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Not a Well-Crafted Housing: Product-by-Process Claim Element Isn’t Limiting

by | Aug 25, 2022 |

The US Court of Appeals for the Federal Circuit affirmed a ruling that certain claims reciting a “housing . . . being cast in one piece” should be construed as a product-by-process claim element and affirmed the subsequent finding of invalidity of all challenged claims. Kamstrup A/S v. Axioma Metering UAB, Case No. 21-1923 (Aug. 12, 2022) (Reyna, Mayer, Cunningham, JJ.)

Kamstrup owns a patent directed to an ultrasonic flow meter housing in the form of a monolithic polymer structure that is cast in one piece. The patent specification explains that the invention can be fabricated with fewer steps compared to existing meters, since only a single step is used to form the monolithic polymer structure. Axioma petitioned for inter partes review of all claims of the patent, and the Patent Trial & Appeal Board (Board) found each claim unpatentable as either obvious or anticipated.

The Board construed the claim term “being cast in one piece” to be a product-by-process claim element. Kamstrup did not present any evidence showing that this claim element provided structural or functional differences distinguishing the housing itself from the prior art, and therefore the Board determined that the housing element was not entitled to patentable weight. The Board subsequently invalidated the independent claim and various dependent claims based on a prior art meter having a housing. The Board also found the remaining dependent claims to be invalid based on two additional references, which the Board determined were sufficiently analogous to flow meter technology to merit consideration in its obviousness analysis.

On appeal, Kamstrup challenged the Board’s product-by-process construction. The Federal Circuit explained that product-by-process claiming is designed to enable an applicant to claim an otherwise patentable product that resists definition other than by the process by which it is made. Where a product-by-process claim element is implicated, structural and functional differences distinguishing the claimed product from the prior art must be shown in order for that claim element to be relevant (limiting) to the anticipation or obviousness inquiry. If no structural or functional differences are shown, the element is given no patentable weight. Turning to the claim element at issue, the Court found that the plain meaning of the term “housing . . . being cast in one piece” implicated a product-by-process interpretation since it described the structure “being” cast in a particular way. The Court also affirmed the Board’s finding of invalidity because Kamstrup failed to identify any disclosure in the specification, prosecution history or extrinsic evidence of any structural or functional differences between the housing element as claimed and the prior art.

Kamstrup also argued that the two secondary prior art references were not analogous prior art because they fell within the field of “medical devices for thermodilution,” and therefore they should not be included in an obviousness analysis. The Federal Circuit disagreed, finding that the references were directed to “sensing or measuring fluid flow and fluid flow characteristics such as temperature,” which is related to “flow meters that include different types of sensors.”



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Since Vacatur Seeks Equitable Relief, Clean Hands Matter

by | Jun 30, 2022 |

In an opinion related to its 2021 ruling that a decision in earlier inter partes reexaminations of related patents had a preclusive effect that collaterally estopped the Patent Trial & Appeal Board (Board) from making new findings on the same issue, the US Court of Appeals for the Federal Circuit vacated the Board’s decision on remand since the patent at issue expired. SynQor, Inc. v. Vicor Corp, Case No. 20-1259 (Fed. Cir. Jun. 17, 2022) (Chen, Prost, JJ.), (Lourie, J., dissenting) (non-precedential).

Background

After being sued by SynQor, Vicor petitioned for reexamination of several SynQor patents (including the ’021 and ’190 patents). In the ’190 patent reexamination proceeding, Vicor successfully argued that the ’190 patent claims (including new claims sought to be added by SynQor) were unpatentable over two references. After appeals to the Board (which reversed the examiner) and Federal Circuit (which reversed-in-part, vacated-in-part), the case was remanded to the Board to consider the examiner’s obviousness rejections in light of the Court’s conclusion that prior art patents anticipated certain claims.

