`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`LUYE PHARMA GROUP LTD., LUYE PHARMA (USA) LTD.,
`SHANDONG LUYE PHARMACEUTICAL CO., LTD. and NANJING
`LUYE PHARMACEUTICAL CO., LTD.,
`Petitioners,
`v.
`
`ALKERMES PHARMA IRELAND LTD. and ALKERMES
`CONTROLLED THERAPEUTICS, INC.
`Patent Owner.
`____________
`
`Case IPR2016-01096
`Patent 6,667,061 B2
`____________
`
`Record of Oral Hearing
`Held: August 28, 2017
`____________
`
`
`
`Before LORA M. GREEN, ROBERT A. POLLOCK, and
`JACQUELINE T. HARLOW, Administrative Patent Judges.
`
`
`
`
`
`
`
`
`
`
`
`
`Case IPR2016-01096
`Patent 6,667,061 B2
`
`
`APPEARANCES:
`
`ON BEHALF OF PETITIONER:
`PAUL H. KOCHANSKI, ESQUIRE
`TEDD W. VAN BUSKIRK, ESQUIRE
`Lerner David Littenberg Krumholz & Mentlik LLP
`600 South Avenue West
`Westfield, New Jersey 07090
` (908) 654-5000
`
`ON BEHALF OF PATENT OWNER:
`
`
`HA KUNG WONG, ESQUIRE
`Fitzpatrick IP
`1290 Avenue of the Americas
`New York, New York 10104-3800
` (212) 218-2571
`
`
`The above-entitled matter came on for hearing on Monday, August
`
`28, 2017, commencing at 1:00 p.m., at the U.S. Patent and Trademark
`Office, 600 Dulany Street, Alexandria, Virginia.
`
`
`
`2
`
`
`
`Case IPR2016-01096
`Patent 6,667,061 B2
`
`
`P R O C E E D I N G S
`- - - - -
`JUDGE GREEN: Good afternoon. Welcome,
`everyone. Please make sure that all cell phones are turned
`off, as they can interfere with microphones. We are on the
`record. This is the final oral hearing in IPR2016-01096.
`This proceeding involves U.S. Patent Number 6,667,061.
`At this time, I would like counsel to introduce yourselves
`and your colleagues, beginning with Petitioner.
`MR. KOCHANSKI: Good afternoon, Your Honor.
`Paul Kochanski for the Petitioner. Before getting started
`with argument, I'd like to handle two matters of business.
`Number one, I'd like to provide the Court with a set of our
`demonstrative exhibits, if I can be so allowed.
`JUDGE GREEN: Sure.
`MR. KOCHANSKI: And, secondly, at the close of
`last week, the Patent Owner objected to certain of our
`demonstratives -- Petitioner's demonstratives, and that was
`50 and 55.
`JUDGE GREEN: Correct.
`MR. KOCHANSKI: We would like to withdraw
`those demonstratives and receive authorization from the
`Board to refile our demonstratives with those omitted.
`JUDGE GREEN: That's fine. That will be great.
`MR. KOCHANSKI: Thank you very much, Your
`Honor.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`
`
`3
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`Case IPR2016-01096
`Patent 6,667,061 B2
`
`
`JUDGE GREEN: And if you could do that by maybe
`next week, that would be great.
`MR. KOCHANSKI: That will be no problem, Your
`Honor. Thank you.
`JUDGE GREEN: Okay. And if you could also get
`the paralegal -- do you have a couple sets of
`demonstratives? Or if we could just have one set of
`demonstratives for each party in the record, that would be --
`so if you have to the paralegals expunge some
`demonstratives, let's try and get the record cleaned up.
`MR. KOCHANSKI: Thank you.
`JUDGE GREEN: Okay, then, I want Patent Owner's
`counsel to introduce yourselves.
`MR. WONG: Yes. Ha Kung Wong on behalf of the
`Patent Owners. With me from Fitzpatrick Cella is also
`Linda Roberts and Scott Reed and Una Fan. And then we
`have from Alkermes here, we have Kathy Claire, and John
`Kirkland, and we have Melissa from Johnson and Johnson
`here.
