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`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________________________
`
`RESMED PTY LTD., RESMED INC., AND RESMED CORP.,
`Petitioners,
`
`v.
`
`FISHER & PAYKEL HEALTHCARE LIMITED,
`Patent Owner.
`__________________________________
`
`Case No. IPR2019-00179
`Patent No. 9,333,315
`__________________________________
`
`DECLARATION OF PATRICK W. TRUITT, JR. IN SUPPORT OF
`PATENT OWNER FISHER & PAYKEL HEALTHCARE LIMITED’S
`PRELIMINARY RESPONSE
`
`
`
`Fisher & Paykel Ex. 2001
`ResMed v. Fisher & Paykel
`IPR2019-00179
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`
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`ResMed v. Fisher & Paykel
`IPR2019-00179 - U.S. Patent No. 9,333,315
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`
`I, Patrick W. Truitt, Jr., declare and state as follows:
`
`I. INTRODUCTION
`
`1.
`
`I have been retained on behalf of Fisher & Paykel Healthcare Limited
`
`(“FPH”). I am making this declaration on behalf of FPH in the matter of IPR2019-
`
`00179 before the Patent Trial and Appeal Board (PTAB) of the United States Patent
`
`and Trademark Office. This matter involves a petition for inter partes review of
`
`U.S. Patent No. 9,333,315 (“the ’315 patent”) filed by ResMed Pty Ltd., ResMed
`
`Inc., and ResMed Corp. (“Petitioner”).
`
`2.
`
`I am being compensated for my work in this matter on an hourly-fee
`
`basis. My compensation does not depend in any way on the outcome of this matter.
`
`II. QUALIFICATIONS AND PERSONAL BACKGROUND
`
`3.
`
`I have worked as a mechanical engineer in the medical device field for
`
`over fifteen years. I have been a member of the American Society of Mechanical
`
`Engineers (ASME) since 1998, and a member of the Society of Plastics Engineers
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`(SPE) since 2000. A copy of my curriculum vitae is submitted as FPH2002.
`
`4.
`
`In 1988, I enlisted in the United States Navy and was accepted in the
`
`Naval Nuclear Power Program. I attended the Naval Nuclear Power School in
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`Orlando, Florida and the Naval Nuclear Prototype School in Ballston Spa, New
`
`York. I graduated from the program in 1990 in the top 3 of my class, and was granted
`
`a Nuclear Operator’s License from the Department of Energy, where I was
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`IPR2019-00179 - U.S. Patent No. 9,333,315
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`responsible for training students on the operation of a 100 megawatt nuclear reactor.
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`I was granted Secret Clearance as part of my involvement with that program. From
`
`1990 to 1992, I served as a staff instructor in the Naval Nuclear Prototype School in
`
`Ballston Spa, New York.
`
`5.
`
`From 1993 to 1994, I attended Allegheny Community College in
`
`Pittsburgh, Pennsylvania, where I received an Associates of Science
`
`in
`
`Environmental Science Technologies.
`
`6.
`
`From 1994 to 1996, I worked for L.V.R. Inc. as a refractory sales
`
`engineer, in which I designed refractory installation projects for the power, cement
`
`and steel-making industries.
`
`7.
`
`I graduated from Bridgewater University in 2000 with a Bachelor of
`
`Science in Mechanical Engineering and a minor in Electrical Engineering.
`
`8.
`
`From 1996 to 2005, I worked for Respironics, Inc. as a senior
`
`mechanical engineer on several new product development projects, including several
`
`products related to CPAP devices. During my tenure at Respironics, I was lead
`
`Mechanical Engineer on the design of Chronic and Acute ventilators, patient
`
`interface devices such as nasal cannula and several CPAP machines. In 2006, I
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`worked for Renal Solutions as a lead mechanical engineer, where I designed and
`
`built kidney dialysis machines for in home use.
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`9.
