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`Timothy Devlin (to be 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
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`Greg Gardella (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
`
`Seth W. Wiener (California State Bar No. 203747)
`Law Offices of Seth W. Wiener
`9107 Wilshire Boulevard, Suite 450
`Beverly Hills, CA 90210
`Telephone: (925) 487-5607
`Email: sethwiener@yahoo.com
`
`Attorneys for Plaintiff
`FULFILLIUM, INC.
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`AMENDED COMPLAINT FOR TRADE SECRET MISAPPROPRIATION AND PATENT INFRINGEMENT
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`Case 2:17-cv-08419-RGK-PLA Document 39 Filed 11/20/17 Page 2 of 76 Page ID #:893
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`UNITED STATES DISTRICT COURT
`CENTRAL DISTRICT OF CALIFORNIA
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`
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`Case No. 2:17-cv-08419
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`FULFILLIUM, INC.,
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`Plaintiff,
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`vs.
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`RESHAPE MEDICAL, INC.,
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`Defendant.
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`AMENDED COMPLAINT FOR
`TRADE SECRET
`MISAPPROPRIATION AND
`PATENT INFRINGEMENT
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`DEMAND FOR JURY TRIAL
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`Case 2:17-cv-08419-RGK-PLA Document 39 Filed 11/20/17 Page 3 of 76 Page ID #:894
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`Plaintiff Fulfillium, Inc. (“Fulfillium” or “Plaintiff”), for its
`
`Complaint against ReShape Medical, Inc. (“ReShape” or “Defendant”)
`alleges the following:
`
`NATURE OF THE ACTION
`1.
`This is an action for trade secret misappropriation and patent
`infringement arising under the Uniform Trade Secrets Act, CA. Civ. Code §3426
`et seq. and/or Mass. Gen. Laws ch. 93, § 42-42A and the Patent Laws of the
`United States, 35 U.S.C. § 1 et seq.
`THE PARTIES
`2.
`Fulfillium is a corporation organized and existing under the laws of
`the State of Delaware, with an address at 1136 Orchard Avenue, Napa, California
`94558.
`3.
`On information and belief, ReShape is a corporation organized and
`existing under the laws of the State of Delaware with its principal place of
`business at 100 Calle Iglesia, San Clemente, California 92672. ReShape can be
`served via its registered agent Corporation Service Company, 2711 Centerville
`Road, Suite 400, Wilmington, Delaware 19808.
`JURISDICTION AND VENUE
`4.
` Upon information and belief, Defendant sells and offers to sell
`products and services throughout the United States, including in this judicial
`district, and introduces products and services into the stream of commerce that
`incorporate infringing technology knowing that they would be sold in this judicial
`district and elsewhere in the United States.
`5.
`This is an action for trade secret misappropriation and patent
`infringement arising under the Uniform Trade Secrets Act, CA. Civ. Code §3426
`et seq. and/or Mass. Gen. Laws ch. 93, § 42-42A, and the Patent Laws of the
`United States, Title 35 of the United States Code, respectively.
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`Case 2:17-cv-08419-RGK-PLA Document 39 Filed 11/20/17 Page 4 of 76 Page ID #:895
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`6.
`This Court has subject matter jurisdiction under 28 U.S.C. §§ 1331
`and 1338(a).
`7.
`Venue is proper in this judicial district under 28 U.S.C. §§ 1391(b),
`(c), (d) and/or 1400(b). On information and belief, Defendant conducts business
`in this district, the claims alleged in this Complaint arise in this District, and acts
`of infringement have taken place and are continuing to take place in this District.
`8.
`On information and belief, Defendant is subject to this Court’s
`general and specific personal jurisdiction because Defendant has sufficient
`minimum contacts within the State of California and this District, pursuant to due
`process and/or the California Long Arm Statute, because Defendant purposefully
`availed itself of the privileges of conducting business in the State of California
`and in this District, because Defendant regularly conducts and solicits business
`within the State of California and within this District, and because Fulfillium’s
`causes of action arise directly from Defendant’s business contacts and other
`activities in the State of California and this District.
`GENERAL ALLEGATIONS
`9.
`Dr. Richard D. Y. Chen was born in Taiwan in 1958 and emigrated to
`the United States in 1972. Dr. Chen obtained an undergraduate degree in
`biochemistry and molecular biology from Harvard University in 1979. Dr. Chen
`next attended medical school at Northwestern University and obtained an M.D. in
`1983. Dr. Chen performed his internship in general surgery and continued in his
`residency in neurosurgery at the Johns Hopkins Hospital in the 1980s.