`
`JUDGE GREEN: Okay, thank you very much.
`Welcome to the Board. If you can just wait a minute.
`MR. KOCHANSKI: Okay.
`JUDGE GREEN: Consistent with our previous
`order, Petitioner and Patent Owner have 45 minutes to
`present their arguments. Petitioner will proceed first to
`present its case-in-chief as to the challenged claims and
`
`
`
`4
`
`
`
`Case IPR2016-01096
`Patent 6,667,061 B2
`
`
`may reserve rebuttal time to respond to the arguments made
`by Patent Owner. Thereafter, Patent Owner will respond to
`Petitioner's case.
`I would like to start with a housekeeping note. We
`note that, on Thursday of last week, Petitioner sent
`authorization to file a second motion to exclude evidence.
`Petitioner states that they were informed by a paralegal that
`they would be allowed a second motion. According to
`Petitioner, without that second motion, they would have no
`recourse to exclude evidence served after that motion to
`exclude was filed. Would you like to address that matter
`now, before we start formal argument in this case?
`MR. KOCHANSKI: Mr. Van Buskirk from our
`office will address that.
`JUDGE GREEN: Okay. And, Patent Owner, you
`can respond. You know, we'll do it like -- we'll pretend
`we're on the phone.
`MR. VAN BUSKIRK: Thank you, Your Honors.
`The exhibits --
`JUDGE GREEN: I'm sorry. Just we want to keep
`this very brief.
`MR. VAN BUSKIRK: Of course. The exhibits that
`we sought to exclude were first presented at a deposition
`which occurred on July 13th. On July 24th, we were
`actually served with a copy of those exhibits and, within
`five business days thereafter, on July 31st, we filed our
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`
`
`5
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`Case IPR2016-01096
`Patent 6,667,061 B2
`
`
`objections. We believe that we were conforming with -- I'm
`sorry, abiding by the rules given -- set out in part 42. After
`10 business days passed, in which the Patent Owners had an
`opportunity to supplement and did not, we filed our motion,
`and it's that motion which has now been objected to as
`somehow being improper under the rules. And, as we
`stated in our brief correspondence last week, without an
`opportunity to file a motion to exclude, we don't believe we
`have any recourse to address these. As a belt and
`suspenders matter, we did contact the Board, spoke with a
`paralegal, explained the circumstances, and were told that,
`as of right, we could file such a motion.
`JUDGE GREEN: I mean, you are allowed one
`motion as of right. I would say the best course -- you don't
`necessarily have a right to file two full motions to exclude,
`so the best course in these kind of circumstances is always
`to kind of give the panel a heads up, because they may not
`give you the full pages on a second motion to exclude.
`So, Patent Owner, do you have anything you'd like to
`
`say?
`
`MR. WONG: Yes, Your Honor. We only want to
`mention the fact that there are two rules here. One is in
`42.64(a) on deposition evidence and, there, they object to
`admissibility. Deposition evidence must be made during a
`deposition, which they did, and that was on July 13th. And,
`of course, as you mentioned, Your Honor, they had a
`
`
`
`6
`
`
`
`Case IPR2016-01096
`Patent 6,667,061 B2
`
`
`motion to exclude on July 24th, 11 days later. And we
`believe that they should have included those arguments in
`that motion or, at minimum, put us on notice that they were
`intending to file another motion to exclude. Honestly, at
`this point, they are filing it four business days prior to the
`oral hearing. It doesn't even allow us sufficient time to
`respond to those objections or to their motion to exclude.
`So we believe that, in seeking a second motion to exclude,
`they are violating the scheduling order, which already
`contemplated one motion to exclude, they're ignoring the
`procedures of 42.64 with regard to deposition exhibits, and
`they're unfairly prejudicing us at the oral argument to the
`extent the record will contain Petitioner's unrebutted
`arguments about these exhibits in deposition testimony.
