Source: https://www.schwabe.com/newsroom-publications-14638
Timestamp: 2019-04-26 08:38:26+00:00

Document:
In MIT v. Shire and Poly-America v. API, the Circuit arguably reaches two different conclusions from similar factual scenarios. In MIT, a first panel rules that there is no prosecution history disclaimer where the claims being argued at the time did not include the pertinent language allegedly being disclaimed. In Poly-America, a second panel concludes that there is such a disclaimer even though the pertinent language was not in the claims being argued. The apparent justification is that in the latter case the specification also supports the disclaimer but one wonders why the panel did not just rely on the specification to reach its claim construction.
In FairWarning v. Iatric, patent claims directed to a system for monitoring access of a patient’s ‎protected health information fail under an Alice analysis, with the panel distinguishing the recent McRO and Enfish cases.
Thanks to my colleague in Seattle, Katherine Lee, for her help with this week’s report.
MIT v. Shire – MIT sued Shire Pharma for infringement of two patents directed to a system for growing artificial organ tissue, based on Shire’s sale of its Dermagraft product for treating diabetic foot ulcers. The district court broadly construed the claims to cover skin that is grown using the claimed process. The panel affirms the broad construction and rejects Shire’s argument that the claims are indefinite.
The panel first rejects Shire’s argument that MIT disclaimed a construction of “vascular organ tissue” that included “skin.” This ruling is based on the ordinary meaning of the term, that the specification supports the broad construction, and that the prosecution argument on which Shire relies did not constitute a “clear and unmistakable” disavowal of the broader construction. The portions of the prosecution history cited by Shire were in the course of MIT’s arguments that it was entitled to coverage for “non-skin” cells. When MIT presented that argument to the Examiner, the claims did not include the term “vascularized organ tissue,” so there was no clear and unmistakable disavowal.
The panel also affirms the construction of “cells derived from a vascularized tissue” to include both parenchymal and non-parenchymal (e.g., bone-forming) cells. Shire argued that the specification repeatedly refers to the cells of the invention as “parenchymal,” but the panel holds that the specification’s noting “an advantage of the present method” being “a means for selective transplantation of parenchymal cells” does not amount to a clear and unmistakable disclaimer.
Finally, even though the district court used non-technical and contemporaneous dictionaries, Shire does not explain how technical dictionaries contemporaneous with the filing date would define the term any differently. Given the foregoing, the panel also agrees with the district court that the claim language is sufficiently definite under Nautilus.
While conceding she is bound by the Circuit’s 2013 en banc Bosch decision, Judge O’Malley writes in concurrence that she agrees with the panel’s construction and ruling on definiteness, but believes the Circuit should not continue its practice of exercising jurisdiction in cases where the district court has yet to determine damages and/or willfulness.
Poly-America v. API – The panel holds that the specification and prosecution history of Poly-America’s patent contain clear and unequivocal statements that the inventor intended to limit the claimed invention to a trash bag with “short seals” at its upper corners that extend inwardly to narrow the bag’s upper opening. In light of the inventor’s disavowal, the panel affirms the district court’s construction.
Specifically, the specification states: “In looking at both FIG. 1 and FIG 2, it is important to note that one of the characteristics of the present invention is a reduction in upper width . . . resulting from the extended short seals.” According to the opinion, directing the reader to Figures 1 and 2 does not limit the import of this clear statement that describes a characteristic feature of the invention. The panel also holds that the inventor disavowed a broad construction because the specification disparages prior art based on the absence of that feature.
Poly-America’s reply to the examiner’s second rejection of all claims also contains a clear and unmistakable disavowal of short seals that do not extend inwardly: The argument was that the relaxed upper opening width of Schneider is the exact same as the bag proper width, not less than ‎the bag proper width as required by Applicant’s independent claims. ‎According to the opinion: “It is irrelevant that the terms “bag proper width” and “relaxed upper opening width” are not present in claim 10 [an independent claim], which was being argued at the time, because when considered in light of the specification, it is clear that all of the claimed trash bags have a “relaxed upper opening width” and a “bag proper width.” Ultimately, according to the opinion, the only meaning that matters in claim construction is the meaning in the context of the patent.
Finally, as the Circuit has done in several recent cases, it rejects Poly-America’s argument based on claim differentiation, holding that claim differentiation cannot override clear statements of claim scope found in the specification and prosecution history.
