UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`EDGE ENDO, LLC,
`
`Petitioner,
`
`v.
`
`MAILLEFER INSTRUMENTS HOLDING S.A.R.L.,
`
`Patent Owner.
`
`Case No. IPR2018-01349
`U.S. Patent No. 9,801,696
`
`DECLARATION OF JOHN MCSPADDEN, DDS
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`(cid:48)(cid:36)(cid:44)(cid:47)(cid:47)(cid:40)(cid:41)(cid:40)(cid:53)(cid:3)(cid:40)(cid:59)(cid:43)(cid:44)(cid:37)(cid:44)(cid:55)(cid:3)(cid:21)(cid:19)(cid:19)(cid:20)
`(cid:40)(cid:71)(cid:74)(cid:72)(cid:3)(cid:40)(cid:81)(cid:71)(cid:82)(cid:15)(cid:3)(cid:47)(cid:47)(cid:38)(cid:3)(cid:89)(cid:17)(cid:3)(cid:48)(cid:68)(cid:76)(cid:79)(cid:79)(cid:72)(cid:73)(cid:72)(cid:85)(cid:3)(cid:44)(cid:81)(cid:86)(cid:87)(cid:85)(cid:88)(cid:80)(cid:72)(cid:81)(cid:87)(cid:86)(cid:3)(cid:43)(cid:82)(cid:79)(cid:71)(cid:76)(cid:81)(cid:74)(cid:3)(cid:54)(cid:17)(cid:68)(cid:17)(cid:85)(cid:17)(cid:79)(cid:17)
`(cid:38)(cid:68)(cid:86)(cid:72)(cid:3)(cid:44)(cid:51)(cid:53)(cid:21)(cid:19)(cid:20)(cid:27)(cid:16)(cid:19)(cid:20)(cid:22)(cid:23)(cid:28)
`
`

`

`Declaration of John McSpadden, DDS
`U.S. Patent No. 9,801,696
`
`TABLE OF CONTENTS
`
`I.
`
`BACKGROUND AND QUALIFICATIONS.................................................3
`
`II.
`
`COMPENSATION ..........................................................................................5
`
`III. MATERIALS CONSIDERED ........................................................................6
`
`IV. SUMMARY OF MY OPINION......................................................................6
`
`V.
`
`LEGAL PRINCIPLES USED IN MY ANALYSIS........................................9
`
`A.
`
`PATENT CLAIMS ...................................................................................10
`
`B.
`
`C.
`
`PRIOR ART............................................................................................10
`
`ANTICIPATION ......................................................................................11
`
`D. OBVIOUSNESS.......................................................................................11
`
`E.
`
`F.
`
`A PERSON OF ORDINARY SKILL............................................................14
`
`CLAIM CONSTRUCTION.........................................................................16
`
`VI. PETITIONER’S GROUNDS OF CHALLENGE .........................................17
`
`VII. SUMMARY OF THE ’696 PATENT ...........................................................18
`
`VIII. CLAIM CONSTRUCTION ..........................................................................22
`
`A.
`
`B.
`
`“POINT” ................................................................................................22
`
`“A TAPERED ROD DEFINED BY A SINGLE CONTINUOUS TAPER
`FUNCTION” ...........................................................................................23
`
`C.
`
`“POLYGONAL CROSS-SECTION”.............................................................25
`
`IX. PETITIONER HAS NOT ESTABLISHED A REASONABLE
`LIKELIHOOD THAT THE CHALLENGED CLAIMS ARE
`INVALID.......................................................................................................26
`
`A.
`
`THE CLAIMED “FIRST PORTION” IS NOT DISCLOSED OR
`SUGGESTED BY THE ART CITED IN THE PETITION .................................26
`
`i
`
`

