IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`CORPAK MEDSYSTEMS, INC. and HALYARD HEALTH, INC.,
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`Petitioners
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`v .
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`KIRN MEDICAL DESIGN, L.L.C. and APPLIED MEDICAL TECHNOLOGY,
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`INC.,
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`Patent Owner
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`U.S. Patent No. 6,631,715 to Kirn
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`Inter Partes Review No.: IPR2017-01990
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`Petition for Inter Partes Review of U.S. Patent No. 6,631,715 Under
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`35 U.S.C. §§ 311-319 and 37 C.F.R. § 42
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`DECLARATION OF TERRY LAYTON, PH.D
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`CORPAK Ex 1004, Page 1
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`I.
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`II.
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`III.
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`TABLE OF CONTENTS
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`OVERVIEW OF MY ENGAGEMENT ....................................................... 1
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`QUALIFICIATIONS AND PROFESSIONAL BACKGROUND................ 2
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`LEGAL STANDARDS ............................................................................... 5
`A.
`Obviousness ....................................................................................... 5
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`IV. BASIS FOR OPINIONS .............................................................................. 8
`A. Materials Considered ......................................................................... 8
`B.
`State of the Art ................................................................................... 9
`C.
`Person of Ordinary Skill in the Art (“POSA”) ...................................11
`D.
`The 715 Patent and Claim 18 ...........................................................12
`E.
`GROUND 1: OBVIOUSNESS OF CLAIM 18 OF THE 715
`PATENT OVER BALLANTYNE IN VIEW OF SIMMONS ...........15
`1.
`Ballantyne ...............................................................................16
`2.
`Simmons .................................................................................23
`i.
`Claim 18 Would Have been Obvious Over Ballantyne in
`View of Simmons ...................................................................27
`i)
`Element 18a: A method of placing and securing at
`least one tube through a nose into a patient
`comprising ....................................................................31
`Element 18b: Inserting the at least one tube into a
`first or second nare of the nose ......................................32
`Element 18c: Inserting an end portion of a flexible
`member having a magnet attached thereto into a
`first nare of the nose ......................................................32
`Element 18d: Inserting a magnetic probe into a
`second nare of the nose for attracting said magnet
`and said end portion of said flexible member ................33
`Element 18e: Removing said probe from the
`second nare of the nose thereby retrieving said end
`portion of said flexible member through the second
`nare of the nose .............................................................33
`Element 18f: And snapping the at least one tube
`into a channel formed in a receiver ...............................34
`GROUND 2: OBVIOUSNESS OF CLAIM 18 OF THE 715
`PATENT OVER BALLANTYNE IN VIEW OF IZUMI ..................40
`1.
`Izumi ......................................................................................41
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`ii)
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`iii)
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`iv)
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`v)
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`vi)
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`F.
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`i
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`CORPAK Ex 1004, Page 2
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`G.
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`i.
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`Claim 18 Would Have been Obvious Over Ballantyne in
`View of Izumi .........................................................................43
`GROUND 3: OBVIOUSNESS OF CLAIM 18 OF THE 715
`PATENT OVER BALLANTYNE IN VIEW OF BIERMAN
`AND SIMMONS ..............................................................................52
`1.
`Bierman ..................................................................................53
`i.
`Claim 18 Would Have been Obvious Over Ballantyne in
`View of Bierman and Simmons ..............................................55
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`V.
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`SECONDARY CONSIDERATIONS .........................................................67
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`VI. CONCLUSION ..........................................................................................67
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`ii
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`CORPAK Ex 1004, Page 3
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`EXHIBITS
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`EXHIBIT 1001 U.S. Patent No. 6,631,715
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`EXHIBIT 1002 U.S. Patent No. 5,185,005 (“Ballantyne”)
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`EXHIBIT 1003
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`“A New Nasal Bridle for Securing Nasoentereal Feeding
`Tubes” by Jeffrey A. Meer
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`EXHIBIT 1004 Declaration of Dr. Terry Layton
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`EXHIBIT 1005
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`EXHIBIT 1006
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`“Securing of intermediate duration feeding tubes” by W.
