Case 2:23-cv-00229-JRG Document 1 Filed 05/24/23 Page 1 of 55 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
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`FOR THE EASTERN DISTRICT OF TEXAS
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`MARSHALL DIVISION
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`WILLOW INNOVATIONS, INC.,
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`Case No. 2:23-cv-00229
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`Plaintiff,
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`Jury Trial Demanded
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`v.
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`CHIARO TECHNOLOGY, LTD.,
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`Defendant.
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`COMPLAINT FOR PATENT INFRINGEMENT
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`Plaintiff Willow Innovations, Inc. (“Willow” or “Plaintiff”) brings this case for willful
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`patent infringement against Defendant Chiaro Technology, Ltd. d/b/a Elvie (“Elvie” or
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`“Defendant”). Elvie infringes seven patents that cover Willow’s innovative and ground-breaking
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`wearable breast milk pump. Willow’s product revolutionized this fundamentally important
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`function of human child rearing, and improved the lives of mothers and babies throughout the U.S.
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`Elvie’s launch of its infringing product amounts to willful patent infringement, and Willow has
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`been damaged to the tune of tens of millions of dollars as a result. Willow seeks redress from this
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`Court and a jury for Elvie’s deliberate and wrongful acts.
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`Case 2:23-cv-00229-JRG Document 1 Filed 05/24/23 Page 2 of 55 PageID #: 2
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`THE PARTIES
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`1.
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`Plaintiff Willow Innovations, Incorporated is a corporation organized and existing
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`under the laws of the State of Delaware, having a principal place of business at 1975 El Camino
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`Real, Suite 306, Mountain View, CA 94040. On October 21, 2020, Willow changed its name from
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`“Exploramed NC7, Inc.” to “Willow Innovations, Inc.”
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`2.
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`Defendant Chiaro Technology, Limited is a corporation organized and existing
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`under the laws of the United Kingdom, with its principal place of business at 63-66 Hatton Garden,
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`EC1N 8LE, London, United Kingdom. On the information and belief, Elvie is the trading name
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`of Chiaro Technology Limited and conducts business, either directly or through its agents, on an
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`ongoing basis in this judicial district and elsewhere in the United States.
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`BACKGROUND
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`3.
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`Traditional breast milk pumps were decades overdue for innovation. Enter the
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`Willow Pump. Founded in 2014, Willow revolutionized the way women pump with the world’s
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`first spillproof, in-bra wearable breast pump. Selected as one of TIME Magazine’s 25 Best
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`Inventions, the Willow pump was the first to get rid of the heavy motors, tubes, and electrical
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`cords—and put moms in control. Traditional pumps required nursing moms to sacrifice hours of
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`their day connected to an electrical outlet or to a heavy, conspicuous appliance. Pumping in public
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`required either exposing a breast in public, or relying on a public bathroom or similarly
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`inconvenient location.1 Willow was the first to make it possible to pump anywhere, giving moms
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`1 The inconvenience of traditional pumps is a factor for many women who abandon breast-
`feeding. The benefits of breast-feeding are widely known, and include reduced risk of disease
`for infants and various health benefits for the mother. See
`https://www.cdc.gov/breastfeeding/about-breastfeeding/why-it-matters.html. The American
`Academy of Pediatrics (AAP) updated their policy statement in July 2022 to support
`breastfeeding for at least the first two years. See https://doi.org/10.1542/peds.2022-057988.
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`back their privacy, dignity, and freedom of movement. Since then, Willow has grown into a market
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`leader, providing moms with industry-leading suction technology. Willow has gradually grown
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`its array of product offerings, with a primary focus on the U.S.—the world’s largest market for
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`breast pumps.
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`4.
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`Also in 2014, Willow filed for its first United States patent application. It now
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`holds more than 35 issued U.S. patents covering the functionality and designs of its products, with
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`additional applications currently pending before the United States Patent Office (“USPTO”). In
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`addition, Willow holds dozens of international patents in jurisdictions such as Australia,
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`Singapore, China, Europe, Japan, Korea, Hong Kong, and the United Kingdom. To protect its
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`hard-earned innovations, Willow provides notice to prospective infringers of its extensive patent
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`portfolio via its website. https://onewillow.com/about-willow/patents/. This publication also
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`satisfies the standard for constructive notice under 35 U.S.C. § 287(a) for purposes of virtual patent
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`marking.
