IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`FULFILLIUM, INC.,
`
`Plaintiff,
`
`Civil Action No. ______________
`
`v.
`
`RESHAPE MEDICAL, INC.,
`
`Defendant.
`
`JURY TRIAL DEMANDED
`
`COMPLAINT FOR TRADE SECRET MISAPPROPRIATION AND PATENT
`
`INFRINGEMENT
`
`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 Del. Code Ann. Title
`
`6 §2001 et seq., and the Patent Laws of the United States, 35 U.S.C. § 1 et seq.
`
`THE PARTIES
`
`2.
`
`Fulfillum 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.
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`Fulfillium Exhibit 2013, Page 1
`ReShape v. Fulfillium
`Case IPR2018-00958
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`
`FOR THE DISTRICT OF DELAWARE
`
`FULFILLIUM, INC.,
`
`Plaintiff,
`
`Civil Action No. ______________
`
`v.
`
`RESHAPE MEDICAL, INC.,
`
`Defendant.
`
`JURY TRIAL DEMANDED
`
`COMPLAINT FOR TRADE SECRET MISAPPROPRIATION AND PATENT
`
`INFRINGEMENT
`
`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 Del. Code Ann. Title
`
`6 §2001 et seq., and the Patent Laws of the United States, 35 U.S.C. § 1 et seq.
`
`THE PARTIES
`
`2.
`
`Fulfillum 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.
`
`Fulfillium Exhibit 2013, Page 1
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`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 Del. Code Ann. Title
`
`6 §2001 et seq., and the Patent Laws of the United States, Title 35 of the United States Code,
`
`respectively.
`
`6.
`
`7.
`
`This Court has subject matter jurisdiction under 28 U.S.C. §§ 1331 and 1338(a).
`
`Venue is proper in this judicial district under 28 U.S.C. §§ 1391(b), (c), (d) and/or
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`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
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`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
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`State of Delaware and this District, pursuant to due process and/or the Delaware Long Arm
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`Statute, because Defendant purposefully availed itself of the privileges of conducting business in
`
`the State of Delaware and in this District, because Defendant regularly conducts and solicits
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`business within the State of Delaware 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
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`Delaware and this District. Further, this Court has personal jurisdiction over Defendant because
`
`Fulfillium Exhibit 2013, Page 2
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`it is incorporated in Delaware and has purposely availed itself of the privileges and benefits of
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`the laws of the State of Delaware.
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`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.
`
`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
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`impede the flow of ingested food and thereby effectively reduce the calories consumed. To
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`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
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`Fulfillium Exhibit 2013, Page 3
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`chambers filled with fluids.
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`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
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`favorably with the willingness to commit to participate further in developing the medical device
`
`and procedure.
`
`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. On
`
`January 25, 2005, Dr. Chen spoke with Dr. Samuel Wu, M.D. of SV Life Sciences to discuss
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`Fulfillium Exhibit 2013, Page 4
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`Fulfillium’s technology on a confidential basis. On February 10, 2005, Dr. Chen attended a
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`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
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`City, California. Dr. Chen understood the meeting to be confidential and, consistent with that,
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`Dr. Chen’s presentation slides were all marked “STRICTLY CONFIDENTIAL.”
`
`17.
`
`Thereafter, SV Life Sciences representatives had due diligence calls with various
`
`Fulfillium scientific advisors.
`
`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, however, that SV Life Sciences’
`
`medical device group was headquartered in Boston and thus 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. 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 the history and evolution of
`
`the design of such devices, the efficacy and harm of certain design features, the pre-existing and
`
`alternative treatments, clinical results of those treatment methods, Fulfillium’s product design
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`Fulfillium Exhibit 2013, Page 5
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`and treatment method, Fulfillium’s preferred clinical trial design for regulatory approval, and
`
`Fulfillium’s business strategy.
`
`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
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`Fulfillium Exhibit 2013, Page 6
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`compensate his business partner, a practicing radiologist in Minnesota, and would not proceed
`
`without including his business partner.
`
`25.
`
`Thereafter, Mr. Wallace broke off discussions with Dr. Chen and instead,
`
`unbeknownst to Dr. Chen and with support from SV Life Sciences, sought to launch a new
`
`company based on Dr. Chen’s technology. 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 Mr.
`
`Wallace and SV Life Sciences were proposing. Dr. Chen presumed that Mr. Wallace 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 Mr.
`
`Wallace’s venture was premised not on some alternative solution but rather Dr. Chen’s
`
`technology.
`
`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.
`
`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 entire “playbook.” ReShape
`
`Medical copied, among other things, Dr. Chen’s device design, his gastric delivery method, his
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`Fulfillium Exhibit 2013, Page 7
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`clinical trial design, his selection of the principal investigator, his techniques for preventing fluid
`
`leakage, and his methods for sizing the balloons.
`
`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.