`Frederick McGuirt
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`“The Bridle: Increasing the Use of Nasoenteric Feedings” by
`Albert Barrocas
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`EXHIBIT 1007 U.S. Patent No. 5,752,511 (“Simmons”)
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`EXHIBIT 1008 U.S. Patent No. 5,097,827 (“Izumi”)
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`EXHIBIT 1009
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`Patent Owner’s Initial Infringement Contentions
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`EXHIBIT 1010
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`“Feeding Tube Anchor” by Albert Levenson
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`EXHIBIT 1011
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`EXHIBIT 1013
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`PCT International Application Publication No. WO 99/20334
`(“Bierman”)
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`IPR2017-00646, Paper 9 (Decision) (P.T.A.B. July 26, 2017)
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`EXHIBIT 1015
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`IPR2017-00646, Paper 7 (Preliminary Response) (P.T.A.B.
`April 28, 2017)
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`iii
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`CORPAK Ex 1004, Page 4
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`I, Terry N. Layton, Ph.D., do hereby declare and say as follows:
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`I have been asked to provide testimony as to what one of ordinary skill in the
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`art would have understood with respect to the patent at issue and various prior art
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`reference(s). I provide this testimony below.
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`I.
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`OVERVIEW OF MY ENGAGEMENT
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`1.
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`Counsel for Petitioners has requested that I provide declaratory
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`evidence, in the form of analysis and opinions, in the above-captioned Inter Partes
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`Review proceeding (“IPR”). I understand that this IPR involves U.S. Patent No.
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`6,631,715. I refer to this patent as either the “ 715 patent” or as “EX1001” in this
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`declaration.
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`2.
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`For this IPR, I have been asked to provide analysis and expert
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`opinions on whether Claim 18 of the 715 patent, under the claim construction
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`standards that apply during Inter Partes Review proceedings, is invalid under 35
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`U.S.C. § 103 as having been obvious over specific references in the prior art from
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`the standpoint of one of ordinary skill in the art (“POSA”) as defined below as of
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`the relevant priority date.1
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`3.
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`Further, I have personal knowledge of the facts contained in this
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`Declaration, am of legal age, and am otherwise competent to testify.
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`4.
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`For my work as an expert in the IPR engagement, I am being
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`1 The relevant priority date is discussed below.
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`1
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`CORPAK Ex 1004, Page 5
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`compensated at the rate of $300/hour for consulting/discovery, $350/hour for
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`report writing, and $400/hour for deposition or PTAB trial testimony. My
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`compensation is not contingent on the opinions I reach or on the outcome of this
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`IPR or any other legal action, mediation, arbitration, or the terms of any settlement
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`in this case.
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`5.
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`I reserve the right to supplement my opinions to address any
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`information obtained, or positions taken, based on any new information that comes
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`to light throughout this proceeding.
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`II. QUALIFICIATIONS AND PROFESSIONAL BACKGROUND
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`6.
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`I received a Bachelor of Science degree in Zoology/Physiology from
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`the University of Wyoming in 1966 and studied Electrical Engineering at the
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`University of Illinois at Urbana-Champaign. I earned an M.S. in Bioengineering
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`from the University of Illinois at Chicago in 1972, and a Ph.D. in Biomedical
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`Engineering from the University of Virginia in 1975.
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`7.
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`I have worked in the medical device field for more than 40 years, and
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`have been actively involved with the engineering, research, product design,
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`development, and manufacturing of medical devices, including FDA regulated
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`medical devices and medical fluid collection and administration devices. A copy
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`of my curriculum vitae is attached as Exhibit A.
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`8.
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`From 1975 to 1988, I was employed by The Kendall Company,
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`2
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`CORPAK Ex 1004, Page 6
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`starting out as a research scientist, and ultimately being promoted to Manager of
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`Medical & Sports Medicine Divisions. During that time, I designed, tested,
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`developed, and/or managed a variety of products in the dental, medical, and sports
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`fields. These projects involved body fluid collection devices and fluid
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`administration systems including, for example, Foley urinary catheters which were
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`attached to the leg of the patient as common clinical practice.
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`9.
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`From 1988 to 1990, I was employed by Baxter Healthcare
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`Corporation (“Baxter”), where I was a manager of the Advanced Device
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`Technology group. During that time, I was involved in the design and
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`management of products and components for fluid administration devices such as
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`IV systems/tubing which were attached and stabilized.