`JUDGE GREEN: Well, at this point, we have no
`argument, correct?
`MR. WONG: Correct.
`JUDGE GREEN: Because we expunged the original
`one. So if we do allow any briefing, we would allow both
`sides' briefing before a final decision is entered. Would you
`have any -- if we allowed them a shorter motion to exclude
`at this time, where you'd also have time to respond, would
`you be -- would you oppose that?
`MR. WONG: No, Your Honor, if we have time to
`respond and it doesn't include the prejudices, I believe we
`can agree to that.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`
`
`7
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`Case IPR2016-01096
`Patent 6,667,061 B2
`
`
`JUDGE GREEN: Okay. Petitioner, how many pages
`do you think you need?
`MR. VAN BUSKIRK: Your Honor, our motion has
`already been filed, and I believe it was four pages.
`JUDGE GREEN: What I had looked at was a bit
`longer. But four pages? I can handle four pages.
`MR. VAN BUSKIRK: We can do it in four pages,
`Your Honor.
`JUDGE GREEN: And when can you have that in?
`MR. VAN BUSKIRK: We can have it in by -- today
`is Monday. We can have it to you on Wednesday.
`JUDGE GREEN: Okay. And then, Patent Owner,
`you can have four pages as well. If they come in on
`Wednesday, when would you like to have yours in?
`MR. WONG: Could we have the five business days,
`Your Honor, to the following Wednesday, just because of
`the fact that there's a Labor Day weekend in between.
`JUDGE GREEN: Yes, I had forgotten. Yes, that
`should be fine. Are you okay with that, Patent Owner?
`MR. VAN BUSKIRK: That's fine with us. Thank
`
`you.
`
`JUDGE GREEN: Okay.
`MR. WONG: Thank you, Your Honor.
`JUDGE GREEN: Okay. So that's our order. And,
`since it's on the record, I am not going to write an order
`summarizing that, but you authorized to file four pages by
`
`
`
`8
`
`
`
`Case IPR2016-01096
`Patent 6,667,061 B2
`
`
`Wednesday, and you are authorized to file four pages in
`reply. And, if you think you need to so reply, you can have
`two pages by the following Wednesday, because I know
`that's the normal order of these motions.
`MR. VAN BUSKIRK: Thank you, Your Honor.
`JUDGE GREEN: Okay, thank you. And thank you
`for letting us take care of this here. I know they came in
`awfully late last week, so I just wanted to make sure we had
`everything taken care of before we started oral argument.
`Okay, counsel for Petitioner, you may proceed.
`Would you like to reserve time for rebuttal?
`MR. KOCHANSKI: Thank you, Your Honor. We'd
`like to reserve 25 minutes for our rebuttal.
`JUDGE GREEN: Okay. And I will warn you that
`you're only allowed to respond to arguments made by
`Patent Owner in your rebuttal.
`MR. KOCHANSKI: That we understand, Your
`Honor.
`JUDGE GREEN: Okay, thank you.
`MR. KOCHANSKI: To begin this morning -- excuse
`me, this afternoon, what we have here is a very simple
`issue. Putting aside everything that's been filed in terms of
`briefing and the like, and all the evidence and arguments
`that the party made, what we are here is talking about
`something very basic, and that is a -- the invention -- the
`alleged invention of an injection vehicle.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`
`
`9
`
`
`
`Case IPR2016-01096
`Patent 6,667,061 B2
`
`
`In looking at the injection vehicle, we believe that --
`and put up slide 3 -- that, as listed, the injection vehicle,
`which is important to this context, is the fluid phase of said
`suspension has a viscosity greater than about 20 centipoise,
`cp, and less than about 600 centipoise at 20 degrees C.
