UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`SINCLAIR PHARMA LIMITED, SINCLAIR PHARMA US, INC., VIORA,
`INC., EMA AESTHETICS, LTD., AESTHETIC MANAGEMENT
`PARTNERS, LLC, AND AESTHETIC MANAGEMENT PARTNERS, INC.,
`Petitioner
`
`v.
`
`HYDRAFACIAL LLC,
`Patent Owner.
`
`Patent No. 11,865,287 to Ignon et al.
`Issue Date: January 9, 2024
`Title: Devices and methods for treating skin
`
`Case No. IPR2025-00145
`Patent No. 11,865,287
`
`DECLARATION OF HAROLD J. WALBRINK IN SUPPORT OF
`PETITION FOR INTER PARTES REVIEW OF CLAIMS 1–12, 14–20, 22–
`26, 28–37, and 39–45 OF U.S. PATENT NO. 11,865,287 UNDER 35 U.S.C.
`§§ 311-319 AND 37 C.F.R. §§ 42.100 ET SEQ.
`
`Sinclair Pharma et al.
`EUNSUNG-1028
`
`

`

`Patent No. 11,865,287
`IPR2025-00145
`
`
`
`Walbrink Decl. in Support of Petition
`Requesting Inter Partes Review
`
`TABLE OF CONTENTS
`
`INTRODUCTION ......................................................................................... 1
`I.
`II. QUALIFICATIONS ...................................................................................... 1
`III. MATERIALS AND OTHER INFORMATION CONSIDERED ............. 4
`IV. SUMMARY OF MY OPINIONS ................................................................. 4
`V. CONCLUSION .............................................................................................. 5
`
`
`
`i
`
`

`

`Patent No. 11,865,287
`IPR2025-00145
`
`Walbrink Decl. in Support of Petition
`Requesting Inter Partes Review
`
`1.
`
`I, Harold Walbrink, of Laguna Niguel, California, declare that:
`
`
`
`I. INTRODUCTION
`I have been retained by Sinclair Pharma Limited, Sinclair Pharma US,
`2.
`
`Inc., Viora, Inc., EMA Aesthetics, Ltd., Aesthetic Management Partners, LLC, and
`
`Aesthetic Management Partners, Inc. (collectively “Petitioner”) to provide this
`
`declaration concerning the technical subject matter relevant to a petition for inter
`
`partes review of U.S. Patent No. 11,865,287 (“’287 patent”).
`
`3.
`
`Specifically, I was asked to review the declaration of Eric Simon that
`
`was submitted by the petitioner in IPR2024-01491 as Exhibit 1003 and form an
`
`opinion of whether I agreed with the facts, analysis, and conclusions in that
`
`declaration.
`
`II. QUALIFICATIONS
`I am the Founder and Chief Executive Officer of Xinetix, Inc. in
`4.
`
`Laguna Niguel, California. Xinetix is a business and technology development
`
`consulting company providing product development services to startup and mid-tier
`
`medical device companies. As the Chief Executive Officer, I have provided both
`
`technical management and product design services to client companies.
`
`5.
`
`I received my Bachelor of Science degree in engineering from
`
`California State University, Fullerton, with an emphasis on electrical engineering. I
`
`
`
`-1-
`
`

`

`Patent No. 11,865,287
`IPR2025-00145
`
`Walbrink Decl. in Support of Petition
`Requesting Inter Partes Review
`
`
`later took coursework towards a certificate in microprocessor systems engineering
`
`at the University of California, Irvine.
`
`6.
`
`From 2007 to 2010, I served as a senior partner in Business Catalytics,
`
`LLC in Laguna Hills, California. In this role, I headed up the research and
`
`development and manufacturing process focused activities.
`
`7.
`
`I served in a variety of electrical engineering roles from 1971 to 1983.
`
`These roles were focused in the areas of communications, control systems, and
`
`imaging with several aerospace and commercial companies.
`
`8.
`
`From 1983 to 1999, I served as the director of research and
`
`development for surgical instrumentation at Alcon Surgical in Irvine, California. In
`
`this role I designed and developed innovative ophthalmic surgical instrumentation,
`
`devices, and disposable products.
`
`9.
`
`From 1990 to 1995, I worked in various roles at Birtcher Medical
`
`Systems in Irvine, California. I managed product design activities for a diverse range
`
`of product technologies including radiofrequency electrosurgical, video endoscopy,
`
`surgical instruments, electrocardiogram, Doppler ultrasound, and physical therapy
`
`devices.
`
`10. From 1999 to 2003, I worked as the Chief Operating Officer, Executive
`
`Vice President, and General Manager of Newport Medical Instruments in Costa
`
`
`
`-2-
`
`

