Trials@uspto.gov
`571-272-7822
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`
`
`
`Paper No. 38
`Entered: January 28, 2025
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________
`
`KINDERFARMS LLC,
`Petitioner
`
`v.
`
`GENEXA INC.,
`Patent Owner.
`______________
`
`PGR2023-00051
`Patent 11,617,795 B2
`______________
`
`Record of Oral Hearing
`Held: December 12, 2024
`______________
`
`
`
`
`Before DEBORAH KATZ, MICHAEL J. FITZPATRICK, and
`SUSAN L. C. MITCHELL, Administrative Patent Judges.
`
`
`
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`571-272-7822
`
`
`
`
`Paper No. 38
`Entered: January 28, 2025
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________
`
`KINDERFARMS LLC,
`Petitioner
`
`v.
`
`GENEXA INC.,
`Patent Owner.
`______________
`
`PGR2023-00051
`Patent 11,617,795 B2
`______________
`
`Record of Oral Hearing
`Held: December 12, 2024
`______________
`
`
`
`
`Before DEBORAH KATZ, MICHAEL J. FITZPATRICK, and
`SUSAN L. C. MITCHELL, Administrative Patent Judges.
`
`
`
`
`
`
`
`
`
`
`
`
`
`PGR2023-00051
`Patent 11,617,795 B2
`
`
`
`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER:
`
`
`BRIAN NOLAN, ESQ.
`SHANTELLE LAFAYETTE, ESQ.
`Mayer Brown LLP
`1999 K St NW
`Washington, DC 20006
`(202) 263-5282
`bnolan@mayerbrown.com
`slafayette@mayerbrown.com
`
`
`
`ON BEHALF OF THE PATENT OWNER:
`
`
`ADAM PIVOVAR, ESQ.
`Cooley LLP
`1299 Pennsylvania Avenue NW
`Suite 700
`Washington, DC 20004
`(202) 842-7800
`apivovar@cooley.com
`
`
`
`
`The above-entitled matter came on for hearing on Thursday,
`
`December 12, 2024, commencing at 1:00 p.m. EST, at the U.S. Patent and
`Trademark Office, 600 Dulany Street, Alexandria, Virginia/via video-
`conference.
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`
`
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`PGR2023-00051
`Patent 11,617,795 B2
`
`
`P R O C E E D I N G S
`- - - - -
`
`1:00 p.m.
`JUDGE KATZ: Just going to get set up here. Okay, so good
`
`afternoon. We are here for oral arguments in post-grant review PGR2023-
`00051 which pertains to patentability challenges for U.S. Patent 11,617,795.
`
`So I'm Judge Katz. This is Judge Mitchell, and Judge Fitzpatrick is on
`the screens. All right. Let me first ask who will be appearing for Petitioner?
`
`MR. NOLAN: Good afternoon, Your Honor. Brian Nolan of Mayer
`Brown on behalf of KinderFarms with my colleague.
`
`MS. LAFAYETTE: Shantelle Lafayette, also for Mayer Brown for
`KinderFarms.
`
`JUDGE KATZ: Okay, thank you. And do you have anybody else? I
`don't see anybody else with you.
`
`JUDGE FITZPATRICK: I'm sorry. I need to interrupt, Judge Katz. I
`can tell that you must have asked somebody to introduce themselves. So I
`heard them, but I didn't hear you. Is --
`
`JUDGE KATZ: I think it's my mic. Can you hear me now?
`
`JUDGE FITZPATRICK: Okay, there we go. Yes, thank you.
`
`JUDGE KATZ: Okay. Hope it'll stay on, my mic. Okay. All right,
`so is there any -- there's nobody else in the room, but is there anybody else
`who you want to introduce who is online or isn't in?
`
`MR. NOLAN: Yes, we have the current CEO of KinderFarms, I
`believe, is online and one of the co-founders of KinderFarms is also online.
`
`JUDGE KATZ: Can you give us their names?
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`MS. LAFAYETTE: Kristin Recchiuti. I'm probably not saying her
`
`last name properly, Recchiuti, and Jeremy Adams.
`
`JUDGE KATZ: Okay, we may, the court reporter may ask you for
`spellings of those afterwards.
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`MS. LAFAYETTE: I can get that to you.
