Case 2:23-cv-00229-JRG Document 64 Filed 06/21/24 Page 1 of 71 PageID #: 3580
`
`
`
`
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE EASTERN DISTRICT OF TEXAS
`MARSHALL DIVISION
`
`WILLOW INNOVATIONS, INC.,
`
`Case No. 2:23-cv-00229
`
`Plaintiff,
`
`Jury Trial Demanded
`
`v.
`
`CHIARO TECHNOLOGY LTD.,
`
`Defendant.
`
`WILLOW’S SECOND AMENDED COMPLAINT FOR PATENT INFRINGEMENT
`
`Plaintiff Willow Innovations, Inc. (“Willow” or “Plaintiff”) brings this case for willful
`
`patent infringement against Defendant Chiaro Technology Ltd. d/b/a Elvie (“Elvie” or
`
`“Defendant”). Elvie infringes eight patents that cover Willow’s innovative and ground-breaking
`
`wearable breast milk pump. Willow’s product revolutionized this fundamentally important
`
`function of human child rearing, and improved the lives of mothers and babies throughout the U.S.
`
`Elvie’s launch of its infringing product amounts to willful patent infringement, and Willow has
`
`been damaged to the tune of tens of millions of dollars as a result. Willow seeks redress from this
`
`Court and a jury for Elvie’s deliberate and wrongful acts.
`
`THE PARTIES
`
`1.
`
`Plaintiff Willow Innovations, Incorporated is a corporation organized and existing
`
`under the laws of the State of Delaware, having a principal place of business at 1975 El Camino
`
`
`
`- 1 -
`
`

`

`Case 2:23-cv-00229-JRG Document 64 Filed 06/21/24 Page 2 of 71 PageID #: 3581
`
`
`
`Real, Suite 306, Mountain View, CA 94040. On October 21, 2020, Willow changed its name from
`
`“Exploramed NC7, Inc.” to “Willow Innovations, Inc.”
`
`2.
`
`Defendant Chiaro Technology Limited is a corporation organized and existing
`
`under the laws of the United Kingdom, with its principal place of business at 63-66 Hatton Garden,
`
`EC1N 8LE, London, United Kingdom. On the information and belief, Elvie is the trading name
`
`of Chiaro Technology Limited and conducts business, either directly or through its agents, on an
`
`ongoing basis in this judicial district and elsewhere in the United States.
`
`BACKGROUND
`
`3.
`
`Traditional breast milk pumps were decades overdue for innovation. Enter the
`
`Willow Pump. Founded in 2014, Willow revolutionized the way women pump with the world’s
`
`first spillproof, in-bra wearable breast pump. Selected as one of TIME Magazine’s 25 Best
`
`Inventions, the Willow pump was the first to get rid of the heavy motors, tubes, and electrical
`
`cords—and put moms in control. Traditional pumps required nursing moms to sacrifice hours of
`
`their day connected to an electrical outlet or to a heavy, conspicuous appliance. Pumping in public
`
`required either exposing a breast in public, or relying on a public bathroom or similarly
`
`inconvenient location.1 Willow was the first to make it possible to pump anywhere, giving moms
`
`back their privacy, dignity, and freedom of movement. Since then, Willow has grown into a market
`
`leader, providing moms with industry-leading suction technology. Willow has gradually grown
`
`
`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. 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.
`
`- 2 -
`
`

