`JS 44 (Rev. 10/20) - TXND (10/20)
`
`Case 3:21-cv-01166-X Document 1-14 Filed 05/21/21 Page 1 of 1 PageID 177Case 3:21-cv-01166-X Document 1-14 Filed 05/21/21 Page 1 of 1 PageID 177
`The JS 44 civil cover sheet and the information contained herein neither replace nor supplement the filing and service of pleadings or other papers as required by law, except as
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`JUDGE
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`MAG. JUDGE
`
`High Energy Ozone LLC d/b/a Far-UV Sterilray and S.
`Edward Neister
`
`Strafford County
`
`Kaufman County
`
`King & Spalding LLP. 500 West 2nd St., Austin, TX 78701
`(512) 457-2000
`
`Larson Electronics LLC
`
`6
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`6
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`35 U.S.C. §§ 100 et seq
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`This is an action for Infringement of US Patent Nos. 8,975,605 and 9,700,642
`
`6
`
`6
`
`May 21, 2021
`
`/s/Jill R. Carvalho
`
`1
`
`EXHIBIT 1019
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`
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`
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`Case 3:21-cv-01166-X Document 1 Filed 05/21/21 Page 1 of 38 PageID 1Case 3:21-cv-01166-X Document 1 Filed 05/21/21 Page 1 of 38 PageID 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF TEXAS
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`Civil Action No.
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`3:21-cv-1166
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`JURY TRIAL DEMANDED
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`))
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`)
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`)))))))
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`)
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`HIGH ENERGY OZONE LLC d/b/a FAR-
`UV STERILRAY and S. EDWARD
`NEISTER,
`
` Plaintiffs,
`
`
`
`v.
`
`LARSON ELECTRONICS LLC,
`
` Defendant.
`
`COMPLAINT
`
`Plaintiffs High Energy Ozone LLC d/b/a Far-UV Sterilray (“HEO3”) and Mr.
`
`S. Edward Neister (“Mr. Neister”) (collectively, “Plaintiffs”), allege as follows:
`
`INTRODUCTION
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`1. More than fifteen years ago, physicist S. Edward Neister developed and
`
`patented methods for deactivating or destroying harmful microorganisms using a
`
`new spectrum of ultraviolet (UV) light. Mr. Neister’s methods included the
`
`development and use of Krypton-Chloride excimer lamps that emit a peak
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`wavelength at 222 nm in conjunction with other wavelengths. Unlike the 254 nm
`
`UV light—which had been used for decades for sanitization but was dangerous to
`
`humans—applying 222 nm UV light does not penetrate human skin or eyes, making
`
`it far better and more useful than traditional lamps and methods of use.
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`2. Mr. Neister’s patented technology became the foundation for the family
`
`business. Mr. Neister and his brother John Neister originally founded the company
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`2
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`
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`that would become HEO3 in 2005 in a small town in New Hampshire. HEO3 is
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`producing and selling lamps designed to perform Mr. Neister’s patented methods of
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`killing harmful microorganisms.
`
`3.
`
`The global COVID-19 pandemic took the world by surprise in early
`
`2020, but the hard work of and vision by the Neister brothers anticipated such a
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`crisis. Their Excimer Wave Sterilray™ technology, products, and patented methods
`
`positioned HEO3 to be a global leader in UV light disinfection technology, providing
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`sanitization devices to aid in the fight against the disease.
`
`4.
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`As a result of the pandemic, interest in UV light disinfection technology
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`reached new heights. Market entrants sprung forth to capitalize on sanitization
`
`using far-UV light in the 222 nm range—including through unauthorized use of
`
`HEO3’s patented technology.
`
`5. HEO3’s patented technology asserted in this case includes U.S. Patent
`
`Nos. 8,975,605 (the “’605 patent”) and 9,700,642, (the “’642 patent”) (collectively, the
`
`“Asserted Patents”), true and correct copies of which are attached hereto as Exhibits
`
`1 and 2, respectively.
`
`6. Defendant Larson Electronics LLC (“Larson”), founded in 1973, is one
`
`such company trading on HEO3’s patented technology. As described below, multiple
`
`Larson products utilize HEO3’s patented systems and methods.
`
`7.
`
`To protect its hard-earned intellectual property rights, HEO3 sent a
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`notice letter to Larson to notify it of HEO3’s patents and to offer to open licensing
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`discussions, a true and correct copy of which is attached as Exhibit 3. But still
`
`Larson refused to cease its infringing activities. This action followed.
