Case 8:18-cv-01265-RGK-PLA Document 35 Filed 08/15/18 Page 1 of 104 Page ID #:1200
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`Timothy Devlin (admitted pro hac vice)
`James Gorman III (to be admitted pro hac vice)
`Devlin Law Firm LLC
`1306 N. Broom Street, 1st Floor
`Wilmington, DE 19806
`Telephone: (302) 449-9010
`Facsimile: (302) 353-4251
`Email: tdevlin@devlinlawfirm.com
` jgorman@devlinlawfirm.com
`
`Greg Gardella (to be admitted pro hac vice)
`Cook Alciati (to be admitted pro hac vice)
`Gardella Grace P.A.
`455 Massachusetts Ave, NW, Suite 507
`Washington, DC 20001
`Telephone: 703-556-9600
`Facsimile: 703-740-4541
`Email: ggardella@gardellagrace.com
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` calciati@gardellagrace.com
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`Attorneys for Plaintiff
`FULFILLIUM, INC.
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`UNITED STATES DISTRICT COURT
`CENTRAL DISTRICT OF CALIFORNIA
`WESTERN DIVISION
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`
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`Case No. 8:18-cv-01265-RGK-PLA
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`FIRST AMENDED COMPLAINT
`FOR TRADE SECRET
`MISAPPROPRIATION AND
`PATENT INFRINGEMENT
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`DEMAND FOR JURY TRIAL
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`FULFILLIUM, INC.,
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`Plaintiff,
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`vs.
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`RESHAPE MEDICAL LLC, SV
`HEALTH INVESTORS, LLC,
`INTERSECT PARTNERS, LLC AND
`RESHAPE LIFESCIENCES, INC.
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`Defendants.
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`Plaintiff Fulfillium, Inc. (“Fulfillium” or “Plaintiff”), for its
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`Complaint against ReShape Medical LLC (“ReShape Medical LLC”), SV
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`Health Investors, LLC (“SV Health”), Intersect Partners, LLC (“Intersect
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`Partners”), and ReShape Lifesciences Inc. (“ReShape
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`Lifesciences”)(collectively “Defendants”) alleges the following:
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`NATURE OF THE ACTION
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`1.
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`This is an action for trade secret misappropriation and patent
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`infringement arising under the Uniform Trade Secrets Act, CA. Civ. Code §3426
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`et seq. and/or Mass. Gen. Laws ch. 93, § 42-42A and the Patent Laws of the
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`United States, 35 U.S.C. § 1 et seq.
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`THE PARTIES
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`2.
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`Fulfillium is a corporation organized and existing under the laws of
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`the State of Delaware, with an address at 1136 Orchard Avenue, Napa, California
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`94558.
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`3.
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`On information and belief, ReShape Medical LLC is a limited
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`liability company organized and existing under the laws of the State of Delaware
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`with its principal place of business at 100 Calle Iglesia, San Clemente, California
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`92672. ReShape Medical LLC can be served via its registered agent The
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`Corporation Trust Company, Corporation Trust Center, 1209 Orange Street,
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`Wilmington, Delaware, 19801. ReShape Medical LLC is a wholly owned
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`subsidiary of ReShape Lifesciences and the surviving entity of the merger of a
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`subsidiary of ReShape Lifesciences and ReShape Medical, Inc.
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`4.
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`On information and belief, SV Health is a limited liability company
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`organized and existing under the laws of the State of Delaware with its principal
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`place of business at One Boston Place, 201 Washington Street, Suite 3900,
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`Boston, Massachusetts 02108. SV Health Investors can be served via its registered
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`agent The Corporation Trust Company, Corporation Trust Center, 1209 Orange
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`Street, Wilmington, Delaware, 19801. SV Health maintains a business in the
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`State of California at 1700 Owens Street, Suite 585, San Francisco, CA 94158.
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`5.
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`On information and belief, ReShape Lifesciences is a corporation
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`organized and existing under the laws of the State of Delaware with its principal
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`place of business at 1001 Calle Amanecer, San Clemente, California 92673.
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`ReShape Lifesciences can be served via its registered agent The Corporation Trust
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`Company, Corporation Trust Center, 1209 Orange Street, Wilmington, DE 19801.
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`ReShape Lifesciences is the corporate parent of ReShape Medical LLC and
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`ultimate bearer of certain liabilities of the now merged and extinguished entity,
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`ReShape Medical, Inc.