`What we submit is that there is nothing unexpected, there is
`nothing inventive and, in fact, the prior art, as we've
`discussed in our briefing, has demonstrated that. This claim
`and this patent is not related to a new particle, a new
`microparticle, nor is it related to new excipients or new
`injection formulations. As pointed out by the Petitioner,
`that is in the prior art. Microparticles were known,
`microparticles were known in the concentrations set forth in
`the claim, excipients were known to be within the
`concentration of the claim to give a viscosity of 20 cp and
`less than 600, and the manner in which an injectable
`suspension was made was also well known, as we've shown
`in Dr. DeLuca's declaration.
`What we have here by the Patent Owner with respect
`to this patent is a recognition of inherent properties of
`known substituents in known formulations. We will submit
`that is unpatentable.
`JUDGE GREEN: Now, you seem to be resting your
`argument on inherency. Did you make any argument in
`your petition that arriving at this particular viscosity would
`have been obvious to the ordinary artisan?
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`
`
`10
`
`
`
`Case IPR2016-01096
`Patent 6,667,061 B2
`
`
`MR. KOCHANSKI: Arriving at this particular
`viscosity would, based upon the teachings of the patent,
`would be obvious in terms of what's set forth therein.
`JUDGE GREEN: Okay, no. But before we were
`talking about inherency, which is more of a -- you know,
`that you're discovering a property that hasn't been explicitly
`taught by the prior art, correct?
`MR. KOCHANSKI: Correct.
`JUDGE GREEN: Okay. Obviousness would be, it
`would have been obvious to get to this particular viscosity
`for these particular reasons. As I read the petition, there's
`only an inherency argument and not an obviousness
`argument as to the viscosity. What I'm asking is, is my
`reading of the petition correct or is there an obviousness
`argument as to why the ordinary artisan would have gotten
`this particular viscosity in the petition?
`MR. KOCHANSKI: No, you're not incorrect, Your
`Honor.
`JUDGE GREEN: Okay.
`MR. KOCHANSKI: Okay. What we are relying
`upon is the inherency that the viscosity, based upon the
`Patent Owner's arguments, would be inherent each and
`every time, necessarily and always, as we put in. With
`respect to one of ordinary skill in the art, as Dr. DeLuca has
`put in his declaration, viscosity was an afterthought, a
`consequence of solving the problem of suspendability and
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`
`
`11
`
`
`
`Case IPR2016-01096
`Patent 6,667,061 B2
`
`
`injectability of an injectable formulation. That was a
`consequence. One of ordinary skill in the art would know,
`okay, would recognize all these factors in developing a
`injectable formulation to have a certain viscosity to achieve
`the suspendability of the microparticles.
`JUDGE GREEN: But that's an obviousness
`argument more than an inherency argument, correct?
`MR. KOCHANSKI: That is nothing more than --
`that is correct, Your Honor.
`JUDGE GREEN: So that's -- we're not discussing
`that here because you did not make that obviousness
`argument in your petition.
`MR. KOCHANSKI: That is correct, Your Honor.
`JUDGE GREEN: Okay.
`MR. KOCHANSKI: Okay. So let's talk about the
`inherency argument and necessarily and always and how
`the Petitioner gets there. If I go to slide 12, please, as is
`stated in the background of the invention, okay, the Patent
`Owner specifically identified the fact, in the background as
`prior art, that it was known to have injection vehicles with a
`cp of approximately 19.7, three-tenths shy of the greater
`than 20 cp set forth in the patent. That was known, no
`question, and that's admitted by the Patent Owner.
`Go to slide 13, please. In slide 13, the patent also
`discloses very clearly in column 3, at lines 3 and 8 and
`further at lines 18 and 34, another formulation that was
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`
`
`12
`
`
`
`Case IPR2016-01096
`Patent 6,667,061 B2
`
`
`known, and that was the formulation which the Patent
`Owner disclaimed. That is 3 percent sodium
`carboxymethyl cellulose, which I will abbreviate it and call
`CMC, 1 percent polysorbate 20, and 0.9 percent of sodium
`chloride. And, again, this was disclaimed, as the language
`is quite clear. What the Patent Owner says, the invention --
`the injection vehicle not being this particular composition
`formulation. This disclaimer, it's quite ironic, and it kind of
`makes one question.
