`Trials@uspto.gov
`571-272-7822
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`Paper 75
`Entered: April 20, 2023
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`SLAYBACK PHARMA LLC,
`Petitioner,
`
`v.
`
`EYE THERAPIES, LLC,
`Patent Owner.
`____________
`
`IPR2022-00142
`Patent 8,293,742 B2
`____________
`
`Record of Oral Hearing
`Held: February 27, 2023
`____________
`
`Before TINA E. HULSE, ROBERT A. POLLOCK, and RYAN H. FLAX,
`Administrative Patent Judges.
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`IPR2022-00142
`Patent 8,293,742 B2
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`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER:
`
`ROBERT FREDERICKSON, III
`Goodwin Proctor LLP
`100 Northern Avenue
`Boston, MA 02210
`rfrederickson@goodwinlaw.com
`
`LINNEA P. CIPRIANO
`Goodwin Procter LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018
`lcipriano@goodwinlaw.com
`
`ON BEHALF OF THE PATENT OWNER:
`
`BRYAN C. DINER
`CAITLIN E. O'CONNELL
`CHRISTINA JI-HYE YANG
`JUSTIN J. HASFORD
`Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
`901 New York Ave, NW
`Washington, D.C. 20001-4413
`bryan.diner@finnegan.com
`caitlin.oconnell@finnegan.com
`christina.yang@finnegan.com
`justin.hasford@finnegan.com
`
`The above-entitled matter came on for hearing on Monday, February
`27, 2023, at 1:00 p.m., at the U.S. Patent and Trademark Office, 600 Dulany
`Street, Alexandria, Virginia before Walter Murphy, Notary Public.
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`IPR2022-00142
`Patent 8,293,742 B2
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`P R O C E E D I N G S
`- - - - -
`JUDGE POLLOCK: Good morning -- or good afternoon,
`
`everyone. I'm Judge Pollock. With me in the hearing room is
`Judge Flax and joining us virtually is Judge Hulse.
`
`This is the final hearing in IPR2022-00142, involving
`Claims 1 to 6 of U.S. Patent Number 8,293,742.
`
`Petitioner is Slayback Pharma, LLC and Patent Owner is
`Eye Therapies, LLC.
`
`Let's begin with appearances. Counsel for Petitioner,
`would you please introduce yourself and your colleagues?
`
`MR. FREDERICKSON: Yes, Your Honor, good afternoon,
`Robert Frederickson on behalf of the Petitioner from the law
`firm of Goodwin Procter. With me is my colleague Linnea
`Cipriano, also from Goodwin Procter. And we also have Anjum
`Swaroop, Jeffrey Martin, and Deepti Jain from Dr. Reddy's
`Laboratories, the real party in interest.
`
`JUDGE POLLOCK: Good afternoon.
`
`MR. FREDERICKSON: Good afternoon.
`
`JUDGE POLLOCK: Patent Owner, please introduce
`yourself and who's with you.
`
`MR. DINER: Good afternoon, Judge Pollock, Bryan Diner
`for the Patent Owner, Eye Therapies. I'm joined by colleagues
`Caitlin O'Connell, Christina Yang, Justin Hasford; and,
`representing the Patent Owner, Kristi McIntyre and Bob Rowlett.
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`IPR2022-00142
`Patent 8,293,742 B2
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`JUDGE POLLOCK: Good afternoon.
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`Ms. O'Connell, are you here as a LEAP practitioner?
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`MS. O'CONNELL: Yes, Your Honor.
`
`JUDGE POLLOCK: Welcome.
`
`MS. O'CONNELL: Thank you.
`
`JUDGE POLLOCK: As we stated in our hearing order,
`
`each party will have 60 minutes of time to present their
`arguments. Because Patent Owner has notified us that we have a
`LEAP practitioner for today's argument, Patent Owner will have
`an additional 15 minutes of argument time.
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`The parties have also requested the hearing room be closed
`for a portion of the hearing so the parties may discuss
`confidential information. That request has been granted and we
`will close the hearing room at the end of the hearing to do so.
