UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MEDTRONIC, INC., AND MEDTRONIC VASCULAR, INC.,
`Petitioners,
`v.
`TELEFLEX INNOVATIONS S.À.R.L.,
`Patent Owner.
`
`
`Case No.: IPR2020-01344
`U.S. Patent No: RE46,116
`
`
`
`DECLARATION OF RICHARD A. HILLSTEAD, PH.D., FAHA
`
`
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`IPR2020-01344
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`TABLE OF CONTENTS
`
` INTRODUCTION .......................................................................................... 1
`I.
`II. QUALIFICATIONS ....................................................................................... 1
`III. SCOPE OF WORK ....................................................................................... 4
`IV. LEGAL PRINCIPLES ................................................................................... 5
`A. Claim Construction .......................................................................................... 5
`B. Written Description .......................................................................................... 5
`V.
` THE PERSON OF ORDINARY SKILL IN THE ART .............................. 6
`VI.
`ʼ116 PATENT AND PRIORITY CHAIN ..................................................... 7
`A. Summary of the ʼ116 Patent ............................................................................ 7
`B. Priority Chain of ʼ116 Patent ......................................................................... 10
`C. Effective Filing Date of the ’116 Patent ........................................................ 10
`1. The Claims of the ʼ116 Patent Recite a Side Opening Outside of the
`Substantially Rigid Segment. ..................................................................... 11
`2. The Patentee Didn’t Describe an Extension Catheter with a Side
`Opening Outside of the Substantially Rigid Portion Until Filing the
`ʼ059 Application (Issued as ʼ850 Patent) on January 26, 2012. ................ 13
`3. The patentee didn’t describe a side opening with “at least two
`inclined slopes” until, at best, filing the ʼ161 Application (issued
`as ʼ380 patent) on November 1, 2013. ....................................................... 24
`VII. PRIOR ART ................................................................................................. 25
`A. Overview of Kontos ....................................................................................... 25
`B. Overview of Ressemann and Common Teachings in the Art ........................ 29
`C. Background on catheter sizes ........................................................................ 32
`D. Overview of Takahashi .................................................................................. 33
`E. Overview of Common Knowledge Related to Flexibility and
`Reinforcement ................................................................................................ 35
`F. Overview of Kataishi ..................................................................................... 41
`VIII. A POSITA WOULD UNDERSTAND THAT RESSEMANN’S
`VALVE 184 INCLUDES A SINGLE SEAL. ............................................. 45
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`IX. KONTOS AND RESSEMANN COMBINATION .................................... 46
`A. A POSITA would have been motivated to modify Kontos to add a side
`opening, as taught by Ressemann. ................................................................. 46
`B. Kontos as modified by Ressemann’s angled proximal side opening is
`more rigid than the distal end portion of the tubular structure. ..................... 57
`C. Kontos as modified by Ressemann discloses reinforcing the tubular
`structure with a braid or a coil that is surrounded by a polymer. .................. 58
`D. Kontos as modified by Ressemann discloses a reinforcing braid or coil
`that is 20 to 30 cm. ......................................................................................... 62
`E. Kontos as modified by Ressemann discloses a side-opening structure
`having at least two inclined slopes. ............................................................... 64
`F. Kontos’s support assembly 10, as modified by Ressemann, has at least
`three different regions of flexibility. .............................................................. 72
`G. Kontos (as modified by Ressemann’s angled side opening) discloses that