`

`Patent No. 11,865,287
`IPR2025-00145
`
`Walbrink Decl. in Support of Petition
`Requesting Inter Partes Review
`
`
`Mesa, California. In this role I developed an advanced generation critical care
`
`ventilator product platform.
`
`11.
`
`I have also served in a variety of interim management positions between
`
`1995 and 2016. These included several research and development roles and senior
`
`leadership roles for a variety of medical technology companies.
`
`12.
`
`I have over 40 years of product design and development within the
`
`healthcare, commercial, and aerospace industries. My experience ranges from
`
`company chairman to hands-on engineering. I am a recognized authority on medical
`
`device design in the areas of ophthalmology, electrosurgery, and respiratory care.
`
`13.
`
`I have completed over fifty new product design and development
`
`projects. I am a named inventor on nine U.S. medical device patents.
`
`14. Additional
`
`information regarding my education and
`
`technical
`
`experience is included in my Curriculum Vitae, which is attached to this Report as
`
`Exhibit A.
`
`15.
`
`I am being compensated at my usual consulting rate of $585 per hour
`
`for my consulting services in consulting on this matter. I am also being reimbursed
`
`for all reasonable expenses incurred due to this matter. No part of my compensation
`
`is contingent upon the nature of my findings, the presentation of my findings in
`
`testimony, or the outcome of this matter, and I have no interest in the matter or with
`
`either party.
`
`
`
`-3-
`
`

`

`
`
`Patent No. 11,865,287
`IPR2025-00145
`
`Walbrink Decl. in Support of Petition
`Requesting Inter Partes Review
`
`III. MATERIALS AND OTHER INFORMATION CONSIDERED
`In drafting this declaration and forming the opinions herein, I relied on
`16.
`
`my years of education, research, and industry and academic experience. I also relied
`
`on the materials listed in Appendix B.
`
`17.
`
`I reserve the right to rely upon these materials and other materials to
`
`rebut arguments raised by the Patent Owner.
`
`18.
`
`I reserve the right to supplement this declaration in response to
`
`additional evidence that may become known.
`
`19.
`
`In connection with any testimony, I may be asked to give to the Patent
`
`Trial and Appeal Board, I may use as exhibits various documents that relate to
`
`matters set forth in this declaration.
`
`IV. SUMMARY OF MY OPINIONS
`20. After considering the Simon declaration and the other materials listed
`
`in Appendix B, I agree with the facts, analysis, and conclusions in the Simon
`
`declaration, and I adopt the testimony in Sections III–XV of the Simon declaration
`
`as my own for purposes of this proceeding.
`
`21.
`
`I declare all statements made herein of my own knowledge are true
`
`and that all statements made on information and belief are believed to be true; and
`
`further that the statements were made with the knowledge that willful false
`
`
`
`-4-
`
`

`

`Patent No. 11,865,287
`IPR2025-00145
`
`Walbrink Decl. in Support of Petition
`Requesting /nter Partes Review
`
`statements and the like so madeare punishable by fine or imprisonment, or both,
`
`under Section 1001 of Title 18 of the United States Code.
`
`Vv.
`
`CONCLUSION
`
`Thereby declare that all statements made of my own knowledgeare true and
`
`that all statements made on information and belief are believed to be true. I further
`
`declare that these statements were made with the knowledgethat willful false
`
`statements and the like so made are punishable by fine or imprisonment, or both,
`
`under Section 1001 of the Title 18 of the United States Code.
`
`By:
`Dated: Avvewllrtocoz
`
`Harold Walbrink
`
`-5-
`
`

`

`Patent No. 11,865,287
`IPR2025-00145
`
`Walbrink Decl. in Support of Petition
`Requesting Inter Partes Review
`
`APPENDIX A
`
`
`
`
`
`
`
`
`
`
`

