`
`
`Filed: September ___, 2023
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`KinderFarms LLC,
`Petitioner
`v.
`Genexa Inc.,
`Patent Owner
`
`
`Case PGR2023-00051
`U.S. Patent No. 11,617,795
`
`
`DECLARATION OF MICHAEL CROWLEY
`IN SUPPORT OF KINDERFARMS LLC’S PETITION TO
`INSTITUTE A POST-GRANT REVIEW OF U.S. PAT. NO.
`11,617,795 PURSUANT TO 35 U.S.C. §§ 321 et seq. AND 37
`C.F.R. §§42.1-42.80, 42.200-42.207
`
`
`
` KINDERFARMS Ex. 1003
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`Page 1 of 242
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`25
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`

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`I.
`
`II.
`
`III.
`
`IV.
`
`Table of Contents
`
`
`Page
`INTRODUCTION........................................................................................ 1
`A.
`Summary of Opinions .......................................................................... 1
`B.
`Background and Qualifications ............................................................ 3
`C.
`Previous Testimony and Compensation ............................................... 7
`D. Materials Considered ............................................................................ 8
`THE ’795 PATENT ..................................................................................... 8
`A.
`The Disclosure of the ‘795 Patent ........................................................ 9
`B.
`The File History of the ‘795 Patent .................................................... 17
`C.
`The Priority Date To Which the ’795 Patent is Entitled .................... 21
`STATE OF THE ART BEFORE NOVEMBER 2, 2017 .......................... 22
`A. Oral Liquid Formulations that Contain Acetaminophen.................... 22
`1.
`Solutions, Suspensions and Emulsions – An Overview .......... 22
`2.
`Acetaminophen Oral Formulations – An Overview ................ 25
`3.
`Oral Administration of Acetaminophen and the
`“Bitterness Issue” ..................................................................... 26
`Sweeteners and Syrups in Oral Liquid Drug Formulations ............... 27
`1.
`Sweeteners and Syrups – An Overview ................................... 27
`2.
`Agave Syrups ........................................................................... 30
`3.
`Taste Masking of Pharmaceuticals with Sweeteners and
`Syrups ....................................................................................... 32
`A. Viscosity of Oral Liquid Drug Formulations ..................................... 34
`1.
`Viscosity of Liquids – An Overview ....................................... 34
`2.
`Viscosity of Liquid Formulations Administered Orally .......... 35
`THE PRIOR ART RELIED UPON ........................................................... 36
`A.
`French Patent Publication 2,993,458 ................................................. 37
`B. WO2012/018742A2 and US2009/01485580A1 ................................ 40
`C.
`U.S. Patent No. 4,684,666 .................................................................. 44
`D. WO 95/00133 ..................................................................................... 46
`
`B.
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`Table of Contents
`(continued)
`
`Page
`
`LEGAL STANDARDS FOR OBVIOUSNESS AND
`INDEFINITENESS .................................................................................... 49
`CLAIM CONSTRUCTION AT THE PTAB ............................................ 52
`VI.
`PERSON OF ORDINARY SKILL IN THE ART ..................................... 52
`VII.
`VIII. CLAIM CONSTRUCTION OF CERTAIN CLAIM TERMS .................. 54
`A.
`“agave syrup” – claims 1 to 24 ........................................................... 54
`B.
`“a viscosity of less than [] centipoise at about 22 degrees” –
`claims 1 to 24 ..................................................................................... 55
`“palatable” – claims 1 to 6 and 18 to 24 ............................................ 56
`C.
`“stable” – claims 7 to 18 .................................................................... 56
`D.
`“consisting essentially of” – claims 18 to 24 ..................................... 57
`E.
`GROUNDS ................................................................................................ 59
`A.
`Explanation of Ground 1 .................................................................... 59
`1. Motivation To Combine FR458 with the ‘4666 Patent
`and/or WO133 .......................................................................... 59
`Claim 1 and its Dependent Claims are Obvious over
`FR458 when Combined with the ‘4666 Patent and/or
`WO133 ..................................................................................... 62
`Claim 7 and its Dependent Claims are Obvious over
`FR458 when Combined with the ‘4666 Patent and/or
`WO133 ..................................................................................... 79
`Claims 18 and its Dependent Claims are Obvious over
`FR458 when Combined the ‘4666 Patent and/or WO133 ....... 97
`Explanation for Ground 2 ................................................................. 108
`1. Motivation to Combine WO742 with the ‘4666 Patent
`and/or WO133 ........................................................................ 108
`Claim 1 is Obvious over WO742 when Combined the
`‘4666 Patent and/or WO133 .................................................. 110
`Claim 7 is Obvious over WO742 when Combined with
`the ’580 Publ., and the ‘4666 Patent and/or WO133 ............. 122
`
`V.
