KinderFarms LLC, v. Genexa Inc.,
`PGR2023-00051
`U.S. Patent No. 11,617,795
`
`December 12, 2024
`
`DEMONSTRATIVE – NOT AN EXHIBIT
`
`1
`
`KINDERFARMS Ex. 1054
`KINDERFARMS LLC. v. GENEXA INC.
`PGR2023-00051
`
`
`PGR2023-00051
`U.S. Patent No. 11,617,795
`
`December 12, 2024
`
`DEMONSTRATIVE – NOT AN EXHIBIT
`
`1
`
`KINDERFARMS Ex. 1054
`KINDERFARMS LLC. v. GENEXA INC.
`PGR2023-00051
`
`
`
`Table of Contents
`
`1. The Prosecution History of the ’795 Patent…………………………………………….………………..……….………………………………………….….Slide 3
`
`2. Claim Construction……………………………………………………………………………………………………...……....………………………………………...Slide 8
`
`3. The Problems Purportedly Addressed by the ’795 Patent………………………………………………………………………………………………Slide 13
`
`4. The Purported Solution Was Also Known…………………………………………………………………………………………………………….………..Slide 18
`
`5. The Claims of the ’795 Patent…………………………………………………………………………………………………………………………………….....Slide 23
`
`6. The State of the Art…………………………………………………………………………………………………………………………………………………..….Slide 27
`
`7. The Challenged Claims Are All Invalid……………………………………………………………………………………………………………………….….Slide 54
`a) The Challenged Claims Are All Obvious ……………………………………………………………….......................................................................Slide 56
`b) Motivation to Combine and Reasonable Expectation of Success.................................................................................................................Slide 61
`c) Genexa’s Arguments Fail Regarding Lack of Motivation to Combine and Reasonable Expectation of Success………………Slide 73
`
`8. The Prior Art Discloses All of the Claim Limitations that Genexa Challenges………………………………………………………………..….Slide 92
`
`9. Claim 18 and Its Dependent Claims Are Indefinite……………………………………………………………………………………………………….Slide 124
`
`10. Dr. Berkland’s Testimony Should Be Given Less Weight………………………………………………………………………………………….……Slide 128
`
`11. The POSITA………………………………………………………………………………………………………………………………………………………………..Slide 134
`
`12. The Prior Art Discloses the Unchallenged Limitations…………………………………………………………………………………………..…….Slide 136
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`2
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`
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`
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`The Prosecution History of the
`‘795 Patent
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`3
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`
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`U.S. Patent No. 11,617,795B2 (the “’795 Patent”)
`
`• Assignee: Genexa Inc.
`• Filing date: Aug. 4, 2022
`• Issue date: Apr. 4, 2023
`• Provisional filed: Nov. 2, 2017
`• Earliest priority date: Jun. 8, 2021
`(CIP filing date)
`• 24 claims (3 independent)
`
`See Pet. (Paper 2), 8-11 (citing to Ex. 1001 and Ex. 1003); Ex. 1003 (Crowley Decl.), ¶¶23, 32, 36 (citing to Ex. 1001).
`
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`4
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`Ex. 1001, cover page
`
`
`
`The Specification of the ’795 Patent is a Wholesale Rewriting of
`the Original Application Filed by Genexa
`
`Ex. 1001, cover page
`
`• The specification of the
`‘529 application does not
`mention:
`• Any specific APIs,
`including
`acetaminophen
`• Any specific
`formulation viscosity,
`let alone a preferred
`viscosity range
`
`See Pet. (Paper 2), 9-10 (citing Ex. 1001, Ex. 1009 and Ex. 1003) ; Ex. 1003 (Crowley Decl.), ¶¶36 (citing Ex. 1001), 40-41 (citing Ex. 1009).
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`5
`
`Ex. 1009, 1-2
`
`
`
`No IDS and the Examiner Only Identified a Single Reference
`
`Ex. 1002, 20
`
`Ex. 1043, 1107-1108
`
`See Pet. (Paper 2), 12-13 (citing Ex. 1002, Ex. 1043 and Ex. 1003); Ex. 1003 (Crowley Decl.), ¶¶ 38-39 (citing Ex. 1002 and Ex. 1043).
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`6
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`
`
`The Examiner Allowed the Claims of the ’795 Patent Without the
`Benefit of the Prior Art Cited in Grounds 1 and 2
`Examiner’s Reasons for Allowance
`Prior Art NOT Provided to the Examiner
`
`FR458
`
`c
`
`Ex. 1004, 8
`
`Ex. 1002, 17
`
`WO742
`
`Ex. 1007, 23
`See Pet. (Paper 2), 5 (citing Ex. 1004 and Ex. 1007), 11-13 (citing Ex. 1002 and Ex. 1003); Ex. 1003 (Crowley Decl.), ¶¶38-39 (citing Ex. 1002).
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`
`
`
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`Claim Construction
`
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`8
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`
`
`The ’795 Patent Defines “Agave Syrup” and “Syrup” Separately
`
`Ex. 1001, 2:6-13
`
`Ex. 1001
`See Pet. (Paper 2), 7 (citing Ex. 1003), 15-16 (citing Ex. 1001), ; Ex. 1003 (Crowley Decl.), ¶¶ 28 and 93-94 (citing Ex. 1001).