`

`Case 2:23-cv-00229-JRG Document 64 Filed 06/21/24 Page 3 of 71 PageID #: 3582
`
`
`
`its array of product offerings, with a primary focus on the U.S.—the world’s largest market for
`
`breast pumps.
`
`4.
`
`Also in 2014, Willow filed for its first United States patent application. It now
`
`holds more than 35 issued U.S. patents covering the functionality and designs of its products, with
`
`additional applications currently pending before the United States Patent Office (“USPTO”). In
`
`addition, Willow holds dozens of international patents in jurisdictions such as Australia,
`
`Singapore, China, Europe, Japan, Korea, Hong Kong, and the United Kingdom. To protect its
`
`hard-earned innovations, Willow provides notice to prospective infringers of its extensive patent
`
`portfolio via its website. https://onewillow.com/about-willow/patents/. This publication also
`
`satisfies the standard for constructive notice under 35 U.S.C. § 287(a) for purposes of virtual patent
`
`marking.
`
`5.
`
`Today, Willow is a market leader in “femtech”—a shorthand term used to describe
`
`technology products and services that support women’s health. The femtech industry is projected
`
`to be worth $50 billion by 2025. Willow’s product offerings include wearable pumps, containers,
`
`pumping bras, carrying bags, and other accessories. https://onewillow.com/#. Willow offers for
`
`sale these products via its website and through select retailers and online marketplaces, such as
`
`Target, Best Buy, buybuy Baby, and Amazon.
`
`6.
`
`Elvie is based in the United Kingdom and launched its Elvie Pump system in 2018
`
`at the London Fashion Week. https://techcrunch.com/2018/09/14/kegel-trainer-startup-elvie-is-
`
`launching-a-smaller-smarter-breast-pump/. Later that year, Elvie received clearance from the U.S.
`
`Food
`
`and Drug Administration
`
`to market
`
`the Elvie Pump
`
`in
`
`the U.S.
`
`https://www.accessdata.fda.gov/cdrh_docs/pdf18/K181863.pdf. In its pre-market notification
`
`report submitted to the FDA, Elvie admitted that its breast pump is substantially equivalent to the
`
`- 3 -
`
`

`

`Case 2:23-cv-00229-JRG Document 64 Filed 06/21/24 Page 4 of 71 PageID #: 3583
`
`
`
`Willow Pump. See id. (citing product code “HGX” to show the Willow Pump was an FDA-cleared
`
`predicate device to the Elvie Pump).
`
`7.
`
`Elvie has exploited Willow’s patented technology to secure more than $150 million
`
`in funding from investors. Most recently, in 2021, Elvie secured $97 million in its Series C funding
`
`round. https://techcrunch.com/2021/09/07/womens-health-tech-brand-elvie-tops-up-series-c-to-
`
`97m/.
`
`8.
`
`Elvie has leveraged Willow’s patents to establish itself as a major manufacturer and
`
`distributor of consumer breast feeding equipment. Willow brings this suit to protect its
`
`constitutional patent rights against Elvie’s past and continued infringement.
`
`JURISDICTION AND VENUE
`
`9.
`
`This is a civil action for patent infringement, false advertising, and unfair
`
`competition arising under the laws of the United States, 35 U.S.C. §§ 100 et seq. This Court has
`
`jurisdiction over the subject matter of this action pursuant to 28 U.S.C. §§ 1331, 1338(a), and
`
`1367(a).
`
`10.
`
`The Court has supplemental jurisdiction over Willow’s unfair competition claim
`
`under Texas common law because it is so related to the federal false advertising claim that it forms
`
`part of the same case or controversy. Namely, Willow’s unfair competition claim derives from
`
`the same nucleus of operative fact as the federal false advertising claim because both claims are
`
`based on Elvie’s false and misleading advertisements in commerce regarding the alleged silence
`
`of the Elvie Pump. Thus, these claims will implicate overlapping facts and evidence.
`
`11.
`
`This Court has personal jurisdiction over Elvie at least because it (1) has committed
`
`acts of patent infringement and contributed to and induced acts of patent infringement by others in
`
`this District; (2) regularly did business or solicited business in this District; (3) engaged in other
`
`- 4 -
`
`

