I. 
`II. 
`III. 
`
`IV. 
`VI. 
`
`IPR2017-00453
`U.S. Patent No. 9,199,055
`DECLARATION OF THOMAS SPRINKLE
`IN SUPPORT OF PATENT OWNER’S RESPONSE TO
`PETITION FOR INTER PARTES REVIEW
`
`IPR2017-00453
`U.S. Patent No. 9,199,055
`
`TABLE OF CONTENTS
`
`SUMMARY OF OPINIONS .............................................................................................. 4 
`QUALIFICATIONS ........................................................................................................... 6 
`APPLICABLE LEGAL STANDARDS ............................................................................. 9 
`A. 
`Claim Interpretation .................................................................................................9 
`B. 
`Burden of Proof........................................................................................................9 
`C. 
`Obviousness ...........................................................................................................10 
`ONE OF ORDINARY SKILL IN THE ART ................................................................... 14 
`SDG’S PORTABLE OXYGEN CONCENTRATOR TECHNOLOGY AND THE ‘055
`PATENT ........................................................................................................................... 20 
`A. 
`Broadest Reasonable Interpretation of “Removable Module” Limitation .............28 
`B. 
`Broadest Reasonable Interpretation of “Replaceable by a User” Limitation ........34 
`VII.  CLAIM INTERPRETATION ........................................................................................... 39 
`VIII.  PRIOR ART REFERENCES ............................................................................................ 41 
`A. 
`McCombs ...............................................................................................................41 
`B.  Whitley ...................................................................................................................50 
`C. 
`Jagger .....................................................................................................................55 
`D. 
`Occhialini ...............................................................................................................67 
`CLAIMS 12 AND 21 OF THE ‘055 PATENT ARE NOT OBVIOUS OVER McCOMBS
`IN VIEW OF WHITLEY AND THE AAPA ................................................................... 67 
`CLAIMS 12 AND 21 OF THE ‘055 PATENT ARE NOT OBVIOUS OVER McCOMBS
`IN VIEW OF WHITLEY AND OCCHIALINI................................................................ 68 
`CLAIMS 12 AND 21 OF THE ‘055 PATENT ARE NOT OBVIOUS OVER JAGGER
`IN VIEW OF McCOMBS AND THE AAPA .................................................................. 69 
`SECONDARY CONSIDERATIONS OF NONOBVIOUSNESS ................................... 74 
`XII. 
`XIII.  CONCLUSION ................................................................................................................. 75 
`
`
`IX. 
`
`X. 
`
`XI. 
`
`
`
`1
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`Exhibit 2040
`Page 1 of 77
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`

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`IPR2017-00453
`U.S. Patent No. 9,199,055
`INTRODUCTION
`1.
`I, Thomas Sprinkle, have been retained by the law firm of Friedman, Suder &
`
`Cooke, P.C. (“FSC”), on behalf of its client Separation Design Group IP Holdings
`
`LLC (“SDG”), in connection with Inter Partes Review No. IPR2017-00453 of U.S.
`
`Patent No. 9,199,055 (which I will refer to in this declaration as “the ‘055 Patent”).
`
`I understand that the ‘055 Patent is owned by SDG and that SDG has sued Inogen,
`
`Inc. (“Inogen”) for infringement of the ‘055 Patent. I understand that Inogen, a
`
`manufacturer of oxygen concentrator devices, filed a Petition for inter partes review
`
`of the ‘055 Patent which has been instituted by the Patent Trials and Appeals Board.
`
`2.
`
`I am being compensated at my standard hourly rate for my work on this
`
`matter, including providing this declaration. My compensation is not dependent on
`
`the outcome of this inter partes review and in no way affects the substance of my
`
`testimony in this declaration. I have no financial interest in ‘055 Patent, SDG, any
`
`entity affiliated with the foregoing entities, or in the outcome of this inter partes
`
`review or any of the lawsuits involving the ‘055 Patent.