On remand, the Board affirmed almost all of the examiner’s rejections and applied a new ground of rejection to one of SynQor’s proposed new claims. However, before the Board issued its final decision regarding the new claims, the ’190 patent expired and SynQor appealed to the Federal Circuit to vacate the Board’s decisions regarding the new claims on the ground that the ’190 patent’s expiration rendered the Board’s patentability decision moot. The Court agreed and vacated the Board’s decisions, explaining that the inability to issue the new claims meant that “the Board’s patentability determinations were unreviewable for mootness” since the Court would be “frustrated by the vagaries of circumstance” (thereby falling under the Supreme Court’s Munsingwear doctrine) from reviewing the Board’s determinations on the merits.

Similarly, in the ’021 patent’s reexamination, the examiner rejected all challenged claims, including two new claims that SynQor proposed. The Board affirmed the examiner’s rejections, and on appeal the Federal Circuit affirmed-in-part, vacated-in-part and remanded for the Board to reconsider two obviousness grounds it deemed the Board had unjustifiably reached inconsistent conclusions on (relative to a separate reexamination proceeding for another related patent). On remand, the Board again found SynQor’s proposed new claims unpatentable, unaware that the ’021 patent had expired over a year prior. In its rehearing petition, SynQor informed the Board of the ’021 patent’s expiration and asked the Board to vacate its decision on the merits. SynQor appealed after the Board declined to do so.

Appeal on the ’021 Patent

On appeal, SynQor requested that the Federal Circuit vacate the Board’s decision (for the same reasoning as in the ’190 patent appeal). Vicor argued that the Court lacked Article III jurisdiction to consider the request, and that SynQor was not entitled to equitable relief because of its failure to inform the Board of the ’021 patent’s expiration date, which caused the remand decision to be issued. Vicor also argued that the timing of the ’021 patent expiring before [...]

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Robotic Skepticism May Not Trump Motivation to Combine

by | May 12, 2022 |

The US Court of Appeals for the Federal Circuit vacated and remanded a Patent Trial & Appeal Board (Board) decision finding the challenged claims patentable because the Board impermissibly rested its motivation-to-combine analysis on evidence of general skepticism in the field of invention. Auris Health, Inc. v. Intuitive Surgical Operations, Case No. 21-1732 (Fed. Cir. Apr. 29, 2022) (Dyk, Prost, JJ.) (Reyna, J., dissenting).

Intuitive owns a patent that describes an improvement over earlier robotic surgery systems that allows surgeons to remotely manipulate surgical tools using a controller. The patent focuses on solving the problem of swapping surgical tools by implementing a pulley system that allows tools to be swapped in and out more quickly. Auris petitioned for inter partes review (IPR) of the patent, arguing that a combination of two references disclosed every limitation of the challenged claims. Auris further argued that a skilled artisan would be motivated to combine the references to decrease the number of assistants needed during surgery. While the Board agreed that the combination of the two references disclosed every limitation of the challenged claims, it found that a person of ordinary skill in the art would not be motivated to combine the references because of general skepticism from surgeons “about performing robotic surgery in the first place.” Auris appealed.

The Federal Circuit began by explaining that the motivation-to-combine inquiry asks whether a skilled artisan “not only could have made but would have been motivated to make the combinations . . . of prior art to arrive at the claimed invention.” The Court also explained that as to the “‘would have’ question, ‘any need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed.’”

The Federal Circuit concluded that generic industry skepticism about robotic surgery cannot, on its own, preclude a finding of a motivation to combine. The Court explained that although industry skepticism can play a role as a secondary consideration in an obviousness finding, such evidence must be specific to the invention and not simply the field as a whole. The Court concluded that the Board’s motivation-to-combine determination was based almost exclusively on evidence of general skepticism. Thus, the Court vacated the decision and remanded the case, directing the Board to examine the evidence using the correct obviousness criteria.

