`571-272-7822
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`Paper No. 28
`Entered: September 24, 2020
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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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`SANDOZ INC.,
`Petitioner,
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`v.
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`PHARMACYCLICS LLC,
`Patent Owner.
`____________
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`IPR2019-00865
`Patent 9,795,604 B2
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`Record of Oral Hearing
`Held: June 19, 2020
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`Before SHERIDAN K. SNEDDEN, SUSAN L. C. MITCHELL, and
`DAVID COTTA, Administrative Patent Judges.
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`IPR2019-00865
`Patent 9,795,604 B2
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`APPEARANCES:
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`ON BEHALF OF THE PETITIONER:
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`KIRK BRADLEY, ESQ.
`Alston & Bird
`One Atlantic Center
`1201 West Peachtree Street
`Suite 4900
`Atlanta, GA 30309-3424
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`ON BEHALF OF THE PATENT OWNER:
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`WILLIAM B. RAICH, ESQ.
`Finnegan, Henderson, Farabow,
`Garrett & Dunner, LLP
`901 New York Avenue, NW
`Washington, DC 20001-4413
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`The above-entitled matter came on for hearing on Friday, June 19,
`2020, commencing at 9:00 a.m. EDT, by video/by telephone.
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`IPR2019-00865
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`P R O C E E D I N G S
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`JUDGE COTTA: Good morning. This is the Final Hearing in
`IPR2019-00865 regarding Claims 1, 4, 6 through 10, 13, 15, 24, 28 through
`31, 35, 39, 43 through 46, 50 through 53 and 55. This is patent number
`9,795,604. The Petitioner is Sandoz, Inc., the Patent Owner is
`Pharmacyclics LLC. The hearing is open to the public and a full transcript
`of the hearing will be made part of the record.
`I'm Judge Cotta, with me are Judges Snedden and Mitchell. Counsel
`for Petitioner, could you please identify yourself for the record?
`MR. BRADLEY: Good morning, Your Honors, this is Kirk Bradley
`of Alston & Bird on behalf of the Petitioner, Sandoz, Inc.
`JUDGE COTTA: Okay and counsel for Patent Owner, would you
`kindly identify yourself for the record?
`MR. RAICH: Good morning, Your Honors, this is Bill Raich from
`Finnegan on behalf of Patent Owner, Pharmacyclics.
`JUDGE COTTA: Okay, so as set forth in our Hearing Order of May
`15th, each side has one hour to present its case. My colleagues and I will do
`our best to keep track of time, but we suggest that the parties do the same.
`Counsel for the Petitioner, would you like to reserve any time for rebuttal?
`MR. BRADLEY: Yes, Your Honor, I would like to reserve 15
`minutes, please.
`JUDGE COTTA: Okay. And counsel for Patent Owner, you're
`entitled to the last word today, if you wish, would you like to reserve any of
`your time?
`MR. RAICH: I would, Your Honor, I'd like to reserve 10 minutes.
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`JUDGE COTTA: Okay. Before we begin there are a few things that
`I'd like to cover. First, on behalf of the Board, we'd like to thank you all for
`your flexibility in participating in this all video hearing. Given that this is a
`departure from our typical practice, I first emphasize that our primary
`concern is your right to be heard. So, if at any point during the proceeding
`you encounter technical or other difficulties that you feel undermine your
`ability to adequately represent your client, please let us know immediately.
`Second, when you're not speaking, please mute your microphone to
`make for a clearer record. Third, for the benefit of the court reporter, please
`identify yourself every time you speak. Fourth, we have access to the entire
`record including demonstratives. For the benefit of the record and to enable
`us to follow along better please when referring to each demonstrative paper
`or exhibit do so by slide or page number and give us a few seconds to find it.
`Finally, should you come to a good faith belief that the pace of this
`proceeding prevents you from adequately explaining your position, please
`speak up and we'll consider extending the allotted time.
`Petitioner, you go first as you bear the burden of showing
`unpatentability of the challenged claims. You can begin whenever you're
`ready.
`MR. BRADLEY: Thank you, Your Honors, and good morning again.
`Kirk Bradley on behalf of Petitioner. I would like to start in our slide deck
`at slide 24, please. Slide 24, the '085 Publication anticipates and renders
`obvious all challenged claims. And I want to start here because, really, this
`is the core of all four of Petitioner's independent ground of unpatentability
`for all of its challenged claims.