`the support assembly 10 in combination with guide catheter 38 assists in
`resisting axial and shear forces exerted by an interventional cardiology
`device that tend to dislodge a guide catheter from a branch artery. .............. 75
`H. Kontos in combination with Ressemann teaches increasing the inner
`diameter of Kontos’s tube 16 to deliver a greater variety of PCI catheters. . 79
`I. Kontos in combination with Ressemann or common knowledge in the
`art teaches a marker band embedded in tube 16. ........................................... 81
`X. KONTOS IN COMBINATION WITH RESSEMANN IN FURTHER
`VIEW OF TAKAHASHI ............................................................................. 82
`A. A POSITA would be motivated to further combine Takahashi with
`Kontos and Ressemann. ................................................................................. 82
`XI. KONTOS IN COMBINATION WITH RESSEMANN AND
`TAKAHASHI IN FURTHER VIEW OF KATAISHI AND/OR THE
`COMMON KNOWLEDGE OF A POSITA .............................................. 86
`A. A POSITA would be motivated to modify Kontos/Ressemann/Takahashi
`in view of Kataishi to arrive at proximal opening with two inclines. ........... 86
`XII. KONTOS IN COMBINATION WITH RESSEMANN AND
`TAKAHASHI IN FURTHER VIEW OF ROOT AND/OR THE
`COMMON KNOWLEDGE OF A POSITA .............................................. 90
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`XIII. BY JANUARY 2012, A POSITA WAS MOTIVATED TO REPLACE
`THE MATERIAL OF ROOT’S SUBSTANTIALLY RIGID SIDE
`OPENING WITH A MORE FLEXIBLE MATERIAL. .......................... 91
`XIV. CONCLUDING REMARKS ...................................................................... 94
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`EXHIBIT LIST
`
`
`Exhibit Description
`1401 U.S. Patent No. RE 46,116 (“the ’116 patent”)
`1402
`File history for U.S. Patent No. 8,292,850
`1403
`File history for U.S. Patent No. RE 46,116
`1407 U.S. Patent No. 7,736,355 (“Itou”)
`1408 U.S. Patent No. 7,604,612 (“Ressemann”)
`1409 U.S. Patent No. 5,439,445 (“Kontos”)
`1410 New Method to Increase a Backup Support of a 6 French Guiding
`Coronary Catheter, Catheterization and Cardiovascular Interventions
`63: 452-456 (2004) (“Takahashi”)
`Excerpt from Grossman’s Cardiac Catheterization, Angiography, and
`Intervention (6th edition) (2000) (chapters 1, 4, 11, 23-25).
`1418 U.S. Patent No. 5,891,056 (“Ramzipoor”)
`1424 Boston Scientific, Summary of Safety and Effectiveness Data,
`TAXUS™ Express2™ Drug-Eluting Coronary Stent System (March 4,
`2004)
`1425 U.S. Publication Application No. 2005/0015073 (“Kataishi”)
`1426 U.S. Patent No. 5,489,278 (“Abrahamson”)
`1428 Baim, Randomized Trial of a Distal Embolic Protection Device
`During Percutaneous Intervention of Saphenous Vein Aorto-Coronary
`Bypass Grafts, Circulation 105:1285-1290 (2002) (“Baim”)
`The sliding rail system (monorail): description of a new technique for
`intravascular instrumentation and its application to coronary
`angioplasty, Z. Kardio. 76:Supp. 6, 119-122 (1987) (“Bonzel”)
`1433 U.S. Publication Application No. 2004/0236215 (Mihara)
`1435 U.S. Publication Application No. 2004/0010280 (“Adams ’280”)
`1440
`Excerpt of McGraw-Hill Dictionary of Scientific and Technical Terms
`(5th edition) (1994) (defining “flexural modulus”)
`iv
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`
`
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`1415
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`1432
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`Exhibit Description
`1443 Curriculum Vitae of Dr. Richard A. Hillstead, Ph.D.
`1446 U.S. Patent No. 6,042,578 (“Dinh”)
`1447 WO 97/37713 (“Truckai”)
`1448
`Terumo Heartrail II product literature
`1449 Medtronic Launcher product literature
`1450 U.S. Patent No. 5,980,486 (“Enger”)
`1451 U.S. Patent No. 5,911,715 (“Berg”)
`1454 U.S. Patent No. 5,120,323 (“Shockey”)
`1455
`Sakurada, Improved Performance of a New Thrombus Aspiration
`Catheter: Outcomes From In Vitro Experiments and a
`Case Presentation (“Sakurada”)
`1461 U.S. Patent No. 5,690,613 (“Verbeek”)
`1462
`lserson, J.-F.-B. Charrière: The Man Behind the “French” Gauge,
`The Journal of Emergency Medicine. Vol. 5 pp 545-548 (1987)
`1479 Complaint in Vascular Solutions, LLC. v. Medtronic, Inc., D. Minn.,
`No. 19-cv-01760 (October 11, 2019), D.I. 1-14.