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`9
`
`
`
`The ’795 Patent Does not Specify the Type or Viscosity of the
`Agave Syrup
`
`Ex. 1001, 1:31-41
`
`Ex. 1001, 2:4-11
`
`Ex. 1001, 4:42-51
`
`Ex. 1001, 5:11-19
`
`Ex. 1001, 2:40-56
`
`Ex. 1001, 5:25-32
`
`See Pet. (Paper 2), 14-15; Reply (Paper 25), 20 and 22
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`10
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`Ex. 1001, 4:11-24
`
`
`
`Patent Owner Agrees That “Agave Syrup” is Not Restricted to a
`Particular Type of Agave Syrup
`
`POR (Paper 20), 13
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`11
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`
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`The Viscosity Limitations Only Pertain to the Pharmaceutical
`Syrup Formulations – Which Comprise More than Agave Syrup
`
`Ex. 1001, claims 1-4, 7, 15, 18-21
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`12
`
`See Pet. (Paper 2), 14-15; Reply (Paper 25), 10
`
`
`
`
`
`The Problems Purportedly
`Addressed by the 795 Patent
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`13
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`
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`The’795 Patent Purports to Address Several Known Problems
`
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`14
`
`See Pet. (Paper 2), 5-6; Ex. 1003 (Crowley Decl.), ¶25; Reply (Paper 25), 7
`
`Ex. 1001, 1:12-28
`
`
`
`The Lack of Suitability of Solid Dosage Forms for the Very Young
`and the Elderly Were Known
`
`FR458
`
`WO133
`
`Ex. 1004, 2:39-45
`
`Ex. 1006. 1:13-20
`
`See Pet. (Paper 2), 20 (citing Ex. 1004), 26 (citing Ex. 1006); Ex. 1003 (Crowley Decl.), ¶¶ 62 (citing Ex. 1004), 76 (citing Ex. 1006); Reply, 7 and 10.
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`15
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`
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`The Terrible Taste of Liquid Forms of Certain Analgesics Was
`Known
`
`FR458
`
`WO133
`
`Ex. 1004, 2:39-45
`
`Ex. 1006. 1:13-20
`
`See Pet. (Paper 2), 20 (citing Ex. 1004), 26 (citing Ex. 1006); Ex. 1003 (Crowley Decl.), ¶¶ 62 (citing Ex. 1004), 76 (citing Ex. 1006); Reply, 7 and 10.
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`16
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`
`
`The Use of Unnatural and Artificial Excipients for Taste-Masking
`Bitter Analgesics Was Known
`
`FR458
`
`Heyer 2009
`
`Ex. 1004, 3:70-77
`
`See Pet. (Paper 2),18 fn, 10 (citing Ex. 1008), 60 (citing Ex. 1004); Ex. 1003 (Crowley Decl.), App. D, 5, 19, 39.
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`17
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`Ex. 1008, [0008]-[0009]
`
`
`
`
`
`The Purported Solution Was
`Also Known
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`18
`
`
`
`The Solution Taught by the ’795 Patent
`
`Ex. 1001, abstract, 1:31-35
`
`See Pet. (Paper 2), 6-7 (citing Ex. 1003); Ex. 1003 (Crowley Decl.), ¶¶ 24 (citing Ex. 1001), 26 (citing Ex. 1001).
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`19
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`
`
`The Prior Art Cited in the Grounds Teaches Formulations with the
`Same Components
`
`FR458
`
`WO742
`
`Ex. 1004, 8
`
`Ex. 1007, 23
`
`See Pet. (Paper 2), 5 (citing Ex. 1004 and Ex. 1007), 20-21 (citing Ex, 1004), 29-54 (citing Ex. 1004), 56-68 (citing Ex. 1007), ; Ex. 1003 (Crowley Decl.), ¶¶ 65 (citing Ex. 1004), 69 (citing Ex. 1007).
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`20
`
`
`
`The ’795 Patent Acknowledges its Viscosity Ranges Are Borrowed
`from the Art
`
`’795 Patent
`
`Exhibit
`
`The ’4666 Patent
`(Ex. 1005)
`WO133
`(Ex. 1006)
`Valinoti 2016
`(Ex. 1036)
`Neves 2010
`(Ex. 1046)
`Subramaniam
`(Ex. 2020)
`
`Oral
`Formulation
`Viscosity Range
`100 to 3000 cP
`
`200 to 900 cP
`
`20 to 1780 cP
`
`2.8 to 412.3 cP
`
`307.33-2408.33cP
`
`Ex. 1005, 4:10-11, claim 11
`Ex. 1006, 8:1-3
`Ex. 1036, abstract, table 2
`Ex. 1046, abstract, table 4
`Ex. 2020, abstract, table 1
`
`See Pet., (Paper 2), 7 (citing Ex. 1001, Ex. 1003, Ex. 1005 and Ex. 1006); Ex. 1003 (Crowley Decl.), ¶28 (citing Ex. 1001), ¶58 (citing Ex. 1036); Reply (Paper 25), 8, 15 (citing Ex. 1003, Ex. 1046 and Ex. 2020).
`
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`21
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`Ex. 1001, col. 2, lns. 12-27
`
`
`
`The Disclosed Viscosities Are Typical For Oral Formulations That
`Are Pourable and Drinkable
`
`Dr. Crowley’s Declaration
`
`’795 Patent
`
`Ex. 1001, cover page
`
`Ex. 1003, ¶28
`
`See Pet., (Paper 2), 7 (citing Ex. 1001, Ex. 1003); Ex. 1003 (Crowley Decl.), ¶24 (citing Ex. 1001); Reply (Paper 25), 8-9 fn. 3 and 14-15 (citing Ex. 1003)
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`22
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`
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`
`
`The Claims of the “795 Patent
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`23
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`
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`Claim 1 and Dependent Claims
`
`1.
`
`(a)
`(b)
`
`(c)
`
`2.
`
`3.
`
`4.
`
`5
`
`6.
`
`A pharmaceutical syrup formulation for oral administration comprising:
`
`acetaminophen,
`agave syrup, and
`
`a diluent, wherein the syrup formulation has a viscosity of less than 1500 centipoise at about 22
`degrees; wherein the acetaminophen is suspended in the syrup; and wherein the syrup is palatable.