`
`MR. NOLAN: Thank you, Your Honor.
`
`JUDGE KATZ: Okay, thank you. And for patent owner?
`
`MR. PIVOVAR: Good afternoon, Your Honor, Adam Pivovar of
`Cooley LLP on behalf of patent owner. And with me today is my colleague,
`Dan Knauss --
`
`MR. KNAUSS: Good afternoon.
`
`MR. PIVOVAR: -- also of Cooley and lead counsel in this
`proceeding, and Steve Smith, another one of our colleagues from Cooley.
`We're all attorneys of record. No one else is here with us today besides
`those people, in person.
`
`Online, I believe, people intending to join was going to be Janet
`Spielberg, who is in-house counsel for patent owner, as well as Brianna
`Patterson, who is counsel of record on behalf of patent owner but is listening
`in remotely. Thank you, Your Honor.
`
`JUDGE KATZ: Okay, thank you. All right, so just a few
`housekeeping things to begin. Recording of PTAB hearings is prohibited.
`We do have a court reporter with us today who will provide a transcript of
`the hearing that will become part of the record.
`
`To ensure that the transcript is clear, please speak directly into the
`microphone, as I just demonstrated you shouldn't, and identify specific slide
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`PGR2023-00051
`Patent 11,617,795 B2
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`numbers, numbers in figures and other pertinent identifying information as
`you make your arguments so that the record is complete.
`
`I think that this proceeding is being streamed since we have people in
`attendance, so if the parties wish to discuss anything that's confidential, you
`need to let us know before so we can make arrangements. I don't think
`there is anything. There haven't been any requests or anything confidential,
`either party. Okay, thank you.
`
`So each of you requested 45 minutes to argue their case, and
`Petitioner has a LEAP Practitioner. So Petitioner will receive an extra 15
`minutes of argument time, so that's 60 minutes for Petitioner, 45 minutes for
`patent owner.
`
`The LEAP Practitioner must provide us with something meaningful
`and substantive during the hearing today. So I will try to use the clock here
`to give you an idea of how the time is going. We'll see if that -- if I am
`capable of doing that. If not, I will try to five you a 5-minute warning when
`we're coming to the end of your time.
`
`Okay, so the Panel, we have reviewed the record. Judge Mitchell and
`Judge Fitzpatrick and I have reviewed the record. We also see that both
`parties have filed demonstratives and we see that you've also filed objections
`to each other's demonstratives.
`We want to remind you that demonstratives are not evidence. They're
`just a means for making new arguments. Oh, and they are not -- they are not
`a means for making new arguments, which I think has been your objections.
` We will address the arguments that you have to each other's demonstratives
`in our final written decision when the time comes, if necessary.
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`PGR2023-00051
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`
`When referring to the demonstratives, please make sure, again, to
`indicate the slide number for the record so that the record is complete.
`Okay, so I think we're about ready to begin. Judge Mitchell or Judge
`Fitzpatrick, do you have anything else to add to the preliminary --
`
`JUDGE FITZPATRICK: Just one thing I would just, for those
`objections to the demonstratives, whether it's in demonstratives or otherwise,
`if counsel or opposing counsel makes an argument that's not in the record,
`you can use your time to point that out, but whether or not it's tied to a
`demonstrative or not. Thanks.
`
`JUDGE KATZ: Thank you. Okay, so we will begin today with
`Petitioner followed by Patent Owner. Petitioner will then get a chance for
`rebuttal and patent owner will get a chance for surrebuttal. So, Petitioner,
`how much time would you like to reserve for that rebuttal?
`
`MR. NOLAN: Brian Nolan, Your Honor, on behalf of Patent Owner -
`- Petitioner. We would like to reserve 15 minutes, Your Honor.
`
`JUDGE KATZ: Okay, so that will be 45 minutes for the argument
`and 15 minutes for rebuttal. Okay, Ms. Layfayette, if you would like to,
`whenever you're ready.
`
`MS. LAFAYETTE: Okay.
`
`JUDGE KATZ: Go ahead, when you're ready.
`MS. LAFAYETTE: Good afternoon, Your Honors. So I will be
`starting us off by providing an overview of the 795' patent, its prosecution
`history and some claim construction issues.
