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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`GRÜNENTHAL GMBH,
`Petitioner,
`
`v.
`
`ANTECIP BIOVENTURES II LLC,
`Patent Owner.
`____________
`
`Case PGR2018-00062
`Patent 9,707,245 B2
`____________
`
`Record of Oral Hearing
`Held: July 31, 2019
`____________
`
`
`
`Before TONI R. SCHEINER, GRACE KARAFFA OBERMANN, and
`SHERIDAN K. SNEDDEN, Administrative Patent Judges.
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`Case PGR2018-00062
`Patent 9,707,245 B2
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`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER:
`
`
`JAMES R. TYMINSKI, ESQUIRE
`BRUCE C. HAAS, ESQUIRE
`KATHERINE E. ADAMS, ESQUIRE
`Venable LLP
`Rockefeller Center
`1270 Avenue of the Americas, 24th Floor
`New York, New York 10020
`
`
`
`ON BEHALF OF THE PATENT OWNER:
`
`
`BRENT A. JOHNSON, ESQUIRE
`Maschoff Brennan
`100 Spectrum Center Drive, Suite 1200
`Irvine, California 92618
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`
`
`
`The above-entitled matter came on for hearing on Wednesday, July
`
`31, 2019, commencing at 10:00 a.m., at the U.S. Patent and Trademark
`Office, 600 Dulany Street, Alexandria, Virginia.
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`P R O C E E D I N G S
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`MS. BOBO: All rise.
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`JUDGE OBERMANN: Good morning. You may be seated. It’s just
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`going to take us a couple of minutes to get our computers awake and then
`we’ll begin. This is a final hearing in Grünenthal GMBH versus Antecip
`Bioventures II LLC. It’s Case PGR 2018-00062, and at issue are certain
`claims of Patent 9, 707, 245.
`
`I’m Grace Obermann and I have with me today Judge Toni Scheiner,
`as well as Judge Sheridan Snedden. We issued an order on July 10th that
`will cover this proceeding. Both sides were given 60 minutes of total
`argument time to present their case.
`I will just remind counsel that you are to confine yourselves to
`arguments and evidence that was raised in a principal brief. By that I mean,
`the Petition, the full response, the reply, and the sur-reply in this case. Both
`sides may reserve some rebuttal time, and when you come to the podium
`please let me know whether you'd like to reserve any of your primary time
`for rebuttal.
`And with that, I'd like to have counsel please introduce yourselves for
`the record. We’ll start with Petitioner.
`MR. TYMINSKI: Good morning, Your Honor, this is James
`Tyminski from Venable LLP on behalf of the Petitioner in this case, and I’m
`joined today by lead counsel, Bruce Haas, also of Venable LLC, Katherine
`Adams, and William Solander.
`JUDGE OBERMANN: Thank you. And it’s Mr.?
`MR. TYMINSKI: Tyminski.
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`JUDGE OBERMANN: Tyminski. Thank you, Mr. Tyminski. Will
`you be providing all the argument today for your client?
`MR. TYMINSKI: Yes, I’ll provide the entire argument.
`JUDGE OBERMANN: Thank you very much. And who do we have
`for Patent Owner?
`MR. JOHNSON: Good morning, Your Honors. It’s Brent Johnson
`from Maschoff Brennan. I represent the Patent Owner.
`JUDGE OBERMANN: Thank you Mr. Johnson. With that when
`you're ready, if you can approach the podium Mr. Tyminski, and if you'd just
`halt for a second and tell me whether you'd like to reserve any rebuttal time,
`and I can set your clock.
`MR. TYMINSKI: Yes, I would like to reserve time for rebuttal. I'd
`like to reserve 20 minutes.
`JUDGE OBERMANN: Okay. If you give me just a minute, I’m
`going to set the clock up for 40 minutes. You'll be able to see it right behind
`me, and when you're ready I’ll start the clock ticking.