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`5.
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`Today, Willow is a market leader in “femtech”—a shorthand term used to describe
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`technology products and services that support women’s health. The femtech industry is projected
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`to be worth $50 billion by 2025. Willow’s product offerings include wearable pumps, containers,
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`pumping bras, carrying bags, and other accessories. https://onewillow.com/#. Willow offers for
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`sale these products via its website and through select retailers and online marketplaces, such as
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`Target, Best Buy, buybuy Baby, and Amazon.
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`6.
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`Elvie is based in the United Kingdom and launched its Elvie Pump system in 2018
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`at the London Fashion Week. https://techcrunch.com/2018/09/14/kegel-trainer-startup-elvie-is-
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`However, data indicate that only 1 in 4 infants is exclusively breastfed by the time they reach 6
`months old. See https://www.cdc.gov/breastfeeding/data/nis_data/results.html.
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`Case 2:23-cv-00229-JRG Document 1 Filed 05/24/23 Page 4 of 55 PageID #: 4
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`launching-a-smaller-smarter-breast-pump/. Later that year, Elvie received clearance from the U.S.
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`Food
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`and Drug Administration
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`to market
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`the Elvie Pump
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`in
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`the U.S.
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`https://www.accessdata.fda.gov/cdrh_docs/pdf18/K181863.pdf. In its pre-market notification
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`report submitted to the FDA, Elvie admitted that its breast pump is substantially equivalent to the
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`Willow Pump. See id. (citing product code “HGX” to show the Willow Pump was an FDA-cleared
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`predicate device to the Elvie Pump).
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`7.
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`Elvie has exploited Willow’s patented technology to secure more than $150 million
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`in funding from investors. Most recently, in 2021, Elvie secured $97 million in its Series C funding
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`round. https://techcrunch.com/2021/09/07/womens-health-tech-brand-elvie-tops-up-series-c-to-
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`97m/.
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`8.
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`Elvie has leveraged Willow’s patents to establish itself as a major manufacturer and
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`distributor of consumer breast feeding equipment. Willow brings this suit to protect its
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`constitutional patent rights against Elvie’s past and continued infringement.
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`JURISDICTION AND VENUE
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`9.
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`This is a civil action for patent infringement arising under the patent laws of the
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`United States, 35 U.S.C. §§ 100 et seq. This Court has jurisdiction over the subject matter of this
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`action pursuant to 28 U.S.C. §§ 1331 and 1338(a).
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`10.
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`This Court has personal jurisdiction over Elvie at least because it (1) has committed
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`acts of patent infringement and contributed to and induced acts of patent infringement by others in
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`this District; (2) regularly did business or solicited business in this District; (3) engaged in other
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`persistent courses of conduct and derived substantial revenue by its offering of infringing products
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`and services and providing infringing products and services in this District; and (4) purposefully
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`established substantial, systematic, and continuous contacts with this District and should have
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`reasonably expected to be subject to suit here by its offering of infringing products and services
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`and providing infringing products and services in this District.
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`11.
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`Elvie has sold their breast pumps and related products within this District via the
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`following means:
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`a. Through its own online store at http://www.elvie.com, customers—including those
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`in this District and throughout Texas—can purchase Elvie’s suite of products.
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`Upon information and belief, Elvie uses its agents and distribution partners to direct
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`infringing products purchased online to customers in this District. Elvie also uses
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`its website to engage with and support its customers. For example, Elvie provides
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`instructions for using the Elvie Pump through a variety of publicly-available
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`resources, including product manuals, answers to common questions, and how-to
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`videos.
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`https://www.elvie.com/assets/manuals/elvie_pump_manual_en.pdf;
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`https://www.elvie.com/en-us/support/elvie-pump.