`The pharmaceutical syrup formulation of claim 1, wherein the syrup formulation has a viscosity of
`less than 1000 centipoise at about 22 degrees
`The pharmaceutical syrup formulation of claim 1, wherein the syrup formulation has a viscosity of
`less than 750 centipoise at about 22 degrees
`The pharmaceutical syrup formulation of claim 1, wherein the syrup formulation has a viscosity of
`less than 600 centipoise at about 22 degrees
`The pharmaceutical syrup formulation of claim 1, wherein 0.01 to 2 grams of acetaminophen is
`suspended per 100mL of the syrup
`The pharmaceutical syrup formulation of claim 1, wherein 0.01 to 1 grams of acetaminophen is
`suspended per 100mL of the syrup
`
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`Ex. 1001, claims 1-6
`
`See Pet., (Paper 2), 8
`
`24
`
`
`
`Claim 7 and Dependent Claims
`
`7.
`
`(a)
`(b)
`(c)
`(d)
`(e)
`
`8.
`
`9.
`
`10.
`
`A stable pharmaceutical syrup formulation for oral
`administration comprising:
`acetaminophen;
`agave syrup;
`acidic preservative;
`a flavoring agent, and
`a diluent, wherein the syrup formulation has a viscosity of
`less than 1500 centipoise at about 22 degrees, and
`wherein the acetaminophen is suspended in the syrup.
`The pharmaceutical syrup formulation of claim 7, wherein
`the acetaminophen is between 0.01 to 2% of the
`formulation weight.
`The pharmaceutical syrup formulation of claim 7, wherein
`the diluent is about 5% of the formulation by weight.
`The pharmaceutical syrup formulation of claim 7, wherein
`the agave syrup is less than 98% of the formulation by
`weight.
`
`11.
`
`12.
`
`13.
`
`14.
`
`15.
`
`16.
`
`17.
`
`The pharmaceutical syrup formulation of claim 7, wherein
`the agave syrup is less than 95% of the formulation by
`weight.
`The pharmaceutical syrup formulation of claim 7, wherein
`the diluent is water.
`The pharmaceutical syrup formulation of claim 7, wherein
`the agave syrup is about 95% of the formulation by weight.
`The pharmaceutical syrup formulation of claim 13, wherein
`the acidic preservative comprises citric acid.
`The pharmaceutical syrup formulation of claim 7, wherein
`the composition is a medicinal preparation formulated as a
`syrup; and wherein the composition has a viscosity from
`about 1500 centipoise to about 400 centipoise at about 22
`degrees.
`The pharmaceutical syrup formulation of claim 7, wherein
`the formulation is orally administered for veterinary and
`human use.
`The pharmaceutical syrup formulation of claim 7, wherein
`the flavoring agent is a bitter-taste-blocking ingredient.
`See Pet., (Paper 2), 8-9
`Ex. 1001, claims 7-17
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`25
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`
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`Claim 18 and Dependent Claims
`
`18.
`
`(a)
`(b)
`
`(c)
`
`(d)
`
`(e)
`
`19.
`
`20.
`
`A stable, palatable pharmaceutical syrup
`formulation for oral administration consisting
`essentially of:
`a therapeutically effective amount of acetaminophen;
`agave syrup;
`
`acidic preservative;
`
`a flavoring agent, and
`
`a diluent, wherein the syrup formulation has a viscosity
`of less than 1500 centipoise at about 22 degrees and the
`acetaminophen is suspended in the syrup.
`The formulation of claim 18, wherein the pharmaceutical
`syrup formulation has a viscosity of less than 1000
`centipoise at about 22 degrees.
`The formulation of claim 18, wherein the pharmaceutical
`syrup formulation has a viscosity of less than 1500
`centipoise at about 22 degrees.
`
`21.
`
`22.
`
`23.
`
`24.
`
`The formulation of claim 18, wherein the pharmaceutical
`syrup formulation has a viscosity of less than 1500
`centipoise at about 22 degrees.
`The formulation of claim 18, wherein the agave syrup is less
`than 98% of the formulation by weight.
`The formulation of claim 18, wherein the agave syrup is less
`than 95% of the formulation by weight.
`The formulation of claim 18, wherein the agave syrup is
`about 95% of the formulation by weight.
`
`Ex. 1001, claim 18-24
`
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`See Pet., (Paper 2), 9
`
`26
`
`
`
`
`
`The State of the Art
`
`DEMONSTRATIVE – NOT AN EXHIBIT
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`27
`
`
`
`The ‘795 Patent Does Not Teach Anything New
`
`Rather, it is
`
`“simply arrang[ing] old [ingredients] with each
`performing the same function it had been known to
`perform…[a] predictable use of prior art elements
`according to their established functions”
`
`KSR Intern. Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007)
`
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`See Pet. (Paper 2), 29, 55.
`
`28
`
`
`
`Patent Owner and its Expert Agree that Agave is a Known
`Sweetener
`
`Ex. 2009 (Berkland Decl.), ¶43
`
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`29
`
`See POR (Paper 20), 4 (citing Ex. 2009); Reply (Paper 25), 3 fn. 1 (citing Ex. 2009)
`
`
`
`The Benefits of Using Agave Syrup in Oral Pharmaceutical
`Formulations Were Known to a POSITA
`
`The prior art teaches replacing refined
`or artificial sweeteners with natural
`agave syrup in oral medicines to:
`• Reduce calorie intake
`• Promote colon health through
`improved digestion and intestinal
`microflora growth
`• Lower-glycemic index
`• Provide essential vitamins and
`minerals (vitamins B,C,D,E, Ca, Fe, P,
`Mg, K, Se, Cr)
`• Reduce inflammation
`
`Ex. 1008, cover page
`
`See Pet. (Paper 2), 3-4 (citing Ex. 1008); Ex. 1003 (Crowley Decl.), ¶¶53 and 70 (citing Ex. 1008).
