which they are a part." Id . The specification is the "single best guide to the meaning of a disputed term," Vitronics Corp. v. Conceptronic, Inc. , 90 F.3d 1576 (Fed. Cir. 1996), and "is, thus, the primary basis for construing the claims." Phillips . A court should also consider the patent's prosecution history, and may rely on dictionary definitions, "so long as the dictionary definition does not contradict any definition found in or ascertained by a reading of the patent documents." Id .
Columbia argues that "there is a heavy presumption that claim terms carry their accustomed meaning in the relevant community at the relevant time" which can only be "overcome in only two circumstances: the patentee has expressly defined a term or has expressly disavowed the full scope of the claim." For this proposition, it cites to several recent cases including Thorner v. Sony Computer Entertainment America LLC , 669 F.3d 1362 (Fed. Cir. 2012), a case where we stated that "it is not enough for a patentee to simply disclose a single embodiment or use a word in the same manner in all embodiments, the patentee must clearly express an intent to redefine the term" and that "the standard for disavowal of claim scope is similarly exacting."
Our case law does not require explicit redefinition or disavowal. See, e.g., Aventis Pharma S.A. v. Hospira, Inc. , 675 F.3d 1324 (Fed. Cir. 2012) ("This clear expression need not be in haec verba but may be inferred from clear limiting descriptions of the invention in the specification or prosecution history."). Indeed, our en banc Phillips opinion rejected this very approach. In Phillips , we rejected a line of cases following Texas Digital Systems, Inc. v. Telegenix, Inc. , where we held that "terms used in the claims bear a 'heavy presumption' that they . . have the ordinary meaning that would be attributed to those words by persons skilled in the relevant art and, unless compelled otherwise, a court will give a claim term the full range of its ordinary meaning." Specifically, Phillips rejected an approach "in which the specification should be consulted only after a determination is made, whether based on a dictionary, treatise, or other source, as to the ordinary meaning or meanings of the claim term in dispute." As Phillips carefully explained, such an approach "improperly restricts the role of the specification in claim construction" to determining "whether the presumption in favor of the dictionary definition of the claim term has been overcome by an explicit definition of the term different from its ordinary meaning, or whether the inventor has disavowed or disclaimed scope of coverage." "The specification is always highly relevant to the claim construction analysis" and is, in fact "the single best guide to the meaning of a disputed term." Id .
Phillips makes clear that "the claims . . . do not stand alone. Rather they are part of a fully integrated written instrument, consisting principally of a specification that concludes with the claims." The only meaning that matters in claim construction is the meaning in the context of the patent. See id . (quoting Netword, LLC v. Centraal Corp. , 242 F.3d 1347 (Fed. Cir. 2001) ("The claims are directed to the invention that is described in the specification; they do not have meaning removed from the context from which they arose.")).
Thus, we reject Columbia's argument that the presumption of plain and ordinary meaning "can be overcome in only two circumstances: when the patentee has expressly defined a term or has expressly disavowed the full scope of the claim in the specification and the prosecution history." As our en banc opinion in Phillips made clear, "a claim term may be clearly redefined without an explicit statement of redefinition" and "even when guidance is not provided in explicit definitional format, the specification may define claim terms by implication such that the meaning may be found in or ascertained by a reading of the patent documents."
We have previously followed this approach, for example, holding that the claim term "electrochemical sensor" excluded cables and wires based on critical language in the claims and specification, despite there having been no explicit disclaimer of cables or wires. See In re Abbott Diabetes Care Inc. , 696 F.3d 1142 (Fed. Cir. 2012); see also AIA Eng'g Ltd. v. Magotteaux Int'l S/A , 657 F.3d 1264 (Fed. Cir. 2011) (where "the specification reveals a special meaning for a term that differs from the meaning it might otherwise possess, that special meaning governs"); Comput. Docking Station Corp. v. Dell, Inc. , 519 F.3d 1366 (Fed. Cir. 2008) ("Occasionally specification explanations may lead one of ordinary skill to interpret a claim term more narrowly than its plain meaning suggests."); Astrazeneca AB v. Mut. Pharm. Co. , 384 F.3d 1333 (Fed. Cir. 2004) (The patentee "seems to suggest that lexicography requires a statement in the form 'I define _________ to mean _________ ,' but such rigid formalism is not required.").