`

`Case 2:23-cv-00229-JRG Document 64 Filed 06/21/24 Page 5 of 71 PageID #: 3584
`
`
`
`persistent courses of conduct and derived substantial revenue by its offering of infringing products
`
`and services and providing infringing products and services in this District; and (4) purposefully
`
`established substantial, systematic, and continuous contacts with this District and should have
`
`reasonably expected to be subject to suit here by its offering of infringing products and services
`
`and providing infringing products and services in this District.
`
`12.
`
`Elvie has sold their breast pumps and related products within this District via the
`
`following means:
`
`a. Through its own online store at http://www.elvie.com, customers—including those
`
`in this District and throughout Texas—can purchase Elvie’s suite of products.
`
`Upon information and belief, Elvie uses its agents and distribution partners to direct
`
`infringing products purchased online to customers in this District. Elvie also uses
`
`its website to engage with and support its customers. For example, Elvie provides
`
`instructions for using the Elvie Pump through a variety of publicly-available
`
`resources, including product manuals, answers to common questions, and how-to
`
`videos.
`
`
`
`https://www.elvie.com/assets/manuals/elvie_pump_manual_en.pdf;
`
`https://www.elvie.com/en-us/support/elvie-pump.
`
`b. Elvie has authorized at least nine retailers and distributors to sell its products, as
`
`described at https://www.elvie.com/en-us/partners/b2b-partners. These partners
`
`include major retailers such as Walmart, Amazon, Target, Costco, and Best Buy—
`
`all of which maintain stores, warehouse facilities, and/or distribution centers in this
`
`District. As detailed below, customers in this District may purchase Elvie products
`
`- 5 -
`
`

`

`Case 2:23-cv-00229-JRG Document 64 Filed 06/21/24 Page 6 of 71 PageID #: 3585
`
`
`
`from authorized sellers via (1) the authorized seller’s website; or (2) the authorized
`
`seller’s brick-and-mortar store located within the District:2
`
`Elvie Pump – Hands-Free, Wearable Electric Double Breast Pump, Walmart (last visited May 15,
`
`2023), https://www.walmart.com/ip/Elvie-Pump-Hands-Free-Wearable-Electric-Double-Breast-
`
`Pump/347662224?fulfillmentIntent=In-store&adsRedirect=true (showing Elvie Double Electric
`
`Breast Pump is available for online purchase and also is in stock at Marshall Supercenter in
`
`Marshall, TX).
`
`
`
`
`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
`ale=en-US&seoIndex=1 (advertising job based at Amazon facility, called “DDX2,” in
`McKinney, TX).
`
`- 6 -
`
`

`

`Case 2:23-cv-00229-JRG Document 64 Filed 06/21/24 Page 7 of 71 PageID #: 3586
`
`
`
`
`
`Elvie Pump – Double Electric Breast Pump, TARGET (last visited May 15, 2023),
`
`https://www.target.com/p/elvie-pump-double-electric-breast-pump/-/A-75662623#lnk=sametab
`
`(showing Elvie Double Electric Breast Pump is available for online purchase and also is in stock
`
`at Target in Longview, TX).
`
`13.
`
`Elvie purposefully avails itself of the benefit of conducting business in Texas by
`
`marketing and selling its products to citizens in the state (including in this District). The United
`
`States is the largest market in the world for breast pump products, and Texas is the second largest
`
`state in the United States by population. Given the size of the market and the significant presence
`
`of retailers, distributors, and other business partners in the state, Elvie has specifically targeted
`
`Texas as a key market for its products. For example, in August 2022, Elvie’s Chief Commercial
`
`Officer, Aoife Zakaras-Nally, provided comments to the Houston Chronicle3 touting the benefits
`
`
`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.
`
`- 7 -
`
`