`

`Declaration of John McSpadden, DDS
`U.S. Patent No. 9,801,696
`
`1.
`
`2.
`
`Petitioner Conflates Two Separate Elements—a “Tip” and
`“Tip Portion”—in Its Attempt to Demonstrate that the Claimed
`“First Portion” is Disclosed by the Prior Art ..........................29
`
`Neither the “Tip” nor Petitioner’s “Tip Portion” Satisfies the
`Limitations for the “First Portion” of Claim 1 ........................32
`
`B.
`
`C.
`
`THE MCSPADDEN GROUNDS (NOS. 1-3) ARE NOT
`REASONABLY LIKELY TO PREVAIL FOR THE ADDITIONAL
`REASON THAT THE INSTRUMENT SHOWN IN FIGURE 3A OF
`MCSPADDEN-186 DOES NOT HAVE A SINGLE CONTINUOUS
`TAPER FUNCTION .................................................................................69
`
`THE SCIANAMBLO GROUNDS (NOS. 4-5) ARE NOT
`REASONABLY LIKELY TO PREVAIL FOR THE ADDITIONAL
`REASON THAT THE PETITION DOES NOT EXPLAIN WHY THE
`INVENTION AS A WHOLE IS ALLEGED TO BE OBVIOUS..........................75
`
`1.
`
`2.
`
`The Petition Picks and Chooses Features from Distinct
`Embodiments Without Explaining How Those Features Render
`Obvious the Invention as a Whole ............................................75
`
`Petitioner’s Combination Fails to Produce a File Having the
`Claimed “First Portion” for the Additional Reason that
`Petitioner Does Not Demonstrate that At Least Two Cutting
`Edges of Scianamblo’s First Portion would be Located on the
`Envelope....................................................................................86
`
`D.
`
`THE BADOZ GROUNDS (NOS. 6-7) ARE NOT REASONABLY
`LIKELY TO PREVAIL FOR THE ADDITIONAL REASON THAT
`PETITIONER DOES NOT DEMONSTRATE THAT AT LEAST TWO
`CUTTING EDGES OF BADOZ’S FIRST PORTION WOULD BE
`LOCATED ON THE ENVELOPE ................................................................89
`
`X.
`
`CONCLUSION..............................................................................................94
`
`ii
`
`

`

`Declaration of John McSpadden, DDS
`U.S. Patent No. 9,801,696
`
`I, John McSpadden, declare as follows:
`
`I.
`
`Background and Qualifications
`
`1.
`
`My curriculum vitae (CV) detailing my educational background and
`
`professional experience is enclosed as Appendix A. I hold a Doctorate in Dental
`
`Surgery from the University of Tennessee College of Dentistry and a Bachelor of
`
`Science degree in Biology from the University of Tennessee.
`
`2.(cid:3)
`
`I have more than fifty years of experience in the field of endodontic(cid:3)
`
`instrumentation. I have founded six companies specializing in endodontic devices.
`
`Those companies were ITI, LLC, Advanced Endodontic Concepts, LLC, NT
`
`Company, LLC, Cloudland Institute, LLC, Tycom Endo (a division of Tycom
`
`Co.), and NanoEndo, LLC. Each of those companies sold products internationally,
`
`and each was acquired by a major dental company.
`
`3.(cid:3)
`
`I am a listed inventor on at least twenty-two United States utility(cid:3)
`
`patents relating to endodontic instruments and techniques, including U.S. Patent
`
`Nos. 4,299,571; 4,332,561; 4,353,698; 4,457,710; 4,605,025; 4,904,185; 5,035,617;
`
`5,067,900; 5,083,923; 5,104,316; 5,275,562; 5,7(cid:22)5,689; 5,882,198; 5,902,106;
`
`5,938,440; 5,980,250; 6,293,794; 6,419,488; 6,9(cid:25)6,774; 7,223,100; 7,731,498; and
`
`8,182,265. I am a listed inventor on three of the patent references cited in the
`
`Petition: U.S. Patent Publication Nos. 2004/0023186 and
`
`2006/0228668; and U.S. Patent No. 5,882,198.
`
`3
`
`