`
`3.
`
`I have reviewed and am familiar with the ‘055 Patent (Ex. 1001) and its
`
`prosecution history (Ex. 1009).
`
`4.
`
`I have reviewed and am familiar with the Petition for Inter Partes Review
`
`filed by Inogen on December 8, 2016 (Paper 2) (“Petition”) and the Declaration of
`
`Brenton Taylor (Exh. 1011) (“Taylor Decl.”), the Board’s Institution Decision in
`
`
`
`2
`
`Exhibit 2040
`Page 2 of 77
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`

`

`IPR2017-00453
`U.S. Patent No. 9,199,055
`this case dated June 16, 2017 (Paper 10) (“Institution Decision”), and at least the
`
`following documents:
`
`
`
`U.S. Patent Application Publication 20060117957 (Ex. 1002)
`
`(“McCombs”);
`
`
`
`U.S. Patent Application Publication 20070137487 (Ex. 1003)
`
`(“Whitley”);
`
`
`
`
`
`U.S. Patent No. 7,297,029 (Ex. 1004) (“Occhialini”);
`
`U.S. Patent Application Publication 20060174874 (Ex. 1005)
`
`(“Jagger”);
`
`5.
`
`I have also reviewed and am familiar with the following documents:
`
` U.S. Patent No. 9,592,360 B2, entitled “Gas Concentrator with
`
`Removable Cartridge Adsorbent Beds” which lists Brenton Taylor as
`
`an inventor and is assigned to Inogen;
`
` the prosecution history for U.S. Patent No. 9,592,360 B2;
`
` the transcripts of the depositions of Brenton Taylor taken as part of this
`
`IPR proceeding as well as those conducted in relation to the pending
`
`litigation between SDG and Inogen; and,
`
`
`
`3
`
`Exhibit 2040
`Page 3 of 77
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`

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`IPR2017-00453
`U.S. Patent No. 9,199,055
`6.
`In addition, I have reviewed and am familiar with any other documents I
`
`specifically reference in this declaration.
`
`I.
`
`7.
`
`SUMMARY OF OPINIONS
`
`Based on my review and analysis of the materials in this matter, including the
`
`Petition and the prior art references identified therein, as well as my experience and
`
`education, I provide the following opinions.
`
`8.
`
`It is my opinion that none of the prior art references identified and relied on
`
`by Petitioner, whether alone or in combination, disclose all of the limitations of
`
`claims 12 or 21 of the ‘055 Patent. It is further my opinion that it would not be
`
`obvious to modify or combine one or more of the prior art references to disclose all
`
`of the limitations of claims 12 or 21 of the ‘055 Patent.
`
`9.
`
`In particular, it is my opinion that claims 12 and 21 are not obvious over
`
`McCombs in view of Whitley and further in view of the applicant admitted prior art
`
`(“AAPA”). Each of the asserted references fail to disclose a POC comprising a
`
`removable module comprising at least one adsorbent bed in accordance with the
`
`broadest reasonable interpretation of those terms in view of the disclosure of the
`
`specification of the ‘055 Patent. Accordingly, the asserted references also fail to
`
`disclose a POC implemented with a removable module designed for user
`
`replacement because neither McCombs nor Whitley, either standing alone or when
`
`
`
`4
`
`Exhibit 2040
`Page 4 of 77
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`

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`IPR2017-00453
`U.S. Patent No. 9,199,055
`combined in the manner suggested by Petitioner, comprise a component
`
`configuration in which a removable module comprising at least one adsorbent bed
`
`is so easily replaceable that the full range of intended users would be able to perform
`
`the replacement procedure, as these terms are described in the specification of the
`
`‘055 Patent.
`
`10.
