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`UNITED STATES PATENT AND TRADEMARK OFFICE
`___________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________
`
`DR. REDDY'S LABORATORIES S.A., and
`DR. REDDY'S LABORATORIES, INC.,
`Petitioner,
`
`v.
`
`INDIVIOR, U.K., LIMITED,
`Patent Owner.
`___________
`
`Case IPR2019-00329
`Patent 9,687,454 B2
`___________
`
`Record of Oral Hearing
`Held: March 3, 2020
`____________
`
`
`
`
`Paper No. 48
`Entered: March 26, 2020
`
`Trials@uspto.gov
`571-272-7822
`
`
`
`
`
`
`
`
`
`Before SUSAN L. C. MITCHELL, ZHENYU YANG, and
`RICHARD J. SMITH, Administrative Patent Judges.
`
`
`
`
`
`Case IPR2019-00329
`Patent 9,687,454 B2
`
`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER:
`
`IRA J. LEVY, ESQUIRE
`ROBERT FREDERICKSON, III, ESQUIRE
`Goodwin Procter
`
`100 Northern Avenue
`Boston, MA 02210
`
`ON BEHALF OF THE PATENT OWNER:
`
`PETER P. CHEN, ESQUIRE
`Covington Burling, LLP
`3000 El Camino Real
`Palo Alto, CA 94306
`
`
`
`The above-entitled matter came on for hearing on Tuesday, March 3,
`2020, commencing at 12:59 p.m., at the U.S. Patent and Trademark Office,
`600 Dulany Street, Alexandria, Virginia, before Donna Jenkins, Notary
`Public.
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`Case IPR2019-00329
`Patent 9,687,454 B2
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`P R O C E E D I N G S
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`JUDGE MITCHELL: Good afternoon everyone. We have a
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`final hearing this afternoon in IPR 2019- 00329. I am Judge
`Mitchell and seated to my right is Judge Yang and appearing
`remotely is Judge Smith. I would like to get appearances for the
`parties on the record if we could. Who do I have for Petitioner?
`
`MR. LEVY: May it please the Court, my name is Ira Levy.
`I am lead counsel for Petitioner's Dr. Reddy's Laboratories S.A.,
`and Dr. Reddy's Laboratory, Inc. With me is back-up counsel
`Mr. Robert Frederickson who will be arguing today. Also with
`me is Ms. Alexandra Valenti, back- up counsel and we're also
`pleased Your Honor to be joined today by Mr. Andrew Allen,
`Director of IP at Dr. Reddy's and Deepti Jain, Associate Director
`of Intellectual Property at Dr. Reddy's.
`
`JUDGE MITCHELL: Great. Thank you and welcome, and
`who do I have for Patent Owner.
`
`MR. CHEN: Yes. Thank you, Your Honor, and good
`afternoon. My name is Peter Chen, I'm with Covington &
`Burling. I'm lead counsel today for the Patent Owner, Indivior
`UK, Ltd. With me is my colleague, Isaac Belfer, at counsel table
`and in addition we have from Indivior the General Counsel of
`Intellectual Property for the corporation, Ms. Kathryn Jones and
`seated next to her is Ms. Lisa Stahl who is patent counsel at
`Indivior. Thank you very much.
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`JUDGE MITCHELL: Great. Thank you and welcome. I
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`know that we set forth our procedure for how we're going to
`handle the oral argument in our Hearing Order and we're going to
`follow that, but I just wanted to emphasize a couple of things
`before we get started as a reminder. So each party has 45
`minutes total time to present arguments and certainly to assist
`Judge Smith who is following along with your argument and also
`just for the clarity of the record when we go back and look at the
`transcript, if you refer to an exhibit that you certainly state the
`exhibit number and the page to which you are referring, and
`when you're referring to a demonstrative that you state the slide
`number.
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`Also please make sure that you stay at the podium so that
`the mike can pick up everything that you say so that Judge Smith
`can hear everything and not miss any of your statements. Also
`please be aware that Judge Smith cannot see what's projected on
`the screen. He certainly has the demonstratives and can follow
`along but if you pull up an exhibit, if you please just give him a
`minute to pull it up so that he can continue to follow along with
`your argument. The Petitioner has the burden of showing
`unpatentability of the challenged claims, so the Petitioner goes
`first. The Patent Owner will then have an opportunity to present
`a response and in addition to the Petitioner being able to reserve
`rebuttal, Patent Owner may reserve a little bit of time for
`rebuttal. So Petitioner, would you like to reserve any time?