`

`Declaration of John McSpadden, DDS
`U.S. Patent No. 9,801,696
`
`4.
`
`I have contributed to four textbooks regarding endodontic
`
`instrumentation and technique. I am the sole author of Mastering Endodontic
`
`Instrumentation, which is cited as an exhibit in the Petition. I was a contributing
`
`author to Clinique Endodontie, Endodontics, and Pathways of the Pulp.
`
`5.
`
`I have frequently lectured on endodontic instrument design and
`
`clinical technique. I have spoken at thirty-one endodontic graduate programs in
`
`the United States and more than a dozen universities and endodontic societies
`
`overseas, including in France, Britain, Italy, and Japan.
`
`6.
`
`I have received numerous professional recognitions and awards for
`
`my contributions to the field of endodontics. Those awards include the President’s
`
`Award for Outstanding Contribution to Endodontics, the International Louis I.
`
`Grossman Award for Outstanding Contribution to Endodontics, and the Ralph F.
`
`Summers Award for Outstanding Publication. Each of these was awarded by the
`
`American Association of Endodontics. I have also been recognized as an
`
`Honorary Member of the French Endodontic Society, La Société Française
`
`d’Endodontie.
`
`7.
`
`Based on my education and experience, I believe I am qualified to
`
`render opinions in the field of endodontic instruments, including the properties and
`
`geometries associated with endodontic instruments of the type at issue in this
`
`proceeding.
`
`4
`
`

`

`Declaration of John McSpadden, DDS
`U.S. Patent No. 9,801,696
`
`II.
`
`Compensation
`
`8.
`
`I have been retained in this matter by Rothwell, Figg, Ernst &
`
`Manbeck, P.C. (“RFEM”). I am being compensated at my standard consulting rate
`
`of $400 per hour for my work in this matter. I have no financial stake or
`
`ownership interest in the outcome of the Petition for Inter Partes Review filed by
`
`Edge Endo LLC (“Petitioner”) in IPR2018-01349 (“this Proceeding”) or any
`
`related action. My compensation in no way depends upon my testimony or the
`
`outcome of the Petition for Inter Partes Review.
`
`9.
`
`I understand that RFEM represents Maillefer Instruments Holding
`
`S.A.R.L. (“Maillefer” or “Patent Owner”), Dentsply Sirona Inc., (“DSI”) and Tulsa
`
`Dental Products LLC d/b/a Dentsply Sirona Endodontics (“Tulsa Dental”)
`
`(collectively, “Dentsply” or “Dentsply Sirona”). I understand that Maillefer owns
`
`the ’696 patent, and that Maillefer, DSI, and Tulsa Dental are real parties-in-
`
`interest in this Proceeding. I understand that Edge Endo LLC, US Endodontics,
`
`LLC, Charles Goodis, Bobby Bennett, Edge Holdings, LLC, Guidance
`
`Endodontics, LLC, Peter Brasseler Holdings, LLC, SG Healthcare Corp., SanDev
`
`Corp., and Henry Schein, Inc. are real parties-in-interest in this Proceeding. To my
`
`knowledge, I have no financial stake or ownership interest in any real party-in-
`
`interest in this Proceeding or (cid:87)(cid:75)(cid:72)(cid:3)(cid:1932)696 patent.
`
`5
`
`

`

`Declaration of John McSpadden, DDS
`U.S. Patent No. 9,801,696
`
`III. Materials Considered
`
`10.
`
`In preparing this declaration, I have considered my own knowledge
`
`and experience, including my work and experience in the field of endodontic
`
`instrumentation, and my work with others involved in the relevant art. In addition
`
`(cid:87)(cid:82)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:80)(cid:68)(cid:87)(cid:72)(cid:85)(cid:76)(cid:68)(cid:79)(cid:86)(cid:3)(cid:70)(cid:76)(cid:87)(cid:72)(cid:71)(cid:3)(cid:75)(cid:72)(cid:85)(cid:72)(cid:76)(cid:81)(cid:15)(cid:3)(cid:44)(cid:3)(cid:75)(cid:68)(cid:89)(cid:72)(cid:3)(cid:85)(cid:72)(cid:68)(cid:71)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:1932)696 patent, and reviewed the file
`
`history for its underlying application, U.S. Application No. 14/651,677. I have
`
`also considered the documents cited herein and those listed in Appendix B.
`
`IV.
`
`Summary of My Opinion
`
`11. Claim 1 of the ’696 patent relates generally to an instrument for
`
`drilling root canals having: (1) a tip, (2) a first portion of the active part that
`
`extends from the tip and is centered with at least two cutting edges located on the
`
`envelope, and (3) a second portion of the active part that extends following the first
`
`portion towards the rear of the active part with at least one cross-section that has a
`
`center of mass offset from the axis of rotation and at least one cutting edge located
`
`set back within the envelope.
`
`1. An instrument for drilling dental root canals comprising:
`
`a tapered rod defined by a single continuous taper function and having
`over at least an active part of its length a polygonal cross-section
`forming at least two cutting edges, said active part terminating by a
`point and being defined by an envelope of a cylindrical or conical
`shape along its entire length, the longitudinal axis of the envelope
`coinciding with the axis of rotation of the instrument,
`
`6
`
`