`If we go to slide 38, the patent discloses, as I said
`before, an injection vehicle of -- that it disclaims a 3 percent
`by volume sodium carboxymethyl cellulose, 1 percent
`polysorbate 20, and 0.9 percent sodium chloride. This is
`exactly what we're saying is the prior art. As shown in the
`Johnson patent, Exhibit 1009, at column 12, lines 39 to 45,
`Johnson specifically discloses that identical formulation.
`Now, that becomes very important. Why? Well, if
`we go to slide 35, okay, Dr. Johnson, an employee of
`Alkermes, and still an employee of Alkermes, is an inventor
`both on the '061 patent, upon which this IPR was instituted,
`and also is the inventor -- one of the named inventors on the
`Johnson reference, the 1000 --Exhibit 1009.
`JUDGE GREEN: I understand he's on both patents,
`but what are we supposed to assume? What fact do you
`want us to assume because of that?
`MR. KOCHANSKI: And what we can assume here,
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`
`
`13
`
`
`
`Case IPR2016-01096
`Patent 6,667,061 B2
`
`
`what is very strange about this whole proceeding, we've
`heard nothing from Dr. Johnson. We hear a lot about the
`differentiation, different types of CMC, a lot of technical
`arguments put forward by the Patent Owner, but the person
`who has an answer to that is the person who was a named
`inventor with respect to both formulations.
`JUDGE GREEN: I don't recall. Did you ever seek to
`depose Dr. Johnson in this proceeding?
`MR. KOCHANSKI: No, we did not, Your Honor.
`No, we did not.
`JUDGE GREEN: And then do you have --
`MR. KOCHANSKI: Nor did we think it was
`necessary to.
`JUDGE GREEN: Okay. And as to the Johnson
`vehicle, do you have any data as to that, you saying a CMC,
`a pharmaceutical -- as you say that the ordinary artisan
`would have chosen a pharmaceutical grade CMC. Have
`you done any testing as to that and submitted any evidence?
`MR. KOCHANSKI: The Petitioner has done no
`testing. The Petitioner, as we set forth, relies solely on
`inherency and inherency based upon comments and
`admissions made by the Patent Owner, Your Honor. So
`let's go to that. Let's go to that issue.
`Slide 16, please.
`JUDGE GREEN: But, before we leave this --
`MR. KOCHANSKI: Yes.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`
`
`14
`
`
`
`Case IPR2016-01096
`Patent 6,667,061 B2
`
`
`JUDGE GREEN: -- so the only evidence that we
`have that this -- that the Johnson vehicle would have a
`viscosity over 20 is the measurements made in the patent at
`issue itself, correct?
`MR. KOCHANSKI: The measurements set forth in
`the '061 patent, that is correct, and the interpretation of
`those measurements by Dr. Tracy during the prosecution of
`the application that resulted in the '061 patent.
`JUDGE GREEN: But Dr. Tracy did no testing
`either?
`MR. KOCHANSKI: Dr. Tracy did no testing, nor
`have we seen any -- again, another missing figure, nor have
`seen any testimony put forward by the Patent Owner with
`respect to Dr. Tracy and what Dr. Tracy did.
`JUDGE GREEN: Did you seek to take the
`deposition of Dr. Tracy?
`MR. KOCHANSKI: We didn't think it was
`necessary to take his deposition.
`JUDGE GREEN: Okay.
`MR. KOCHANSKI: We believe that his declaration
`is sufficient as it stands and it speaks for itself.
`JUDGE GREEN: Okay. I do remind you that the
`burden here is all yours.
`MR. KOCHANSKI: Yes, it is, Your Honor.
`JUDGE GREEN: Okay.
`MR. KOCHANSKI: And our burden is, more likely
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`
`
`15
`
`
`
`Case IPR2016-01096
`Patent 6,667,061 B2
`
`
`than not, preponderance of the evidence, and we believe
`that the evidence, in fact, shows that based upon his
`declaration with respect to this viscosity issue. So let's
`discuss the viscosity issue with respect to Dr. Tracy.