`

`Expert Witness / Consultant Curriculum Vitae
`
`Harold J. Walbrink
`
`58 Coronado Pointe
`
`Laguna Niguel, California 92677
`
`Cell: (949) 697-9462
`
`Email: halwalbrink@xinetixinc.com
`
`Expertise
`
`▪ Medical Device development
`▪ Product Commercialization
`▪ Technology-based Business Strategies
`▪ Device Design
`▪ Project Management
`
`▪ Regulatory Affairs
`▪
`Intellectual Property
`▪ Executive Management
`▪ Human Factors / User Experience
`▪ Regulatory Submissions
`
`Professional Summary
`
`Mr. Walbrink is a high-tech entrepreneur with 45 years product, technology, and business
`
`development experience within healthcare (38 years), commercial, and aerospace
`
`industries. Expert at delivering significant revenue and asset growth through
`
`identification, development, and execution of innovative technology-based business
`
`strategies and plans. Broad leadership experience ranging from company Chairman,
`
`CXO, to hands-on engineering for startup to later-stage private and public companies in
`
`domestic and international markets. Recognized authority on medical device design in the
`
`areas of Ophthalmology, Electrosurgery, Microfluidics, Endoscopic surgery, and
`
`Respiratory care.
`
`Mr. Walbrink career achievements include six business startups, three business
`
`turnarounds, seven major project turnarounds, over fifty new product design and
`
`development projects, named inventor on nine US medical device patents, and served as
`
`an expert witness in 32 medical device patent infringement and product liability legal
`
`cases.
`
`Confidential Resume of Harold J. Walbrink
`Printed: 02/05/21
`
`Page 1
`
`

`

`Expert Witness / Consultant Curriculum Vitae
`
`Employment History
`
`From:
`To:
`
`Xinetix, Inc., Laguna Niguel, CA
`1995
`Present CEO/Founder
`
`Founded Xinetix, a business and technology development company providing
`turn-key product development and interim management services to startup and
`mid-tier domestic and international medical device companies. Recognized as a
`clinical and technical expert in the areas of Ophthalmology, Electrosurgery,
`Respiratory care, Endoscopic surgery, and thermally induced tissue
`modification Xinetix is renowned for blending business acumen with in-depth
`technical expertise to develop effective, profitable technology-based products
`and business strategies. Xinetix has an established reputation for selection and
`development of appropriate technologies and processes to meet the unique
`market and business needs. Management assignments have included strategic
`business planning, fundraising, intellectual property development, product
`development, operations management, regulatory affairs, and manufacturing
`startup. Assumed Board level and interim executive level positions as
`Chairman, CEO, COO, and Executive Vice President while providing general
`business, technical management, and product design services to over sixty
`client companies. Served as an expert witness on thirty-two product liability
`and patent infringement legal cases
`
`From:
`To:
`
`2007
`2010
`
`Business Catalytics, LLC, Laguna Hills, CA
`Founding Partner / Senior Partner
`
`Founding partner of this business process re-engineering and optimization consulting
`firm serving clients in the healthcare and medical device industry. Headed up the
`research and development and manufacturing process focused activities for the firm.
`Responsible for business strategy, new business development, and implementation
`team management. Employed Design For Six Sigma tool sets and techniques for
`analysis, process reengineering and optimization. Assignments included assessment of
`organizational and employee capabilities resulting in reorganization and realignment
`of personnel to meet operational objectives, implementation of R&D product
`development process, product development, and process evaluation and
`reengineering.
`
`Confidential Resume of Harold J. Walbrink
`Printed: 02/05/21
`
`Page 2
`
`

`

`Expert Witness / Consultant Curriculum Vitae
`
`From:
`To:
`
`2007
`2009
`
`Apieron, Inc., Menlo Park, CA
`Vice President of Research and Development
`
`Contracted through Xinetix to lead research and development efforts to develop a
`novel respiratory diagnostic device to detect early onset of respiratory infections in
`asthmatic patients before physical symptoms could be detected.
`
`From:
`To:
`
`1999
`2003
`
`Newport Medical Instruments, Costa Mesa, CA
`COO/Executive Vice President/General Manager
`
`Contracted through Xinetix to implement a turnaround of financially troubled
`privately held Japanese critical care ventilator manufacturer. The company was
`losing $2 mill on $15 mil annual international. Revitalized this 20-year-old company
`through new product introductions, company restructuring and product / process
`improvements. Increased company profitability from $2 mil loss to $200 K annual
`profit within two years Implemented formal strategic planning processes and
`established formal corporate technology development planning processes.
`Successfully completed development and launch of the e500 world-class critical
`care ventilator. Served as primary liaison in acquisition of the HT50 ambulatory
`critical care ventilator from Flight Medical, an Israeli OEM homecare and transport
`ventilator supplier contributing over $7 mil in annual revenue.
`
`From:
`To:
`
`2005
`2019
`
`Sarah Green Enterprises, Irvine, CA
`President
`
`Music Recording and Entertainment executive responsible for artist development,
`contract negotiation, and overseeing recording and production at Capital Records.
`The artist gained a substantial fan base in the Los Angeles market and has released
`three albums and several original singles as downloads on Spotify.
`
`From:
`To:
`
`2005
`2007
`
`Glaukos Corporation, Laguna Hills, CA
`Acting Vice President of Research and Development
`
`Contracted through Xinetix as interim executive management to lead early-stage
`development efforts to commercialize the pioneering Micro Invasive Glaucoma
`Management (MIGS) device to treat glaucoma. Glaukos was the first to market and
`has maintained its leadership position in this field culminating in a successful
`venture capital exist via initial public offering in 2018
`
`Confidential Resume of Harold J. Walbrink
`Printed: 02/05/21
`
`Page 3
`
`