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`30
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`
`
`Agave Syrup’s Properties Are Described in the Prior Art
`
`Ex. 1008, [0005] (cited on page 15 of the Petition)¶
`
`Ex. 1030, (cited in Reply (Paper 25), 10 fn 4 for the proposition that
`this reference “reports agave syrup with a viscosity of 212cP”)*
`
`Ex. 1027, 22 (cited in Ex. 1003 at ¶52*)
`
`Ex. 1007, 7:5-23 (cited on page 22 of the Petition)
`
`Ex. 1031, 1 (cited on p. 1 of POR and in Ex. 1003 at ¶52*)
`*Ex. 1003, ¶ 52 is cited in the Petition at pp. 4fn.1 and15 and it notes that “[t]he viscosity of agave syrup is reported to be around 212mPa-S, or 212cP”
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`
`
`FR458 Disclosure
`
`
`
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`32
`
`
`
`FR458 Overview
`
`Ex. 1004, cover page
`
`See Pet. (Paper 2), 19-21; Ex. 1003 (Crowley Decl.), ¶¶61-65.
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`33
`
`
`
`FR458 Discloses Oral Pharmaceutical Formulations Based on
`Low-Glycemic Index Organic Agave Syrup
`
`Claims
`
`Ex. 1004, 12
`
`Ex. 1004, 3:58-77
`
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`34
`
`See Pet. (Paper 2), 29-30; Ex. 1003 (Crowley Decl.), ¶¶107, 114, App. D, 5, 19, 38-39.
`
`
`
`FR458 Discloses Oral Pharmaceutical Formulations that Include
`Acetaminophen Suspended in Agave Syrup
`
`Ex. 1004, 3:86-90
`
`Ex. 1004, 5:127-133
`
`Ex. 1004, 8
`
`Ex. 1004, 10
`
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`35
`
`See Pet. (Paper 2), 19-21, 30; Ex. 1003 (Crowley Decl.), ¶122, App. D, 8-10, 25-27, 44-47.
`
`
`
`FR458 Teaches the Use of the Same Compositions as the ’795
`Patent For the Same Reasons
`FR458
`
`‘795 Patent
`
`Ex. 1004, 8
`
`Ex. 1004, 3:70-77
`
`Ex. 1001, 1: 31-41
`
`Ex. 1001, 1: 23-28
`
`See Pet. (Paper 2), 5-7 (citing Ex. 1001), 19-21 (citing Ex. 1004), 29-54 (citing Ex. 1001 and 1004), 60 (citing Ex. 1003); Ex. 1003 (Crowley Decl.), ¶¶24-25 (citing Ex. 1001), 63 (citing Ex. 1004).
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`36
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`
`
`WO742 Disclosure
`
`
`
`
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`37
`
`
`
`WO742 Overview
`
`Ex. 1007, cover page
`
`See Pet. (Paper 2), 22-24; Ex. 1003 (Crowley Decl.), ¶¶66-70.
`
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`38
`
`
`
`WO742 Discloses An Orally-Acceptable Pharmaceutical Carrier
`Based on Agave Syrup
`
`Ex. 1007, 9:18-25
`
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`39
`
`See Pet. (Paper 2), 22; Ex. 1003 (Crowley Decl.), ¶67.
`
`
`
`WO742 Teaches the Same Composition as the ’795 Patent
`
`WO742
`
`‘795 Patent
`
`Ex. 1001, 1: 31-35
`
`Ex. 1007, 23
`
`See Pet. (Paper 2), 5-9 (citing Ex. 1001), 22-24 and 56-68 (citing Ex. 1007); Ex. 1003 (Crowley Decl.), ¶¶ 24-26 (citing Ex. 1001), ¶¶ 66-70 and 199-265(citing Ex. 1007).
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`40
`
`
`
`Patent Owneris Wrong Abouta
`POSITA’s Knowledge of Agave
`Syia058)
`
`
`
`
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`41
`
`
`
`A POSITA Would Have Viewed the Use of Agave Syrup as an
`Ingredient in an Oral Pharmaceutical Formulations as Predictable
`
`In these formulations, agave syrup is an
`
`“old [ingredient]… performing the
`same function it had been known to
`perform”
`
`KSR Intern. Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007)
`(citing Sakraida v. Ag pro, Inc., 425 U.S. 273, 282 (1976))
`
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`42
`
`See Pet. (Paper 2), 29, 55; Reply (Paper 25), 3-4 fn. 1.
`
`
`
`Patent Owner Complains That Petitioner Has Not Provided
`Evidence that Agave is an “Old” Oral Formulation Ingredient
`
`POR (Paper 20), 1
`
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`43
`
`POR (Paper 20), 2
`
`
`
`Patent Owner Ignores the Prior Art Cited in the Grounds that
`Describe Using Agave Syrup for Exactly This Purpose
`
`FR458
`
`WO742
`
`Ex. 1004, 8
`
`Ex. 1007, 23
`
`Published January 24, 2014
`
`Published February 9, 2012
`
`See Pet. (Paper 2), 19-22 (citing Ex. 1004), 22-24 (citing Ex. 1007); Ex. 1003 (Crowley Decl.), ¶¶61-65 (citing Ex. 1004), ¶¶66-70 (citing Ex. 1007); Reply (Paper 25), 2-3.
`
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`44
`
`
`
`Patent Owner Ignores the Prior Art that Describes Using Agave
`Syrup for Exactly This Purpose
`
`Heyer, 2009
`
`Ex. 1008, cover
`
`Ex. 1008, abstract
`
`Ex. 1008, [0003]
`
`Published June 11, 2009
`
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`45
`
`See Pet. (Paper 2), 27; Ex. 1003 (Crowley Decl.), ¶70, 130 fn. 29.