Judge Reyna issued a dissenting opinion in which he disagreed as to whether  the Federal Circuit should implement a rule that general skepticism cannot  support a finding of no motivation to combine. Judge Reyna expressed concern that the majority opinion could be understood to create an inflexible, rigid rule that the Board cannot consider evidence of skepticism toward the invention , including whether that skepticism would have dissuaded a skilled artisan from making the proposed combination. Judge Reyna also argued that notwithstanding the majority opinion, the Board did not rely solely on general skepticism, but rather provided additional explanation as to why the “no [...]

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Federal Circuit Won’t Rescue Parachute Patent

by | Mar 24, 2022 |

The US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board (Board) decision that claims to a ballistic parachute were obvious over the prior art based on knowledge attributable to artisans and denying the patentee’s motion to substitute proposed amended claims, finding that they lacked written description. Fleming v. Cirrus Design Corp., Case No. 21-1561 (Fed. Cir. Mar. 10, 2022) (Lourie, Hughes, Stoll, JJ.)

Cirrus Design filed a petition for inter partes review on certain claims of Fleming’s patent related to ballistic parachute systems on an aircraft. The challenged claims relate to an autopilot system that increases the aircraft’s pitch, reduces the aircraft’s roll or changes the aircraft’s altitude when a ballistic parachute deployment request is made. Fleming moved to amend some of the challenged claims, effectively cancelling those claims. In its final written decision, the Board found the remaining original claims obvious over the prior art and found that the amended claims lacked written description and were indefinite. Fleming appealed both the obviousness determination and the denial of the motion to amend.

Fleming argued that the Board’s obviousness determination was incorrect because the prior art did not disclose the commands to the autopilot to alter the aircraft’s pitch, roll or altitude. The Board acknowledged that neither of the primary prior references included the claimed commands upon the receipt of a deployment request, but nevertheless, concluded that a person of ordinary skill in the art would have had the motivation to combine the prior art disclosures to arrive at the claimed invention. The Federal Circuit concluded that the Board’s findings were supported by substantial evidence, citing to the Supreme Court’s 2007 KSR decision for the proposition that it is appropriate to consider a person of ordinary skill in the art’s knowledge, creativity and common sense, so long as they do not replace reasoned analysis and evidentiary support. Here the Court noted with approval the Board’s finding that aircraft autopilots are programmable and can perform flight maneuvers and deploy a parachute. The Court also noted that an artisan would have understood that certain maneuvers, such as stabilizing at an appropriate altitude, should be performed prior to deploying a whole-aircraft parachute. The Board concluded that a person of ordinary skill in the art would be motivated to reprogram the autopilot to take Fleming’s proposed actions prior to releasing the parachute to improve safety outcomes.

Fleming also appealed the Board’s rejection of his argument that the prior art taught away from claimed invention because a person of ordinary skill in the art would deem the combination unsafe. He argued that the prior art taught that autopilot systems should not be used in the sort of emergency situations that would lead to the deployment of a ballistic parachute. The Board rejected that argument, and the Federal Circuit found that the substantial evidence supported the Board’s determination that the prior art did not teach that a person of ordinary skill in the art would never use an autopilot system during [...]

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Apply That Formulation: Presumption of Obviousness Based on Overlapping Ranges

by | Mar 24, 2022 |

The US Court of Appeals for the Federal Circuit found a method of treatment claims pertaining to topical formulations to be obvious, applying the presumption of obviousness of overlapping ranges theory. Almirall, LLC v. Amneal Pharmaceuticals LLC & Amneal Pharmaceuticals of New York, LLC, Case No. 020-2331 (Fed. Cir. Mar. 14, 2022) (Lourie, Chen, Cunningham, JJ.)

Almirall’s patent generally claims methods of treating acne or rosacea with formulations containing certain concentrations or concentration ranges of dapsone and acryloyldimethyl taurate (a type of thickening agent known as A/SA). The claims also contain a negative claim limitation of “wherein the topical composition does not comprise adapalene.”