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`6.
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`On information and belief, Intersect Partners is a limited liability
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`company organized and existing under the laws of the State of Nevada with places
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`of business in Nevada and Minnesota. Intersect Partners can be served via its
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`registered agent Sierra Corporate Services – Reno, 100 West Liberty Street 10th
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`Floor, Reno, NV 89501.
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`7.
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`On information and belief, ReShape Medical LLC’s predecessors,
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`ReShape Medical, Inc. and Abdominis, Inc. (“Abdominis”) were founded, funded,
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`owned and controlled in relevant respect through a joint venture between by SV
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`Life Sciences, LLC, which has reorganized as SV Health Investors, LLC and
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`Intersect Partners.
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`8.
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`The website of SV Health Investors states that “SV Health Investors,
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`formerly SV Life Sciences, is a leading healthcare and life sciences venture
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`capital and growth equity firm.” SV Health Investors and its predecessor SV Life
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`Sciences have at all relevant times held one or more seats on ReShape Medical,
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`Inc.’s Board of Directors.
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`9.
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`The first heading of the About Us page of SV Health Investors’
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`website is “Hands-on business partners.” Exhibit 5. The page explains that SV
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`Health Investors “work hands-on with our portfolio companies as trusted advisers
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`and partners from formation to exit. We help them develop business strategy,
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`make connections within our networks, and guide them through both smooth and
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`turbulent times toward a successful exit.” Id. According to the website, “[t]he SV
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`team has more than 400 aggregate years of healthcare operating experience –
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`which means we can work as true partners with our entrepreneurs, and develop
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`strong relationships with them through the full life cycle of their ventures.” Id.
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`10. On information and belief, SV Health and its predecessor SV Life
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`Sciences along with Intersect Partners have directed, controlled, actively induced
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`and/or conspired with ReShape Medical, Inc., and subsequently ReShape Medical
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`LLC, to take the actions that form the basis for this Second Amended Complaint.
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`11. Upon information and belief, Intersect Partners and SV Health have
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`jointly managed ReShape Medical since its inception.
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`12. On October 2, 2017, EnteroMedics, Inc. acquired ReShape Medical,
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`Inc. for cash and securities in the value of approximately $38 million. This
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`acquisition and merger was announced on October 3, 2017.
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`http://ir.enteromedics.com/releasedetail.cfm?ReleaseID=1042545. ReShape
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`Medical LLC is an additional entity that resulted from this merger. On October
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`23, 2017, EnteroMedics, Inc. announced its name change to ReShape Lifesciences
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`Inc. http://ir.enteromedics.com/releasedetail.cfm?ReleaseID=1044913.
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`JURISDICTION AND VENUE
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`13.
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` Upon information and belief, each of ReShape Medical LLC and
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`ReShape Lifesciences sells and offers to sell products and services throughout the
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`United States, including in this judicial district, and introduces products and
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`services into the stream of commerce that incorporate infringing technology
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`knowing that they would be sold in this judicial district and elsewhere in the
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`United States.
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`14. This is an action for trade secret misappropriation and patent
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`infringement arising under the Uniform Trade Secrets Act, CA. Civ. Code §3426
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`et seq. and/or Mass. Gen. Laws ch. 93, § 42-42A, and the Patent Laws of the
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`United States, Title 35 of the United States Code, respectively.
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`15. This Court has subject matter jurisdiction under 28 U.S.C. §§ 1331
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`and 1338(a).
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`16. Venue is proper in this judicial district under 28 U.S.C. §§ 1391(b),
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`(c), and (d). On information and belief, each Defendant conducts business in this
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`district, the claims alleged in this Complaint arise in this District, and acts of trade
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`secret misappropriation and infringement have taken place and are continuing to
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`take place in this District.
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`17. Venue is proper in this judicial district under 28 U.S.C. § 1400(b).
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`On information and belief, ReShape Medical LLC and ReShape Lifesciences have
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`committed acts of infringement in this District and have a regular and established
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`place of business within this District.
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`18. On information and belief, each Defendant is subject to this Court’s
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`general and specific personal jurisdiction because each Defendant has sufficient
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`minimum contacts within the State of California and this District, pursuant to due
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`process and/or the California Long Arm Statute, because each Defendant
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`purposefully availed itself of the privileges of conducting business in the State of
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`California and in this District, because each Defendant regularly conducts and
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`solicits business within the State of California and within this District, and
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`because Fulfillium’s causes of action arise directly from each Defendant’s
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`business contacts and other activities in the State of California and this District.