`

`Expert Witness / Consultant Curriculum Vitae
`
`From:
`To:
`
`2004
`2008
`
`Emergent Respiratory Products, Irvine, CA
`Vice President of Research and Development
`
`Contracted through Xinetix provide technical leadership of this ambulatory CPAP
`respiratory ventilation company after the product was recalled following initial
`launch. Initiated product redesign implemented manufacturing process
`improvements, resulting in successful product relaunch. Positioned the company for
`acquisition by respiratory care distributor Bound Tree.
`
`From:
`To:
`
`2000
`2001
`
`The Source, LLC, Capistrano Beach, CA
`Chief Executive Officer Chairman of the Board
`
`Founding team member of this health and wellness company. Developed company
`vision and strategic plan, established brand identity, and instrumental in
`development of a personal wellness coaching product line.
`
`From:
`To:
`
`1999
`2000
`
`Visionary Medical Technologies Poway, CA
`Vice President Engineering
`
`Contracted through Xinetix to develop an internet-based telehealth diagnostic
`otological device for in-home diagnosis of pediatric ear infections.
`
`From:
`To:
`
`1996
`1997
`
`MicroDexterity Systems, Inc., Memphis, TN
`President
`
`Contracted through Xinetix to work with Cal Tech, the Jet Propulsion Laboratory,
`and Sandia Labs to develop a Dexterity Enhanced Surgical Robotic system for use
`in ophthalmic surgery. Responsible for executive leadership and regulatory
`direction.
`
`From:
`To:
`
`1995
`1997
`
`Ixion Corporation, Seattle, WA
`Vice President of Operations
`
`Contracted through Xinetix to develop manufacturing processes and build
`manufacturing infrastructure for commercialization of a gastrointestinal
`diagnostic procedure simulator.
`
`Confidential Resume of Harold J. Walbrink
`Printed: 02/05/21
`
`Page 4
`
`

`

`Expert Witness / Consultant Curriculum Vitae
`
`From:
`To:
`
`1990
`1995
`
`Birtcher Medical Systems, Irvine, CA
`1994-1995 Senior Vice President, Operations and Technology
`1991-1995 Vice President, General Manager
`1990-1994 Vice President, Research and Development
`
`Assumed broad cross-functional responsibility for General Management,
`Operations, Research and Development and Regulatory Affairs as a Senior
`Executive Officer for this public company. Administered a $21 million
`operating budget for three US manufacturing facilities with 145 direct
`employees and a 130-man Maquiladora operation in Juarez, Mexico. Revenues
`grew from $6 to $56 million by negotiating domestic and international OEM
`supply agreements and acquisition/consolidation of three healthcare businesses.
`Realized major profitability improvements through product refinement /
`repositioning, new product introductions, and manufacturing process
`improvements.
`
`Developed corporate technology strategy and managing product design activities for
`a diverse range of product technologies including RF electrosurgical, video
`endoscopy, surgical instruments, ECG, doppler ultrasound, and physical therapy
`devices. Responsible for all patent and trademark activities including infringement
`litigation oversight. Inventor on five U.S. patent applications for medical devices
`resulting in issuance of three patents. Key contributor in corporate financing
`activities which including private placement, secondary, and regulation S stock
`offerings as well as venture capital funding. As Corporate Regulatory Officer, I was
`responsible for Quality Systems Regulation implementation, FDA 510(k)
`submissions, Engineering Change Control and Documentation Systems, and Quality
`Assurance programs. Led FDA GMP audits and successfully cleared an FDA 483
`Warning Letter well ahead of the three-month deadline.
`
`From:
`To:
`
`1983
`1990
`
`Alcon Surgical (Formerly CooperVision Surgical), Irvine, CA
`Director of Research and Development, Surgical Instrumentation
`
`Responsible for identification, conceptualization, design, development, and
`technical support of ophthalmic surgical instrumentation, devices, and
`disposable products totaling $79 M annual sales. Provided long-range strategic
`direction and daily administration for five ophthalmic business segments in a
`department with 64 technical personnel and annual budget of $5.9 M.
`Recognized for the ability to develop well-targeted, innovative products and
`bring them to market on schedule and within budget. Chosen as team leader for
`a company-wide effort to improve quality of existing products Product
`technologies included surgical and diagnostic ultrasound, fluidics,
`microsurgical instruments, ophthalmic lasers, and micro-endoscopy. Authored
`the CooperVision Product Introduction Protocol and was co-inventor on five
`US patents.
`
`Confidential Resume of Harold J. Walbrink
`Printed: 02/05/21
`
`Page 5
`
`