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`10. From 1991 to 1994, I was employed by Packer Engineering as its
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`Director of Biomedical Engineering. During that time, I consulted on and made
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`numerous technology assessments of a variety of health related products in the
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`biomedical field and conducted failure mode investigations of medical devices.
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`11. From 1994 to 1999, I was employed by Integra and the NeuroCare
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`Group as its Vice-President, Group Technical Officer. During this time, I was
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`involved in developing and releasing to the market new products relating to
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`neurosurgical implants and monitoring devices, assessing new technologies,
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`licensing patents, and purchasing patents and companies. I was also involved in
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`3
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`CORPAK Ex 1004, Page 7
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`developing and releasing to the market medical devices such as cerebral spinal
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`fluid (CSF) collection bags and valves.
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`12. Since 1999, I have been employed by Laytech. I have been involved
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`in consulting and technology assessment. In addition, since 2000, I have been a
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`Visiting Professor in Bioengineering at the University of Illinois at Chicago
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`teaching to future Bioengineers the skill sets needed for the medical device
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`industry.
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`13. Many invasive medical devices such as nasogastric tubes,
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`endotracheal tubes, foley catheters, and vascular catheters, require precise and
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`unique installation and attachment means depending on the requirements for the
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`clinical use of the device. During my career, I have been involved in several
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`industry and teaching projects for the design of catheters and tubes for insertion
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`and attachment mechanisms for catheters and tubes to prevent or minimize
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`dislodgement or movement of the inserted tube. The experience I have had with
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`endotracheal and nasogastric tubes and with various types of catheters has given
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`me wide and varied experience with their design for insertion and also their
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`attachment mechanisms in both design and analysis of the devices. Because many
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`invasive medical devices require insertion into the body, my work constantly
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`requires me to discern the easiest method of installation of attachment and securing
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`mechanisms. Furthermore, the courses I teach that are focused on the design of
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`4
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`medical devices explore attachment and securing mechanisms including the use of
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`nasogastric and endotracheal attachment and securing mechanisms.
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`14.
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`I am an inventor on eighteen issued patents and have authored
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`numerous publications and presentations related to medical devices. A list of my
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`patents and publications is included in Exhibit A.
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`III. LEGAL STANDARDS
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`A. Obviousness
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`15.
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`I have been informed by counsel that a claimed invention is not
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`patentable under 35 U.S.C. § 103 if the differences between the invention and the
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`prior art are such that the subject matter as a whole would have been obvious at the
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`time the invention was made to a POSA to which the subject matter pertains.
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`16.
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`I understand that a patent claim is invalid if the differences between
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`the claimed invention and prior art are such that the subject matter as a whole
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`would have been obvious at the time the invention was made to a POSA to which
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`the patent pertains.
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`17.
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`I understand the following factors should be used in making an
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`obviousness determination: a) the scope and content of the prior art; b) the
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`differences between the prior art and the claimed invention; c) the level of ordinary
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`skill in the pertinent art; and d) secondary considerations evidencing
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`nonobviousness. I understand these may be referred to as the four Graham factors.
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`5
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`18.
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`I also have been informed by counsel that secondary considerations of
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`nonobviousness include, but are not limited to: long-felt need, praise by others in
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`the industry, licensing of the claimed invention, departure from accepted
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`principles, widespread recognition by those in the art of the invention’s
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`significance, and commercial success. I understand that there must be a
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`demonstrated nexus between the claimed invention and the secondary
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`considerations of nonobviousness being considered.
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`19.
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`I have been informed by counsel that an invention composed of
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`several elements is not proved obvious merely by demonstrating that each of its
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`elements was independently known or in the prior art, but that there must be an
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`apparent reason or motivation to combine the known elements in the fashion
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`claimed by the patent at issue.
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`20. Counsel has informed me that a rationale needs to be provided as to
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`why the prior art references would have been combined to render the claims of the
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`patent obvious.
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`21.
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`I understand that obviousness requires a reasonable expectation of
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`success. I further understand that whether a proposed modification or combination
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`of the prior art has a reasonable expectation of success is determined at the time the
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`invention was made.
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`22.
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`I understand that using the claimed invention as a blueprint to piece
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`6
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`together various elements in the prior art amounts to hindsight reasoning, which is
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`not allowed.2 This is sometimes referred to as the prohibition on the use of
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`hindsight reasoning in an obviousness determination.
