UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`NEOCHORD, INC.
`Petitioner
`
`v.
`
`UNIVERSITY OF MARYLAND, BALTIMORE
`Patent Owner
`
`______________
`
`Case No. IPR2016-00208
`Patent No. 7,635,386
`______________
`
`
`
`
`
`DECLARATION OF DR. JOHN GARRETT
`IN SUPPORT OF PATENT OWNER’S RESPONSE
`
`
`
`
`
`University of Maryland, Baltimore
`IPR2016-00208
`
`Exhibit 2001
`Page 1 of 42
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`

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`Declaration of Dr. John Garrett
`Case No. IPR2016-00208
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`I.
`
`2.
`
`2
`
`
`
`INTRODUCTION AND QUALIFICATIONS .............................................. 4
`A.
`Engagement Overview ......................................................................... 4
`B.
`Summary of Opinions .......................................................................... 5
`C. Qualifications and Experience ............................................................. 5
`1.
`Education ................................................................................... 6
`2.
`Career ......................................................................................... 6
`3.
`Publications ................................................................................ 7
`4.
`Curriculum Vitae ........................................................................ 7
`D. Materials Considered ............................................................................ 7
`LEGAL PRINCIPLES USED IN THE ANALYSIS ..................................... 7
`A.
`Person Having Ordinary Skill in the Art (“POSITA”) ........................ 8
`B.
`Prior Art .............................................................................................. 10
`C.
`Broadest Reasonable Interpretations .................................................. 10
`D.
`Legal Standards for Anticipation & Obviousness .............................. 10
`III. THE ‘386 PATENT ...................................................................................... 20
`A.
`Interpretation of Claim Limitations in the ‘386 Patent ...................... 20
`1.
`Petitioner’s and Dr. Aklog’s BRI for “Percutaneously
`Accessing” is Inconsistent with the ‘386 Patent
`Disclosure ................................................................................. 21
`Petitioner’s and Dr. Aklog’s BRI for “Percutaneously
`Accessing” is Inconsistent with a POSITA’s
`Understanding of the Term ...................................................... 24
`IV. CLAIMS 19, 22 AND 23 ARE PATENTABLE UNDER 35 U.S.C. §
`102 ................................................................................................................ 30
`A. Ground 1: Claims 19, 22, and 23 are Not Anticipated by
`Speziali. .............................................................................................. 30
`CLAIMS 1-23 ARE PATENTABLE UNDER 35 U.S.C. § 103 ................. 32
`A. Ground 2: Claims 20 and 21 are Not Rendered Obvious by
`Speziali in view of Bachman .............................................................. 32
`
`II.
`
`V.
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`University of Maryland, Baltimore
`IPR2016-00208
`
`Exhibit 2001
`Page 2 of 42
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`

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`Declaration of Dr. John Garrett
`Case No. IPR2016-00208
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`B. Ground 3: Claims 19, 22 and 23 are Not Rendered Obvious by
`Lattouf I in view of Carpentier. .......................................................... 35
`1.
`Lattouf I Does Not Disclose the “Percutaneously
`Accessing” Limitation of Claim 19. ........................................ 35
`Carpentier does not Disclose an Artificial Chordae
`Tendinae ................................................................................... 38
`C. Ground 4: Claims 20 and 21 are Not Rendered Obvious by
`Lattouf I in view of Bachman. ........................................................... 39
`VI. CONCLUSION ............................................................................................. 41
`
`
`
`2.
`
`3
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`
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`University of Maryland, Baltimore
`IPR2016-00208
`
`Exhibit 2001
`Page 3 of 42
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`