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`MR. FREDERICKSON: Yes, Your Honor, ten minutes
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`please.
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`JUDGE MITCHELL: Great. Thank you. So whenever
`you're ready.
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`MR. FREDERICKSON: May it please the Board. Good
`afternoon, my name is Robert Frederickson on behalf of
`Petitioner. We are here today because the challenged claims of
`the 454 patent are not entitled to the priority date of the 571
`application which was filed on August 7, 2009. That is the only
`issue for the Board to decide in today's proceeding. If the 454
`claims cannot claim priority to the filing date of the 571
`application, Patent Owner does not contest that Myers anticipates
`all challenged claims.
`
`Slide 1, please. Seven years after the 571 patent was filed
`application was filed in the summer of 2016, the United States
`District Court for the District of Delaware held that the invention
`as it was described and claimed in the 571 application was
`invalid as obvious. In direct response to that ruling in
`September of 2016, the Applicants abruptly amended all claims
`in the then pending 454, the application that led to the 454
`patent. That amendment included limitations claiming that the
`specific amounts of polymers and pharmaceutical films were an
`aspect of the invention. The limitations at issue are directed
`towards specific values and bounded ranges of the amount of
`polymers and films and they are expressed in two forms. The
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`Case IPR2019-00329
`Patent 9,687,454 B2
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`first form is as a percentage of the total amount of polymer vis-
`à-vis the overall weight of the film and the parties have referred
`to that as the polymer weight percentages and the second form
`was the amount of polymer expressed as a ratio to the amount of
`buprenorphine in the films which is the active ingredient. The
`parties following the nomenclature in the patent itself has
`referred to those as the (b) : (a) ratios. Both sets of limitations
`do not have written description support in the 571 application
`and as a result all of the challenged claims are not entitled to
`that August, 2009 priority date.
`
`Slide 7 please. The Federal Circuit has set out the
`framework for today, the decision that the Board will have to
`make, and I'll direct the Board to the Federal Circuit's decisions
`in Purdue, in General Hospital, and in Lockwood. General
`Hospital and Purdue really deal with circumstances that we have
`today where there was a broad disclosure of numeric ranges and
`the Applicants tried to claim more specific values as part of their
`claims, and what the Federal Circuit has held is that the person
`of ordinary skill in the art must be able to immediately discern
`those narrowed limitations at issue. That was the Court's
`announcement in General Hospital. Purdue has the same type of
`holding where it says that the application, the disclosure, must
`have blaze marks that direct the person of ordinary skill in the
`art, such that that person can recognize that the inventor
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`Case IPR2019-00329
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`invented what is claimed as of the filing date of that original
`application.
`
`In our petition and in Dr. Das's declaration, we've walked
`through the 571 application and demonstrated that there's no
`blaze marks, no pointers, no indicators that the polymer weight
`percentages or these (b) : (a) ratios were something that a person
`would immediately be able to discern from that application.
`
`Slide 8, please. A critical corollary to the Federal Circuit's
`written description case law is the notion that the standard for
`written description is not whether a claim is obvious or not. The
`Federal Circuit has held that both in Research Corporations and
`the Lockwood cases and that's a critical issue for today's case
`because much of the evidence that Patent Owner has submitted
`throughout the course of this proceeding through Dr. Cremer's
`declarations and through the arguments made in Patent Owner's
`response and surreply are directed towards what a person of
`ordinary skill in the art would understand generally, what a
`person of ordinary skill in the art would think is important when
`constructing or manufacturing or making certain pharmaceutical
`films and you'll be able to see that I think today certainly in
`some of the demonstratives that Patent Owner has submitted for
`today's hearing where Dr. Cremer is talking about the overall
`general importance that certain properties may or may not have
`to a person of ordinary skill in the art. Critically, that's not the
`standard for written description. The Federal Circuit has been
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`crystal clear that disclosure, the hallmark of the written
`description requirement is the disclosure itself and it's not
`whether or not a person of ordinary skill in the art could
`speculate as to other modifications that that person may want to
`make or not want to make, but whether the application
`communicates to the person of ordinary skill in the art that the
`applicants, that the inventors had that particular feature in mind
`when they filed for their application.