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`2
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`3
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`
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`NATURE OF THE ACTION
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`8.
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`This is an action for infringement of the ’605 patent and the ’642 patent
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`pursuant to the Patent Laws of the United States of America, 35 U.S.C. §§ 100 et
`
`seq.
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`PARTIES
`
`9.
`
`Plaintiff HEO3 is a company organized and existing under the laws of
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`the State of New Hampshire with its principal place of business at 30 Centre Road,
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`Suite 6, Somersworth, NH 03878.
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`10. Plaintiff S. Edward Neister resides and works in the state of New
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`Hampshire. He is the founder of HEO3 and its Chief Technology Officer.
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`11. On information and belief, Defendant Larson is a corporation organized
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`and existing under the laws of the State of Texas with its principal place of business
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`at 9419 U.S. Highway 175, Kemp, TX 75143.
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`JURISDICTION AND VENUE
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`12. This Court has subject matter jurisdiction over this action under at
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`least 28 U.S.C. §§ 1331, 1338.
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`13. This Court has personal jurisdiction over Larson because it is
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`incorporated in the State of Texas. On information and belief, Larson maintains its
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`principal place of business in this District.
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`14. Venue is proper in this District under 28 U.S.C. §§ 1391(b)-(c) and
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`1400(b) because Larson maintains its principal place of business in this District and
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`has committed acts of infringement in this District.
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`3
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`4
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`
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`FACTUAL BACKGROUND
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`HEO3’s 222 nm UV Technology
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`15. HEO3 is a leading developer of disinfection equipment using 222 nm
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`UV technology. HEO3’s disinfection technology provides a safe and environmentally
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`sound means of disinfection using far-UV light to kill bacteria, viruses, mold, and
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`fungi in seconds or less. It has been validated by over 40 third-party labs as having
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`a greater than 99.99% effective kill rate.
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`16. HEO3’s technology permits users to sterilize surfaces without harsh
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`chemicals. Additionally, unlike more commonly used UV sterilization techniques,
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`HEO3’s technology is mercury free and does not produce ozone—a significant
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`advance in terms of safety and environmental impact.
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`17. HEO3 offers a wide range of products utilizing its 222 nm UV
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`technology. These include, for example: luminaire fixtures; air and surface
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`disinfection units for disinfecting ambient air and surfaces in a room; surface
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`disinfection rails and disinfection wands for disinfecting surfaces and air; pathogen
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`reduction boxes for disinfecting high-touch items (such as handheld medical
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`equipment) that can be placed inside the boxes; and airduct units for disinfecting
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`air passing through HVAC units.
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`18. HEO3 does business under the tradename Far UV SterilrayTM and its
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`products feature Mr. Neister’s patented Excimer Wave SterilrayTM Technology.
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`Customers across the globe use Excimer Wave SterilrayTM products to create safer
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`work, home, and medical environments.
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`19. As described on its website, HEO3’s goal is to reduce the spread of
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`infections and the burdens of such illnesses on our healthcare system. Over the past
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`year alone, HEO3 has been approached by numerous and diverse organizations—
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`including NFL teams, airlines, and robotic companies that specialize in the
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`disinfection of office spaces, military barracks, public transportation, and
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`hospitals—that have expressed interest in using HEO3’s technology to help prevent
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`spread of COVID-19.
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`20. HEO3’s 222 nm UV technology is described and claimed in the Asserted
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`Patents, on which Mr. Neister is the sole inventor. Mr. Neister has worked in the
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`field of laser and UV light technology for over six decades. Mr. Neister drew on his
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`decades of experience to develop HEO3’s 222 nm UV technology claimed in the
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`Asserted Patents.
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`21. Prior to Mr. Neister’s inventions, UV disinfection methods typically
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`used light at 254 nm generated by mercury-based lamps. Mr. Neister discovered
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`that single line wavelengths emitted from an “excimer” lamp—a lamp using inert
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`gases to generate photons at wavelengths matching the maximum absorption bands
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`for DNA nitrogenous bases, proteins, amino acids, and other component bonds of
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`microorganisms—could be significantly more effective than standard 254 nm
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`photons for destroying DNA. As described in the ’605 patent, “[k]ill action times are
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`reduced from 10’s to 100’s of seconds to times of 0.1 seconds.” Ex. 1 at 4:65-67.