In a final written decision, the Patent Trial & Appeal Board (Board) relied on three main references in its finding that the challenged claims would have been obvious. One reference (Garrett) disclosed dapsone formulations with a different type of thickening agent (Carbopol®). Garrett did not disclose any formulations that contained adapalene. Another reference (Nadau-Fourcade) described formulations containing exemplary types of thickeners, including both Carbopol® and A/SA agents. The last reference (Bonacucina) disclosed dispersions containing sodium acryloyldimethyl taurate that can be used for topical administration. All three references disclosed formulations with thickening agents within the claimed ranges.

The Board applied a presumption of obviousness based on the overlapping ranges of the thickening agents and ultimately concluded that it would have been obvious to a person of ordinary skill in the art (POISTA) to substitute the A/SA agents taught in either Nadau-Fourcade or Bonacucina for the Carbopol® agent disclosed in Garrett. The Board found that the claimed range of thickening agents overlapped with Garrett, Nadau-Fourcade and Bonacucina. The Board also relied on an expert presented by Amneal who testified that a POSITA would have appreciated that the different gelling agents are interchangeable to find a reasonable expectation of success in terms of a rationale for combing the prior art.

Almirall appealed, contending that the Board erred in presuming obviousness based on the overlapping ranges found in the prior art references. Almirall argued that the presumption of obviousness only applies when a single reference discloses all the claimed ranges, whereas the Board relied on different references to create the presumption (Garrett with either Nadau-Fourcade or Bonacucina). Citing the evidence showing the interchangeability of the two different types of thickeners, the Federal Circuit found that the Board did not err in applying the presumption, citing to its 2018 case of E.I. du Pont de Nemours & Co. v. Synvina: “[t]he point of our overlapping range cases is that, in the absence of evidence indicating that there is something special or critical about the claimed range, an overlap suffices to show that the claimed range was disclosed in—and therefore obvious in light of—the prior art.” The Court also noted that this case did not turn on the presumption, since the combination of prior art was simply involved the substitution of one known thickening agent for another as there was no evidence to challenge the substitutability.

The Federal Circuit [...]

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Hypothetical Device Doesn’t Meet Domestic Industry Requirement

by | Mar 17, 2022 |

In a consolidated appeal from the International Trade Commission (Commission) and two inter partes review (IPR) proceedings before the Patent Trial & Appeal Board (Board), the US Court of Appeals for the Federal Circuit affirmed the Commission’s findings that a hypothetical device does not meet the domestic industry requirement, as well as findings by the Board and the Commission that asserted claims of the involved patents were invalid as obvious. Broadcom Corp. v. ITC, Case Nos. 20-2008; 21-1260, -1362, -1511 (Mar. 8, 2022) (Lourie, Hughes, Stoll, JJ.)

Broadcom filed a complaint at the Commission alleging a violation of 19 U.S.C. § 1337 based on products imported by many respondents, including Renesas Electronics, that allegedly infringed two patents. The first patent is directed to reducing power consumption in computer systems, and the second patent is directed to a memory access unit that improves upon conventional methods of requesting data located at different addresses within a shared memory. The Commission’s administrative law judge issued an initial determination that Broadcom failed to satisfy the technical prong of the domestic industry requirement for the power consumption patent and that one of the asserted claims of the memory access patent was obvious over the prior art. The Commission affirmed both findings.

During the course of the Commission investigation, Renesas petitioned for IPR of both patents. The Board found that two asserted claims of the power consumption patent were obvious but Renesas failed to show that six other asserted claims would have been obvious. The Board also found that all petitioned claims of the memory access patent would have been obvious over the cited art.

Both parties appealed. Renesas appealed the Board’s ruling that six claims of the power consumption patent would not have been obvious in light of the cited art, and Broadcom appealed the Board’s ruling that two claims of the power consumption patent and five claims of the memory access unit patent would have been obvious. Broadcom also appealed the Commission’s decision that there was no violation with respect to the power consumption patent and that the asserted claims of the memory access unit patent would have been obvious.

