UNITED STATES PATENT AND TRADEMARK OFFICE
`
`—————
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`—————
`
`SLAYBACK PHARMA LLC,
`Petitioner,
`
`v.
`
`EYE THERAPIES, LLC,
`Patent Owner.
`
`—————
`
`Case No.: IPR2022-00142
`
`U.S. Patent No.: 8,293,742
`
`—————
`
`PETITIONER’S LIST OF OBJECTIONS TO
`PATENT OWNER’S DEMONSTRATIVES
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`—————
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`—————
`
`SLAYBACK PHARMA LLC,
`Petitioner,
`
`v.
`
`EYE THERAPIES, LLC,
`Patent Owner.
`
`—————
`
`Case No.: IPR2022-00142
`
`U.S. Patent No.: 8,293,742
`
`—————
`
`PETITIONER’S LIST OF OBJECTIONS TO
`PATENT OWNER’S DEMONSTRATIVES
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Pursuant to the Board’s Order Setting Oral Argument (Paper 54), Petitioner
`
`respectfully submits the following objections to Patent Owner’s oral argument
`
`demonstratives. Copies of the objected-to demonstratives are attached hereto as
`
`Exhibit A, and one-sentence statements of the reason for each objection are listed
`
`in the table below.
`
`Demonstrative
`
`2, 72
`
`4, 14–18, 83
`
`100
`
`Reason for Objection
`Petitioner objects to these demonstratives because a
`portion of the cited evidence—paragraphs 6 and 7 of
`Exhibit 2023—are the subject of Petitioner’s Motion to
`Exclude Evidence (Paper 57), and these
`demonstratives should be excluded for the same
`reasons stated in Petitioner’s Motion.
`Petitioner objects to these demonstratives because they
`present a new argument that was not presented in any
`of Patent Owner’s papers, particularly to the extent that
`Patent Owner argues that the prior art does not disclose
`the claim limitation “consisting essentially of
`administering brimonidine.”
`Petitioner objects to this demonstrative because it
`presents a new argument that was not presented in any
`of Patent Owner’s papers.
`
`Dated: February 23, 2023
`
`Respectfully submitted,
`
`By: /Linnea P. Cipriano/
`
`Linnea P. Cipriano
`(Reg. No. 67,729)
`Goodwin Procter LLP
`620 Eighth Avenue
`New York, NY 10018
`Phone: (212) 813-8800
`
`
`
`Cell: (443) 235-1739
`Fax: (212) 937-2204
`lcipriano@goodwinlaw.com
`
`Counsel for Petitioner
`Slayback Pharma LLC
`
`
`
`
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a copy of the foregoing Petitioner’s
`
`List of Objections to Patent Owner’s Demonstratives was served on February 23,
`
`2023, by electronic mail to:
`
`Bryan Diner
`
` bryan.diner@finnegan.com
`
`Justin Hasford
`
`Justin.hasford@finnegan.com
`
`Caitlin O’Connell caitlin.o’connell@finnegan.com
`
`Christina Yang christina.yang@finnegan.com
`
`
`
`Dated: February 23, 2023
`
`
`
`Respectfully submitted,
`
`By: /Linnea P. Cipriano/
`
`Linnea P. Cipriano
`(Reg. No. 67,729)
`Goodwin Procter LLP
`620 Eighth Avenue
`New York, NY 10018
`Phone: (212) 813-8800
`Cell: (443) 235-1739
`Fax: (212) 937-2204
`lcipriano@goodwinlaw.com
`
`Counsel for Petitioner
`Slayback Pharma LLC
`
`
`
`
`EXHIBIT A
`EXHIBIT A
`
`
`
`Lumify - the #1 Eye Doctor Recommended
`Redness Reducer
`
`EX-2191, EX-2055, EX-2081
`
`Paper 30 at 2, 67-69; EX-2020, ¶313; EX-2023, ¶¶6-7
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`2
`
`Eye Therapies Exhibit 2216, 2 of 101
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`Overview of Issues to be Addressed
`
`• Petitioner failed to prove inherent anticipation
`– radial keratotomy patients do not inevitably have eye redness
`– brimonidine administered with other drugs that can prevent development of
`hyperemia
`– “about 0.025%” does not encompass 0.03%
`• Petitioner’s obviousness arguments are hindsight-driven
`– brimonidine caused redness
`– brimonidine whitening was concentration dependent
`• optimize upward, if at all
`– POSA would have increased, not decreased, the pH
`• Patented invention showed objective indicia of non-obviousness
`– unexpected superior results
`– industry praise and rapid commercial success for Lumify
`
`See generally ,Paper 30 at 39-69
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`4
`
`Eye Therapies Exhibit 2216, 4 of 101
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`Brimonidine Administered With Other Drugs That Can
`Prevent Development of Hyperemia
`
`• Dr. Sher and Petitioner argue that brimonidine is the only drug
`administered in radial keratotomy in Example 1
`
`• But Dr. Sher admitted that it would be malpractice not to administer other
`drugs
`
`EX-1002, ¶112
`
`A. Yes. You could not do [radial keratotomy] without
`anesthetizing the cornea. It probably would be
`malpractice
`
`Neal Sher
`
`EX-2213, 22-24-23:13
`
`Paper 59 at 8-9
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`14
`
`Eye Therapies Exhibit 2216, 14 of 101
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`Brimonidine Administered With Other Drugs That Can
`Prevent Development of Hyperemia
`• Dr. Sher admitted that anti-inflammatories (steroids & NSAIDs) and
`antibiotics are typically administered
`Q. Okay. Well, were only anesthetics used as a way of
`addressing the pain that a patient may feel? And my
`question is presurgically.