We have also found that a patent applicant need not expressly state "my invention does not include X" to indicate his exclusion of X from the scope of his patent because "the patentee's choice of preferred embodiments can shed light on the intended scope of the claims." Astrazeneca ; see also On Demand Mach. Corp. v. Ingram Indus., Inc. , 442 F.3d 1331 (Fed. Cir. 2006) ("When the scope of the invention is clearly stated in the specification, and is described as the advantage and distinction of the invention, it is not necessary to disavow explicitly a different scope."); Edwards Lifesciences LLC v. Cook Inc. , 582 F.3d 1322 (Fed. Cir. 2009) (finding disavowal implicitly); Boss Control, Inc. v. Bombardier Inc. , 410 F.3d 1372 (Fed. Cir. 2005) (same).
Application of the Foregoing Requires Reversal of the District Court's Construction
Columbia challenges the district court's construction of "byte sequence feature," limiting the construction to only "machine code instructions." Columbia argues that the term "byte sequence feature" is an umbrella term for the properties or attributes of sequences of bytes that are extracted from any part of an executable, including not only machine code instructions but also other information. It contends that this construction is apparent from a simple examination of the plain meaning of the claim language and that nothing in the specification limits the broad plain meaning of the claim language. The district court, it urges, erred in relying on the specification to limit the ordinary meaning.
However, as discussed above and as Phillips teaches, "the specification is always highly relevant" and "is often the best guide to the meaning of a disputed term." In this case, the district court's construction is well supported by the specification. The specification states twice that the "byte sequence feature" is useful and informative "because it represents the machine code in an executable." These are not simply descriptions of the preferred embodiment but are statements defining "byte sequence feature." Further, the provisional application similarly defined byte sequence feature, stating that "the byte sequence feature is the most informative because it represents the machine code in an executable instead of resource information " which is not made of machine code instructions.
Columbia points to language in the specification that states that, in another embodiment, "extracting the byte sequence features from the executable attachment may comprise creating a byte string representative of resources referenced by said executable attachment." This single sentence in the specification cannot overcome the overwhelming evidence in other parts of the specification and the provisional application demonstrating that the intended definition of this term does not include information other than machine code instructions. The patentee cannot rely on its own use of inconsistent and confusing language in the specification to support a broad construction that is otherwise foreclosed.
As we have previously found, the "construction that stays true to the claim language and most naturally aligns with the patent's description of the invention will be, in the end, the correct construction." Renishaw PLC v. Marposs Societa' per Azioni , 158 F.3d 1243 (Fed. Cir. 2003). The district court's construction of "byte sequence feature" is correct.
The Panel Affirms Construction of "Probabilistic Model of Normal Computer System Usage"
Columbia next challenges the district court's construction of "probabilistic model of normal computer system usage." The Microsoft Windows operating system contains a registry, which is a library of common low-level settings for the operating system and for other applications. When programs are executed, they may read from or change the information in this database. The theory underlying the invention in Columbia's patents is that malicious programs access the registry in different ways than normal programs do. Thus, as for email attachments in the '544 and '907 patents, a computer model is "taught" to distinguish between accesses to the registry which indicate a malicious program and normal accesses to the registry. The model then can be used to detect malicious accesses to the database and identify malicious programs.
The district court, in its original claim construction order, construed the term to mean a "model of typical attack-free computer system usage that employs probability." The district court furthered construed the term "normal computer system usage" to mean "typical attack-free computer system usage," relying on the specification. After Columbia moved for clarification of the district court's construction of this term, the district court clarified that the model described in the '084 and '306 patents must be generated with "only attack-free data." Again, contrary to Phillips , Columbia argues that the district court erred in departing from the plain and ordinary meaning and instead relied on the specification to erroneously import a negative limitation from the specification despite no "clear and unmistakable" disclaimer of the claim scope.
The district court was correct in finding that, according to the patentee's own words in the specification, the "probabilistic model of normal computer system usage" is built using only attack-free data. According to the specification, the model is built by gathering features from the records of normal processes that access the Windows registry." The invention then takes these features (which were gathered from normal processes) and builds "a probabilistic model of normal computer system usage based on records of a plurality of processes that access the Windows registry and that are indicative of normal computer system usage, e.g., free of attacks." The specification consistently describes an implementation where the inventors ran ordinary programs to "generate normal data for building an accurate and complete training model." '084 patent; '306 patent ("statistics of the values of these features over normal data are used to create the probabilistic model of normal registry behavior"); id . (probability "estimated over the normal data"); id . ("From the normal data . . ."). Nothing in the specification describes any embodiment which uses attack data to build the model. The provisional patent application, incorporated by reference into the specification, similarly describes creating the model using only normal data. ("Statistics . . over normal data are used to create the model of normal registry behavior.")