The Federal Circuit first addressed the Commission’s decision that there was no domestic industry for the power consumption patent. Citing its 2013 decision in Microsoft Corp. v. ITC, the Court explained that a complainant must show that a domestic industry product exists that actually practices at least one claim of the asserted patent. Broadcom identified its System on a Chip (SoC) as a domestic industry article, but there was no dispute that the SoC did not contain a “clock tree driver” required by the asserted claims. To overcome this admitted deficiency, Broadcom argued that a domestic industry existed because Broadcom collaborates with customers to integrate the SoC with external memory to enable retrieval and execution of the clock tree driver feature. The Court rejected this argument, finding that Broadcom posited only a hypothetical device and failed to identify a specific integration [...]

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Count On It, Plural Term Means More Than One

by | Mar 17, 2022 |

The US Court of Appeals for the Federal Circuit affirmed Patent Trial & Appeal Board (Board) patentability decisions after determining that the Board did not err in construing multiple terms within the challenged patents. Apple Inc. v. MPH Technologies Oy, Case Nos. 21-1532; -1533; -1534 (Fed. Cir. Mar. 9, 2022) (Moore, C.J.; Prost, Taranto, JJ.)

MPH owns three patents related to a method for forwarding a message from a first computer to a second computer via an intermediate computer via a network and provides secure message forwarding without relying on any extra encapsulation overhead. Apple petitioned for inter partes review (IPR) of MPH’s patents, challenging the claims in the three patents as obvious over a combination of non-patent literature (RFC3104) and a US patent (Grabelsky). During the proceedings, a series of claim construction disputes were raised. The Board issued final written decisions, finding that Apple failed to show that some claims would have been obvious over the combination of RFC3104 and Grabelsky. Apple appealed.

In seeking to overturn the Board’s decision, Apple raised four claim construction disputes. First, Apple argued that the Board erred in finding that the claim limitation “information fields” requires “two or more fields.” Apple argued that “a plural term covers one or more items” and thus the claim limitation was taught by Grabelsky, which uses a single field. Apple further argued that a word such as “plurality” must be used to clarify that the limitation requires more than one item. The Federal Circuit rejected Apple’s argument, explaining that common English usage presumes that a plural term refers to two or more items. The Court found that the Board did not err in construing the claim limitation because the term “information fields” is plural, thus requiring more than one field, and nothing in the claim language or written description suggested otherwise.

Second, Apple argued that the Board’s interpretation that the message was sent from the mobile computer directly to the first address was inconsistent with the claim limitation “intermediate computer configured to receive from a mobile computer a secure message sent to the first network address” in one of MPH’s patents. Apple argued that the passive language of the claim limitation suggested that “the mobile computer need not send the message to the first network address so long as the message is sent there eventually,” and thus the claim limitation was taught by RFC3104, in which a message sent to a first network address is received at another address before being forwarded to the first network address. The Federal Circuit rejected Apple’s arguments, finding that the Board did not err in construing the claim limitation because the plain language established direct sending of the message from the mobile computer to the first address, and nothing in the remainder of the claims or written description suggested otherwise.

Third, Apple argued that the Board erred in construing the term “substitute” in the claim limitation “substitute the unique identity read from the secure message with another unique identity prior to [...]

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Long-Felt Need Not Felt Long Enough to Overcome Obviousness

by | Feb 24, 2022 |

The US Court of Appeals for the Federal Circuit upheld a finding that patents covering Narcan, a naloxone-based intranasal opioid overdose treatment, were obvious despite evidence of long-felt need. Adapt Pharma Operations Ltd. v. Teva Pharms. USA, Inc., Case No. 20-2106 (Fed. Cir. Feb. 10, 2022) (Prost, Stoll, JJ.) (Newman, J., dissenting).