`
`The parties have been informed that Petitioner would like
`to reserve five of its 60 minutes and Patent Owner would like to
`reserve ten of its 75 minutes argument time to discuss any
`confidential information.
`
`Are those still the amounts of time the parties would like
`reserve; Petitioner?
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`MR. FREDERICKSON: Yes for Petitioner.
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`JUDGE POLLOCK: Mr. Diner?
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`MR. DINER: Yes for Patent Owner.
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`JUDGE POLLOCK: All right, then we will close the
`hearing room when there are 15 minutes left in the hearing. For
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`IPR2022-00142
`Patent 8,293,742 B2
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`the public portion of the hearing, we'll start with the Petitioner,
`then hear Patent Owner's response; then, assuming Petitioner and
`Patent Owner both reserve any of that original time, we will hear
`Petitioner's rebuttal and, finally, Patent Owner's surrebuttal.
`
`Once the public portion of the hearing is complete, we will
`take a quick break to close the hearing room, during which that
`time anyone who is not permitted to hear confidential
`information under the protective order will leave the hearing
`room and the IT technician will close the public line. It is up to
`the parties and their representatives to determine who is
`authorized to remain.
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`When we resume the hearing, as we discussed during the
`prehearing conference, we will hear first from Petitioner and
`then Patent Owner, and then Petitioner's rebuttal and, finally,
`Patent Owner's rebuttal.
`
`We have your slides. We have received both sides'
`objections to those slides and we will address those quickly here.
`
`Regarding Petitioner's objections to Slides 2 and 72 for
`citing evidence that's subject to Petitioner's motion to exclude,
`we will take those objections under advisement pending the
`outcome of that motion. For now, Patent Owner may rely on
`those slides during today's argument.
`
`Patent Owner, when you come to Slides 2 and 72, would
`you please note that they are subject to those objections as a
`reminder to the panel.
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`IPR2022-00142
`Patent 8,293,742 B2
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`MR. DINER: Yes, Your Honor.
`
`JUDGE POLLOCK: Regarding Petitioner's new argument
`
`objections, those objections are denied as we can determine for
`ourselves whether the argument is new.
`
`Regarding Patent Owner's objections that Petitioner's slides
`misstate whether an issue is disputed, those objections are denied
`as Patent Owner can address the dispute during today's argument.
`
`Both parties are cautioned not to interrupt opposing
`counsel's presentation, but may briefly enter any additional
`objections during a break or at the end of an opposing party's
`presentation.
`
`As a reminder, please remember to be explicit when you're
`referring to any slides on the screen, as Judge Hulse cannot see
`what's being transcript and so that the transcript is clear. In
`addition, Judge Flax and I are often looking at the slides on our
`own screens and will not be necessarily looking at the slides on
`the panels, so please do make sure you refer to them by number.
`
`Are there any questions at this time?
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`MR. DINER: No, Your Honor.
`
`MR. FREDERICKSON: Not from Petitioner.
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`JUDGE POLLOCK: Petitioner, you have 55 minutes of
`public argument time, will you be reserving any time for the
`public portion of your argument?
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`MR. FREDERICKSON: Yes, Your Honor, 15 minutes.
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`JUDGE POLLOCK: Okay, Patent Owner, you have 65
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`IPR2022-00142
`Patent 8,293,742 B2
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`minutes of public argument time, will you be reserving any time
`for the public portion of your argument?
`
`MR. DINER: I'm sorry --
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`JUDGE POLLOCK: Would you like to reserve time for the
`public portion of your argument?
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`MR. DINER: I will do another at least five --
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`JUDGE POLLOCK: Five?
`
`MR. DINER: -- so, actually, Judge Pollock, what we're
`going to probably do is wait and see, but generally speaking, 15
`minutes that we'll reserve, and probably five will go to --
`between five and ten will go to the surrebuttal and maybe less
`than seven will go to the confidentiality.
`
`JUDGE POLLOCK: Okay. All right, my colleagues and I
`will do our best to keep track of the time, but we suggest that the
`parties do the same. And please do not hesitate to speak up if
`you believe we have miscalculated the time.