The prosecution history also confirms this conclusion. To distinguish some prior art, the patentee said that the prior art did not suggest "a technique for predicting events which were not observed during training." In other words, what distinguished the invention from the prior art is that it could predict whether a registry access was malicious from a model that was built using only normal data. If the model were built on attack data and then subsequently used to predict attacks, it would not be "predicting events which were not observed during training."
Columbia points to two patent applications incorporated into the specification describing databases used to store information to build models that have passing references to attack data's being stored in the database. These fleeting references cannot overcome the overwhelming evidence in the specification and the prosecution history, especially given the specification did not "even refer with any detailed particularity" to the passages Columbia now argues support its construction. The district court's conclusion that the model of the '084 and '306 patents must be built with only attack-free normal data is correct.
The Court Reverses the Construction of Anomalous
Lastly, Columbia argues that the district court incorrectly construed the term "anomalous." In a more traditional analysis, the panel reverses the district court construction and therefore reverses the stipulated judgment of non-infringement of the asserted claims of the '115 and '322 patents because it was based on an incorrect claim construction, and remand for further proceedings consistent with this opinion.
Comment: This holding that disavowal may be by implication is not only arguably inconsistent with Thorner v. Sony Computer Entertainment America LLC , 669 F.3d 1362 (Fed. Cir. 2012), cited in the opinion, but also is difficult to reconcile with other cases in which the Circuit has reversed findings of disavowal either in the specification or in the prosecution history. See Avid Technology, Inc. v. Harmonic, Inc. , 2016 U.S. App. LEXIS 1439 (Fed. Cir. Jan. 29, 2016) (prosecution history); Tom Tom, Inc. v. Adolph , 790 F.3d 1315 (Fed. Cir. 2015) (prosecution history); Shire Dev., LLC v. Watson Pharms., Inc. , 787 F.3d 1359 (Fed. Cir. 2015) (prosecution history); Vederi, LLC v. Google, Inc. , 744 F.3d 1376 (Fed. Cir. 2014) (prosecution history); Hill-Rom Servs. v. Stryker Corp. , 755 F.3d 1367 (Fed. Cir. 2014) (specification); and Pacing Techs., LLC v. Garmin Int'l, Inc. , 778 F.3d 1021 (Fed. Cir. 2015) (specification), all of which held that the disavowal must be "both clear and unmistakable." This opinion may be particularly relevant where a term or phrase, which does not have an ordinary meaning in the art, is used. Repeated use of such a term in a particular way in a specification, disclosure of a single embodiment or a consistent theme in the embodiments in the specification may all be held to limit a claim term "by implication."
Purdue Pharma L.P. v. Epic Pharma, LLC , Fed. Cir. Cases 2014-1294, -1296, -1306–1307, -1311–1314 (February 1, 2016)
Oxycodone hydrochloride—the active pharmaceutical ingredient in OxyContin®—is an opioid analgesic used to treat moderate to severe pain. This consolidated appeal concerns four patents associated with the reformulated version of OxyContin®.
I. Invalidity of The Low-ABUK Patents
The low-ABUK patents at issue recite an improved formulation of oxycodone hydrochloride. Those patents describe an oxycodone salt with extremely low levels of a particular impurity, 14-hydroxycodeinone ("14-hydroxy"), which belongs to a class of potentially dangerous compounds known as alpha, beta unsaturated ketones ("ABUKs"). The prior art method of synthesizing oxycodone hydrochloride involved three steps: first, thebaine, a derivative of the opium poppy, was oxidized to form 14-hydroxy; second, the 14-hydroxy was converted to oxycodone free base through hydrogenation; and third, the oxycodone free base was reacted with hydrochloric acid to form oxycodone hydrochloride. The end product created by that process, however, contained high levels of 14-hydroxy, on the order of 1500 parts per million.
In January 2004, the FDA became concerned that 14-hydroxy was potentially toxic and thus mandated that oxycodone hydrochloride manufacturers either provide evidence that the 14-hydroxy levels in their formulations were safe or reduce the amount of 14-hydroxy to less than 10 ppm. Purdue argued that the manner in which they made the invention, dealing with materials found by the FDA to be toxic, supports their non obviousness arguments. However, apparently relying in part on the language in section 103 providing that patentability shall not be negatived by the manner in which the invention was made, the panel does not find that argument persuasive.