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`b. Elvie has authorized at least nine retailers and distributors to sell its products, as
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`described at https://www.elvie.com/en-us/partners/b2b-partners. These partners
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`include major retailers such as Walmart, Amazon, Target, Costco, and Best Buy—
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`all of which maintain stores, warehouse facilities, and/or distribution centers in this
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`District. As detailed below, customers in this District may purchase Elvie products
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`from authorized sellers via (1) the authorized seller’s website; or (2) the authorized
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`seller’s brick-and-mortar store located within the District:2
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`2 Elvie’s distribution partners, such as Costco and Amazon, also maintain facilities in this
`District. See https://www.costco.com/warehouse-locations/mckinney-tx-1284.html (showing
`Costco warehouse in McKinney, TX); https://hiring.amazon.com/jobDetail/en-US/Amazon-
`Delivery-Station-Warehouse-
`Associate/McKinney/a0R4U00000EP4YeUAL#/jobDetail?jobId=a0R4U00000EP4YeUAL&loc
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`Case 2:23-cv-00229-JRG Document 1 Filed 05/24/23 Page 6 of 55 PageID #: 6
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`Elvie Pump – Hands-Free, Wearable Electric Double Breast Pump, Walmart (last visited May 15,
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`2023), https://www.walmart.com/ip/Elvie-Pump-Hands-Free-Wearable-Electric-Double-Breast-
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`Pump/347662224?fulfillmentIntent=In-store&adsRedirect=true (showing Elvie Double Electric
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`Breast Pump is available for online purchase and also is in stock at Marshall Supercenter in
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`Marshall, TX).
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`ale=en-US&seoIndex=1 (advertising job based at Amazon facility, called “DDX2,” in
`McKinney, TX).
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`Case 2:23-cv-00229-JRG Document 1 Filed 05/24/23 Page 7 of 55 PageID #: 7
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`Elvie Pump – Double Electric Breast Pump, TARGET (last visited May 15, 2023),
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`https://www.target.com/p/elvie-pump-double-electric-breast-pump/-/A-75662623#lnk=sametab
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`(showing Elvie Double Electric Breast Pump is available for online purchase and also is in stock
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`at Target in Longview, TX).
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`12.
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`Elvie purposefully avails itself of the benefit of conducting business in Texas by
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`marketing and selling its products to citizens in the state (including in this District). The United
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`States is the largest market in the world for breast pump products, and Texas is the second largest
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`state in the United States by population. Given the size of the market and the significant presence
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`of retailers, distributors, and other business partners in the state, Elvie has specifically targeted
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`Texas as a key market for its products. For example, in August 2022, Elvie’s Chief Commercial
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`Officer, Aoife Zakaras-Nally, provided comments to the Houston Chronicle3 touting the benefits
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`3 The Houston Chronicle’s parent company, the Hearst Corporation, states that the Chronicle has
`“825,000
`daily
`readers
`and
`1.4
`million
`readers
`on
`Sunday.”
`https://www.hearst.com/newspapers/houston-
`chronicle#:~:text=In%20addition%20to%20the%20Houston,million%20unique%20visitors%20e
`ach%20month.
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`and commercial success of the Elvie Pump. https://www.houstonchronicle.com/lifestyle/renew-
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`houston/health/article/Breastfeeding-will-never-be-free-But-it-can-be-
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`17339050.php?cmpid=gsa-chron-result. Houston is a particularly important market for Elvie,
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`given the size and reach of its medical community. See id. (Dr. Stan Spinner, chief medical officer
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`of Texas Children’s Hospital based in Houston, describing the benefits of breastfeeding).
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`13.
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`In addition, on information and belief, Elvie exercises control over its distributors,
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`retailers, and other partners that conduct Elvie’s business in Texas. For example, Elvie limits its
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`product warranty—ranging in duration from 90 days to two years from the date of purchase—to
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`those products purchased directly
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`from Elvie and
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`its authorized
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`sellers.
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` See
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`https://www.elvie.com/en-us/warranty (“[T]his limited warranty applies only to original
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`purchasers of Elvie Product(s) that were purchased from Chiaro or a Chiaro authorized seller in
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`the United States, unless otherwise prohibited by law.”). On its website, Elvie provides
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`instructions for anyone interested in becoming an authorized seller of Elvie products.
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`https://www.elvie.com/en-us/partners/b2b-partners.
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`14.
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`Elvie, directly and through subsidiaries or intermediaries (including distributors,
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`retailers, and others), has purposefully and voluntarily placed its infringing products into this
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`District and into the stream of commerce with the intention and expectation that the infringing
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`products will be purchased for use in Texas and in this District. Elvie has imported, offered for
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`sale and sold, and continues to import, offer for sale and sell, infringing products for delivery and
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`use in this District. Thus, Elvie has intentionally targeted Texas, and this District, for its business
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`activities, and has purposefully availed itself of the benefits of conducting business in Texas such
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`that it should reasonably anticipate being subject to its laws and the jurisdiction of its courts.