`
`So --
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`JUDGE FLAX: Fifty five to begin with for them?
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`JUDGE POLLOCK: Fifty five to begin with for Petitioner.
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`JUDGE FLAX: Okay -- no --
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`JUDGE POLLOCK: Oh, I'm sorry, no, no, no, no.
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`JUDGE FLAX: Petitioner will have 40 --
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`MR. FREDERICKSON: Forty.
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`JUDGE POLLOCK: Forty.
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`JUDGE FLAX: -- and then 55 for Patent Owner.
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`JUDGE POLLOCK: Yeah.
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`JUDGE FLAX: Okay, gotcha.
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`JUDGE POLLOCK: Higher math.
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`JUDGE FLAX: There's a lot of numbers going here.
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`(Pause.)
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`JUDGE POLLOCK: Judge Hulse seems to be ready and
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`we're ready on the timer.
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`Petitioner, please begin.
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`MR. FREDERICKSON: Thank you very much, Your
`Honors. Again, Robert Frederickson on behalf of the Petitioner.
`
`There are three general topics I'd like to address during the
`first 40 minutes of this presentation, the first of which is that the
`Ground 1, Gil, discloses the administration of low concentrations
`of brimonidine to patients suffering from red eye by virtue of the
`radial keratotomy surgery that they have undergone, and that
`disclosure inherently anticipates Claims 1 and 2 of the '742
`patent.
`
`Number two, all of the asserted claims of the '742 patent
`should be found to be obvious in view of the prior art cited in the
`petition. For this portion of the argument, I'll be focusing on
`Claim 3 as the bellwether claim, so to speak, because it contains
`all of the limitations of Claims 1 and 2, and adds only a range of
`pHs that were already captured by prior art brimonidine products
`on the market.
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`And, finally, the third topic I hope to address is Patent
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`IPR2022-00142
`Patent 8,293,742 B2
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`Owner's evidence of secondary considerations and why Patent
`Owner has failed to establish that there is the appropriate nexus
`between its proffered evidence and some of the flaws within that
`evidence.
`
`So, with that introduction, I'd like to turn to Ground 1 and
`Slide Number 7, which is the recitation of the key limitations
`from Claims 1 and 2 of the '742 patent.
`
`Now, based on where things stood at the conclusion of the
`papers, from Petitioner's perspective, two of the five limitations
`at issue were undisputed, and I'd like to focus particularly on
`limitation 1.1 consisting essentially of administering
`brimonidine. At no point during the proceedings, at least on the
`written record, did Patent Owner suggest that Gil failed to
`disclose this limitation. That was the basis of the objection that
`we launched to some of the slides that we received and we would
`encourage the Board to look at the -- to the extent the Patent
`Owner in this particular proceeding and this argument argues
`that there's any dispute with respect to limitation 1.1, that was
`not a dispute that was presented at any point prior to today in the
`submission of the demonstratives.
`
`After that, the three limitations that were disputed in the
`papers are the preamble and then two claim construction
`disputes, the construction of the phrase "ocular condition" in
`limitation 1.2 and the meaning of the phrase "about 0.025
`percent."
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`IPR2022-00142
`Patent 8,293,742 B2
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`I'm going to start with the preamble, "A method for
`
`reducing eye redness."
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`Now, during the prehearing conference call we had with the
`Board there were some questions about what does that mean, a
`method for reducing eye redness, and is it in fact a limitation.
`
`Throughout this proceeding, the Petitioner treated and
`assumed that the preamble "A method for reducing eye redness"
`was a limitation. We presented evidence about how Gil
`disclosed inherently the method for reducing eye redness by
`virtue of the fact that it disclosed the administration of low
`concentrations of brimonidine for purposes of, among other
`things, treating neurogenic inflammation, which the Board
`correctly found to be a proximal cause of eye redness.
`
`JUDGE FLAX: Counsel, if the preamble is a limitation, I
`know that you've also argued, at least in your reply brief, that
`there's no efficacy limitation to these claims, how does the
`preamble fit in? What kind of a limitation is it if it isn't the
`limitation, what is it limiting?