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`GENERAL ALLEGATIONS
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`19. Dr. Richard D. Y. Chen was born in Taiwan in 1958 and emigrated to
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`the United States in 1972. Dr. Chen obtained an undergraduate degree in
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`biochemistry and molecular biology from Harvard University in 1979. Dr. Chen
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`next attended medical school at Northwestern University and obtained an M.D. in
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`1983. Dr. Chen performed his internship in general surgery and continued in his
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`residency in neurosurgery at the Johns Hopkins Hospital in the 1980’s.
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`20. Dr. Chen obtained a Master’s Degree in Business Administration
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`from Stanford University in 1990. Following matriculation, Dr. Chen began
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`working in the investment banking department at Morgan Stanley & Company.
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`Thereafter, Dr. Chen continued working in financial services making investments
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`in and assisting start-up companies primarily in the technology sector.
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`21.
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`In 1999, Dr. Chen started conceiving innovative ideas of his own by
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`combining his experiences at the crossroads of medicine and technology. After
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`the tragic events of September 11, 2001, prospects in the technology investment
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`markets began to slow. Dr. Chen decided to focus on developing and
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`commercializing these ideas into entrepreneurial ventures.
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`22. Dr. Chen conceived of a bariatric medical device and procedure
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`whereby a novel balloon device is delivered endoscopically to reduce the interior
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`volume of the stomach and impede the flow of ingested food and thereby
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`effectively reduce the calories consumed. To mitigate potentially fatal
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`consequences of premature rupture and migration, which were significant
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`deficiencies in earlier devices within this class, safety was provided by two or
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`more chambers filled with fluids.
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`23. Because obesity is a complex, multifactorial disease, Dr. Chen
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`invested at least two years’ time i) analyzing critically over a thousand scientific
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`papers relating from the genetic basis of obesity to interventions in clinical
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`therapy to the psychosocial impact of the disease, and ii) attending scientific
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`research conferences on the basic underpinnings of the field and major medical
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`conferences in the United States and overseas to learn about the state of the art in
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`therapy and how the various medical specialties played their role in its treatment.
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`Gaining insight from these activities, Dr. Chen further refined key elements of his
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`idea and its implementation into everyday medical practice.
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`24. Dr. Chen then presented his idea, on a confidential basis, to leading
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`researchers and clinicians in the field, including the former presidents of the
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`American Gastroenterology Association, the American Society of Bariatric
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`Surgeons and its overseas counterpart, the International Federation for the Surgery
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`of Obesity. Practically everyone he contacted responded favorably with the
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`willingness to commit to participate further in developing the medical device and
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`procedure. Each of these disclosures was subject to a mutual understanding and
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`obligation of confidentiality. Only individuals who were under written
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`obligations of confidentiality were provided information regarding Fulfillium’s
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`trade secrets.
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`25. Dr. Chen contributed funds and his intellectual property to form
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`Fulfillium, Inc. in 2004 and filed his first provisional patent application on May 3,
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`2004. Dr. Chen raised seed capital from friends and family to take the idea to the
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`next stage of development. Dr. Chen attended trade shows in medical device
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`manufacture. Dr. Chen engaged consultants including engineers to help develop
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`the device and former regulators to explore the pathway for FDA approval.
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`Prototypes were constructed and animal lab facilities were evaluated.
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`26. Dr. Chen next embarked on raising venture capital to prove the
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`concept. Given his past experience in the venture business, Dr. Chen adopted a
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`set of practices for disclosure to protect the intellectual properties he developed.
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`Under this set of practices, Dr. Chen did not disclose any trade secret information
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`to anyone unless he had confirmed an agreement that it would be kept
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`confidential. On January 25, 2005, Dr. Chen spoke with Dr. Samuel Wu, M.D. of
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`SV Life Sciences (predecessor of SV Health) to discuss Fulfillium’s technology
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`on a confidential basis. All parties confirmed that the conversations regarding Dr.
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`Chen’s ideas were subject to an oral agreement of confidentiality. On February
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`10, 2005, Dr. Chen attended a meeting including the SV Life Sciences team in
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`Boston led by partner David Milne via a videoconference call hosted at the SV
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`Life Sciences offices at 950 Tower Lane, Ste. 1535, Foster City, California. Dr.