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`Moving to Slide 25 we see here Claim 1 of the 604 Patent. The main
`thing I want to point out here is that the chemical structure is shown in the
`claim, but there's no dispute that that chemical structure represents the drug
`compound Ibrutinib. And I do want to note for Your Honors also that there's
`a certificate of correction appended to the patents that corrects the stereo
`chemistry shown here. But in any event, there's no dispute that the
`compound itself is Ibrutinib.
`Moving to slide 26. On this slide we've taken the exact language of
`the claim and substituted the chemical compound for the word Ibrutinib and
`then we've broken it down into three parts: the preamble; the one method
`step that recited; and, then the thereby clause. And we power coded these so
`that we can follow along easier.
`On Slide 27, it's really the beginning of the focus of the claim where
`we have the preamble reciting a method of treating chronic GVHD. The
`'085 Publication expressly discloses that limitation, if it's a limitation. I note
`that it's a preamble, the Board doesn't have to decide whether this preamble
`is limiting or not. It doesn't matter because it's expressly disclosed.
`Here we see on Slide 27, paragraph 116 through 120 of the '085
`Publication where the publication describes and defines the word treating. It
`defines it as including inhibiting the disease and for leaving the disease.
`And, in fact, that definition of treating is very similar to the definition of
`treating used in the '604 Patent. It's found in the '604 Patent at column 26
`line 47 to 51. In the '604 patent, it talks about lessening the severity of the
`disease, relieving a condition of the disease and that's the same thing we see
`here in the '085 Publication. In paragraph 120, we see a specific reference to
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`a therapeutically effective amount, which is an amount that's sufficient to
`assess the treatment of the disease.
`Moving to Slide 28 we can see that in the '085 Publication the
`treatment of diseases includes methods of treating Graft Versus Host
`Disease. That's the disease recited in Claim 1. It says that in paragraph 98
`of the '085 Publication.
`Now, I'll note that paragraph 98 of the '085 Publication references
`Graft Versus Host Disease and it doesn't specify acute or chronic. But
`looking here at slide 29, it's well-known persons of skill in the art including
`both Patent Owners and Petitioner's expert that GVHD only has two types,
`acute and chronic. The experts spoke, said so during this trial, also the art of
`record, for example the Shimabukuro reference which is Exhibit 1003 at
`page 7, even that one says, "GVHD has been divided into two forms, acute
`and chronic." In fact, the '604 Patent makes the same point at column 28,
`lines 53 to 54. And it says, quote, "GVHD presents in both acute and
`chronic forms."
`So, what does that mean for that? What that means is when the '085
`Publication discloses, expressly discloses administering Ibrutinib to treat
`GVHD, a person of skill in the art immediately knows that that disclosure is
`disclosure of acute and chronic GVHD.
`Looking at slide 30 we can see here at the top, this is a quote from the
`Bristol Meyers case by the Federal Circuit and here the Federal Circuit says,
`"The disclosure of a small genus, for example GVHD. The disclosure of a
`small genus may anticipate the species acute and chronic even if the species
`has not been cells recited." And the idea is that a person of skill in the art
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`would immediately through GVHD and immediately know that's acute,
`that's chronic. Anticipation can still be found.
`Moving to slide 31 we can see here is that the '085 Publication
`expressly discloses a treatment of GVHD is accomplished by administering
`a therapeutically effective amount of Ibrutinib, but also importantly, it's
`inherent in any event. The Bristol Meyers Squibb case makes clear that,
`"Newly discovered results of known processes directed to the same purpose
`are not patentable because the results are inherent."
`Another case cited in our brief is the King Pharmaceuticals case. In
`that case, there was a preamble much like the one we have here. That
`preamble recited a method of increasing the bio-availability of Copaxone , a
`different drug. That preamble to put off circuit health (phonetic) was
`inherent. The Federal Circuit said that when you administer Copaxone with
`(inaudible), it inherently achieves that result. The same thing is true here. It
`expressly disclosed and it's inherent.
`Moving to slide 32, it's not only expressly disclosed and inherent for
`purposes of anticipation, but also, it's readily obvious. It would have been
`obvious to a person of skill in the art reading the '085 Publication to
`appreciate as a disclosure of administering Ibrutinib to treat GVHD in
`conflict to treating chronic GVHD.
`JUDGE COTTA: Counsel, not to interrupt you, but I guess before we
`get too far down the road of obviousness, I'd like to touch a little bit on
`enablement and specifically, what's required to enable the disclosure of the
`'085 Publication and treatment of a graft versus host disease.