`
`We're all familiar with the 795' patent, and if it's all right with Your
`Honors, I will refer to the patent by its last three digits as well as the
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`PGR2023-00051
`Patent 11,617,795 B2
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`applications that are in our petition and described by their last three digits,
`unless you would like me to say the full numbers, which can be a mouthful.
`
`So the 795' patent was issued to Genexa on April 4th, 2023 and it
`compromises 24 claims, three of which are independent. All of the claims
`have been challenged in this proceeding, as you're aware.
`The 795' patent issued from the 637 application, which was filed on
`August 4th, 2022, so just eight short months later it issued. The 637
`application is a continuation of Application 414, which was filed on June 8th
`2021. And that application, the 414 application is itself a continuation, in
`part, of the 529 application.
`So I'll stop there. There are other applications in the patent family,
`but those are the main ones that we'll be discussing. And --
`JUDGE FITZPATRICK: Counsel, whenever you -- I'm sorry to
`interrupt. Whenever you think it's helpful that we're also visually looking at
`a demonstrative, let us know the number, please.
`
`MS. LAFAYETTE: Oh, sorry, that was Slide 4. Thank you for
`pointing that out.
`
`JUDGE FITZPATRICK: Thank you.
`
`MS. LAFAYETTE: And I just advanced to Slide 5. And as we note
`in the petition the 529 application is -- or the 795 patent, its specification is a
`wholesale rewriting of the specification of the 529 application which reflects
`the original application Genexa filed in this patent family.
`
`As such, the challenged claims in the PGR are completely untethered
`from the disclosure of the original patent application that Genexa filed. Of
`particular relevance is the fact that the 529 application does not mention any
`specific APIs including acetaminophen nor does it disclose any particular
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`Patent 11,617,795 B2
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`formulation viscosity ranges including those that are claimed in the
`challenged claims of the 795 patent.
`So in essence, the elements that were added to the specification of the
`414 patent, which is a continuation and part of the 529, are the
`acetaminophen API as well as the viscosity ranges and some other matter.
`Since the claims of the 795 patent require acetaminophen and
`viscosity at a minimum, particular viscosity ranges, it's our position that the
`earliest possible priority date for the challenged claims is June 8th, 2021.
`And it's our understanding that Genexa does not contest this, so that would
`be the earliest possible priority date for the purposes of our state of the art
`review and other discussions in this proceeding.
`I'm now advancing to Slide 6, or at least I'm trying to. So going back
`to the 637 application, which is the one that issued as the 795 patent, this
`application underwent a very cursory review by the patent examiner. As I
`mentioned, the review took all of eight months before the patent issued, and
`it was completely unaided by the Patent Owner who did not file any IDS's
`identifying relevant prior art references.
`The examiner, for their part, did conduct five searches for prior art
`references using a combination of different key words. They used
`acetaminophen syrup, Agave syrup -- sorry, Agave, water and diluent -- and
`managed to identify a single prior art reference which is shown here on Slide
`6.
`
`And critically, the examiner did not include in their search terms the
`word, Paracetamol, which is a common pseudonym used to describe the
`same molecule that is acetaminophen. However that term is more
`commonly used outside the U.S.
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`PGR2023-00051
`Patent 11,617,795 B2
`
`
`The single prior art reference that the examiner identified in -- with
`respect to the 637 application is shown here. It's a 2014 research article
`published in the Journal of American Medical Association of Pediatrics. It
`disclosed a composition that is for treating nighttime cough in babies and
`toddlers that is comprised of Agave syrup, a flavoring agent and an acetic
`preservative.
`Additionally, this publication discloses, if we look at the paragraph on
`the right, the second highlighted sentence, it also discloses the co-
`administration of acetaminophen along with this Agave syrup-based cough
`remedy.
`The -- just going back to the, how quickly the patent application
`progresses through the patent examination, we also want to point out that,
`not only was this examination very quick, didn't identify a lot of prior art, it
`also led to the examiner missing the fact that Claims 20 and 21 in the 795
`application are identical.
`These are dependent claims. They both depend on the same
`independent claim, 18. And, in fact, neither of these claims add any new
`limitations because they claim the same viscosity range that is already called
`for by Claim 18.