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`Chen understood the meeting to be confidential and, consistent with that, Dr.
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`Chen’s presentation slides were all marked “STRICTLY CONFIDENTIAL.” All
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`parties confirmed that the conversations surrounding this meeting were subject to
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`an oral agreement of confidentiality.
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`27.
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`In addition, SV Life Sciences representatives had due diligence calls
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`with various Fulfillium scientific advisors. These due diligence phone calls were
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`for expert validation of Fulfillium’s therapeutic concept and did not include
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`presentations of Fulfillium’s product development plans or trade secrets.
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`28. Dr. Wu informed Dr. Chen that the due diligence was “looking good”
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`and that SV Life Sciences was contemplating a term sheet. Dr. Wu noted that
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`although he, in California, had taken a point person role in the development of the
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`deal, SV Life Sciences’ medical device group was headquartered in Boston and he
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`was not part of the group. Thus, going forward SV Life Sciences would prefer to
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`partner with a venture capital firm in California who could more effectively
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`monitor Fulfillium’s activities.
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`29. Among other venture capital firms, Dr. Chen separately gave a
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`confidential presentation to Sprout Partners. Dr. Chen delivered the presentation
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`to Sprout partners Jeani Delagardelle at Sprout’s Menlo Park office and Andrew
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`Firlik, M.D. via conference call on March 4, 2005. Sprout and Fulfillium
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`understood that the conversations surrounding this presentation were confidential
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`because the parties previously signed and executed a written non-disclosure
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`agreement. Ms. Delagardelle later invited Dr. Chen to attend as Sprout’s guest at
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`the annual American Heart Association luncheon, a key event in the industry. Ms.
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`Delagardelle took on a lead role by referring another venture capital firm as a
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`potential co-investor. Dr. Chen eventually made an introduction between SV Life
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`Sciences and Sprout.
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`30. During the foregoing meetings and communications with SV Life
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`Sciences and Sprout, Dr. Chen provided confidential and detailed disclosures of
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`Fulfillium’s preferred clinical trial design and regulatory approval strategy. All of
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`the relevant parties to the foregoing meetings and communications understood the
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`conversations that occurred were subject to either oral or written agreements of
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`confidentiality.
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`31. On information and belief, neither SV Life Sciences nor Sprout had
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`any substantial previous knowledge or experience with balloon treatments for
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`obesity.
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`32. On information and belief, all of SV Life Sciences’ and Sprout’s
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`knowledge concerning Dr. Chen’s novel balloon designs for obesity as of the
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`Spring of 2005 was supplied by Dr. Chen.
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`33.
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`In the Spring of 2005, Ms. Delagardelle indicated that the due
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`diligence process would be delayed somewhat due to the fact that the healthcare
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`group principals of Sprout were forming a new firm, New Leaf Venture Partners.
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`Ms. Delagardelle asked Dr. Chen if this would pose a problem. Dr. Chen
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`responded that time was of the essence but a short delay under the circumstances
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`would be manageable.
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`34. Meanwhile, Dr. Chen continued to interface with SV Life Sciences.
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`SV Life Sciences arranged for Dr. Chen to meet George Wallace (venture partner
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`for SV Life Sciences) on May 16, 2005 at a restaurant in Chicago. During the
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`meeting Mr. Wallace proposed terms and conditions under which he would work
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`with Fulfillium. In addition to other compensation, Mr. Wallace demanded
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`greater than 25% stake in Fulfillium after the first round of financing by venture
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`capital firms. Given the ownership dilution that typically occurs during the first
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`round of financing, Mr. Wallace was effectively demanding majority ownership of
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`Fulfillium. Dr. Chen noted that Mr. Wallace’s requested equity share was more
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`than two to four times greater than that typically allotted to a CEO brought in to
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`run a company at Fulfillium’s stage of development. Mr. Wallace offered no
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`justification other than to say that he needed to compensate his business partner, a
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`practicing radiologist in Minnesota, and would not proceed without including his
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`business partner. Dr. Chen never disclosed the trade secrets to Mr. Wallace.