`
`MR. FREDERICKSON: So I think the parties largely
`agree, and I'll go to Slide 15, because the Board's decision in the
`Mylan v. Regeneron case is particularly instructive where there
`was a similar type of debate.
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`And so, to answer Your Honor's question, in method-of-
`treatment claims, when courts have found that a method for
`achieving some therapeutic benefit is a limitation, the ordinary
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`IPR2022-00142
`Patent 8,293,742 B2
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`meaning of that is -- for reducing eye redness, in this case --
`means that the drug is being administered for the intentional
`purpose of reducing eye redness. It's an administration of the
`drug for the purposes of achieving a specific effect.
`
`That is not to say that it will actually work in every patient
`because, A, that's not required by the claims and, B, it's not
`really commensurate with how treating physicians will treat a
`patient. They don't treat and administer drugs knowing that a
`particular drug will work all the time.
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`JUDGE FLAX: Does eye redness have to exist in the
`patient?
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`MR. FREDERICKSON: Some baseline form of eye redness
`does need to exist in the patient and that's why Gil in particular
`would inherently anticipate that limitation because the evidence,
`certainly from Petitioner's expert, Dr. Sher, has established that
`eye redness necessarily presents during radial keratotomy
`surgery. And that's one of the fundamental disputes between the
`parties is whether and to what extent eye redness does appear
`during radial keratotomy surgery, and I can go to Slide 11.
`
`
`JUDGE HULSE: Before you move on, I have a
`question. So when you're talking about intent to reduce eye
`redness, how does that factor into an inherency analysis where, if
`Gil is only teaching reducing pain, how is that -- how are they
`intending to reduce eye redness?
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`MR. FREDERICKSON: A couple of reactions to that, Your
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`IPR2022-00142
`Patent 8,293,742 B2
`
`Honor. First, we would dispute the characterization that Gil is
`only intending to reduce pain. As the Board found in the
`institution decision, Gil discloses a method for treating both pain
`and neurogenic inflammation by virtue of administering low
`concentrations of brimonidine.
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`And so, with respect to Gil in particular, that reference
`does teach the treatment of neurogenic inflammation, which the
`Board correctly found to be a proximal cause of redness and
`pain.
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`We acknowledge that the focus -- certainly the focus of
`Example 1 in Gil is the treatment -- the primary readout is a
`treatment of pain readout, but very importantly Example 1 also
`refers to the monitoring of symptoms of ocular inflammation.
`And I can show that on Slide Number 8.
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`At the bottom, in Example 1, it says "Efficacy is assessed
`by evaluation by pain intensity, pain relief, subjective global
`analgesic efficacy. Symptoms of ocular inflammation (burning,
`stinging, tearing, etc.) are also recorded."
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`And what Dr. Sher testified is that a person of ordinary
`skill in the art, having read the entire disclosure of Gil and
`seeing that reference to the monitoring of ocular inflammation, a
`person would have immediately understood that the inventors of
`the '553 patent expected to see a difference in a patient's eyes.
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`So, Judge Hulse, with respect to the characterization of Gil,
`we would dispute and encourage the Board to stick with the
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`IPR2022-00142
`Patent 8,293,742 B2
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`original findings in the institution decision that Gil is not limited
`to the treatment of pain.
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`The second response to your question is more of the legal
`issue. How could a prior art anticipate an intent when that intent
`hadn't been recognized in the prior art? And that's the entire
`reason the doctrine of inherency exists, it's because it prevents
`patent owners or patentees from recognizing incidental or new
`benefits from prior art methods that have already existed.
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`So Gil certain discloses, if we take out all the references to
`neurogenic inflammation, we take out all the references to
`redness throughout the disclosure of Gil, and if we assume that it
`only discloses the treatment of pain, that is still enough for there
`to be inherency of a method for reducing eye redness. And the
`reason for that is because redness and pain present
`simultaneously by virtue of the radial keratotomy surgery that's
`being done.
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`And so even if Gil was exclusively focused on the
`treatment of pain, that method of administration, inherently, is
`also treating the redness components of radial keratotomy
`surgery. And we know that from Dr. Sher's testimony, on Slide
`11, that radial keratotomy surgery necessarily causes eye
`redness.
