IPR2015-00632, Paper No. 77
`April 27, 2016
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`trials@uspto.gov
`571-272-7822
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
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`US ENDODONTICS, LLC,
`Petitioner,
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`v.
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`GOLD STANDARD INSTRUMENTS, LLC,
`Patent Owner.
`____________
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`Case IPR2015-00632
`Patent 8,727,773 B2
`____________
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`Held: April 5, 2016
`____________
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`
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`BEFORE: JOSIAH C. COCKS, HYUN J. JUNG, and
`TIMOTHY J. GOODSON, Administrative Patent Judges.
`
`The above-entitled matter came on for hearing on Tuesday, April
`5, 2016, commencing at 2:00 p.m., at the U.S. Patent and
`Trademark Office, 600 Dulany Street, Alexandria, Virginia.
`
`
`
`
`April 27, 2016
`
`trials@uspto.gov
`571-272-7822
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`US ENDODONTICS, LLC,
`Petitioner,
`
`v.
`
`GOLD STANDARD INSTRUMENTS, LLC,
`Patent Owner.
`____________
`
`Case IPR2015-00632
`Patent 8,727,773 B2
`____________
`
`Held: April 5, 2016
`____________
`
`
`
`
`
`BEFORE: JOSIAH C. COCKS, HYUN J. JUNG, and
`TIMOTHY J. GOODSON, Administrative Patent Judges.
`
`The above-entitled matter came on for hearing on Tuesday, April
`5, 2016, commencing at 2:00 p.m., at the U.S. Patent and
`Trademark Office, 600 Dulany Street, Alexandria, Virginia.
`
`
`
`
`
`Case IPR2015-00632
`Patent 8,727,773 B2
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`APPEARANCES:
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`ON BEHALF OF THE PETITIONER:
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`JEFFREY S. GINSBERG, ESQ.
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`ABHISHEK BAPNA, ESQ.
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`Patterson Belknap Webb & Tyler LLP
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`1133 Avenue of the Americas
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`New York, New York 10036-6710
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`ON BEHALF OF PATENT OWNER:
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`STEVEN LIEBERMAN, ESQ.
`JOSEPH HYNDS, ESQ.
`JASON M. NOLAN, Ph.D., ESQ.
`DEREK F. DAHLGREN, ESQ.
`Rothwell Figg
`607 14th Street, N.W., Suite 800
`Washington, DC 20005
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`and
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`DAVID A. ZDURNE, ESQ.
`LINDI BARTON-BROBST, ESQ.
`DENTSPLY International
`Susquehanna Commerce Center
`221 West Philadelphia Street
`York, Pennsylvania 17405-0872
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`Case IPR2015-00632
`Patent 8,727,773 B2
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`P R O C E E D I N G S
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`JUDGE COCKS: Good afternoon. Welcome to the
`Board. This is oral argument for IPR2015-00632 involving
`Patent 8,727,773. Let's begin with introduction of counsel, but
`before we do so, we are joined by Judge Goodson remotely, so in
`order for him to hear us, you must stand up to the podium when
`you speak.
`So, that being said, will Petitioner's counsel please
`introduce themselves.
`MR. GINSBERG: Sure, Your Honor. My name is Jeff
`Ginsberg, I represent the Petitioner, U.S. Endodontics. I am with
`the law firm of Patterson Belknap Webb & Tyler. With me as
`back-up counsel is Abhishek Bapna.
`JUDGE COCKS: All right. Thank you, Mr. Ginsberg.
`And, counsel for Patent Owner, please do the same.
`MR. LIEBERMAN: Good morning, Your Honor.
`Steve Lieberman from Rothwell Figg. I represent the Patent
`Owner. With me today at counsel table is Derek Dahlgren. Also
`present in court are Jason Nolan and Joe Hynds, Mr. Hynds is
`lead counsel, they're both from Rothwell Figg. And also present
`in the courtroom are two representatives of Dentsply, David
`Zdurne and Lindi Barton-Brobst.
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`JUDGE COCKS: And, Mr. Lieberman, will you be
`giving the presentation today for the Patent Owner?
`MR. LIEBERMAN: I will be.
`JUDGE COCKS: Okay. Thank you.
`MR. LIEBERMAN: Thank you, Your Honor.