`

`Expert Witness / Consultant Curriculum Vitae
`
`From:
`To:
`
`1980
`1983
`
`Applied Technology Associates (ATA), Corona, CA
`Systems Engineer/Electrical Engineering Consultant
`
`From:
`To:
`
`1981
`1983
`
`Telease Technologies, Inc., Brea, CA
`Project Manager/ Video Processing Engineer
`
`Contracted through ATA as project manager and systems engineer for
`development of a secure video subscription cable television system project
`funded by Select TV in Los Angeles, CA.
`
`From:
`To:
`
`1980
`1981
`
`General Atomics, San Diego, CA
`Control Systems Engineer
`
`Subcontracted through ATA to design and implement a control system for
`Doublet Fusion Reactor project. Tasked with system level electronic design,
`fabrication, and test of the forty-megawatt DC power supply for the Neutral
`Plasma Beam Injector control and safety interlock system.
`
`From:
`To:
`
`1978
`1979
`
`Eocom Corporations, Tustin, CA
`Systems Engineer/Sr. Electrical Engineer
`
`Project manager responsible for design and implementation of a Time-
`Division Multiple Access, satellite linked video archiving system for
`scanned digital video streams multiplexed between several remote
`locations
`
`From:
`To:
`
`1977
`1978
`
`General Dynamics Corporation, Pomona, Ca
`Electrical Engineer – Missile Guidance Systems
`
`Responsible for analog/digital design of RADAR missile guidance receiver and
`warhead safe and arming circuits.
`
`From:
`To:
`
`1974
`1977
`
`Hughes Aircraft Company, Fullerton, CA
`1975 - Member of Technical Staff –
`Secure Communications/RADAR Signal Processing
`
`Responsible for digital design of Universal Message Encoder to convert analog
`and digital end user inputs into digital TDMA data streams for the Secure Data
`Encoder as part of the military AWACS communication system.
`
`From:
`To:
`
`1971
`1974
`
`C.E. Cox Company, Santa Ana, CA
`1972 - Orthopedic Device Engineer – External Fixation of Femoral
`Fractures
`1971 - Telecommunications Technician – Telco Test Equipment
`
`Confidential Resume of Harold J. Walbrink
`Printed: 02/05/21
`
`Page 6
`
`

`

`Expert Witness / Consultant Curriculum Vitae
`
`Patents
`
`Patent
`Number
`
`W.O.
`20/033736 A1
`
`Issue Date
`
`Title
`
`2020
`
`Apparatus and Methods to Adjust ocular Blood Flow
`
`W.O.
`01/08578 A1
`
`2001
`
`Device & Method for Location and Marking of a Cavity and
`Sentinel Lymph Nodes PTC
`
`1996
`
`Microsurgical Cassette
`
`1996
`
`Irrigator/Aspirator Surgical Probe and Valve Assembly
`
`1993
`
`Portable Device Controlling Fluid Flow to Surgical Site
`
`1993
`
`Laparoscopic Surgical Handpiece
`
`1992
`
`Laparoscopic Gas Coagulation Handpiece
`
`1992
`
`Laparoscopic Pressure Relief Device
`
`1991
`
`Fluid Handling Method, System, and Apparatus
`
`1987
`
`Microsurgical Cassette
`
`U.S.
`5,499,969
`
`U.S.
`5,514,089
`
`U.S.
`5,261,883
`
`Birtcher US
`Application
`
`Birtcher US
`Application
`
`Birtcher US
`Application
`
`U.S.
`5,041,096
`
`U.S.
`5,364,342
`
`Education
`
`Year College/University
`
`Degree
`
`1975
`
`California State University Fullerton,
`Fullerton, CA
`
`B.S. Engineering, Electrical Engineering
`emphasis
`
`1972
`
`Fullerton College, Fullerton, CA
`
`AA, Liberal Arts
`
`Confidential Resume of Harold J. Walbrink
`Printed: 02/05/21
`
`Page 7
`
`