`1481 U.S. RE45,380 (“the ’380 patent”)
`1496 U.S. Patent No. 4,886,507 (“Patton”)
`1497
`Excerpt of Patrick W. Serruys, Handbook of Coronary Stents (4th
`Edition) (2002)
`1498 U.S. Patent No. 5,167,636 (“Clement”)
`1499 U.S. Patent No. 5,897,497 (“Fernandez”)
`1500 Originally filed Abstract, Specification, Drawings, and Claims from
`the ’032 File History
`1501 Originally filed Abstract, Specification, Drawings, and Claims from
`the ’413 File History
`1503 Originally filed Abstract, Specification, Drawings, and Claims from
`the ’380 File History
`
`
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`1508
`
`Exhibit Description
`1505 Originally filed Abstract, Specification, Drawings, and Claims from
`the ’379 File History
`1506 Non-Final Rejection from the ’379 File History filed on 2017-07-20
`1507 Applicant Initiated Interview Summary from the ’379 File History
`filed on 2018-01-24
`Ex. 7 of Teleflex Infringement Disclosures and Claim Chart, Vascular
`Solutions LLC et al. v. Medtronic, Inc., 19:cv-01760-PJS-TNL (March
`1, 2020)
`1509 Mamas A. Mamas, Distal Stent Delivery with the Guideliner Catheter:
`First in Man Experience (2010)
`1510 Amendment to the claims from the ’379 File History filed on 2017-
`06-12
`1511 Applicant Arguments and Remarks Made in an Amendment from the
`’379 File History filed on 2018-01-19
`1512 U.S. Patent Application Publication US2017/0260219 (“Root”)
`
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`IPR2020-01344
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`
`I.
`
`Introduction
`1.
`I have been retained by Robins Kaplan LLP on behalf of Medtronic,
`
`Inc. and Medtronic Vascular, Inc. (“Medtronic”) as an independent expert to
`
`provide my opinion on the disclosures of certain patents.
`
`2.
`
`I am informed that Medtronic intends to use my opinion in support of
`
`its petition to the Patent Trial and Appeal Board (“PTAB”) for Inter Partes Review
`
`(“IPR”) of U.S. Patent No.: RE46,116.
`
`3.
`
`I make this declaration based on my personal education, experience,
`
`and knowledge in the field of medical device product development.
`
`II. Qualifications
`4. My curriculum vitae is being submitted as Ex-1443.
`
`5.
`
`I have been actively involved in the design and development of
`
`medical devices for more than thirty years. I held several progressive, Product
`
`Research and Development positions with Cordis Corporation (J&J) from 1987 to
`
`1993 where I was responsible for the design and development of numerous
`
`vascular intervention devices including stents and angioplasty balloon catheters. I
`
`pioneered device development in the Cordis Coronary Stent program as a Senior
`
`Corporate Research Engineer. During my tenure at Cordis, I also held the position
`
`
`
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`of Senior Engineer, Custom Products, where I was responsible for designing a
`
`wide variety of customized catheters and devices for individual physicians.
`
`6.
`
`From 1993 until 1999, I directed new technology development for
`
`Georgia-based Novoste Corporation, primarily focusing on intravascular
`
`brachytherapy and catheter based delivery systems for the treatment of coronary
`
`restenosis following angioplasty and stenting.
`
`7.
`
`In 1999, I became a founding member of The Innovation Factory, a
`
`private medical device incubator in Duluth, GA. At The Innovation Factory, I
`
`served as Chief Science Officer and was primarily responsible for early clinical
`
`investigations, and overall R&D in a wide variety of life science ventures.
`
`8.
`
`I was a principal partner and founding member in Accuitive Medical
`
`Ventures I and II (2004 – 2008). Accuitive Medical Ventures is a $225M venture
`
`capital fund focused entirely on growing early stage medical device companies into
`
`attractive candidates for acquisition. In 2008, I joined another medical device
`
`venture fund, Georgia Venture Partners (GVP), where I remain a partner today.
`
`9.
`
`I have managed numerous, diverse, multi-disciplinary development
`
`teams from product concept through clinical approval to sales release. I am a
`
`frequent speaker on the importance of innovation and intellectual property creation
`
`and capture as it relates to the entrepreneurial process in the medical device
`
`industry at conferences and scientific sessions.
`2
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`10. Currently, I am CEO of Richard A. Hillstead Inc., a medical device
`
`development and entrepreneurship consulting firm located near Atlanta, GA. I am
`
`also the current Chairman and former CEO of Biofisica Inc., a Georgia wound
`
`healing device company. I am a past Chairman and co-founder of Cerebral
`
`Vascular Applications, Inc. (CVA), a Georgia company dedicated to reducing the
`
`incidence of stroke through closure of the atrial appendage of the heart. I am a
`
`former member of the Emory University New Technology Advisory Board, where
`
`I participated in reviewing promising new medical device technologies and
`
`recommended development strategies.