`
`IX.
`
`
`
`2.
`
`3.
`
`4.
`
`B.
`
`2.
`
`3.
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`Table of Contents
`(continued)
`
`C.
`
`Page
`Explanation of Ground 3 .................................................................. 136
`1.
`In the alternative, Claims 1 to 24 are Indefinite based
`upon the use of the subjective terms “palatable” and
`“stable” and the use of “consisting essential of” without
`providing direction on ingredients that materially affect
`the basic and novel aspect of the invention ........................... 136
`CONCLUSION ........................................................................................ 140
`SUPPLEMENTATION ......................................................................... 141
`
`X.
`XI.
`
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`Case PGR2023-00051
`U.S. Patent No. 11,617,795
`Michael M. Crowley Declaration
`
`I.
`
`INTRODUCTION
`1.
`I, Michael M. Crowley, have been retained by Mayer Brown LLP on
`
`
`
`behalf of KinderFarms LLC (“KinderFarms” or “Petitioner”) as a technical expert
`
`in this proceeding. I understand that KinderFarms has petitioned for post-grant
`
`review of U.S. Patent No. 11,617,795 (“the’795 Patent”) and requested that the
`
`United States Patent and Trademark Office (“USPTO”) cancel claims 1 to 24 of
`
`the ’795 Patent as unpatentable. The following discussion and analysis address the
`
`basis of KinderFarms’s petition.
`
`A.
`2.
`
`Summary of Opinions
`In my opinion, French Patent Publication No. 2,993,458 (“FR458”),
`
`when combined with U.S. Patent No. 4,684,666 (“the ’4666 Patent”) and/or WO
`
`95/00133 (“WO133”), teaches all of the limitations of claims 1-24 of the’795 Patent.
`
`FR458 teaches liquid pharmaceutical formulations for oral administration that
`
`contain, at a minimum, an API (e.g. acetaminophen), a diluent and certified organic
`
`agave syrup. WO133 teaches taste-masked acetaminophen suspensions for oral
`
`administration with viscosities that range from 200 to 900 centipoise. The ‘4666
`
`Patent teaches stabilized liquid analgesic compositions with viscosities that range
`
`from 100 to 3000 centipoise. These prior art references address palatable liquid
`
`pharmaceutical compositions for oral administration that contain bitter-tasting APIs
`
`1
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`Case PGR2023-00051
`U.S. Patent No. 11,617,795
`Michael M. Crowley Declaration
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`like acetaminophen and ibuprofen. As described below, a person of ordinary skill
`
`
`
`in the art (“POSITA”) would have understood that these references teach each
`
`limitation of the claims 1-24 of the ’795 Patent. Moreover, a POSITA would have
`
`been motivated to combine these references with a reasonable expectation of success
`
`because they all: (1) pertain to the same field of art, (2) disclose orally administrable
`
`liquid compositions comprising analgesics and (3) seek to address similar problems
`
`by similar means.
`
`3.
`
`In my opinion, WO 2012/018742A2 (“WO742”), combined with U.S.
`
`Patent No. 4,684,666 (“the ‘4666 Patent”) and/or WO 95/00133 (“WO133”), teaches
`
`all of the limitations of claims 1-17 of the ’795 Patent. WO742 teaches orally
`
`administered antitussive compositions that contain acetaminophen and agave nectar.
`
`As described below, a person of ordinary skill in the art (“POSITA”) would have
`
`understood that these references teach each limitation of claims 1-17 of the ’795
`
`Patent. Moreover, a POSITA would have been motivated to combine these
`
`references with a reasonable expectation of success because they all: (1) pertain to
`
`the same field of art, (2) disclose orally administrable liquid compositions that can
`
`comprise analgesics and (3) seek to address similar problems by similar means.
`
`2
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`Case PGR2023-00051
`U.S. Patent No. 11,617,795
`Michael M. Crowley Declaration
`
`
`
`
`B.