In the field of organ transplantation, surgeons face the challenge of donor scarcity in addition to the technical complexity of transplanting whole or segmented organs into organ recipients. Given the limited availability of implantable organs, scientists have developed methods of growing artificial organ tissue in vitro by seeding cells onto support structures, known as scaffolds or matrices. These scaffolds are engineered to allow cells to attach and grow, while enabling the diffusion of vital cell nutrients to the cells to contribute to the growth of new functional tissue. The ’193 and ’830 patents claim three-dimensional, synthetic, biodegradable structures for growing tissue for vascularized organs as well as methods for creating those structures.
The parties dispute whether prosecution history disclaimer applies to the asserted claims. In particular, Shire argues that prosecution disclaimers apply to the terms “vascularized organ tissue” and “cells derived from a vascularized tissue.” During claim construction proceedings in the district court, Shire argued that the term “vascularized organ tissue” should be construed to exclude skin as an organ based on various statements made during the prosecution of the asserted patents. Shire made similar arguments regarding construction of the term “cells derived from a vascularized tissue,” arguing that MIT had made statements during prosecution that limited the term to certain types of cells, namely parenchymal cells and bone forming cells. Shire further argued that the term “three-dimensional scaffold” was indefinite under 35 U.S.C. § 112. The district court, however, determined that prosecution history disclaimer did not apply and additionally held that the term “three dimensional scaffold” was not indefinite.
The doctrine of prosecution disclaimer precludes patentees from recapturing through claim interpretation specific meanings disclaimed during prosecution. In order for prosecution disclaimer to attach, the disavowal must be both clear and unmistakable. Where the alleged disavowal is ambiguous, or even amenable to multiple reasonable interpretations, we have declined to find prosecution disclaimer. Avid Tech., Inc. v. Harmonic, Inc.,812 F.3d 1040 (Fed. Cir. 2016). The party seeking to invoke prosecution history disclaimer bears the burden of proving the existence of a “clear and unmistakable” disclaimer that would have been evident to one skilled in the art. Trivascular, Inc. v. Samuels, 812 F.3d 1056 (Fed. Cir. 2016).
On the first term, “vascularized organ tissue,” the district court determined that there was no clear and unmistakable disclaimer that would exclude skin from the term’s ordinary meaning. The court therefore construed the term “vascularized organ tissue” according to its ordinary meaning as “vascularized tissue from an organ,” reasoning that because “the dermal layer of skin contains blood vessels, this term encompasses skin.” We agree with the district court.
Shire nonetheless argues that skin should be excluded from the construction of “vascularized organ tissue” based on certain statements made by MIT during prosecution of the asserted patents’ family. First, Shire pulls out a single sentence from the 1988 interview summary prepared during prosecution of the parent ’018 application, which stated that the asserted prior art “was limited to extremely thin pieces of collagen matrix for use in preparing skin substitutes, which could not be used to create organ equivalents.” These statements, however, were made in the context of different claims that did not include the terms “vascularized organ tissue” or even “organ tissue.” Reading the selected sentence in the context of the entire summary and the claim terms then at issue reveals that MIT emphasized the structure of the invention’s scaffold, not the type of organ it can be used to grow.
MIT’s attempt to add the “non-skin” limitation during prosecution of the asserted patents reinforces our conclusion that the asserted claims as issued include skin within their scope. MIT tried to narrow the application claims early in prosecution to exclude skin organ cells, but the examiner rejected the “non-skin” limitation under § 112 as new matter. MIT never again sought to limit the claims to exclude skin organ cells. Since claims to “vascularized organ tissue” were ultimately allowed over the prior art without the proposed “non-skin” amendment, it is difficult to infer that a skilled artisan would interpret other isolated statements by MIT during the course of the prosecution history as a clear and unmistakable disclaimer of claim scope. Rather, we determine that a skilled artisan, reading the prosecution history as a whole, would conclude that MIT’s invention does in fact cover vascularized skin.
The claims themselves do not distinguish between parenchymal and non-parenchymal cells. Shire acknowledges that bone-forming cells, a type of non-parenchymal cell, fall within the claims’ scope. Similarly, Shire’s expert agrees that the ordinary meaning of “cells derived from a vascularized tissue” would encompass both the parenchymal and non-parenchymal cells. In addition, several dependent claims expressly include organs with parenchymal and non-parenchymal cells. For example, claim 11 of the ’193 patent lists smooth muscle cells, which are non-parenchymal stromal cells, not parenchymal cells.