`

`Declaration of John McSpadden, DDS
`U.S. Patent No. 9,801,696
`
`wherein for any cross-section of the active part, at least one of the at
`least two cutting edges is located on the envelope,
`
`said active part has a first portion extending from the point and a
`second portion extending following the first portion towards the rear
`of the active part,
`
`any cross-section of the first portion has a center of mass located on
`the axis of rotation, said at least two cutting edges defined by said
`cross-section of the first portion being located on the envelope,
`
`at least one cross-section of the second portion has a center of mass
`offset with respect to the axis of rotation, at least one cutting edge
`defined by said cross-section of the second portion being located set
`back within the envelope.
`
`Ex. 1001, claim 1.
`
`12.
`
`I have been asked to provide my opinion of the level of ordinary skill
`
`in the art to which the ’696 patent pertains and to interpret the claim terms “point,”
`
`“a tapered rod defined by a single continuous taper function,” and “polygonal
`
`cross-section,” using the broadest reasonable interpretation standard by ascribing
`
`to them meaning they would have to a person of ordinary skill in the art in light of
`
`the specification and prosecution history of the ’696 patent.
`
`13. After reviewing the ’696 patent claims, patent specification, and
`
`prosecution history, it is my opinion that a POSITA would understand the term
`
`“point” to mean the “tip” of the endodontic instrument.
`
`7
`
`

`

`Declaration of John McSpadden, DDS
`U.S. Patent No. 9,801,696
`
`14.
`
`It is further my opinion that a POSITA would understand the term “a
`
`tapered rod defined by a single continuous taper function” to mean “a tapered rod
`
`that continues to taper inwardly along its active length.”
`
`15. And, it is my opinion that a POSITA would understand the term
`
`“polygonal cross-section” to mean “a cross-section which has a plurality of straight
`
`or curved sides.”
`
`16.
`
`I have also been asked to provide my opinion regarding whether claim
`
`1 of the ’696 patent is anticipated by or rendered obvious over the cited references.
`
`17.
`
`It is my opinion that the Petition does not show that the claimed “first
`
`portion” which must (1) extend from the point (i.e., the tip) and (2) be centered is
`
`anticipated or obvious over the prior art. Instead of referring to a single structure
`
`that satisfies both of these limitations, Petitioner instead refers to a “tip portion”
`
`and the “tip,” respectively. As a result, the Petition does not demonstrate that this
`
`element is present in the three primary references upon which it relies—
`
`McSpadden-186, Badoz, and Rouiller.
`
`18.
`
`I understand that the Petition alleges that claim 1 of the ’696 patent is
`
`anticipated by or obvious over the McSpadden-186 reference. It is my opinion that
`
`claim 1 of the ’696 patent is not anticipated by or obvious over the McSpadden-
`
`186 reference for the additional reason that the instrument shown in the
`
`8
`
`

`

`Declaration of John McSpadden, DDS
`U.S. Patent No. 9,801,696
`
`embodiment upon which the Petition relies, Figure 3A, does not have a single
`
`continuous taper function.
`
`19.
`
`I understand that the Petition does not allege that claim 1 of the ’696
`
`patent is anticipated by the Scianamblo reference. My opinion therefore only
`
`addresses obviousness, and it is my opinion that claim 1 of the ’696 patent is not
`
`obvious over the Scianamblo reference for the additional reason that the Petition
`
`does not explain how the invention as a whole is alleged to be obvious.
`
`20.
`
`I understand that the Petition does not allege that claim 1 of the ’696
`
`patent is anticipated by the Badoz reference. My opinion therefore only addresses
`
`obviousness, and it is my opinion that claim 1 of the ’696 patent is not obvious
`
`over the Badoz reference for the additional reason that the Petition does not
`
`demonstrate that at least two cutting edges of the first portion would be located on
`
`the envelope as required by claim 1.
`
`V.
`
`Legal Principles Used in My Analysis
`
`21.
`
`I am not a patent attorney nor have I independently researched the law
`
`on patentability. Rather, RFEM attorneys have explained to me the legal
`
`principles upon which I have relied in forming the opinions I set forth in this
`
`declaration.
`
`9
`
`