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`If we can go to slide 10, please. So in slide 10 what we
`have here is a brief summary, an overview of the evidence that
`was submitted in our original petition much of which was recited
`in the Board's Institution decision and critically nothing has
`changed since the Board's Institution and today's hearing. We
`have a single disclosure in the 571 application that directs the
`person of ordinary skill in the art that the inventors thought you
`could use any desired amount of polymer and then they provided
`two open ended ranges that provide a bottom value, at least 25
`percent or at least 50 percent. There's no disclosure of bounded
`ranges in the 571 application. We agree that particularly the
`polymer weight percentages, they're expressed as percentages.
`You can't have more than 100 percent of any one particular
`ingredient and as the Board recognized in the Institution
`decision, there's necessarily some end point. There has to be,
`you can't go more than 100 percent but there's no disclosure
`whatsoever of what the end point may or may not be.
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`Case IPR2019-00329
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`Another critical point is that, and this is bullet No. 3,
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`there's no disclosure that the specific amount of polymers,
`critically the amount of polymer in the film, was any defining
`characteristic of the invention that the Applicants thought that
`the total amount whether it's 48 percent or 55 percent or 60
`percent had any defining characteristics in the film. That point
`has gone undisputed throughout this proceeding and in fact in
`Patent Owner's surreply at page 6, Patent Owner concedes the
`point when they argue that our argument, Petitioner's argument
`that the 571 application did not need to expressly link the
`amount of polymer with the inventive characteristics of the film
`was not relevant to the inquiry. That's not correct. The fact that
`the Applicants have not linked any inventive characteristics of
`these films with the total amount of polymer in the film is
`essential to the written description requirement because without
`that, there's just no blaze marks, no indication that a person of
`ordinary skill in the art would think that the amount, a specific
`value whether it's 48.2 percent or 58.6 percent, had any meaning
`to the inventors when they filed this application.
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`JUDGE MITCHELL: But counsel, how specific do they
`have to be? I mean do they have to be right on the money to
`fulfil the written description requirement or is there some wiggle
`room in there for them to not quite be as specific as the claim?
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`MR. FREDERICKSON: To use Your Honor's verbiage
`there's certainly permissible wiggle room here. We are not -- we
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`Case IPR2019-00329
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`have been accused of arguing and we are not arguing that there
`needs to be a verbatim disclosure within the application that you
`can map one to one in the claim. That is not our argument and
`you see that reflected in some of the case law that Patent Owner
`has cited and that the Federal Circuit has addressed that this isn't
`one of the cases on the fringes where the disclosure is to 67
`percent and the claim is directed to 70 percent. There's cases
`that the disclosure was 3.5 percent and the claim was about 5
`percent. We're not arguing on the fringes of particular numeric
`values.
`What we are trying to do though is take the application as a
`whole and communicate what would a person of ordinary skill in
`the art have thought these inventors had truly invented and here
`if we can turn to slide 11, this is the 571 application, this is
`paragraph 65. This is the only disclosure in the entirety of the
`571 application that discusses the amount of polymer in the film
`and all the inventors said when they filed this application in
`2009 was use some minimum amount of film or some minimum
`amount of polymer such that you have enough to have a
`polymeric film.
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`What they do not say is use up to some maximum level or
`there's some guidance pointing a person of ordinary skill in the
`art that a maximum level would be something that was desirable
`or something that would have an inventive characteristic, or
`something that the inventors were even thinking about at all. All
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`Case IPR2019-00329
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`this discuses is use a minimum amount of film and so when you
`look at the claims that exist in the 454 patent, what you have
`particularly as it relates to polymer weight percentages are very
`specific values, claim 1, a range of 40 to 60 percent. There's
`certainly nothing in paragraph 65 here that suggests that the
`inventors thought that there was any defining characteristics of
`their films and having polymer weight percentage of 40 to 60
`percent or even the more precise numbers, which I'll get to table
`1 and table 5 in a minute, of 48.2 and 58.6 percent. Those
`numbers a person of ordinary skill in the art certainly could be
`able to calculated but nothing in paragraph 65 or any of the text
`of the disclosure that holds out those particular numbers or
`numbers in between those particular numbers of having any
`significance, any criticality to their invention being preferred
`end points , all the things that the Board found (indiscernible) in
`the Institution decision, excuse me.