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`35. Thereafter, no further discussion took place between Mr. Wallace and
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`Dr. Chen. Instead, unbeknownst to Dr. Chen, decision makers in SV Life
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`Sciences sought to launch a new company with Mr. Wallace as the CEO based on
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`Fulfillium’s technology and trade secrets, which were misappropriated despite the
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`repeated oral agreements of confidentiality with SV Life Sciences. In the early
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`summer of 2005, Ms. Delagardelle of New Leaf sent a brief email to Dr. Chen
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`advising that New Leaf was considering a deal that SV Life Sciences was
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`proposing. Dr. Chen presumed that SV Life Sciences was proposing bringing to
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`market an alternative solution that would be different from the technology
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`developed and confidentially disclosed by Dr. Chen. Dr. Chen would later
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`discover that SV Life Sciences’ venture headed by Mr. Wallace was premised not
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`on some alternative solution but rather Fulfillium’s technology and trade secrets.
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`36. On information and belief, Mr. Wallace’s new company, called
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`Abdominis, Inc., was formed during the summer of 2005 and was funded by New
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`Leaf, Intersect Partners, and SV Life Sciences. Upon information and belief, each
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`of SV Life Sciences, Intersect Partners, and New Leaf not only provided capital,
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`but acted in concert to provide direct guidance in the company’s development and
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`controlled the operations of the company through their board membership.
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`37. Abdominis was subsequently renamed ReShape Medical, Inc.
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`Hereafter, “Reshape Medical, Inc.” will refer to Abdominis, Inc. and its successor-
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`in-interest Reshape Medical, Inc.
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`38. As is typical for a medical start-up company, ReShape Medical, Inc.
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`operated in “stealth mode” during development. ReShape Medical, Inc. started
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`pivotal clinical trials in 2012 and applied for FDA approval in 2014. The FDA
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`granted Pre-Marketing Approval to the ReShape Duo™ device and treatment
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`method on July 28, 2015.
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`39. When ReShape Medical, Inc. emerged from stealth mode and began
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`commercial operations, Dr. Chen learned that ReShape Medical, Inc. had copied
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`his trade secrets, including his entire clinical trial “playbook.” ReShape Medical,
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`Inc. copied, among other things, Dr. Chen’s clinical trial design and his selection
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`of the principal investigator.
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`40. On information and belief, the board of directors and officers of
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`ReShape Medical, Inc. knew or had reason to know of the foregoing facts and
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`events at the time ReShape Medical, Inc. first submitted the ReShape Duo™
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`product for FDA approval in 2012.
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`41. On October 2, 2017, EnteroMedics, Inc. acquired ReShape Medical,
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`Inc. for cash and securities in the value of approximately $38 million. This
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`acquisition and merger was announced on October 3, 2017.
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`http://ir.enteromedics.com/releasedetail.cfm?ReleaseID=1042545. ReShape
`
`Medical LLC is an additional entity that resulted from this merger. On October
`
`23, 2017, EnteroMedics, Inc. announced its name change to ReShape Lifesciences
`
`Inc. http://ir.enteromedics.com/releasedetail.cfm?ReleaseID=1044913.
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`42. Upon information and belief, as a result of the aforementioned
`
`merger, ReShape Medical LLC and ReShape Lifesciences Inc. are the entities that
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`now hold the liabilities of ReShape Medical, Inc. Fulfillium reserves the right to
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`include additional entities if it later discovers that ReShape Medical, Inc.’s
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`liabilities have been transferred elsewhere as a result of the aforementioned
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`merger.
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`COUNT I – TRADE SECRET MISAPPROPRIATION
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`43. Fulfillium repeats the allegations of paragraphs 1-42 above as though
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`fully set forth herein.
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`44. This claim is asserted against ReShape Medical LLC, Intersect
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`Partners, and SV Health for misappropriation of Fulfillium’s trade secrets and for
`
`conspiring to misappropriate such trade secrets.
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`45. The specific trade secrets that ReShape Medical, Inc., Intersect
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`Partners, SV Health, and/or their agents misappropriated, despite the repeated oral
`
`and/or written agreements of confidentiality, include at least three aspects of Dr.
`
`Chen’s clinical trial “playbook.” Three key protocols in the playbook optimized
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`the experimental rigor of the trial, especially in combination, in contrast to the
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`typical product development approach to optimize the conditions for favorable
`
`outcomes. The first is the counterintuitive control arm that “stacked the deck”
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`against the experimental arm. To tease out efficacy due to the device alone, the
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`device therapy had to show statistically better results over the most efficacious
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`non-interventional therapy available, namely diet and exercise counseling. The
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`second is the trial primary and secondary endpoints that set high bars for not just
`
`efficacy but clinical efficacy. To gain acceptance in the bariatric scientific
`
`community, not only the results have to be statistically significant, but the
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`difference between the two arms had to be wide enough to warrant an
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`interventional device therapy. The third is the counterintuitive and gastric device-
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`focused principal investigator selection premise. To provide even further
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`confidence in the results to overcome the stigma of gastric balloons, the trial was
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`to be conducted under the watchful eyes of investigators of consummate skill and
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`reputation. All of the above were developed after Dr. Chen’s extensive study of
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`the shortcomings of previous gastric devices.