`
`From 2006 to 2009, I worked for Starr Life Sciences Corp. as an
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`electro-mechanical project engineer responsible for new product development. In
`
`that capacity, I led the full design verification of a veterinary medical device pulse
`
`oximeter.
`
`10. From 2009 to 2012, I worked as a lead mechanical engineer for
`
`Vocollect. My primary responsibilities in that capacity were technical work on
`
`injection-mold part designs, including performing finite element analysis (FEA).
`
`11.
`
`In 2013, I worked for Bayer Health Care as a Principal Mechanical
`
`Engineer. In that capacity, I was the lead engineer on particulate filters for fluid
`
`injectors of contrast agents for CT scan machines, and for sterile fluid path syringe
`
`disposables.
`
`12. Since 2013, I have worked as a Lead Consultant Mechanical Engineer
`
`for Sigenix. In that capacity, I have performed medical device design consulting
`
`services, including for medical device start-up companies, such as Vapotherm High
`
`Flow Nasal Cannula treatment device.
`
`13. Since 2014, I have also worked for TTI Floor Care North America.
`
`From 2014 to 2015, I held the title of Senior Research and Design Scientist. Since
`
`2015, I have held the title of Research and Design Manager. My responsibilities at
`
`TTI have focused on research and design on projects relating to vacuum-robots.
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`14.
`
`I am a named inventor of approximately 15 United States patents, as
`
`well as several pending patent applications. My inventions protected by those
`
`patents are primarily for mechanical and electronic medical devices, including in
`
`CPAP and similar fields. For example, I am a named inventor of the following
`
`patents:
`
`
`
`U.S. Patent No. 6,269,811, titled “Pressure support system with a
`
`primary and a secondary gas flow and a method of using same;”
`
`
`
`U.S. Patent No. 6,581,596, titled “Apparatus and method of providing
`
`high frequency variable pressure to a patient;”
`
`
`
`U.S. Patent No. 6,622,724, titled “Impeller and a pressure support
`
`system and method using such an impeller;”
`
`
`
`U.S. Patent No. 6,644,311, titled “Monitoring fluid flow in a pressure
`
`support system;”
`
`
`
`U.S. Patent No. 6,915,705, titled “Flow sensor and flow resistive
`
`element;”
`
`
`
`U.S. Patent No. 7,975,688, titled “Vibration reducing blower assembly
`
`mounting;”
`
`
`
`U.S. Patent No. 8,561,611, titled “Respiratory device measurement
`
`system;” and
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`U.S. Patent No. 8,701,662, titled “Humidifier with back-flow
`
`prevention valve.”
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`III. MATERIALS CONSIDERED
`
`15.
`
`I have reviewed the specification, claims, and prosecution history of the
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`’315 Patent, which is also Exhibit 1003 in the Petition record.
`
`16.
`
`17.
`
`I have reviewed the Petition for this inter partes review (the “Petition”).
`
`In this declaration, I will use either or both of the following exhibit
`
`numbers and shorthand names to refer to the following documents, which I have also
`
`reviewed and considered:
`
`Record Citation
`
`RMD1009
`
`RMD1010
`RMD1011
`
`
`
`Reference
`Declaration of Anthony
`Michael Ging
`U.S. Pat. Pub. 2005/0011524
`U.S. Pat. Pub. 2004/0226566
`
`Shorthand Name
`
`Ging Declaration
`
`Thomlinson
`Gunaratnam
`
`18. The above-referenced materials are in addition to any other materials
`
`referenced directly or indirectly in this declaration.
`
`IV. SCOPE OF ANALYSIS
`
`19.
`
`I understand that this proceeding involves subjects related to the
`
`patentability of claims 1-19 of the ’315 patent. I have been asked to offer analysis
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`of limited scope regarding the obviousness theories set forth in the Petition and
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`accordingly have therefore limited my analysis to the question of whether, in light
`
`of the arguments set forth in the Petition, claims 1, 6 and 17 would be rendered
`
`obvious to one of ordinary skill in the art at the time of the invention. Claims 1, 6
`
`and 17 are independent claims, from which the remaining claims in the Petition
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`depend. In this declaration, I am not providing analysis or any opinion related
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`specifically to the patentability of any dependent claim.