`JUDGE COCKS: Now, as is set forth in the trial
`hearing order, each side has 45 minutes of argument time. The
`Petitioner bears the burden of showing unpatentability and will
`give their case first and may reserve rebuttal time. The Patent
`Owner will then argue their opposition to Petitioner's case, and
`we will end with the Petitioner using any time they have reserved
`for rebuttal to respond to Patent Owner's case.
`So, Mr. Ginsberg, that being said, whenever you're
`ready, you may begin.
`MR. GINSBERG: Thank you, Your Honor. And we
`would like to reserve 10 minutes for rebuttal.
`JUDGE COCKS: Ten minutes, okay.
`MR. GINSBERG: Good afternoon, Your Honor.
`JUDGE COCKS: Before you begin, actually, I would
`ask the parties to please try and remember to refer to the slide of
`your slide deck for Judge Goodson's benefit.
`MR. GINSBERG: Yes, Your Honor. As mentioned,
`my name is Jeff Ginsberg, I represent Petitioner, U.S.
`Endodontics. As Your Honors are aware, this IPR proceedings
`concerns U.S. Patent Number 8,727,773.
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`Patent 8,727,773 B2
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`Turning to slide 3, the '773 patent contains 17 claims, of
`which claims 1 and 13 are independent. Claim 1 is directed to a
`method for manufacturing an endodontic instrument for use of
`performing endodontic therapy on a tooth. The method provides
`two steps. The first step is providing an elongated shank having a
`cutting edge, the shank comprising a superelastic titanium alloy,
`and the second step is heat-treating the entire shank at a
`temperature of 400° Celsius up to but not including the melting
`point of nickel-titanium.
`And, finally, the claim concludes with a wherein clause
`that recites, "wherein the heat-treated shank has an angle greater
`than 10° of permanent deformation after torque at 45° of flexion
`when tested in accordance with ISO Standard 3630-1."
`Moving to slide 4, this is independent claim 13, it's
`similar to claim 1, but is limited to heat-treating at a specific
`temperature range, specifically 475° Celsius to 525° Celsius.
`Now, in this proceeding, Patent Owner does not
`challenge Petitioner's evidence that the prior art identified in the
`instituted grounds teaches or discloses the composition
`limitations recited in dependent claims 7, 12 and 17. Nor does
`Patent Owner challenge Petitioner's evidence that the prior art at
`issue discloses the atmosphere limitations of claims 4 to 6 and 16,
`the size limitation of claim 8, or the requirement that the claimed
`heat treatment occur at a single temperature restated in claims 9,
`10, 11 and 15.
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`Patent 8,727,773 B2
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`The Patent Owner also does not appear to challenge
`Petitioner's evidence that the prior art identified in the instituted
`grounds discloses making a file that's in accordance with ISO
`Standard 3630-1.
`Turning to slide 5, there is some deposition testimony
`from inventor Neil Luebke, he was asked whether or not he
`claimed to be an inventor of a file within the claimed composition
`range; he stated that, no, that is not what he invented.
`He also testified in Exhibit 1038, page 74, line 13 to 17,
`that he is not the inventor of a file that conforms to ISO Standard
`3630-1. Rather, the Patent Owner argues that the prior art
`disclosed in the instituted grounds does not teach or disclose
`heat-treating an entire shank of an instrument at the claimed times
`and temperatures to achieve the claimed deformation. As set
`forth in Petitioner's papers, Patent Owner is wrong.
`Turning to slide 6, and just stepping back a bit, the
`institution decision provides the Board's claim construction
`ruling, namely that all claim terms are given their ordinary and
`customary meaning.
`Turning to slide 7, this sets forth the grounds upon
`which the trial was instituted, four grounds, and I'm going to start
`with D, the fourth ground, that claims 1 to 17 are unpatentable
`under 35 USC, Section 103(a) over Matsutani and Pelton, and to
`the extent necessary, ISO 3630-1.
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`Patent 8,727,773 B2
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`JUDGE COCKS: Counsel, let me ask you a question.
`Do you understand any claim term at this point to be in dispute
`between the parties, construction-wise?
`MR. GINSBERG: For the purposes of this IPR
`proceeding, no, Your Honor.