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`Further, Willow’s infringement allegations arise out of and relate to Elvie’s commercial activities
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`in Texas.
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`15.
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`Venue is proper in this District under at least 28 U.S.C. §§ 1391(b), (c) and/or
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`1400(b). Venue is proper with respect to Elvie because it is a foreign entity that has committed
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`acts of infringement in this District, as detailed throughout this Complaint. Elvie has committed
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`and continues to commit acts of patent infringement in this District, by, among other things,
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`directly and/or indirectly making, using, selling, offering to sell, or importing products that infringe
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`one or more claims of the Patents-in-Suit.
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`THE ASSERTED PATENTS
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`16.
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`This action involves seven asserted patents: U.S. Patent No. 10,398,816 (“the ’816
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`Patent”), U.S. Patent No. 10,434,228 (“the ’228 Patent”), U.S. Patent No. 10,625,005 (“the ’005
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`Patent”), U.S. Patent No. 10,722,624 (“the ’624 Patent”), U.S. Patent No. 11,185,619 (“the ’619
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`Patent”), U.S. Design Patent No. D832,995 (“the ’D995 Patent”), and U.S. Design Patent No.
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`D977,625 (“the ’D625 Patent”) (collectively, the “Asserted Patents”).
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`17.
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`The Asserted Patents recognized multiple problems with then-existing systems and
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`methods for pumping milk. For example, as the ’624 Patent explains, “[a]lthough a variety of
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`breast pumps are available, most are awkward and cumbersome, requiring many parts and
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`assemblies and being difficult to transport.” Exhibit 1 at 1:30-32. Manual breast pumps can be
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`“onerous” and “painful” to use. Id. at 1:33-34. Some of the available powered breast pumps
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`“require an AC power source to plug into during use,” while other available battery-powered
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`pumps “draw down the battery power fairly rapidly as the motorized pump continuously operates
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`to maintain suction during the milk extraction process.” Id. at 1:36-38. Existing pumps had the
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`further disadvantages of being “clearly visible to an observer when the mother is using it” and
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`“expos[ing] the breast of the mother during use.” Id. at 1:38-41. As the ’624 Patent explains,
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`‘[t]here is a continuing need for a small, portable…wearable breast pump system” that would not
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`expose the breast of the user, and could be “invisible or nearly unnoticeable when worn.” Id. at
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`1:42-46.
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`18.
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`To address these deficiencies in the art, the Asserted Patents provide a wearable,
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`inconspicuous, convenient pump. In various embodiments, “the system defines a natural breast
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`profile” which would “fit comfortably and conveniently into a bra of a user and to present a natural
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`look.” Exhibit 1 at 2:5-8. The pumping devices and storage containers of the inventions can be
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`“sized and shaped to be received within a user’s bra.” Id. at 2:24-26. “Pumping of milk from a
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`breast can occur without creating a change in a total mass and volume of the breast, pump device
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`and storage container. The storage container can be one or more of flexible, or position around
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`the breast.” Id. at 2:26-30.
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`U.S. Patent No. 10,398,816
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`19.
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`On September 3, 2019, the USPTO duly and lawfully issued the ’816 Patent,
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`entitled “Breast pump system with flange.” A true and correct copy of the ’816 Patent is attached
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`as Exhibit 2. By assignment, duly recorded with the USPTO, Willow owns all substantial rights
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`to the ’816 Patent, including the right to sue and recover damages for all infringement. 4
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`20.
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`The ’816 Patent generally relates to a breast pumping system where milk is
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`expressed from the breast under suction, and the milk is moved by the pumping mechanism to a
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`collection container using pressure and all responsive to a controller. See id. at Abstract. The ’816
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`4 Although the Asserted Patents were originally assigned to “Exploramed NC7, Inc.,” that entity
`has since changed its name to “Willow Innovations, Inc.” Ex. 3. Thus, Plaintiff Willow
`Innovations, Inc. is the current assignee and title holder of the Asserted Patents and the owner of
`all rights and interest in the same.
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`Patent further provides for a portion of the system that contacts the skin, called the flange, designed
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`as a “lower profile component” as compared to the prior art. Id. at 20:10-11.
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`21.