`
`11.
`
`I was the 2019 recipient of the Georgia BIO Golden Helix Award for
`
`Industry Growth, the highest award bestowed in the state of Georgia for medical
`
`device design, development, and entrepreneurship.
`
`12.
`
` I am named inventor on approximately eighty issued U.S. patents and
`
`pending applications as well as dozens of international patents. My patents pertain
`
`to medical device design, and a majority of these patents relate specifically to
`
`catheter design. My patents and patent publications have been cited, globally, over
`
`8000 times.
`
`13.
`
`In 2012 and 2013, I served as an Entrepreneur in Residence to the
`
`United States Food and Drug Administration.
`
`
`
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`14.
`I am a Fellow in the American Heart Association (FAHA) on the
`
`Council of Clinical Cardiology, Fellow on the Council on Lifestyle and
`
`Cardiometabolic Health, and am a current member of the Stroke Council and
`
`Council on Cardiopulmonary Resuscitation.
`
`15.
`
`I have no financial interest in Medtronic. I similarly have no financial
`
`interest in the asserted patents, and have had no contact with the named inventors
`
`of the asserted patent.
`
`III. Scope of Work
`16.
`I have been asked to review the ’116 patent and opine on the level of
`
`ordinary skill in the art as of May 3, 2006.
`
`17.
`
`I have also been asked to review the priority chain (i.e., prosecution of
`
`the ʼ116 patent and ancestor patents) and opine on the effective filing date of the
`
`ʼ116 patent.
`
`18.
`
`I have additionally been asked to consider and provide my opinions
`
`on disclosures in the following references:
`
`1)
`
`2)
`
`U.S. Pat. No. 5,439,445 to Kontos (“Kontos”) (Ex-1409);
`
`U.S. Pat. No. 7,604,612 to Ressemann (“Ressemann”)
`
`(Ex-1408)
`
`3)
`
`“New Method to Increase a Backup Support of a 6 French
`
`Guiding Coronary Catheter,” Catheterization and
`4
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`Cardiovascular Interventions, 63:452-456 to Takahashi
`
`(“Takahashi”) (Ex-1410); and
`
`4)
`
`U.S. Pat. Pub. No. 2005/0015073 to Kataishi et al., (“Kataishi”)
`
`(Ex-1425).
`
`IV. Legal Principles
`19.
`I have been informed of the following legal principles from counsel
`
`for Medtronic.
`
`A. Claim Construction
`
`20.
`
`I have been informed by counsel that all patent claim terms are given
`
`their plain and ordinary meaning, as would have been understood by a person of
`
`ordinary skill in the art, at the time of the alleged invention (which, as set forth
`
`herein, is between May 2006 and November 2013) having taken into consideration
`
`the language of the claims, the specification, and the prosecution history of record.
`
`B. Written Description
`
`21.
`
`I have been informed by counsel that a claim is supported by the
`
`written description only when the specification reasonably conveys to a person of
`
`ordinary skill in the art that the inventor(s) had possession of the full scope of the
`
`claimed subject matter as of the effective filing date.
`
`22.
`
`I have been informed by counsel that the “possession” inquiry
`
`requires an objective inquiry into the four corners of the specification from the
`5
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`perspective of a person of ordinary skill in the art, and, based on that inquiry, the
`
`specification must understandably describe the invention to that skilled artisan,
`
`showing that the inventor actually invented the invention claimed.
`
`23.
`
`I have been informed by counsel that an adequate written description
`
`does not require that the specification describe the claimed invention using the
`
`same language as the claim, but there is no written description support if the claims
`
`are merely obvious in view of the specification. I understand this to mean that the
`
`written description inquiry requires a comparison of the claim(s) with what the
`
`specification actually discloses, not what the specification might have included
`
`based on the knowledge of a person of ordinary skill in the art as of the effective
`
`filing date.
`
`V. The Person of Ordinary Skill in the Art
`
`24.
`
`I am not a lawyer and have been informed by counsel of the legal
`
`standards set forth herein. I have also been informed by counsel of factors that may
`
`be considered in determining the level of ordinary skill in the art include (a) the
`
`educational level of the inventor; (b) the type of problem encountered in the art; (c)
`
`prior art solutions to those problems; (d) the rapidity with which inventions are
`
`made; (e) sophistication of the technology; and (f) the educational level of those
`
`working in the field.
`
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`25.
