Case 2:23-cv-00229-JRG Document 68 Filed 07/08/24 Page 1 of 106 PageID #: 4341
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`
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE EASTERN DISTRICT OF TEXAS
`MARSHALL DIVISION
`
`
`WILLOW INNOVATIONS, INC.,
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` Plaintiff and Counterclaim Defendant,
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`
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`CHIARO TECHNOLOGY, LTD.,
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` Defendant and Counterclaim Plaintiff.
`
`
`v.
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`
`
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`
`
`
`Civil Action No. 2:23-cv-00229
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`JURY TRIAL DEMANDED
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`CHIARO TECHNOLOGY, LTD.’S ANSWER TO WILLOW’S SECOND AMENDED
`COMPLAINT FOR PATENT INFRINGEMENT
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`Defendant/Counterclaim Plaintiff Chiaro Technology Ltd. (“Defendant” or “Elvie”)
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`hereby submits its Answer, Defenses, and Counterclaims to Willow’s Second Amended
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`Complaint for Patent Infringement (“Complaint”) filed by Willow Innovations, Inc. (“Willow”
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`or “Plaintiff”). Any and all allegations contained in Plaintiff’s Complaint not expressly admitted
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`in this Answer are denied.
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`GENERAL DENIAL
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`Elvie denies all allegations in Plaintiff’s Complaint except for those specifically admitted
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`below. With respect to the allegations made in the Complaint, upon knowledge with respect to
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`Elvie’s own acts, and upon information and belief as to other matters, Elvie responds and alleges
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`as follows:
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`THE PARTIES
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`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 Real, Suite 306, Mountain View, CA 94040. On October 21, 2020,
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`Willow changed its name from “Exploramed NC7, Inc.” to “Willow Innovations,
`Inc.”
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`ANSWER: Elvie lacks sufficient knowledge and information to form a belief as to the
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`truth of the allegations of Paragraph 1 as pled and denies those allegations on that basis.
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`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.
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`ANSWER: Elvie admits that Chiaro Technology, Limited is a corporation organized
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`and existing under the laws of England and Wales, with its principal place of business at 63-66
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`Hatton Garden, EC1N 8LE, London, United Kingdom. Elvie further admits that Elvie is the
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`trading name of Chiaro Technology Limited. Elvie denies the remaining allegations of Paragraph
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`2.
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`BACKGROUND
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`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.
`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 its array of product offerings, with a primary focus on the U.S.—the
`world’s largest market for breast pumps.
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`ANSWER: Paragraph 3 of the Complaint contains statements that are neither
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`allegations nor averments to which a response is required. To the extent a response is required,
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`Elvie lacks sufficient knowledge and information to form a belief as to the truth of the
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`allegations of Paragraph 3 as pled and denies those allegations on that basis.
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`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.
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`ANSWER: Paragraph 4 contains legal conclusions and allegations to which no
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`response is required. To the extent a response is required, Elvie denies that Willow’s virtual
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`patent marking provides sufficient notice to the public of each patent covering each of Willow’s
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`products. Elvie otherwise lacks sufficient knowledge and information to form a belief as to the
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`truth of the allegations of Paragraph 4 as pled and denies those allegations on that basis.
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`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.
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`ANSWER: Paragraph 5 of the Complaint contains statements that are neither
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`allegations nor averments to which a response is required. To the extent a response is required,
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`Elvie lacks sufficient knowledge and information to form a belief as to the truth of the
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`allegations of Paragraph 5 as pled and denies those allegations on that basis.
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`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
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`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 Willow Pump. See id. (citing product code
`“HGX” to show the Willow Pump was an FDA-cleared predicate device to the Elvie
`Pump).
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`ANSWER: Elvie admits that it has its principal place of business in the United
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`Kingdom. Elvie admits that it received clearance from the U.S. Food and Drug Administration to
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`market the Elvie Pump in the United States and released its Pump system during the 2018
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`London Fashion Week. Elvie also states that the Medela Freestyle is the predicate device that is
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`listed in the Elvie Pump 510(k) premarket notification. Elvie denies the remaining allegations of
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`Paragraph 6.
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`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/.
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`ANSWER: Elvie admits that it has secured Series C funding as of 2021. Elvie denies
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`the remaining allegations of Paragraph 7.
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`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.
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`ANSWER: Denied.