`10. Dr. Chen obtained a Master’s Degree in Business Administration
`from Stanford University in 1990. Following matriculation, Dr. Chen began
`working in the investment banking department at Morgan Stanley & Company.
`Thereafter, Dr. Chen continued working in financial services making investments
`in and assisting start-up companies primarily in the technology sector.
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`Case 2:17-cv-08419-RGK-PLA Document 39 Filed 11/20/17 Page 5 of 76 Page ID #:896
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`11.
`In 1999, Dr. Chen started conceiving innovative ideas of his own by
`combining his experiences at the crossroads of medicine and technology. After
`the tragic events of September 11, 2001, prospects in the technology investment
`markets began to slow. Dr. Chen decided to focus on developing and
`commercializing these ideas into entrepreneurial ventures.
`12. Dr. Chen conceived of a bariatric medical device and procedure
`whereby a novel balloon device is delivered endoscopically to reduce the interior
`volume of the stomach and impede the flow of ingested food and thereby
`effectively reduce the calories consumed. To mitigate potentially fatal
`consequences of premature rupture and migration, which were significant
`deficiencies in earlier devices within this class, safety was provided by two or
`more chambers filled with fluids.
`13. Because obesity is a complex, multifactorial disease, Dr. Chen
`invested at least two years’ time i) analyzing critically over a thousand scientific
`papers relating from the genetic basis of obesity to interventions in clinical
`therapy to the psychosocial impact of the disease, and ii) attending scientific
`research conferences on the basic underpinnings of the field and major medical
`conferences in the United States and overseas to learn about the state of the art in
`therapy and how the various medical specialties played their role in its treatment.
`Gaining insight from these activities, Dr. Chen further refined key elements of his
`idea and its implementation into everyday medical practice.
`14. Dr. Chen then presented his idea, on a confidential basis, to leading
`researchers and clinicians in the field, including the former presidents of the
`American Gastroenterology Association, the American Society of Bariatric
`Surgeons and its overseas counterpart, the International Federation for the Surgery
`of Obesity. Practically everyone he contacted responded favorably with the
`willingness to commit to participate further in developing the medical device and
`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
`obligations of confidentiality were provided information regarding Fulfillium’s
`trade secrets.
`15. Dr. Chen contributed funds and his intellectual property to form
`Fulfillium, Inc. in 2004 and filed his first provisional patent application on May 3,
`2004. Dr. Chen raised seed capital from friends and family to take the idea to the
`next stage of development. Dr. Chen attended trade shows in medical device
`manufacture. Dr. Chen engaged consultants including engineers to help develop
`the device and former regulators to explore the pathway for FDA approval.
`Prototypes were constructed and animal lab facilities were evaluated.
`16. Dr. Chen next embarked on raising venture capital to prove the
`concept. Given his past experience in the venture business, Dr. Chen adopted a
`set of practices for disclosure to protect the intellectual properties he developed.
`Under this set of practices, Dr. Chen did not disclose any trade secret information
`to anyone unless he had confirmed an agreement that it would be kept confidential.
`On January 25, 2005, Dr. Chen spoke with Dr. Samuel Wu, M.D. of SV Life
`Sciences to discuss Fulfillium’s technology on a confidential basis. All parties
`confirmed that the conversations regarding Dr. Chen’s ideas were subject to an
`oral agreement of confidentiality. On February 10, 2005, Dr. Chen attended a
`meeting including the SV Life Sciences team in Boston led by partner David
`Milne via a videoconference call hosted at the SV Life Sciences offices at 950
`Tower Lane, Ste. 1535, Foster City, California. Dr. Chen understood the meeting
`to be confidential and, consistent with that, Dr. Chen’s presentation slides were all
`marked “STRICTLY CONFIDENTIAL.” All parties confirmed that the
`conversations surrounding this meeting were subject to an oral agreement of
`confidentiality.
`17.
`In addition, SV Life Sciences representatives had due diligence calls
`with various Fulfillium scientific advisors. These due diligence phone calls were
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`Case 2:17-cv-08419-RGK-PLA Document 39 Filed 11/20/17 Page 7 of 76 Page ID #:898
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`for expert validation of Fulfillium’s therapeutic concept and did not include
`presentations of Fulfillium’s product development plans or trade secrets.
