The technology documented by the U.S. patent collection has information relevant to every human endeavor, and Valentine’s Day is no exception.  Consider the following patents on solutions to the vexing problems presented by Valentine’s Day:

U.S. Patent No. D85,341 protects a Love Tester.

U.S. Patent No. 5,318,327, protected a Romantic Card

U.S. Patent No. 5,213,509 Protected a Lover’s Game and Method of Play

U.S. Patent No. 6,434,805 protects a Method of Making a Heart-Shaped Diamond

U.S. Patent No. D449,147 Protected a Heart-Shaped Chocolate

U.S. Patent No. 4,194,629 Protected a Love Box

U.S. Patent No. 4,993,184 Protected a Heart-Shaped, Free-Standing, Living Horticultural Plants

U.S. Patent No. 5,727,565 Protects a Kissing Shield

U.S. Patent No. D592,393 Protects a Heart-Shaped Umbrella

U.S. Patent No. D82,863 Protects a Valentine Envelope

U.S. Patent No. D360,366 Protects a Love Clock

U.S. Patent No. D284,595 Protected Cupid Unicorn (Cupicor) the Love Unicorn

U.S. Patent No. 372,594 protects a Pizza Pan

U.S. Patent No. 286,301 Protects a Long Stem Valentine Card

U.S. Patent No. D491,338 Protects Heart-Shaped Pepperoni Slices

There are a number of design patents based upon the shape of a state.

D773,692 Arizona Paving Stone

D652,608 Glove Ornamented with a Map of the State of Alaska

D462261 Compressed Fabric Article Package Having a Simulated California Map Shape
D362645 California Medallion

D686,456 Hawaii Shaped Plate

D603,728 Scoreboard in the form of the State of New York

D704088 Tennessee Ring

D654,318 Texas Shot Glass
D623,001 Barbeque grill shaped like Texas
D610,474 Scoreboard in the form of the State of Texas
D588,027 Scoreboard in the form of the State of Texas
D543,073 Pair of Texas waffle iron molds

D497,334 Texas Grille Insert
D497,333 Texas Grille Insert
D492,625 Texas Grille Insert
D492,624 Texas Grille Insert
D488,674 Texas Mug
D418,447 T shirt compressed in the shape of the state of Texas
D282,136 Texas meat press

In Cumberland Pharmaceuticals, Inc.v. Mylan Institutioal LLC, [2016-1155, 2016-1259] (January 26, 2017) the Federal Circuit affirmed the district court holding that U.S. Patent No. 8,399,445, which describes and claims acetylcysteine compositions substantially free of chelating agents, was not derived from the FDA.

Mylan argued that the claimed invention was obvious from the FDA’s action on Cumberland’s petition to market the predecessor composition that contained a chelating agent.  The FDA asked Cumberland for data supporting the function of the chelating agent, which Mylan argued was proof that the FDA conceived of the idea of acetylcysteine free of chelating agents.

The district court found that Mylan proved neither (1) that anyone at the FDA conceived of the claimed invention before the  patent named inventor nor (2) that there was a reasonable expectation that the claimed formulations, without any chelating agents, would succeed.  The Federal Circuit agreed, noting “[a] request for justification of the inclusion of EDTA, supported by data, is not the same as a suggestion to remove it, let alone to remove it and not replace it with another chelating agent.” The Federal Circuit also rejected the argument that the FDA’s request for data to support the inclusion of EDTA required Cumberland to undertake
research that would have inevitably led it to the invention. Noting that derivation is not proved by showing conception and communication of an idea different from the claimed invention even where that idea would make the claimed idea obvious.

In Eli Lilly and Company v. Teva Parenteral Medicines, Inc., [2015-2067] (January 12, 2017), the Federal Circuit affirmed judgment of inducement of infringement of U.S. Patent No. 7,772,209, and that the the asserted claims were not invalid for indefiniteness, obviousness, or obviousness-type double patenting.

The claims in suit all required pretreatment by administration of folic acid.  The parties agreed, for purposes of appeal, that no single actor performs all steps of the asserted claims.  Rather, the steps are divided between physicians and patients. Though physicians administer vitamin B12 and
pemetrexed, patients self-administer folic acid with guidance from physicians.  Specifically, the Physician Prescribing Information and the Patient Information accompanying the product instructed the patient to self-administer folic acid.