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`20. The specific topics that I have been asked to address, and my analysis
`
`thereof, are set forth in the section of this declaration labeled “SUBSTANTIVE
`
`ANALYSIS OF GROUNDS 1-6.”
`
`21. With respect to the present matter, I have neither analyzed nor
`
`expressed any opinion about any subject that is not expressly included in the section
`
`labeled “SUBSTANTIVE ANALYSIS OF GROUNDS 1-6.”
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`V. LEGAL STANDARDS
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`22.
`
`I am not an attorney and, therefore, I will not offer opinions of law. For
`
`the purposes of this declaration, I have been informed about certain aspects of the
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`law that are relevant to my opinions. The opinions I offer in my declaration involve
`
`the application of my knowledge and experience to the evaluation of the ’315 patent
`
`and the references identified above.
`
` The paragraphs below express my
`
`understanding of current principles related to patentability and how they should be
`
`applied to my analysis.
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`A.
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`Person Of Ordinary Skill In The Art
`
`23.
`
`I have been informed that for purposes of assessing the obviousness of
`
`patent claims, the level of skill possessed by the hypothetical person of ordinary skill
`
`in the art (“POSITA”) is informed by several factors. I understand these factors
`
`include the type of problems encountered in the relevant art, the prior art solutions
`
`to those problems, the rapidity with which innovations are made in the relevant art,
`
`the sophistication of the relevant technology, and the educational level of active
`
`workers in the field.
`
`24.
`
`I understand that the ’315 Patent claims priority to two New Zealand
`
`patent applications, Application Nos. 531332 and 534606, filed February 23, 2004
`
`and August 6, 2004, respectively. I understand that in the Petition for inter partes
`
`review, the Petitioner contends that the earliest date to which any of claims 1-19 is
`
`entitled to priority is August 6, 2004. Therefore, my opinions are based on the
`
`perspective of a POSITA at around the time of August 2004.
`
`25.
`
`It is my opinion that a person of ordinary skill in the field of the ’315
`
`Patent would have had at least a bachelor’s degree in mechanical engineering,
`
`biomedical engineering, industrial design, or a similar technical field, combined with
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`at least two years of experience in the field of medical device masks, respiratory
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`therapy, patient interfaces, or other relevant product design. An increase in
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`experience may compensate for less education and an increase in education may
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`compensate for less experience.
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`26.
`
`I have reviewed paragraphs 20 and 21 of the Ging Declaration stating
`
`his opinion about the level of ordinary skill in the art in 2004. Although it differs
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`slightly from my understanding of the level of ordinary skill in the art stated above,
`
`I do not believe it differs in any material respect with regard to my opinions set forth
`
`herein.
`
`B. Claim Construction
`
`27.
`
`I understand that, in assessing the patentability of a patent claim in
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`petitions for inter partes review filed before November 13, 2018, the patent claim
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`will be construed by giving the claim its broadest reasonable interpretation
`
`consistent with the patent specification. I understand that, under the broadest-
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`reasonable-interpretation standard, a claim term or phrase is generally given its plain
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`and ordinary meaning within the relevant art. In addition to the patent specification,
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`the proper construction of patent claim may be assisted by evidence from the
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`prosecution history of the patent, as well as record evidence that may bear on the
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`meaning, and I also understand that the proper construction should be consistent with
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`the construction a POSITA would reach.
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`C. Obviousness
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`28.
`
`I understand that a claim of an issued patent is unpatentable under
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`35 U.S.C. § 103 if the differences between the claimed subject matter and the prior
`
`art are such that the claimed subject matter as a whole would have been obvious. I
`
`understand that this determination is made from the perspective of a POSITA at the
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`time of the invention. In other words, a reference discloses or teaches a claim
`
`limitation only if a POSITA would, at the relevant time, interpret the reference as
`
`disclosing the claim limitation.