`
`In particular, it is my opinion that claims 12 and 21 are not obvious over
`
`McCombs in view of Whitley and further in view of Occhialini. Each of the asserted
`
`references fail to disclose a POC comprising a removable module comprising at least
`
`one adsorbent bed in accordance with the broadest reasonable interpretation of those
`
`terms in view of the disclosure of the specification of the ‘055 Patent. Accordingly,
`
`the asserted references also fail to disclose a POC implemented with a removable
`
`module designed for user replacement because neither McCombs nor Whitley, either
`
`standing alone or when combined in the manner suggested by Petitioner, comprise
`
`a component configuration in which a removable module comprising at least one
`
`adsorbent bed is so easily replaceable that the full range of intended users would be
`
`able to perform the replacement procedure, as these terms are described in the
`
`specification of the ‘055 Patent.
`
`11.
`
`In particular, it is my opinion that claims 12 and 21 are not obvious over
`
`Jagger in view of McCombs and further in view of the AAPA. Each of the asserted
`
`references fail to disclose a POC comprising a removable module comprising at least
`
`
`
`5
`
`Exhibit 2040
`Page 5 of 77
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`

`

`IPR2017-00453
`U.S. Patent No. 9,199,055
`one adsorbent bed in accordance with the broadest reasonable interpretation of those
`
`terms in view of the disclosure of the specification of the ‘055 Patent. Accordingly,
`
`the asserted references also fail to disclose a POC implemented with a removable
`
`module designed for user replacement because neither Jagger nor McCombs, either
`
`standing alone or when combined in the manner suggested by Petitioner, comprise
`
`a component configuration in which a removable module comprising at least one
`
`adsorbent bed is so easily replaceable that the full range of intended users would be
`
`able to perform the replacement procedure, as these terms are described in the
`
`specification of the ‘055 Patent.
`
`II. QUALIFICATIONS
`
`12. My curriculum vitae (“CV”) is attached hereto as Exhibit A and is
`
`incorporated by reference. It sets forth the details of my educational history, work
`
`history, expert testimony, and other related experience. A list of my recent
`
`consulting work is included in my CV. A brief summary of some of my relevant
`
`background is provided below.
`
`13.
`
`I received my Bachelor of Science degree in Electrical Engineering from
`
`Cleveland State University in 1984. I then continued with my graduate studies at
`
`Santa Clara, where I took courses in Electrical Engineering.
`
`
`
`6
`
`Exhibit 2040
`Page 6 of 77
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`

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`IPR2017-00453
`U.S. Patent No. 9,199,055
`14.
`I have held a variety of positions in the past 20 years in bio-medical
`
`engineering and product development for medical devices, including 10 years of
`
`extensive experience at Invacare Corporation in the Respiratory Products unit where
`
`my focus was on the research, design, development, and manufacturing of oxygen
`
`concentrators and other respiratory products. From 1999 to 2000, I was the Lead
`
`Engineer and then Engineering Manager in the Sleep Therapy Products unit of
`
`Invacare, where my work included the development of a CPAP humidifier, and a
`
`new oxygen conserving device, as well as an engineering study of failures related to
`
`oxygen sensors. From 2000 to 2002, I was the Engineering Director at Invacare
`
`responsible for all respiratory product development, including, among other things,
`
`a nasal CPAP mask, a new stationary at home oxygen concentrator that could
`
`produce 5 L/min of concentrated oxygen product, a high flow oxygen concentrator
`
`that could produce 10 L/min concentrated oxygen product, and a supplemental
`
`“Home Fill” oxygen compressing device to re-fill a patient’s gas cylinders while at
`
`home. From 2002 to 2009, I served as a Principal Engineer in the Respiratory
`
`Products unit of Invacare during which time I led development teams on multiple
`
`projects from concept through FDA clearance and into high-volume production. I
`
`led the development of, and built, a functional prototype of a portable, battery
`
`powered travel oxygen concentrator that was less than 20 lbs in weight, and which
`
`provided pulse flow delivery of concentrated oxygen product while on battery power
`
`
`
`7
`
`Exhibit 2040
`Page 7 of 77
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`

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`IPR2017-00453
`U.S. Patent No. 9,199,055
`and continuous flow delivery while plugged in to a power source. See U.S. Patent
`
`7,455,717. The commercialization of the travel concentrator project was delayed in
`
`favor of other respiratory development projects. However, I later led the product
`
`development team that finally commercialized this product in 2009 known as the
`
`Invacare Solo2. The development of the travel oxygen concentrator prototype
`
`enabled me to provide technical leadership to the team that developed Invacare’s
`
`smaller and lighter 6.4 lbs portable oxygen concentrator product known as the
`
`Invacare XPO2. See U.S. Patent 8,668,767. Coincident with the XPO2 product
`
`development, I was leading the project team developing Invacare’s next generation
`
`of stationary home oxygen concentrators known as the Perfecto2.