`
`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.
`
`34.
`
`Through Mr. Wallace, SV Life Sciences and Sprout, ReShape Medical acquired
`
`confidential, expert validated, trade secret information about all aspects of Fulfillium’s business,
`
`including device design, procedure design, clinical trial design, regulatory strategy, and business
`
`strategy.
`
`35.
`
`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.
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`Fulfillium Exhibit 2013, Page 8
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`36.
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`The actions alleged above constitute a wrongful misappropriation of Fulfillium’s
`
`trade secrets. They also constitute a wrongful conspiracy among the board directors and officers
`
`of and investors in ReShape Medical to misappropriate Fulfillium’s trade secrets.
`
`37.
`
`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.
`
`38.
`
`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.
`
`39.
`
`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 Del. Code Ann. Title 6, § 2003(b)
`
`40.
`
`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
`
`41.
`
`Fulfillium repeats the allegations of paragraphs 1-40 above as though fully set
`
`forth herein.
`
`42.
`
`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
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`Fulfillium Exhibit 2013, Page 9
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`United States Patent and Trademark Office. A true and correct copy of the ’915 patent is
`
`attached as Exhibit 1.
`
`43.
`
`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.
`
`44.
`
`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.
`
`45.
`
`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.
`
`46.
`
`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.
`
`47.
`
`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
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`Fulfillium Exhibit 2013, Page 10
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`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 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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`Fulfillium Exhibit 2013, Page 11
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`48.
`
`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 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.
`
`49.
`
`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
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`Fulfillium Exhibit 2013, Page 12
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`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.
`
`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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`Fulfillium Exhibit 2013, Page 13
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`50.
`
`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.
`
`51.
`
`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.
`
`52.
`
`The Infringing Instrumentalities infringe claim 2 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 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 providing
`
`modulated passage of food through the gastric cavity upon inflation.
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`Fulfillium Exhibit 2013, Page 14
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`53.
`
`Claim 4 generally recites the gastric balloon structure of claim 1, wherein, upon
`
`inflation, the gastric balloon structure is configured to rest within the gastric cavity without
`
`exerting pressure at any point in the gastric cavity sufficient to cause ulceration.
`
`54.
`
`The Infringing Instrumentalities infringe claim 4 of the ‘915 patent. The ReShape
`
`Dual Balloon mimics “the natural curvature of the stomach, the dual gastric balloon is designed
`
`to conform to the patient’s anatomy and enhance tolerability.” See
`
`http://pro.reshapeready.com/about-reshape/#theadvantages. Accordingly, on information and
`
`belief, it is configured to rest within the gastric cavity without exerting pressure at any point in
`
`the gastric cavity sufficient to cause ulceration.
`
`55.
`
`Claim 5 generally recites the gastric balloon structure of claim 4, wherein an outer
`
`surface of each of the isolated non-concentric inflatable chambers is configured to align against
`
`greater and lesser curvatures of the gastric cavity.
`
`56.
`
`The Infringing Instrumentalities infringe claim 5 of the ‘915 patent. The ReShape
`
`Dual Balloon mimics “the natural curvature of the stomach, the dual gastric balloon is designed
`
`to conform to the patient’s anatomy and enhance tolerability.” See
`
`http://pro.reshapeready.com/about-reshape/#theadvantages.
`
`Fulfillium Exhibit 2013, Page 15
`ReShape v. Fulfillium
`Case IPR2018-00958
`
`
`
`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.
`
`
`
`Accordingly, on information and belief, an outer surface of each of the isolated non-concentric
`
`inflatable chambers is configured to align against greater and lesser curvatures of the gastric
`
`
`
`cavity.
`
`57.
`
`Claim 6 generally recites the gastric balloon structure of claim 1, wherein the
`
`valve system comprises a respective valve structure for introducing fluid into each chamber of
`
`the at least two isolated non-concentric inflatable chambers, wherein each respective valve
`
`Fulfillium Exhibit 2013, Page 16
`ReShape v. Fulfillium
`Case IPR2018-00958
`
`
`
`structure includes at least two valves in series.
`
`58.
`
`Upon information and belief, the Infringing Instrumentalities infringe claim 6 of
`
`the ‘915 patent. The chambers of the ReShape balloons are filled after they are positioned in the
`
`patient’s stomach. ReShape™ Integrated Dual Balloon System 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; Further, ReShape’s patent, U.S. 8,142,469,
`
`shows two valves in series as shown below at 206A and 96A:
`
`Accordingly, on information and belief, the ReShape Balloon valve system comprises a
`
`respective valve structure for introducing fluid into each chamber of the two isolated non-
`
`concentric inflatable chambers, wherein each respective valve structure includes at least two
`
`
`
`valves in series.
`
`59.