`JUDGE COCKS: Thank you.
`MR. GINSBERG: Sure.
`Again, turning to slide 8, Petitioner's position, claims 1
`to 17 are unpatentable under 35 USC Section 103(a) over
`Matsutani and Pelton. Now, in support of its position of
`unpatentability of the claims in this ground, Petitioner relies on
`the testimony of Dr. Jon Goldberg. Dr. Goldberg obtained a
`Ph.D. in materials and metallurgical engineering, which was a
`combined degree from the School of Engineering and School of
`Dentistry at the University of Michigan. Since 1975, he has been
`employed as a professor at the University of Connecticut, where
`he teaches a variety of courses on materials engineering and
`material science, including courses on dental materials such as
`titanium alloys.
`In paragraphs 201 to 225 of his declaration, Dr.
`Goldberg provides detailed support for his opinions that claims 1
`to 17 of the '773 patent are obvious in view of Matsutani and
`Pelton. Dr. Goldberg also found that it would have been obvious
`to construct an instrument in accordance with the well-known
`standard ISO 3630-1.
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`Patent 8,727,773 B2
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`Now, tellingly, during Dr. Goldberg's cross
`examination, Patent Owner did not ask him a single question
`concerning his testimony that the combination of Matsutani and
`Pelton render all claims unpatentable. Petitioner points this out at
`paper 57 at page 5. Instead, in its responsive paper, which is
`paper 44, Patent Owner incorrectly asserts that Dr. Goldberg
`acknowledged that Matsutani teaches away from heat-treating the
`entire shank, and that Dr. Goldberg failed to address the several
`methods Matsutani offered for selective or partial heat treatment.
`As set forth in Petitioner's reply paper 57, at pages 5 to
`6, a review of the cited testimony from Dr. Goldberg's declaration
`makes clear that Patent Owner's assertions are completely
`incorrect.
`Moving to slide 10, regarding the alleged invention of
`the '773 patent, Patent Owner asserts that the invention exhibits
`two major improvements over prior art files. One, it fractures
`less often during use; and two, it better negotiates the root canal
`without damaging the tooth. These are the two benefits that the
`Patent Owner cites to. In support, it cites to the Matsutani patent,
`Exhibit 1001, at column 9, lines 19 to 30.
`Moving to slide 11. Matsutani achieves the same goals
`as the alleged invention. It discloses a method of making a
`nickel-titanium file that includes a shaped memory portion
`capable of retaining its shape when bent, so that it will follow the
`root canal with high fidelity during the root canal procedure. The
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`Case IPR2015-00632
`Patent 8,727,773 B2
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`slide here comes from Matsutani, Exhibit 1023, column 4, lines
`45 to 52. The highlighted underlined portion states, "This
`pre-curving of the shape memory portion enables the tip and the
`shape memory portion to follow the root canal with high fidelity
`at the time of inserting the tip into the root canal and performing
`treatment on the root canal.
`Moving to slide 12, Matsutani states that the shape
`memory portion 6, which will stay deformed when bent, has high
`flexibility and high fatigue or fracture resistance.
`Just as a point of reference, if you turn to slide 2, this is
`an exemplary endodontic file. The file has two major
`components. We have the handle portion here, and what we've
`been talking about here and what is disclosed in the claims as a
`shank portion. The working portion of the shank is a portion of
`the shank that has a cutting edge. In Matsutani, the shank is
`referred to as a needle portion identified by reference numeral 1.
`JUDGE COCKS: Counsel, let me ask just to be clear,
`when you say exemplary, exemplary of what, the prior art?
`MR. GINSBERG: This is a sample, actually, of an
`edge Endo endodontic file that was cited in Patent Owner's
`papers. It's a nickel-titanium endodontic file that has a handle
`and a nickel-titanium shank.
`JUDGE COCKS: So, do you understand it to be
`exemplary of the patent?
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`Patent 8,727,773 B2
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`MR. GINSBERG: Just showing a -- excuse me, Your
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`Honor?
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`JUDGE COCKS: Exemplary of the '773 patent?
`MR. GINSBERG: No, just exemplary of a
`nickel-titanium file that includes a handle and a nickel-titanium
`shank.
`
`JUDGE COCKS: Okay.