`
`15.
`
`I have experience with the U.S. patent system, as both an inventor and a
`
`technical expert in patent office proceedings and in the court system. I am the named
`
`inventor on 13 issued patents, the majority of which relate to oxygen concentrators.
`
`One of those patents relates to the use of molecular adsorbent beds as a structural
`
`component within the interior of the oxygen concentrator.
`
`16.
`
`I have a served as an expert in two patent matters, including the ongoing
`
`litigation between SDG and Inogen, in which I provided confidential expert opinions
`
`and expert reports. I have testified in a deposition as an expert witness but have not
`
`testified at trial.
`
`
`
`8
`
`Exhibit 2040
`Page 8 of 77
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`

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`IPR2017-00453
`U.S. Patent No. 9,199,055
`III. APPLICABLE LEGAL STANDARDS
`
`17.
`
`I will not offer opinions on principles of law as I am not an attorney.
`
`Nonetheless, I have been informed by counsel for SDG of the following principles
`
`concerning patentability, and I have used these principles as a framework in arriving
`
`at my opinions stated in this declaration.
`
`A. Claim Interpretation
`
`18.
`
`I understand that a patentability analysis is performed in two steps. First, the
`
`patent claims are interpreted to ascertain their scope. Second, the interpreted claims
`
`are compared to the prior art references.
`
`19.
`
`I understand that during an inter partes review the Patent Trial and Appeals
`
`Board (PTAB) gives patent claims their broadest reasonable interpretation in light
`
`of the specification. I also understand that this interpretation is from the vantage of
`
`one of ordinary skill in the art at the time of the patent’s effective filing date.
`
`B.
`
`Burden of Proof
`
`20.
`
`I understand that the claims in an issued patent are not presumed to be valid
`
`during an inter partes review, and that the Inogen has the burden to show that a
`
`patent claim is not patentable by the preponderance of the evidence.
`
`
`
`9
`
`Exhibit 2040
`Page 9 of 77
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`

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`IPR2017-00453
`U.S. Patent No. 9,199,055
`C. Obviousness
`
`21.
`
`I understand that for a patented invention to be obvious under section 103 of
`
`the patent law, the challenger must identify prior art references that alone or in
`
`combination would have rendered the claimed invention obvious to one of ordinary
`
`skill in the art at the time of the invention.
`
`22. For a claim to be found obvious, every claim limitation must be found present
`
`in the combination of the prior art references before the obviousness analysis
`
`proceeds.
`
`23.
`
`I understand that the factors that should be assessed in the obviousness
`
`analysis include at least: (1) the scope and content of the prior art; (2) the differences
`
`between the prior art and the claim at issue; (3) the level of ordinary skill in the art;
`
`and (4) objective evidence as indicia of nonobviousness.
`
`24.
`
`I further understand that the obviousness inquiry must guard against slipping
`
`into use of hindsight and resist the temptation to read into the prior art the teachings
`
`of the invention at issue. Isolated elements from the prior art should not be picked
`
`and chosen and then combined using the invention as a blueprint if such a
`
`combination would not have been obvious at the time of the invention.
`
`25.