`In the application, an invention resulting in the '061
`patent, the Patent Owner or the applicants originally
`presented claims within the range of 60 centipoise to 600
`centipoise. Based upon that range -- and maybe I should
`say also, there was a prior application, the parent
`application to the '061 patent application, also had claims in
`that scope. The claims are a little -- the independent claims
`are a little narrow, but the claims are also 60 cp to 600 cp.
`In rejecting the earlier parent application, the same
`examiner, who rejected the claims in the '061 patent, cited
`the Kino reference, as in the '061 case, as showing each and
`every claim limitation and stating that, absent some
`unexpected results, Kino discloses all the limitations. And
`to determine the viscosity, something that you asked for,
`would be within the skill of one of ordinary skill in the art
`to optimize viscosity.
`JUDGE GREEN: Did you make that argument in
`your petition?
`MR. KOCHANSKI: Yes we did, Your Honor.
`JUDGE GREEN: That it would be obvious to
`optimize the viscosity?
`MR. KOCHANSKI: Yes, we did. We put it in.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`
`
`16
`
`
`
`Case IPR2016-01096
`Patent 6,667,061 B2
`
`
`JUDGE GREEN: Where's that in your petition?
`MR. KOCHANSKI: That would be DeLuca
`paragraph 9 and 10 and --
`JUDGE GREEN: No, in the petition, please.
`MR. KOCHANSKI: -- DeLuca supplementary --
`JUDGE GREEN: In the petition.
`MR. KOCHANSKI: In the petition, my associate
`will determine that, Your Honor.
`JUDGE GREEN: Okay, thank you.
`MR. KOCHANSKI: And we'll provide it to you.
`Thank you.
`JUDGE GREEN: Thank you.
`MR. KOCHANSKI: So, going further, let's go to
`slide 19, please. In response to this office action, what the
`Patent Owner did was, again, relied upon a declaration it
`previously provided in the parent case, that being the Tracy
`declaration. And in that declaration, Dr. Tracy comes to the
`conclusion that -- or, excuse me, the applicant, in its
`response, relying upon the Tracy declaration, comes to the
`conclusion that Tracy declaration evidences that the test
`examples of Kino would be under or significantly under
`less than 20 cp.
`Can I have slide 18, please? Let's look a little further
`at the Tracy declaration. In reaching that conclusion -- and
`this is how -- this is what we base our inherency argument
`on. In reaching that conclusion, Dr. Tracy, in reviewing not
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`
`
`17
`
`
`
`Case IPR2016-01096
`Patent 6,667,061 B2
`
`
`only the Kino patent, but reviewing the patent in suit and
`also, as he states below, based upon his knowledge and
`experience, determined that the viscosity controlling
`component of what was disclosed in the injection vehicle in
`Kino and what was also disclosed in the injection vehicle
`formula 1 and 2, and I think it's slide 14, which are set forth
`in the '061 patent, formula 1 having a CMC concentration
`of 1.5 percent and formula 2 having a concentration of.75
`percent -- go back to 18, please -- determined that, again,
`based upon what was stated in the patent with respect to
`CMC, that, since 1.5 percent concentration of CMC had a
`viscosity of 27 cp or.5 percent concentration of CMC had a
`viscosity of 7 cp and finally that, using that, determined
`that, since Kino had a viscosity concentration of.5, that,
`since CMC was a viscosity controlling component, Kino
`would have to have a viscosity less than 7.
`JUDGE GREEN: Now, are you arguing that's
`incorrect?
`MR. KOCHANSKI: I'm sorry, Your Honor?
`JUDGE GREEN: Are you arguing that's incorrect?
`MR. KOCHANSKI: What's incorrect?
`JUDGE GREEN: This paragraph five.
`MR. KOCHANSKI: No, I am not.
`JUDGE GREEN: Okay.