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`23. With regard to claim construction, I understand that in an Inter Partes
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`review, claim terms are generally given their broadest reasonable interpretation in
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`light of the specification of the patent in which they appear. I understand that
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`under the broadest reasonable interpretation standard, claim terms are presumed to
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`be given their ordinary and customary meaning as understood by a POSA in the
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`context of the entire disclosure at the time of the invention. I understand that one
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`must be careful not to read a specific embodiment appearing in the written
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`description into the claim if the claim language is broader than the embodiment. I
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`further understand that any special definition for a claim term must be set forth
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`with reasonable clarity, deliberateness, and precision. I have considered each of
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`the claim terms using the broadest reasonable interpretation standard, i.e., ordinary
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`and customary meaning as understood by a POSA in the context of the entire
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`disclosure at the time of the invention.
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`2 In connection with my opinions, I did not use hindsight bias, nor did I use
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`the claims as a blueprint to determine whether any of the claimed elements existed
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`in the prior art.
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`7
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`24.
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`I understand that petition for IPR was previously filed against Claim
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`18 of this patent and was denied. The Board explained that “snapping the at least
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`one tube into a channel formed in a receiver,” as recited by Claim 18 means “that
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`snapping occurs with respect to a tube and a channel, based on the express
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`language…” EX1013 at 8. I apply the same construction herein.
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`IV. BASIS FOR OPINIONS
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`A. Materials Considered
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`25.
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`I have reviewed and considered the ’715 patent (EX1001) and the
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`prosecution file history for the ’715 patent. For purposes of my assessment, I have
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`been informed by counsel that the effective date of the 715 patent claims is no
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`earlier than September 1, 20003, and that I should consider that date in assessing
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`the state of the art in forming my opinions. I have considered and reviewed all
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`documents cited in this Declaration and all documents cited in the Petition and the
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`3 I have been informed that the Patent Owner has stated in its Infringement
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`Contentions served in the parallel district court case styled Applied Medical Tech.,
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`Inc. v. Corpak Medsystems, Inc., Case No. 1:16-CV-02190-PAG (N.D. Ohio), that
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`Claim 18 is entitled to priority only to August 24, 2001. See EX1001, Patent
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`Owners Initial Non-Infringement Contentions, at 2. The opinions I express in this
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`declaration remain the same applying either date.
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`8
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`Exhibit list, as well as any document referenced in this Declaration.
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`B.
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`26.
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`State of the Art
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`I provide the following discussion below as background information,
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`and although I provide it here for context as to the relevant technology, it also
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`serves as the “Scope and Content of the Prior Art,” which is one of the
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`considerations I reference above in an obviousness analysis.4
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`27. Nasal bridles are not new and have been used in the medical care field
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`since at least 1980 to prevent accidental dislodgement of a nasogastric
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`tube. EX1003, Jeffrey A. Meer, A New Nasal Bridle for Securing Nasoentereal
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`Feeding Tubes, 13 J. Parenteral & Enteral Nutrition, 331, 331 (1989). Nasogastric
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`tubes are commonly used to deliver medication and/or nutrition to hospitalized
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`patients. Dislodgement of feeding tubes is common as it occurs in approximately
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`one half of patients. Id. Dislodgement results in many issues such as delayed
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`feeding, increased risk of aspiration, expenditure of health care professionals’ time,
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`and increased hospital stay time. Id. The earliest designs of nasal bridles were
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`4 I have been informed that “scope and content of the prior art” serves to
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`provide an understanding of the state of the art the POSA would find themselves as
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`of the priority date.
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`difficult to install, and thus health care professionals opted for alternative, albeit
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`lesser, means for securing feeding tubes. Id.
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`28. The nasal bridle was originally described as “a length of material
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`looped around the patient’s nasal septum and then secured to the feeding tube.”
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`EX1005, W. Frederick McGuirt, Securing of intermediate duration feeding tubes,
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`90 Laryngoscope, 2046-2048 (1980). One of the earliest methods of installing the
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`nasal bridle involved inserting a flexible tube into the nare (used interchangeably
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`with “nostril” herein”) of a patient, extracting the tube from the patient’s mouth,
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`tying umbilical tape to the catheter, and then removing the catheter from the nostril
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`in order to pull the tape through the nostril. Id. The catheter is then passed
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`through the other nare and umbilical tape introduced into the patient’s nasal cavity
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`in the same, aforementioned manner. Id. The above figures provide an illustration
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`of this method of installing a nasal bridle. Id.