`MR. GINSBERG: Turning to slide 14 of the
`presentation, now, we already saw that Matsutani achieves the
`same goals as the alleged invention. Now, Matsutani achieves
`these goals by the exact same precise method disclosed in the
`'773 patent, specifically by heat-treating a superelastic
`nickel-titanium shank, which you just looked at, of an endodontic
`instrument such that it will be able to retain its deformed shape
`when subject to bending forces.
`The two cites here come directly from Matsutani. We
`have Exhibit 1023, column 4, lines 31 to 35, it talks about the
`shape memory portion and the needle portion 1, that's the shank,
`the needle portion 1 of Matsutani is equivalent of the shank. And
`you can see that by looking at figure 2, for example, from
`Matsutani, reference numeral 1 right here, that is pointing to the
`nickel-titanium shank.
`And again, Matsutani discloses that shape memory
`portion in the needle portion 1 is provided with the bending
`characteristic by performing heat treatment on a nickel-titanium
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`Case IPR2015-00632
`Patent 8,727,773 B2
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`alloy so as to cause a nickel-titanium alloy to not recover a
`memory shape in the range of room temperature or body
`temperature. Therefore, the shape memory portion does not
`exhibit the characteristic of returning to its original shape but can
`be deformed to a preferable shape. You bend it, it's going to stay
`bent. It will satisfy the claim limitation of the -- of claims 1 and
`13, the independent claims in the '773 patent, and all of the claims
`that depend therefrom.
`Turning to slide 16 --
`JUDGE COCKS: I'm sorry, counsel, let me ask you
`one question. You say you bend it and it will stay bent; in all
`circumstances?
`MR. GINSBERG: Matsutani specifically discloses that
`you want to heat-treat a portion of the nickel-titanium shank, such
`that when you bend it, it is going to stay bent during the root
`canal procedure. So, during the treatment conditions, when
`you're using it in a patient, it's going to be inserted into root canal,
`that shape memory portion is going to bend and when it's bent,
`subjected to bending forces, it's going to retain its shape.
`So, in response to your question, Your Honor, in all
`conditions during clinical use of the file, Matsutani specifically
`discloses that in order to accomplish that, you want to raise the
`shape recovery temperature of the nickel-titanium to above body
`temperature, the temperature of the mouth, and you do that by
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`Case IPR2015-00632
`Patent 8,727,773 B2
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`heat-treating the nickel-titanium shank, specifically disclosed in
`Matsutani.
`As I just mentioned, turning to slide 16, Matsutani
`specifically teaches that raising the shape recovery temperature
`through heat treatment will result in the shape memory portion
`being capable of retaining its deformed shape when bent.
`Specific disclosure of this is at Exhibit 1023, column 5, lines 46
`to 57.
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`Specifically, it discloses that heat-treating the shape
`memory portion to above the shape recovery temperature to
`increase it so that the shape recovery temperature is above body
`temperature, which is 37° Celsius.
`Now, turning to slide 17, Patent Owner included some
`slides with its demonstrative exhibit, that's Exhibit 2053, about
`potential problems that can arise with files that are used during a
`root canal procedure such as zipping, transportation and
`perforation. Patent Owner claims that these are issues that can
`arise when you're using a superelastic nickel-titanium file, a file
`that when you bend it, it's going to return to its original shape
`when the bending force is removed.
`Patent Owner asserts that the likelihood of these issues
`are reduced when the practitioner uses a nickel-titanium file that
`has been heat-treated so that the file will follow the curvature of
`the root canal. Again, this is precisely what is taught by
`Matsutani. If you look at slide 18, which comes from Exhibit
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`Case IPR2015-00632
`Patent 8,727,773 B2
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`1023, column 8, lines 40 to 47, it states, "Moreover, even when
`treatment for the root canal progresses, and where the tip reaches
`the root sharp mouth, because the shape memory portion 6 is
`easily bent, the shape memory portion does not apply a repulsive
`force to the wall of the tooth [sic]." When it's inserted the root
`canal and bending forces are applied, it's going to follow that
`shape of the root canal, it's not going to want to bend back and hit
`the tooth enamel.
`Matsutani specifically states, "This prevents the shape
`memory portion from cutting the wall of the root canal more
`heavily near the root sharp mouth, and in the center of curve and
`deviating from the root canal." This is exactly what the alleged
`invention, the '773 patent, discloses.