Moreover, the respective specifications do not limit the term “cells derived from a vascularized tissue” to parenchymal cells, but instead use the term to also refer to several types of non-parenchymal stromal cells, namely cells forming smooth muscle and blood vessel endothelial cells. Shire points out that the specifications “repeatedly refer to the cells of the invention as ‘parenchymal,’ ‘functional,’ or cells possessing the ‘necessary’ or ‘desired’ function.” But Shire has not shown that these descriptions are synonymous, such that the invention should be limited to only parenchymal cells, especially in the face of the broad ordinary meaning of “cells derived from a vascularized tissue.” And the specifications’ reference to “an advantage of the present method” being “a means for selective transplantation of parenchymal cells” does not amount to a clear and unmistakable disclaimer restricting the claims to only parenchymal cells.
Finally, Shire pulls out statements from the prosecution of the ’193 patent and a related patent that it argues disclaim non-parenchymal cells. The pending claims in these patent applications at the time of the statements, however, did not include the limitation in dispute—“cells derived from a vascularized tissue”—and do not clearly and unmistakably show that MIT intended to limit the claims at issue to only parenchymal cells.
After reading the full prosecution history in light of the then-pending claim language, we conclude that a skilled artisan would not read MIT’s statement made during prosecution of the ’417 patent—and directed to very different claim language—as limiting the term “cells derived from a vascularized tissue” to parenchymal cells. We, like the district court, determine that the ordinary meaning applies because Shire has not shown that a clear and unmistakable disclaimer attaches to limit the claim scope.
Finally, Shire appeals the district court’s determination that the term “three-dimensional scaffold” is not indefinite, as well as the court’s ultimate construction of the term as “a supporting structure that allows cells to attach along its width, length, and height.” We affirm the district court’s validity determination and adopt its claim construction.
Shire asserts that the term “three-dimensional scaffold” is indefinite because the intrinsic record provides “no guidance” as to the meaning of “three-dimensional.” The district court rejected this argument and construed the term “three dimensional” according to its accepted, ordinary meaning, as confirmed by dictionary definitions. Shire complains that the dictionaries cited by the district court are from the present day and are not technical in nature. Yet Shire does not explain how technical dictionaries or dictionaries contemporaneous to the patents’ filing date would define the term any differently. Moreover, the district court’s construction is consistent with Shire’s own expert’s opinion regarding the term’s ordinary meaning at the time of the invention.
I agree with the majority that the district court did not err either in its construction of the disputed claim terms or in its conclusion that the term “three dimensional scaffold” was not indefinite. However, while I understand I am bound by the Bosch decision (Robert Bosch, LLC v. Pylon Manufacturing Corp., 719 F.3d 1305 (Fed. Cir. 2013) (en banc)), I continue to believe that case was in error, so I do not believe this court should continue its practice of exercising jurisdiction in cases where, as here, the district court has yet to determine damages and/or willfulness.
The ’308 patent is directed toward a trash bag made from two panels of polymeric material joined at the sides and the bottom to form an enclosed bag. Each panel is folded over and sealed to form a “hem,” and inside each hem is a drawstring. A principal feature of the claimed invention is Poly-America’s use of inwardly extended short seals to reduce the width of the trash bag’s upper opening. When coupled with elastic drawstrings, the narrowed opening allows those drawstrings to wrap around the rim of a trash receptacle more securely than prior art trash bags that do not have a narrowed upper opening.
Throughout its written description, the ’308 patent indicates the significance of the extended short seal feature and the reduced upper opening width the extended short seals provide. It is important to note that one of the characteristics of the present invention is a reduction in the upper width (when the bag is in a relaxed state) of the bag resulting from the extended short seals.
The ’308 patent has three independent claims: 1, 10, and 16. Claim 10 differs from claims 1 and 16 in that it does not explicitly provide for a narrowed opening. Claim 1 includes a limitation of “the relaxed upper opening width being less than the bag proper width.” Claim 16 describes “the distance between an interior edge of the first short seal and an interior edge of the second seal being less than a bag proper width.” In contrast, claim 10 does not expressly state any limitation as to the size of the short seals or the relationship between the size of the upper opening and the bag proper.
API’s proposed construction was: “A seal for securing the elastic drawstring, which seal is located adjacent to a side seal, and that is not substantially aligned with the side seal, but extends inwardly from the interior edge of the side seal.” The district court explained that this construction was consistent with the specification and the prosecution history. Under the district court’s construction of short seal, the accused device would not infringe claim 10, because API’s accused bags are conventional drawstring trash bags with short seals that are substantially aligned with the side seal—i.e., the short seals do not extend inwardly, so the width of the relaxed upper opening is equal to the bag proper width.