`
`29.
`
`I further understand that the determination of obviousness is based on
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`four factors, sometimes referred to as the Graham factors. They are: (a) the scope
`
`and content of the prior art, (b) the differences between the prior art and the claimed
`
`invention, (c) the level of ordinary skill in the pertinent art, and (d) any objective
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`indicia of nonobviousness, such as commercial success, industry praise, and
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`unexpected results.
`
`30. To assess the differences between prior art and the claimed subject
`
`matter, it is my understanding that the law requires the claimed invention to be
`
`considered as a whole. I understand that this assessment requires showing that one
`
`of ordinary skill in the art at the time of invention, confronted by the same problems
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`as the inventor and with no knowledge of the claimed invention, would have selected
`
`the elements from the prior art and combined them in the claimed manner.
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`31.
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`I further understand that there must be a reason that would have
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`prompted a POSITA to combine the elements in the references in the way the
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`claimed new invention does. I understand that the person of ordinary skill must have
`
`had a reasonable expectation of success in combining the teachings to arrive at the
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`claimed invention. I further understand that a reason to combine or expectation of
`
`success is undermined if the combination or modification of the technology
`
`disclosed in the prior art would interfere with an objective of the technology
`
`disclosed in the prior art or if the prior art teaches away from making the combination
`
`or modification.
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`32. All of my analysis and opinions in this declaration are from the
`
`perspective of a POSITA at the time of invention. Where my declaration does not
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`expressly include language indicating that my analysis is from the perspective of a
`
`POSITA throughout, it should be understood that my analysis and opinions are from
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`the perspective of a POSITA at the time of invention. For example, my opinion that
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`a reference does not disclose or teach a claim limitation should be understood to
`
`mean that, in my opinion, a POSITA at the time of invention would interpret the
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`reference as not disclosing the limitation.
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`VI. SUBSTANTIVE ANALYSIS OF GROUNDS 1-6
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`33. Again, all of my analysis and opinions in this declaration are from the
`
`perspective of a POSITA at the time of invention, though I may not expressly repeat
`
`this every time I state my analysis or conclusions.
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`34.
`
`I understand that, in Grounds 1-6, Petitioner contends that claim 1-19
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`of the ’315 Patent would have been obvious based on Thomlinson in view of
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`Gunaratnam. Pet. at 3. Only claims 1, 6 and 17 are independent. Using Petitioner’s
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`limitation-numbering scheme for convenience, Claim 17, the shortest of the
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`independent claims, is reproduced below, with emphasis on the limitations (the
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`“headgear extension limitations”) that will be the focus of my analysis in this
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`declaration (17.4, 17.6):
`
`Claim 17
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`17.P A mask assembly for delivering positive airway pressure to a
`user, the mask comprising:
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`17.1 a rigid mask body;
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`17.2 an inspiratory conduit connected to the rigid mask body;
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`17.3 a prong part comprising a hollow body and first and second nasal
`prongs extending from the hollow body, the hollow body
`removably connected to the mask body;
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`17.4 a first headgear extension having a distal end connected to the
`rigid mask body on a distal side of the prong part at a location
`spaced from a user in use, and a proximal end disposed
`proximally toward a user in use,
`
`17.5
`
`the first headgear extension extending from the rigid mask body,
`at least along a first lateral direction extending laterally away
`from the rigid mask body and beyond an outer periphery of the
`prong part and along a second direction extending more
`proximally toward the user than the first direction in use; and
`
`17.6 a second headgear extension having a distal end connected to the
`rigid mask body on the distal side of the prong part at a location
`spaced from a user in use, and a proximal end disposed
`proximally toward a user in use,
`
`17.7
`
`the second headgear extension extending from the rigid mask
`body at least along a third lateral direction extending laterally
`away from the rigid mask body and beyond the outer periphery
`of the prong part and along a fourth direction more proximally
`toward the user than the third direction in use.