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`Declaration of Dr. John Garrett
`Case No. IPR2016-00208
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`
`1.
`
`I, John Garrett, M.D., declare as follows:
`
`2.
`
`I have personal knowledge of the facts stated in this declaration, and
`
`could and would testify to these facts under oath if called upon to do so.
`
`I.
`
`INTRODUCTION AND QUALIFICATIONS
`A. Engagement Overview
`3.
`I have been retained by counsel for Harpoon Medical, Inc.
`
`(“Harpoon”) in this case as an expert in the relevant art. Harpoon is the exclusive
`
`licensee of U.S. Patent No. 7,635,386 (“the ‘386 patent”), which is owned by
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`University of Maryland, Baltimore (“Patent Owner”). It is my understanding that
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`Harpoon has control over this inter partes review proceeding based on their
`
`exclusive licensee agreement with Patent Owner. I am being compensated for my
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`work at the rate of $950 per hour. No part of my compensation is contingent upon
`
`the outcome of this petition.
`
`4.
`
`I was asked to study the ‘386 patent, its prosecution history, the
`
`Petition, the Declaration of Dr. Aklog, and the other exhibits filed in this
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`proceeding, and to render opinions on anticipation and obviousness or non-
`
`obviousness of certain ones of the claims of the ‘386 patent in light of the
`
`teachings of the prior art, as understood by a person of ordinary skill in the art in
`
`the 2006 time frame. I understand that the claims being challenged in the Petition
`
`are claims 1-23 (“the challenged claims”), the review of which has been instituted
`4
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`University of Maryland, Baltimore
`IPR2016-00208
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`Exhibit 2001
`Page 4 of 42
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`

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`Declaration of Dr. John Garrett
`Case No. IPR2016-00208
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`on various grounds.
`
`B.
`5.
`
`Summary of Opinions
`
`After studying the ‘386 patent, relevant excerpts of its file history, the
`
`Petition, the Declaration of Dr. Aklog, and the exhibits by Petitioner, and after
`
`considering the subject matter of the claims of the ‘386 patent in light of the state
`
`of technical advancement in the area of mitral valve repair in the 2006 time frame,
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`I reached the conclusions discussed herein.
`
`6.
`
`In light of these general conclusions, and as explained in more detail
`
`throughout this declaration, it is therefore my opinion that each of the challenged
`
`claims of the ‘386 patent addressed in this declaration are valid as they were not
`
`anticipated or obvious in the 2006 time frame in light of the knowledge of skill in
`
`the art at that time and the teachings, suggestions, and motivations present in the
`
`prior art. This declaration, and the conclusions and opinions herein, provide
`
`support for the Patent Owner’s Response in the Inter Partes Review of the ‘386
`
`patent filed by Petitioner and instituted by the Board. I have reviewed the Patent
`
`Owner’s Response in its entirety as well as its corresponding exhibits.
`
`C. Qualifications and Experience
`7.
`I possess the knowledge, skills, experience, training and the education
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`to form an expert opinion and testimony in this matter. I have over 30 years of
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`experience as a heart surgeon and have performed over 500 mitral and/or tricuspid
`5
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`University of Maryland, Baltimore
`IPR2016-00208
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`Exhibit 2001
`Page 5 of 42
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`

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`Declaration of Dr. John Garrett
`Case No. IPR2016-00208
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`valve repairs during my career.
`
`Education
`
`1.
`I received my M.D. from the University of Alabama in Birmingham
`
`8.
`
`and completed my general surgery residency there as well. I completed my
`
`cardiovascular and thoracic residency in Houston at the Texas Heart Institute. My
`
`mentor there was Dr. Denton Cooley. I joined the faculty at the University of
`
`Texas Medical Center and worked for two years as an assistant professor prior to
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`going into private medical practice in cardiovascular and thoracic surgery. I have
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`also completed a mitral valve repair course in Paris under Dr. Alain Carpentier, the
`
`author of a prior art reference asserted by Petitioner.
`
`Career
`
`2.
`I have spent my entire career at Virginia Hospital Center, and
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`9.
`
`currently hold several positions there. I am Chief Surgeon of the Department of
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`Cardiac, Thoracic and Vascular Surgery; Director of Physician Operations; and
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`Chairman of the Board of Directors. I have held these positions for 26 years, 8
`
`years, and 16 years, respectively.
`
`10. My specialty is in thoracic and vascular surgery. I have performed
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`thousands of such surgeries over the course of my career. And, as I mentioned
`
`before, I have performed over 500 mitral and/or tricuspid valve repairs during my
`
`6
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`University of Maryland, Baltimore
`IPR2016-00208
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`Exhibit 2001
`Page 6 of 42
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`