`
`
`
`Patent Owner and its Expert Ignore this Textbook Which
`Describes Using Agave Syrup for Exactly This Purpose
`
`*Ex. 1003 (Crowley Decl.), ¶53 (cite Ex. 1033 discussing pediatric formulations) is cited on p. 5 of the Petition ( “many others had proposed using agave syrup in medicines much earlier.”)
`
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`46
`
`Ex. 1033, 356 (cited in Petition at p. 5
`and Ex. 1003 at ¶53*)
`
`Published 2014
`
`
`
`Patent Owner Ignores This Peer-Reviewed Article Cited in the
`Petition Which Describe an Agave Syrup-Based Cough Treatment
`
`Ex. 1043, 1108 (cited in the Petition at pp. 12-13 and in Ex. 1003 at para ¶39)
`
`Published 2014
`
`Ex. 1043, 1107
`
`DEMONSTRATIVE – NOT AN EXHIBIT
`
`47
`
`
`
`Patent Owner Also Ignores That Agave Syrup-Based Oral Liquid
`Health Products Were Available Commercially
`
`Reply (Paper 25), 4 fn1
`
`Ex. 1052, 2 (cited in Reply (Paper 25) at 4 fn1)
`Marketing Start Date: February 1, 2019
`
`DEMONSTRATIVE – NOT AN EXHIBIT
`
`48
`
`
`
`Patent Owner Also Ignores That Agave Syrup-Based Oral Liquid
`Health Products Were Available Commercially
`
`Reply (Paper 25), 4 fn1
`
`Marketing Start Date: February 15, 2017
`
`Ex. 1048, 3-5 (cited in Reply (Paper 25) at 4 fn1)
`
`DEMONSTRATIVE – NOT AN EXHIBIT
`
`49
`
`
`
`A POSITA Would Know How to Modify an Agave Syrup to Achieve
`a Desired Viscosity
`
`Petition
`
`Pet. (Paper 2), 4 fn. 1 (cited in Reply at page 21)
`
`Dr. Crowley’s Declaration
`
`Ex. 1003, ¶52 (cited in Petition at 4 fn. 1 and Reply at page 20)
`
`DEMONSTRATIVE – NOT AN EXHIBIT
`
`See Pet. (Paper 2), 4 (citing Ex. 1003).
`
`50
`
`
`
`Patent Owner Asserts that a POSITA Could Only Select an
`Appropriate Agave Syrup Viscosity with the ’795 Patent’s Teachings.
`
`Ex. 1051, 138:7-21
`
`Ex. 1051, 139:4-17
`
`See Reply (Paper 25), 11, 19 and 21 (citing Ex. 1051).
`
`DEMONSTRATIVE – NOT AN EXHIBIT
`
`51
`
`Sur-Reply (Paper 29), 18
`
`
`
`The ’795 Patent Says Nothing About the Viscosity of the Agave
`Syrup
`
`Ex. 1001, 1:31-41
`
`Ex. 1001, 2:4-11
`
`Ex. 1001, 4:42-51
`
`Ex. 1001, 5:11-19
`
`Ex. 1001, 2:40-56
`
`Ex. 1001, 5:25-32
`
`DEMONSTRATIVE – NOT AN EXHIBIT
`
`Ex. 1001, 4:11-24
`
`See Reply(Paper 25), 20 and 22
`
`52
`
`
`
`The ’795 Patent Explains That the Desired Formulation Viscosity
`Can Be Achieved By Adding Water.
`
`Ex. 1001, 5:25-32
`
`Ex. 1001, 4:15-17
`
`Ex. 1001, 4:42-52
`
`DEMONSTRATIVE – NOT AN EXHIBIT
`
`53
`
`See Pet. (Paper 2), 7-8; Reply (Paper 25), 19-20; Ex. 2009 (Berkland Decl.), ¶¶62-63
`
`
`
`
`
`The Challenged Claims AreAll
`Invalid
`
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`
`54
`
`
`
`PGR2023-00051 Grounds of Institution
`
`Grounds
`
`1
`
`2
`
`3
`
`Claims
`Challenged
`1-24
`
`1-17
`
`35 U.S.C. §
`
`References/Basis
`
`103
`
`103
`
`a) FR458 and the ‘4666 Patent.
`b) FR458 and WO133.
`c) FR458, the ‘4666 Patent, and WO133.
`
`a) WO742 and the ‘4666 Patent.
`b) WO742 and WO133.
`c) WO742, the ‘4666 Patent, and WO133.