`18. Dr. Wu informed Dr. Chen that the due diligence was “looking good”
`and that SV Life Sciences was contemplating a term sheet. Dr. Wu noted that
`although he, in California, had taken a point person role in the development of the
`deal, SV Life Sciences’ medical device group was headquartered in Boston and he
`was not part of the group. Thus, going forward SV Life Sciences would prefer to
`partner with a venture capital firm in California who could more effectively
`monitor Fulfillium’s activities.
`19. Among other venture capital firms, Dr. Chen separately gave a
`confidential presentation to Sprout Partners. Dr. Chen delivered the presentation
`to Sprout partners Jeani Delagardelle at Sprout’s Menlo Park office and Andrew
`Firlik, M.D. via conference call on March 4, 2005. Sprout and Fulfillium
`understood that the conversations surrounding this presentation were confidential
`because the parties previously signed and executed a written non-disclosure
`agreement. Ms. Delagardelle later invited Dr. Chen to attend as Sprout’s guest at
`the annual American Heart Association luncheon, a key event in the industry. Ms.
`Delagardelle took on a lead role by referring another venture capital firm as a
`potential co-investor. Dr. Chen eventually made an introduction between SV Life
`Sciences and Sprout.
`20. During the foregoing meetings and communications with SV Life
`Sciences and Sprout, Dr. Chen provided confidential and detailed disclosures of
`Fulfillium’s preferred clinical trial design and regulatory approval strategy. All of
`the relevant parties to the foregoing meetings and communications understood the
`conversations that occurred were subject to either oral or written agreements of
`confidentiality.
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`Case 2:17-cv-08419-RGK-PLA Document 39 Filed 11/20/17 Page 8 of 76 Page ID #:899
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`21. On information and belief, neither SV Life Sciences nor Sprout had
`any substantial previous knowledge or experience with balloon treatments for
`obesity.
`22. On information and belief, all of SV Life Sciences’ and Sprout’s
`knowledge concerning Dr. Chen’s novel balloon designs for obesity as of the
`Spring of 2005 was supplied by Dr. Chen.
`23.
`In the Spring of 2005, Ms. Delagardelle indicated that the due
`diligence process would be delayed somewhat due to the fact that the healthcare
`group principals of Sprout were forming a new firm, New Leaf Venture Partners.
`Ms. Delagardelle asked Dr. Chen if this would pose a problem. Dr. Chen
`responded that time was of the essence but a short delay under the circumstances
`would be manageable.
`24. Meanwhile, Dr. Chen continued to interface with SV Life Sciences.
`SV Life Sciences arranged for Dr. Chen to meet George Wallace (venture partner
`for SV Life Sciences) on May 16, 2005 at a restaurant in Chicago. During the
`meeting Mr. Wallace proposed terms and conditions under which he would work
`with Fulfillium. In addition to other compensation, Mr. Wallace demanded
`greater than 25% stake in Fulfillium after the first round of financing by venture
`capital firms. Given the ownership dilution that typically occurs during the first
`round of financing, Mr. Wallace was effectively demanding majority ownership of
`Fulfillium. Dr. Chen noted that Mr. Wallace’s requested equity share was more
`than two to four times greater than that typically allotted to a CEO brought in to
`run a company at Fulfillium’s stage of development. Mr. Wallace offered no
`justification other than to say that he needed to compensate his business partner, a
`practicing radiologist in Minnesota, and would not proceed without including his
`business partner. Dr. Chen never disclosed the trade secrets to Mr. Wallace.
`25. Thereafter, no further discussion took place between Mr. Wallace and
`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
`Fulfillium’s technology and trade secrets, which were misappropriated despite the
`repeated oral agreements of confidentiality with SV Life Sciences. In the early
`summer of 2005, Ms. Delagardelle of New Leaf sent a brief email to Dr. Chen
`advising that New Leaf was considering a deal that SV Life Sciences was
`proposing. Dr. Chen presumed that SV Life Sciences was proposing bringing to
`market an alternative solution that would be different from the technology
`developed and confidentially disclosed by Dr. Chen. Dr. Chen would later
`discover that SV Life Sciences’ venture headed by Mr. Wallace was premised not
`on some alternative solution but rather Fulfillium’s technology and trade secrets.