`
`It is my understanding that a reason must be shown that would have prompted
`
`a person of ordinary skill in the art to combine known elements in the fashion
`
`
`
`10
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`Exhibit 2040
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`

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`IPR2017-00453
`U.S. Patent No. 9,199,055
`claimed by the patents at issue. Combinations on obviousness grounds cannot be
`
`sustained by mere conclusory statements; instead, there must be some articulated
`
`teaching, suggestion, or motivation with some rational underpinning to support the
`
`legal conclusion of obviousness.
`
`26.
`
`I understand that prior references as a whole need to be considered, including
`
`aspects that teach away from a claimed invention which may rebut showing of
`
`obviousness.
`
`27.
`
`I also understand that if a combination of two or more prior art references are
`
`used to render a claimed invention obvious, there must be a reasonable expectation
`
`of success in making or practicing the claimed invention based on such combination.
`
`The combination cannot modify a prior art reference such that it would render the
`
`reference unsatisfactory for its intended purpose or change the principle of operation
`
`of the reference.
`
`28.
`
`I understand that it is impermissible to use the patent as a template (and
`
`reason) for combining prior art references as that would be applying hindsight. The
`
`ordinary skilled artisan would have to be motivated to combine references to create
`
`the combination of features required by the patent independent of the patent.
`
`29.
`
`In addition, I understand the obviousness analysis cannot discount at the time
`
`of invention, the inventor’s insights, and willingness to confront and overcome
`
`
`
`11
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`IPR2017-00453
`U.S. Patent No. 9,199,055
`obstacles, and even serendipity where the pathway to the invention seems to follow
`
`the logical steps to produce these patented properties.
`
`30.
`
`I understand that in making a determination on obviousness, one must also
`
`consider secondary considerations or objective evidence that may indicate
`
`nonobviousness. I understand that these secondary considerations help illuminate
`
`the subjective determination involved in the hypothesis used to draw the legal
`
`conclusion of obviousness based upon the first three obviousness inquiries.
`
`31.
`
`It is my understanding that objective considerations focus attention on
`
`economic and motivational issues rather than technical issues, and is therefore more
`
`judicially cognizable in assessing patent validity than are the highly technical facts
`
`often present in patent litigation. I also understand that objective considerations may
`
`be the most pertinent, probative, and revealing evidence available to the decision
`
`maker in reaching a conclusion about obviousness. Under certain circumstances,
`
`the evidence of secondary considerations may be particularly strong and entitled to
`
`such weight that it may be decisive.
`
`32.
`
`I understand that examples of secondary considerations that must be
`
`considered as part of an obviousness inquiry include, but are not limited to:
`
`(1) The invention’s commercial success - Were products covered
`by the claim commercially successful due to the merits of the claimed
`invention rather than due to advertising, promotion, salesmanship, or
`features of the product other than those found in the claim?
`
`
`
`12
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`Page 12 of 77
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`

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`IPR2017-00453
`U.S. Patent No. 9,199,055
`
`(2) Long felt but unresolved needs - Was there long felt need for a
`solution to the problem facing the inventors, which was satisfied by
`the claimed invention?
`
`(3) The failure of others - Did others try, but fail, to solve the
`problem solved by the claimed invention?
`
`(4)
`Skepticism by experts - Did experts and those skilled in the art
`express skepticism that a particular solution would solve the problem
`with which the art was faced?
`
`(5)
`Praise by others - Did others in the field praise the claimed
`invention?
`
`(6) Unexpected results - Did the claimed invention achieve
`unexpectedly superior results over the closest prior art?
`
`(7) Recognition of a problem – Was the problem or the source of
`the problem solved by the claimed invention known in the art?
`
`(8) Copying of the invention - Did others copy the claimed
`invention?
`
`(9) Commercial acquiescence and licensing - Did others accept
`licenses under the patent because of the merits of the claimed
`invention, attempt to design around the invention, or simply refraining
`from action?