`
`1-24
`
`112(b)
`
`In the alternative, the following terms are indefinite
`because they are not defined in the specification:
`a) “palatable”
`b) “stable”
`c) “consisting essentially of”
`
`DEMONSTRATIVE – NOT AN EXHIBIT
`
`See Pet. (Paper 2), 2-3
`
`55
`
`
`
`The Challenged ClaimsAreAll
`Obvious
`
`
`
`
`DEMONSTRATIVE – NOT AN EXHIBIT
`
`56
`
`
`
`Patent Owner’s Complaint that Petitioner’s Grounds 1 and 2 are
`Ambiguous is Incorrect
`
`POR (Paper 20), 37
`
`DEMONSTRATIVE – NOT AN EXHIBIT
`
`See Reply(Paper 25), 6-7
`
`57
`
`
`
`The Petition Clearly Articulates Three Separate Prior Art
`Combinations For Each Obviousness Ground
`
`When the Petition describes the prior art combinations cited in Grounds 1
`and 2, it expressly describes the three separate combinations in each
`
`Ground 1
`
`Ground 2
`
`Pet. (Paper 2), 28, fn14
`
`Pet. (Paper 2), 54, fn26
`
`DEMONSTRATIVE – NOT AN EXHIBIT
`
`See Reply(Paper 25), 6-7
`
`58
`
`
`
`Afterwards, the Use of And/Or Is Confined to Headers
`
`Pet. (Paper 2), 29
`
`DEMONSTRATIVE – NOT AN EXHIBIT
`
`See Reply (Paper 25), 6
`
`59
`
`
`
`Dr. Crowley Clearly Articulates the Three Separate Combinations
`of Prior Art Relied on in Each Obviousness Ground
`
`DEMONSTRATIVE – NOT AN EXHIBIT
`
`60
`
`Ex. 1003, ¶129
`
`See Pet. (Paper 2), 33
`
`
`
`Motivation to Combine and
`Reasonable Expectation of Success
`
`
`DEMONSTRATIVE- NOT AN EXHIBIT
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`DEMONSTRATIVE – NOT AN EXHIBIT
`
`61
`
`
`
`Genexa Does Not Dispute
`
`• June 8, 2021, is the earliest possible priority date to which the ’795 Patent is
`entitled.
`• FR458, the ‘4666 Patent, WO133 and WO742 are prior art to the ’795 Patent.
`• All the limitations of independent claims 1, 7 and 18 are disclosed by the
`prior art cited in the Petition except potentially the viscosity limitations.*
`• The limitations of dependent claims 10-12, 14, 16 and 22-23 are disclosed by
`the prior art cited in the Petition.
`
`* Genexa states that “none of the proposed combinations disclose viscosities that meet the claim limitations.” See POR at 3. But Genexa
`never explains how the individual teachings of the ’4666 patent and WO133 do not disclose the claimed viscosity ranges.
`
`DEMONSTRATIVE – NOT AN EXHIBIT
`
`See POR (Paper 20), generally
`
`62
`
`
`
`KSR’s Flexible Motivation to Combine Standard Still Stands
`
`“The motivation-to-combine analysis is a flexible one.
`‘[A]ny need or problem known in the field of
`endeavor at the time of the invention and addressed
`by the patent can provide a reason for combining the
`elements in the manner claimed…’”
`
`Intel Corporation v. PACT XPP Schweiz AG, 61 F.4th 1373, 1379 (Fed. Cir. 2023)
`(citing KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 420-421 (2007))
`
`DEMONSTRATIVE – NOT AN EXHIBIT
`
`63
`
`See Pet. (Paper 2), 27; Reply (25), 7-8
`
`
`
`The Prior Art Cited in Ground 1 Are In the Same Field of Art and
`Address the Same Problem as The ’795 Patent
`
`Pet. (Paper 2), 28
`
`DEMONSTRATIVE – NOT AN EXHIBIT
`
`64
`
`
`
`FR458 and the ’4666 Patent Also Address Another Problem in the
`Art
`
`FR458
`
`The ‘4666 Patent
`
`Ex. 1004, 3: 70-77
`
`Ex. 1005, 2: 15-21
`
`DEMONSTRATIVE – NOT AN EXHIBIT
`
`65
`
`See Pet. (Paper 2), 28-29; Ex. 1003 (Crowley Decl.), ¶101; Rely (Paper 25), 3.
`
`
`
`A POSITA Exercises Ordinary Creativity When Combining
`References
`
`“And ‘[a] person of ordinary skill is also a person of ordinary
`creativity, not an automaton.’ So. ‘in many cases[,] a person of ordinary
`skill will be able to fit the teachings of multiple patents together like
`pieces of a puzzle.
`That’s why the motivation-to-combine analysis ‘need not seek out precise
`teachings directed to the specific subject matter of the challenged claim,
`for a court can take account of the inferences and creative steps that
`a person of ordinary skill in the art would employ.’”
`
`Intel Corporation v. PACT XPP Schweiz AG, 61 F.4th 1373, 1379 (Fed. Cir. 2023)
`(citing KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 420-421 (2007))
`
`DEMONSTRATIVE – NOT AN EXHIBIT
`
`66
`
`See Pet. (Paper 2), 27; Reply (Paper 25), 7-8.
`
`
`
`A POSA Would Have Been Motivated to Combine the Teachings of
`FR458 and WO133 and/or the ‘4666 Patent
`
`Ex. 1003, ¶2
`
`Pet. (Paper 2), 29
`
`See Pet. (Paper 2), 19-20, 25-26; Ex. 1003 (Crowley Decl.), ¶¶62, 74, 80, 100-103; Reply (Paper 25), 2-3
`
`DEMONSTRATIVE – NOT AN EXHIBIT
`
`67
`
`
`
`The Prior Art Cited in Ground 2 Are In the Same Field of Art and
`Pertain to Oral Formulations with Analgesic
`
`Pet. (Paper 2), 55
`
`DEMONSTRATIVE – NOT AN EXHIBIT
`
`68
`
`
`
`A POSITA Would Combine WO742’s Safer Antitussive Formulation
`with the Analgesic Formulations of the Secondary References
`
`Pet. (Paper 2), 55
`
`DEMONSTRATIVE – NOT AN EXHIBIT
`
`69
`
`
`
`A POSA Would Have Been Motivated to Combine the Teachings of
`WO742 and WO133 and/or the ‘4666 Patent Like Puzzle Pieces
`
`Ex. 1003, ¶¶2-3
`
`Pet. (Paper 2), 55
`
`Pet. (Paper 2), 55
`
`See Pet. (Paper 2),22-23, 25-26; Ex. 1003 (Crowley Decl.), ¶¶67, 74, 80, 195-198; Reply (Paper 25), 4-5
`
`DEMONSTRATIVE – NOT AN EXHIBIT
`
`70
`
`
`
`As Noted by the Board, a POSITA’s Predictable Use of Prior Art
`Elements is Obvious
`
`“The combination of familiar elements according to known
`methods is likely to be obvious when it does no more than yield
`predictable results.”