`I'm now advancing to Slide 7. In the examiner's reasons for
`allowance, she indicated that the claims of the 795 patent were free of the
`art, so this one prior art reference we just discussed, for the simple fact that,
`while it disclosed acetaminophen, Agave syrup, acetic preservative, a
`diluent, it did not disclose the acetaminophen mixed inside of or included in
`the Agave syrup formulation.
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`PGR2023-00051
`Patent 11,617,795 B2
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`
`However, this justification for allowing the 795 patent claims cannot
`stand in view of the prior art that we have raised in our petition. And in
`particular, if you look at the right of this slide, you can see the two primary
`references cited in Grounds 1 and 2 of the petition, FR458 and W0742,
`which is how we refer to them in the petition.
`
`Both disclose formulations that include agave syrup, acetaminophen,
`or Paracetamol, however you would like to call it, as well as other
`ingredients that are called out in the 795 patent claims.
`
`So unless Your Honors have any questions for me on the file history
`or anything that I've said in the last few slides, I'll move on to claim
`construction.
`Okay, so the petition only offered a construction for a single claim
`term, and that's agave syrup. And in particular, what the petition says, at
`Page 15, is that the Board should construe agave syrup to encompass all
`liquid materials derived from an Agave plant that is free-flowing,
`irrespective of its other properties.
`In reaching this construction, the petition noted that a POSITA would
`understand that agave syrup can be obtained from different species of
`Agave, can be light or darker in color and with a thicker or thinner
`consistency which we have said in both Dr. Crowley's report and the
`petition, is essentially referring to its viscosity. And this is also at Page 15
`of the petition.
`Patent Owner has not disputed our construction of agave syrup and
`agrees that the 795 patent does not limit the agave syrup to any particular
`type or any particular properties.
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`PGR2023-00051
`Patent 11,617,795 B2
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`
`I've moved on to Slide 9 of the Petitioner's demonstratives. The
`Petitioner's construction of agave syrup is also informed by the specification
`of the 795 patent, as it should be, and notably, the 795 patent defines agave
`syrup on -- in Column 2 -- sorry. And the 795 patent is Exhibit 1001 at
`Column 2 from Line 6 to 9.
`And it's defined as a processed juice obtained from the Agave species
`of plant. That's it. It's a very broad definition. It's also worth noting that
`just below that, the specification defines syrup separately, to mean, a
`formulation that has flow without applied pressures and is sticky or tacky to
`the touch.
`It also notes, right in the next sentence, that the syrup, formulation
`syrup, can have a viscosity of the type used with pharmaceutical suspensions
`or syrup formulations. So in other words, the specification of the 795 patent
`is telling us that agave syrup and syrup or the formulation are different
`things.
`And the syrup formulation is required to have a particular viscosity
`range, and those viscosity ranges are those of the type found in
`pharmaceutical suspensions and syrups.
`Dr. Crowley testified that, in his experience, at Paragraph 28 of his
`report, which is Exhibit 1003, that formulations that fall in the viscosity
`range taught by the specification of the 795 patent are typical for orally
`administered liquids that are pourable and drinkable.
`I'm advancing to Slide 10. The 795 patent says almost nothing about
`the agave syrup that is included in the formulation. It doesn't describe its
`properties anywhere. Here we're showing a number of different excerpts
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`PGR2023-00051
`Patent 11,617,795 B2
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`from the 795 patent specification, and the only information we're really
`given about the agave syrup is the amount to include in the formulation.
`JUDGE KATZ: So Ms. Lafayette --
`MS. LAFAYETTE: Yes.
`JUDGE KATZ: -- if can take you back to the -- what you were just
`discussing about the word syrup --
`MS. LAFAYETTE: Right.
`JUDGE KATZ: -- if we go to the claim, say, Claim 1 --
` MS. LAFAYETTE: Is it okay if I pull up a slide that has it?
`
`JUDGE KATZ: Yes, please.
`
`MS. LAFAYETTE: Okay. Yes.
`
`JUDGE KATZ: Okay, and that's Slide ---
`
`MS. LAFAYETTE: I'm on Slide 12.
`
`JUDGE KATZ: -- 12. Okay. So can you take us through that word,
`
`syrup, in the claim? What is the, specifically, Element E in Claim 1? What
`is the viscosity? Is it referring to --
`
`MS. LAFAYETTE: Right.