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`Declaration of Dr. John Garrett
`Case No. IPR2016-00208
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`career, which makes my experience particularly relevant to the subject matter of
`
`the ‘386 patent.
`
`Publications
`
`3.
`I am the author of several journal and conference publications, which
`
`11.
`
`are also listed on the attached curriculum vitae. (Ex. 2002.)
`
`4.
`Curriculum Vitae
`12. Additional details of my education and employment history, and
`
`publications are set forth in my current curriculum vitae, which is provided as Ex.
`
`2002.
`
`D. Materials Considered
`13. My analysis is based on my experience as a heart surgeon since 1986
`
`and my experience with both open-heart and percutaneous mitral and tricuspid
`
`valve repairs, including the documents I have read and authored and systems I
`
`have developed and used since then.
`
`14. Furthermore, I have reviewed the Petition for Inter Partes Review of
`
`the ‘386 patent, Dr. Aklog’s Declaration in support of that Petition, and the prior
`
`art references asserted in that Petition. I have also reviewed the Patent Owner’s
`
`Response in its entirety, as well as the exhibits filed in support of that Response.
`
`II. LEGAL PRINCIPLES USED IN THE ANALYSIS
`15.
`I am not a patent attorney, nor have I independently researched the
`7
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`University of Maryland, Baltimore
`IPR2016-00208
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`Exhibit 2001
`Page 7 of 42
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`

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`Declaration of Dr. John Garrett
`Case No. IPR2016-00208
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`law on patent validity. Attorneys for the Patent Owner explained certain legal
`
`principles to me that I have relied upon in forming my opinions set forth in this
`
`report.
`
`A.
`16.
`
`Person Having Ordinary Skill in the Art (“POSITA”)
`
`I understand that I must undertake my assessment of the claims of the
`
`‘386 patent from the perspective of what would have been known or understood by
`
`a POSITA as of the earliest claimed priority date of the patent claim, which I
`
`understand is March 7, 2006. The opinions and statements that I provide herein
`
`regarding the ‘386 patent and the references that I discuss are made from the
`
`perspective of the person of ordinary skill in the art in the early 2006 time frame.
`
`17. Counsel has advised me that to determine the appropriate level of one
`
`of ordinary skill in the art, I may consider the following factors: (a) the types of
`
`problems encountered by those working in the field and prior art solutions thereto;
`
`(b) the sophistication of the technology in question, and the rapidity with which
`
`innovations occur in the field; (c) the educational level of active workers in the
`
`field; and (d) the educational level of the inventor.
`
`18. The relevant medical field for the ‘386 patent is heart surgery, and in
`
`particular valve repair procedures. Based on this, and the four factors above, it is
`
`my opinion that POSITA would hold a medical degree, be board certified in
`
`thoracic surgery and be skilled in performing cardiac surgery for at least 10 years.
`8
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`University of Maryland, Baltimore
`IPR2016-00208
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`Exhibit 2001
`Page 8 of 42
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`

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`Declaration of Dr. John Garrett
`Case No. IPR2016-00208
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`19. Unless otherwise specified, when I mention a POSITA or someone of
`
`ordinary skill, I am referring to someone with at least the above level of knowledge
`
`and understanding.
`
`20. Based on my experiences, I have a good understanding of the
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`capabilities of a person of ordinary skill in the relevant field. Indeed, in addition to
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`being a person of at least ordinary skill in the art, I have worked closely with many
`
`such persons over the course of my career.
`
`21. Although my qualifications and experience exceed those of the
`
`hypothetical person having ordinary skill in the art defined above, my analysis and
`
`opinions regarding the ‘386 patent have been based on the perspective of a person
`
`of ordinary skill in the art in the March 2006 time frame.
`
`22. My opinions regarding the level of ordinary skill in the art are based
`
`on, among other things, the content of the ‘386 patent, my years of experience as a
`
`cardiac surgeon (performing both open-heart and percutaneous procedures), my
`
`understanding of the basic qualifications that would be relevant to a surgeon tasked
`
`with investigating methods and systems in the relevant area, and my familiarity
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`with the backgrounds of colleagues and co-workers, both past and present.
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`23. My opinions herein regarding the person of ordinary skill in the art
`
`and my other opinions set forth herein would remain the same if the person of
`
`ordinary skill in the art were determined to have somewhat more or less education
`9
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`University of Maryland, Baltimore
`IPR2016-00208
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`Exhibit 2001
`Page 9 of 42
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`