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`29.
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`Indeed, additional references disclose the installation of a nasal bridle
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`by introducing the bridle into the patient’s nares, extracting the bridle from the
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`patient’s mouth, and forming a bridle into a loop ultimately positioned behind the
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`patient’s nasal septum. EX1006, Albert Barrocas, The Bridle: Increasing the Use
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`of Nasoenteric Feedings. 2 Nutritional Support Servs., 8, 8-10 (1982); EX1003 at
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`331-33; EX1010, Albert Levenson, Feeding Tube Anchor, 5 Nutritional Support
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`Servs. 8, 40, 42 (1985).
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`C.
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`30.
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`Person of Ordinary Skill in the Art (“POSA”)
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`I understand that a POSA is a hypothetical person who, at the time of
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`the invention, is presumed to know of all relevant art and is a person of ordinary
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`creativity. A POSA in the field of the 715 patent would have had education
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`and/or experience in the biological sciences, engineering, and medical device
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`manufacturing and design along with knowledge of the scientific literature in the
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`field. Although education and experience levels may vary, a POSA would have
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`had at least a bachelor’s degree in biology, bioengineering, biomedical
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`engineering, zoology or equivalent. A POSA also would have had work
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`experience in the field of medical devices including several years of experience
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`designing fluid administration and/or fluid collection devices and the attachment
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`mechanisms for the devices including experience with devices used in
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`nasogastric/nasoenteric intubation and attachment systems.
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`31. A person holding only a bachelor’s degree would be required to have
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`had five years of relevant work experience to qualify as a POSA, but a person with
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`a more advanced degree, such as a Master of Science, could qualify as a POSA
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`with fewer years of experience.
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`32.
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`I consider myself to have at least such “ordinary skill in the art” with
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`respect to the subject matter of the 715 patent at the relevant time. Moreover, all
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`opinions that I express in this declaration are from the perspective of a POSA.
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`D. The 715 Patent and Claim 18
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`33.
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`I have reviewed and considered the 715 patent in view of general
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`knowledge in the relevant field measured from the time of the earliest possible
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`12
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`priority date for the 715 patent, which I understand to be September 1, 2000.5
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`34. The thirty-two claims and the specification of the 715 patent are
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`generally directed to “systems for placing and securing a nasal tube; and more
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`particularly to such a system which utilizes magnets in the placement of a bridle
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`used in combination with a receiver to secure the nasal tube.” EX1001, 715
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`patent at 1:8-12. The specification of the 715 patent describes an apparatus and a
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`corresponding method for use in “placing and securing at least one nasal tube in a
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`patient.” EX1001, 715 patent at 2:21-32.
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`35.
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`It is my opinion that the apparatus described in the specification and
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`the claims of the 715 patent is straightforward. The 715 patent describes an
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`apparatus and method for installing and securing nasal a tube within the nose of a
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`patient. See EX1001, 715 patent at 2:21-32. The apparatus consists of a “flexible
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`member” having a magnet secured to one end, a “magnetic probe,” and a
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`“receiver.” Id. It is also my opinion that the method disclosed in the specification
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`and the claims of the 715 patent are similarly straightforward. The method
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`5 I have been informed by counsel that, in the related district court litigation,
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`Patent Owner has stated that Claim 18 is only entitled to claim priority as of
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`August 24, 2001. Regardless of which priority date is used (i.e., September 1,
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`2000 or August 24, 2001), the opinions of a POSA would not change.
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`13
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`requires insertion of the magnetic end of the flexible member into a first nare of the
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`nose and insertion of the magnetic probe into the second nare of the nose so that a
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`magnetic coupling occurs. EX1001, 715 patent at 6:30-46. Then, the magnetic
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`probe is withdrawn from the nose such that the flexible member is pulled “into the
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`first nare and out through the second nare” and thus “looped around the nasal
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`septum.” EX1001, 715 patent at 6:61-66. The magnetic probe and the flexible
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`member are separated and the end portions of the flexible member and the nasal
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`tube are secured in the receiver. EX1001, 715 patent at 7:1-14.