`MR. TYMINSKI: Good morning, may it please the Board. My name
`is James Tyminski. I’ll be arguing on behalf of the Petitioner today. I'd like
`to start by taking a look at Claim 1 of the 245 Patent.
`It is the only independent claim in the patent, and it’s directed to a
`method of treating pain associated with Complex Regional Pain Syndrome,
`abbreviated CRPS, by administering neridronic acid to a human being with
`CRPS where a bone fracture was a predisposing event for that CRPS, and
`where the neridronic acid is in a salt or an acid form.
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`The main element of this principal independent claim that’s in dispute
`here today is the bone fracture as a predisposing even for CRPS. So, I think
`that’s where most of the discussion will be centered on.
`Moving to Slide 3, this is a summary of the grounds that are set forth
`in our Petition, so I’ll start by talking about why the bulk of the claims are
`anticipated, or obvious, over the Varenna 2012 Reference alone.
`JUDGE OBERMANN: Are you going to treat the issue that seems to
`have crystalized towards the end, and that is Varenna’s prior art status? Is
`that going to be part of your presentation?
`MR. TYMINSKI: Yes, I do plan to address that as part of my initial
`presentation, and I expect Patent Owner to say about that so I may also
`address it in rebuttal.
`JUDGE OBERMANN: Okay.
`MR. TYMINSKI: After discussing obviousness, or anticipation over
`Varenna alone, I’ll move on to why all the claims are obvious over Varenna
`2012 in combination with other prior art. And then finally I’ll discuss
`Petitioner’s Section 112, written description ground.
`So, beginning with anticipation by Varenna 2012, this applies the
`claims 1 through 4, 9 and 10, 12, 14, 16 through 18, 23 to 24, and 27
`through 29. On Slide 5, I've shown Independent Claim 1, again, and just
`moving on to Slide 6, how Varenna 2012 teaches these claim elements.
`The first quote here is from Varenna 2012. It concludes that
`neridronic acid is effective to treat CRPS. We know it’s effective to treat
`pain because the efficacy measure that Varenna used was a reduction in
`visual VAS pain scores. So, we know that Varenna broadly teaches that
`neridronic acid is effective to treat CRPS.
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`JUDGE OBERMANN: And those were done in human patients,
`correct?
`MR. TYMINSKI: Yes, this was a human clinical study. It was a
`double-blind, placebo controlled, clinical study, which was also followed by
`an open-ended extension phase. So, all these were human patients.
`And then we know from Dr. Poree, Petitioner’s expert, who I will talk
`a little bit more about later, we know that the use of the term “neridronate”
`in Varenna 2012 signifies that a salt form was used.
`So, really, in this case I think that all of the elements of this claim,
`except for the bone fracture as a predisposing event for CRPS, are present in
`Varenna 2012, and that’s not really in serious dispute here in this
`proceeding. So, it really comes down to, as the Board noted in the
`Institution Decision, the question of whether bone fracture as a predisposing
`event for CRPS is taught by Varenna 2012.
`If we move on to Slide 8, this is Table 1 from the Varenna 2012
`Reference, and it indicates that fracture patients were included in both the
`neridronate and placebo arms of the human clinical study. And, what the
`human clinical study tells us is, broadly and generally, that neridronate
`reduces pain in CRPS patients.
`It also states that the author’s analyzed whether any of the baseline
`variables that they looked at when they were including patients in their
`study, had any impact on the outcome of the study.
`So, they looked at it, at factors like, the predisposing event, the site of
`the disease, and the disease duration. And, they included all of the patients
`in that statistical analysis. That means they also included the patients who
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`had fracture as a predisposing event for CRPS. It means everyone who was
`intended to be treated in the study was included in that statistical analysis.
`And what Varenna concludes is that the only baseline variable that
`had any impact on the results of the study, which were positive, which we
`know showed efficacy; the only variable that had any impact was whether
`the patient was assigned to the treatment group and actually got neridronate,
`or whether they were signed to the placebo group and didn’t get it. They
`couldn’t identify any baseline factor, other than that, that impacted the
`outcome measures in the study.