`
`35. The above emphasized headgear extension
`
`limitations have
`
`counterparts in remaining independent claims 1 and 6. The relevant limitations of
`
`those claims are reproduced below, with claim 6 appearing first because of the
`
`similarity of its relevant claim language to that in claim 17.
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`Claim 6
`
`6.4
`
`6.6
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`a first headgear extension having a distal end connected to the
`rigid mask body on a distal side of the prong part at a location
`spaced from a user in use, and a proximal end disposed
`proximally toward a user in use,
`
`a second headgear extension having a distal end connected to the
`rigid mask body on the distal side of the prong part at a location
`spaced from a user in use, and a proximal end disposed
`proximally toward a user in use,
`
`Claim 1
`
`1.5
`
`1.7
`
`the first headgear extension having a distal end connected to the
`left peripheral side of the rigid mask body on a distal side of the
`prong part at a location spaced from a user in use, and a
`proximal end disposed proximally toward a left side of a user’s
`face in use,
`
`the second headgear extension having a distal end connected to
`the right peripheral side of the rigid mask body on the distal
`side of the prong part at a location spaced from a user in use,
`and a proximal end disposed proximally toward a right side of a
`user’s face in use,
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`ResMed v. Fisher & Paykel
`IPR2019-00179 - U.S. Patent No. 9,333,315
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`A. Grounds 1-2: Gunaratnam Alone Does Not Disclose The Headgear
`Extension Limitations
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`36. For Grounds 1 and 2, Petitioner argues that the headgear extension
`
`limitations in independent claims 1, 6 and 17 are obvious in view of Gunaratnam
`
`alone. Pet. at 12-15, 17, 34-35.1 Petitioner argues that three separate embodiments
`
`in Gunaratnam disclose the headgear extension limitations. Pet. at 12-14, 17.
`
`Petitioner identifies these embodiments as relating to Figures 1-8 (“first
`
`embodiment”), Figures 25-31 (“second embodiment”), and Figures 60-61 and 108-
`
`113 (“third embodiment”) in Gunaratnam. Pet. at 8-9. In my opinion, these
`
`embodiments do not disclose the headgear extension limitations.
`
`1.
`
`The First And Second Gunaratnam Embodiments Do Not
`Disclose The Headgear Extension Limitations
`
`37. Petitioner identifies the Gunaratnam components 26 and 226,
`
`respectively, in Gunaratnam embodiments 1 and 2, as the alleged headgear
`
`extensions claimed in the ’315 patent. Pet. at 12-14. Petitioner relies on these
`
`components as satisfying the headgear extension limitations for each of independent
`
`claims 1, 6 and 17 in Grounds 1 and 2. Pet. at 12-14, 17, 34-35.
`
`
`1 See Pet. at 3 (Ground 1 challenging claims 1, 4-14, 16-19; Ground 2
`
`challenging claims 2 and 15, which depend from claims 1 and 6, respectively).
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`38. Components 26/226 are described in Gunaratnam as “second connector
`
`portions,” and are described as having hollow inlet conduits that deliver gas to the
`
`frame and nozzle assembly. See, e.g., RMD1011 at [0199], [0242]. These are shown
`
`in the Gunaratnam Figures 9-10 and 32-33 below.
`
`First Embodiment
`
`
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`
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`Second Embodiment
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`39. Gunaratnam discloses two functions for the second connector portions
`
`26/226: to connect the frame to the headgear assembly, and to connect the gas inlet
`
`conduits to the frame/nasal assembly. See, e.g., RMD1011 at [0177], [0236]. As
`
`seen above in Figures 9-10 and 32-33, however, the only structures on the second
`
`connector portions 26/226 that connect to a headgear assembly are crossbars 70 and
`
`270, respectively. See also RMD1011 at [0197], [0241].