`I have reviewed the ’116 patent. For the ’116 patent, a person of
`
`ordinary skill in the art (“POSITA”) at the time of the alleged invention1 would
`
`have had (a) a medical degree; (b) completed a coronary intervention training
`
`program, and (c) experience working as an interventional cardiologist.
`
`Alternatively, a POSITA would have had (a) an undergraduate degree in
`
`engineering, such as mechanical or biomedical engineering; and (b) three years of
`
`experience designing medical devices, including catheters or catheter-deployable
`
`devices. Extensive experience and technical training might substitute for education,
`
`and advanced degrees might substitute for experience. Additionally, a POSITA
`
`with a medical degree may have access to a POSITA with an engineering degree,
`
`and one with an engineering degree might have access to one with a medical
`
`degree.
`
`VI.
`
`ʼ116 Patent and Priority Chain
`
`A.
`
`Summary of the ʼ116 Patent
`
`26. U.S. Patent No. RE46,116 is titled: Coaxial Guide Catheter for
`
`Interventional Cardiology Procedures. Ex-1401 at cover page. The ’116 patent
`
`issued on August 23, 2016. Id.
`
`
`1 My definition does not change if the invention date (“effective filing date”) is
`
`2006 or sometime in 2012 or 2013.
`
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`27. The ’116 patent describes “catheters used in interventional cardiology
`
`procedures.” Ex-1401, 1:36-37. More particularly, the ’116 patent recites an
`
`extension catheter (referred to in the ʼ116 patent as a “coaxial guide catheter”) that
`
`extends through the lumen of and beyond the most distal portion of the guide
`
`catheter (i.e., into the branch artery). Id., Abstract. The specification of the ʼ116
`
`patent further explains that the purported invention is “a system that [is]
`
`deliverable through [a] standard guide catheter[] for providing backup support by
`
`providing the ability to effectively create deep seating in the ostium of the coronary
`
`artery.” Id., 3:12-16.
`
`28. Figure 1 shows guide extension catheter 12, which has a tubular
`
`portion that includes a flexible distal tip 16 (pink) and a reinforced portion 18
`
`(blue), as well as rigid portion 20 (yellow). Id., 3:62-65, 6:45-49, Fig. 1.
`
`Ex-1401, Fig. 1 (color and annotations added).
`
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`29. The ʼ116 patent also describes the transition at or near the rigid
`
`portion. In particular, the ʼ116 patent shows a “side opening,” (red circle), which
`
`may have “inclined slopes.” Id., Figs. 4, 13-16; see also id., 7:14-25, 9:7-17,
`
`claims 25, 42, 44, 45.
`
`Ex-1401 Fig. 4 (color and annotations added (and figure inverted to orient figure
`
`similarly to Fig. 1)).
`
`30. The ʼ116 patent issued with 30 claims that are numbered claims 25
`
`through 55.2
`
`
`
`
`2 I understand that when the patentee sought reissuance of the ʼ850 patent, original
`
`claims 1-24 were cancelled.
`
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`B.
`Priority Chain of ʼ116 Patent
`
`31. The patent application—Appl. No. 14/195,435—that ultimately issued
`
`as the ʼ116 patent was filed on March 3, 2014. The ʼ435 Application was filed as a
`
`continuation application that purports to claim priority to a patent application filed
`
`on May 3, 2006. Id., [60], [64].
`
`32. The relevant priority chain for the ʼ116 patent is set forth below:
`
`C. Effective Filing Date of the ’116 Patent
`
`33.
`
`I understand that a patentee seeking reissuance of a patent cannot
`
`introduce new matter into the reissue application. I also understand that in order to
`
`rely on the filing date of an earlier application (including for a re-issue
`
`
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`application), 35 U.S.C. § 120 requires that the earlier application include a
`
`disclosure that complies with the written description requirement. I also understand
`
`that to comply with the written description requirement of § 112 the patentee must
`
`describe the invention sufficiently to convey to a POSITA that the patentee had
`
`possession of the claimed invention at the time of the application, i.e., that the
`
`patentee invented what is claimed.
`
`34.
`
`It is my opinion that the claims of the ʼ116 patent (“Challenged
`
`Claims”) recite a side opening in a region of the extension catheter that is separate
`
`and distinct from the substantially rigid segment. It is also my opinion that the
`
`patentee was not in possession of (i.e., did not describe) an extension catheter with
`
`the side opening anywhere other than the substantially rigid segment until the
`
`filing of the ʼ059 Application (issued as ʼ850 patent) on January 26, 2012.