`

`Expert Witness / Consultant Curriculum Vitae
`
`Continuing Education
`
`1985 BUSINESS KINETICS, IRVINE, CA
`Certificate, Operations Planning and Cost Control
`
`1982 UNIVERSITY OF CALIFORNIA, IRVINE, IRVINE, CA.
`Certificate, Microprocessor Systems Engineering
`
`1981 HEWLETT PACKARD, CONOGA PARK, CA.
`H.P. Model 1000 & 9000 Computer Operations and Programming
`
`Board Activities
`
`Board Member Enlighten Technologies, Inc. Laguna Hills, CA 2006-2012
`Ophthalmic Medical Device Developer
`
`Board Member
`
`Scieran Technologies, Inc. Laguna Hills, CA
`Ophthalmic Surgical Systems Developer
`
`Chairman
`
`The Source, LLC, San Juan Capistrano, CA
`Personal Health and Wellness Company
`
`1998-2004
`
`2000-2002
`
`Board Member Refractec, Inc., Irvine, CA
`Conductive Keratoplasty – Vision Correction
`
`1995-1997
`
`Awards and Honors
`
`2014 -Excellence In Entrepreneurship Award -Orange County Business Journal
`
`2013 – Xinetix, 10th Fastest Growing Privately Held Company – Orange County Business Journal
`
`Conferences / Speaking Engagements
`
`•
`
`•
`
`•
`
`•
`
`Panelist / Speaker, Pasadena Bar Association – “The Interplay Between Patent Re-
`examination and Patent Litigation” Pasadena, CA, 2015
`
`Speaker, Pacific Design Conference, “Partnering Effectively with Outside Consultants”,
`Long Beach, CA, 1995.
`
`Speaker, Asian / American Engineering Society Conference, “Imaging and Virtual Reality
`Meet Medicine”, Los Angeles, CA, 1995.
`
`Speaker, Medical Data International Conference on Healthcare Reform, American College
`of Surgeons, San Francisco, CA, 1993.
`
`Confidential Resume of Harold J. Walbrink
`Printed: 02/05/21
`
`Page 8
`
`

`

`Expert Witness / Consultant Curriculum Vitae
`
`Professional Associations and Achievements
`
`2018 – 2020
`
`Mentor, Bridge to Connect, University of California, Irvine
`
`2014 – 2018
`
`Member, College Leadership Council, School of Engineering and
`Computer Science, California State University, Fullerton
`
`2007 – 2009
`
`Church Elder, Jubilee South Coast Church, San Juan Capistrano, CA
`
`2004 - 2009
`
`Baseball Coach, Rancho Niguel Little League, Laguna Niguel, CA
`
`2007
`
`2006
`
`1995
`
`1995
`
`1993
`
`Leader, Missions Outreach, ZOE International Orphanage, Chiang Mai,
`Thailand
`
`Executive Producer, Sarah Green, Emergency Album Capital Records,
`Hollywood, CA
`
`Speaker, Pacific Design Conference, “Partnering Effectively with Outside
`Consultants”, Long Beach, CA
`
`Speaker, Asian / American Engineering Society Conference, “Imaging
`and Virtual Reality Meet Medicine”, Los Angeles, CA
`
`Speaker, Medical Data International Conference on Healthcare Reform,
`American College of Surgeons, San Francisco, CA
`
`Legal Case Work and Experience
`
`Served as technical, engineering, and business expert witness in numerous patent
`infringement, patient injury, and business-related legal matters for both plaintiffs and
`defendants. All cases involved medical devices or the medical device industry in general.
`
`In the course of my legal work, I have participated in a total of 31 cases resulting in:
`
`
`Expert reports
`Testimony at deposition
`Testimony in court / ITC
`
`29 reports
`16 times
` 6 times
`
`The following pages summarize my legal case work
`
`Confidential Resume of Harold J. Walbrink
`Printed: 02/05/21
`
`Page 9
`
`