`Now, turning to slide 19. Matsutani discloses
`heat-treating up to about three quarters of the working portion of
`the shank. Just turning back to slide 15, the working portion of
`the shank, again, is a portion of the shank with the cutting
`grooves formed therein. Specific disclosure in Matsutani of
`heat-treating up to three quarters of the working portion of the
`shank, that could be found at column 5, lines 20 to 29. It states,
`"The length of the shape memory portion 6 in the work portion 4
`is not limited to a special value." Specific disclosure at the end of
`that paragraph, "Although the maximum length is not limited to a
`special length, the maximum length is about three-quarters of the
`whole length of the work portion 4."
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`Case IPR2015-00632
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`Turning to slide 21. Matsutani, despite Patent Owner's
`representations to the contrary, does not teach away from the
`alleged invention of the '773 patent. Patent Owner relies on one
`passage from Matsutani to suggest that this reference would
`discourage a person of ordinary skill in the art from heat-treating
`the entire superelastic nickel-titanium shank of an endodontic
`instrument. Patent Owner's position lacks merit.
`The cited passage merely states that a problem "may"
`occur if the entire shank is heat-treated. It says, "a problem may
`occur in that the position of a rotational axis is not fixed, but is
`made eccentric." This is not a teaching away. In recognition of
`this issue, and to try to cover up this issue, this failing that
`Matsutani does not, in fact, and Patent Owner cannot prove that
`Matsutani teaches away from the alleged invention, they
`submitted a declaration from their expert, Dr. Sinclair, who
`declared that in his declaration that he submitted as Exhibit 2026,
`at paragraph 167, he stated that Matsutani selectively heat treats a
`portion of the file because heat-treating any more than
`three-quarters of the working portion would make the file
`difficult to cut the root canal.
`Patent Owner, relying on this paragraph of Dr. Sinclair's
`declaration, made the same assertion, that's at paper 44 at 48;
`however, during Dr. Sinclair's cross examination, he conceded, as
`he had to, that Matsutani says a problem may occur, not would, as
`he originally declared. Patent Owner's improper attempt to
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`change "may" to "would" only highlights the weakness of its
`position. This is testimony right from Dr. Sinclair's deposition,
`"But you agree that the reference itself, Matsutani itself, states, a
`problem may occur, not that a problem would occur. Correct?
`"Answer: Matsutani states a problem may occur, yes.
`JUDGE GOODSON: Mr. Ginsberg, can you elaborate
`on what this problem is that Matsutani says may occur if you
`treated more than three-quarters of the file? Is it basically -- is it
`basically that there's too much flexibility if you do more than
`three-fourths of the file?
`MR. GINSBERG: From what I understand, Your
`Honor, what Matsutani was saying, that there may be a problem
`with the rotational axis of the file, which is essentially a drill bit,
`it's a -- the file is used in a rotary instrument, that's used in
`basically a drill, during a root canal procedure, and Matsutani
`merely states that if the entire instrument was made such that it
`wasn't superelastic, such that it would stay bent when subjected to
`bending forces, a problem may occur towards the portion of the
`file near where the drill bit goes into the drill device, the actual
`rotating instrument. That's all it was suggesting, that there may
`be a problem.
`And, in fact, it turned out that when Dr. Luebke -- I'll
`get to this in a moment -- first heat-treated the entire shank, he
`experienced no such problem and he testified that the heat-treated
`shank or the entire shank was heat-treated, worked perfectly.
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`Now, turning to slide 24, this is a quote from Dr.
`Goldberg's declaration, who testified at length that a person of
`ordinary skill in the art would have been motivated to heat-treat
`the entire shank based on the teachings of Matsutani. As I
`mentioned, Petitioner -- the Patent Owner did not ask Dr.
`Goldberg a single question during cross examination regarding
`this teaching. Rather, the Patent Owner attempts to rely on its
`witness' tortured and implausible testimony that it would be --
`that it would not be more difficult to partially heat-treat a shank
`that is comprised of nickel-titanium.
`Now, turning to slide 25, Matsutani --
`JUDGE COCKS: Counsel, can I ask you to go back
`one slide?