`
`40. Crossbars 70/270 are structured to connect to headgear assembly
`
`20/220, which is shown for headgear assembly 20 in Figure 18 below.
`
`
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`41.
`
`In my opinion, a POSITA would see crossbars 70/270 as the only
`
`potential “headgear extension” counterparts disclosed in Gunaratnam, not the entire
`
`structure of the second connector portions 26/226. The much larger overall structure
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`of the second connector portions 26/226 is a conduit that conveys gas to the user via
`
`the frame and nasal assembly. RMD1011 at [0198] (“The rear portion 62 also
`
`provides an elongated conduit 72 adapted to be connected to an inlet conduit that
`
`delivers breathable gas to the frame 16 and nozzle assembly 18.”), [0241] (“The rear
`
`portion 262 also provides a pair of conduits 272 adapted to be connected to an inlet
`
`conduit that delivers breathable gas to the frame 216 and nozzle assembly 218.”). A
`
`POSITA would understand that the overall shape and direction of the second
`
`connector portion 26/226 is designed to position the gas inlet tube, not the headgear
`
`connections. Thus, a POSITA would consider the crossbar structure, and not the
`
`larger gas conduit structure, to be the structure responsible for connecting the
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`headgear.
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`42. Crossbars 70/270, by virtue of their location on the second connector
`
`portions 26/226, have a specific orientation relative to the frame, nasal assembly and
`
`the user. Petitioner’s declarant, Mr. Ging, has offered no showing that the
`
`orientation of the crossbars 70/270 satisfy the various requirements of the headgear
`
`extension limitations claimed in the ’315 patent.
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`43. Also, as demonstrated in the annotated Figure 1 below, I note that the
`
`structure on the second connector portions 26/226 having the headgear-connecting
`
`crossbars 70/270 does not extend in a “second direction extending more proximally
`
`toward the user” as required by limitations 1.6, 1.7, 6.5, 6.7, 17.5, and 17.7.
`
`
`44. Additionally, it is my opinion that the entire second connector portions
`
`26/226 do not disclose the headgear extension limitations. The second connector
`
`portions 26/226 attach to the frame (16 and 216, respectively) using large, circular
`
`connection structures. As Figures 1 and 25 show below, these connections are made
`
`on the side of the frame, relative to what Petitioner identifies as the “lateral” side of
`
`the nasal assembly. Pet. at 13-14.
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`These connections along the lateral side of nasal assembly are not connections “on
`
`a distal side of the prong part” as required by the claims of the ’315 patent.
`
`45.
`
`I note that Petitioner also characterizes this connection as occurring on
`
`the “distal” side of the nasal assembly. Pet. at 13-14. However, Petitioner provides
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`no support for this characterization. On the contrary, Gunaratnam’s figures above
`
`show the second connector portions 26/226 employ a large, circular connection
`
`structure that attaches to a corresponding circular structure (24/224) on the side of
`
`frame 16/216. Gunaratnam specifically requires this type of large, circular
`
`connection structure to allow the frame (and thus the nasal assembly) to rotate/adjust
`
`relative to the second connector portions 26/226 to facilitate positioning of the nasal
`
`assembly in a customized position. RMD1011 at [0179], [0240].
`
`46. As Figures 1 and 25 above show, the large, circular structure of the
`
`second connector portions 26/226 are positioned next to the user’s face in use and
`
`thus connect to the frame not only on the lateral side of the nozzle assembly, but on
`
`the proximal side as well. I note the specification states the following: “The front
`
`and rear portions 60, 62 are angled with respect to one another such that the second
`
`connector portions 26 follow the contour of the patient’s face in use, as shown in
`
`FIG. 1.” RMD1011 at [0194] (emphasis added). Thus, Gunaratnam’s figures and
`
`specification show that the “first/front side 60,” Pet. at 13, runs along the contour of
`
`the user’s face in use based on a connection to the frame that is neither on a distal
`
`side of the prong part, nor at a location spaced from a user in use as required by
`
`independent claims 1, 6 and 17.