`A. And frequently nonsteroidal drops, there are a number of
`them, including diclofenac, which I did a lot of
`research on and have the patent -- one of the patents
`for corneal pain. Would use that preop and then postop.
`And related drops -- and related drops to various NSAIDS
`can be used.
`Would ketorolac be one?
`Q.
`Yes.
`A.
`[...]
`Frequently, in almost all cataract surgery, in almost
`any of these types of surgeries that we've been
`discussing, a mixture of an antibiotic and a steroid
`would be used postoperatively to reduce postoperative
`inflammation and possibly to prevent infection.
`EX-2213, 18:10-19:20
`
`Neal Sher
`
`Paper 59 at 8-9
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`15
`
`Eye Therapies Exhibit 2216, 15 of 101
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`Brimonidine Administered With Other Drugs That Can
`Prevent Development of Hyperemia
`
`• Dr. Sher admitted that the anti-inflammatories and antibiotics can prevent
`redness from developing
`Q. Just so that I'm clear, it is possible that they could
`have used in RK surgery a steroid preoperatively and
`postoperatively to reduce inflammation?
`Yes.
`A.
`[...]
`Q.
`Any other symptoms that that cocktail of antibiotics
`and steroids may have been used to address?
`A. Well, the -- the steroids would address all the signs of
`inflammation. So it would reduce swelling of the
`conjunctiva. It would reduce redness. It would reduce
`inflammation, pain, and depending on the procedure and
`depending on how much -- how many drops you used
`postoperatively and what regimen.
`
`Neal Sher
`
`EX-2213, 19:21-21:8
`
`Paper 59 at 8-9
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`16
`
`Eye Therapies Exhibit 2216, 16 of 101
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`Brimonidine Administered With Other Drugs That Can
`Prevent Development of Hyperemia
`• Dr. Sher admitted that saline drops are administered during radial keratotomy
`
`Q. So is it fair to say that the tear or wetting drops that
`may be administered during or preoperatively to RK
`surgery help to lubricate the eye?
`A. Yes.
`Q. And they could be applied before surgery as well as
`during surgery?
`A. It could be. It's generally during because patients are
`blinking before the surgery.
`
`Neal Sher
`
`EX-2213, 27:19-28:3
`
`• The saline drops can reduce eye redness
`
`“[I]f a patient had hyperemia due to dry eyes, Refresh Plus® lubricant could have
`reduced redness rather than brimonidine.”
`
`EX-2020, ¶173
`
`Paper 59 at 8-9
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`17
`
`Eye Therapies Exhibit 2216, 17 of 101
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`Petitioner’s Failure of Proof
`
`Petitioner Failed to Carry Its Heavy Burden of Proving Inherency because:
`
`1. Radial keratotomy patients of Example 1 would have been
`administered other drugs with brimonidine (Sher: would have been
`“malpractice” not to do so)
`
`2. Other drugs used in radial keratotomy would admittedly impact
`development of hyperemia
`
`3. Not all patients would unavoidably have hyperemia
`
`4. No proof that 0.03% brimonidine in a prophetic, incomplete radial
`keratotomy protocol would necessarily and inevitably reduce
`hyperemia
`
`Paper 30 at 40-43
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`18
`
`Eye Therapies Exhibit 2216, 18 of 101
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`Lumify - the #1 Eye Doctor Recommended
`Redness Reducer
`
`EX-2191, EX-2055, EX-2081
`
`Paper 30 at 2, 67-69; EX-2020, ¶313; EX-2023, ¶¶6-7
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`72
`
`Eye Therapies Exhibit 2216, 72 of 101
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`’553 Patent, Example 1 ‒ Used Other Drugs That Can Prevent
`Development of Hyperemia
`
`• ’553 Patent, Example 1 used other drugs that can
`prevent development of hyperemia
`• Dr. Sher admitted:
`– that a radial keratotomy surgeon would use anesthetics, anti-
`inflammatories (e.g., steroids, NSAIDs), antibiotics, and/or
`lubricants before and during radial keratotomy
`• EX-2213, 15:19-16:5, 16:15-18, 18:10-22, 18:25-19:7, 19:15-25, 20:10-19,
`26:16-28:3
`– these anti-inflammatories (e.g., steroids, NSAIDs), antibiotics,
`and/or lubricants could impact development of hyperemia
`• EX-2213, 18:10-19:25, 20:3-21:8, 26:16-28:3, 41:17-42:4
`
`Paper 30 at 40-41, 53; EX-2020, ¶¶145-146, 234-235;
`Paper 59 at 8-9
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`83
`
`Eye Therapies Exhibit 2216, 83 of 101
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`A Disclosed Range Does Not Disclose
`the Endpoints or the Intermediate points
`
`“The disclosure is only that of a range, not a specific
`temperature in that range, and the disclosure of a range
`is no more a disclosure of the end points of the range
`than it is of each of the intermediate points.”
`
`Atofina v. Great Lakes Chem. Corp., 441 F.3d 991, 1000 (Fed. Cir. 2006)
`
`EX-2020, ¶159
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`100
`
`Eye Therapies Exhibit 2216, 100 of 101
`Slayback v. Eye Therapies - IPR2022-00142
`
`
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