The low-ABUK patents continue from application No. 11/391,897, known as the "Chapman Application." The PTO previously determined the claims of that application to be obvious and we affirmed that ruling. Purdue eventually amended the Chapman claims to include the claims now on appeal. Unlike the claims in the Chapman Application, the claims at issue here are product claims instead of process claims, and they explicitly recite 8α as the source of at least a portion of the minimal amounts of 14-hydroxy remaining in the oxycodone API. In 2010, the PTO allowed the claims and issued the low-ABUK patents.
Purdue challenges the conclusion that the claims of the low-ABUK patents are invalid as obvious. Those claims recite an oxycodone API product with low ABUK levels. The district court found that the prior art taught that oxidation of thebaine produced 14-hydroxy and that it was well known in the art that 14-hydroxy could be removed using hydrogenation. The court further determined that the discovery of 8α was not necessary to the claimed invention: a skilled artisan would recognize that hydrogenation could be used to remove the remaining 14-hydroxy, regardless of the source of the 14-hydroxy. Moreover, the court concluded that the claim limitation requiring that the remaining 14-hydroxy is at least in part "derived from 8α" is a product-by-process limitation and thus immaterial in the obviousness determination. Finally, the district court found that the secondary considerations did not demonstrate nonobviousness.
A. Discovery of 8α
First, Purdue contends that the court failed to properly credit the discovery of 8α as the core of the claimed inventions. It relies heavily on Eibel Process Co. v. Minnesota & Ontario Paper Co. , 261 U.S. 45 (1923), for the proposition that "where an inventor discovers a nonobvious source of a problem and then applies a remedy in response, the invention is nonobvious and worthy of a patent—even if the remedy, standing alone, would generally appear to be known in the art." Purdue's reliance on Eibel Process is misplaced. Even if determining the source of 14-hydroxy in the end product was not obvious, that problem did not need to be solved to arrive at the claimed invention; thus, Eibel Process does not apply. As discussed above, the claimed invention in Eibel Process was a machine that remedied the problem of wrinkled paper at high-speed printing. But, here, Purdue did not claim the remedy of the problem of remaining 14-hydroxy in the oxycodone API—performing a second hydrogenation step. Instead, it claimed the end product—an oxycodone API with low ABUK levels.
Purdue argues that even if these were process limitations, they should not be disregarded. However, we have clearly stated that "in determining validity of a product-by-process claim, the focus is on the product and not the process of making it." Greenliant Sys., Inc. v. Xicor LLC , 692 F.3d 1261 (Fed. Cir. 2012) (quoting Amgen Inc. v. F. Hoffman-La Roche Ltd. , 580 F.3d 1340 (Fed. Cir. 2009)). "That is because of the . . . longstanding rule that an old product is not patentable even if it is made by a new process." Purdue looks to the exception we carved out in Amgen : "if the process by which a product is made imparts 'structural and functional differences' distinguishing the claimed product from the prior art, then those differences 'are relevant as evidence of no anticipation' although they 'are not explicitly part of the claim.'" As previously discussed, however, the fact that the 14-hydroxy is derived from 8α imparts no structural or functional differences in the low-ABUK hydrocodone API as compared to the prior art. Thus, the court did not err in disregarding the process limitation in its obviousness determination.
B. Secondary Considerations
Finally, Purdue contends that the court erroneously discounted the secondary considerations which it argues demonstrate nonobviousness. Purdue first points to Rhodes's commercial success; it says that Rhodes became Purdue's oxycodone API supplier by marketing the low-ABUK features of its product to Purdue, which resulted in almost $71 million in sales in 2010. As the court found, however, Rhodes was not successful at marketing its low-ABUK oxycodone API to any significant customer other than Purdue, which is its corporate affiliate. Thus, the court did not clearly err in concluding that there was no nexus between the low-ABUK product of the patents and the commercial success of Purdue or Rhodes.
Purdue next argues that the failure of others is shown by the experience of Teva's oxycodone API supplier, Noramco. Purdue claims Noramco was unable to obtain low ABUK levels until 2007, years after Purdue discovered 8α, and only then by infringing the low-ABUK patents. But, as the court found, there is no evidence that Noramco tried but failed to create low-ABUK oxycodone API. Thus, the district court did not clearly err in finding that Purdue failed to prove the failure of others or long-felt but unaddressed need.