`26. On information and belief, Mr. Wallace’s new company, called
`Abdominis, Inc., was formed during the summer of 2005 and was funded by New
`Leaf and SV Life Sciences. Upon information and belief, both SV Life Sciences
`and New Leaf not only provided capital, but as typical early stage venture capital
`firms, provided direct guidance in the company’s development and controlled the
`operations of the company through their board membership.
`27. Abdominis was subsequently renamed ReShape Medical, Inc.
`Hereafter, “Reshape Medical” will refer to Abdominis, Inc. and its successor-in-
`interest Reshape Medical, Inc.
`28. As is typical for a medical start-up company, ReShape Medical
`operated in “stealth mode” during development. ReShape Medical started pivotal
`clinical trials in 2012 and applied for FDA approval in 2014. The FDA granted
`Pre-Marketing Approval to the ReShape Duo™ device and treatment method on
`July 28, 2015.
`29. When ReShape Medical emerged from stealth mode and began
`commercial operations, Dr. Chen learned that ReShape Medical had copied his
`trade secrets, namely, his entire clinical trial “playbook.” ReShape Medical
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`copied, among other things, Dr. Chen’s clinical trial design and his selection of
`the principal investigator.
`30. On information and belief, the board of directors and officers of
`ReShape Medical knew or had reason to know of the foregoing facts and events at
`the time ReShape Medical first submitted the ReShape Duo™ product for FDA
`approval in 2012.
`COUNT I – TRADE SECRET MISAPPROPRIATION
`31. Fulfillium repeats the allegations of paragraphs 1-30 above as though
`fully set forth herein.
`32. This claim is asserted against ReShape Medical for misappropriation
`of Fulfillium’s trade secrets and for conspiring to misappropriate such trade
`secrets.
`33. The specific trade secrets that ReShape and/or its agents
`misappropriated, despite the repeated oral and/or written agreements of
`confidentiality, relate to at least three aspects of Dr. Chen’s clinical trial
`“playbook.” Three key protocols in the playbook optimized the experimental
`rigor of the trial, especially in combination, in contrast to the typical product
`development approach to optimize the conditions for favorable outcomes. The
`first is the counterintuitive control arm that “stacked the deck” against the
`experimental arm. To tease out efficacy due to the device alone, the device
`therapy had to show statistically better results over the most efficacious non-
`interventional therapy available, namely diet and exercise counseling. The 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 difference between the
`two arms had to be wide enough to warrant an interventional device therapy. The
`third is the counterintuitive and gastric device-focused principal investigator
`selection premise. To provide even further confidence in the results to overcome
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`the stigma of gastric balloons, the trial was to be conducted under the watchful
`eyes of investigators of consummate skill and reputation. All of the above were
`developed after Dr. Chen’s extensive study of the shortcomings of previous
`gastric devices.
`34. The disclosures of each of these three trade secrets were made
`pursuant to the aforementioned written and/or oral agreements of confidentiality
`to SV Life Sciences and New Leaf. On information and belief, these trade secrets
`were conveyed to Mr. Wallace and ReShape Medical, who each used them for
`their own benefit.
`35. A significant portion of the information used by ReShape Medical to
`design its device and obtain FDA approval constitute Fulfillium trade secrets in
`that they: (a) constitute information that derives independent economic 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
`reasonable efforts to maintain their secrecy.
`36. Through SV Life Sciences (and its misappropriation of Dr. Chen’s
`trade secrets, which were protected via repeated confidentiality agreements), Mr.
`Wallace, and Sprout, ReShape Medical acquired confidential, expert validated,
`trade secret information about all aspects of Fulfillium’s business, including
`clinical trial design and regulatory strategy. Specifically, ReShape
`misappropriated at least the three aforementioned aspects of Dr. Chen and
`Fulfillium’s clinical trial playbook.
`37. Upon information and belief, ReShape Medical has relied upon and
`used that trade secret information in some or all aspects of its business, including
`raising capital, product design, procedure design, and FDA clinical trial design.
`38. The actions alleged above constitute a wrongful misappropriation of
`Fulfillium’s trade secrets. They also constitute a wrongful conspiracy among the
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`AMENDED COMPLAINT FOR TRADE SECRET MISAPPROPRIATION AND PATENT INFRINGEMENT
`AMENDED COMPLAINT FOR TRADE SECRET MISAPPROPRIATION AND PATENT INFRINGEMENT
`PAGE 11
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`Case 2:17-cv-08419-RGK-PLA Document 39 Filed 11/20/17 Page 12 of 76 Page ID #:903
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`board directors and officers of and investors in ReShape Medical to
`misappropriate Fulfillium’s trade secrets.