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`So what some of the arguments that we've seen from Patent
`Owner that they revolved over the course of time, and we'll start
`with slide 13. This is the 669 application and what Patent Owner
`first did, and this relates to claim 1 which is the 40 to 60 percent
`range, the first thing that Patent Owner pointed to to the
`examiner was this paragraph 33 and what was in the 669
`application is -- excuse me, is paragraph 32 in the 669
`application and paragraph 33 in the 571 application where you
`certainly see the numeric values 40 percent to 60 percent appear
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`Case IPR2019-00329
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`in the application. But what's critical, and Dr. Das explained
`this in her declaration, was that this paragraph talks about the
`relative amounts of different polymers vis- à-vis one another. So
`the percentage that's given is the total amount of polymer and
`what we've highlighted in accordance with some embodiments
`polyethylene oxide, that's a particular polymer, may range from
`about 20 percent to 100 percent by weight in the polymer
`component. So if you add up all the polymer, not the total
`weight of all of the ingredients in a particular film, then the
`application teaches that you could use this particular polymer in
`that particular amount and so we asked Dr. Cremer, who is
`Patent Owner's expert, is he relying on this particular paragraph,
`the paragraph that Applicants pointed the examiner to as
`supporting claim 1 and he disavowed it. He said no, we're not
`looking at paragraph 33 in the 571 application as providing
`written description support. So the paragraph that was identified
`during prosecution not being relied on today.
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`But what Dr. Cremer did do is he's offered a series of
`different opinions and we can turn to slide 14, please. This was
`from his initial declaration Exhibit 201, paragraph 42. I don't
`want to belabor the point and spend too much time on it but the
`first thing that Dr. Cremer did from the perspective of a person
`of ordinary skill in the art as it related to that bottom value of
`about 40 percent in claim 1 is then he said well, 40 percent is
`much closer to 48.2 percent which is the polymer weight
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`percentage that you can calculate from some of the formulations
`in tables 1 and 5 and since 40 is closer to 48.2 than it is to 25,
`that makes sense for being a lower bound and so again, and this
`will be indicative of maybe a theme of what Dr. Cremer did is
`he looked at the claims first and then tried to figure out what's
`the justification for where did these numbers come from.
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`So at his deposition, if we can turn to slide 15, this is
`Exhibit 1030, pages 101 to 102, we asked Dr. Cremer to apply
`that same logic to some other potential polymer weight ranges
`whether it's 41 percent which would also be closer to 48.2
`percent than the 25 percent or 42 percent or 43 percent or here at
`this particular quotation this 45 percent. Dr. Cremer, what about
`a limitation that was directed to 45 percent to 60 percent? And
`what Dr Cremer, he just refused to answer those questions. He
`called it a fictitious question. At some points he referred to it as
`fictitious ranges and in some respects that's the point we're
`trying to make, that you can't come up with these ranges by
`looking at the application first and determining whether or not
`the person of ordinary skill in the art would have immediately
`discerned them.
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`We had Dr. Cremer sitting for his deposition. He's
`certainly a person of ordinary skill in the art and we asked him
`are you able to discern these other end points, these other
`bounded ranges and at his deposition he refused to do it and so
`Dr. Cremer, at least the logic that he applied to say, well 40 to
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`60 percent is immediately discernible, he should be able to carry
`that through other bounded ranges and see if he's also able to
`immediately discern to those limitations and he just wasn't able
`to do it. So Dr. Cremer does not repeat and Patent Owner did
`not repeat that particular argument in their Patent Owner
`response. They've advanced different arguments and we can turn
`to slide 16, please.
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`Slide 16 is, and I've broken these up -- whether they're two
`or three separate arguments -- I've broken up into three sets of
`slides. The first kind of general principle that we have from Dr.
`Cremer and Patent Owner is that they advance this argument that
`as a matter of fact, the 571 application does disclose bounded
`ranges. They keep on referring to the disclosed ranges in the
`application and how they reach that conclusion is they start with
`that paragraph 65 that I put on the screen a minute ago that starts
`with the at least 25 percent and then they go to some of the
`examples that have polymer weight percentages, here's 58.6
`percent, they calculated that number. Another example had
`polymer weight percentage of 48.2 percent and they said because
`I have a low number that I was able to find in one portion of the
`specification and a high number that I was able to find in another
`part of the specification, lo and behold, the Applicants had
`possession of in fact bounded ranges.