`MR. BRADLEY: Yes, Your Honor. If Your Honor would turn
`please to Slide 36. Slide 36 is a summary of the Patent Owner's argument
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`relating to enablement and we can see here at the top of the slide that in the
`Patent Owner response they argued that the '085 Publication is not enabling
`because it lacks guidance and working examples that that's what they said.
`But then in their sur reply, they say, Patent Owner does not require a
`working examples, or proof of efficacy. So, I'm unclear whether Patent
`Owner even contends anymore that working examples are required, but
`clearly they're not.
`If we move to slide 37, we see, first of all --
`JUDGE COTTA: My understanding of it was that Patent Owner was
`talking about the lack of guidance and working examples as one of the
`Wands factors, the guidance provided by the prior art publication. Is that --
`do you have a different understanding?
`MR. BRADLEY: I'm, frankly, a little unclear of what exactly they're
`arguing with enablement, but I think regardless of their position, it's readily
`counteracted, and if we look at slide 37, we can see the beginning of that.
`Slide 37 shows at the top that prior art publications and patents are presumed
`to be enabled. So, out of the gate the '085 Publication is presumed to be
`enabled.
`And now, let's turn to the enablement standard itself. At the bottom of
`slide 37, we quoted from the In re Gleave case by the Federal Circuit. And
`the Federal Circuit says that a prior reference is enabling if a person of
`ordinary skill knows how to use the method in light of the reference, would
`know how to practice that method; would know how to carry it out. That's
`all that's required.
`If we look at slide 38, we can see here that Claim 1, which is the
`foundation for all these claims, Claim 1 requires just one step. It requires
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`administering a therapeutically effective amount of Ibrutinib. That's the
`only step. To enable that, all that we have to have is a person of skill in the
`art has to know how to use that method in light of the reference. Absolutely
`they do. A person of skill in the art would read the '085 Publication and it
`expressly says to administer a therapeutically effective amount of Ibrutinib.
`There's no experimentation needed at all, much less unduly experimentation.
`So, the invention is enabled.
`Going back to Slide 33, we can see here on Slide 33 that I've already
`discussed the preamble and now, I'm moving into that administrative step
`which is the only step, administering to a patient having cGVHD, a
`therapeutically effective amount of Ibrutinib. I just explained how it's
`enabled and now here on Slide 34 we can see it's expressly disclosed in the
`'085 Publication. Paragraph 94 uses the same words in the same order. It
`says -- it talks about administering to a patient a therapeutically effective
`amount of Ibrutinib. On slide 35, we can see on the left-hand side we have
`quote from paragraph 30 of the '085 Publication, and it talks about
`therapeutically effective amounts of Ibrutinib. It includes, for example, as
`we'll see later, 220 milligrams per day. It reflects that those expressly. It
`also reflects the prices within the ranges disclosed here.
`Also, on paragraph 120 of the '085 Publication shown on the right side
`of '535, we can see that the '085 Publication specifically defines
`therapeutically effective amounts. The publication makes clear that this
`means the amount of Ibrutinib that when administered through a mammal
`for treating a disease it's sufficient to affect such treatment for the disease.
`So, we clearly have a disclosure in the '085 Publication of the lone method
`that's required by Claim 1.
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`If we jump forward now to slide 39, I've checked off that lone method
`step. The only remaining aspect of Claim 1 is the thereby clause tacked on
`at the end. The thereby clause says, "thereby treating the cGVHD in the
`patient."
`Looking at slide 40, we see here what we've argued in our brief which
`is that if thereby clause is nothing more than a non-limiting statement of
`intended purpose. Because it's not limiting, it doesn't -- does not need to be
`disclosed in order to anticipate or for obviousness. Regardless, apart from
`that the '085 Publication expressly and inherently discloses treating the
`cGVHD for the reasons I said earlier in the preamble. So, we have several
`bases here, it's both non-limiting and even if the Board were to find it to be
`limiting it's expressly and inherently disclosed.
`On slide 41, at that top left slide, we see an example of the pertinent
`case law from the Federal Circuit. And here in the Minton decision the
`Federal Circuit makes clear that these work through clauses and a method
`claim are not given patentable weight when it simply expresses the intendant
`results of a process step positively recited. Here, we have a process step
`positively recited of administering through a patient with cGVHD, a
`therapeutically effective amount of Ibrutinib.
`That process that is positively recited the intended result is to treat
`cGVHD. That's the thereby clause is not given any patentable weight. Now,
`we'll go to slide --
`JUDGE COTTA: Is there any need for us to construe this claim
`limitation? Does it affect the outcome in any way?