`So, based on this, Petitioner’s expert, Dr. Poree, offers an opinion that
`hasn’t been challenged in this case by any other expert or any other
`evidence, that the particular type of precipitating events does not influence
`outcome measures in the study.
`JUDGE OBERMANN: This is critical, so I’m going to just stop you
`for a second, but I did notice that your friend did challenge Dr. Poree’s
`conclusion that that particular disclosure in Varenna, would include
`fractures.
`I noticed there was something in, I think it was the sur-reply, where
`they basically are saying that that doesn’t find support in the Reference
`itself. And that the conclusion that your expert has drawn from the
`disclosure, sort of, exceeds the disclosure. What's your response to that?
`MR. TYMINSKI: Well, my first response to that is that the opposing
`argument against Dr. Poree’s interpretation of the Reference is merely
`attorney argument.
`Dr. Poree is a medical doctor with 20 years of experience in this field.
`So, where faced with a competition between an expert’s interpretation of
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`how a POSA would read the Reference, and an attorney’s version, I think we
`should give Dr. Poree’s interpretation more credence.
`But second, Dr. Poree looked at the Reference in its entirety. He
`looked at Varenna 2012 as a whole, and that’s what you have to do and an
`obviousness analysis is look at the Reference from the perspective of POSA,
`and look at the Reference as a whole, not just one single, isolated statement.
`So, when we look at Varenna 2012, it not only talks about the
`multivariate regression analysis and lists some examples of the precipitating
`events, and site of disease that were analyzed, but it also says that they could
`not identify any other factors influencing the outcome measures of the study.
`And it broadly concludes that this is the treatment of choice; neridronate is
`the treatment of choice for CRPS.
`So, Dr. Poree’s opinion is based on the entirety of the Reference and
`he is an expert who has interpreted the Reference in that way, in that it has
`been challenged by Patent Owner, but it hasn’t been challenged by any
`opposing evidence or expert testimony as to how a POSA would read this
`Reference.
`But there's even more in Varenna 2012 beyond the initial double-blind
`phase of the study, and beyond the baseline variable regression analysis,
`because we also know that fracture patients were included in the placebo
`arm of the study. And the results from the double-blind phase were so
`encouraging that the Varenna Group then offered neridronate to all of the
`patients in the placebo arm of the study, in an open-ended extension phase.
`And, what we know from the results of that phase, is that allodynia
`and hyperalgesia, two forms of pain, disappeared in all of the patients, and at
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`an investigator, global assessment, the disease was considered resolved in all
`patients at the end of the open-ended extension phase.
`So, we know, from both the placebo phase and the baseline regression
`analysis, and the open-ended extension phase, that Varenna expressly
`teaches that neridronate is effective to treat CRPS induced by a fracture.
`And again, Dr. Poree’s opinion that all these elements are checked off,
`as you can see on Slide 14, is based on the Reference as a whole; he takes
`Varenna for everything that it teaches to a POSA. And again, he's the only
`expert in this case.
`Turn it to Slide 15, Patent Owner didn’t submit any expert testimony,
`they didn’t even depose Dr. Poree in this case, and they're not refuting any
`of his expert opinions by their own admission in their sur-reply on Page 11,
`that’s Paper Number 21.
`So, turning to the issue of whether Varenna 2012 is prior art, Varenna
`2012 has two statements on it’s face, on the face of the document; and this is
`Exhibit 1005, that indicate that it is, in fact, prior art.
`We have the statement at the top of the first page of the Reference,
`Page 534, that indicates that it was published on the 30th of November 2012.
`And at the bottom we also have a copyright statement that states that it was
`copyrighted in 2012, and it was published on behalf of the British Society
`for Rheumatology, by Oxford University Press.