`
`JUDGE KATZ: -- the word, syrup, which occurs twice in the claims,
`or 3 times, but.
`
`MS. LAFAYETTE: Absolutely. So it's Petitioner's position that if
`you look at Claim 1 -- if it's okay with you, I'll just explain the claim and
`then I'll answer your question.
`
`JUDGE KATZ: Mm-hmm.
`
`MS. LAFAYETTE: So the claim starts with a preamble that says, a
`pharmaceutical syrup formulation for oral administration compromising --
`so it's a comprising claim that then goes on to list at A, B and C the
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`Patent 11,617,795 B2
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`components that are required at a minimum, so acetaminophen, agave syrup
`and a diluent.
`
`Then after the comma in C, it describes the properties of the syrup
`formulation. And given that the preamble says "a" pharmaceutical syrup
`formulation, and this is Claim Construction 101 which I'm still learning, but
`we believe the syrup formulation refers back to the pharmaceutical
`formulation that is described in the preamble.
`
`And this is also consistent with that portion of the specification I
`showed you. If I can go back to Slide 9, where it's defined agave syrup
`separately, and then the term syrup to mean a formulation, and then it goes
`on to describe the viscosity of that syrup.
`
`And, but while we've cut off at the top of the second paragraph, in the
`second column of Exhibit 1001, if you continue reading down, it then
`describes all of the different viscosity ranges that are disclosed for this
`syrup. At no point is the word, agave, mentioned in that paragraph.
`
`So to answer your question, our position is that the viscosity is only
`referring to the pharmaceutical syrup formulation, which does include agave
`syrup, but it includes other things. And because it's a comprising claim, it
`can include other things beyond what is listed here.
`
`JUDGE KATZ: Thank you.
`
`MS. LAFAYETTE: Thank you. Actually, you pretty much took my
`last point and --
`
`JUDGE KATZ: I'm sorry.
`
`MS. LAFAYETTE: -- made it a -- no, no, that's great. So if it's
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`Patent 11,617,795 B2
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`all right with you, and if you, unless you have any other questions for me, I'll
`turn the reigns over to Brian who will walk you through our invalidity
`arguments.
`
`JUDGE FITZPATRICK: One quick question.
`
`MS. LAFAYETTE: Of course.
`
`JUDGE FITZPATRICK: I tried to get it out but I was on mute. In
`Claim 1, for example --
`
`MS. LAFAYETTE: Yeah.
`
`JUDGE FITZPATRICK: -- in Subsection C or Element C, it's the one
`in where there's a couple hearing clauses, or three maybe.
`
`MS. LAFAYETTE: Yeah.
`
`JUDGE FITZPATRICK: The first one, types of syrup formulation,
`refers back to the preamble, as you just said. And that's what has the
`viscosity limitation, talks about the whole, in your view, the whole plan, the
`whole intention.
`
`The next two mentions the syrup. That -- what's your view? Is that
`referring back to Element -- just Element B or is that referring back to the
`preamble?
`
`MS. LAFAYETTE: Yes. It's referring to the preamble. So our view
`is, after the diluent, that comma, that's when the claim is describing the
`properties of the formulation. And that makes sense because once you mix
`these three things together or however many components, depending on
`what else you add, you'll have a formulation that will have a viscosity. So
`that's the first part.
`It'll be the formulation that the acetaminophen is suspended in. The
`acetaminophen's not going to selectively go to the agave in a formulation
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`that also includes water and potentially other ingredients. And then you'll
`also have the final syrup that will be palatable or not.
`So that's over view, that all of those components after the comma
`following diluent, refer back to the properties of the pharmaceutical syrup
`formulation that is mentioned in the preamble of the claim.
`JUDGE FITZPATRICK: Okay, and I don't know that it would even
`matter, but I'm hung up on the fact that it just says syrup twice. Or, in C, it
`says, syrup formulation. And that says, syrup, by itself, and then it says,
`syrup, by itself. And it probably doesn't mean anything here, but would it
`matter to your case, I guess, is if the mentions of syrup -- the last two
`mentions of syrup in Claim 1, if those refer back to Element B only?
`MS. LAFAYETTE: It would matter. However, it's our position that
`they don't. And I think -- it is a good point you're raising and one that Patent
`Owner has attempted to raise as well.