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`22. One of the wavelengths Mr. Neister found to be particularly useful for
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`disinfection was 222 nm, falling within the “far-UV” range. HEO3’s Excimer Wave
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`SterilrayTM products utilize photons at this wavelength, amongst others.
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`5
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`23. Recognizing Mr. Neister’s discoveries, the United States Patent and
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`Trademark Office (“USPTO”) issued the Asserted Patents. Mr. Neister is the sole
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`inventor of the Asserted Patents and related applications that are currently
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`pending.
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`Larson’s Far-UV Sanitation Lighting Products
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`24. Although Larson has been in the lighting business for decades, only
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`with the rise of the COVID-19 pandemic has it begun to manufacture, market, and
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`sell lighting products containing Far-UV wavelengths including 222 nm. Upon
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`information and belief, in or around June 2020, Larson began fabricating and
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`selling products that perform Mr. Neister’s patented processes for destroying or
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`deactivating the DNA or RNA (i.e., the organic bonds and proteins) of
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`microorganisms on substances or surfaces of the Asserted Patents.
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`25.
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`In Larson’s “Far UV Catalog 2020, a true and correct copy of which is
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`attached hereto as Exhibit 4, Larson touts itself as a “one-stop shop for all of your
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`UV sanitation needs,” and it “caters to custom fabrication and rapid engineering for
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`far-UV products”. See Ex. 4, Far UV Catalog 2020, at 2. A search of Larson’s
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`website, www.larsonelectronics.com, reveals more than 120 lighting products for
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`sanitation. These products incorporate either “ozone-free excimer lamps or compact
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`microplasma boards that generate far-UV 222 nm bands.” Id. at 1.
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`26. Larson’s Far UV Catalog 2020 states the following:
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`Far-UV sanitation lights from Larson Electronics are ultraviolet (UV)
`devices for disinfecting surfaces, equipment and the air. These units
`emit far-UV 222 nm light, which is capable of eliminating up to 99% of
`viruses, bacteria, mold and spores. Far-UV 222 nm light is considered to
`be eye and skin safe for humans. Long-term use of far-UV lamps does
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`not cause inflammation, redness or irritation. This time-saving solution
`does not require rooms or spaces to be empty prior to UV treatment.
`Unlike conventional UV 254 nm bands that can cause burns on the skin
`and corneal damage, far-UV wavelengths also do not require personal
`protective equipment during sanitation (see Far-UV Fact Sheet for more
`information). As a result, the far-UV disinfection products in this catalog
`are recommended for use in the following: occupied areas, industrial,
`businesses, commercial locations, transit areas, schools, daycares,
`senior-care facilities, healthcare establishments, hospitals, offices and
`more.
`Ex. 4 at 1.
`
`27.
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`In terms of specific products, Larson states, “[a]ll products in this
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`catalog are equipped with far-UV 222 nm lamps, which can inactivate 99%
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`viruses, bacteria, mold and spores.” Id. at 3. Furthermore, in response to the
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`question, “What types of far-UV 222 nm lights are used in these products?” Larson
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`answers: “[a]rtificial light sources that generate far-UV 222 nm light and are
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`found in the sanitization products in this catalog include excimer lamps and
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`microplasma boards,” and the specialty excimer lamps include “one atom of
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`krypton (Kr) and one atom of chlorine (Cl).” Id. at 4.
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`28. Larson’s website reflects at least three categories of 222 nm light
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`sources that Larson fabricates into lighting products. First, Larson markets and
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`sells a 10W Far UV Microplasma Board – (1) 10W Microplasma Board, 222 nm
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`UVC Sanitation – Delrin Mount - Power Supply with 120V Plug (FRL-EMP-
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`FUVC-MP-10-2X2-KT-120V) (hereinafter, “Microplasma Board”), as shown below.
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`Ex. 5, Microplasma Board Spec Sheet at 1. Larson states that “[t]his unit is Made
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`in USA – Manufactured in Texas.” Id. The product “features a 2” x 2” glass chip
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`and disinfects 99% of viruses, bacteria, mold and spores from ceilings in occupied
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`areas. This eye and skin safe disinfection unit uses one 10-watt microplasma
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`board that emits far-UV 222 nm germicidal light.” Id.
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`29. The Microplasma Board includes the following “Ratings”:
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`Id. “Suggested Applications” include: “Sanitation, disinfection, retail spaces,
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`lobbies, commercial locations, industrial parks, schools, public transportation
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`hubs, airports, office buildings, medical centers, and more; kills 99% of viruses,
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`bacterial, mold, and spores.” Id. at 2.