`

`Expert Witness / Consultant Curriculum Vitae
`
`Summary of Legal Case Work
`
`Date
`
`Action
`Parties
`
`October 2020
`to Present
`
`Patent Infringement
`RAI Strategic Partners & R.J.
`Reynolds Vapor Company v.
`Altria Client Services LLC; Philip
`Morris USA, Inc.
`
`July 2020 to
`Present
`
`Patent Infringement
`Fisher & Paykel Healthcare v
`Flexicare Incorporated
`
`December
`2019 to
`Present
`
`Patent Infringement
`Glaukos Corporation v. Ivantis,
`Inc.
`
`April 2019 to
`January 2020
`
`Patent Infringement
`Intuitive Surgical, Inc. v. Auris
`Health, Inc.
`
`Venue
`Case
`Attorney
`Firm
`United States District Court
`Eastern District of Virginia
`Alexandria Division
`Cas No: 1:20-cv-00393-LO-TCB
`Thomas Yeh,
`Latham & Watkins
`Los Angeles, California
`United States District Court
`Central District of California
`Southern Division
`Case No: 8:19-cv-00835
`Peter Sauer, Jeff Mills
`King & Spalding
`Austin, Texas
`United States District Court
`Central District of California
`Southern Division
`Case No. 8:18-cv-00620
`Ajay Krishnan, Kristen Lovin
`Keker, Van Nest & Peters
`San Francisco, California
`United States District Court
`District of Delaware
`Case No. 18-1359-MN
`Sorin Zaharia, Diek Van Nort
`Morrison & Foerster LLP
`San Francisco, California
`
`Assignment
`Patents
`Work Product
`Outcome
`Defendant’s Expert Technical Witness Re: certain
`electronic vapor and heated tobacco products.
`Patent No 9,814,265
`Technical / engineering analysis and testing of Vuse
`Altos vaping products
`Case in process
`
`Defendant’s Expert Re: transmembrane diffusion
`of certain exhaled gases in respiratory care patient
`circuits used for critical care ventilation
`Multiple patents
`Forensic testing of products
`Casein process
`
`Defendant’s Expert Witness Re: Flow
`characteristics and testing of Minimally Invasive
`Glaucoma Stent devices (MIGS).
`U.S. Patents 6,626,858, 9,827,143
`Produced an expert technical report and testified
`at deposition
`Awaiting trial in early 2021
`Defendant’s Technical Expert Re: robotic surgical
`systems and devices
`US Patents 9452276 & 8620473
`General technical consulting
`Case transferred to alternate law firm; assignment
`completed
`
`Confidential Resume of Harold J. Walbrink
`Printed: 02/05/21
`
`Page 10
`
`

`

`Expert Witness / Consultant Curriculum Vitae
`
`Date
`
`Action
`Parties
`
`July 2018 to
`May 2019
`
`Patent Infringement
`Styku, LLC v. Fit3D, Inc
`
`October 2017
`to February
`2019
`
`Patent Infringement
`Karl Storz Endoscopy- America,
`Inc. v. Stryker Corporation and
`Stryker Communications, Inc.
`
`October 2016
`to May 2017
`
`Patent Infringement
`ResMed v. Fisher Paykel
`
`August 2016
`
`Misappropriation of Trade
`Secrets
`Masimo v. Sotera Wireless
`
`Venue
`Case
`Attorney
`Firm
`California Central District Court
`Case No. 2-17-cv-01882
`Peter DeJonge, Kurt Hendricks
`Thorpe, North, & Western
`Salt Lake City, Utah
`
`United States District Court
`Northern District of California
`Case No. C 14-00876 RS
`Robert A. Surrette, Scott McBride,
`Carey Prill
`McAndrews, Held & Malloy, Ltd
`Chicago, IL
`
`U.S. International Trade
`Commission
`Washington D.C.
`Inv. No. 337-TA-1022
`William Adams
`Knobbe Martens, Irvine, Ca
`
`California Central Bankruptcy
`Court
`8:16-ap-01255
`Perry Oldham
`Knobbe Martens, Irvine, Ca
`
`Assignment
`Patents
`Work Product
`Outcome
`Defendant’s Technical Expert Re: computer digital
`imaging and processor architecture
`U.S. Patent 9526442
`Produced declarations Re: Computer architecture
`used to make body measurements from digital
`image capture data
`Case settled out of court
`Defendant’s Technical Expert Re: medical multi-
`controller networks integrated operating room
`control
`U.S. Patent Nos.; 8,069,420; and 8,439,821
`Produced Non-infringement and Invalidity Expert
`Reports
`Testimony at deposition
`Case settled February 21, 2019
`Defendant’s Technical Expert Re: Domestic
`Industry – opined regarding the extent to which
`ResMed’s US distributed products incorporate claim
`elements of U.S. Patents Nos. 9,119,931, &
`8,960,196. Produced Expert Report, testified at
`video deposition, produced direct testimony
`document to be read into ITC transcript at hearing.
`Complainant withdrawn.
`Plaintiff’s Technical Expert Re: examined and
`compared Sotera product features with those of
`Masimo to determine similarities, including software
`code and architecture reviews. Generated an
`expert report and testified at video deposition and
`US Bankruptcy Court.
`Case settled 2019
`
`Confidential Resume of Harold J. Walbrink
`Printed: 02/05/21
`
`Page 11
`
`