`However, if we go back to the definitions that are given to the
`specification of the 795 patent, they make it clear that the term, syrup, by
`itself, means the formulation. And for that reason, we -- it's our position that
`it's the syrup formulation that has the specific viscosity requirements as well
`as the other features that we discussed.
`
`JUDGE FITZPATRICK: Thank you.
`
`MS. LAFAYETTE: Thank you.
`
`MR. NOLAN: Thank you, Your Honors. Brian Nolan on behalf of
`KinderFarms. At this point I would like to discuss the obviousness
`arguments and the other arguments that KinderFarms has presented against
`the patent, the 795 patent.
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`PGR2023-00051
`Patent 11,617,795 B2
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`We believe that everything that's disclosed in these claims -- that are
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`claimed in this patent, the Claims 1 through 24, was known in the art and is
`shown in the collection of references that we have presented.
`We have presented, as our main references, two base references in
`separate grounds. One is Exhibit 1004. We refer to that as e is Exhibit
`1004. We refer to that as FR458. And then with that we have articulating
`combinations for the secondary references. The secondary references go to
`identifying the specific viscosity of the formulation that Ms. Lafayette was
`just discussing.
`In fact, as Ms. Lafayette has explained, those viscosity levels or
`ranges in those formulations, as the 795 admits at Column 4, are those that
`are typically used in -- for oral liquid pharmaceutical formulations.
`And so you will see the viscosity range in Patent 4666. It has a
`viscosity range, as far as we're concerned, of 100 to 3000 CP. And CP refers
`to Centipoise. Patent Owner objects or disagrees with that position and
`suggests that, at most, it discloses a viscosity range -- and if you look in the
`specification, the preferred embodiment talks of about 1000 CP to 3500 CP.
`But as Your Honors can understand and see by looking at these
`claims, even at about 1000, would encompass and teach most of the claim
`limitations. There are just a few, I think one that's 750 CP and one that's 600
`CP, that if the about 1000 is the appropriate reading of the 4666 patent, then
`it would be a question on whether that's disclosed.
`But that is, in our view, irrelevant because, if you look at W01666,
`that's Exhibit 1006, we talk about combining that with FR458. That has has
`a viscosity range of 200 Centipoise to 900 Centipoise. And all of -- that
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`PGR2023-00051
`Patent 11,617,795 B2
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`would encompass all of the range, and that is W0133, if I misspoke on that
`one.
`
`And so that's the first grounds, so we have in that W, we have FR458
`combined with the 4666 patent. And then separately, we have FR458
`combined with W0133. And then we also have just, we added in
`additionally, that you could combine all three of those references.
`And these are in our petition and they are in our, I think it was
`Footnote 14 in the petition and it is in our Expert Declaration as well. But I
`can -- I point to you more specifically of that later.
`The second ground is based on W0742. And again, that discloses an
`agave syrup acetaminophen formulation with the diluent. So that this does
`discuss most of the limitations in the claim. These are oral liquid
`formulations so they will have a viscosity.
`While W0742 does talk about agave having thicker or thinner
`consistency, it doesn't talk about the specific viscosity of the final
`formulation. But again, those secondary references that we just discussed
`clearly show that.
`So with that introduction, I would like to start off and talk about what
`is the problems purportedly identified in the 795 patent. And if we can go to
`Petitioner's Slide 14, on Petitioner's Slide 14 you will see that the 795 patent
`identifies what it purports to be problems.
`
`The problems would be that two patient populations, pediatric patient
`populations and elderly patient populations, have difficulties taking solid
`dosage forms, have difficulty taking pills or capsules. And so a liquid
`formulation would be preferrable for those two patient populations.
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`PGR2023-00051
`Patent 11,617,795 B2
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`They also note that when you make a liquid formulation, again, we're
`
`looking at the patent on Petitioner's Slide 14, that those may have -- the API
`may make those formulations taste bitter or sour. And so you're going to
`want to have a masking agent in there.
`
`And second -- and finally, although it's a little inconsistent, it talks
`about the desire to avoid artificial and unnatural masking agents. But if you
`look at the patent, it talks specifically allowing the flavoring agents to be
`artificial vanilla, artificial chocolate and artificial fruit flavors as well.