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`JURISDICTION AND VENUE
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`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).
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`ANSWER: Paragraph 9 of the Complaint states legal conclusions to which no
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`response is required. To the extent a response is required, Elvie admits that Plaintiff purports to
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`bring a civil action for patent infringement arising under the patent laws of the United States, 35
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`U.S.C. §§ 100 et seq. Further, Elvie does not contest subject matter jurisdiction over Plaintiff’s
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`claims under 28 U.S.C. §§ 1331, 1338(a), and 1367(a) for purposes of this this action only. Elvie
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`specifically denies that any cause of action for false advertising or unfair competition arises
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`under 35 U.S.C. §§ 100 et seq. Elvie denies the remaining allegations of Paragraph 9.
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`10. This 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.
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`ANSWER: Paragraph 10 contains legal conclusions and allegations to which no
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`response is required. To the extent a response is required, Elvie does not contest the Court’s
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`exercise of subject matter jurisdiction over it for purposes of this action only. Elvie denies the
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`remaining allegations of Paragraph 10.
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`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 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.
`
`ANSWER: Paragraph 11 contains legal conclusions and allegations to which no
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`response is required. To the extent a response is required, Elvie does not contest the Court’s
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`exercise of personal jurisdiction over it for purposes of this action only. Elvie denies the
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`remaining allegations of Paragraph 10.
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`12. Elvie has sold their breast pumps and related products within this District via the
`following means:
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`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.
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`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
`from authorized sellers via (1) the authorized seller’s website; or (2) the authorized
`seller’s brick-and-mortar store located within the District:
`
`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).
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`6
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`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).
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`ANSWER: Elvie admits that it has made its products available for sale on its website,
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`as well as other retailer websites including Walmart, Amazon, and Target. Elvie does not contest
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`personal jurisdiction for purposes of this action only. Elvie denies the remaining allegations of
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`Paragraph 11.
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`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 Chronicle touting the benefits 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).
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`ANSWER: Paragraph 13 contains legal conclusions and allegations to which no
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`response is required. To the extent a response is required, Elvie admits that Plaintiff purports to
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`present comments by Aoife Zakaras-Nally cited in the Houston Chronicle article from August 1,
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`2022, titled “Breastfeeding will never be free. But it can be made easier. Here’s how new
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`technology helps moms.” Elvie denies the remaining allegations of Paragraph 13.
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`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
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`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.
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`ANSWER: Paragraph 14 contains legal conclusions and allegations to which no
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`response is required. To the extent a response is required, Elvie admits that Plaintiff purports to
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`present an incomplete selection or summary of text from Elvie’s webpages, but the actual and
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`complete disclosure of the webpages speaks for themselves and are controlling. Elvie denies the
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`remaining allegations of Paragraph 14.
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`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.
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`ANSWER: Paragraph 15 contains legal conclusions and allegations to which no
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`response is required. To the extent a response is required, Elvie does not contest the Court’s
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`exercise of personal jurisdiction over it for purposes of this action only. Elvie denies the
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`remaining allegations of Paragraph 15.
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`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.
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`ANSWER: Paragraph 16 contains legal conclusions and allegations to which no
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`response is required. To the extent a response is required, Elvie does not contest venue for
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`purposes of this action only. Elvie denies the remaining allegations of Paragraph 16.
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`THE ASSERTED PATENTS
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`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”).
`
`ANSWER: Elvie denies that this action purportedly involves seven asserted patents,
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`as Willow added an eighth patent in its First Amended Complaint: U.S. Patent No. 10,398,816
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`(“the ’816 Patent”); U.S. Patent No. 10,434,228 (“the ’228 Patent”); U.S. Patent No. 10,625,005
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`(“the ’005 Patent”); U.S. Patent No. 10,722,624 (“the ’624 Patent”); U.S. Patent No. 11,185,619
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`(“the ’619 Patent”); U.S. Design Patent No. D832,995 (“the ’D995 Patent”); U.S. Design Patent
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`No. D977,625 (“the ’D625 Patent”); and U.S. Patent No. 10,688,229 (“the ’229 patent”)
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`(collectively, the “Asserted Patents”). Elvie denies the remaining allegations of Paragraph 17.
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`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 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.