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`Declaration of Dr. John Garrett
`Case No. IPR2016-00208
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`and/or experience than I have identified above.
`
`B.
`24.
`
`Prior Art
`
`I understand that the law provides categories of information that
`
`constitute prior art that may be used to anticipate or render obvious patent claims.
`
`To be prior art to a particular patent under the relevant law, a reference must have
`
`been made, known, used, published, or patented, or be the subject of a patent
`
`application by another, before the priority date of the patent. I also understand that
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`the POSITA is presumed to have knowledge of the relevant prior art.
`
`25. As discussed below, I understand that the challenged claims of the
`
`‘386 patent are entitled to a March 7, 2006 priority date.
`
`C. Broadest Reasonable Interpretations
`26.
`I understand that, in Inter Partes Review, the claim terms are to be
`
`given their broadest reasonable interpretation (BRI) in light of the specification.
`
`See 37 C.F.R. § 42.100(b). In performing my analysis and rendering my opinions,
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`I have interpreted claim terms for which the Petitioner has not proposed a BRI
`
`construction by giving them the ordinary meaning they would have to a POSITA,
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`reading the ‘386 Patent with its earliest priority filing date (March 7, 2006) in
`
`mind, and in light of its specification and file history.
`
`D. Legal Standards for Anticipation & Obviousness
`27.
`I have been provided the following instruction from the Model Patent
`
`10
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`University of Maryland, Baltimore
`IPR2016-00208
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`Exhibit 2001
`Page 10 of 42
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`

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`Declaration of Dr. John Garrett
`Case No. IPR2016-00208
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`Jury Instructions for the Northern District of California (June 17, 2014) for
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`anticipation, and instructions from the Federal Circuit Bar Association Model
`
`Instructions regarding obviousness, which is reproduced in part below. I apply this
`
`understanding in my analysis, with the caveat that I have been informed that the
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`Patent Office will find a patent claim invalid in inter partes review if it concludes
`
`that it is more likely than not that the claim is invalid (i.e., a preponderance of the
`
`evidence standard), which is a lower burden of proof than the “clear and
`
`convincing” standard that is applied in United States district court (and described
`
`in the jury instruction below):
`
`4.3a1 ANTICIPATION
`
`A patent claim is invalid if the claimed invention is not
`new. For the claim to be invalid because it is not new, all
`of its requirements must have existed in a single device
`or method that predates the claimed invention, or must
`have been described in a single previous publication or
`patent that predates the claimed invention. In patent law,
`these previous devices, methods, publications or patents
`are called “prior art references.” If a patent claim is not
`new we say it is “anticipated” by a prior art reference.
`
`The description in the written reference does not have to
`be in the same words as the claim, but all of the
`requirements of the claim must be there, either stated or
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`University of Maryland, Baltimore
`IPR2016-00208
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`Exhibit 2001
`Page 11 of 42
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`

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`Declaration of Dr. John Garrett
`Case No. IPR2016-00208
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`necessarily implied, so that someone of ordinary skill in
`the field of [identify field] looking at that one reference
`would be able to make and use the claimed invention.
`
`Here is a list of the ways that [alleged infringer] can
`show that a patent claim was not new [use those that
`apply to this case]:
`
`[– if the claimed invention was already publicly known
`or publicly used by others in the United States before
`[insert date of conception unless at issue];]
`
`[– if the claimed invention was already patented or
`described in a printed publication anywhere in the world
`before [insert date of conception unless at issue]. [A
`reference is a “printed publication” if it is accessible to
`those interested in the field, even if it is difficult to
`find.];]
`
`[– if the claimed invention was already made by someone
`else in the United States before [insert date of conception
`unless in issue], if that other person had not abandoned
`the invention or kept it secret;]
`
`[– if the claimed invention was already described in
`another issued U.S. patent or published U.S. patent
`application that was based on a patent application filed
`before [insert date of the patent holder’s application
`
`12
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`University of Maryland, Baltimore
`IPR2016-00208
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`Exhibit 2001
`Page 12 of 42
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`