`MR. GINSBERG: Of course, Your Honor.
`JUDGE COCKS: To slide 24. Dr. Goldberg's
`testimony there, the entire shank, treating the entire shank would
`have been easier and less expensive, you cited to paragraph 206.
`On what does he base that testimony?
`MR. GINSBERG: This is based on his years of
`experience and his knowledge of dental materials. He actually
`teaches dental students, he has patents on titanium alloys, he is
`familiar with heat treatment of nickel-titanium alloys, he studies
`their structure, whether they're in the Martensite form or their
`Austenite form. And, you know, based on his experience, based
`on his knowledge of how -- of just heat treatment, if you take a
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`file, if you take a shank, and you stick it into the oven, all you
`have to do is stick the entire shank -- as he testified, you put the
`entire shank into the oven. I'm not sure if -- excuse me, I'm not
`sure if Dr. Goldberg actually mentioned that, but in terms of an
`exemplary way of heat-treating an entire shank, you just stick the
`entire portion into the oven.
`As is well known, nickel-titanium conducts heat. So, if
`you were only going to partially heat-treat a nickel-titanium
`component, you're going to have to include some insulating
`means, some way that you're going to shield the non-heat-treated
`portion such that the heat doesn't transfer up to the file. That --
`there's no question that's going to be much more difficult than
`simply heat-treating the entire shank.
`Now, Patent Owner cites to some deposition testimony
`from a District Court proceeding, the related District Court
`proceeding where Dr. Goldberg said, well, I'm not familiar with
`the common methods of heat-treating nickel-titanium alloy. His
`testimony was referring to, you know, which methods would be
`more common than the other. He wasn't saying that he's not
`familiar with what would happen if you heat-treat a
`nickel-titanium alloy. And it's clearly just common sense, in
`addition to Dr. Goldberg's testimony, it's common sense that it's
`more simple to heat-treat an entire shank, where you're having a
`metal component that you're trying to heat-treat that if you don't
`heat-treat the entire component, it's going to conduct heat, the
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`whole thing is going to be heat-treated. You have to include
`additional steps such that the non-heat-treated portion is not going
`to experience that heat treatment.
`And these nickel-titanium shanks, you don't heat-treat in
`commercial application, you're not treating one, you're
`heat-treating hundreds if not thousands at the same time. So,
`there's really no legitimate dispute that heat-treating an entire
`shank versus trying to come up with some mechanism to partially
`heat-treat the shank is just as easy.
`JUDGE COCKS: But, counsel, let me ask you,
`legitimate or not, is that testimony in dispute in this case?
`MR. GINSBERG: Well, Petitioner does not agree to --
`as we come into a couple of slides, you will see that Patent
`Owner's own expert, Dr. Sinclair, grudgingly did admit that it
`would be easier to heat-treat the entire shank, versus just partially
`heat-treating the shank, and he actually testified, as we will get to
`in a minute, that he was trying to come up with ways that you
`could partially heat-treat multiple shanks at once, and he actually
`testified, well, those methods haven't been invented yet.
`So, I think the record is replete with references that
`made clear that heat-treating an entire shank is, in fact, easier,
`less expensive, than heat-treating just a portion of the shank.
`JUDGE GOODSON: But doesn't that cut against your
`argument in the sense that if it's easier and less expensive, then
`why would the prior art teach to go to that extra trouble and
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`expense unless they believe that it achieved an important
`objective?
`MR. GINSBERG: Again, you know, in terms of what it
`actually teaches, Your Honor, all we're doing is looking at one
`sentence from Matsutani that's in -- I'll go back to slide 21, that
`says a problem "may" occur. It does not say that a problem "will"
`occur. And in light of the fact that it would be easier to heat-treat
`the entire shank, Petitioner maintains that this is not a teaching
`away.
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`If you look at the actual heat-treatment methods
`disclosed in Matsutani, where they're disclosing methods of
`partial heat treatment, that's in figures 4(a) to (e), four of those
`methods are set forth in slide 25 and the other two are set forth in
`slide 26. You will see that these methods require some additional
`steps, some cooling mechanism, either a water bath, electrical
`current, to keep the non-heat-treated portion from being
`heat-treated.