`In this case, we have facial evidence, on face of the Reference, that
`this a journal article from a periodical journal that was published by a well-
`known and reputable publisher.
`JUDGE OBERMANN: How do we know that it’s well-known, and
`that this is what it appears to be.
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`MR. TYMINSKI: Well, on the face of the article it says it was
`published by Oxford University Press, I think that’s a --
`JUDGE OBERMANN: So, do we need to take judicial notice of that?
`You don’t have anyone testifying about this being a typical journal.
`MR. TYMINSKI: I don’t think we have anyone testifying that it’s a
`typical journal, or about who Oxford University Press is. I mean, we do
`have testimony from Dr. Phillip Robinson that the Reference was actually
`publicly available before the priority date, and accessed by him, and
`retrieved, and posted to twitter so that other people could access it before the
`priority date.
`JUDGE OBERMANN: Where is that testimony?
`MR. TYMINSKI: That’s in the declaration of Dr. Phillip Robinson,
`which we submitted, and I would direct the Board to Slide 51, 55. So, this is
`the declaration of Dr. Phillip Robinson. It’s referenced in Petitioner’s reply
`at Page 5, and what Dr. Robinson has testified to is that he has personal
`knowledge that Varenna was available before what is the admitted earliest
`possible priority date of the 245 Patent.
`And he actually posted a tweet linking to it showing where you could
`retrieve a copy of the Reference. And he testified that he reviewed a copy of
`it, and that evidence was provided after we made an initial showing in the
`Petition based on the face of the Reference that was sufficient to institute.
`Patent Owner challenged that in the Patent Owner response, and then
`in reply we submitted this additional evidence to respond to those
`arguments.
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`JUDGE OBERMANN: So, they make a big deal about that process,
`but there was nothing unusual about it under Dynamic Drinkware, it’s
`simply a shifting of production of evidence not of burden.
`MR. TYMINSKI: Right, we are not arguing that the burden to prove
`that the patent is invalid shifts to the Patent Owner. That’s not the case. The
`ultimate burden of persuasion is always on the Petitioner.
`But in this case, we made a threshold showing at the institution
`decision phase in our Petition that the Board countenanced, and that was
`sufficient evidence at that point. So, that was evidence to prove that it was
`more likely than not that Varenna was prior art, because the standard in
`institution in a PGR is more likely than not.
`So, now I think the burden of production switches to Patent Owner, us
`having made that initial showing more likely than not, to come forward with
`some evidence to say that this Reference was not actually published on date
`that it says on it’s face that it was published on.
`And I think this is a perfectly acceptable process that we've gone
`through, and I would point the Board to the Genzyme versus Biomarine
`case, it’s a Federal Circuit case, 825F3D1360 which says that what can't be
`introduced later on in a proceeding is new arguments, or new theories, not
`new evidence supporting theories that have already been made.
`And a very similar procedure to what we did here actually happened
`in the Motorola Mobility versus Intellectual Ventures IPR, where there was
`an initial showing and then Petitioner came back with reply evidence to
`respond to Patent Owner arguments that a reference was not prior art. And
`that IPR 2014-00501, that Motorola Mobility’s IPR.
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`So, I think we do have some evidence in support of Varenna’s public
`accessibility in addition to the evidence that’s on the face of the Reference.
`And I just wanted to point out on Slide 18, some of the arguments that
`Patent Owner makes in response.
`They contend that the copyright date and publication date are hearsay.
`They make some arguments about whether the document is authentic;
`whether it is indeed what Petitioner says it is.
`But Patent Owner didn’t object to this Exhibit 1005. They didn’t
`object to the exhibit. They didn’t object to any of the dates. They didn’t
`move to exclude it. So, any of these evidentiary objections are waived.
`And what it comes down to is there's evidence that the Reference was
`publicly accessible and available before the priority date, and based on
`what's on the face of the Reference, and what's in Dr. Robinson’s
`declaration, it’s clear that there is evidence showing that, and there's no
`evidence on the other side to refute any of those statement.