`MR. BRADLEY: It does not, Your Honor, because the treatment is
`enhanced in processing the claim step so, there's no terms in here that
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`require construction and the Board need not even determine whether it's
`limiting or not. Frankly, respectfully, the way Petitioner would ask the
`Board to deal with the preamble and the thereby clause is to say for the
`preamble, we don't have to determine whether it's limiting or not because it's
`inherently satisfied and is expressly and inherently disclosed in the prior art.
`And the same thing for the thereby clause, the Board should find that it's
`non-limiting, but should go on and find that even if it is limiting, it doesn't
`matter because it's expressly and inherently disclosed in the '085 Publication.
`And so I think like with each of those errors in the quiver, there's the
`preamble and the thereby clause can be readily knocked down.
`Now, I don't want to spend too much time on it because, again, the
`thereby clause is non-limiting and also expressly and inherently disclosed.
`But I do want to mention on slide 42, I do want to mention that the Patent
`Owner tries to make it a big deal about prosecution of this '604 patent. The
`Patent Owner argues that during prosecution the Patent Owner somehow
`expressly relies on the thereby clause in order to get around and while I don't
`want to dwell on it, I want to make the key points because that's just not
`correct. What really happens is the clause adding this thereby clause was
`added after all the substantive rejections had already been listed.
`If we skip ahead to Slide 48 --
`JUDGE COTTA: Counsel, I think that's correct, but during
`prosecution wasn't there also an amendment to Claim 1 that added the same
`limitation at a point when all the substantive limita -- rejections were still
`pending?
`MR. BRADLEY: The claim that was prosecuted during -- excuse me,
`the prosecuted claim was 21. If Your Honor turns to slide 45, slide 45 says,
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`newly added Claim 21, and it was added by an amendment. This is the
`Claim 21, this is the claim that eventually became Claim 1. And what
`happened was on slide 46 we see in response to adding that Claim and the
`other aspects of that amendment, the Patent Office withdrew all of the
`substantive rejections. So, after Claim 21 was added, the Patent Office
`withdrew all the rejections. They withdrew the 112 rejection; they withdrew
`the Section 102 and 103 rejections, that's shown on slide 46 by the Exhibits
`20, 30 at three and four.
`Then on slide 47, we see here that what happened because Claim 21
`was newly introduced, it was provisionally rejected on the grounds of non-
`statutory double patenting. There were several applications pending at the
`same time and whichever one's issued later we're going to get a double
`patenting rejection.
`Moving then to slide 48, now we have the Patent Owner's amendment
`and response in April of 2017. This is at the very end of the prosecution
`which was the last step in this paper. And here the Patent Owner
`acknowledges that the only rejection that's remaining is this provisional
`rejection for double patenting. There are no substantive rejections still
`pending. That was in April of 2017.
`If we move then to slide 49, we're still in that exact same amendment
`and response in April of 27 (sic). And again, the Patent Owner said, there's
`no substantive rejection pending, and that was correct. And we see here
`what they did with Claim 21. At the end of that Claim, with no rejection
`pending on the substance, they struck the last phrase and substituted this
`thereby clause on July (crosstalk) --
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`JUDGE COTTA: Just to be clear, Counsel, I understand the course of
`prosecution, but I guess you would have us just ignore the amendment to
`the, I could say, the response to the April 22, 2016 office action where the
`patentee amended Claim 1 which is very similar to Claim 21 to delete the
`prevention and add treating, and I believe they also added a thereby treating
`on the patient as well.
`MR. BRADLEY: The purpose of that amendment was to overcome
`the 112 rejection because the Patent Owner had not enabled prevention. It's
`easier to treat a disease than it is to prevent it on the front end. And the
`disclosure in the '604 Patent enabled treatment, but did not enable
`prevention. And so what they did was they realized, oh, we cannot get
`prevention and so what we -- what they did was they rationed the back
`announcement, and said okay, rather than getting prevention which would
`include treatment will only go and get treatment. So, this was a narrowing
`rejection to eliminate the fact that they were not entitled to preventing the
`disease. So --
`JUDGE COTTA: Do you have any authority to support that we
`should treat an amendment to overcome a 112 rejection differently from an
`amendment to overcome a prior art?