`So, Petitioner maintains that that disclosure that there
`may be a problem is not a teaching away. A person of skill in the
`art at the time of the invention reading that reference would
`understand that all that's saying is that a problem may occur;
`clearly it's easier to heat-treat the entire instrument, and it would
`be obvious to try that method to see if, in fact, a problem would
`occur.
`
`Turning to -- did I answer your question, Your Honor?
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`JUDGE GOODSON: Yes, thank you.
`MR. GINSBERG: Turning to slide 27. This is a quote
`from the KSR case: "When there is a design need or market
`pressure to solve a problem and there are a finite number of
`identified, predictable solutions, a person of ordinary skill has
`good reason to pursue the known options within his or technical
`grasp..." At the very least, Petitioner maintains it would have
`been obvious to try heat-treating the entire shank in light of
`Matsutani's disclosure, Exhibit 1023, of heat-treating a portion.
`Going to slide 29. Further confirming Petitioner's
`position that it would have been obvious to heat-treat the entire
`shank based on Matsutani's disclosure, Dr. Luebke acknowledged
`that he never experienced any problems when heat-treating the
`entire shank. Here's his deposition testimony that appears at
`Exhibit 1038, pages 164 to 165. "In any of the files that you've
`heat-treated, have you ever experienced any issues resulting from
`the heat treatment of the entire shank?
`"Answer: Not at all.
`"Question: They work better than files that are not
`heat-treated. Correct?
`"Answer: Absolutely."
`Next slide, slide 30, continuing with Dr. Luebke's
`testimony. "Did you encounter any problems with regard to the
`position of a rotational axis not being fixed?
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`"Answer: I don't like the word 'fixed.' I had no
`problems with the rotation of the instrument and a -- either in a
`tooth or in a plastic block."
`So, when Dr. Luebke treated the entire shank, the
`problem that Matsutani merely says may occur, Dr. Luebke
`readily found that problem did not exist. There was no issue.
`Turning to slide 31. Now, this is what I was referencing
`before. Dr. Sinclair, Patent Owner's expert, fought with me but
`begrudgingly acknowledged that it would, in fact, be easier to
`heat-treat an entire nickel-titanium shank as opposed to partially
`heat-treating the same, agreeing with Dr. Goldberg.
`'Question: You agree that it's easier to heat-treat an
`entire nickel-titanium endodontic shank?
`"Answer: It's not so much easier."
`Of course, he had to acknowledge that it is much easier
`to heat-treat an entire shank than partially heat-treating a
`nickel-titanium alloy that conducts heat. As I mentioned, when
`he was trying to think up ways of heat-treating multiple shanks at
`the same time through selective heat treatment, just partially
`heat-treating them so that a portion is going to remain cool, so
`that you're not going to have the heat-treatment effect, Dr.
`Sinclair testified that such method has not even been invented yet.
`That's at Exhibit 1040, page 183, line 20, to page 184, line 11.
`Going back to Matsutani and the additional disclosure
`in that reference. Slide 32. Matsutani also discloses the claimed
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`bending that is recited in the wherein clause of claims 1 and 13 of
`the '773 patent. The files were subjected to bending to determine
`whether the heat-treated portion would retain its deformed shape
`after being subjected to bending forces. This is precisely what
`Luebke was going after. That's what he says is his invention in
`the '773 patent.
`The description of the use of the bend test to determine
`the permissive steps of the claimed deformation is set forth at
`column 8, lines 30 to 32. If you look at the description of the
`bend test that's set forth in Matsutani, up on slide 32, you'll see,
`it's a precise test that's disclosed in the ISO Standard 3630. The
`tip of the file is secured, there is a 45° bend that is placed on the
`file, and then you determine the amount of deformation.
`Matsutani did this test to its heat-treated files, the shape
`memory heat-treated portion when it was bent, stayed bent. It's
`certainly going to satisfy the 10° permanent defamation limitation
`set forth in the wherein clause of the '773 patent.
`Just real quickly, this is a reproduction of the ISO 3630
`standard that was in effect at the time the first edition was
`published in 1992. It talks about this 45° bend test. The second
`edition didn't come out until 2008, but that's replicated here in
`slide 34, and that also discloses that the bend test is a 45° test. It's
`exactly what's disclosed in Matsutani.
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