Finally, Purdue points to the fact that Noramco credited Purdue and Rhodes with the discovery of 8α and contends that such recognition shows praise from competitors. But recognition that Rhodes discovered that 8α is a byproduct of thebaine oxidation does not equal praise for the invention—the low-ABUK oxycodone API. Finally, Purdue contends that the court wholly ignored evidence showing that Purdue and Rhodes were surprised over their discovery and solution. But, again, there was no surprise as to the patented product. Even if it was unexpected that thebaine oxidation would create 8α, it was not surprising that, after the FDA mandate, manufacturers would create a low-ABUK oxycodone API or that they would do so using the known technique of hydrogenation.
II. Invalidity of the '383 Patent
Purdue and Grunenthal also challenge the conclusion that the claims of the '383 patent are invalid as anticipated, or, in the alternative, obvious. On appeal, Grunenthal contends that the district court clearly erred in finding that McGinity discloses all of the limitations of the asserted claims and that the district court impermissibly combined discrete disclosures in McGinity to arrive at its anticipation determination. Grunenthal also asserts a number of grounds of error in the district court's obviousness determination.
The panel first rejects Grunenthal's arguments that McGinity fails to disclose all of the limitations of the claimed invention. Then the Circuit turns to the argument that the district court erred by using distinct sections of McGinity and reassembling them into an embodiment to find that all of the limitations were present. See Application of Arkley , 455 F.2d 586 (C.C.P.A. 1972) (noting that an anticipating reference "must clearly and unequivocally disclose the claimed compound or direct those skilled in the art to the compound without any need for picking, choosing, and combining various disclosures not directly related to each other by the teachings of the cited reference"). Grunenthal argues that the court impermissibly chose only those examples that included the claimed amount of PEO to find anticipation.
These arguments are without merit. The disclosures pointed to by the district court are all "directly related" and thus there is no impermissible picking and choosing. We conclude that the court did not clearly err in finding that the McGinity reference discloses every limitation in the asserted claims of the '383 patent. We thus affirm the anticipation determination and do not reach the question of obviousness.
TriVascular, Inc. v. Shaun L.W. Samuels , Fed. Cir. Case 2015-1631 (February 5, 2016)
Dr. Samuels sued TriVascular for infringement of a '575 patent directed to an intraluminal vascular stent used for treatment of unduly enlarged or constricted vascular walls. The patent claims intraluminal stents that can be affixed to a vascular wall without penetrating the vessel wall via the use of an inflatable and deflatable cuff that is inflated by introducing fluid into each of the "circumferential ridges" surrounding the stent, and when inflated, the stent lodges securely in the vessel.
TriVascular filed for inter partes review, which the Board instituted on the following two grounds: (1) obviousness over Samuel's '851 patent and a '745 patent to Todd; and (2) obviousness over a '088 patent to Lazarus and the '745 Todd patent. In its Institution Decision, the Board construed the phrase "circumferential ridge disposed about the inflatable cuff' to mean "raised strip disposed circumferentially about the outer surface of the inflatable cuff." Applying its claim construction, the Board then found that Samuels had not demonstrated that the Samuels '851 reference taught away from the substitution of the penetrating anchoring barbs taught in the reference, nor did Samuels establish that removing the barbs would destroy the objective of the reference. Accordingly, the Board explained that TriVascular had established a reasonable likelihood of success on two potential grounds.
The Board's final decision, however, was that TriVascular failed to meet its burden of demonstrating that the challenged claims were unpatentable over the applied art: the Board found that the prior art did not teach the "circumferential ridges" taught in the '575 patent at issue, based on its claim construction at institution, because the ridges were continuous and not made up of a series of discontinuous inflatable protrusions formed circumferentially about the cuff, which TriVascular had argued was known in the prior art. Based on this claim construction, the Board found TriVascular failed to prove the claims were invalid as obvious.
On appeal, TriVascular argued that the Board erred in its construction of the term "circumferential ridges" and in its holding that TriVascular did not carry its burden to demonstrate invalidity.
TriVascular argued that the Board erred in its claim construction requiring the term "circumferential ridges" to mean a "raised strip disposed circumferentially about the outer surface of the inflatable cuff," and argued the correct meaning is "an elevated part of the outer surface disposed about the inflatable cuff that can be either continuous or discontinuous " because 1) the Board's construction is inconsistent with the plain meaning of the term "circumferential ridges"; and 2) Dr. Samuels is barred by prosecution history disclaimer from arguing for a narrower construction.