In 2012, during the growing opioid crisis, the US Food & Drug Administration (FDA) identified a need for an improved intranasal naloxone treatment that could be FDA-approved and deliver the same amount of naloxone to the blood as an injectable formulation. In 2015, Adapt filed a patent application for Narcan, a method of nasally administering naloxone using about 4 mg of naloxone, benzalkonium chloride (BZK) and three other excipients. After Teva submitted an abbreviated new drug application (ANDA) to sell a generic version of Narcan, Adapt sued Teva for infringement. After a two-week bench trial, the district court determined that Adapt’s patents were obvious in view of prior art. Adapt appealed.

The Federal Circuit found no error in the district court’s conclusions that a skilled artisan would have been motivated to combine the prior art, that the prior art did not teach away from the claimed combination and that Adapt’s evidence regarding unexpected results, copying and industry skepticism was not probative of nonobviousness. The Court noted that a skilled artisan would have been motivated to improve on existing treatments because their shortcomings were well known, and the FDA had explicitly identified a need for an improved intranasal product. The claimed excipients also were separately taught in the prior art within the claimed concentration ranges. The Court agreed that a skilled artisan would have been motivated to combine these components to achieve the tonicity and pH required for a drug to be tolerable in the nose and to preserve and stabilize the formulation. While the prior art suggested that BZK causes naloxone degradation, the Court found that this did not teach away from its use because BZK was commonly used in intranasal formulations.

Turning to secondary considerations of nonobviousness, the Federal Circuit affirmed the following:

  • Narcan’s 56% increase in bioavailability was not “evidence of unexpected results” because BZK was a known permeation enhancer expected to increase bioavailability.
  • “[C]opying in the ANDA context is not probative of nonobviousness because . . . bioequivalence is required for FDA approval.”
  • The FDA’s recommendation to increase naloxone dosage in intranasal formulations negated any alleged industry skepticism regarding the higher dosage.

While the Federal Circuit found that the district court erred in finding there was no long-felt but unmet need for an effective intranasal naloxone product, the Court concluded that this error was harmless because the long-felt need began just three years before the patents’ priority date, which was not long enough to overcome the “strong case of obviousness . . . in view of the plethora of prior art.” The Court further agreed that competitors’ alleged failure to obtain FDA approval was not probative of nonobviousness and ultimately affirmed the district [...]

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Specification Sheds Light on Broadest Reasonable Interpretation

by | Feb 17, 2022 |

The US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board (Board) obviousness decision, finding that the Board did not err in restricting the broadest reasonable interpretation of a claim term based on its use in the specification. Quanergy Systems, Inc. v. Velodyne Lidar USA, Inc., Case Nos. 20-2070; -2072 (Fed. Cir. Feb. 4, 2022) (Newman, Lourie, O’Malley, JJ.)

Velodyne owns a patent directed to a lidar-based 3D point cloud measuring system that can be used in self-driving vehicles to sense their surroundings. Quanergy petitioned for inter partes review of Velodyne’s patent, challenging the claims as obvious over a Japanese patent application (Mizuno). During the proceedings, the Board construed the broadest reasonable interpretation of the term “lidar (light detection and ranging)” to mean “pulsed time-of-flight (ToF) lidar” based on the written description of Velodyne’s patent and found that Mizuno’s system was not a ToF lidar system. The Board also presumed a nexus between the claimed pulsed ToF lidar system and Velodyne’s evidence of commercial success, relying on mapping the features of the claimed ToF lidar system to Velodyne’s commercial products. Based on its obviousness analysis and presumption of nexus, the Board issued final written decisions, finding that Velodyne’s patent was not unpatentable as obvious. Quanergy appealed.

Quanergy raised two arguments on appeal: The Board erred in its construction of the term “lidar,” and the Board erred in its obviousness analysis. Addressing claim construction, Quanergy argued that the Board did not use the broadest reasonable interpretation of “lidar” since “lidar” merely requires the use of laser light for detection and ranging, and thus “lidar” includes not only “pulsed ToF lidar” but also triangulation and other detection techniques described in Mizuno. The Federal Circuit rejected Quanergy’s argument, finding that the Board did not err in construing the term “lidar” according to its broadest reasonable interpretation because the written description focuses exclusively on “pulsed ToF lidar.”