`Very quickly, looking at some of the dependent claims, we have
`several depending claims that provide limitations. For example, Claim 2,
`the CRPS is limited to Type 1, and Claim 3, the neridronic acid is limited to
`a salt form, and then in Claims 4 and 9, the neridronic acid has to be
`administered intravenously, or parenterally.
`These elements of these additional dependent claims, as shown on
`Slide 24, are plainly present in Varenna. It was an intravenous study
`involving neridronate salt and the patients were given four intravenous
`infusions of neridronate, and they all had CRPS 1.
`There is also Slide 25, there's many dependent claims in the 245
`Patent that deal with specific dosing regimens. So, they talk about how
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`often the neridronate is administered, or the specific amount of neridronate
`present in a dosage form or when it is administered over a period of time.
`And for all of Claims 10, 12, 14, 16 through 18, and 23 through 24,
`the four infusions of 100 milligrams of neridronate given in Varenna falls
`within these claim limitations, as the Board found preliminarily in the initial
`Institution Decision.
`Moving on to Slide 27, which talks about Claims 27 through 29, these
`are limitations regarding the age of the patients, or the particular pain score
`that those patients had. And these elements are also present in Varenna
`because the patients had to have a pain score of at least 50 millimeters,
`which is a 5 on a 1 - 10 scale, and the mean age of the patients was 58.2. S,
`that means that some patients over 18 and over 40 years of age must have
`been included in the study.
`Unless the board has any other questions on anticipation, I’ll move on
`to our obviousness ground, which is Ground 4 in the Petition.
`Even if the Board is to accept all of the Patent Owner’s arguments on
`anticipation by Varenna 2012, for the sake of argument, those same claims
`are nevertheless obvious, over Varenna 2012 considered alone.
`Again, there's really no serious dispute here that elements 1, 2 and 4
`of this claim are disclosed in Varenna 2012. So, what it comes down to is
`the fracture induced CRPS limitation once again.
`And again, we know that fracture patients were included in both the
`neridronate and the placebo arm of the study. We also know, based on
`Varenna, that it broadly concludes without reference to any particular
`precipitating event, or any particular cause of CRPS, that neridronate is
`effective to treat CRPS generally.
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`And we also know from the open extension phase of the study, where
`the patients receiving placebo got neridronate, we know that all of those
`patients no longer had allodynia or hyperalgesia pain. And we know that
`they all were seen as having their disease resolve at an investigator
`assessment.
`So, I think it’s also important to know that the results from the
`placebo portion of the study were so encouraging and so positive that the
`authors then moved on to give all of the patients in the group that did not
`receive neridronate, they moved on to give them the actual treatment.
`I think that within the Reference itself it actually shows that there's a
`motivation to give neridronate to patients with fracture induced CRPS
`because the results of the placebo controlled portion of the study were
`enough for Varenna to give neridronate to all CRPS patients in the placebo
`group, including those that had fractures. So, within the Reference itself we
`see the motivation to do this actually carried out by Varenna himself in his
`own study.
`And the way I think of this as an obviousness argument is if a Dr. who
`treats pain had a copy of Varenna 2012 and she had just read it, and then a
`patient walks into her office having fracture induced CRPS, would that
`doctor be motivated to give neridronate to that patient, and would she
`reasonably expect that it would work based on what she had just read in
`Varenna 2012.
`And I think here on Slide 34, at paragraphs 127 and 128 of Dr.
`Poree’s declaration, we see that the answer is clearly yes; that Dr. Poree
`concluded that to a POSA it would very clear that neridronate is effective to
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`treat any type of CRPS, including fracture induced CRPS, and that you have
`a reasonable expectation that it would work.
`So, even if we get into a discussion about whether fracture induced
`CRPS is expressly disclosed in Varenna, and whether it expressly shows that
`those patients were treated and benefitted, at the end of the day, the claims
`are clearly obvious over Varenna 2012, even assuming for the sake of
`argument, that that limitation isn't expressly present.