`39. As a direct and proximate result of the actions alleged above,
`Fulfillium has been shut out of the market. By misappropriating Fulfillium’s
`technology and launching a competing company, ReShape Medical prevented
`Fulfillium from raising the funds required to bring its product to market.
`40. As a direct and proximate result of the actions alleged above,
`ReShape Medical has been unjustly enriched in an amount no less than the
`business opportunity deprived from Fulfillium.
`41.
`In doing the acts hereinabove alleged, ReShape Medical and its
`investors have engaged in willful and malicious misappropriation by reason
`thereof, and Fulfillium is entitled, as against each of them, to twice the amount of
`its actual damages and/or the amounts by which ReShape Medical has been
`unjustly enriched as exemplary damages pursuant to Civil Code § 3426.3(c)
`and/or Mass. Gen. Laws ch. 93, § 42-42A.
`42. By the aforesaid acts, ReShape Medical has irreparably injured
`Fulfillium and such injury will continue unless enjoined by this Court.
`COUNT II – RESHAPE MEDICAL’S INFRINGEMENT OF U.S. PATENT
`NO. 9,456,915
`43. Fulfillium repeats the allegations of paragraphs 1-42 above as though
`fully set forth herein.
`44. On October 4, 2016, U.S. Patent No. 9,456,915 (“the ‘915 patent”),
`entitled “Methods, Devices, and Systems for Obesity Treatment,” was duly and
`legally issued by the United States Patent and Trademark Office. A true and
`correct copy of the ’915 patent is attached as Exhibit 1.
`45. Fulfillium is the assignee and owner of the right, title and interest in
`and to the ‘915 patent, including the right to assert all causes of action arising
`under said patents and the right to any remedies for infringement of them.
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`AMENDED COMPLAINT FOR TRADE SECRET MISAPPROPRIATION AND PATENT INFRINGEMENT
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`PAGE 12
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`Case 2:17-cv-08419-RGK-PLA Document 39 Filed 11/20/17 Page 13 of 76 Page ID #:904
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`46. On information and belief, ReShape Medical is engaged in the
`business of making, using, selling, offering to sell, and/or importing medical
`devices. A description of ReShape Medical’s business is available on its business
`website, which is located at http://pro.reshapeready.com. A screenshot of the
`homepage of ReShape Medical’s business website is attached as Exhibit 3.
`47. As part of its business, ReShape Medical makes, uses, offers to sell,
`sells, and/or imports a dual intragastric balloon for weight loss, including
`ReShape’s “Duo Balloon” device, which is placed inside the patient’s stomach for
`weight loss. ReShape Medical has purposefully sold and offered for sale such
`Duo Balloon devices throughout the United States.
`48. Upon information and belief, ReShape Medical has and continues to
`directly infringe at least claims 1-2 and 4-27 of the ‘915 patent by making, using,
`selling, importing and/or providing and causing to be used medical devices for
`weight loss, including but not limited to, those sold under the name ReShape Duo
`Balloon (the “Infringing Instrumentalities” or “ReShape Balloon”). For clarity the
`terms “Infringing Instrumentalities” and “ReShape Balloon” are understood to
`include the balloon device intended for delivery into the gastric cavity, as well as
`any delivery system for that balloon device.
`49. Representative claim 1 of the ‘915 patent recites a “gastric balloon
`structure for deploying in a gastric cavity of a patient, comprising: at least two
`isolated non-concentric inflatable chambers, wherein each chamber of the at least
`two isolated non-concentric inflatable chambers has a respective inflated state
`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
`chambers of the at least two isolated non-concentric inflatable chambers
`unaffected.” The Infringing Instrumentalities infringe claim 1 of the ‘915 patent.
`The ReShape Dual Balloon “is a temporary implant designed to facilitate weight
`loss by occupying space in the stomach.” ReShape™ Integrated Dual Balloon
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`AMENDED COMPLAINT FOR TRADE SECRET MISAPPROPRIATION AND PATENT INFRINGEMENT
`AMENDED COMPLAINT FOR TRADE SECRET MISAPPROPRIATION AND PATENT INFRINGEMENT
`PAGE 13
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`Case 2:17-cv-08419-RGK-PLA Document 39 Filed 11/20/17 Page 14 of 76 Page ID #:905
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`System Instructions for Use, PN 03-0300 Rev. D, p. 1,
`https://reshapeready.com/wp-
`content/uploads/2015/07/ReShape_Instructions_For_Use.pdf. The figure below,
`taken from ReShape’s instruction manual, shows the dual balloon in a patient’s
`stomach. The ReShape website states that “[i]n the unlikely event of individual
`gastric balloon leakage or deflation, the independently sealed ReShape weight loss
`balloons are designed to minimize risk of migration or obstruction.”