`
`1.
`
`The Claims of the ʼ116 Patent Recite a Side Opening
`Outside of the Substantially Rigid Segment.
`35. The Challenged Claims require that the side opening of the extension
`
`catheter is in a region separate and distinct from the substantially rigid segment.
`
`36. For example, when claim 25 first introduces “a side opening,” Patent
`
`Owner chose not to describe the location as being in the substantially rigid segment
`
`or the tubular structure. Ex-1401, 13:62-14:25. Instead, Claim 25 recites a separate
`
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`“segment defining the side opening.” Id., 14:3-4. In other words, because the side
`
`opening “define[s]” its own region, it cannot be in the substantially rigid segment.
`
`37. This interpretation is confirmed later in claim 25 when describing how
`
`the interventional cardiology device travels within the extension catheter. After
`
`defining the side opening, claim 25 explains that the balloon catheter or stent is
`
`advanced “through a hemostatic valve … along a substantially rigid segment of the
`
`guide extension catheter, through the side opening, and through the tubular
`
`structure.” Ex-1401, 14:20-25 (emphasis added). If the side opening did not define
`
`its own region (i.e., separate from, for example, the substantially rigid segment),
`
`there would be no reason to recite that the stent or catheter passes through the side
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`opening after the substantially rigid segment and before the tubular structure.
`
`38. My interpretation of the Challenged Claims is confirmed by how the
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`patentee recited other patent claims in the Teleflex family. For example, claim 3 of
`
`the ʼ380 patent recited that the “tubular structure further comprises structure
`
`defining a proximal side opening.” Ex-1481, 11:33-40. In other words, the side
`
`opening is in the tubular structure. Conversely, claim 9 recites that “the
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`substantially rigid portion includes from distal to proximal direction, a cross-
`
`sectional shape having a full circumference portion, a hemicylindrical portion and
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`an arcuate portion.” Id. at 11:58-61. I interpret this language as requiring the side
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`opening to be in the substantially rigid segment. Patent Owner knows how to recite
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`IPR2020-01344
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`that the side opening is in the substantially rigid segment or the tubular portion. It
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`chose not to do so in the ʼ116 patent.
`
`39.
`
`I note that it also appears that Patent Owner interprets the claims of
`
`the ʼ116 patent as having a side opening in a region separate from the substantially
`
`rigid segment. Ex-1508, 4, 12.
`
`40. All of the Challenged Claims either recite or depend from a claim that
`
`recites “a segment defining a side opening” or “a segment defining an arcuate
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`cross-sectional shape” (claim 51).
`
`2.
`
`The Patentee Didn’t Describe an Extension Catheter with a
`Side Opening Outside of the Substantially Rigid Portion
`Until Filing the ʼ059 Application (Issued as ʼ850 Patent) on
`January 26, 2012.
`I understand that the Challenged Claims cannot claim priority to the
`
`41.
`
`filing of the original May 3, 2006 application unless the entire priority chain
`
`provides written description support for the Challenged Claims.
`
`42. There is no written description support for an extension catheter with
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`a side opening outside of the substantially rigid portion until, at earliest, January
`
`26, 2012. I understand that this means that the “effective filing date” of the ʼ116
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`patent cannot be earlier than January 26, 2012.
`
`43.
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`I reviewed the following as-filed patent abstracts, figures,
`
`specifications, and claims of the applications in the priority chain:
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`IPR2020-01344
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`U.S. Patent No.
`
`8,048,032
`8,142,413
`8,292,850
`RE45,380
`RE46,116
`RE47,379
`
`
`
`U.S. Patent Application
`No. (Exhibit No.)
`11/416,629 (Ex-1500)
`12/824,734 (Ex-1501)
`13/359,059 (Ex-1402)
`14/070,161 (Ex-1503)
`14/195,435 (Ex-1403)
`14/984,273 (Ex-1505)
`
`Patent Application Filing
`Date
`May 3, 2006
`June 28, 2010
`Jan. 26, 2012
`Nov. 1, 2013
`March 3, 2014
`Dec. 30, 2015
`
`44. The abstracts, figures, and specifications of the originally filed patent
`
`applications in the above table are substantively identical. For that reason, unless
`
`otherwise noted, I cite only the ʼ629 Application below.