`

`Expert Witness / Consultant Curriculum Vitae
`
`Date
`
`Action
`Parties
`
`February 2016
`to April 2016
`
`Patent Infringement
`Orthophoenix v. DFine
`
`December
`2014
`November
`2015
`
`Patent Infringement
`Transcend Medical, Inc. v.
`Glaukos Corporation
`
`November
`2014
`March 2015
`
`Patent Infringement
`Karl Storz Endoscopy- America,
`Inc. v. Stryker Corporation and
`Stryker Communications, Inc.
`
`December
`2013
`May 2014
`
`Business Dissolution
`Armand Maaskamp, Trustee of
`the Maaskamp Family Trust v.
`Theodore Wortrich, Trustee of
`the Wortrich Family Trust
`
`Venue
`Case
`Attorney
`Firm
`United States District Court
`District of Delaware
`C.A. No.13-1003 (LPS) (D. Del.)
`Mathew Lehr
`Davis Polk & Wardwell, LLC
`Menlo Park, Ca
`United States District Court For
`the District of Delaware
`C.A. NO. 13-830 (MSG)
`Mathew Lehr
`Davis Polk & Wardwell, LLC
`Menlo Park, Ca
`
`United States District Court
`Northern District of California
`Case No. C 14-00876 RS
`Robert A. Surrette, Merle S. Elliott,
`Caroline A. Teichner
`McAndrews, Held & Malloy, Ltd
`Chicago, IL
`
`Superior Court of The State of
`California County of Orange,
`Central Justice Center
`No. 30-2012-00566392
`Natu Patel
`The Patel Law Firm, P.C., Laguna
`Hills, CA
`
`Assignment
`Patents
`Work Product
`Outcome
`Defendant’s Technical Expert Re: design and use
`of Kyphoplasty devices
`U.S. Patent Nos. 6,248,110; 6,981,981; 6,663,647;
`7,044,954; 6,280,456; 6,623,505; 6,440,138;
`6,863,672; 7,153,307; 6,241,734
`Consulted with defense attorney
`Complaint withdrawn
`Plaintiffs’ Technical Expert Re: design of
`ophthalmic intraocular stents and delivery devices
`used to treat glaucoma.
`U.S. Patent Nos. 7,857,782, 8,075,511, &
`8,579,846
`Produced Expert Report - non-infringement
`Produced IPR’s, Testimony at deposition
`Case settled in November 2015
`Defendant’s Technical Expert Re: medical multi-
`controller networks used in the hospital operating
`room
`U.S. Patent Nos. 7,844,657; 8,069,420; and
`8,439,821
`Produced Expert Report
`Produced IPR’s for 7,844,657; 8,069,420; and
`8,439,821
`Testimony at deposition
`Case settled out of court
`Complainant’s Technical Expert Re: fluid surge
`restrictors used in ophthalmic surgical procedures
`U.S. Patent Nos. 8,475,402 and 8,092,427,
`U.S. Patent Nos. 7,914,482 and 8,372,038
`Generated Expert Report
`Testified at deposition and bench trial
`Plaintiff granted business dissolution
`
`Confidential Resume of Harold J. Walbrink
`Printed: 02/05/21
`
`Page 12
`
`

`

`Expert Witness / Consultant Curriculum Vitae
`
`Date
`
`Action
`Parties
`
`May 2011
`December
`2011
`
`Patent Infringement
`Stryker Corp. et al., v. Zimmer,
`Inc. and Zimmer Surgical, Inc.
`
`March 2011
`December
`2011
`
`Patent Infringement
`King Pharmaceuticals, Inc. et al.
`