The Federal Circuit noted that where no single actor performs all steps of a method claim, direct infringement only occurs if the acts of one are attributable to the other such that a single entity is responsible for the infringement.  The performance of method steps is attributable to a single entity in two types of circumstances: (1) when that entity directs or controls others performance, or (2) when the actors form a joint enterprise.  In  Akamai V, the Federal Circuit held that directing or controlling others’ performance includes circumstances in which an
actor: (1) conditions participation in an activity or receipt of a benefit upon others’ performance of one or more steps of a patented method, and (2) establishes the manner or timing of that performance.  However the Federal Circuit also said that other factual scenarios may arise which warrant attributing others’ performance of method steps to a single actor.

Regarding the first Akamai V prong, the district court found from the product labelling that “taking folic acid in the manner specified is a condition of the patient’s participation in [the] treatment.”  Regarding the
second prong, the district court found that physicians would “prescrib[e] an exact dose of folic acid and direct[] that it be ingested daily.” The district court concluded that the performance of all steps of the
asserted claims would be attributable to the prescribing physicians. The Federal Circuit agreed, finding the record replete with evidence that physicians delineate the step of folic acid administration that patients must perform if they wish to receive pemetrexed treatment.  The Federal Circuit further found that the evidence regarding the critical nature of folic acid pretreatment and physicians’ practices supported a finding that physicians cross the line from merely guiding or instructing patients to take folic acid to conditioning the treatment on their administration of folic
acid.  The Federal Circuit rejected the argument that an actor
can only condition the performance of a step by imposing a legal obligation to do so, by interposing that step as an unavoidable technological prerequisite to participation, or both.  Conditioning is not limited to legal obligations or technological prerequisites.

The Federal Circuit also found sufficient control over the manner and timing of performance, again relying upon the written instructions and the testimony.

Although the Federal Circuit found that the two-prong Akamai V
test was met, it did not end the inquiry because the patent owner also has the burden of further proving “specific intent and action to induce
infringement.”  Takeda argued that Lily did not show what physicians do, just what they may do.  The Federal Circuit rejected this argument, finding taht the label simply must encourage, recommend, or promote infringement, and that it is irrelevant that some users may ignore the warnings in the proposed label.

The Federal Circuit rejected arguments that “Vitamin B12” made the claims indefinite, and arguments that the claims were obvious, and that they were invalid for obviousness type double patenting.

In Asmark Danmark A/S v. CMI USA Inc., [2016-1026, 2016-1183] (December 6, 2016), the Federal Circuit affirmed the district court’s rulings on infringement,
invalidity, and damages, but remanded as to the injunction insofar as it covered conduct of Cooler Master (who was not a party) that goes beyond abetting a new violation by CMI.

The Federal Circuit said that the standards for reaching conduct by persons
not adjudicated liable for the underlying wrong, reflected in Federal Rule of Civil Procedure 65(d), are highly fact specific, and the Federal Circuit said that a determination of the propriety of the injunction’s reach “would benefit from further findings and, if sought and needed, further record development.”

The district court granted the prevailing patent owner’s motion for an injunction against both CMI and Cooler Master, even though Cooler Master had dismissed as a party.
Cooler Master appealed the injunction, and rejoined as a party.  Cooler Master argued that its dismissal with prejudice precluded the district court from subjecting Cooler Master to the injunction’s obligations, and that in any event the injunction is too broad in scope insofar as the injunction reaches Cooler Master’s conduct (sale, importation, etc., involving the products other than conduct that abets a new violation by CMI, the only party adjudicated liable for infringement.

The Federal Circuit said that Cooler Master did not argue that the district
court lacked personal jurisdiction; that Cooler Master lacked notice
or an opportunity to be heard; or that the injunction is improper under eBay, or because Cooler Master does not sufficiently threaten to engage in the covered conduct. Cooler Master’s complaint was that the challenged obligations imposed on Cooler
Master were improper for reasons it could invoke if they were imposed through contempt.

The Federal Circuit rejected Cooler Master’s contention that it could not be enjoined because the dismissal with prejudice was an adjudication that has claim-preclusive effect. While the premise was correct, the “claim” covered by the dismissal, which concerned Cooler Master’s pre-dismissal conduct, which was different from the conduct subject to the injunction, which is Cooler Master’s future conduct.

The fundamental principle relevant to appellants’ narrower, scope objection to the injunction was that an injunction may not “make punishable the conduct of persons who act independently and whose rights have not been adjudged according to law.  However, the Federal Circuit said that an injunction may reach certain conduct by persons not held liable where the conduct is not undertaken “independently” of the persons who have been held liable.  The injunction imposed two sorts of obligations
on Cooler Master—it restricts conduct by Cooler Master that abets a new violation by CMI; but  it also restricts conduct by Cooler Master that does not abet a new violation by CMI.  The Federal Circuit found that there is a there is a current live dispute about the permissibility of barring Cooler Master from engaging in U.S.-focused activities involving the infringing products other than through CMI.  The Federal Circuit did not think it advisable to resolve the issue of the proper scope of the injunction without a fuller picture of the facts described by the district court, so it remanded the case for further development of the record, while leaving the injunction intact.