`http://pro.reshapeready.com/about-reshape/#theadvantages. In other words, each
`balloon inflates and deflates independently. See also
`https://www.youtube.com/watch?v=U91FsjtMf3o.
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`50. Claim 1 further recites “a valve system for introducing a fluid into
`the at least two isolated non-concentric inflatable chambers and for retaining,
`upon inflation, the fluid in the at least two isolated non-concentric inflatable
`chambers.” The chambers of the ReShape balloons are filled after they are
`positioned in the patient’s stomach. ReShape™ Integrated Dual Balloon System
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`AMENDED COMPLAINT FOR TRADE SECRET MISAPPROPRIATION AND PATENT INFRINGEMENT
`AMENDED COMPLAINT FOR TRADE SECRET MISAPPROPRIATION AND PATENT INFRINGEMENT
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`Case 2:17-cv-08419-RGK-PLA Document 39 Filed 11/20/17 Page 15 of 76 Page ID #:906
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`Instructions for Use, PN 03-0300 Rev. D, pp. 16-17, https://reshapeready.com/wp-
`content/uploads/2015/07/ReShape_Instructions_For_Use.pdf. “The ReShape™
`Valve Sealant is necessary to seal the device valves and prevent balloon leakage.”
`Id.; see also https://www.youtube.com/watch?v=U91FsjtMf3o; U.S. Pat. No.
`8,142,469 at Fig. 1, 3-5.
`51. Claim 1 further recites “a flexible central spine spanning a gap
`between and fixedly attached to both a first chamber of the at least two isolated
`non-concentric inflatable chambers and a second chamber of the at least two
`isolated non-concentric inflatable chambers; wherein the gastric balloon structure,
`in its inflated state, assumes a curved shape conforming to a natural three-
`dimensional kidney shape of the gastric cavity, such that the flexible central spine
`flexibly conforms, upon at least partially filling the at least two isolated non-
`concentric inflatable chambers, the gastric balloon structure to the natural three-
`dimensional kidney shape of the gastric cavity.” The flexible central spine
`element is illustrated in the video provided on ReShape’s website, a frame from
`which is reproduced below. See https://reshapeready.com/reshape-cc/; see also
`https://www.youtube.com/watch?v=U91FsjtMf3o.
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`The conformance of the dual balloon to the stomach of the patient is shown in the
`image above and is also illustrated in Figure 1 of ReShape’s instructions for use,
`reproduced below.
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`AMENDED COMPLAINT FOR TRADE SECRET MISAPPROPRIATION AND PATENT INFRINGEMENT
`AMENDED COMPLAINT FOR TRADE SECRET MISAPPROPRIATION AND PATENT INFRINGEMENT
`PAGE 15
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`RESHAPE 1021
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`Case 2:17-cv-08419-RGK-PLA Document 39 Filed 11/20/17 Page 16 of 76 Page ID #:907
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`52. The final recitation in claim 1 is that “a respective fluid volume for
`filling each chamber of the at least two isolated non-concentric inflatable
`chambers is selected based upon dimensions of the gastric cavity of the patient.”
`ReShape’s instructions for use state as follows:
`2.4. Determine the desired inflation volume for each balloon. A fill volume of
`375 cc is recommended for patients < 64.5” in stature and 450 cc for patients ≥
`64.5” in stature.
`See https://reshapeready.com/wp-
`content/uploads/2015/07/ReShape_Instructions_For_Use.pdf at 16. ReShape
`instructs the user to determine the size of the patient and to select a corresponding
`fill volume for the balloon structure.
`53. Claim 2 generally recites the gastric balloon structure of claim 1,
`wherein the gastric balloon structure is designed to provide for modulated passage
`of food through the gastric cavity upon inflation.
`54. The Infringing Instrumentalities infringe claim 2 of the ‘915 patent.
`The ReShape Dual Balloon “is a temporary implant designed to facil