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`Declaration of Dr. John Garrett
`Case No. IPR2016-00208
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`filing date] [or] [insert date of conception unless at
`issue];]
`
`[– if [named inventor] did not invent the claimed
`invention but instead learned of the claimed invention
`from someone else;]
`
`[– if the [patent holder] and [alleged infringer] dispute
`who is a first inventor, the person who first conceived of
`the claimed invention and first reduced it to practice is
`the first inventor. If one person conceived of the claimed
`invention first, but reduced to practice second, that
`person is the first inventor only if that person (a) began to
`reduce the claimed invention to practice before the other
`party conceived of it and (b) continued to work diligently
`to reduce it to practice. [A claimed invention is “reduced
`to practice” when it has been tested sufficiently to show
`that it will work for its intended purpose or when it is
`fully described in a patent application filed with the
`PTO].]
`
`[Since it is in dispute, you must determine a date of
`conception for the [claimed invention] [and/or] [prior
`invention]. Conception is the mental part of an inventive
`act and is proven when the invention is shown in its
`complete form by drawings, disclosure to another or
`other forms of evidence presented at trial.]
`
`13
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`University of Maryland, Baltimore
`IPR2016-00208
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`Exhibit 2001
`Page 13 of 42
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`

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`Declaration of Dr. John Garrett
`Case No. IPR2016-00208
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`(Model Patent Jury Instructions for the Northern District of California at 30-31,
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`§ 4.3a1 (July 1, 2015).)
`
`4.3a2 STATUTORY BARS
`
`A patent claim is invalid if the patent application was not
`filed within the time required by law. This is called a
`“statutory bar.” For a patent claim to be invalid by a
`statutory bar, all of its requirements must have been
`present in one prior art reference dated more than one
`year before the patent application was filed. Here is a list
`of ways [alleged infringer] can show that the patent
`application was not timely filed: [choose those that
`apply]
`
`[– if the claimed invention was already patented or
`described in a printed publication anywhere in the world
`before [insert date that is one year before effective filing
`date of patent application]. [A reference is a “printed
`publication” if it is accessible to those interested in the
`field, even if it is difficult to find.];]
`
`[– if the claimed invention was already being openly used
`in the United States before [insert date that is one year
`before application filing date] and that use was not
`primarily an experimental use (a) controlled by the
`inventor, and (b) to test whether the invention worked for
`its intended purpose;]
`
`14
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`University of Maryland, Baltimore
`IPR2016-00208
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`Exhibit 2001
`Page 14 of 42
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`

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`Declaration of Dr. John Garrett
`Case No. IPR2016-00208
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`[– if a device or method using the claimed invention was
`sold or offered for sale in the United States, and that
`claimed invention was ready for patenting, before [insert
`date that is one year before application filing date]. [The
`claimed invention is not being [sold] [or] [offered for
`sale] if the [patent holder] shows that the [sale] [or] [offer
`for sale] was primarily experimental.] [The claimed
`invention is ready for patenting if it was actually built, or
`if
`the
`inventor had prepared drawings or other
`descriptions of
`the claimed
`invention
`that were
`sufficiently detailed to enable a person of ordinary skill
`in the field to make and use the invention based on
`them.];]
`
`[– if the [patent holder] had already obtained a patent on
`the claimed invention in a foreign country before filing
`the original U.S. application, and the foreign application
`was filed at least one year before the U.S. application.]
`
`For a claim to be invalid because of a statutory bar, all of
`the claimed requirements must have been either (1)
`disclosed in a single prior art reference, (2) implicitly
`disclosed in a reference to one skilled in the field, or (3)
`must have been present in the reference, whether or not
`that was understood at the time. The disclosure in a
`reference does not have to be in the same words as the
`claim, but all the requirements must be there, either
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`University of Maryland, Baltimore
`IPR2016-00208
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`Exhibit 2001
`Page 15 of 42
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`

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`Declaration of Dr. John Garrett
`Case No. IPR2016-00208
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`described in enough detail or necessarily implied, to
`enable someone of ordinary skill in the field of [identify
`field] looking at the reference to make and use the
`claimed invention.
`
`(Model Patent Jury Instructions for the Northern District of California at 32,
`
`§ 4.3a2 (July 1, 2015).)
`
`4.3c OBVIOUSNESS
`
`Even though an invention may not have been identically
`disclosed or described before it was made by an inventor,
`in order to be patentable, the invention must also not
`have been obvious to a person of ordinary skill in the
`field of technology of the patent at the time the invention
`was made.
`
`[Alleged infringer] may establish that a patent claim is
`invalid by showing, by clear and convincing evidence,
`that the claimed invention would have been obvious to
`persons having ordinary skill in the art at the time the
`invention was made in the field of [insert the field of the
`invention].
`
`In determining whether a claimed invention is obvious,
`you must consider the level of ordinary skill in the field
`[of the invention] that someone would have had at the
`time the [invention was made] or [patent was filed], the
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`University of Maryland, Baltimore
`IPR2016-00208
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`Exhibit 2001
`Page 16 of 42
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`