`4.
`
`Background and Qualifications
`I have over 30 years of experience in the pharmaceutical product
`
`development field, including hands-on industry experience and consulting
`
`experience. To date, I have developed or consulted on the development of upwards
`
`of 50 drug product formulations that have been manufactured under Good
`
`Manufacturing Practices (“GMP”) and tested in human clinical studies. My full
`
`curriculum vitae is attached as Appendix A to this report.
`
`5.
`
`I am currently the president of Theridian Technologies, LLC, a
`
`pharmaceutical consulting firm established in 2009. In this role, I have provided drug
`
`product development consulting services to more than 60 companies, mostly in the
`
`pharmaceutical industry. Much of my consulting work is focused on formulation
`
`development, particularly as it relates to utilization of different excipients, drug
`
`release and formulation science.
`
`6.
`
`Since 2020, I have also held a position as an Adjunct Professor of
`
`Molecular Pharmaceutics and Drug Delivery in the College of Pharmacy at the
`
`University of Texas at Austin. I teach undergraduate and graduate students in the
`
`Molecular Pharmaceutics and Drug Delivery Division a number of courses,
`
`including “Product Development,” “Advanced Manufacturing Pharmacy” and
`
`“Advanced Pharmaceutical Processing.”
`
`3
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`Michael M. Crowley Declaration
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`7.
`
`In 2015, I co-founded Oticara, Inc. (“Oticara”), a specialty
`
`pharmaceutical company dedicated to developing novel drug products for the
`
`treatment of infectious diseases. I currently serve as a formulation development
`
`consultant for Oticara. I have also served on the Board of Directors of NanoPore
`
`Therapeutics, Inc., a startup company developing novel technologies for drug
`
`delivery, since 2020.
`
`8.
`
`From 2003 to 2009, I was an owner (member) and employee at
`
`PharmaForm LLC (“PharmaForm”), a contract research organization providing
`
`formulation and drug product development services. As a PharmForm employee, I
`
`managed multiple customer-oriented drug product development projects from the
`
`pre-formulation stage all the way through to commercial production. These drug
`
`products included liquid and semi-solid formulations of small and large molecular
`
`weight compounds, including syrups and suspensions, and solid oral, transdermal
`
`and trans-mucosal dosage forms. One drug product of particular relevance that I
`
`helped to develop at PharmaForm was a generic liquid acetaminophen product for
`
`oral administration to children. During my time at PharmaForm, I also held different
`
`executive roles,
`
`including Vice President, Drug Delivery Technology &
`
`Manufacturing.
`
`4
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`Case PGR2023-00051
`U.S. Patent No. 11,617,795
`Michael M. Crowley Declaration
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`9.
`
`From 1995 to 2000, I worked in research and development at Mission
`
`Pharmacal Company (“Mission Pharmacal”), a privately held pharmaceutical
`
`company based in San Antonio, Texas. Mission Pharmacal develops branded and
`
`generic pharmaceutical products, and provides contract development and
`
`manufacturing services to pharmaceutical companies. During my time at Mission
`
`Pharmacal, I was responsible for product and process development of both
`
`nutritional supplements and drug products, in oral and topical dosage forms.
`
`10. From 1992 to 1995, I worked as a chemist developing pharmaceutical
`
`formulations at Warner-Jenkinson Company, in St. Louis, Missouri. In this role, I
`
`managed pharmaceutical projects involving the application of excipients in
`
`connection with various pharmaceutical dosage forms, including solutions,
`
`suspensions, tablets and pellets. Some of these dosage forms were for oral
`
`administration.
`
`11. From 1988 to 1989, I was employed as a formulations chemistry
`
`research analyst at Monsanto Company, in St. Louis, Missouri. I was responsible for
`
`the generation of data using many different analytical methods, including
`
`viscometry. I also provided training on various analytical methods and equipment
`
`operations to other analysts, and assisted them with troubleshooting.
`
`5
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`Case PGR2023-00051
`U.S. Patent No. 11,617,795
`Michael M. Crowley Declaration
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`12.
`
`I earned a B.S. in chemistry from the University of Missouri – St. Louis
`
`in 1990, an M.A. in organic chemistry from Washington University in St. Louis in
`
`1991 and a Ph.D. in molecular pharmaceutics from the University of Texas in 2003.