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`The ’816 Patent recognized a problem with then-existing systems and methods for
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`pumping milk. As the ’816 Patent explains, “[a]lthough a variety of breast pumps are available,
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`most are awkward and cumbersome, requiring many parts and assemblies and being difficult to
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`transport.” Exhibit 2 at 1:23-25. Manual breast pumps can be “onerous” and “painful” to use. Id.
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`at 1:25-27. Some of the available powered breast pumps “require an AC power source to plug into
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`during use,” while other available battery-powered pumps “draw down the battery power fairly
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`rapidly as the motorized pump continuously operates to maintain suction during the milk extraction
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`process.” Id. at 1:27-31. Existing pumps had the further disadvantages of being “clearly visible
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`to an observer when the mother is using it” and “expos[ing] the breast of the mother during use.”
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`Id. at 1:31-34. In addition, “[m]any existing breast pump systems can cause considerable
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`discomfort to the user over time. One cause of such discomfort is chafing of the nipple against the
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`nipple flange/housing as the nipple stretches and contracts during the pumping session. There is
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`a continuing need for a breast pump system that is more comfortable to the user, even over repeated
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`pumping sessions.” Id. at 1:49-55.
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`22.
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`The ’816 Patent describes specific improvements to then-existing systems and
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`methods for pumping milk. For example, in various embodiments, “the system defines a natural
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`breast profile” which would “fit comfortably and conveniently into a bra of a user and to present
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`a natural look.” Id. at 2:14-18. In addition, the claimed system maintains “at least a latch suction
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`level at all times,” which results in a “more secure and persistent seal to the breast and significantly
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`reduce[d] potential for leaks.” Id. at 20:3-6. This has several benefits to the user, including “less
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`friction on the side of the nipple against the flange wall, thereby greatly reducing the risk of
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`irritation, skin damage, pain, swelling, etc.” Id. at 19:64-67. Additionally, because “the nipple
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`travels less, this allows for the skin attachment member/flange to be designed as a lower profile
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`component, as its length can be shorter…” Id. at 20:9-11. This benefit in turn limits the “overall
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`amount of protrusion of the system from the breast to less than that in the prior art…” Id. at 20:
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`13-15.
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`23.
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`As an example of the improvements in the ’816 Patent over the prior art, Figure 8
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`provides a flange of an embodiment of the invention, and Figure 9 provides an exemplary prior art
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`flange:
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`24.
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`The claims of the ’816 Patent capture specific technological improvements. For
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`example, Claim 1 of the ’816 Patent provides for “a flange attached to the breast pump shell and
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`configured to receive the breast” with a “rigid nipple receiving portion.” Id., Claim 1, 50:56-61.
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`Claim 6 of the ’816 Patent adds a limitation to a “control loop [] used to adjust a speed of the
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`compression member to vary or maintain the suction pressure.” Id., Claim 6, 51:12-16.
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`25.
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`The claimed improvements of the ’816 Patent, including the ability to maintain
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`suction and the corresponding characteristics of the claimed flange, were not routine, conventional,
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`or well-known. These improvements were advantageous and inventive over the prior art systems
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`that were cumbersome, difficult to transport, inefficient and/or inconvenient to power, and difficult
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`to use discreetly. The ’816 Patent recognized the unconventional and advantageous nature of the
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`claimed small, portable, self-powered, energy efficient, wearable breast pump system. Id. at 1:35-
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`49. As the ’816 Patent explains, these improvements were advantageous and inventive over the
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`prior art systems with less comfortable skin contact portions. The ’816 Patent recognized the
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`unconventional and advantageous nature of achieving a shorter protrusion of the system from the
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`breast, by providing improved suction and, in turn, the claimed flange. The improved systems and
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`methods of the ’816 Patent, recited in the claims, provide technological benefits over the prior art.
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`U.S. Patent No. 10,434,228
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`26.
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`On October 8, 2019, the USPTO duly and lawfully issued the ’228 Patent, entitled
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`“Breast pump system and methods.” A true and correct copy of the ’228 Patent is attached as
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`Exhibit 4. By assignment, duly recorded with the USPTO, Willow owns all substantial rights to
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`the ’228 Patent, including the right to sue and recover damages for all infringement.
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`27.
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`The ’228 Patent generally relates to a breast pumping system where milk is
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`expressed from the breast under suction, and the milk is moved by the pumping mechanism to a
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`collection container using pressure. See id. at Abstract.
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`28.