In In re Nuvasive, Inc., [2015-1672, 2015-1673] (November 9, 2016), the Federal Circuit reversed one of two PTAB decisions because the patent owner was not given adequate notice of the grounds of invalidity asserted against the patent.  The Federal Circuit said that the Board’s ultimate reliance on material not adequately identified by petitioner in the cited reference, together with the Board’s refusal to allow NuVasive to respond
fully once that material was called out, violated NuVasive’s rights under the Administrative Procedure Act.

The Federal Circuit described the Board’s conduct:

NuVasive objected to Medtronic’s argument regarding

Michelson’s Figure 18, which it contended was a new ground of invalidity asserted for the first time on reply. It requested leave to file motions to strike or, alternatively, surreplies, which the Board denied. NuVasive also attempted to address the matter at oral argument, but the Board refused to allow NuVasive to make substantive arguments in response. When Medtronic made arguments relating to Michelson’s Figure 18 in its rebuttal time, NuVasive objected again, but the Board assured NuVasive that it understood NuVasive’s position and would consider the propriety of Medtronic’s arguments when making a final decision.

Under the Administrative Procedure Act, the Federal Circuit must “hold unlawful and set aside agency action . . . not in accordance with law [or] . . . without observance of procedure required by law.” 5 U.S.C. § 706. A patent owner is undoubtedly entitled to notice of and a fair opportunity to meet the grounds of rejection, based on due-process and APA guarantees.   For a formal adjudication like the inter partes review considered here, the APA imposes particular requirements on the PTO: The agency must timely inform the patent owner of the matters of fact and law asserted, 5 U.S.C. §554(b)(3),
must provide all interested parties opportunity for the submission and consideration of facts and arguments and hearing and decision on notice, 5 U.S.C. §554(c), and must allow a party to submit rebuttal evidence as may be required for a full and true disclosure of the facts, 5 U.S.C. § 556(d).

The Federal Circuit said that although the Board is not limited to citing only portions
of the prior art specifically drawn to its attention, in this case it is clear that the Board treated Michelson’s Figure 18 as an essential part of its obviousness findings
identifying claim elements in the prior art.  Under the APA’s standards, NuVasive was entitled to an adequate opportunity to respond to the asserted facts about Michelson. And under the APA’s fact-specific standard, common sense, and this court’s precedent, that entitlement was not lessened in this case by virtue of the opportunity NuVasive had to respond to other factual assertions about Michelson.

In one of the IPRs the Federal Circuit found that the Notice was adequate, based upon the way that the reference  was described in the Petition, but in the other there was no notice before NuVasive filed its patent owner response.  It was only after the petitioner’s reply that NuVasive as given fair notice, but at no point after the Reply did the Board give NuVasive the required opportunity to respond to that point.

In REG Synthetic Fuels, LLC v. Neste Oil Oyj, [2015-1773] (November 8, 2016), the Federal Circuit affirmed-in-part, reversed-in-part, vacated-in-part, and remanded the PTAB’s unpatentability determinations or claims U.S. Patent No. 8,231,804 directed to paraffin compositions
containing primarily even-carbon-number paraffins, and the Board’s exclusion of certain REG exhibits.

REG complained that the allegedly anticipatory reference discloses area percentages rather than the claimed weight percentages, and petitioners conversion of the area percentages to weight percentages was unreliable.  The Federal Circuit agreed with Petitioner that the conversion was reliable, relying in part upon REG’s own expert who agreed that the conversion could be calculated, concluding that substantial evidence supported anticipation.

With respect to anticipation by other claims, the Federal Circuit found that REG had successfully antedated the allegedly anticipating reference based on admitted exhibits, and exhibits that the Board improperly excluded.   With respect to the excluded exhibits, the Board partially excluded emails with a third party in which the inventor disclosed his conception of the invention on grounds of hearsay.  However, the significance of the email was that they were written, not their content, and thus the Federal Circuit found that the email should not have been excluded.

The Federal Circuit reversed the exclusion of evidence, and based upon the evidence of conception in that improperly excluded evidence, concluded that REG has successfully antedated the reference, and reversed the finding of anticipate.