`
`
`
`(10) Proceeding contrary to accepted wisdom – Did the claimed
`invention represent a course of action counter to the prevailing
`opinions in the field?
`
`13
`
`
`
`
`
`Exhibit 2040
`Page 13 of 77
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`IPR2017-00453
`U.S. Patent No. 9,199,055
`IV. ONE OF ORDINARY SKILL IN THE ART
`
`33.
`
`I have considered what was reasonably known by one of ordinary skill in the
`
`art as of the effective filing date of the ‘055 Patent, which I understand to be October
`
`5, 2009.
`
`34. Patents are written to be understood by persons of ordinary skill in the art –
`
`commonly referred to as a POSITA – where “art” can fairly be described as the field
`
`of the invention. In my opinion, a person of ordinary skill in the art for the ‘055
`
`Patent would have a Bachelor’s or equivalent degree in electrical, mechanical,
`
`chemical, or materials engineering or a related discipline and at least two years of
`
`relevant work experience with oxygen concentrators and/or or in the field of gas
`
`separation technology, or alternatively at least seven years of relevant work
`
`experience with oxygen concentrators and/or or in the field of gas separation
`
`technology. This relevant work experience could consist of designing, developing,
`
`evaluating, researching, and/or studying oxygen concentrators or gas separation
`
`technology, through which a POSITA would acquire knowledge of human factors
`
`engineering and design for usability and how those considerations affect POC
`
`design.
`
`35.
`
`In light of my educational background and extensive professional and
`
`practical experience with oxygen concentrators, I meet and exceed the requirements
`
`of a person skilled in the art as it pertains to the subject matter of inventions taught
`
`
`
`14
`
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`

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`IPR2017-00453
`U.S. Patent No. 9,199,055
`in the ‘055 Patent. As a person of skill in the art, I have an understanding of portable
`
`oxygen concentrators, their mechanical, electrical, and pneumatic inner workings
`
`and operative characteristics, and the use of portable oxygen concentrators to aid
`
`patients with providing supplemental oxygen. Additionally, I am familiar with and
`
`have applied human factors and/or usability analysis in design of oxygen
`
`concentrators and understand the considerations implicated and effects on design
`
`attendant to this analysis.
`
`V. BACKGROUND OF OXYGEN CONCENTRATORS
`
`36. Chronic obstructive pulmonary disease (COPD) is second leading cause of
`
`disability and the third leading cause of death in the U.S. There are an estimated 24
`
`million people afflicted with COPD in the U.S. Oxygen therapy combined with
`
`exercise has been shown to be an effective treatment to prolong life for COPD
`
`patients. Inogen estimates that 2.5 to 3 million patients in the US are using oxygen
`
`therapy for treatment, which is estimated to grow 7-10% per year.
`
`37. The use of compressed oxygen in small cylinders for treatment of COPD
`
`began in the early 1950s. Large cylinders of oxygen were delivered to the patient’s
`
`home for nocturnal use and for small transfill cylinders for use during short trips
`
`outside the home. Oxygen delivery was typically made by a Durable Medical
`
`Equipment (DME) provider who set the equipment up in the patient’s home, and
`
`
`
`15
`
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`U.S. Patent No. 9,199,055
`made deliveries of refills when needed, which was typically several times per month.
`
`See Exh. 1001 at Col. 1, lns. 38-42.
`
`38.
`
`In the 1980s, companies began developing oxygen concentrators that used the
`
`Skarstrom pressure swing adsorption cycle (first patented in 1960, U.S. Patent No.
`
`2,944,627) to produce concentrated oxygen. An oxygen concentrator is an
`
`electromechanical device that removes nitrogen from an airstream, leaving only
`
`oxygen and a little inert argon. Oxygen concentrators typically produce an oxygen
`
`product having an oxygen purity of 85–95%. The main components of oxygen
`
`concentrators which utilize a pressure swing adsorption (PSA) process to produce
`
`concentrated oxygen include: a compressor to provide feed air and move the air
`
`through the device, molecular adsorbent bed(s) that remove the nitrogen from the
`
`feed air to produce a concentrated oxygen product, multiple valves, electronics, a
`
`battery or other power source, and an outer case or shell to house the components.