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`The ’228 Patent recognized a problem with then-existing systems and methods for
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`pumping milk. As the ’228 Patent explains, “[w]hen a user has completed the pumping phase of
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`extracting milk…, it is useful and efficient to purge as much milk that remains…from the tubing
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`[] and into the milk collection container [].” Id. at 41:8-11.
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`29.
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`The ’228 Patent describes specific improvements to then-existing systems and
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`methods for pumping milk. In particular, the ’228 Patent provides systems with numerous
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`methods for avoiding loss of milk after extraction from the breast. For example, Figure 38
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`Case 2:23-cv-00229-JRG Document 1 Filed 05/24/23 Page 14 of 55 PageID #: 14
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`illustrates events that may be carried out to perform a purge. Id. at 14:37-39. Figures 39A and
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`39B further provide additional arrangements that may be provided to help prevent loss of milk out
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`of the system.
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`30.
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`The claims of the ’228 Patent capture specific technological improvements. For
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`example, Claim 1 provides an automated method of pumping milk, “wherein the milk is pumped
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`from the breast to the collection container upwardly through the milk flow path relative to a bottom
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`of the breast contacting structure.” Id. at Claim 1, 50:44-47.
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`31.
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`The claimed improvements of the ’228 Patent were not routine, conventional, or
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`well-known. As the ’228 Patent explains, these improvements were advantageous and inventive
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`over the prior art techniques without the provided methods of avoiding milk loss. The ’228 Patent
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`recognized the unconventional and advantageous nature of directing the flow of milk upward. The
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`improved systems and methods of the ’228 Patent, recited in the claims, provide technological
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`benefits over the prior art.
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`U.S. Patent No. 10,625,005
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`32.
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`On April 21, 2020, the USPTO duly and lawfully issued the ’005 Patent, entitled
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`“Breast pump assembly with remote interface.” A true and correct copy of the ’005 Patent is
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`Case 2:23-cv-00229-JRG Document 1 Filed 05/24/23 Page 15 of 55 PageID #: 15
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`attached as Exhibit 5. By assignment, duly recorded with the USPTO, Willow owns all substantial
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`rights to the ’005 Patent, including the right to sue and recover damages for all infringement.
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`33.
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`The ’005 Patent generally relates to a breast pumping system where milk is
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`expressed from the breast under suction, and the milk is moved by the pumping mechanism to a
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`collection container using pressure. See id. at Abstract. The ’005 Patent provides for a remote
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`user interface system, including user control functionality. Id. at Claim 1, 28:33-34.
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`34.
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`The ’005 Patent recognized a problem with then-existing systems and methods for
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`pumping milk. As the ’005 Patent explains, “[t]here is a continuing need for a small, portable,
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`self-powered, energy efficient, wearable breast pump that is easy to use, that mimics natural
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`nursing, and is…nearly unnoticeable when worn.” Id. at 1:54-58. In particular, it would be
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`desirable to “easily and accurately monitor[] the volume of milk pumped by the system” and to
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`“track milk volume pumped per session.” Id. at 1:59-67.
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`35.
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`The ’005 Patent describes specific improvements to then-existing systems and
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`methods for pumping milk. For example, a remote user interface system allows for “at least the
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`session start time, the session end time and total volume of milk extracted from the breast” to be
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`“stored and tracked.” Id. at 25:15-17. Live data and historical data can be treated differently, and
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`be downloaded to an external device during or immediately after a session, or downloaded as
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`multiple session data. Id. at 25:27-46. The remote user interface “can also include specific user
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`control functionality, and various related easy to understand displays.” Id. at 26:15-16. Figures
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`30 and 31 provide exemplary aspects of a remote user interface system:
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`Case 2:23-cv-00229-JRG Document 1 Filed 05/24/23 Page 16 of 55 PageID #: 16
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`36.
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`The claims of the ’005 Patent capture specific technological improvements. For
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`example, Claim 1 is directed to a breast pump with a wireless transmitter, a “language protocol for
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`two-way communication between the breast pump and an external device,” and a “remote user
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`interface including user control functionality” and “an input for the human to adjust the breast
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`pump with the external device.” Id. at Claim 1, 28:25-41.
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`37.
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`The claimed improvements of the ’005 Patent were not routine, conventional, or
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`well-known. As the ’005 Patent explains, these improvements were advantageous and inventive
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`over the prior art techniques that did not allow for a remote user interface system. The ’005 Patent
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`recognized the unconventional and advantageous nature of a wireless system that empowered
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`nursing mothers to control the operation of the breast pump through an external device. The
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`improved systems and methods of the ’005 Patent, recited in the claims, provide technological
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`benefits over the prior art.