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`36. Claim 18 is reproduced below:
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`18. A method of placing and securing at least one tube
`through a nose into a patient comprising:
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`inserting the at least one tube into a first or second nare of
`the nose;
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`inserting an end portion of a flexible member having a
`magnet attached thereto into a first nare of the nose;
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`inserting a magnetic probe into a second nare of the nose for
`attracting said magnet and said end portion of said flexible
`member;
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`removing said probe from the second nare of the nose
`thereby retrieving said end portion of said flexible member
`through the second nare of the nose; and
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`snapping the at least one tube into a channel formed in a
`receiver.
`
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`EX1001, 715 patent at Claim 18. Claim 18 is generally directed to the method
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`described in paragraph 35, supra, in that it discloses a method for installing a nasal
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`bridle by inserting the magnetic end of a flexible member into one nare of the nose
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`and looping the flexible member through the nose by retrieving the magnetic end
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`using a magnetic probe inserted into the other nare of the nose. The claim further
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`specifies that “at least one tube” is “snapp[ed]” into “a channel formed in a
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`receiver,” which as discussed above has been explained by the Board to mean “that
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`snapping occurs with respect to a tube and a channel.” EX1001, 715 patent at
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`Claim 18; EX1013 at 8.
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`37.
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`I have been informed by counsel that the preamble to Claim 18
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`includes the transition term “comprising.” EX1001, 715 patent at Claim 18. As
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`stated, I have also been informed by counsel that this transition term means that the
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`claim is open ended and may include other elements than the ones recited in the
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`claim. As also stated, I understand that a reference may invalidate the claim if, in
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`addition to disclosing the elements of the claim, it also discloses other elements.
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`E. GROUND 1: OBVIOUSNESS OF CLAIM 18 OF THE 715
`PATENT OVER BALLANTYNE IN VIEW OF SIMMONS
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`38.
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`I have provided my understanding of the law of obviousness above.
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`After considering the four factors, it is my opinion that U.S. Patent No. 5,185,005
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`in view of U.S. Patent No. 5,752,511 renders Claim 18 obvious.
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`39.
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`I have provided some information about the scope and content of the
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`prior art above in paragraphs 26-29. See supra at ¶¶ 26-29.
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`40. Further, I have defined a POSA in paragraphs 30-32. See supra at ¶¶
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`30-32.
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`41.
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`I will address secondary considerations later in this declaration. See
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`infra at ¶¶ 123-125.
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`42. Hereinafter, U.S. Patent No. 5,185,005 will be referred to as either the
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`“Ballantyne” or “EX1002.”
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`1.
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`Ballantyne
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`43. Ballantyne is entitled “Method and Apparatus for Securing a
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`Nasogastric Tube,” was filed on June 4, 1991, and issued on February 9, 1993, and
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`I have been informed by counsel that Ballantyne is prior art to the 715 patent.6
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`44. The Abstract of Ballantyne, like Claim 18 of the 715 patent,
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`describes a method for installing a nasal bridle through the nose of a patient:
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`A nasogastric tube anchor, and a method of its use
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`employing a bridle which passes through the patient's
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`nostrils and nasopharynx, the ends of the bridle being
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`fastened to a nasogastric tube exterior to the patient's nose
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`to anchor said tube against undesired movement relative
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`6 I have been informed by counsel that Ballantyne was disclosed to the PTO during
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`prosecution. However, the reference was not cited in an Office Action or referred
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`to during prosecution. I further understand that the fact that a reference was
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`disclosed to the PTO does not preclude use of it for an IPR.
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`to the patient's nostril. Installation tools and methods are
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`provided for positioning said bridle within the patient's
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`nose such that one end of the bridle extends from each
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`nostril.
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`EX1002, Ballantyne, Abstract.
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`45.
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`In further similarity to Claim 18, Ballantyne teaches a method for
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`anchoring a nasogastric tube by inserting a nasal bridle into one nostril, through the
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`nasopharynx and beyond the nasal septum, and drawing the tube out of the other
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`nostril. EX1002, Ballantyne, Abstract and 2:20-32. Figure 2, which appears
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`below, shows the installed nasal bridle as disclosed by Ballantyne.