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`If we can turn to slide 17, please. As a preliminary matter,
`all of this is disputed by Dr. Das in her declaration in paragraphs
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`60 and 61. I know there's at least some arguments with Patent
`Owner that you can file a reply declaration from Dr. Das with
`our reply papers and all of the review of what was in the
`disclosure of the 571 application and what was not in the
`disclosure of the 571 application we put our best foot forward in
`our position and Dr. Das addressed all these issues in her
`declaration and so it didn't seem that there was any need for us
`to submit a second declaration in reply saying everything I said
`in my first declaration still holds true.
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`JUDGE SMITH: Counsel.
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`MR. FREDERICKSON: Yes.
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`JUDGE SMITH: Counsel, I have a question. Go back to
`slide 16.
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`MR. FREDERICKSON: Sure.
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`JUDGE SMITH: So what struck me is that both parties
`have submitted declarations which essentially have no extrinsic
`support for the position and I'm just curious on what your view is
`how we're supposed to weigh the two declarations since they are
`saying exactly the opposite thing and yet they don't bring in any
`extrinsic evidence to support how a POSA would have read the
`specification.
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`MR. FREDERICKSON: So, and I agree with Your Honor's
`question. The premise of the question is I don't think whether or
`not there is extrinsic evidence makes the written -- I don't want
`to say matters for purposes of written description -- but that's not
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`the right inquiry and the reason for that, and what Dr. Das did,
`was to look at what was in the disclosure. It's the disclosure
`that's key. Not necessarily what a person of ordinary skill in the
`art might have known or might have been able to modify or how
`they could have manufactured different films but what does the
`disclosure teach the person of ordinary skill in the art about what
`the inventors regarded to be their invention and so what Dr. Das
`did, she didn't make any sweeping statements about what a
`person of ordinary skill in the art may or may not know, but what
`did the inventors communicate. What were they holding out
`their invention to be? What were the defining characteristics of
`their invention? And on that point there's very little in the
`disclosure. There's the one paragraph we showed you and the
`numbers that you calculate from table 1.
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`Now what Dr. Cremer has done is again, you're right, he's
`made these sweeping statements about what a person of ordinary
`skill in the art may or may not have known and again, he also
`doesn't cite any extrinsic evidence to substantiate any of those
`statement. Our primary response to that is as a legal matter it's
`largely irrelevant whether or not a person of ordinary skill in the
`art would have wanted and adjusted particular optional
`ingredients, for example, or whether they would have thought
`that oh, maybe that a polymer weight percentage of 40 percent
`would have the same general properties as a polymer weight
`percentage of 50 percent. It's legally irrelevant to the question
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`of written description which focuses on the disclosure and
`focuses on what the Applicants communicated to be the defining
`characteristics of their invention. The last point --
`
`JUDGE SMITH: Counsel, but the written description
`requirement is met by how a person of ordinary skill in the art
`would have understood what is written and I just found it frankly
`difficult to sort through the two declarations given that both of
`them seem to not point to anything supporting the notion of how
`a person of ordinary skill in the art would have read, for
`example, the greater than at least 25 percent and other than just
`sort of just a blanket opinion, so my question really is how are
`we to weigh the two declarations? How are we to evaluate that?
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`MR. FREDERICKSON: Well, Dr. Das's declaration was
`focused on what was disclosed and what was not disclosed in the
`571 application. That to us is the central inquiry for the panel to
`resolve. We agree that inquiry is viewed through the lens of a
`person of ordinary skill in the art but it's not how that person of
`ordinary skill in the art would have made a film or manufactured
`a film or how they made or modified the film to make it better or
`worse or what have you. It was what does the disclosure
`communicate and throughout the Federal Circuit's cases you see
`a number of different things that the Federal Circuit has pointed
`to of examples of what may be in an application that provides
`written description support and what doesn't. For example, if
`there was an express disclosure that we regard a bounded range
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`of 40 to 60 percent to be part of our invention, we probably
`wouldn't be here today. But we know that's not in the 571
`application.
`
`We also know that there's no pointers anywhere in the 571
`application that the person of ordinary skill in the art would have
`understood that the Applicants regarded the amount of polymer
`to be within their invention and if we can turn to slide 10,
`please, slide 25 please, I'm sorry. So one of the other factors is
`what is the person of ordinary skill in the art reading the
`application understand, are these inventive characteristics of the
`particular film and what we have -- again I think I've gone too
`far, I apologize -- what the undisputed testimony is was that
`there's nothing in the 571 application that points to the amount
`of polymer being an inventive quality. It's slide 19 is the one
`I'm looking for, I apologize, and so there's no discussion about
`the mucoadhesive properties of these films vis-à-vis the amount
`of polymer, absorption, dissolution of pharmacokinetic profile.