`MR. KOCHANSKI: I am not arguing that it's
`incorrect. In fact, based upon the record and based upon
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`
`
`18
`
`
`
`Case IPR2016-01096
`Patent 6,667,061 B2
`
`
`what was done, that is correct. As can be seen in looking at
`the Tracy declaration, there is nothing contained in the
`Tracy declaration where Tracy -- Dr. Tracy indicates what
`type of CMC, what were the conditions, how was it mixed,
`the effects of other things. What Dr. Tracy did and what we
`did as petitioners here is treat validity the same way as they
`treated patentability.
`JUDGE GREEN: Now, was the examiner's rejection
`based on inherency that Kino inherently had this viscosity?
`MR. KOCHANSKI: The examiner's rejection was
`based -- no, the examiner never said that it was based on
`inherency. What the examiner said, again, is that Kino
`showed all the limitations of the claims and that the
`viscosity limitation -- the optimal viscosity could be easily
`determined by one of ordinary skill in the art.
`JUDGE GREEN: So I guess the argument was that 7
`was so far away from 20 that you wouldn't have optimized
`up to 20?
`MR. KOCHANSKI: Or less than 7 was so far away,
`you wouldn't optimize. I guess that was the examiner's
`position. We don't know what the examiner's position is.
`That isn't stated. However, one thing we do know is that, as
`admitted by the Patent Owner in its papers on page 14 of its
`response, Dr. Tracy assumed, for purpose of his declaration,
`that the CMC that was used in Kino was identical to that
`that was used and disclosed in the '061 patent in formulas 1
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`
`
`19
`
`
`
`Case IPR2016-01096
`Patent 6,667,061 B2
`
`
`and 2. And, based upon that assumption, based upon his
`knowledge and experience, he was able to make a
`one-to-one comparison with respect to the CMC. And all
`we're saying here, when we talk about the Johnson
`reference now and we talk about the Gustafsson reference
`now, is that, in evaluating the invalidity or validity of the
`'061 patent, that same rationale should go forward here.
`That is, as Dr. Tracy --
`JUDGE GREEN: So we should assume that all of
`these references used the same CMC is what you're saying?
`MR. KOCHANSKI: That is absolutely correct, Your
`Honor.
`JUDGE GREEN: Do you know what that CMC is?
`MR. KOCHANSKI: No, we do not know what that
`CMC is, nor do -- nor did the -- nor did Dr. Tracy know
`what that CMC is, nor does the patent and, very
`importantly, there is no disclosure in the patent when it
`discusses, if you go back to slide 14 --
`JUDGE GREEN: No, I do understand that. But I
`guess my worry is, you know, to the extent that the
`examiner could have made an inherency argument, all
`applicant at that time had to show is that, you know, this
`CMC solution that you're using would have fallen outside
`of that and, therefore, does not necessarily have the same
`viscosity as that as claimed. That's all they had to show.
`They didn't have to tell you all the other variables and
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`
`
`20
`
`
`
`Case IPR2016-01096
`Patent 6,667,061 B2
`
`
`everything else that went into that showing because
`inherency is something --
`MR. KOCHANSKI: The only problem --
`JUDGE GREEN: -- because inherency is --
`MR. KOCHANSKI: The only problem --
`JUDGE GREEN: -- such a strict standard.
`MR. KOCHANSKI: The only problem with that
`argument, Your Honor, the only problem with that
`argument is that there was nothing in the disclosure, in the
`specification to support such arguments because there's
`nothing in the specification that discloses what the CMC
`was, what grade it was, whatever. Even in, when you look
`at the preferred embodiment of the invention in column 16
`of Exhibit 1001, slide 63 and 64, it talks about a 3 percent
`CMC concentration. There is no identification in there with
`respect to what the CMC was. What the Patent Owner did
`is relied upon, to get his patent, was to rely upon solely the
`one-to-one comparison. The assumption that Dr. Tracy
`made and that anyone reading that patent would make that
`the CMC grade and type was not important, that all CMCs
`were the same and, therefore, one can compare them one to
`another.