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`And what Dr. Sher explained is that the figure on the right -
`hand side, that's a figure from Dr. Noecker, Patent Owner's
`expert, and what that figure shows is what radial keratotomy
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`IPR2022-00142
`Patent 8,293,742 B2
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`surgery is, which is something that both parties agree. It's a
`correction to the cornea that is made -- that is offered for the
`purposes of improving eyesight and, to do that, the
`ophthalmologist makes a series of precise incisions into the
`tissue. Those tissue -- that tissue damage, as Dr. Sher explains,
`produces this inflammatory reaction that produces substances in
`the eye that necessarily present as redness.
`
`And that makes sense. The eye is being mechanically held
`in place, there is damage, acute damage by virtue of the fact of a
`series of precise incisions to the tissue, the delicate tissue in the
`cornea. That incision will trigger this inflammatory cascade that
`results in both redness and pain.
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`And so, by virtue of even just treating the pain, the
`administration of brimonidine will also be treating the redness by
`virtue of its inherent vasoconstricting properties.
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`Now --
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`JUDGE HULSE: But what about the testimony that Patent
`Owner has cited from Dr. Sher saying that you can have
`inflammation without redness, what is your response to that?
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`MR. FREDERICKSON: We address that on Slide 12.
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`As a general matter and in the abstract, those are correct
`statements. Outside of the context of radial keratotomy, you can
`have inflammation that produces pain and you can have
`inflammation that produces redness. And Dr. Sher, that was
`what Dr. Sher acknowledged in the abstract and as general
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`IPR2022-00142
`Patent 8,293,742 B2
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`propositions, but Dr. Sher never conceded that radial keratotomy
`does not necessarily result in redness. We've put on his
`declaration and his deposition transcript and in both instances
`Dr. Sher repeatedly said all radial keratotomy patients have some
`degree of eye redness after the procedure.
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`During his deposition: I have never seen a patient who I've
`cut the cornea on, for that matter, or done a cataract surgery on,
`any of these procedures, who have not had some eye redness,
`some tearing, some irritation symptoms after the surgical
`procedure. That's my experience.
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`JUDGE HULSE: Did you ask those questions -- sorry to
`interrupt -- did you ask those questions of Dr. Noecker?
`
`MR. FREDERICKSON: Did we -- so Dr. Noecker
`presented it more in the abstract, nothing specific to radial
`keratotomy and Dr. Noecker's experiences with radial keratotomy
`specifically.
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`JUDGE HULSE: But on cross-examination you didn't ask
`him whether he's ever had any LASIK patients who haven't
`experienced eye redness, or any sort of question like that?
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`MR. FREDERICKSON: No, that's not in the record, Your
`Honor.
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`Now, what Dr. Sher testified -- and this notion that Dr.
`Sher admitted something about radial keratotomy surgery, that
`testimony is on pages 113 and 114, which stands for the
`unremarkable proposition that radial keratotomy is intended to
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`IPR2022-00142
`Patent 8,293,742 B2
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`make precision incisions in the cornea, which is avascular. So
`that was Dr. Noecker, sort of the framework with which Dr.
`Noecker presented the evidence was that the cornea is avascular
`and, therefore, by making the incisions in the cornea, the surgeon
`would not necessarily expect redness to result because there's no
`blood vessels in the cornea, but that misses the larger point and
`Dr. Noecker never referred to that by producing that -- by
`making those incisions, creating that inflammatory reaction, the
`eye is naturally going to produce substances that result in
`redness.
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`And so there's two ships passing in the night, so to speak,
`between what Dr. Noecker has testified as to the reason that eye
`redness does not necessarily present and Dr. Sher's evidence that
`the eye redness will necessarily present because and by virtue of
`this inflammatory reaction.
`
`JUDGE POLLOCK: Mr. Frederickson, I'm a little puzzled
`by the interaction between your interpretation of the preamble
`and your inherency case.