`And again, Dr. Poree’s testimony on this point is not challenged, it’s
`not rebutted by any opposing expert testimony or any other evidence, other
`than attorney argument.
`So, what Patent Owner then turns to, to support these claims and to
`say that they're not obvious is supposed evidence of unexpected results.
`And what they point to is a 2017 reference, Varenna 2017, that’s Exhibit
`Number 1015 to the Petition; and they say that this data that is disclosed in
`Varenna 2017 is evidence of unexpected results.
`I think it’s important to note that the Patent Owner did not generate
`this data. This is data that was generated by the same Varenna group that
`performed the initial Varenna 2012 study. This analysis was done on some
`of the same patients that were included in the Varenna 2012 study, and all of
`these patients received the same course of neridronate treatment as Varenna
`gave in the original 2012 study.
`Now, what we see here is that in Table 2, fracture patients were
`somewhat more likely to respond to treatment that patients that had other
`forms of CRPS. But there's nothing in Varenna 2017 that suggests that the
`authors found this result surprising.
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`They don’t say that they are surprised by it, or that it was unexpected
`based on their earlier work. In fact, it’s just the opposite. At Page 1136 of
`Varenna 2017, they actually suggest that these results are consistent with the
`data in their earlier 2012 clinical study. And I think it’s easy to see why.
`And that’s because the responder percentage here in Varenna 2017, is
`83.1%; whereas in Varenna 2012, overall, all of the patients responded at a
`rate of 73.2%.
`So, we don’t have any evidence, there's no evidence in the Reference
`itself that says that that’s unexpected. Patent Owner hasn’t produced any
`evidence, any expert testimony or any statement in the art that indicates that
`these results were unexpected. So, what we’re left with is, is 83.1% in
`Varenna 2012 for fracture, an unexpectedly high rate; or is 57.1 for surgery
`an unexpectedly low rate? There's not testimony that says that the 83.1%
`response rate is unexpected over the 73.2 response rate seen previously.
`So, Patent Owner is comparing the responder percentage for fracture
`to the responder percentage for the other predisposing events listed in
`Varenna 2017, but that’s the wrong comparison. The comparison is whether
`it’s unexpected compared to the prior art, not whether it’s unexpected
`compared to the other precipitating events listed in the Varenna 2017
`Reference. The prior art teaches that 73% of patients respond. We have no
`idea whether 83.1% is unexpected over what was already taught in the prior
`art.
`
`And again, we know that based on the case law, in Slide 36, which we
`have cited in our Petition and in our reply, that attorney argument is not the
`kind of evidence that can refute a prima facie case of obviousness. So,
`lawyer’s argument is not enough. There has to be some evidence that these
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`results would have been unexpected to a POSA and there really is nothing
`like that here.
`So, all we have is Dr. Poree’s testimony, which appears in paragraphs
`175 and 177 of his declaration, where he says, that it’s not unexpected that
`the fracture patients responded to treatment. You already would have
`expected them to respond to that treatment based on Varenna 2012. So,
`there's nothing unexpected about their response in Varenna 2017.
`So, that’s really the only evidence we have in this case, is Dr. Poree’s
`own rebutted opinions as to whether these results would be unexpected, and
`he says they would not.
`Moving on to obviousness over Varenna 2012 in combination with
`other prior art, namely the Bruehl Reference, and one or more of Gatti, La
`Montagna, or Muratore. I think we can go back to the scenario that I talked
`about before about a doctor having a CRPS patient with fracture induced
`CRPS walk into her office, after she read Varenna 2012.
`But now, let's suppose she also has these additional references at her
`disposal that she has also read. So, she's also read Bruehl and what does
`Bruehl tell her? Bruehl tells her that fracture is one of the most common
`precipitating events, or predisposing events, for CRPS. And she also knows,
`based on Gatti, La Montagna, and Muratore, that there's overwhelming
`evidence in the prior art that neridronate, or neridronic acid is effective to
`treat CRPS generally, without reference to any particular precipitating event.