`
`See Exh. 1001 at Col. 8, lns. 63-67.
`
`39. An oxygen concentrating utilizing a PSA process typically includes two or
`
`more molecular adsorbent beds, each of which consists of a bed of molecular
`
`adsorbent, which is an adsorbent that has greater affinity for nitrogen than oxygen.
`
`The molecular adsorbent is typically zeolite, which is an engineered crystalline bead.
`
`The compressor moves feed air into one of the cylinders through a valve. As the air
`
`passes through the adsorbent bed, the nitrogen is adsorbed onto the zeolite while the
`
`
`
`16
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`U.S. Patent No. 9,199,055
`oxygen passes through. The oxygen exits the cylinder through a valve into a small
`
`reservoir, called an accumulator, from which it can then be delivered to the patient.
`
`Once the zeolite in the first cylinder becomes saturated with nitrogen, the inlet valve
`
`closes and the compressor air is diverted to the second cylinder where the adsorption
`
`process is repeated. Meanwhile, the first cylinder is depressurized and purged using
`
`some of the oxygen produced by the second cylinder, and the nitrogen in the zeolite
`
`is desorbed and released to the atmosphere. See Exh. 1001 at Col. 10, lns. 51-57;
`
`Exh. 2002 at [0006]-[0007].
`
`40. The first oxygen concentrators developed in the 1980s used plug-in electric
`
`compressors and a material called molecular sieve to separate the oxygen from air.
`
`These oxygen concentrators weighed 50 lbs and were intended for in home use, but
`
`could be wheeled from room to room and plugged into a convenient electrical outlet.
`
`The big advantage to the DME was that the oxygen concentrator reduced the need
`
`to service the patient with oxygen cylinder delivery. Because reimbursement by
`
`insurance is a fixed amount, the DMEs could improve profitability by decreasing the
`
`number of truck deliveries over the average 3-year period of time that the average
`
`patient would be using oxygen therapy. A large cylinder was still needed as a backup
`
`oxygen source in the event of power loss or equipment failure and a small transfill
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`cylinder would be used for trips outside the house, but the oxygen concentrator could
`
`provide the majority of the needed oxygen.
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`
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`17
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`Exhibit 2040
`Page 17 of 77
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`IPR2017-00453
`U.S. Patent No. 9,199,055
`41.
`In the 1990s, companies extended the oxygen concentrator concept into
`
`portable battery powered devices that could be used for trips outside the house. This
`
`could potentially eliminate the need for pressurized oxygen bottles. These units
`
`typically weighed 15-20 lbs so they often had to have small wheels attached for ease
`
`of transport. The units had battery packs that could be easily replaced so the patient
`
`could carry extras for longer trips and the battery packs could be recharged anywhere
`
`there was electricity, so the patient had much greater freedom of movement and
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`travel. Compressed oxygen, on the other hand, relied on having made plans for
`
`cylinders being available at one’s destination beforehand- a complicated procedure.
`
`42. With the widespread acceptance of conservers, companies began to focus their
`
`efforts on the miniaturization of portable oxygen concentrators. Respironics, Inogen,
`
`and AirSep produced portable oxygen concentrators that weighed less than 10 lbs
`
`and, in some cases, could be used both as portables and for nocturnal use. This
`
`allowed the DME to be reimbursed for both stationary and portable oxygen devices
`
`with only one device. Portable oxygen concentrators thereafter began replacing other
`
`methods of oxygen delivery and are now the fastest growing segment of oxygen
`
`delivery equipment.