Turning to obviousness, Quanergy argued that the Board erred in concluding that Velodyne’s claims were nonobvious over Mizuno because the expert testimony that the Board relied upon focused only on one particular embodiment of Mizuno’s device, which was not directed to a pulsed ToF lidar system. The Federal Circuit rejected this argument, finding that the Board did not err because Mizuno described “detect[ing] light reflected at an angle using position or image sensors, neither of which are used in pulsed time-of-flight lidar systems.” Based on this description, the Court found that Mizuno’s device was not a ToF lidar system.

Quanergy also argued that the Board failed to consider the issue of unclaimed features before presuming nexus. Quanergy argued that Velodyne’s evidence of commercial success related to those unclaimed features, such as a 360-degree horizontal field of view, a wide vertical field of view, a dense 3D point cloud and software, all of which were critical and materially impacted the functionality of Velodyne’s products. The Federal Circuit rejected this argument, finding that the Board did not err in finding a presumption of nexus [...]

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Seeing Eye to Eye: Preliminary Injunction Affirmed for Patent Filed After Accused Product Was Sold

by | Feb 17, 2022 |

The US Court of Appeals for the Federal Circuit affirmed the grant of a preliminary injunction, finding that the district court did not abuse its discretion, clearly err in its underlying factual findings or abuse its discretion in setting the scope of the preliminary injunction. BlephEx, LLC v. Myco Indus., Inc., Case Nos. 2021-1149; -1365 (Fed. Cir. Feb. 3, 2022) (Moore, Schall, O’Malley, JJ.)

Myco sells AB Max, a mechanical device with an attached swab used for treating an eye condition known as blepharitis. Myco began marketing AB Max at a trade show in February 2019. One month later, BlephEx filed an application that later issued as a patent. The patent is directed toward cleaning debris from an eye during treatment of ocular disorders, including blepharitis. According to the patent, prior art treatment for blepharitis included at-home treatment where the patient would use a cotton swab, fingertip or scrubbing pad to scrub the eyelid margin in order to remove debris. Patients would often fail to adequately cleanse the eyelid margin, however. The patent’s solution is an electromechanical device with an attached swab for use by an eyecare professional to clean the patient’s eyelid margins.

The day the patent issued, BlephEx sued Myco and its chairman, John R. Choate, alleging that Myco’s AB Max infringed BlephEx’s newly issued patent. BlephEx moved the district court for a preliminary injunction prohibiting Myco from selling, distributing or offering the AB Max for sale. Myco opposed, arguing that a prior art reference (Nichamin) raised a substantial question of invalidity. The district court disagreed with Myco and granted the injunction. The district court noted that to anticipate, a prior art reference must disclose all elements of a claim arranged as in the claim, and Nichamin did not disclose combining the electromechanical applicator device depicted in one embodiment with a swab disclosed in another. The district court also rejected Myco’s argument that the patent examiner failed to consider Nichamin because he did not substantively discuss it during prosecution. The district court further rejected Myco’s obviousness argument as unsupported by expert evidence, finding Myco failed to overcome “the safety concerns of attaching a swab that is soaked in an abrasive to the Nichamin hand-held device.”

After the district court granted the preliminary injunction, Myco moved for reconsideration and argued that the preliminary injunction was overbroad because the AB Max had noninfringing uses. The district court rejected Myco’s argument, finding it was untimely and presented hypothetical noninfringing uses that were “outweighed by evidence that the only actual use of the AB Max was to treat anterior blepharitis,” which would likely infringe the asserted patent. Myco appealed.

The Federal Circuit affirmed the preliminary injunction grant. With respect to Myco’s anticipation argument, the Court found “Myco offers nothing other than attorney argument as to what the highly skilled artisan would do,” and this was insufficient to raise a substantial question of validity. The Court also noted that Myco had “put all of its eggs in the anticipation basket” and fatally failed [...]

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