Broad Claim Language and Unpredictability in the Art Lead to Non-Enablement

In Enzo Life Sciences, Inc. v.  Roche Molecular Systems, Inc., Appeal Nos. 2017-2498, -2499, -2545, -2546, broad patent claims were invalid as not enabled because the relevant art was unpredictable and practicing the full scope of the claims would require undue experimentation.

Enzo filed suits alleging infringement of the ’180 Patent by Roche, Becton Dickinson, and Abbott, and infringement of the ’405 Patent by Abbott alone.  Both patents relate to the use of non-radioactively labeled polynucleotides in nucleic acid hybridization and detection applications.  The district court granted summary judgment holding that the asserted claims of the ʼ180 Patent and ’405 Patent were not enabled.  Enzo appealed.

The Federal Circuit analyzed whether the ‘180 Patent specification enabled the creation of a labeled probe that is both hybridizable and detectable upon hybridization, as the asserted claims required.  The court noted that the scope of the claims was “quite broad” and “encompasses all phosphate-labeled polynucleotides that are hybridizable and detectable,” placing “almost no limitations on the structure of the claimed polynucleotide,” and providing only “broad categories” of labels to be used.  The court noted that the specification’s guidance as to how such variables would affect the functionality of the claimed probes was sparse, and that at the time of the invention, the art was highly unpredictable.  Although Enzo argued that the ’180 Patent disclosed a working example, the court found the example to be a “paper” example which was never actually tested.  Further, the court explained that even if the paper example worked, each labeled “polynucleotide would need to be tested,” so “undue experimentation would still be required with regard to the many other embodiments of the claims based on the number of possible embodiments and the unpredictability in the art.”  As to the ’405 Patent, the court stated that since the claims were broader than those of the ’180 Patent, they were invalid as not enabled for the same reasons.  Thus, the Federal Circuit affirmed.

Aesthetic Appeal Does Not Render Design Patent Invalid

In Automotive Body Parts Association v. Ford Global Technologies, LLC, Appeal No. 2018-1613, aesthetic appeal is not an invalidating form of functionality for design patents; patent exhaustion and repair doctrines apply equally to utility patents and design patents.

ABPA, an association of auto body part companies, filed a declaratory judgement action against Ford seeking to invalidate design patents covering vehicle hood and headlight designs.  According to ABPA, consumers prefer replacement parts that restore the original appearance of the vehicle. ABPA argued that Ford’s design patents were invalid, because aesthetic appeal rendered the designs functional.  ABPA also argued that Ford’s design patents were unenforceable under the doctrines of exhaustion and repair, and could not bar sales of replacement auto body parts that look like Ford’s original patented parts.  The district court denied ABPA’s motion for summary judgment and sua sponte entered summary judgement in favor of Ford.  

The Federal Circuit affirmed.  On invalidity, the Court reasoned that the statutory basis and economic value of design patents derives from aesthetic appeal.  If aesthetic appeal were functional so as to invalidate a design patent, that would gut the principles underlying design patents.  The Court declined to extend the concept of aesthetic functionality in trademark law to design patents.  The Court also explained that the exhaustion and repair doctrines apply only to authorized sales of the components actually sold.  The repair doctrine does not allow wholesale replacement of component parts that are themselves protected by patent.  Also, exhaustion does not apply to the unauthorized replacement parts manufactured by third parties.  

 Patent Claims Reordering Conventional Steps May Be Ineligible Under § 101

In Solutran, Inc v. Elavon, Inc., Appeal Nos. 2019-1345, -1460, method claims directed to performing conventional steps in a new order may be insufficient to render claims patent eligible under § 101.

Solutran sued Elavon for patent infringement. The patent claims covered a method for processing paper checks, which comprised the following steps in sequence: a) receiving a data file with information from the checks, but not including images of the checks; b) crediting a merchant’s account; c) creating digital images of the checks; and d) using a computer to match the digital images to the data file. Elavon moved for summary judgment, claiming that the patent was directed to an abstract idea under § 101. The district court denied Elavon’s motion, and affirmatively held the claims to be patent eligible, finding that the claims focused on the physical processing and transporting of paper checks. After entry of final judgment of infringement, Elavon appealed.

The Federal Circuit reversed, finding under Alice step one that the claims were directed to the abstract idea of “crediting a merchant’s account as early as possible while electronically processing a check.” The Federal Circuit explained that the physicality of the paper checks being processed and transported is not enough to exempt the claims from being directed to an abstract idea, since the claims recite conventional actions in a generic way and do not improve any underlying technology.  Under Alice step two, the Federal Circuit did not find an inventive concept sufficient to render the claims patent eligible.  The Federal Circuit noted that the patent specification described each individual step of the claims as conventional and explained that reordering conventional steps was insufficient to constitute an inventive concept.

 Federal Circuit Rejects Written Description Analysis That Ignored Relevant Factors

In In Re: Global IP Holdings LLC, Appeal No. 2018-1426, a written description support for a claimed genus depends on the criticality or importance of the expressly disclosed species and the predictability of the relevant technology.