`
`47.
`
`I also note that Petitioner’s attempt to rely on the second connector
`
`portions 26 as the headgear extension, rather than the crossbars that actually connect
`
`-20-
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`ResMed v. Fisher & Paykel
`IPR2019-00179 - U.S. Patent No. 9,333,315
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`to the headgear, is inconsistent with Petitioner’s showing on limitations 6.2 and 17.2.
`
`Those limitations require that the “inspiratory conduit connect[] to the rigid mask
`
`body.” Pet. at 10.
`
`48. When arguing that inspiratory conduit limitations 6.2 and 17.2 are
`
`satisfied, Petitioner relies on the specific feature of the second connector portion 26
`
`relating to the conduit connection (conduit 72). Id.
`
`49.
`
`In contrast, as discussed above, when relying on the second connector
`
`portion 26 for the headgear extension limitations, Petitioner does not rely on the
`
`specific structure (crossbar 70) dedicated to connecting the headgear. Pet. at 12-13.
`
`Instead, Petitioner relies on the entire second connector portion 26, including the
`
`structure dedicated to supplying air (conduit 72), as it did for the inspiratory conduit
`
`limitations 6.2 and 17.2. Id.
`
`2.
`
`The Third Gunaratnam Embodiment Does Not Disclose The
`Headgear Extension Limitations
`
`50. Petitioner identifies yoke 608 in Figures 108-110, which Petitioner
`
`describes as the “third embodiment” in Gunaratnam, as disclosing the headgear
`
`extension limitations in each of independent claims 1, 6 and 17 in Grounds 1 and 2.
`
`-21-
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`ResMed v. Fisher & Paykel
`IPR2019-00179 - U.S. Patent No. 9,333,315
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`Pet. at 14-15, 17, 34-35. 2 In my opinion, this third embodiment fails to establish the
`
`headgear extension limitations for many of the same reasons above.
`
`51. Petitioner admits that the yokes attach via ring 610. Pet. at 14;
`
`RMD1011 at [0379]. This can be seen in Figures 109 and 110 below.
`
`
`
`
`2 Petitioner’s analysis of this third embodiment appears only at Pet. at 14-15,
`
`where Petitioner addresses limitations 6.4 and 17.4. Petitioner again relies on that
`
`analysis for its showing on the remaining limitations (i.e., 6.6, 17.6, 1.5 and 1.7).
`
`Pet. at 17, 34-35.
`
`-22-
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`
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`ResMed v. Fisher & Paykel
`IPR2019-00179 - U.S. Patent No. 9,333,315
`
`
`
`52. This circular ring structure allows the cushion assembly to be
`
`“adjustably rotated with respect to the headgear, to a position which best fits the
`
`patient.” RMD1011 at [0379]. As can be seen from the figures above, this ring
`
`structure connects to the frame circumferentially, attaching on lateral and proximal
`
`sides of the nasal assembly.
`
`53.
`
`In my opinion, figures 109 and 110 above also show that the attachment
`
`location of the yokes to the frame are not “spaced from a user in use” as the claims
`
`of the ’315 patent require. The figures above instead demonstrate that the yokes
`
`attach at points that would directly abut the user’s face when in use. I note that
`
`Petitioner’s declarant Mr. Ging cites no evidence to support that Gunaratnam’s
`
`yokes attach at a location “spaced from a user in use.” RMD1009 ¶ 51 (at page 42);
`
`Pet. at 14.
`
`-23-
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`
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`ResMed v. Fisher & Paykel
`IPR2019-00179 - U.S. Patent No. 9,333,315
`
`
`54. For the reasons discussed above, it is my opinion that the first, second
`
`and third embodiments in Gunaratnam do not disclose the headgear extension
`
`limitations of independent claims 1, 6 and 17.