`JUDGE GREEN: What about the handbook that you
`submitted? I forget which -- Exhibit 1008. Looking at your
`slide 65, I mean, that's pretty clear evidence that not all
`CMCs are the same. You have low viscosity, medium
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`
`
`21
`
`
`
`Case IPR2016-01096
`Patent 6,667,061 B2
`
`
`viscosity, high viscosity, you have ranges of viscosities.
`MR. KOCHANSKI: Well, what's very important
`about that, all CMCs aren't the same, but where it talks
`about low viscosity, it has a viscosity between -- at 4
`percent, between 15 and 200.
`JUDGE GREEN: So what does that tell us about 3
`percent?
`MR. KOCHANSKI: What does that tell us about
`what, Your Honor?
`JUDGE GREEN: About 3 percent.
`MR. KOCHANSKI: Three percent should fall within
`that range. But, again --
`JUDGE GREEN: Do we have any evidence of that?
`MR. KOCHANSKI: Again, the important aspect is,
`is not so much that -- what the handbook says, but, more
`importantly, is what does this disclosure, the specification
`say. And, in this regard, the disclosure and specification
`doesn't support all these other factors to be considered.
`Again, as Dr. DeLuca said in his declaration, very clearly,
`a person of ordinary skill in the art would take those factors
`into consideration in coming up with a injectable
`formulation.
`JUDGE GREEN: I do understand that, but that's an
`obviousness argument and not an inherency argument, and
`you're saying that we're in the land of inherency. So, if
`we're in the land of obviousness, I would really like to have
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`
`
`22
`
`
`
`Case IPR2016-01096
`Patent 6,667,061 B2
`
`
`that -- you tell me where we are with that in the petition, as
`filed.
`
`MR. KOCHANSKI: I didn't hear you, Your Honor.
`JUDGE GREEN: You're talking about, if it's
`obvious for the ordinary artisan -- and we're running low on
`time -- that the ordinary artisan would have understood
`viscosity, would have understood syringability, injectability
`and everything, and would have optimized to get to the
`correct viscosity the CMC and the other components.
`MR. KOCHANSKI: That is correct, Your Honor.
`JUDGE GREEN: That is an obviousness argument
`and not an inherency argument. And I need -- I want -- if
`we're making an obviousness argument, I need to know
`where that is in your petition. So that's where we are now.
`I need to know where that in the petition.
`MR. KOCHANSKI: And, as Your Honor has
`recognized, the argument here is inherency. It's not
`obviousness.
`JUDGE GREEN: It sounds like your counsel has
`something different to say.
`MR. KOCHANSKI: You asked for support in the
`petition for why we'd oppose an optimized viscosity to
`balance injectability and suspendability. That's found in the
`petition at pages 7 through 9, and in the reply, pages 3
`through 5 and page 15.
`JUDGE GREEN: Well, 7 through 9 is more of a
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`
`
`23
`
`
`
`Case IPR2016-01096
`Patent 6,667,061 B2
`
`
`background. It's not part of your ground, is it? I mean, the
`only thing I see in your ground is Johnson is silent as to the
`viscosity of the described formulation, uses 3 percent, what
`the vehicle is, that the ordinary artisan would appreciate that
`CMC is the viscosity enhancing agent and, based on Patent
`Owner's admission during prosecution of the '061 patent
`and the Tracy declaration and what would be known to the
`ordinary artisan, the ordinary artisan would reasonably
`expect the injection vehicle of Johnson, having 3 percent
`CMC, to have a viscosity greater than 27 cp at 20 degrees C
`and certainly within the claimed range.
`So I don't know, why would I have pulled in or why
`would we expect to have pulled in pages 6 to 7 or 5 to 7 or
`7 to 9 into the challenge?
`MR. KOCHANSKI: It's the recognition -- it's the
`recognition of the inherent properties of known
`formulations, Your Honor, as you just recited there when
`you read those pages.
`JUDGE GREEN: Okay. You're three minutes over,
`so you have 22 minutes, if y
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