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`30. Larson fabricates and sells down-light products using one or more of
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`its Microplasma Boards, including the following representative products: Far-UV
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`Sanitation Fixture; Far-UV Recessed Can Light (6”, 8”, 10”, 12”); Far-UV Gimble
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`Track Light; Far-UV Recessed Square Light (6”, 8”, 10”, 12”); 12” Far-UV
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`Sanitation Strip Light; 10W Far-UV Sanitation Light; and 10W Far-UV
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`Disinfection Desktop Light (collectively, “Representative Microplasma Board
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`Products”).
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`31. One such Representative Microplasma Board Product is the Far-UV
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`Recessed 12” Can Light – (1) 10W Microplasma Board, 222 nm UVC Sanitation –
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`Recessed Mount (IND-CDL-RD-12-FUVC-MP-1L-V1). See Ex. 6, Can Light Spec
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`Sheet, and shown below.
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`Larson states, “[t]his eye and skin safe disinfection unit uses one 10-watt
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`microplasma board that emits far-UV 222 nm germicidal light,” and that, “[t]his
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`far-UV unit is capable of achieving up to 3 log (99.9%) cumulative disinfection per
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`day.” Id. at 1-2.
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`32. Additionally, Larson includes the following table:
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`
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`Id. at 2. Larson states, “[w]hen mounted at 8ft or below, this fixture effectively
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`deactivates organisms twice in one hour, and is actively weakening organisms in
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`the air and on surfaces. Airborne organisms will have a higher exposure rate
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`while traveling through the air and closer to the fixture.” Id. Its “Applications”
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`include: “Sanitation, disinfection, restaurants, retail spaces, lobbies, commercial
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`buildings, industrial parks, schools, public transportation hubs, airports, office
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`buildings, medical centers and more; kill 99% of viruses, bacteria, mold and
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`spores.” Id. at 3.
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`33. Second, Larson fabricates and sells a 40W UV Excimer Lamp – 222 Far
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`UVC Disinfection – Surface Mount – Quartz Glass/Ozone Free (FRL-EMX-6-40W-
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`FUVC) (hereinafter, “Excimer Lamp”), as shown below:
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`Ex. 7, Excimer Lamp Spec Sheet at 1. Like the Microplasma Board, Larson states
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`that “[t]his unit is Made in USA – Manufactured in Texas.” Id. This Excimer Lamp
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`“offers 40 uW/cm2 UV intensity at 222nm UV wavelength,” and “can disinfect 99%
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`of viruses, bacteria, mold and spores in facilities and on surfaces.” Id. at 1-2.
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`Furthermore, Larson states that, “[c]onsidered to be eye and skin safe, the far-UV
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`lamp offers instant start and cool operation.” Id.
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`34. The Excimer Lamp includes the following “Ratings/Features”:
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`Id. at 1. “Suggested Applications” include: “Sanitation, disinfection, commercial
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`locations, industrial parks, medical centers, labs, manufacturing and
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`semiconductors; kills 99% of viruses, bacteria, mold, and spores.” Id. at 2.
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`35. Larson fabricates and sells down-light products using one or more of its
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`Excimer Lamps, including the following representative products: 120W Far-UV
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`Excimer Disinfection Fixture – (3) 222nm Lamp –Pivoting Back Mount (3-Foot or 4-
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`Foot); 80W Far-UV Excimer Disinfection Fixture – (2) 222nm Lamp – Pivoting Back
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`Mount (3-Foot); 40W Far-UV Excimer Disinfection Fixture – (1) 222 nm Lamp –
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`Pivoting Back Mount (2-Foot); 120W Far-UV Excimer Disinfection Fixture – (3)
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`222nm Lamp – L Bracket End Mount (3-Foot); 80W Far-UV Excimer Disinfection
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`Fixture – (2) 222nm Lamp – L Bracket End Mount (2-Foot, 3-Foot, 4-Foot); 40W
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`Far-UV Excimer Disinfection Fixture – (1) 222nm Lamp – L Bracket End Mount (2-
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`Foot); and 40W Far-UV Excimer Disinfection Fixture – (1) 222nm Lamp – L
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`Bracket End Mount (1-Foot) (collectively, “Representative Excimer Lamp
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`Products”).