`

`Declaration of John McSpadden, DDS
`U.S. Patent No. 9,801,696
`
`A.
`
`Patent Claims
`
`22.
`
`I have been informed that patent claims are the numbered sentences at
`
`the end of each patent. I have been informed that the claims are important because
`
`the words of the claims define what a patent covers. I have also been informed that
`
`the figures and text in the rest of the patent provide a description and/or examples
`
`and help explain the scope of the claims, but that the claims themselves define the
`
`scope of the patent’s coverage.
`
`23.
`
`I have also been informed that an “independent claim” expressly sets
`
`forth all of the elements that must be met in order for something to be covered by
`
`that claim. I have also been informed that a “dependent claim” does not itself
`
`recite all of the elements of the claim but refers to another claim for some of its
`
`elements. In this way, the claim “depends” on another claim and incorporates all
`
`of the elements of the claim(s) from which it depends. I also have been informed
`
`that dependent claims add additional elements. I have been informed that, to
`
`determine all the elements of a dependent claim, it is necessary to look at the
`
`recitations of the dependent claim and any other claim(s) on which it depends.
`
`B.
`
`Prior Art
`
`24.
`
`I have been informed that the law provides categories of information
`
`referred to as “prior art” that may be used to anticipate or render obvious patent
`
`claims. I have been informed that, to be prior art with respect to a particular patent
`
`10
`
`

`

`Declaration of John McSpadden, DDS
`U.S. Patent No. 9,801,696
`
`in the context of an IPR proceeding, a reference must have been published, or
`
`patented, or be the subject of a patent application by another, before the priority
`
`date of the patent.
`
`25.
`
`Further, I have been informed that statements by a patent applicant or
`
`patentee, including statements in the patent that something is in the “prior art,” can
`
`constitute prior art that can be used to anticipate or render obvious patent claims.
`
`That is, prior art can be created by admissions of the patent applicant or patentee.
`
`26.
`
`I also understand that a person of ordinary skill in the art (“POSITA”)
`
`is presumed to have knowledge of all prior art. I set forth my understanding of a
`
`POSITA below in Paragraph 37.
`
`C.
`
`Anticipation
`
`27.
`
`I have been informed that a patent claim is unpatentable for
`
`anticipation under 35 U.S.C. § 102 if the recited invention is described in a single
`
`prior-art reference that discloses each claim element, either expressly or
`
`inherently. I have been informed that in order for a reference to inherently
`
`anticipate, the inherent subject matter must necessarily follow from the teachings
`
`of the reference as opposed to being a mere possibility.
`
`D.
`
`Obviousness
`
`28.
`
`I have been informed and understand that, if every element of a claim
`
`is not found explicitly or implicitly in a single prior art reference, the claim may
`
`11
`
`

`

`Declaration of John McSpadden, DDS
`U.S. Patent No. 9,801,696
`
`still be unpatentable if the differences between the claimed elements and the prior
`
`art are such that the subject matter as a whole would have been obvious at the time
`
`the invention was made to a POSITA. I have also been informed that a
`
`determination of whether the claims of a patent are rendered obvious by prior art is
`
`a two-step analysis: (1) determining the meaning and scope of the claims, and (2)
`
`comparing the properly construed claims to the prior art.
`
`29.
`
`I have been informed and understand that a patent claim is obvious
`
`when it is only a combination of old and known elements, with no change in their
`
`respective functions, and that these familiar elements are combined according to
`
`known methods to obtain predictable results. I have been informed and understand
`
`that the following four factors are considered when determining whether a patent
`
`claim is obvious: (1) the scope and content of the prior art; (2) the differences
`
`between the prior art and the claim; (3) the level of ordinary skill in the art; and
`
`(4) additional considerations of objective evidence, sometimes referred to as
`
`“secondary considerations,” tending to prove obviousness or non-obviousness.
`
`30.
`
`I have been informed that secondary considerations may include:
`
`unexpected, surprising, or unusual results; substantially superior results;
`
`synergistic results; long-felt, but unmet, need; commercial success; and copying by
`
`others. I have also been informed and understand that there must be a connection
`
`between these additional factors and the scope of the claim language.
`
`12
`
`