Applying the broadest reasonable interpretation standard de novo , the Circuit finds that the Board had correctly concluded "circumferential ridges" did not encompass discontinuous points arranged in a circular pattern on the surface of a stent as a matter of plain meaning, and as supported by the written description and the definition of "ridge" in a general purpose dictionary (finding the definition of "ridge" as "a raised strip (as of plowed ground)" to be in accord with the specification's description of a raised strip).
The Circuit rejects TriVascular's proposed construction as contrary to the plain meaning of the claim term and its extrinsic evidence (ridge meaning "discontinuous" protrusions as found in the Blue Ridge Mountains in the Appalachian Mountain Range) unrelated to the topic at issue and illogical to apply over an on-point general dictionary definition.
The Board rejects TriVascular's prosecution history disclaimer argument as improperly focused on Dr. Samuels' "Amendment B," and unpersuasive in view of the subsequent prosecution history, which showed that the positions of the Examiner and the patent applicant changed later in prosecution, resulting in a claim that included the limitation "at least one circumferential ridge disposed about the inflatable cuff" and omitted the "continuously" language of Amendment B. The Board found it significant that other amendments were made to the relevant claim, which apparently convinced the examiner of the patentability of the claimed invention over the prior art, without regard to the proposed addition of the word "continuously" to the claims. Thus, the panel affirms the Board's conclusion that TriVascular has failed to meet its burden of demonstrating the existence of a "clear and unmistakable" disclaimer that would have been evident to one skilled in the art.
TriVascular next argued that the Board should have found the '575 patent's claims invalid under the instituted ground of obviousness over Samuels '851 in view of Todd.
In reviewing the prior art, the Circuit concludes a key point of distinction between the '575 patent and the prior art is that the '575 patent teaches the use of inflatable , circumferential ridges that do not penetrate the vessel wall. TriVascular argued that the Board wrongly concluded the claims were not obvious because the Board improperly required the references to be physically "bodily incorporated" into each other, and because the Board ignored the state of the art and its predictability. TriVascular also argued that, contrary to the Board's findings, a skilled artisan would have been motivated to combine Samuels '851 and Todd by replacing the barbs of Samuels '851 with the gripping protuberances of Todd to obtain the desirable result of non-penetrating stent fixation by substituting the inflatable, penetrating barbs of Samuels '851 with the noninflatable, nonpenetrating protuberances of Todd.
The Circuit agrees with the Board that TriVascular's argument stretches too far, because TriVascular's proposed substitution would destroy the basic objective of the barbs, which is to penetrate surrounding tissue rather than simply stabilize the stent within the vessel. Moreover, it would not have been obvious to substitute the inflatable barbed recesses with the non-penetrating protuberances of Todd because the protuberances taught in Todd were not inflatable, as recited in the asserted claims. Thus, the Board's findings regarding the lack of a motivation to combine are supported by substantial evidence.
TriVascular next contends that the Board's conclusion of nonobviousness is inconsistent with the Board's findings in its Institution Decision, since the Board found that TriVascular had initially demonstrated a reasonable expectation of success in demonstrating obviousness. TriVascular argues that the Board should not have changed its view of the patent's validity without clearly explaining why it had done so.
The Circuit notes that upon making an Institution Decision, the Board is considering the matter preliminarily without the benefit of a full record. The Board is free to change its view of the merits after further development of the record, and should do so if convinced its initial inclinations were wrong. To conclude otherwise would incorrectly collapse the preliminary and full stages of an IPR, each having its own analysis, into one, and would render a patentee's appeal rights "close to illusory."
The Court notes that TriVascular's argument fails to appreciate the significant difference between a petitioner's burden to establish a "reasonable likelihood of success" at institution, and actually proving invalidity by a preponderance of the evidence at trial. Therefore, the Board's findings in its Final Written Decision were thus not inconsistent with those in its Institution Decision; they were made under a qualitatively different standard.
Given the explicit teachings of these references, and absent other evidence, the Circuit concludes that TriVascular had not met its burden of showing that the Board's findings are not supported by substantial evidence. Without evidence of a sufficient motivation to combine the teachings of the references and the lack of a reasonable expectation of success in combining the prior art, the Circuit finds no error in the Board's conclusion that TriVascular failed to satisfy its burden of proving the claims invalid.