`All you have is a table 1 which has here certain formulations that
`the inventor made and then you have table 5 which talks about
`the adjustments to the pH, adjustments to the buffers and the
`effect that managing the buffer would have or would not have on
`the pharmacokinetic properties that were filled (phonetic). To
`the extent that the Applicant --
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`JUDGE MITCHELL: Counsel.
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`MR FREDERICKSON: Oh, I'm sorry.
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`JUDGE MITCHELL: Can I ask you, why isn't that enough
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`though? If I'm looking -- if I'm one of skill in the art and I'm
`looking at the examples and I'm seeing the ranges that are in the
`claims, wouldn't that let me know these are the types of films
`that work, you know, they're in the application. Wouldn't that
`let me know some of the bounds or at least reasonably know the
`bounds of the range for the polymer?
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`MR. FREDERICKSON: So to the extent the inquiry was
`how to make and replicate a pharmaceutical film I think that's
`fair, but if the inquiry is what did the Applicants regard to be
`part of their invention, what did they have possession of? That's
`the separate inquiry that the written description test provides and
`here we have nothing in the application that the Applicants
`indicated that any intermediate values or anything within these
`particular ranges, this isn't a situation where you have a page full
`of testing data and Applicants are directing towards particular
`properties that a film does or doesn't have and they want to
`capture some subset of that range, that's not this disclosure.
`What we have is the very broad and very open ended
`disclosure use some minimum amount of film. Make sure you
`have enough polymer in there so your film doesn't fall apart.
`But other than that, we Applicants are going to give you no
`guidance whatsoever, we're going to focus on other things that
`we regarded to be our invention, the pH and the pharmacokinetic
`profiles and then what they did is they made two sets of films
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`Case IPR2019-00329
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`essentially and these two data points, they have nothing in
`between the two data points other than -- and we can go to table
`5, slide 20 -- nothing in between the two data points and very
`important, and this distinguishes this case from a lot of the cases
`that are cited by both sides is we have this data on table 5 where
`we have polymer weight percentages and what the Applicants did
`in table 5 is they made three film formulations and those three
`film formulations had 50.6 percent polymer weight percentage,
`48.2 percent and 48.2 percent and what the Applicants said was
`one of these films we regard to be inventive, the other two of
`these films we don't regard to be inventive because they don't
`work. They didn't achieve the desired effect, they didn't achieve
`the desired result and so you have a situation -- this isn't like
`Purdue where there was inconclusive data in terms of what was
`in and what was out, we have expressed data about what was in
`and what was out -- and there's nothing that a person of ordinary
`skill in the art would have been able to discern from whether or
`not that number 48.2 percent actually had any significance for
`the Applicants, whether that was something that they regarded to
`be part of the invention, an important defining characteristic of
`their invention -- that's the language that you have in the Purdue
`case -- and so that's a critical distinction that Patent Owner does
`not really address. They focus on the test formulation 2 and they
`say because test formulation 2 worked and that had a particular
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`weight percentage of 48.2 percent, that means that 48.2 percent
`and anything close to 48.2 percent falls within our invention.
`But they ignore the express teachings, as Dr. Das pointed
`to, that 48.2 percent also didn't work. It was just not a
`component of the film that Applicants were focused on. It was
`not a component of the film that there were any blaze marks in
`the application that direct a person to pay attention to other than
`make sure your film doesn't fall apart, make sure you have
`enough polymer in there in order to you have a self supporting
`film but we're going to move on and focus on these other
`ingredients.
`JUDGE MITCHELL: So your -- Petitioner's position is
`what, if you're using the claims you're looking in hindsight you
`might be able to tease out the range. But otherwise a POSA
`looking at those would not immediately discern this claimed
`range?
`MR. FREDERICKSON: That's exactly correct and if you
`look at slide 21, this is a summary slide of some of the examples
`that Dr. Cremer set forth in his declaration and really that's
`exactly the point that Your Honor just made is that what Dr.
`Cremer did is he picked certain formulations from certain aspects
`of the table and then he started to remove certain ingredients. So
`for exa
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