`MR. BRADLEY: The authority is the Copaxone and Bristol Meyers
`and even the Allergen Sales cases decided by the parties. In those cases the
`issue was, for example, when Allergen Sales such is the case that Patent
`Owner likes to refer to, in that case the wherein clauses were, quote,
`"explicitly relied on to distinguish over the prior art." The Federal Circuit
`made clear in that case that they were talking about distinguishing over the
`prior art. I don't have a case that expressly says it must be only prior art, but
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`certainly that makes sense when you think about the policy of it all because
`you're looking at what are the substantive rejections? When are you going
`to be able to get and write up what the prior art discloses? And here in
`Claim 1 that we're dealing with in this case, there were no substantive
`rejections pending and they added the thereby treatment clause.
`I'll reiterate also, because I don't want to get too hung up on this
`aspect, this really doesn't even matter because as I've shown, the only five
`publication expressly and narrowly discloses it anyway. And so, I do think
`the prosecution supports our argument that it was not relied on in order to
`get allowance of these claims. Also, on --
`JUDGE COTTA: Can we -- can I -- I just wanted to jump into a
`different topic, and I'm sorry for the quick transition. But I wanted to talk
`specifically about Claims 4, 13 and 15. And as I understand it, you argue
`that the '085 Publication discloses combination therapy, and therefore,
`anticipates Claims 4, 13 and 15.
`And I guess my question is, I could see how this argument might
`apply to Claim 4 which encompasses steroid dependent GVHD, but how
`would it apply to Claims 13 and 15 which are directed to steroid resistant or
`refractory GVHD?
`MR. BRADLEY: Yes, Your Honor. If Your Honor will turn please
`to slide 56.
`JUDGE COTTA: Okay, give me a second.
`MR. BRADLEY: On Slide 56, I want to be clear about the
`anticipation of Claims 4, 13 and 15. There are two reasons why these were
`anticipated. And the first is the point, Your Honor, was just mentioning.
`And that is on slide 57. On slide 57, we have paragraph 121 of the '085
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`Publication. And while this does mention combination therapy that even
`more aptly here, what it references is that Ibrutinib can be used sequentially
`with other drugs. And the potential aspect --
`JUDGE COTTA: Just to be clear here, do you read the sequentially
`there to mean two drugs not used in combination therapy where one drug has
`failed?
`MR. BRADLEY: I read this as, and Dr. Ferrara testified that this
`means that Ibrutinib is being disclosed as a treatment sequentially with
`steroids and he understands that to mean what everyone has been doing in
`the art for decades which is giving steroids as a first line defense and then --
`excuse me, as a first line treatment and then when that failed, if that failed
`moving on to a second line treatment option like Ibrutinib, like other drugs
`that are available sequential in that aspect. And with --
`JUDGE COTTA: I guess my concern with that reading is if you look
`at the first sentence of paragraph 121 it's talking about a combination
`therapy, and then if you look at the second sentence, it talks about such other
`drugs. So, it's building on the combination therapy. So, I'm struggling to
`see how you would see paragraph 121 as supporting using one drug like a
`steroid until it's failed and then switching over as opposed to combination
`therapy where one drug is administered sequentially after another drug.
`MR. BRADLEY: So, in paragraph 121, in that second sentence, Your
`Honor, reference is it talks about contemporaneously or sequentially. And
`all I can say is if we look at slide 59, we can see here that Dr. Ferrara is
`talking about paragraph 124 which specifically mentions the glucocorticoids
`which is a steroid. Gluten (phonetic) specifically talks about glucocorticoid
`context. And here on slide 59 there's an excerpt from Dr. Ferrara's
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`testimony when he's reading it from the '085 Publication where it talks about
`the glucocorticoids and it lists several examples like Prednisone and
`Cortisone, and he says here in the highlighted language, these are all steroids
`that we use to treat graft versus host disease. So, we say it's telling me here,
`meaning the '085 Publication is telling me here that use the Ibrutinib in
`combination with that. And if we look back at 5 -- Your Honor doesn't need
`to flip if you don't want to I can read it, but slides 5 and 6 make very clear,
`the slides 5 and 6 make very clear that for decades prior to the five to eight
`years, physicians, persons of skill in the arts have been using steroids as the
`first line treatment option.
`Dr. Koreth who is the Patent Owner's, expert made clear that steroids
`have been repeatedly used for decades. On top of slide 6, he says that we've
`routinely used steroids as our first go to, I think that is almost universal in
`the field.
`So, looking back at slide 56, slide 56, if you recall a moment ago I
`mentioned that we had two reasons for anticipation of Claims 4, 13 and 15.