`
`Claim 7 generally recites the gastric balloon structure of claim 6, wherein a first
`
`Fulfillium Exhibit 2013, Page 17
`ReShape v. Fulfillium
`Case IPR2018-00958
`
`
`
`valve structure of a first chamber of the at least two isolated non-concentric inflatable chambers
`
`includes a one-way valve in series with an additional one-way valve.
`
`60.
`
`Upon information and belief, the Infringing Instrumentalities infringe claim 7 of
`
`the ‘915 patent. The chambers of the ReShape balloons are filled after they are positioned in the
`
`patient’s stomach. ReShape™ Integrated Dual Balloon System 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; Further, ReShape’s patent, U.S. 8,142,469,
`
`shows two one-way valves in series as shown below at 206A and 96A:
`
`Accordingly, on information and belief, the ReShape Balloon valve structure includes a
`
`one-way valve in series with an additional one-way valve.
`
`61.
`
`Claim 8 generally recites the gastric balloon structure of claim 1, wherein the
`
`flexible central spine is in fluid communication with the valve system.
`
`
`
`Fulfillium Exhibit 2013, Page 18
`ReShape v. Fulfillium
`Case IPR2018-00958
`
`
`
`62.
`
`Upon information and belief, the Infringing Instrumentalities infringe claim 8 of
`
`the ‘915 patent. 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.
`
`Further, ReShape’s patent, U.S. 8,142,469, shows that the inflation lumens and valves are carried
`
`by the flexible central spine as shown below:
`
`
`
`Accordingly, on information and belief, the ReShape Balloon’s flexible central spine is in
`
`
`
`Fulfillium Exhibit 2013, Page 19
`ReShape v. Fulfillium
`Case IPR2018-00958
`
`
`
`fluid communication with the valve system.
`
`63.
`
`Claim 9 generally recites the gastric balloon structure of claim 8, wherein the
`
`flexible central spine encloses an inflation lumen for introducing the fluid into the at least two
`
`isolated non-concentric inflatable chambers.
`
`64.
`
`Upon information and belief, the Infringing Instrumentalities infringe claim 9 of
`
`the ‘915 patent. The chambers of the ReShape balloons are filled after they are positioned in the
`
`patient’s stomach. ReShape™ Integrated Dual Balloon System 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. 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/.
`
`Further, ReShape’s patent, U.S. 8,142,469, shows that the inflation lumens and valves are carried
`
`by the flexible central spine as shown below:
`
`
`
`Fulfillium Exhibit 2013, Page 20
`ReShape v. Fulfillium
`Case IPR2018-00958
`
`
`
`
`
`Accordingly, on information and belief, the ReShape Balloon’s flexible central spine
`
`encloses an inflation lumen for introducing the fluid into the at least two isolated non-concentric
`
`inflatable chambers.
`
`65.
`
`Claim 10 generally recites the gastric balloon structure of claim 1, wherein the
`
`gastric balloon structure is designed to maintain the introduced volume of fluid while deployed
`
`in the gastric cavity of the patient without controlled adjustment.
`
`66.
`
`The Infringing Instrumentalities infringe claim 10 of the ‘915 patent. The
`
`ReShape dual balloons are both filled with saline and remain at a generally fixed volume until
`
`they are removed. See https://www.youtube.com/watch?v=U91FsjtMf3o;
`
`https://reshapeready.com/wp-content/uploads/2015/07/ReShape_Instructions_For_Use.pdf, Sec.
`
`2.1 – 2.7 at p. 15-16, https://reshapeready.com/wp-
`
`content/uploads/2015/07/ReShape_Instructions_For_Use.pdf.
`
`67.
`
`Claim 11 generally recites the gastric balloon structure of claim 1, wherein each
`
`chamber of the at least two isolated non-concentric inflatable chambers is filled with a same
`
`Fulfillium Exhibit 2013, Page 21
`ReShape v. Fulfillium
`Case IPR2018-00958
`
`
`
`fluid.
`
`68.
`
`The Infringing Instrumentalities infringe claim 11 of the ‘915 patent. The
`
`ReShape dual balloons are both filled with saline and remain at a fixed volume until they are
`
`removed. See https://www.youtube.com/watch?v=U91FsjtMf3o; https://reshapeready.com/wp-
`
`content/uploads/2015/07/ReShape_Instructions_For_Use.pdf, Sec. 2.1 – 2.7 at p. 15-16.
`
`69.
`
`Claim 12 recites “a method for treating obesity in a patient, comprising:
`
`measuring one or more dimensions of a gastric cavity of the patient in a feeding state . . . .” The
`
`ReShape Dual Balloon “is a temporary implant designed to facilitate weight loss by occupying
`
`space in the stomach.” ReShape™ Integrated Dual Balloon System Instructions for Use, PN 03-
`
`0300 Rev. D, p. 1. 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.
`
`70.
`
`Claim 12 further recites “determining, based on the one or more dimensions of the
`
`gastric cavity, a respective
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