`

`Case 2:23-cv-00229-JRG Document 64 Filed 06/21/24 Page 8 of 71 PageID #: 3587
`
`
`
`and commercial success of the Elvie Pump. https://www.houstonchronicle.com/lifestyle/renew-
`
`houston/health/article/Breastfeeding-will-never-be-free-But-it-can-be-
`
`17339050.php?cmpid=gsa-chron-result. Houston is a particularly important market for Elvie,
`
`given the size and reach of its medical community. See id. (Dr. Stan Spinner, chief medical officer
`
`of Texas Children’s Hospital based in Houston, describing the benefits of breastfeeding).
`
`14.
`
`In addition, on information and belief, Elvie exercises control over its distributors,
`
`retailers, and other partners that conduct Elvie’s business in Texas. For example, Elvie limits its
`
`product warranty—ranging in duration from 90 days to two years from the date of purchase—to
`
`those products purchased directly
`
`from Elvie and
`
`its authorized
`
`sellers.
`
` See
`
`https://www.elvie.com/en-us/warranty (“[T]his limited warranty applies only to original
`
`purchasers of Elvie Product(s) that were purchased from Chiaro or a Chiaro authorized seller in
`
`the United States, unless otherwise prohibited by law.”). On its website, Elvie provides
`
`instructions for anyone interested in becoming an authorized seller of Elvie products.
`
`https://www.elvie.com/en-us/partners/b2b-partners.
`
`15.
`
`Elvie, directly and through subsidiaries or intermediaries (including distributors,
`
`retailers, and others), has purposefully and voluntarily placed its infringing products into this
`
`District and into the stream of commerce with the intention and expectation that the infringing
`
`products will be purchased for use in Texas and in this District. Elvie has imported, offered for
`
`sale and sold, and continues to import, offer for sale and sell, infringing products for delivery and
`
`use in this District. Thus, Elvie has intentionally targeted Texas, and this District, for its business
`
`activities, and has purposefully availed itself of the benefits of conducting business in Texas such
`
`that it should reasonably anticipate being subject to its laws and the jurisdiction of its courts.
`
`- 8 -
`
`

`

`Case 2:23-cv-00229-JRG Document 64 Filed 06/21/24 Page 9 of 71 PageID #: 3588
`
`
`
`Further, Willow’s infringement allegations arise out of and relate to Elvie’s commercial activities
`
`in Texas.
`
`16.
`
`Venue is proper in this District under at least 28 U.S.C. §§ 1391(b), (c) and/or
`
`1400(b). Venue is proper with respect to Elvie because it is a foreign entity that has committed
`
`acts of infringement in this District, as detailed throughout this Complaint. Elvie has committed
`
`and continues to commit acts of patent infringement in this District, by, among other things,
`
`directly and/or indirectly making, using, selling, offering to sell, or importing products that infringe
`
`one or more claims of the Patents-in-Suit.
`
`THE ASSERTED PATENTS
`
`17.
`
`This action involves seven asserted patents: U.S. Patent No. 10,398,816 (“the ’816
`
`Patent”), U.S. Patent No. 10,434,228 (“the ’228 Patent”), U.S. Patent No. 10,625,005 (“the ’005
`
`Patent”), U.S. Patent No. 10,722,624 (“the ’624 Patent”), U.S. Patent No. 11,185,619 (“the ’619
`
`Patent”), U.S. Design Patent No. D832,995 (“the ’D995 Patent”), U.S. Design Patent No.
`
`D977,625 (“the ’D625 Patent”), and U.S. Patent No. 10,688,229 (“the ’229 Patent”) (collectively,
`
`the “Asserted Patents”).
`
`18.
`
`The Asserted Patents recognized multiple problems with then-existing systems and
`
`methods for pumping milk. For example, as the ’624 Patent explains, “[a]lthough a variety of
`
`breast pumps are available, most are awkward and cumbersome, requiring many parts and
`
`assemblies and being difficult to transport.” Exhibit 1 at 1:30-32. Manual breast pumps can be
`
`“onerous” and “painful” to use. Id. at 1:33-34. Some of the available powered breast pumps
`
`“require an AC power source to plug into during use,” while other available battery-powered
`
`pumps “draw down the battery power fairly rapidly as the motorized pump continuously operates
`
`to maintain suction during the milk extraction process.” Id. at 1:36-38. Existing pumps had the
`
`- 9 -
`
`