`
`KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007)
`
`DEMONSTRATIVE – NOT AN EXHIBIT
`
`71
`
`See Institution Decision (Paper 8), 22
`
`
`
`A POSITA Would Have Had a Reasonable Expectation of Success in
`Combining the Prior Art Elements from Grounds 1 and 2
`
`Ex. 1003, ¶102
`
`DEMONSTRATIVE – NOT AN EXHIBIT
`
`72
`
`See Pet. (Paper 2), 29, 55; Reply (Paper 25), 3-4; Ex. 1003 (Crowley Decl.), ¶¶ 102, 197.
`
`
`
`Genexa's Lack of Motivation to
`Combine and Reasonable
`Expectation of Success Arguments
`Fail
`
`
`DEMONSTRATIVE- NOT AN EXHIBIT
`
`DEMONSTRATIVE – NOT AN EXHIBIT
`
`73
`
`
`
`The Crux of Genexa’s Arguments:
`An Allegedly Incorrectly Presumed Viscosity for Agave Syrup
`
`POR (Paper 20), 24
`
`POR (Paper 20), 28
`
`DEMONSTRATIVE – NOT AN EXHIBIT
`
`74
`
`
`
`The Submitted Evidence Shows That Agave Syrup Can Have a
`Viscosity of 212cP
`
`Patent Owner Response
`
`Soto 2011
`
`POR (Paper 20), 28
`
`Ex. 1030, (cited in Reply (Paper 25), 10 fn 4 for the proposition that this
`reference “reports agave syrup with a viscosity of 212cP”)
`
`See also Pet. (Paper 2), 31, 57; Ex. 1003 (Crowley Decl.), ¶¶50, 52 (also noting that agave syrup has been reported to have a viscosity of 212cP)
`
`DEMONSTRATIVE – NOT AN EXHIBIT
`
`75
`
`
`
`The Petition Explains Agave Syrup Can Have Thicker or Thinner
`Consistency (i.e., Viscosity)
`
`Pet. (Paper 2), 4 fn 1
`
`Pet. (Paper 2), 22
`
`DEMONSTRATIVE – NOT AN EXHIBIT
`
`76
`
`
`
`The Petition Explains Agave Syrup Can Have Thicker or Thinner
`Consistency (i.e., Viscosity)
`
`WO742
`
`Soto 2011
`
`Ex. 1007, 7:15-23 (cited on page 22 of the Petition)
`Vera-Guzmán 2011
`
`Ex. 1030, (cited in Reply (Paper 25), 10 fn 4 for the proposition that this
`reference “reports agave syrup with a viscosity of 212cP”)*
`
`Ex. 1031, 1 (cited on p. 1 of POR and in Ex. 1003 at ¶52*)
`
`*Ex. 1003 (Crowley Decl.), ¶52 also notes that “[t]he viscosity of agave syrup is reported to be around 212mPa-S, or 212cP”
`
`DEMONSTRATIVE – NOT AN EXHIBIT
`
`77
`
`
`
`Dr. Crowley Explains That Agave Syrup Can Have Other Viscosities
`
`Ex. 1003, ¶93
`
`Ex. 1003, ¶68
`
`DEMONSTRATIVE – NOT AN EXHIBIT
`
`78
`
`See Pet. (Paper 2), 14-15; Ex. 1003 (Crowley Decl.), ¶¶50-52
`
`
`
`Patent Owner’s Focus on the Viscosity of Agave Syrup is a Red
`Herring
`
`1.
`
`(a)
`(b)
`
`(c)
`
`A pharmaceutical syrup formulation for oral administration comprising:
`
`acetaminophen,
`agave syrup, and
`
`a diluent, wherein the syrup formulation has a viscosity of less than 1500 centipoise at about 22
`degrees; wherein the acetaminophen is suspended in the syrup; and wherein the syrup is palatable.
`
`The claims do not recite a viscosity for the agave syrup
`
`Ex. 1001, claims 1-4
`
`DEMONSTRATIVE – NOT AN EXHIBIT
`
`79
`
`See Reply (Paper 25), 10
`
`
`
`The ’795 Patent Only Discusses Acceptable Viscosities for the
`Final Syrup Formulation
`
`Ex. 1001, 2: 9-27
`
`See Pet. (Paper 2), 14-16;Ex. 1003 (Crowley Decl.), ¶¶ 28, 93-94; Reply (Paper 25), 10
`
`DEMONSTRATIVE – NOT AN EXHIBIT
`
`80
`
`
`
`WO133 and the ‘4666 Patent Disclose the Independent Claims’
`Viscosity Limitations
`
`Patent Owner Response
`
`Petition
`
`POR (Paper 20), 24
`
`See also Pet. (Paper 2), 57; Institution Decision (Paper 8) at 24-25; Reply (Paper 25), 10-12
`
`Pet. (Paper 2), 31
`
`DEMONSTRATIVE – NOT AN EXHIBIT
`
`81
`
`
`
`WO133 and the ‘4666 Patent Also Disclose the Dependent
`Claims’ Viscosity Limitations
`
`Patent Owner Response
`
`Petition
`
`POR (Paper 20), 24
`
`Pet. (Paper 2), 34
`
`See also Pet. (Paper 2), 60; Ex. 1003 (Crowley Decl.), ¶¶ 132-133, 227-228; Reply (Paper 25), 10-12
`
`DEMONSTRATIVE – NOT AN EXHIBIT
`
`82
`
`
`
`Dr. Berkland Asserts that a POSITA Would Expect Example 1 of
`FR458 to Have a Viscosity <200 cP If Made with 212cP Agave Syrup
`
`Ex. 2009 (Berkland Decl.), ¶150 (cited in Reply (Paper 25), 11, 11 fn. 5)
`
`Ex. 1004, 8: Example 1, 199-204 (cited in the Petition at p. 32)
`
`DEMONSTRATIVE – NOT AN EXHIBIT
`
`See also Reply (Paper 25), 1
`
`83
`
`
`
`Patent Owner’s Expert Asserts that The Formulation Cited in
`Example 1 of FR458 Would Have a Viscosity <200cP
`
`“[I]t is well settled that ‘a disclosure
`that anticipates under §102 also
`renders the claim invalid under §103,
`for ‘anticipation is the epitome of
`obviousness.’”