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`46. Upon information and belief, based on EnteroMedics’s acquisition of
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`ReShape Medical, Inc. and the publically available regulatory documents relating
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`to said merger, ReShape Medical LLC assumed all, or at least a portion of, the
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`liabilities of ReShape Medical, Inc., including the present trade secret
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`misappropriation claims. To the extent that ReShape Medical LLC has taken on
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`the liability of ReShape Medical, Inc., it is liable for ReShape Medical, Inc.’s
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`misappropriation; and/or to the extent ReShape Medical LLC continues to rely on
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`and/or profit from ReShape Medical, Inc.’s misappropriation, it is liable for that
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`continuing activity. Fulfillium reserves the right to assert this count against
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`additional entities if it later discovers that ReShape Medical, Inc.’s liabilities have
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`been transferred elsewhere as a result of the aforementioned merger.
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`47. The disclosures of each of these three trade secrets were made
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`pursuant to the aforementioned written and/or oral agreements of confidentiality
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`to SV Life Sciences, Intersect Partners and New Leaf. On information and belief,
`
`these trade secrets were conveyed to Mr. Wallace, Intersect Partners, ReShape
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`Medical LLC and SV Health who each used them for their own benefit.
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`48. A significant portion of the information used by ReShape Medical,
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`Inc. to design its device and obtain FDA approval constitute Fulfillium trade
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`secrets in that they: (a) constitute information that derives independent economic
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`value from not being generally known to the public or to other persons who can
`
`obtain economic value from its disclosure or use; and (b) have been the subject of
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`reasonable efforts to maintain their secrecy.
`
`49. Through SV Life Sciences (SV Health) and Intersect Partners (and
`
`their misappropriation of Dr. Chen’s trade secrets, which were protected via
`
`repeated confidentiality agreements), Mr. Wallace, and Sprout, ReShape Medical
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`LLC, Intersect Partners, and SV Health acquired confidential, expert validated,
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`trade secret information about all aspects of Fulfillium’s business, including
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`clinical trial design and regulatory strategy. Specifically, ReShape Medical LLC,
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`Intersect Partners, and SV Health misappropriated at least the three
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`aforementioned aspects of Dr. Chen and Fulfillium’s clinical trial playbook.
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`RESHAPE 1025
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`

`

`Case 8:18-cv-01265-RGK-PLA Document 35 Filed 08/15/18 Page 15 of 104 Page ID
` #:1214
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`50. Upon information and belief, ReShape Medical LLC, Intersect
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`Partners, and SV Health have relied upon and used that trade secret information in
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`some or all aspects of its business, including commitment to launch, raising
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`capital, product design, procedure design, and FDA clinical trial design.
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`51. The actions alleged above constitute a wrongful misappropriation of
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`Fulfillium’s trade secrets. They also constitute a wrongful conspiracy among the
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`board directors and officers of and investors in ReShape Medical LLC, Intersect
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`Partners, and SV Health to misappropriate Fulfillium’s trade secrets.
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`52. As a direct and proximate result of the actions alleged above,
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`Fulfillium has been shut out of the market. By misappropriating Fulfillium’s
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`technology and launching a competing company, ReShape Medical LLC, Intersect
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`Partners, and SV Health prevented Fulfillium from raising the funds required to
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`bring its product to market.
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`53. As a direct and proximate result of the actions alleged above,
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`ReShape Medical LLC, Intersect Partners, and SV Health have been unjustly
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`enriched in an amount no less than the business opportunity deprived from
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`Fulfillium.
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`54.
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`In doing the acts hereinabove alleged, each of ReShape Medical
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`LLC, Intersect Partners, and SV Health and its investors have engaged in willful
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`and malicious misappropriation by reason thereof, and Fulfillium is entitled, as
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`against each of them, to twice the amount of its actual damages and/or the
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`amounts by which ReShape Medical LLC, Intersect Partners, and SV Health have
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`been unjustly enriched as exemplary damages pursuant to Civil Code § 3426.3(c)
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`and/or Mass. Gen. Laws ch. 93, § 42-42A.