`
`If, as I think you said, that the preamble only requires an
`intent to treat redness, why do we have to go so far as to find
`that every patient would have redness? I mean, if redness is a
`reasonably- expected outcome for radial keratotomy; why doesn't
`that cover the intent to treat?
`
`MR. FREDERICKSON: That's a fair question, Your Honor,
`and I agree with you that Petitioner certainly does not take on or
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`think it needs to prove that every single patient has to suffer
`from radial keratotomy surgery. Rather, the standard set out and
`we've cited in the paper is that a limitation -- and this is Slide 13
`-- a limitation where the entire invention is inherent and in the
`public domain if it is the natural result flowing from the explicit
`disclosure in the prior art.
`
`So it's not Petitioner's burden to disprove every possibility
`about what an individual patient may or may not suffer from or
`what their reactions may or may not be. These are biological,
`complex biological systems and that would be an impossible
`burden, I think, in any sort of method-of-treatment case for a
`petitioner to meet. Rather, the burden only requires that it is the
`natural result flowing from the explicit disclosure.
`
`And so what the explicit disclosure in Gil is is that patients
`are undergoing this acute damage to the delicate tissue in the
`eye, the precision incisions, that precision incision creates a
`cascade of inflammatory reactions, that's the natural response to
`damage to the eye, the cornea, and that cascade of natural
`inflammatory reactions results in redness, it also results in pain.
`
`And so what the Gil's teaching is that the natural result
`from radial keratotomy surgery is pain and redness. And by
`administering brimonidine, we know, by virtue of the Patent
`Owner's own admissions, that the low concentrations of
`brimonidine, its inherent function in the surface of the eye as a
`vasoconstrictor and the natural result of applying a
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`vasoconstrictor to an inflamed eye that presents as redness is a
`reduction in that redness.
`
`So I agree with the premise of Your Honor's questions. We
`don't have to disprove it, but there was some suggestion in Patent
`Owner's paper that natural results need to be inevitable and like
`the only consequence of a particular -- that's not the burden, but
`even if it were and even if it was more rigorous than we believe
`it is, the evidence establishes that this surgery results in redness
`and the administrations of the low concentrations of brimonidine
`treat that.
`
`If the Board had any other questions about the preamble, I
`was going to move on to a couple of the other limitations in
`Ground 1.
`
`So the other two principal arguments are claim construction
`arguments that I hope to address relatively briefly, the first is
`ocular condition and the meaning of ocular condition, and the
`second is the limitation about 0.025 percent.
`
`I'll turn to Slide 17, which just summarizes the state of play
`with respect to the two competing constructions for ocular
`condition.
`
`The reality is there's three fundamental problems with what
`Patent Owner is trying to do and they all run afoul of the same
`rule of claim construction. Patent Owner is trying to read in a
`series of limitations that appear nowhere in the specification to
`narrowly define ocular condition to get around the prior art, get
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`around Gil. Patent Owner is trying to read in a causation
`requirement that the condition causes hyperemia; that doesn't
`appear in the claim language and isn't supported in the
`specification.
`
`And then Patent Owner is trying to read in two negative
`limitations: ocular condition does not include subconjunctival
`hemorrhage and ocular condition does not include the effects of
`radial keratotomy.
`
`There's no support for any of those negative limitations in
`the specification and so the Board shouldn't read them in; rather,
`as the Board found in the institution decision and we set forth in
`our papers, the definition of ocular condition is quite broad and
`quite all-encompassing.
`
`The second primary claim construction dispute -- and I'll
`turn to Slide 21 -- involves the meaning phrase "about 0.025%."
`And what the Board found correctly, relying on the Federal
`Circuit's ruling in the institution decision, in Slide 22, is that
`"When 'about' is used as part of a numeric range, 'the use of the
`word 'about' avoids strict numerical boundaries to the specified
`parameter."
`
`That's the entire meaning of the word "about" is to -- let's
`avoid putting strict lines around what numbers fall within or
`around a particular number, but let's look to the criticality of the
`invention.
`
`There's a lot of space in the papers talking about these
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`IPR2022-00142
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`limitations and what is in and not in the specification, and I only
`want to highlight one point from the papers we received from
`Patent Owner and the declaration that its expert, Dr. Noecker,
`submitted, and I'll go to Slide 28.