`
`43. For small POCs designed to be carried by elderly people with a physical
`
`disability or infirmity, the weight and size of the oxygen concentrator components
`
`is of the utmost importance. Therefore, to meet the needs of its patients, the industry
`
`
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`18
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`Page 18 of 77
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`IPR2017-00453
`U.S. Patent No. 9,199,055
`trend has been to continue to make the devices smaller and lighter. See Exh. 1001
`
`at Col. 1, ln. 65 – Col. 2, ln. 16. However, with POCs now weighing 6 lbs or less, it
`
`is more difficult to continue to reduce the size and weight, and advances are made
`
`in smaller steps. The miniaturization of portable oxygen concentrators leads to more
`
`complex designs compared to stationary units, and the system size, weight, and
`
`complexity may lead to fewer mitigative options or design choices against
`
`contamination and other wear and tear effects that can lead to unacceptably short
`
`maintenance intervals. See Exh. 2001 at [0008].
`
`44. Over time and after repeated cycles, moisture from the air can begin to
`
`degrade the effectiveness of the adsorbent within the adsorbent beds of a POC to
`
`adsorb nitrogen, and the level of oxygen content of the oxygen product will be
`
`reduced.1 This moisture problem becomes more pronounced as the size of the
`
`adsorbent beds and the amount of the adsorbent comprising the adsorbent bed is
`
`reduced. For example, larger oxygen concentrators were typically implemented with
`
`oversized adsorbent beds relative to their oxygen producing capacity to
`
`accommodate greater resilience to the effects of moisture degradation before oxygen
`
`production capacity dropped to unacceptable levels. Portable oxygen concentrators
`
`(POCs), however, contain adsorbent beds of sizes more closely matched to the
`
`
`1 Other imbalances in the pressures between the two adsorbent beds can also cause the zeolite in the adsorbent beds
`to degrade.
`
`
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`19
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`Page 19 of 77
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`IPR2017-00453
`U.S. Patent No. 9,199,055
`desired oxygen production capacity to reduce system weigh and are, therefore, more
`
`susceptible falling below acceptable oxygen production levels due to moisture
`
`degradation of the adsorbent.
`
`45. Given the size, weight, and operational logistics of POCs, complete removal
`
`of moisture content is impractical. Attempts to reduce or remove the moisture
`
`content in the feed air in POCs typically involved implementation of an air dryer
`
`and/or a desiccant layer within the POC to contact the feed air prior to contacting
`
`the adsorbent. Even with using such moisture reduction means, once the level of the
`
`oxygen in the output drops below a certain level for providing adequate oxygen to a
`
`patient, typically at some point in the range of 75-85%, the adsorbent beds must be
`
`replaced or a new oxygen concentrator must be provided. See Exh. 1001 at Col. 12,
`
`lns. 16-27; Exh. 2001 at [0009].
`
`VI. SDG’S PORTABLE OXYGEN CONCENTRATOR TECHNOLOGY
`AND THE ‘055 PATENT
`46. Based on my discussion with Doug Galbraith, I understand that in or around
`
`early 2009, SDG recognized that with the industry trend of smaller and lighter
`
`portable oxygen concentrators, two of the three major components of oxygen
`
`concentrators – the compressor and batteries – cannot be miniaturized beyond what
`
`manufacturers can technically achieve. Consequently, SDG focused its efforts on
`
`reducing the size and weight of the third major component of oxygen concentrators
`
`– the adsorbent beds. However, through its research of smaller adsorbent bed
`
`
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`20
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`Exhibit 2040
`Page 20 of 77
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`IPR2017-00453
`U.S. Patent No. 9,199,055
`technology, SDG discovered that moisture degradation would occur more rapidly
`
`than with the larger adsorbent beds such as those used on stationary oxygen
`
`concentrators and larger portable oxygen concentrators, and as a result, the smaller
`
`adsorbent beds would have to be replaced more frequently.
`
`47. As most oxygen concentrators are provided to patients by a DME (or HME)
`
`provider, the DME is responsible for the maintenance, includ