`
`B. Grounds 3-6: Thomlinson In View Of Gunaratnam Does Not Disclose
`The Headgear Extension Limitations
`
`55. Petitioner argues in Grounds 3-6 that the combination of Thomlinson
`
`in view of Gunaratnam discloses the headgear extension limitations of independent
`
`claims 1, 6 and 17.3 Pet. at 42-49, 51, 61-62. In my opinion, a POSITA would not
`
`seek to combine these references to arrive at the headgear extension limitations.4
`
`1.
`
`A POSITA Would Not Be Motivated To Apply Gunaratnam’s
`Yokes To Thomlinson
`
`56. Petitioner alleges that a POSITA would seek to improve Thomlinson
`
`“by simply attaching the distal ends of Gunaratnam’s headgear extensions (yokes)
`
`to locking tabs 38 or a suitably adapted variation of the locking tabs 38, or extending
`
`
`3 See Pet. at 3 (Ground 3 challenging claims 6-7, 9-14, 16-18; Ground 4
`
`challenging claims 1, 3-5, 8, 19; Ground 5 challenging claim 2, which depends from
`
`claim 1; and Ground 6 challenging claim 15, which depends from claim 6).
`
`4 Petitioner again relies on its analysis of limitations 6.4 and 17.4 for the
`
`remaining the headgear extension limitations in Grounds 3-6. Pet. at 51, 61-62.
`
`-24-
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`
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`ResMed v. Fisher & Paykel
`IPR2019-00179 - U.S. Patent No. 9,333,315
`
`them from connections 28, 30 on Thomlinson’s body part (distal portion 16).” Pet.
`
`at 46.
`
`57. Petitioner’s obviousness theory is premised on Petitioner’s allegation
`
`that Thomlinson and Gunaratnam are “similar” nasal interfaces. Pet. at 45. I note
`
`that the embodiments Petitioner points to in Gunaratnam concern very specific
`
`barrel-shaped masks with circular connecting structures along the sides of the frame.
`
`Gunaratnam’s yokes connect to the frame via ring structure that is specifically
`
`designed to allow that barrel-shaped frame (and thus the “nozzle or cushion
`
`assembly 604,” RMD1011 at [0292]) to rotate or adjust relative to the headgear:
`
`As shown in FIG. 109, the cushion assembly may be adjustably rotated
`with respect to headgear, to a position which best fits the patient. In
`FIG. 109, the ring 610 of the yoke 608 of the headgear includes an
`alignment marker 611a and the cushion includes a plurality of
`alignment markers 611b that can be selectively aligned with marker
`611a.
`
`RMD1011 at [0379]. Figure 109 of Gunaratnam, referenced in paragraph [0379]
`
`above, is reproduced below.
`
`-25-
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`
`
`ResMed v. Fisher & Paykel
`IPR2019-00179 - U.S. Patent No. 9,333,315
`
`
`
`
`Thus, the yokes described in Gunaratnam are specifically designed to accommodate
`
`the unique side-inlet, barrel structure of Gunaratnam, and to allow the cushion
`
`assembly to rotate relative to the headgear.
`
`58.
`
`In sharp contrast, as shown in Figure 1 of Thomlinson below,
`
`Thomlinson is a central-inlet mask assembly bearing little resemblance to the
`
`structure of Gunaratnam.
`
`-26-
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`
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`ResMed v. Fisher & Paykel
`IPR2019-00179 - U.S. Patent No. 9,333,315
`
`
`
`59. Not only does Thomlinson not disclose yokes, or teach the need for
`
`yokes, its unique design already accomplishes the adjustability feature that the yokes
`
`in Gunaratnam are designed to provide. Specifically, Thomlinson discloses nasal
`
`prong parts that can be individually rotated in place and thus adjusted to better fit a
`
`patient. As Thomlinson explains:
`
`Additionally, by employing separate nasal prongs, either nasal prong
`10 and 12 can be rotated and/or adapted to be rotatable in the proximal
`portion 14 opening or aperture (e.g., openings 60 or 62) in which the
`prong is positioned and/or releasably engaged, independent
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