`
`But, so this is the purported problem that the 795 patent lays out. But
`these problems are just recitations of the problems that the prior art that we
`have identified -- all of them -- W0742, FR458, 4666 patent and W0742
`have shown.
`
`So we look at Slide 15, Petitioner's Slide 15, we're talking about the
`first aspect. And so these are the primary references. On the left of Slide
`15, we have a citation from FR458 explaining that solid dosage form are
`problematic for pediatric and elderly patient populations. And thus, a liquid
`dosage form is preferred. And you can see the same thing on the right.
`
`So both the W0133 and FR458 are identifying the same problems -- or
`same issue that the patent sought to identify. If we go to Slide 16, Slide 16
`talks about the need to taste mask because when you put these in oral
`formulations the API may be bitter and cause taste issues.
`
`So again, FR458 talks about the needing to cover that unpleasant
`taste. And the same thing with W0133. And then finally, if we go to our
`Slide 17, we'll see this is, again, in the prior art. Now, FR458 is one of the
`primary references. It talks about the desire to minimize artificial
`ingredients.
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`PGR2023-00051
`Patent 11,617,795 B2
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`And then additionally, in our background section, well then we don't
`rely on Heyer 2009. It's Exhibit 1008. It provides a very detailed summary
`of what was known in the art. And again, it's talking about avoiding
`artificial sweeteners and, specifically, using -- it talks about using agave
`syrup and the like in medicines and health products to do this.
`So the problems that the 795 patent purports to address were known in
`the art and were identified in our prior art references. And not only were the
`problems identified, but the purported solutions that the 795 patent offers
`was also identified.
`So if we can go to Slide 19, you'll see the abstract of the 795 talks
`about the desire to make a pharmaceutical formulation with agave, with
`some API, an active pharmaceutical ingredient and a diluent. And this is a
`drinkable oral formulation, so any drinkable formulation will have some --
`any liquid has some sort of viscosity. And they suggested here the viscosity
`has to be one that is drinkable, which is -- makes sense, because if it's not
`drinkable, it's not an oral liquid formulation that you could administer to
`pediatric or elderly patient populations.
`And, but this, again, if we go to our prior art references and we go to
`Exhibit -- the next slide, please, which would be Slide 20, we have included
`the primary references on the left. You can see, we have the 458. It has
`Paracetamol, as my colleague, Ms. Lafayette, has already explained, that's
`acetaminophen. It has certified Agave syrup and water. And then, on the
`right, W0742 has acetaminophen, agave nectar and purified water.
`
`And so they're providing the same solutions that the 795 patent
`purports to provide. And they also -- the prior art also provides the solution
`of the need for it to be drinkable. And if we can just turn to the next slide,
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`PGR2023-00051
`Patent 11,617,795 B2
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`that shows that the 795 patent admits it is using the viscosities of the type
`that are used in pharmaceutical suspensions or syrup formulations.
`
`They're telling you they're pulling this right out of prior art. And then
`they list the types of viscosity formulations, and on the right, we have a
`chart. And so the 4666 patent is one of our secondary references. Again,
`we've already discussed that viscosity range, 100 to 3000. The W0133 is
`200 to 900 CP. And there are other references that show, that are consistent
`with and actually support the admission in the patent that all they're using is
`the viscosity ranges for oral liquid formulations that are already know.
`
`JUDGE KATZ: So Mr. Nolan, if we can sort of focus in on that range
`in the 4666 patent, because that seems to be something that's at issue. You
`are listing it there on Slide 21 at 100 to 3000 Centipoise, I guess is the right
`way to say it.
`
`And I know that Patent Owner is going to dispute that. So you are
`taking that 100 to 3000 range from the claims. Is that right?
`
`MR. NOLAN: Yeah. So, well in two places because the specification
`talks about a preferred embodiment. And it says that preferred embodiment
`is about 1000 to 3000, so it doesn't say 1000. It says it's about.
`
`It then goes on, after it talks about that, and it says, the final
`formulation can be somewhat less thick. So even 1000 is not the range. It
`doesn't put a specific number on what is meant by somewhat less thick. But
`it does put that in the specification as below that.
`Now if you look at the claims, the claims take about the 100. Now,
`they've said that this is
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