Global IP Holdings, LLC (Global) owns U.S. Patent No. 8,690,233 directed to carpeted automotive vehicle load floors.  The ’233 patent claims a load floor with thermoplastic skins and a thermoplastic cellular core.  Global filed a reissue application seeking to broaden the claims, replacing the term “thermoplastic” with “plastic.”  Global submitted a declaration stating that use of plastic other than thermoplastic for vehicle load floors was known in the art at the time of the invention. 

The Examiner rejected the claims, arguing that the change from “thermoplastic” to “plastic” introduced new matter.  Global argued that disclosure of thermoplastic (species) supported the claiming of plastics (genus) since (1) the type of plastic used was not critical to the invention and (2) plastics other than thermoplastics were a predictable option.  The Board affirmed the examiner’s rejection, finding that “regardless of the predictability of results of substituting alternatives, or the actual criticality of thermoplastics in the overall invention, [Global’s] Specification, as a whole, indicates to one skilled in the art that the inventors had possession only of the skins and core comprising specifically thermoplastic.”  Global appealed.

The Federal Circuit found that the Board applied an incorrect legal standard.  The court held that the level of detail required to satisfy the written description requirement varies depending on the “predictability of the relevant technology,” among other factors.  Further, the court held that “criticality or importance of the expressly disclosed species may be relevant to whether an inventor had possession of a claimed genus.”  Because the Board failed to evaluate these factors, the Federal Circuit vacated the Board’s decision and remanded with instructions for the Board to address them.

 Federal Circuit Denies En Banc Review Regarding Eligibility of Medical Diagnostic Patents

In Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC, Appeal No. 2017-2508, the Federal Circuit voted 7-5 not to review en banc the issue of whether diagnostic claims are eligible for patent protection under § 101.  The Federal Circuit’s denial of en banc review included eight different opinions, all of which indicate that the Supreme Court and/or Congress should intervene to clarify or modify the patent eligibility standards for medical diagnostic claims.  Each of these opinions is summarized below:

Concurring Opinions

Lourie (Joined by Reyna and Chen)

While expressing concerns with the current precedent, Judge Lourie concurred in the court’s decision not to rehear the case en banc because the Federal Circuit is bound by the Supreme Court’s decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc. (“Mayo”), which held that claims focused on detecting new and useful natural laws with conventional steps were patent ineligible.  Judge Lourie suggested only claims directed to a natural law itself, not uses or detection of natural laws, should be excluded from patent eligibility.

Hughes (Joined by Prost and Taranto)

Judge Hughes indicated that Mayo prevents the Federal Circuit from reaching a different result from the panel’s majority, but describes the “bottom line for diagnostics patents” as “problematic” and invited the Supreme Court or Congress to further explicate the eligibility standards for diagnostics patents.

Dyk (Joined by Hughes, Joined in Part by Chen)

Judge Dyk stated that “[a]lthough Mayo’s framework is sound overall. . . the Mayo test for patent eligibility should leave room for sufficiently specific diagnostic patents” and called on the Supreme Court to reconsider the breadth of Mayo.

Chen

Judge Chen stated that the claims at issue do not appear to withstand Mayo’s scrutiny but would likely have been found patent eligible under the framework outlined by the Supreme Court in 1981 in Diamond v. Diehr (“Diehr”), where the claims are read “as a whole.”  Judge Chen noted, however, that there is a serious question as to whether Diehr remains good law in view of Mayo, and encouraged the Supreme Court to resolve the question.

Dissenting Opinions

Moore (Joined by O’Malley, Wallach, and Stoll)

Judge Moore found that the claims at issue are distinguishable from Mayo and should be held eligible.  Judge Moore noted that unlike in Mayo, where the claims recited nothing more than the natural law, the claims at issue here recite concrete steps that “specifically confine their reach to a specific application[.] “  Judge Moore discouraged additional en banc requests regarding diagnostic claims and encouraged parties to seek relief from the Supreme Court or Congress.

Newman (Joined by Wallach)

Judge Newman emphasized “the critical role of the patent system in achieving new diagnostic methods” and stated that “en banc review is needed to provide consistent and correct application of statute and precedent to methods of medical diagnosis.”

Stoll (Joined by Wallach)

Judge Stoll noted that every diagnostic claim before the Federal Circuit since Mayo has been found ineligible.   According to Judge Stoll, Mayo’s principles “are not applicable to every individual diagnostic claim.”   “Certain diagnostic claims, such as the ones at issue in this case, are so narrowly tailored that preemption is not a reasonable concern.”  Judge Stoll wrote that the Federal Circuit was abdicating its responsibility by “consistently bypassing en banc review of a critical issue[.]”

O’Malley

Judge O’Malley stated that Federal Circuit precedent applies the Supreme Court’s holding in Mayo too broadly.  Judge O’Malley further suggested that confusion regarding patent eligibility has been caused by the Supreme Court ignoring Congress’s direction to apply § 101 as written, and stated that “claims directed to uses of natural laws rather than the natural laws themselves would be eligible under § 101[.]”  Judge O’Malley encouraged Congress to clarify that there should be no invention requirement read into § 101.