`
`45. The only disclosure in the ʼ629 Application (including in the abstract,
`
`specification, and claims) for a side opening is in the substantially rigid segment.
`
`The disclosed coaxial guide catheter (extension catheter) includes three parts: “The
`
`coaxial guide catheter includes a tip portion, a reinforced portion, and a
`
`substantially rigid portion.” Ex-1500, 6:4-5.
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`46. The substantially rigid portion includes a cutout (side opening)
`
`portion.
`
`Preferably, the rigid portion may be advantageously formed from a
`stainless steel or Nitinol tube. The rigid portion may be joined to the
`braid or coil portion by welding. The rigid portion may include a cutout
`portion and a full circumference portion. For example, the cutout
`portion may include a section where about 45% of the circumference
`of the cylindrical tubular structure has been removed. The cutout
`portion may also include a section where 75-90% of the circumference
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`IPR2020-01344
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`of the tubular structure has been removed. In one exemplary
`embodiment, the portion having approximately 45% removed may
`extend for approximately 75 cm and the portion having 75-90% of the
`structure removed extends for about 15 cm.”
`
`Id., 6:17-7:3 (emphasis added).
`
`
`47. The ʼ629 Application also described that the “[r]igid portion 20
`
`includes first full circumference portion 34, hemicylindrical portion 36, arcuate
`
`portion 38, and second full circumference portion 40. First full circumference
`
`portion 34 is joined to braid or coil reinforcement 32.” Id., 13:5-7. The
`
`specification describes each of the rigid portion elements:
`
`First full circumference portion 34 is joined to braid or coil
`reinforcement 32. First full circumference portion 34 extends for a
`relatively short distance, for example, .25 cm.
`
`Hemicylindrical portion 36 desirably includes 40% to 70% of the
`circumference of the tube. Hemicylindrical portion 36 may extend, for
`example, approximately 20 to 75 cm in length.
`
`Hemicylindrical portion 36 tapers into arcuate portion 38.
`
`Arcuate portion 38 extends from 25% to 40% of the circumference of
`the tube. Arcuate portion 38 may extend linearly, for example, for about
`15 cm.
`
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`Arcuate portion 38 connects to second full circumference portion 40.
`Second full circumference portion 40 may extend for a short distance,
`for example, approximately 3 cm.
`
`Id., 13:8-17.
`48. Teleflex identified this section “as disclosing the structure of the side
`
`opening” during prosecution of the ʼ379 patent. Ex-1507, 4.
`
`49. Although it does not specifically use the phrase “side opening,” the
`
`specification reiterates that the side opening is located in the substantially rigid
`
`segment: “Rigid portion 20 may extend for approximately ninety cm and include
`
`first full circumference portion 34 (approximately 0.25 cm), hemicylindrical
`
`portion 36 (approximately seventy five cm), arcuate portion (approximately fifteen
`
`cm) and second full circumference portion (approximately three cm.)” Ex-1500,
`
`14:19-15:2.
`
`50. Each Figure shows the side opening in the rigid portion 20. For
`
`example, Figure 4 shows rigid portion 20, including hemicylindrical portion 36 and
`
`arcuate portion 38:
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`Ex-1401, Fig. 4 (color and annotations added).3
`
`51. Similarly, Figures 12-16 show “view[s] of the rigid portion [20] in
`
`accordance with the present invention.” Ex-1500, 11:4-13. In each instance, the
`
`“side opening” in in the substantially rigid portion.
`
`
`
`Ex-1401, Figs. 12-16 (color and annotations added).
`
`52.
`
`In reference with Figures 12-16, the ʼ629 Application states:
`
`In an embodiment depicted in FIGS. 12-15 (sic), rigid portion [20]
`includes full circumference portion 80, greater than 180° portion 82,
`and less than 180° portion 84. Greater than 180° portion 82 may, for
`
`
`3 I cite the Figures found in the as-issued patents, but note that they are
`
`substantively identical to the Figures filed with the ʼ629 Application.
`
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`example, include structure forming approximately 300° of the
`circumference of the cylinder. Less than 180° portion may include, for
`example, structure forming approximately 90° of the circumference of
`a cylinder. Greater than 180° portion 82 may extend approximately 22-
`25 inches. Greater than 180° portion 82 holds tapered inner catheter 14
`within rigid portion 20.
`
`Ex-1500, 17:12-18.
`
`53. The original claims recited in the ʼ629 Application also describe and
`
`uniformly limit the side opening to the rigid portion of the extension catheter.