`
`Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1373 (Fed. Cir. 2019)
`
`DEMONSTRATIVE – NOT AN EXHIBIT
`
`See also Reply (Paper 25), 1
`
`84
`
`
`
`Dr. Berkland’s Testimony is Inconsistent
`
`Dr. Berkland’s Written Testimony
`
`Dr. Berkland’s Oral Testimony
`
`Ex. 2009 (Berkland Decl.), ¶150
`
`Ex. 1004, 8
`
`Ex. 1051, 168:15-169:7
`
`Reply (Paper 25), 11, 11 fn. 5
`
`DEMONSTRATIVE – NOT AN EXHIBIT
`
`85
`
`
`
`Genexa Argues that the Non-Overlapping Viscosities of the ’4666
`Patent and WO133 “Teach Away” from the Combination
`
`DEMONSTRATIVE – NOT AN EXHIBIT
`
`POR (Paper 20), 34-35
`
`Reply (Paper 25), 9-10
`
`86
`
`
`
`The Disclosed Viscosities of the ’4666 Patent and WO133 Overlap
`
`The ‘4666 Patent
`
`WO133
`
`Ex. 1006, 8:1-3 (cited in Petition at pages 31, 58)
`
`Ex. 1005, col.4, lns. 9-17 (cited in Petition at pages 31, 58 and Ex. 1003 at paras 119, 168, 191*)
`
`Ex. 1005, claim 11 (cited in Petition at pages 31, 34, 52-53, 58, 60)
`
`Moreover, a lack of overlap between the viscosity ranges taught by WO133
`and the ’4666 Patent would not affect the 2-reference combinations
`
`DEMONSTRATIVE – NOT AN EXHIBIT
`
`87
`
`* These paragraphs of Ex. 1003 are cited at pages 31-32, 45 and 52-53
`
`Reply (Paper 25), 9
`
`
`
`Claim 11 Does Not Include an “Apparent Error” that a POSITA
`Would “Mentally Disregard”
`Genexa Argues
`
`However, the ’4666 Patent:
`
`• Describes 1000-3000cP as a preferred range.
`(Cited at para 168 of Ex 1003*)
`• States “[f]inished products of somewhat less
`thickness” are acceptable. (Cited at para 168 of Ex.
`1003* and in Reply at page 13, fn. 9)
`• Includes independent claims without viscosity
`requirements. (Cited in Reply at page 13, fn. 9)
`• Recites a very simple stabilized formulation in
`claim 7 that allows ingredients with viscosities
`below 1000cP, upon which claim 11 depends.
`(Cited in Reply at page 13, fn. 9)
`
`POR (Paper 20), 30-31
`
`Patent Owner’s “lack of overlap” arguments are
`predicated on ignoring the explicit disclosure of the ’4666
`Patent and accepting that the 100-3000cP disclosure is an
`obvious error.
`
`* Para 168 of Ex. 1003 is cited in the Pet. (Paper 2) at 44-45
`
`DEMONSTRATIVE – NOT AN EXHIBIT
`
`88
`
`
`
`Even if the ’4666 Patent’s Viscosity is ~1000-3000 cP that Aligns with “Viscosities
`of the type used with pharmaceutical suspensions or syrup formulations”
`
`Somewhat less
`thickness
`
`the ’4666 Patent
`
`WO133
`
`Viscosity range taught
`by the ’795 Patent
`specification
`Petition (Paper 2), 32 fn. 17; Ex. 1001, 2: 13-27
`
`Exhibit
`The ’4666 Patent (Ex. 1005)
`WO133 (Ex. 1006)
`Valinoti 2016 (Ex. 1036)
`Neves 2010 (Ex. 1046)
`Subramaniam (Ex. 2020)
`
`Oral Formulation Viscosity Range
`100 to 3000 cP
`200 to 900 cP
`20 to 1780 cP
`2.8 to 412.3 cP
`307.33-2408.33cP
`
`Viscosity ranges taught
`by the prior art cited in
`the Grounds
`
`See Ex. 1005, 4:10-11, claim 11, Ex. 1006, 8:1-3, Ex. 1036, abstract, table 2, Ex. 1046, abstract, table 4, Ex. 2020, abstract, table 1, which are cited in Pet., (Paper 2), 7 (citing
`Ex. 1001, Ex. 1003, Ex. 1005 and Ex. 1006); Ex. 1003 (Crowley Decl.), ¶28 (citing Ex. 1001), ¶58 (citing Ex. 1036); and Reply (Paper 25) at 8 and 15.
`
`DEMONSTRATIVE – NOT AN EXHIBIT
`
`Reply (Paper 25), 15
`
`89
`
`
`
`Dr. Crowley’s Statements Regarding Suspensions That Are
`Considered “Readily Pourable” Do Not “Teach Away”
`
`• “Readily pourable” is not a claim
`limitation (Reply (Paper 25) at pp. 8-9)
`
`• These
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