`
`So on Slide 28 we've put two of the figures from the '742
`patent on the screen, on the left is Figure 2 and on the right is
`Figure 6. And Dr. Noecker, with particular emphasis on Figure
`6, points to these as being something from which a person of
`ordinary skill in the art would deduce some level of criticality,
`some difference, some meaningful clinical difference between
`five one thousandths of a percentage point to brimonidine in an
`eye drop.
`
`Simply put, first of all, there's nothing in the specification
`for why we would jump straight to Figure 6 or a person of
`ordinary skill in the art would jump straight to Figure 6 and not
`look towards Figure 2, which shows no meaningful differences
`between whatever 0.025 percent is and 0.03 percent might be, so
`we can't know why we elevate Figure 6 -- or Dr. Noecker
`elevates Figure 6 over Figure 2, but then we look at Figure 6; it's
`entirely qualitative. There's no legend, there's data, there's no
`hash marks, there's no error bars, there's no standard deviation,
`there are no data points; the lines have been smoothed, so we
`have no understanding of whether these were precise
`measurements and, if they were precise measurements, where
`they were taken from.
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`Dr. Noecker admitted in his deposition that he didn't know
`
`whether this came from -- this wasn't real clinical data.
`
`And the axes, the axes are oriented in a way that they're
`not linear because of the distance between the spaces, they're not
`logarithmic because of the distances between the spaces. And so
`the notion that a person of ordinary skill in the art, the fact that
`Dr. Noecker would advance a position that an ophthalmologist, a
`person of ordinary skill in the art, would look at these figures
`that are entirely qualitative and draw such a precise quantitative
`understanding from them, it's just -- it's not a credible position,
`particularly when we think about the administration of eye drops
`normally.
`
`Dr. Sher explained this in his declaration. This is an
`imprecise application of a medicine that is often self-
`administered and there's no principled way an individual person
`can control how hard he or she might squeeze the eye drop, how
`much gets into the eye, how much tear may wash some of that
`eye drop away, to make -- for a person of ordinary skill in the art
`to draw any principled conclusion about criticality of five one
`thousandths of a percentage point.
`
`And, for those reasons, we would encourage Board to reject
`the claim construction opinions that are offered by Patent Owner
`in this case and find that Gil does in fact anticipate Claims 1 and
`2 of the '742 patent.
`
`I'll move on to obviousness now, unless there were any
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`questions about Ground 1 or Gil that the Board would like me to
`address.
`
`Slide 36. On Slide 36, we've tried to present an overview
`of what was being -- what the state of the prior art was to the
`person of ordinary skill in the art as of the relevant date here.
`
`We have the disclosure of Gil, which discloses the
`administration of low doses of brimonidine for the purposes of
`treating, among other things, ocular inflammation that presents
`as redness, that's in Example 4, ocular response characteristics of
`neurogenic inflammation include redness. And then, on top of
`that disclosure in Gil, prior art article after prior art article
`reinforces the vasoconstrictive properties of brimonidine and
`points the person of ordinary skill in the art to using low doses
`of brimonidine.
`
`The most significant would be Norden 2002, which is
`Exhibit 1006. Norden 2002 is a journal article that reports a
`clinical study of the application of 0.2 percent of brimonidine to
`patients that were under LASIK surgery. And the conclusion of
`Norden 2002 is unequivocal. We'll put that on the screen at
`Slide 38.
`
`What Norden concluded was that brimonidine administered
`before LASIK may significantly reduce subconjuctival
`hemorrhage and reduce the amount of hyperemia. All of the eyes
`had some hyperemia; however, the hyperemia was lower,
`statistically significantly lower in the brimonidine group.
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`Norden also reinforces the general consensus upon persons
`
`of ordinary skill in the art at the time that brimonidine, which is
`an alpha- 2 adrenergic agonist, was known to be a, quote, "strong
`vasoconstrictor." It was so widely accepted, its vasoconstricting
`properties, that just anecdotally some refractive surgeons now
`ad
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