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`55. By the aforesaid acts, ReShape Medical LLC, Intersect Partners, and
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`SV Health have irreparably injured Fulfillium and such injury will continue unless
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`enjoined by this Court.
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`RESHAPE 1025
`
`

`

`Case 8:18-cv-01265-RGK-PLA Document 35 Filed 08/15/18 Page 16 of 104 Page ID
` #:1215
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`COUNT II – INFRINGEMENT OF U.S. PATENT NO. 9,456,915
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`56. Fulfillium repeats the allegations of paragraphs 1-55 above as though
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`fully set forth herein.
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`57. On October 4, 2016, U.S. Patent No. 9,456,915 (“the ‘915 patent”),
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`entitled “Methods, Devices, and Systems for Obesity Treatment,” was duly and
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`legally issued by the United States Patent and Trademark Office. A true and
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`correct copy of the ’915 patent is attached as Exhibit 1.
`
`58. Fulfillium is the assignee and owner of the right, title and interest in
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`and to the ‘915 patent, including the right to assert all causes of action arising
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`under said patents and the right to any remedies for infringement of them by at
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`least an assignment dated July 16, 2018. (Ex. A.)
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`59. On information and belief, ReShape Medical LLC and ReShape
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`Lifesciences are engaged in the business of making, using, selling, offering to sell,
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`and/or importing medical devices. A description of ReShape Medical LLC and
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`ReShape Lifesciences’ business is available on its business website, which is
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`located at http://pro.reshapeready.com; https://reshapeready.com/. A screenshot
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`of the homepage of ReShape Medical LLC’s business website is attached as
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`Exhibit 3.
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`60. As part of its business, each of ReShape Medical LLC and ReShape
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`Lifesciences makes, uses, offers to sell, sells, and/or imports a dual intragastric
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`balloon for weight loss, including ReShape’s “Duo Balloon” device, which is
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`placed inside the patient’s stomach for weight loss. ReShape Medical LLC and
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`ReShape Lifesciences have purposefully sold and offered for sale such Duo
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`Balloon devices throughout the United States.
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`61. Upon information and belief, each of ReShape Medical LLC and
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`ReShape Lifesciences has and continues to directly infringe at least claims 1-2 and
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`4-27 of the ‘915 patent by making, using, selling, importing and/or providing and
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`causing to be used medical devices for weight loss, including but not limited to,
`
`RESHAPE 1025
`
`

`

`Case 8:18-cv-01265-RGK-PLA Document 35 Filed 08/15/18 Page 17 of 104 Page ID
` #:1216
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`those sold under the name ReShape Duo Balloon (the “Infringing
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`Instrumentalities” or “ReShape Balloon”). For clarity the terms “Infringing
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`Instrumentalities” and “ReShape Balloon” are understood to include the balloon
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`device intended for delivery into the gastric cavity, as well as any delivery system
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`for that balloon device.
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`62. Representative claim 1 of the ‘915 patent recites a “gastric balloon
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`structure for deploying in a gastric cavity of a patient, comprising: at least two
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`isolated non-concentric inflatable chambers, wherein each chamber of the at least
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`two isolated non-concentric inflatable chambers has a respective inflated state
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`volume such that deflation of any single chamber of the at least two isolated non-
`
`concentric inflatable chambers leaves the inflated state volume of the remaining
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`chambers of the at least two isolated non-concentric inflatable chambers
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`unaffected.” The Infringing Instrumentalities infringe claim 1 of the ‘915 patent.
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`The ReShape Dual Balloon “is a temporary implant designed to facilitate weight
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`loss by occupying space in the stomach.” ReShape™ Integrated Dual Balloon
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`System Instructions for Use, PN 03-0300 Rev. D, p. 1,
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`https://reshapeready.com/wp-
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`content/uploads/2015/07/ReShape_Instructions_For_Use.pdf. The figure below,
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`taken from ReShape’s instruction manual, shows the dual balloon in a patient’s
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`stomach. The ReShape website states that “[i]n the unlikely event of individual
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`gastric balloon leakage or deflation, the independently sealed ReShape weight loss
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`balloons are designed to minimize risk of migration or obstruction.”
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`http://pro.reshapeready.com/about-reshape/#theadvantages