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`46. Ballantyne further discloses a method of installing the nasal bridles in
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`a patient’s nasal passages. Figures 3 and 6 exemplify this and are reproduced
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`below.
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`47. The specification of Ballantyne refers to Figures 3 and 6 (and others)
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`further explaining that: “[f]irst installation tool 34 comprises an adequately rigid
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`tube sized to be slidable over bridle member 10, yet narrow enough to be easily
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`insertable into a nostril such that the distal end 68 of first installation assembly 32
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`resides within the nasopharynx beyond the posterior nasal septum.” EX1002,
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`Ballantyne at 5:63-6:1.
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`48. As is described in the quote below, Ballantyne further teaches two
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`installation assemblies containing magnetic members. The magnetic end of one
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`installation assembly, containing the bridle, is inserted into one of the patient’s
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`nostrils, and the magnetic end of the other installation assembly is inserted into the
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`patient’s other nostril. The magnetic members of the two installation assemblies
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`then mate:
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`Referring to FIGS. 3 and 4, in a preferred embodiment,
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`bridle 10 is installed in a patient's nose by a method
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`comprising inserting the distal end 68 of first installation
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`assembly 32 into a first nostril of the patient until magnetic
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`member 40 is positioned beyond the posterior nasal
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`septum. The distal end 66 of second installation assembly
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`56 is then inserted into a second nostril of the patient until
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`magnet 54 is beyond the posterior nasal septum, in close
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`proximity
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`to magnetic member 40. When
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`this
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`configuration is achieved, pulling cord 38 extending from
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`the proximal end of first installation tool 34 is released,
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`allowing magnetic member 40 to be pulled by magnetic
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`force toward and to couple with magnet 54. At this point
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`the two magnets, 40 and 54, are coupled together by
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`magnetic force.
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`EX1002, Ballantyne at 7:14-32 (emphasis added). Figures 3 and 4 are
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`reproduced below.
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`49. Finally, Ballantyne discloses placing the bridle through the nose of the
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`patient by withdrawing the first installation tool from one of the patient’s nostrils.
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`The second installation tool and pulling cord are then withdrawn from the other
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`patient’s nostril and the bridle moved into its final position:
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`Referring to FIG. 6, first installation tool 34 is withdrawn
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`in direction Z from the nostril, while pulling cord 38 and
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`bridle 10 are allowed to slide through tool 34 as it is
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`withdrawn. Tool 34 is slidably removed over cord 38 and
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`bridle 10 until it is entirely separated from cord 38 and
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`bridle 10. Second installation tool 56 is then withdrawn
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`from the second nostril in direction Y, pulling with it
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`magnetic member 40 with the leading end of pulling cord
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`38 attached thereto. As second installation tool 56 and the
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`leading end of pulling cord 38 are withdrawn from the
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`second nostril, the trailing end of pulling cord 38 and the
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`leading end of bridle 10 enter the first nostril. When
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`second installation tool 56 is entirely removed from the
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`second nostril, pulling cord 38 can be grasped and bridle
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`10 pulled into its proper position by exertion of tension on
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`pulling cord 38, pulling the leading end of bridle 10 into
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`the first nostril, around the posterior nasal septum, and
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`down through the second nostril until it passes out of the
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`nasal opening.
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`EX1002, Ballantyne at 7:32-51.
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`50. Ballantyne describes an alternate system and method for installation
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`of the nasal bride, which requires leaving the installation tool 34 in place after the
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`magnets have mated:
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`Alternatively, first installation tool 34 can be left in place
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`in the nostril, or partially withdrawn, after the magnets
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`have coupled, while second installation tool 56 and pulling
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`cord 38 are pulled from the second nostril to draw bridle
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`10 into first installation tool 34, around the posterior nasal
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`septum, and further into its operative position with the
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`leading end of bridle 10 external to the second nostril. First
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`installation tool 34 is then removed from the nostril, while
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`the portion of bridle 10 remaining inside said tool slides
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`relative to said tool and retains its position in the nose. In
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`this way first installation tool 34 may operate to shield
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`nasal tissues from abrasion and irritation while bridle 10 is
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`pulled into position.
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`EX1002, Ballantyne at 7:52-64.
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`51.
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`I