`So now armed with the Varenna data, these additional references that
`also teach that neridronate is effective to treat CRPS and then additionally
`knowing that this is one of the most common predisposing, or precipitating
`events for the condition, at this point, that doctor would certainly be
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`motivated to administer neridronate to that patient, and would reasonably
`expect it would work based on the additional disclosures of these references.
`And again, that is exactly what Dr. Poree tells us at paragraph 142 of
`his declaration cited here on Slide 39. And again, there's no evidence on the
`other side from any expert, or anything in the art, to refute Dr. Poree’s
`opinions.
`I want to briefly touch on obviousness of the dependent claims.
`Patent Owner really has not argued in response to the Institution Decision
`which found that these claims were obvious that any of these additional
`limitations provide anything inventive over the prior art that would be
`different from the analysis for Claim 1; but again, we have several claims
`that deal with particular dosing regimens of neridronic acids.
`We have claims that deal with particular amounts of neridronic acid
`administered within a month. For example, Claim 13 is 100 milligrams to
`300 milligrams administered within one month. Then there's also claims to
`the amount for each dose, but these really don’t add anything more over
`what's in Claim 1 because determining the dose would have been obvious to
`a POSA.
`We have some examples in the art where La Montagna administers 25
`milligrams a month for six months and they say that’s effective for treating
`transient osteoporosis of the hip, which Dr. Poree tells us is a type of CRPS.
`We have Varenna 2012 which shows efficacy at the 100-milligram dose that
`Dr. Varenna administered four times which equates to 400. And he also
`says that there was some degree of efficacy in smaller doses of 200
`milligrams and 300 milligrams.
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`Where these general conditions of the claim were present in the prior
`art, it’s not obvious to optimize the particular dose. The experimentation
`here would have been routine. Dr. Poree tells us that is his declaration, and I
`think beyond that, over and above that, in arguing that these claims are
`enabled, the Patent Owner has also essentially admitted that it would have
`been obvious and routine to reach these dosage amounts because at Page 11
`of the POR, they argue based on the data that’s presented in Varenna 2012,
`that it would have been obvious for a POSA to determine the doses and
`arrive at the doses that are listed in their claim from the broad disclosures in
`their specification and, therefore, the claims are enabled.
`There really doesn’t appear to be much of a dispute in this case, that
`these dosage limitations did not add anything inventive over and above
`what's disclosed and claimed in Claim 1.
`Moving on, I’m on Slide 44, and this is an additional ground for
`Claim 30. And Claim 30 adds the Schwarzer Reference to the references
`that I mentioned earlier, and the grounds for the remainder of the claims, and
`that’s because Claim 30 is the only claim in the 245 Patent that’s directed to
`CRPS Type 2, specifically, and not CRPS generally, or CRPS Type 1.
`The difference between CRPS Type 1 and Type 2 as the Schwarzer
`Reference tells us, and as Dr. Poree has testified, is that CRPS Type 1 is not
`associated with a nerve injury, whereas CRPS Type 2 is associated with a
`nerve injury.
`There are no other clinical differences between the two types of
`CRPS. So, they are diagnosed the same way, they have the same symptoms,
`the same diagnostic criteria are used to identify whether a patient has CRPS.
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`So, it would have been obvious to administer a neridronic acid to treat
`CRPS Type 2. This is in Dr. Poree’s declaration at paragraphs 167 to 173,
`he tells us that a POSA would have that the treatment options available for
`CRPS 1 and 2 would be the same and that a POSA would understand that.
`And he also tells us that because there's not clinical differences between the
`two conditions other than a nerve injury, that a POSA would have been
`motivated to give neridronate to CRPS 2 patients that had their disease
`caused by
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