`

`Case 2:23-cv-00229-JRG Document 64 Filed 06/21/24 Page 10 of 71 PageID #: 3589
`
`
`
`further disadvantages of being “clearly visible to an observer when the mother is using it” and
`
`“expos[ing] the breast of the mother during use.” Id. at 1:38-41. As the ’624 Patent explains,
`
`‘[t]here is a continuing need for a small, portable…wearable breast pump system” that would not
`
`expose the breast of the user, and could be “invisible or nearly unnoticeable when worn.” Id. at
`
`1:42-46.
`
`19.
`
`To address these deficiencies in the art, the Asserted Patents provide a wearable,
`
`inconspicuous, convenient pump. In various embodiments, “the system defines a natural breast
`
`profile” which would “fit comfortably and conveniently into a bra of a user and to present a natural
`
`look.” Exhibit 1 at 2:5-8. The pumping devices and storage containers of the inventions can be
`
`“sized and shaped to be received within a user’s bra.” Id. at 2:24-26. “Pumping of milk from a
`
`breast can occur without creating a change in a total mass and volume of the breast, pump device
`
`and storage container. The storage container can be one or more of flexible, or position around
`
`the breast.” Id. at 2:26-30.
`
`U.S. Patent No. 10,398,816
`
`20.
`
`On September 3, 2019, the USPTO duly and lawfully issued the ’816 Patent,
`
`entitled “Breast pump system with flange.” A true and correct copy of the ’816 Patent is attached
`
`as Exhibit 2. By assignment, duly recorded with the USPTO, Willow owns all substantial rights
`
`to the ’816 Patent, including the right to sue and recover damages for all infringement. 4
`
`21.
`
`The ’816 Patent generally relates to a breast pumping system where milk is
`
`expressed from the breast under suction, and the milk is moved by the pumping mechanism to a
`
`
`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.
`
`- 10 -
`
`

`

`Case 2:23-cv-00229-JRG Document 64 Filed 06/21/24 Page 11 of 71 PageID #: 3590
`
`
`
`collection container using pressure and all responsive to a controller. See id. at Abstract. The ’816
`
`Patent further provides for a portion of the system that contacts the skin, called the flange, designed
`
`as a “lower profile component” as compared to the prior art. Id. at 20:10-11.
`
`22.
`
`The ’816 Patent recognized a problem with then-existing systems and methods for
`
`pumping milk. As the ’816 Patent explains, “[a]lthough a variety of breast pumps are available,
`
`most are awkward and cumbersome, requiring many parts and assemblies and being difficult to
`
`transport.” Exhibit 2 at 1:23-25. Manual breast pumps can be “onerous” and “painful” to use. Id.
`
`at 1:25-27. Some of the available powered breast pumps “require an AC power source to plug into
`
`during use,” while other available battery-powered pumps “draw down the battery power fairly
`
`rapidly as the motorized pump continuously operates to maintain suction during the milk extraction
`
`process.” Id. at 1:27-31. Existing pumps had the further disadvantages of being “clearly visible
`
`to an observer when the mother is using it” and “expos[ing] the breast of the mother during use.”
`
`Id. at 1:31-34. In addition, “[m]any existing breast pump systems can cause considerable
`
`discomfort to the user over time. One cause of such discomfort is chafing of the nipple against the
`
`nipple flange/housing as the nipple stretches and contracts during the pumping session. There is
`
`a continuing need for a breast pump system that is more comfortable to the user, even over repeated
`
`pumping sessions.” Id. at 1:49-55.
`
`23.
`
`The ’816 Patent describes specific improvements to then-existing systems and
`
`methods for pumping milk. For example, in various embodiments, “the system defines a natural
`
`breast profile” which would “fit comfortably and conveniently into a bra of a user and to present
`
`a natural look.” Id. at 2:14-18. In addition, the claimed system maintains “at least a latch suction
`
`level at all times,” which results in a “more secure and persistent seal to the breast and significantly
`
`reduce[d] potential for leaks.” Id. at 20:3-6. This has several benefits to the user, including “less
`
`- 11 -
`
`