`

`Declaration of John McSpadden, DDS
`U.S. Patent No. 9,801,696
`
`31.
`
`In determining obviousness based on a combination of prior art
`
`references, I also understand that there must have been a reason to combine the
`
`teachings, and thus reasons for combining the references must be considered, along
`
`with any evidence that one or more of the references would have taught away from
`
`the claimed invention at the time of the invention.
`
`32.
`
`I have also been informed and understand that some examples of
`
`rationales that may support a conclusion of obviousness include:
`
`(A) combining prior art elements according to known methods to
`
`yield predictable results;
`
`(B) simply substituting one known element for another to obtain
`
`predictable results;
`
`(C) using known techniques to improve similar devices (methods, or
`
`products) in the same way;
`
`(D) applying a known technique to a known device (method, or
`
`product) ready for improvement to yield predictable results;
`
`(E) choosing from a finite number of identified, predictable solutions,
`
`with a reasonable expectation of success—in other words, whether
`
`something is “obvious to try;”
`
`(F) using work in one field of endeavor to prompt variations of that
`
`work for use in either the same field or a different one based on design
`
`13
`
`

`

`Declaration of John McSpadden, DDS
`U.S. Patent No. 9,801,696
`
`incentives or other market forces if the variations are predictable to
`
`one of ordinary skill in the art; and
`
`(G) arriving at a claimed invention as a result of 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.
`
`33.
`
`I have also been informed that other rationales to support a conclusion
`
`of obviousness may be relied upon, for instance, that common sense (where
`
`substantiated) may be a reason to combine or modify prior art to achieve the
`
`claimed invention.
`
`34.
`
`I am also informed that a basis to combine teachings need not be
`
`stated expressly in any prior art reference. However, I understand that there must
`
`be some evidence showing an articulated reasoning with rational underpinnings to
`
`support a motivation to combine teachings and to support the legal conclusion of
`
`obviousness.
`
`E.
`
`A Person of Ordinary Skill
`
`35.
`
`I have been informed that my assessment and determination of the
`
`(cid:83)(cid:68)(cid:87)(cid:72)(cid:81)(cid:87)(cid:68)(cid:69)(cid:76)(cid:79)(cid:76)(cid:87)(cid:92)(cid:3)(cid:82)(cid:73)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:70)(cid:75)(cid:68)(cid:79)(cid:79)(cid:72)(cid:81)(cid:74)(cid:72)(cid:71)(cid:3)(cid:70)(cid:79)(cid:68)(cid:76)(cid:80)(cid:86)(cid:3)(cid:82)(cid:73)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:1932)696 patent must be undertaken from
`
`the perspective of what would have been known or understood by someone of
`
`14
`
`