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`36. One such Representative Excimer Lamp Product is the 120W Far-UV
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`Excimer Disinfection Fixture – (3) 222nm Lamp – 3-Foot Fixture – L Bracket End
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`Mount (IND-DHA-FUVC-EX-36-3L-V1). See Ex. 8, L Bracket Lamp Spec Sheet, and
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`shown below.
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`Larson states that this “sanitation fixture is a powerful and sleek lighting solution
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`for restaurants, businesses, busy locations and occupied areas.” Id. at 2. Germicidal
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`excimer lamps emit far-UV 222 nm light that is generated by specific excimer
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`molecules.” Id. “Applications” include: “Sanitation, disinfection, restaurants, retail
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`spaces, lobbies, commercial locations, industrial parks, schools, public
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`transportation hubs, airports, office buildings, medical centers and more; kill 99% of
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`viruses, bacteria, mold and spores.” Id.
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`37. Larson also fabricates and sells a handheld Far-UV light product that
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`incorporates the Excimer Lamp called the Far-UVC Handheld Surface Sanitizer –
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`(1) 40W 222nm Excimer Lamp – Aluminum – 15’ 16/3 SOOW Cord (IND-HL-HDB-
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`FUVC-EX-1L-120V-15C). See Ex. 9, Handheld Lamp Spec Sheet, and shown below.
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`Larson describes this product as a “Handheld Surface Sanitizer which can disinfect
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`99% of viruses, bacteria, mold and spores on surfaces, work stations, tables and
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`desks, as well as devices, machines and personal equipment. This unit offers far-UV
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`222nm output and comes equipped with a 40-watt excimer lamp.” Id. at 2. The
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`“Suggested Applications” include: “Sanitation, disinfection, retail spaces, lobbies,
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`commercial locations, industrial parks, schools, public transportation hubs,
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`airports, office buildings, medical centers, casinos, labs, hospitals, work stations,
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`hotels and more; kill 99% of viruses, bacteria, mold, and spores.” Id. at 3.
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`38. Third, Larson fabricates and sells, for example, 90W UV Excimer
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`Lamp – 222nm Far UVC Disinfection – Surface Mount – Quartz Glass/Ozone Free
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`(FRL-EMX-18-90W-FUVC) (hereinafter, “Excimer Bulb”), as shown below.
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`Ex. 10, Excimer Bulb Spec Sheet at 1. Like the Microplasma Board and the Excimer
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`Lamp, Larson states that “[t]his unit is Made in USA – Manufactured in Texas.” Id.
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`This exemplary Excimer Bulb “offers 80 uW/cm2 UV intensity at 222nm UV
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`wavelength,” and “can disinfect 99% of viruses, bacteria, mold and spores in
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`facilities and on surfaces.” Id. at 1-2. Furthermore, Larson states that, “[c]onsidered
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`to be eye and skin safe, the far-UV lamp offers instant start and cool operation.” Id.
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`at 1.
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`39. The Excimer Bulb includes the following “Ratings/Features”:
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`Id. This Excimer Bulb is “compatible with 120V AC and 240V AC, 60 Hz and is
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`equipped with flying leads to allow operators to complete wiring connections” and
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`“can be mounted using customer provided clamps or holders.” Id. at 2. “Suggested
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`Applications” include: “Sanitation, disinfection, commercial locations, industrial
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`parks, medical centers, labs, manufacturing and semiconductors; kills 99% of
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`viruses, bacteria, mold and spores.” Id.
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`40. Larson fabricates and sells sanitation lighting products that
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`incorporate one or more Excimer Bulbs, including the following representative
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`products: Far-UV Sanitation Portal – (5) 222 nm Excimer Lamps – 304 SS/Power
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`Cord; 40W Far-UV Sanitation Light – (1) 222 nm UVC Excimer Lamp – Wall Mount
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`with (2) 6” Adjustable Arms; 40W Far-UV Excimer Disinfection Square Shoebox
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`Fixture – (1) 222nm Lamp – 1-foot Fixture – Remote Ballast – Surface Mount
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`Mount [sic]; 240W Far-UVC High Bay Fixture – (6) 222nm Excimer Lamps –
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`Surface Mount; 18” Far-UV Sanitation Wall Sconce Light – (1) 40W 222nm Excimer
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`Lamp – Aluminum/Indoor Use; and Door Barrier Germicidal Far UV-C Fixture – (1)
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`40W 222 nm UV-C Excimer Lamp – 24” Wide – Hospital Grade Stainless Steel
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`(collectively, the “Representative Excimer Bulb Products”).