`

`Case 2:23-cv-00229-JRG Document 64 Filed 06/21/24 Page 12 of 71 PageID #: 3591
`
`
`
`friction on the side of the nipple against the flange wall, thereby greatly reducing the risk of
`
`irritation, skin damage, pain, swelling, etc.” Id. at 19:64-67. Additionally, because “the nipple
`
`travels less, this allows for the skin attachment member/flange to be designed as a lower profile
`
`component, as its length can be shorter…” Id. at 20:9-11. This benefit in turn limits the “overall
`
`amount of protrusion of the system from the breast to less than that in the prior art…” Id. at 20:
`
`13-15.
`
`24.
`
`As an example of the improvements in the ’816 Patent over the prior art, Figure 8
`
`provides a flange of an embodiment of the invention, and Figure 9 provides an exemplary prior art
`
`flange:
`
`
`
`25.
`
`The claims of the ’816 Patent capture specific technological improvements. For
`
`example, Claim 1 of the ’816 Patent provides for “a flange attached to the breast pump shell and
`
`configured to receive the breast” with a “rigid nipple receiving portion.” Id., Claim 1, 50:56-61.
`
`Claim 6 of the ’816 Patent adds a limitation to a “control loop [] used to adjust a speed of the
`
`compression member to vary or maintain the suction pressure.” Id., Claim 6, 51:12-16.
`
`26.
`
`The claimed improvements of the ’816 Patent, including the ability to maintain
`
`suction and the corresponding characteristics of the claimed flange, were not routine, conventional,
`
`- 12 -
`
`

`

`Case 2:23-cv-00229-JRG Document 64 Filed 06/21/24 Page 13 of 71 PageID #: 3592
`
`
`
`or well-known. These improvements were advantageous and inventive over the prior art systems
`
`that were cumbersome, difficult to transport, inefficient and/or inconvenient to power, and difficult
`
`to use discreetly. The ’816 Patent recognized the unconventional and advantageous nature of the
`
`claimed small, portable, self-powered, energy efficient, wearable breast pump system. Id. at 1:35-
`
`49. As the ’816 Patent explains, these improvements were advantageous and inventive over the
`
`prior art systems with less comfortable skin contact portions. The ’816 Patent recognized the
`
`unconventional and advantageous nature of achieving a shorter protrusion of the system from the
`
`breast, by providing improved suction and, in turn, the claimed flange. The improved systems and
`
`methods of the ’816 Patent, recited in the claims, provide technological benefits over the prior art.
`
`U.S. Patent No. 10,434,228
`
`27.
`
`On October 8, 2019, the USPTO duly and lawfully issued the ’228 Patent, entitled
`
`“Breast pump system and methods.” A true and correct copy of the ’228 Patent is attached as
`
`Exhibit 4. By assignment, duly recorded with the USPTO, Willow owns all substantial rights to
`
`the ’228 Patent, including the right to sue and recover damages for all infringement.
`
`28.
`
`The ’228 Patent generally relates to a breast pumping system where milk is
`
`expressed from the breast under suction, and the milk is moved by the pumping mechanism to a
`
`collection container using pressure. See id. at Abstract.
`
`29.
`
`The ’228 Patent recognized a problem with then-existing systems and methods for
`
`pumping milk. As the ’228 Patent explains, “[w]hen a user has completed the pumping phase of
`
`extracting milk…, it is useful and efficient to purge as much milk that remains…from the tubing
`
`[] and into the milk collection container [].” Id. at 41:8-11.
`
`30.
`
`The ’228 Patent describes specific improvements to then-existing systems and
`
`methods for pumping milk. In particular, the ’228 Patent provides systems with numerous
`
`- 13 -
`
`