`

`(cid:82)(cid:85)(cid:71)(cid:76)(cid:81)(cid:68)(cid:85)(cid:92)(cid:3)(cid:86)(cid:78)(cid:76)(cid:79)(cid:79)(cid:3)(cid:76)(cid:81)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:85)(cid:72)(cid:79)(cid:72)(cid:89)(cid:68)(cid:81)(cid:87)(cid:3)(cid:73)(cid:76)(cid:72)(cid:79)(cid:71)(cid:3)(cid:68)(cid:86)(cid:3)(cid:82)(cid:73)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:72)(cid:68)(cid:85)(cid:79)(cid:76)(cid:72)(cid:86)(cid:87)(cid:3)(cid:83)(cid:85)(cid:76)(cid:82)(cid:85)(cid:76)(cid:87)(cid:92)(cid:3)(cid:71)(cid:68)(cid:87)(cid:72)(cid:3)(cid:87)(cid:82)(cid:3)(cid:90)(cid:75)(cid:76)(cid:70)(cid:75)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:1932)696
`
`Declaration of John McSpadden, DDS
`U.S. Patent No. 9,801,696
`
`patent is entitled.
`
`36.
`
`I have been informed that the POSITA is a hypothetical person who is
`
`presumed to have known the relevant art at the time of the invention. I have
`
`further been informed that a POSITA is also a person of ordinary creativity, not an
`
`automaton. I have also been informed that the hypothetical person having ordinary
`
`skill in the art to which the claimed subject matter pertains would, of necessity,
`
`have the capability of understanding the scientific and engineering principles
`
`applicable to the pertinent art. After approximately 50 years of experience, I am
`
`well acquainted with the level of ordinary skill that would have been required to
`
`design, develop, and/or implement the subject matter of the ’696 patent. I have
`
`direct experience with the relevant subject matter and am capable of rendering an
`
`informed opinion regarding what the level of ordinary skill in the art was at the
`
`time of the invention. I am also capable of rendering an informed opinion
`
`regarding what one of ordinary skill in the art would have understood at the time of
`
`the alleged invention.
`
`37. (cid:37)(cid:68)(cid:86)(cid:72)(cid:71)(cid:3)(cid:82)(cid:81)(cid:3)(cid:80)(cid:92)(cid:3)(cid:72)(cid:91)(cid:83)(cid:72)(cid:85)(cid:76)(cid:72)(cid:81)(cid:70)(cid:72)(cid:3)(cid:76)(cid:81)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:73)(cid:76)(cid:72)(cid:79)(cid:71)(cid:15)(cid:3)(cid:68)(cid:81)(cid:68)(cid:79)(cid:92)(cid:86)(cid:76)(cid:86)(cid:3)(cid:82)(cid:73)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:1932)696 patent, and
`
`review of the prior art, it is my opinion that a POSITA in the relevant field as of
`
`the filing date of the ’696 patent would have (i) had a doctoral degree in dental
`
`surgery (DDS), at least 2-3 years of experience performing endodontic procedures
`
`15
`
`

`

`Declaration of John McSpadden, DDS
`U.S. Patent No. 9,801,696
`
`using rotary endodontic instruments, and at least 2-3 years of experience testing,
`
`evaluating, or designing rotary endodontic instruments; (ii) had a bachelor’s,
`
`master’s, or Ph.D. degree in mechanical engineering or a related field, and at least
`
`2-3 years of practical experience testing, evaluating, or designing rotary
`
`endodontic instruments; or (iii) had at least 4-5 years of practical experience in
`
`mechanical design, including at least 2-3 years of experience testing, evaluating, or
`
`designing rotary endodontic instruments. A POSITA also would have had access
`
`to persons with expertise in related disciplines, such as machining and material
`
`sciences. These descriptions are approximate, and a higher level of education or
`
`skill might make up for less experience, and vice-versa.
`
`38.
`
`I am qualified as a person of at least ordinary skill in the art, both now
`
`and as of the time of the invention.
`
`F.
`
`Claim Construction
`
`39.
`
`I have been informed that in this IPR proceeding, claim terms are
`
`given their broadest reasonable interpretation consistent with the specification.1 I
`
`1 I understand that the United States Patent and Trademark Office (“USPTO”) will
`
`be changing the claim construction standard from “broadest reasonable
`
`interpretation” to the standard used in civil actions. Patent Owner’s proposed
`
`constructions are the same under both claim construction standards, and for the
`
`16
`
`

`

`Declaration of John McSpadden, DDS
`U.S. Patent No. 9,801,696
`
`have further been informed that under the broadest reasonable interpretation
`
`standard the words of a claim are generally given their ordinary and customary
`
`meaning as would be understood by a POSITA in question at the time of the
`
`invention in the context of the entire disclosure.
`
`40.
`
`I have also been informed that, in determining the meaning of a
`
`disputed claim limitation, the intrinsic evidence of record is considered by
`
`examining the claim language itself, the written description, and the prosecution
`
`history. I have further been informed that a patentee may act as its own
`
`lexicographer and depart from the ordinary and customary meaning by defining a
`
`term with reasonable clarity, deliberateness and precision, but that there is a
`
`presumption that a claim term carries its ordinary and customary meaning.
`
`VI. Petitioner’s Grounds of Challenge
`
`41.
`
`I understand that Petitioner has challenged the validity claims 1, 2, 5,
`
`and 8-10 of the ’696 patent (the “Challenged Claims”). The Grounds of challenge
`
`presented in the Petition are as follows:
`
`reasons set forth herein, it is my opinion that a POSITA would understand the
`
`claim terms at issue to have the meaning proposed by Patent Owner regardless of
`
`which standard is used.
`
`17
`
`