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`Declaration of Dr. John Garrett
`Case No. IPR2016-00208
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`scope and content of the prior art, and any differences
`between the prior art and the claimed invention.
`
`Keep in mind that the existence of each and every
`element of the claimed invention in the prior art does not
`necessarily prove obviousness. Most,
`if not all,
`inventions rely on building blocks of prior art. In
`considering whether a claimed invention is obvious, you
`may but are not required to find obviousness if you find
`that at the time of the claimed invention [or the patent’s
`filing date] there was a reason that would have prompted
`a person having ordinary skill in the field of [the
`invention] to combine the known elements in a way the
`claimed invention does, taking into account such factors
`as (1) whether the claimed invention was merely the
`predictable result of using prior art elements according to
`their known function(s); (2) whether
`the claimed
`invention provides an obvious solution to a known
`problem in the relevant field; (3) whether the prior art
`teaches or suggests
`the desirability of combining
`elements claimed in the invention; (4) whether the prior
`art teaches away from combining elements in the claimed
`invention; (5) whether it would have been obvious to try
`the combinations of elements, such as when there is a
`design need or market pressure to solve a problem and
`there are a finite number of identified, predictable
`solutions; and (6) whether the change resulted more from
`17
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`University of Maryland, Baltimore
`IPR2016-00208
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`Exhibit 2001
`Page 17 of 42
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`