`
`ANSWER: Elvie admits that Plaintiff purports to present certain incomplete selections
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`of text of the ’624 patent, but the actual and complete disclosure of the ’624 patent speaks for
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`itself and is controlling. Elvie denies the remaining allegations of Paragraph 18.
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`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
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`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.
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`ANSWER:
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`Elvie admits that Plaintiff purports to present certain incomplete selections
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`of text of the ’624 patent, but the actual and complete disclosure of the ’624 patent speaks for
`
`itself and is controlling. Elvie denies the remaining allegations of Paragraph 19.
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`U.S. Patent No. 10,398,816
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`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.
`
`ANSWER: Elvie admits that on its face, the ’812 patent titled “Breast pump system
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`with flange” issued on September 3, 2019. Elvie lacks sufficient knowledge and information to
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`form a belief as to the truth of the remaining allegations of Paragraph 20 as pled and denies those
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`allegations on that basis.
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`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
`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.
`
`ANSWER: Elvie admits that Plaintiff purports to present certain incomplete selections
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`of text of the ’816 patent, but the actual and complete disclosure of the ’816 patent speaks for
`
`itself and is controlling. Elvie denies the remaining allegations of Paragraph 21 that are contrary
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`to the actual and complete disclosure of the ’816 patent.
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`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
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`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.
`
`ANSWER: Elvie admits that Plaintiff purports to present certain incomplete selections
`
`of text of the ’816 patent, but the actual and complete disclosure of the ’816 patent speaks for
`
`itself and is controlling. Elvie denies the remaining allegations of Paragraph 22.
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`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 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.
`
`ANSWER: Elvie admits that Plaintiff purports to present certain incomplete selections
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`of text of the ’816 patent, but the actual and complete disclosure of the ’816 patent speaks for
`
`itself and is controlling. Elvie denies the remaining allegations of Paragraph 23.
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`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:
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`ANSWER: Elvie admits that Plaintiff purports to present certain incomplete selections
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`of figures of the ’816 patent, but the actual and complete disclosure of the ’816 patent speaks for
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`itself and is controlling. Elvie denies the remaining allegations of Paragraph 24 that are contrary
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`to the actual and complete disclosure of the ’816 patent.
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`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.
`
`ANSWER: Elvie admits that Plaintiff purports to present certain incomplete selections
`
`of text of the ’816 patent, but the actual and complete disclosure of the ’816 patent speaks for
`
`itself and is controlling. Elvie denies the remaining allegations of Paragraph 25.
`
`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, 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,
`
`
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`Case 2:23-cv-00229-JRG Document 68 Filed 07/08/24 Page 13 of 106 PageID #: 4353
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`the claimed flange. The improved systems and methods of the ’816 Patent, recited in
`the claims, provide technological benefits over the prior art.
`
`ANSWER: Denied.
`
`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.
`
`ANSWER: Elvie admits that on its face, the ’228 patent titled “Breast pump system
`
`and methods” issued on October 8, 2019. Elvie lacks sufficient knowledge and information to
`
`form a belief as to the truth of the remaining allegations of Paragraph 27 as pled and denies those
`
`allegations on that basis.
`
`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.
`
`ANSWER: Elvie admits that Plaintiff purports to present certain incomplete
`
`summaries of the text of the ’228 patent, but the actual and complete disclosure of the ’228
`
`patent speaks for itself and is controlling. Elvie denies the remaining allegations of Paragraph 28
`
`that are contrary to the actual and complete disclosure of the ’228 patent.
`
`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.
`
`ANSWER: Elvie admits that Plaintiff purports to present certain incomplete selections
`
`of text of the ’228 patent, but the actual and complete disclosure of the ’228 patent speaks for
`
`itself and is controlling. Elvie denies the remaining allegations of Paragraph 29.
`
`30. The ’228 Patent describes specific improvements to then-existing systems and
`methods for pumping milk. In particular, the ’228 Patent provides systems with
`
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`numerous 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.
`
`
`
`ANSWER: Elvie admits that Plaintiff purports to present certain incomplete selections
`
`of text and figures of the ’228 patent, but the actual and complete disclosure of the ’228 patent
`
`speaks for itself and is controlling. Elvie denies the remaining allegations of Paragraph 30.
`
`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.
`
`ANSWER: Elvie admits that Plaintiff purports to present certain incomplete selections
`
`of text of the ’228 patent, but the actua