TriReme Medical, LLC v. AngioScore, Inc. , Fed. Cir. Case 2015-1504 (February 5, 2016)
TriReme sued under 35 U.S.C. Sec. 256 to add Dr. Lotan as an inventor of defendant AngioScore's three patents in suit—all directed to angioplasty balloon catheters marketed under the name AngioSculpt. TriReme claimed to have rights in the patents by assignment from Dr. Lotan, and AngioScore defended that it had acquired all of Dr. Lotan's rights, before the alleged assignment to TriReme; ergo Dr. Lotan had nothing to assign to TriReme. AngioScore relied on a Consulting Agreement with Dr. Lotan, which separately addressed Dr. Lotan's work before and after the May 1, 2003 effective date.
The Agreement provided in Section 9(a), "Inventions Retained and Licensed," that a list of relevant "Prior Inventions" be attached, and the Agreement grants a non-exclusive license in them, "if, in the course of providing the Services, Consultant incorporates into a Company product, process or machine or into any Invention (as defined below)."
Section 9(b) provides:
Assignment of Inventions. Consultant agrees to promptly disclose to the Company and hereby assigns to the Company, or its designee, all right, title and interest in and to all inventions, original works of authorship, developments, concepts, know-how, improvements or trade secrets, whether or not patentable, that Consultant may solely or jointly conceive or develop or reduce to practice during the term of this Agreement that relate to the Services (collectively referred to as "Inventions").
Before the May 1, 2003, effective date, Dr. Lotan performed a single-day study testing AngioSculpt prototypes in pig arteries. During the study, Dr. Lotan discovered a clear retention problem in which the metal spiral on the surface of the balloon dislodged from the device upon retraction from the pigs' arteries. Dr. Lotan suspected that the problem arose because the spiral was only affixed to the balloon at one end—the other end was "free-floating." He subsequently submitted his findings, and a proposed solution using a polymer tube to more securely bond the spiral to the balloon while still allowing the spiral to expand and contract synchronously with the balloon. Dr. Logan did not list this or any other "Prior Invention" in an exhibit to the Agreement.
AngioScore argued that Dr. Lotan was required to list the pig study, pursuant to § 9(a), and his failure to do so resulted in an assignment—not simply a license—of his rights to AngioScore. The district court agreed, reasoning based on the "purpose" of the Consulting Agreement that § 9(a) "together" with § 9(b) operated to assign Dr. Lotan's rights in his inventive contribution to AngioScore as a consequence of his failure to list the pig study. The Circuit reverses that ruling, applying the plain meaning of the contract language, pursuant to California statute, and found that Section 9(a) is entitled "Inventions Retained and Licensed," but nothing in its terms suggests that anything not listed as a "Prior Invention" would not be "retained."
What § 9(a) does, at most, is grant AngioScore a non-exclusive license in the event that the consultant incorporates a Prior Invention into an AngioScore product during the term of the Consulting Agreement. But such license is not exclusive and would not prevent Dr. Lotan from subsequently assigning his rights in those contributions to TriReme. In short, the district court erred to the extent it relied on § 9(a) to find that Dr. Lotan assigned his rights to AngioScore.
Defendant AngioScore alternatively argued that Dr. Lotan "conceived, developed, or reduced to practice [the improvement to the catheter] after the effective date," and therefore Section 9(b) effects an assignment of the invention to AngioScore. The parties disputed the significance of Dr. Lotan's role in the development of AngioSculpt after the May 1, 2003, effective date. It was undisputed that while Dr. Lotan no longer worked on the physical design of the catheter after the effective date, he continued "talking" with AngioScore, performing work relating to designing, implementing, and analyzing clinical trials.
Whether Dr. Lotan assigned his rights under § 9(b) thus depends on whether Dr. Lotan's continued work on AngioSculpt after the effective date in fact amounted to "developing," or "reducing to practice" an "invention," "development," or "improvement" pursuant to § 9(b). The Circuit rules that whether this work falls under § 9(b) remains a question of fact that cannot be resolved on a motion to dismiss. It remands for the district court to consider whether Dr. Lotan's continued work on AngioSculpt after the effective date came within the language of § 9(b).
Comment: This case highlights the importance of careful drafting in agreements that affect IP rights—in this case a consulting agreement. Can discussions related to designing, implementing and analyzing clinical trials rise to the level of "reduction to practice" or "invention" of a catheter device? Keep in mind that state law controls interpretation of contracts.