`

`Case 2:23-cv-00229-JRG Document 64 Filed 06/21/24 Page 14 of 71 PageID #: 3593
`
`
`
`methods for avoiding loss of milk after extraction from the breast. For example, Figure 38
`
`illustrates events that may be carried out to perform a purge. Id. at 14:37-39. Figures 39A and
`
`39B further provide additional arrangements that may be provided to help prevent loss of milk out
`
`of the system.
`
`
`
`31.
`
`The claims of the ’228 Patent capture specific technological improvements. For
`
`example, Claim 1 provides an automated method of pumping milk, “wherein the milk is pumped
`
`from the breast to the collection container upwardly through the milk flow path relative to a bottom
`
`of the breast contacting structure.” Id. at Claim 1, 50:44-47.
`
`32.
`
`The claimed improvements of the ’228 Patent were not routine, conventional, or
`
`well-known. As the ’228 Patent explains, these improvements were advantageous and inventive
`
`over the prior art techniques without the provided methods of avoiding milk loss. The ’228 Patent
`
`recognized the unconventional and advantageous nature of directing the flow of milk upward. The
`
`improved systems and methods of the ’228 Patent, recited in the claims, provide technological
`
`benefits over the prior art.
`
`U.S. Patent No. 10,625,005
`
`- 14 -
`
`

`

`Case 2:23-cv-00229-JRG Document 64 Filed 06/21/24 Page 15 of 71 PageID #: 3594
`
`
`
`33.
`
`On April 21, 2020, the USPTO duly and lawfully issued the ’005 Patent, entitled
`
`“Breast pump assembly with remote interface.” A true and correct copy of the ’005 Patent is
`
`attached as Exhibit 5. By assignment, duly recorded with the USPTO, Willow owns all substantial
`
`rights to the ’005 Patent, including the right to sue and recover damages for all infringement.
`
`34.
`
`The ’005 Patent generally relates to a breast pumping system where milk is
`
`expressed from the breast under suction, and the milk is moved by the pumping mechanism to a
`
`collection container using pressure. See id. at Abstract. The ’005 Patent provides for a remote
`
`user interface system, including user control functionality. Id. at Claim 1, 28:33-34.
`
`35.
`
`The ’005 Patent recognized a problem with then-existing systems and methods for
`
`pumping milk. As the ’005 Patent explains, “[t]here is a continuing need for a small, portable,
`
`self-powered, energy efficient, wearable breast pump that is easy to use, that mimics natural
`
`nursing, and is…nearly unnoticeable when worn.” Id. at 1:54-58. In particular, it would be
`
`desirable to “easily and accurately monitor[] the volume of milk pumped by the system” and to
`
`“track milk volume pumped per session.” Id. at 1:59-67.
`
`36.
`
`The ’005 Patent describes specific improvements to then-existing systems and
`
`methods for pumping milk. For example, a remote user interface system allows for “at least the
`
`session start time, the session end time and total volume of milk extracted from the breast” to be
`
`“stored and tracked.” Id. at 25:15-17. Live data and historical data can be treated differently, and
`
`be downloaded to an external device during or immediately after a session, or downloaded as
`
`multiple session data. Id. at 25:27-46. The remote user interface “can also include specific user
`
`control functionality, and various related easy to understand displays.” Id. at 26:15-16. Figures
`
`30 and 31 provide exemplary aspects of a remote user interface system:
`
`- 15 -
`
`

`

`Case 2:23-cv-00229-JRG Document 64 Filed 06/21/24 Page 16 of 71 PageID #: 3595
`
`
`
`
`
`37.
`
`The claims of the ’005 Patent capture specific technological improvements. For
`
`example, Claim 1 is directed to a breast pump with a wireless transmitter, a “language protocol for
`
`two-way communication between the breast pump and an external device,” and a “remote user
`
`interface including user control functionality” and “an input for the human to adjust the breast
`
`pump with the external device.” Id. at Claim 1, 28:25-41.
`
`38.
`
`The claimed improvements of the ’005 Patent were not routine, conventional, or
`
`well-known. As the ’005 Patent explains, these improvements were advantageous and inventive
`
`over the prior art techniques that did not allow for a remote user interface system. The ’005 Patent
`
`recognized the unconventional and advantageous nature of a wireless system that empowered
`
`nursing mothers to control the operation of the breast pump through an external device. The
`
`improved systems and methods of the ’005 Patent, recited in the claims, provide technological
`
`benefits over the prior art.
`
`U.S. Patent No. 10,722,624
`
`39.
`
`On July 28, 2020, the USPTO duly and lawfully issued the ’624 Patent, entitled
`
`“Breast pump assembly with breast adapter.” A true and correct copy of the ’624 Patent is attached
`
`- 16 -
`
`