`And I'll mention the second one here in a moment. I do want to make clear
`that there's no marked distinction between Claims 4, 13 and 15. Two of
`those claims talks about instances where we have steroid refractory or
`steroid resistant chronic GVHD. Those are of the same ilk and both of those
`are telling you that steroids are just not working to treat the chronic GVHD.
`You get steroids as the first time treatment option and if it's not working
`because the GVHD is resistant or refractory to the steroids, then you move
`on to a second line treatment like Ibrutinib, like other options that have been
`available.
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`The other claim of this group is steroid dependence to GVHD and
`what that means is that the patient is dependent on the steroids. The steroids
`are working, but as soon as you remove the steroids it stops working, they're
`dependent on it. The Patent Owner has not made any distinction between
`these three claims, the parties have treated them together and I think clearly
`so. Those experts have said steroids are the first line defense, everyone
`knows that and not wait for decades. You use these second line treatment
`options only if steroids are not working. And that segue is into the
`anticipation argument that we had set forth and it's shown on slide 56.
`On slide 56, what we have here is a summary of what a person of skill
`in the art would read from the '085 Publication. And if we think back, the
`'08 -- excuse me, the person of skill in the art here, the parties agree this is a
`really knowledgeable person. This person knows chronic GVHD; they
`know treatment options; they know transplantations; they know how GVHD
`works. And when that person is reading the '085 Publication, and they've
`seen reference to Ibrutinib being administered to treat GVHD, they already
`know, oh, we're talking about a second line treatment option. Because we
`know, everyone's known for decades that steroids are the first line options
`and so when you read the '085 and it's talking about Ibrutinib as a BTK
`inhibitor being used as a treatment for GVHD, it's already built in and its
`distinction has thoroughly dependent or refractory or resistance to GVHD
`otherwise, (inaudible). So --
`JUDGE COTTA: I think I understand factually the argument. Can
`you address, briefly, the concern we articulated in the institution decision
`that finding anticipation with respect to these claims draws impermissibly on
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`the knowledge of the person of skill in the art and kind of goes beyond
`what's disclosed in the reference?
`MR. BRADLEY: Yes, Your Honor. I think it's -- honestly, it's a
`fairly fine line there between adding the knowledge of a person of skill in
`the art versus reading what the reference tells a person who is a skill in the
`art. The line is that for participation, we have a person of skill in the art, that
`person is for all intents and purposes, a pro who's been working in years
`with GVHD. When that person with that perspective and that knowledge
`base reads the '085 Publication it tells them that Ibrutinib is being used as a
`second line treatment option because it has to be, everyone knows from that
`perspective, everyone knows steroids is the first line. So, just reading at the
`very beginning, okay, we're talking about a second line treatment option.
`And even if that were not the case, but it is, but as I've mentioned, we talked
`at the outset here paragraph 121 and 124 makes it even clearer by
`specifically saying that the Ibrutinib compound in the '085 Publication could
`be administered sequentially with other drugs. And paragraph 124 says
`steroids and Dr. Ferrara here, on Slide 59 says, when I read this, it's, "It's
`telling me here that it can use Ibrutinib in combination with that." And he
`means with the steroids first and perhaps steroids continue, but Ibrutinib is
`given as a second line treatment option when steroids are not being effective,
`whether it's because the GVHD is resistant or refractory or this is more
`dependent. So, that's the difference.
`I will say, Your Honor, that, respectfully, we would ask the Board to
`find these claims anticipated for the two reasons I just mentioned. But in
`addition, we would ask the Board respectfully, to also find that in any event
`it's absolutely obvious, these Claims are absolutely obvious because for all
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`the reasons I've just explained, a person of skill in the art they all know that
`we're talking about one of these drugs, Ibrutinib, one of the others that are
`used for cGVHD patients. You only get to that phase once steroids are not
`working, or once the patient's cGVHD is dependent on the steroids.
`JUDGE COTTA: Can you address for obviousness with respect to
`these claims the reasonable expectation of success and particularly in light of
`Exhibit 2050 which is the consensus conference on clinical practice in
`chronic GVHD which says, and I'm reading from Page 2, it says: "Although
`different treatment options are available for salvage therapy of steroid
`refractory cGVHD, the trial and error system remains to date the only way to
`identify the drug or drug combination effective in an individual patient.
`MR. BRADLEY: I think the answer to that, as I understand Your
`Honor's point, is that there we're talking about a situation where we have a
`known drug, Ibrutinib. It has been known since at least 2006 when a patent
`application was filed covering that drug. Dr.