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`U.S. Patent No. 10,722,624
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`38.
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`On July 28, 2020, the USPTO duly and lawfully issued the ’624 Patent, entitled
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`“Breast pump assembly with breast adapter.” A true and correct copy of the ’624 Patent is attached
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`Case 2:23-cv-00229-JRG Document 1 Filed 05/24/23 Page 17 of 55 PageID #: 17
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`as Exhibit 1. By assignment, duly recorded with the USPTO, Willow owns all substantial rights
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`to the ’624 Patent, including the right to sue and recover damages for all infringement.
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`39.
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`The ’624 Patent generally relates to a breast milk pump that uses a pumping
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`mechanism to expulse milk from a breast and to then store the milk in a milk collection container.
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`The entire assembly may include both the pump and the storage container. See id. at Abstract.
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`40.
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`The ’624 Patent provides for various embodiments of the breast pumping system.
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`In one example, in order to achieve the desired milk expression, “suction applied to the breast for
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`expression of milk involves a first suction level, and during expulsing, a second suction level is
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`maintained against the breast, the second suction level being lower than the first suction level.” Id.
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`at 1:67-2:4.
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`41.
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`As the ’624 Patent explains, “[a]lthough a variety of breast pumps are available,
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`most are awkward and cumbersome, requiring many parts and assemblies and being difficult to
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`transport.” Id. at 1:30-32. Manual breast pumps can be “onerous” and “painful” to use. Id. at
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`1:32-34. Some of the available powered breast pumps “require an AC power source to plug into
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`during use,” while other available battery-powered pumps “draw down the battery power fairly
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`rapidly as the motorized pump continuously operates to maintain suction during the milk extraction
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`process.” Id. at 1:33-37. Existing pumps had the further disadvantages of being “clearly visible
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`to an observer when the mother is using it” and “expos[ing] the breast of the mother during use.”
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`Id. at 1:37-40.
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`42.
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`The ’624 Patent describes specific improvements to then-existing systems and
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`methods for pumping milk. For example, in various embodiments, “the system defines a natural
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`breast profile” which would “fit comfortably and conveniently into a bra of a user and to present
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`a natural look.” Id. at 2:5-8. Another approach could include “outputting at least one of
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`Case 2:23-cv-00229-JRG Document 1 Filed 05/24/23 Page 18 of 55 PageID #: 18
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`operational and/or sensed parameters, and modifying at least one operational setting based upon”
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`the same. Id. at 3:47-49. An operational setting could include “suction level setting, suction
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`waveform definition, extraction phase time, threshold milk volume estimate per extraction phase
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`expulsion, pressure, rest phase time, heating temperatures, heating times, vibration frequency and
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`vibration times.” Id. at 3:50-55. The ’624 Patent provides a system or method that “can further
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`perform in real-time, or as a feedback loop.” Id. at 3:49-50.
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`43.
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`The claims of the ’624 Patent capture specific technological improvements. For
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`example, Claim 1 is directed to an “automated system for controlling pumping cycles” including
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`a “sensor which detects when the milk collection container is full” and a controller that
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`“automatically changes application of suction” based on the phase of milk expression from the
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`user. Id. at Claim 1, 53:10-54:8.
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`44.
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`The claimed improvements of the ’624 Patent were not routine, conventional, or
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`well-known. As the ’624 Patent explains, these improvements were advantageous and inventive
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`over the prior art systems that were cumbersome, difficult to transport, inefficient and/or
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`inconvenient to power, and difficult to use discreetly. The ’624 Patent recognized the
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`unconventional and advantageous nature of the claimed small, portable, self-powered, energy
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`efficient, wearable breast pump system. Id. at 1:42-46. The claims recited systems with features
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`including control of the pumping cycle. Id. at Claim 1, 53:10-54:8. The improved systems and
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`methods of the ’624 Patent, recited in the claims, provide technological benefits over the prior art.
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`U.S. Patent No. 11,185,619
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`45.
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`On November 30, 2021, the USPTO duly and lawfully issued the ’619 Patent,
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`entitled “Breast pump system with pressure sensor.” A true and correct copy of the ’619 Paten