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`41. One such Representative Excimer Bulb Product includes the Far-UV
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`Sanitation Portal – (5) 222 nm Excimer Lamps – 304 Stainless Steel/Power Cord
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`(IND-DWG-FUVC-5X-R1-120V-25C) (hereinafter, “Sanitation Portal”). See, e.g., Ex.
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`11, Sanitation Portal Spec Sheet, as shown below.
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`“This sanitation portal consists of five, 40-watt excimer lamps. Each light offers 40
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`uW/cm2 UV intensity at 222nm UV wavelength.” Id. at 2. Larson further advertises
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`that the “Sanitation Portal can disinfect 99% of viruses, bacteria, mold and spores
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`at entry/exit points and high traffic areas.” Id. It is “designed for standalone
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`applications” and “can be deployed at entry/exit points of buildings, transit or high
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`traffic areas and busy locations requiring sanitation.” Id. at 3. “Suggested
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`Applications” include: “Sanitation, disinfection, commercial locations, industrial
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`parks, medical centers, labs, manufacturing and semiconductors; kills 99% of
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`viruses, bacteria, mold and spores.” Id.
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`42. Each of Larson’s product spec sheets praise the safety and low risk of
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`using 222 nm light for sanitation in occupied spaces:
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`Far-UV 222 nm light is considered to be eye and skin safe for humans,
`allowing the lamps to be used in occupied areas with minimum risk. The
`222 nm wavelength does not penetrate the cornea of the eye and cannot
`impose corneal impairment. Additionally, this UV band is blocked by the
`top layer of skin (stratum corneum) which protects underlying cells from
`damage. Exposure to far-UV 222 nm lamp does not cause skin
`inflammation or swelling. Due to these safety benefits, extensive
`protective clothing is not required when using this type of sanitation
`light in occupied areas.
`See Exs. 5-6, 8-9 at 2; see also Exs. 7, 10-11 at 2 (“This lamp is considered to be eye
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`and skin safe (the 222nm wavelength cannot penetrate the eyes and skin of
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`humans), making applications suitable in occupied areas.”).
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`43. Upon information and belief, Larson imports its Microplasma Boards,
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`Excimer Lamps, and Excimer Bulbs from outside the United States and either re-
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`sells them alone (with a power source) or fabricates them into the various
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`representative lighting products, described above. Larson describes these products
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`as producing Far-UV or Far UV-C wavelengths of 222 nm. See, e.g., Ex. 4.
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`44. Larson’s Microplasma Boards, Excimer Lamps, and Excimer Bulbs—
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`together with Larson’s Representative Microplasma Board Products, Larson’s
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`Representative Excimer Lamp Products, and Larson’s Representative Excimer Bulb
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`Products—are collectively referred to hereinafter as the “Accused Products.”
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`45. Excimer lamps made from Krypton and Chlorine gas, forming Krypton-
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`Chloride (KrCl), like those fabricated and sold as the Accused Products by Larson
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`emit photons according to known spectral features, including the signature three
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`peaks shown below.
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`See, e.g., Ex. 12, www.EdenPark.com at 5-6 (annotations added). This graph
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`demonstrates that lamps advertised as producing 222 nm wavelengths also produce
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`wavelengths (peaks) around 238 nm and around 257 nm, as recognized and claimed
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`by Mr. Neister’s patents.
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`46.
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`In a recent publication, UV experts show the same signature spectral
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`analysis from tests of three commercially available KrCl excimer lamps like those
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`sold by Larson.
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`See Ex. 13 at 4, Simons, R.M., Blatchley III, E.R., Linden, K., Far UV-C and Its
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`Potential for Disinfection Applications, UV Solutions Magazine, Sept. 10, 2020
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`(available at https://uvsolutionsmag.com/articles/2020/far-uv-c-and-its-potential-for-
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`disinfection-applications/), last accessed May 12, 2021. “Emission spectra from
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`KrCl* lamps show a dominant peak at 222 nm with full-width-half-maximum ~4
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`nm and often a long-wavelength “tail” through the UVGI UV-C range. These off-
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`nominal emissions represent ~5% of the total power output of a typical unfiltered
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`KrCl* lamp. Though optical filtering can be used to limit emissions outside of the
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`222 nm peak, excimer sources are not monochromatic (Image 2), and the full
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`emission spectrum must be considered when evaluating their safety.” Id. (emphas