`

`Declaration of John McSpadden, DDS
`U.S. Patent No. 9,801,696
`
`Ground
`
`Reference(s)
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`Claim(s)
`
`1, 2, 5, 8
`
`Anticipation by U.S. Pat. Appl. No 2004/0023186 to
`McSpadden (“McSpadden-186,” Ex. 1004)
`
`Obviousness over McSpadden-186
`
`1, 2, 5, 8, 10
`
`Obviousness over McSpadden-186 in view of U.S.
`Pat. No. 6,299,445 to Garman (“Garman,” Ex. 1005)
`
`9
`
`Obviousness over U.S. Pat. Appl. No. 2006/0228669
`to Scianamblo (“Scianamblo,” Ex. 1006)
`
`1, 2, 5, 8, 10
`
`Obviousness over Scianamblo in view of Garman
`
`9
`
`Obviousness over WO 01/19279 to Badoz (“Badoz,”
`Exs. 1007 and 1008) in view of U.S. Pat. No.
`5,882,198 to Taylor et al. (“Taylor,” Ex. 1009)
`
`1, 2, 5, 10
`
`Obviousness over Badoz in view of Taylor and in
`further view of Garman
`
`8, 9
`
`42.
`
`In my opinion, none of the Grounds set forth in the Petition
`
`establishes a reasonable likelihood that any claim of the ’696 patent is invalid.
`
`VII. Summary of the ’696 Patent
`
`43.
`
`The ’696 patent claims an endodontic instrument—that is, an
`
`instrument that superficially resembles a drill bit and which is used to clean and
`
`shape a patient’s root canal. Unlike conventional endodontic instruments, the
`
`instrument claimed in the ’696 patent features an active part in which the position
`
`of the instrument’s cross-sectional mass is varied relative to the axis of rotation
`
`along the length of the instrument. Ex. 1001 at claim 1. This variance in offset is
`
`18
`
`

`

`Declaration of John McSpadden, DDS
`U.S. Patent No. 9,801,696
`
`used to modulate the flexibility along the length of the instrument to meet specific
`
`clinical needs that were not previously recognized in the field.
`
`44. Most endodontic files are tapered. This means that the distal end of
`
`the active part of an instrument can be very thin (often, on the order of 100-200
`
`microns), while a portion near the shank of the instrument can be much thicker
`
`(often, on the order of 1,000-1,200 microns). Due to the relative absence of cross-
`
`sectional mass, the distal end of the instrument nearest the tip is the most fragile
`
`part of the instrument. Moreover, this portion is intended to clean the apical third
`
`of the root canal, which can be the most difficult part of the canal to navigate due
`
`to its often tortuous anatomy. This combination of difficult anatomy and reduced
`
`mechanical strength can cause the endodontic instrument to fracture inside the root
`
`canal—a serious complication that produces significant post-operative pain.
`
`45. Moving proximally from the distal third of the file toward the shank, a
`
`conventional file body becomes gradually thicker at a rate determined by the taper
`
`angle of that file. As the file becomes thicker, the cross-sectional mass increases,
`
`and the file body stiffens. This can be problematic because the body of the file
`
`may need to flex in order to follow the natural anatomy of the root canal, most of
`
`which are curved. As elasticity is reduced, however, the force required to bend the
`
`file along a given curved path is increased, which means that the opposing force
`
`applied by the instrument body against the root canal wall is increased. This can
`
`19
`
`

`

`Declaration of John McSpadden, DDS
`U.S. Patent No. 9,801,696
`
`cause the instrument to “screw in” to the canal wall—another negative outcome.
`
`In extreme cases, the instrument can perforate through the dentin of the tooth and
`
`into the surrounding soft tissues.
`
`46.
`
`In conventional instruments, this stiffening was unavoidable because
`
`the file must become thicker (i.e., taper) in order to enlarge the cutting envelope to
`
`adequately clean the proximal regions of the root canal. By shifting the cross-
`
`sectional mass of the instrument relative to axis of rotation, however, the size of
`
`the cutting envelope may be decou