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`Declaration of Dr. John Garrett
`Case No. IPR2016-00208
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`design incentives or other market forces. To find it
`rendered the invention obvious, you must find that the
`prior art provided a reasonable expectation of success.
`Obvious
`to
`try
`is not sufficient
`in unpredictable
`technologies.
`
`In determining whether the claimed invention was
`obvious, consider each claim separately. Do not use
`hindsight, i.e., consider only what was known at the time
`of the invention [or the patent’s filing date].
`
`In making these assessments, you should take into
`account any objective evidence (sometimes called
`“secondary considerations”) that may shed light on the
`obviousness or not of the claimed invention, such as:
`
`(a) Whether the invention was commercially successful
`as a result of the merits of the claimed invention (rather
`than the result of design needs or market-pressure
`advertising or similar activities);
`
`(b) Whether the invention satisfied a long-felt need;
`
`(c) Whether others had tried and failed to make the
`invention;
`
`(d) Whether others invented the invention at roughly the
`same time;
`
`(e) Whether others copied the invention;
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`IPR2016-00208
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`Exhibit 2001
`Page 18 of 42
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`Declaration of Dr. John Garrett
`Case No. IPR2016-00208
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`(f) Whether there were changes or related technologies or
`market needs contemporaneous with the invention;
`
`(g) Whether the invention achieved unexpected results;
`
`(h) Whether others in the field praised the invention;
`
`(i) Whether persons having ordinary skill in the art of the
`invention expressed surprise or disbelief regarding the
`invention;
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`(j) Whether others sought or obtained rights to the patent
`from the patent holder; and
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`(k) Whether the inventor proceeded contrary to accepted
`wisdom in the field.
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`Federal Circuit Bar Association Model Jury Instructions §4.3c (2014).
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`28.
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`I am also informed that the United States Patent Office supplies its
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`examining corps with a Manual of Patent Examining Procedure that provides
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`exemplary rationales that may support a conclusion of obviousness, including:
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`(a) Combining prior art elements according to known
`methods to yield predictable results;
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`(b) Simple substitution of one known element for another
`to obtain predictable results;
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`(c) Use of known technique to improve similar devices
`(methods, or products) in the same way;
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`(d) Applying a known technique to a known device
`(method, or product) ready for improvement to yield
`predictable results;
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`(e) “Obvious to try” – choosing from a finite number of
`identified, predictable solutions, with a reasonable
`expectation of success;
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`(f) Known work in one field of endeavor may prompt
`variations of it for use in either the same field or a
`different one based on design incentives or other market
`forces if the variations are predictable to one of ordinary
`skill in the art; or
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`(g) Some teaching, suggestion, or motivation in the prior
`art that would have led one of ordinary skill to modify
`the prior art reference or to combine prior art reference
`teachings to arrive at the claimed invention.
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`MPEP § 2143. I apply these principles in my analysis below.
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`III. THE ‘386 PATENT
`A.
`Interpretation of Claim Limitations in the ‘386 Patent
`29.
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`I understand that the Petitioner has made determinations about the
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`broadest reasonable interpretations (BRIs) of various claim terms in the ‘386
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`patent. The only term necessary to address for purposes of the Patent Owner’s
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`Response, however, is the BRI for “percutaneously accessing an apical region of
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`the heart.” Petitioner and Dr. Aklog take the position that the BRI for this term is
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`“the process of obtaining access through the skin to a region of a ventricular
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`chamber of the heart near the apex of the heart.” Pet. 12. But, I disagree for the
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`reasons set forth below.
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`1.
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`Petitioner’s and Dr. Aklog’s BRI for “Percutaneously
`Accessing” is Inconsistent with the ‘386 Patent Disclosure
`30. As I mentioned in Part II.C above, I understand from Patent Owner
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`that claim terms are to be given their BRI in light of the specification. The BRI
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`that Petitioner and Dr. Aklog provided does not appear to take the ‘386 patent
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`specification into consideration.
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`31.
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`In my opinion, the specification describes two techniques for
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`“percutaneously accessing” the apical region of the heart. The first technique is an
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`“endovascular” approach, and the second is a “direct needle puncture.” (See, e.g.,
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`Ex. 1001, 11:35-52 (“although the following describes accessing the heart via an
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`apical incision, percutaneous access through direct puncture of the heart
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`(transmyocardial) may also be used … [s]till yet, other percutaneous approaches
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`may be employed where access is made endovascularly”).) I discuss each of these
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`percutaneous approaches below in more detail.
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`32. The endovascular approach is a technique that involves feeding a
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`device through the patient’s vasculature to the apical region of the heart in the
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`appropriate ventricle (the left ventricle for repair of a mitral valve or the right
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`ventricle for repair of a tricuspid valve). In the antegrade approach, the device is
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`fed through “femoral or internal jugular veins” and then the heart is accessed “via
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`the inter-atrial septum (trans-septal) and then into the left atrium.” (Ex. 1001, 6:27-
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`31.) In the retrograde approach, the device is fed through “the femoral artery …
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`the aorta, across the aortic valve into the left side of the heart.” (Ex. 1001, 11:50-
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`52.) This “endovascular” technique does not require any cuts or openings because
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`the device is able to access the apical region of the heart entirely through the
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`patient’s vasculature. This is why the ‘386 patent refers to the endovascular
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`approach as “completely percutaneous”.
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`33. The second technique disclosed in the ‘386 patent is via “direct needle
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`puncture”. The specification explains that “[w]hen a percutaneous approach is
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`sought, no incision into the apex region of the heart need be made, rather access
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`into the apical region may be gained by direct needle puncture, for instance by an
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`18 gauge needle.” (Ex. 1001, 10:2-7 (emphasis added); see also, id., 6:65-7:1
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`(“access to the heart may be gained by direct puncture (i.e., via an appropriately
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`sized needle, for instance an 18 gauge needle) of the heart from the xyphoid
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`region”), 11:35-52 (“although the following describes accessing the heart via an
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`apical incision, percutaneous access through direct puncture of the heart
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`(transmyocardial) may also be used, via the insertion of an appropriate grade
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`needle (e.g., an 18 gauge needle) into the apical region of the heart”).) I understand
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`direct needle puncture to include needle punctures through the skin rather than
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`using a needle after making an incision.
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`34.
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`It is my opinion that the ‘386 patent specification makes clear that a
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`percutaneous access is distinct from a minimally invasive access, where “one or
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`more incisions are made proximate to the thoracic cavity so as to provide a surgical
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`field of access.” (Ex. 1001, 7:26-27.) The specification unequivocally states that
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`