`

`Case 2:23-cv-00229-JRG Document 64 Filed 06/21/24 Page 17 of 71 PageID #: 3596
`
`
`
`as Exhibit 1. By assignment, duly recorded with the USPTO, Willow owns all substantial rights
`
`to the ’624 Patent, including the right to sue and recover damages for all infringement.
`
`40.
`
`The ’624 Patent generally relates to a breast milk pump that uses a pumping
`
`mechanism to expulse milk from a breast and to then store the milk in a milk collection container.
`
`The entire assembly may include both the pump and the storage container. See id. at Abstract.
`
`41.
`
`The ’624 Patent provides for various embodiments of the breast pumping system.
`
`In one example, in order to achieve the desired milk expression, “suction applied to the breast for
`
`expression of milk involves a first suction level, and during expulsing, a second suction level is
`
`maintained against the breast, the second suction level being lower than the first suction level.” Id.
`
`at 1:67-2:4.
`
`42.
`
`As the ’624 Patent explains, “[a]lthough a variety of breast pumps are available,
`
`most are awkward and cumbersome, requiring many parts and assemblies and being difficult to
`
`transport.” Id. at 1:30-32. Manual breast pumps can be “onerous” and “painful” to use. Id. at
`
`1:32-34. Some of the available powered breast pumps “require an AC power source to plug into
`
`during use,” while other available battery-powered pumps “draw down the battery power fairly
`
`rapidly as the motorized pump continuously operates to maintain suction during the milk extraction
`
`process.” Id. at 1:33-37. Existing pumps had the further disadvantages of being “clearly visible
`
`to an observer when the mother is using it” and “expos[ing] the breast of the mother during use.”
`
`Id. at 1:37-40.
`
`43.
`
`The ’624 Patent describes specific improvements to then-existing systems and
`
`methods for pumping milk. For example, in various embodiments, “the system defines a natural
`
`breast profile” which would “fit comfortably and conveniently into a bra of a user and to present
`
`a natural look.” Id. at 2:5-8. Another approach could include “outputting at least one of
`
`- 17 -
`
`

`

`Case 2:23-cv-00229-JRG Document 64 Filed 06/21/24 Page 18 of 71 PageID #: 3597
`
`
`
`operational and/or sensed parameters, and modifying at least one operational setting based upon”
`
`the same. Id. at 3:47-49. An operational setting could include “suction level setting, suction
`
`waveform definition, extraction phase time, threshold milk volume estimate per extraction phase
`
`expulsion, pressure, rest phase time, heating temperatures, heating times, vibration frequency and
`
`vibration times.” Id. at 3:50-55. The ’624 Patent provides a system or method that “can further
`
`perform in real-time, or as a feedback loop.” Id. at 3:49-50.
`
`44.
`
`The claims of the ’624 Patent capture specific technological improvements. For
`
`example, Claim 1 is directed to an “automated system for controlling pumping cycles” including
`
`a “sensor which detects when the milk collection container is full” and a controller that
`
`“automatically changes application of suction” based on the phase of milk expression from the
`
`user. Id. at Claim 1, 53:10-54:8.
`
`45.
`
`The claimed improvements of the ’624 Patent were not routine, conventional, or
`
`well-known. As the ’624 Patent explains, these improvements were advantageous and inventive
`
`over the prior art systems th