Poly-America argues that in construing the term “short seal” to require inward extension, the district court erred by importing limitations from embodiments described in the specification, misreading the prosecution history, and ignoring principles of claim differentiation. We disagree.
Claim terms are generally given their ordinary and customary meaning, which is the meaning they would have to a person of ordinary skill in the art at the time of the invention. Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc). We depart from the plain and ordinary meaning in only two instances. HillRom Servs., Inc. v. Stryker Corp., 755 F.3d 1367 (Fed. Cir. 2014). The first is when a patentee acts as his own lexicographer. The second is when the patentee disavows the full scope of the claim term in the specification or during prosecution. There is no indication or assertion of lexicography in this case. The only question is whether the inventor disavowed trash bags with short seals that do not extend inwardly to narrow the upper opening width in relation to the bag proper width.
Disavowal can be effectuated by language in the specification or the prosecution history. In either case, the standard for disavowal is exacting, requiring clear and unequivocal evidence that the claimed invention includes or does not include a particular feature. While disavowal must be clear and unequivocal, it need not be explicit. Trs. of Columbia Univ. v. Symantec Corp., 811 F.3d 1359 (Fed. Cir. 2016). For example, an inventor may disavow claims lacking a particular feature when the specification describes “the present invention” as having that feature. Luminara Worldwide, LLC v. Liown Elecs. Co., 814 F.3d 1343 (Fed. Cir. 2016). Here, the specification states that: “In looking at both FIG. 1 and FIG 2, it is important to note that one of the characteristics of the present invention is a reduction in upper width . . . resulting from the extended short seals.” Directing the reader to figures one and two, which demonstrate the extended short seal feature, does not limit the import of this clear statement that describes a characteristic feature of the invention.
Similarly, an inventor may disavow claims lacking a particular feature when the specification distinguishes or disparages prior art based on the absence of that feature. That is exactly what the specification to the ’308 patent does by stating that prior art bags are difficult to secure over trash receptacle lips and explaining that the use of extended short seals reduces the claimed bag’s upper opening, making it easy to fit around a trashcan.
Poly-America’s reply to the examiner’s second rejection of all claims also contains a clear and unmistakable disavowal of short seals that do not extend inwardly: “The ‘relaxed upper opening width’ of Schneider is the exact same as the ‘bag proper width,’ not less than the ‘bag proper width’ as required by Applicant’s independent claims.” Despite Poly-America’s contentions, it is irrelevant that the terms “bag proper width” and “relaxed upper opening width” are not present in claim 10, because when considered in light of the specification, it is clear that all of the claimed trash bags have a “relaxed upper opening width” and a “bag proper width.” Ultimately, the only meaning that matters in claim construction is the meaning in the context of the patent.
Poly-America argues that requiring the short seals in claim 10 to be inwardly extended would render redundant dependent claim 13’s provision for “a distance between the first seal and the second seal to a width of the bag proper being greater than 94% but less than 100%.” Construing short seals to require inward extension would inherently provide for a distance between short seals that is less than 100 percent of the bag proper width, but that does not render the more specific range provided by dependent claim 13 redundant.
Poly-America also argues that because other independent and dependent claims explicitly provide for reduced upper opening width, claim differentiation principles preclude importing that limitation into claim 10, which does not contain such an explicit limitation. But claim differentiation does not serve to broaden claims beyond their meaning in light of the patent as a whole, and it cannot override clear statements of claim scope found in the specification and prosecution history.
We find that, under step one of Alice, the claims are directed to an abstract idea. As the ’500 patent specification explains, the invention relates to a system and method of detecting fraud and/or misuse in a computer environment based on analyzing data such as in log files, or other similar records, including user identifier data. The district court found that the ’500 patent is directed to or drawn to the concept of analyzing records of human activity to detect suspicious behavior. We agree. The patented method, as illustrated by claim 1 quoted above, collects information regarding accesses of a patient’s personal health information, analyzes the information according to one of several rules (i.e., related to accesses in excess of a specific volume, accesses during a pre-determined time interval, or accesses by a specific user) to determine if the activity indicates improper access, and provides notification if it determines that improper access has occurred.
We have explained that the realm of abstract ideas includes collecting information, including when limited to particular content. We have also treated analyzing information by steps people go through in their minds, or by mathematical algorithms, without more, as essentially mental processes within the abstract-idea category. And we have found that merely presenting the results of abstract processes of collecting and analyzing information, without more (such as identifying a particular tool for presentation), is abstract as an ancillary part of such collection and analysis. Here, the claims are directed to a combination of these abstract-idea categories. Specifically, the claims here are directed to collecting and analyzing information to detect misuse and notifying a user when misuse is detected.
While the claims here recite using one of a few possible rules to analyze the audit log data, this does not make them eligible under our decision in McRO, Inc. v. Bandai Namco Games America Inc. (Fed. Cir. Sept. 13, 2016), which also involved claims reciting rules. In McRO we held that, in analyzing step one, the claims are considered in their entirety to ascertain whether their character as a whole is directed to excluded subject matter. Of course, claims cannot be directed to laws of nature, natural phenomena, and abstract ideas, but must instead claim patent-eligible applications of those concepts. Indeed, even though a claim can be abstracted to the point that it reflects a patent-ineligible concept—for, at some level, all inventions . . . embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas—that claim may nevertheless be patent eligible if the claim language is directed to a patent-eligible application of that concept.
The claims in McRO were not directed to an abstract idea, but instead were directed to a specific asserted improvement in computer animation, i.e., the automatic use of rules of a particular type. We explained that the claimed improvement was allowing computers to produce “accurate and realistic lip synchronization and facial expressions in animated characters” that previously could only be produced by human animators. The claimed rules in McRO transformed a traditionally subjective process performed by human artists into a mathematically automated process executed on computers. Indeed, Defendants conceded that prior animating processes were driven by subjective determinations rather than specific, limited mathematical rules, such as the mathematical rules articulated in McRO’s claimed method. Thus, the traditional process and newly claimed method stood in contrast: while both produced a similar result, i.e., realistic animations of facial movements accompanying speech, the two practices produced those results in fundamentally different ways.
As such, we explained that it was the incorporation of the claimed rules, not the use of the computer, that improved the existing technological process by allowing the automation of further tasks. This was unlike Flook, Bilski, and Alice, where the claimed computer-automated process and the prior method were carried out in the same way.
The claims here are more like those in Alice than McRO. FairWarning’s claims merely implement an old practice in a new environment. The claimed rules ask whether accesses of PHI, as reflected in audit log data, are 1) “by a specific user,” 2) “during a pre-determined time interval,” or 3) “in excess of a specific volume.” These are the same questions (though perhaps phrased with different words) that humans in analogous situations detecting fraud have asked for decades, if not centuries. Although FairWarning’s claims require the use of a computer, it is this incorporation of a computer, not the claimed rule, that purportedly improves the existing technological process by allowing the automation of further tasks.
Because we find these claims are directed to an abstract idea at step one of the patent-eligibility inquiry, we turn to step two.
None of claims 12-13 and 14-17 add limitations that impart patent eligibility. Claim 12 and its dependent claim 13 are system claims that add the requirement that the system include a “user interface” for selection of a rule, as well as a microprocessor that analyzes audit log data under various rules. But, under our precedent, the features of claims 12 and 13 do not recite that “something more” required to make these claims patent eligible. As we have explained, the use of generic computer elements like a microprocessor or user interface does not alone transform an otherwise abstract idea into patent-eligible subject matter. Claim 14 is a system claim, but it recites limitations that FairWarning admits are analogous to that recited in method claim 1 and argues that they are patentable for the same reasons as claim 1. Claims 15–17 depend from claim 14 and, like claim 14, add nothing more than similar nominal recitations of basic computer hardware, such as a non-transitory computer-readable medium with computer-executable instructions and a microprocessor. The claims here are decidedly not the exception to that rule. The limitations added in FairWarning’s system claims merely graft generic computer components onto otherwise-ineligible method claims. As such, these claims are patent ineligible along with claim 1 and its dependents.
Nonetheless, FairWarning argues that all of the claims, without exception, solve technical problems unique to the computer environment and thus should be patent eligible under DDR Holdings. FairWarning explains that, at the time of the ’500 patent’s filing, audit log data of patient health information tended to have different file formats and that this information was stored in different applications and data stores. FairWarning contends that its system allowed for the compilation and combination of these disparate information sources and that the patented method made it possible to generate a full picture of a user’s activity, identity, frequency of activity, and the like in a computer environment. The mere combination of data sources, however, does not make the claims patent eligible. As we have explained, merely selecting information, by content or source, for collection, analysis, and announcement does nothing significant to differentiate a process from ordinary mental processes, whose implicit exclusion from § 101 undergirds the information-based category of abstract ideas. Furthermore, to the extent that FairWarning suggests that its claimed invention recites a technological advance relating to accessing and combining disparate information sources, its claims do not recite any such improvement.

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