`
`13. My current research, carried out in connection with my positions at
`
`Theridian Technologies and Oticara, focuses on the formulation, development,
`
`optimization and delivery of small organic compounds, peptides and proteins by a
`
`variety of technologies, including hot melt extrusion and thermal processing
`
`techniques, spray drying, depot drug delivery, pulmonary drug delivery, implantable
`
`drug delivery, abuse deterrent delivery and oral drug delivery.
`
`14.
`
`I have authored or co-authored over 30 peer-reviewed published
`
`articles and abstracts relating to the pharmaceutical sciences, several of which
`
`concern formulation techniques and excipients. I have authored four book chapters,
`
`including two titled “Solution, Emulsions, Suspensions, and Extracts,” which were
`
`published in the 2005 and 2012 editions of Remington: The Science and Practice of
`
`Pharmacy. With more than 20 published editions, Remington has been a definitive
`
`textbook and reference work on pharmaceutical sciences in the U.S. for over 100
`
`years. I have also authored or co-authored over 15 clinical study protocols, including
`
`the pharmacy manuals.
`
`6
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`U.S. Patent No. 11,617,795
`Michael M. Crowley Declaration
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`15.
`
`I am a named inventor on five issued U.S. patents and on several
`
`pending US and international patent applications.
`
`16.
`
`I have served as a reviewer for many peer-reviewed journals, including
`
`the Journal of Pharmaceutical Sciences, Drug Development and Industrial
`
`Pharmacy, European Journal of Pharmaceutics and Biopharmaceutics, Journal of
`
`Pharmacy and Pharmacology, European Journal of Pharmaceutical Sciences,
`
`Pharmaceutical Research, International Journal of Pharmaceutics, Journal of
`
`Microencapsulation, S.T.P. Pharma Sciences
`
`(France), Pharmaceutical
`
`Development and Technology, Journal of Controlled Research and AAPS
`
`PharmSciTech.
`
`17. Based on my background and extensive professional involvement with
`
`pharmaceutical product development, I believe that I qualify as an expert in the field
`
`of pharmaceutical
`
`sciences,
`
`including
`
`formulation chemistry, molecular
`
`pharmaceutics and drug delivery.
`
`C.
`18.
`
`Previous Testimony and Compensation
`In the last four years, I have provided testimony through declarations
`
`and/or at depositions in seven proceedings. The information concerning these seven
`
`proceedings is summarized in Appendix B.
`
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`Michael M. Crowley Declaration
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`19.
`
`I am being compensated at a rate of $700 USD per hour, plus expenses,
`
`for work associated with this matter. I receive no other form of compensation related
`
`to this case. My compensation is in no way related to the outcome of this case.
`
`D. Materials Considered
`20. This Declaration sets forth the opinions that I have formed related to
`
`the ’795 Patent, which are based on my personal knowledge, education, research,
`
`experience (personal and professional) and any information that I have reviewed as
`
`of the date of this Declaration.
`
`21. Appendix C is a full listing of the documents that I have reviewed and
`
`relied upon in forming my opinions in connection with providing this declaration. It
`
`includes, among others, the ’795 Patent, the prosecution history of the ’795 Patent
`
`and the prior art that I identified in this declaration.
`
`22. My analysis of the information relevant to this proceeding is ongoing.
`
`I expect to continue reviewing information as it is presented to me, and it is possible
`
`that new information may affect certain conclusions in my declaration. I therefore
`
`reserve the right to supplement this declaration.
`
`II. THE ’795 PATENT
`23.
`I have reviewed the ’795 Patent and portions of its prosecution history.
`
`Ex. 1001; Ex. 1002. I understand that the ’795 Patent issued from U.S. Patent
`
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`Case PGR2023-00051
`U.S. Patent No. 11,617,795
`Michael M. Crowley Declaration
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`Application No. 17/817,637 (the ’637 Application). I understand that the ’637
`
`
`
`Application is related to several other patent applications that all claim priority to
`
`Provisional Application No. 62/580,648, filed on November 2, 2017. Based upon
`
`my analysis provided in Section II.C below, it is my opinion that the earliest priority
`
`date that the ’795 Patent can claim is June 8, 2021. As the publications that I discuss
`
`in this declaration generally pre-date November 2, 2017, and a person of ordinary
`
`skill in the art’s understanding would not have been different in 2021 as compared
`
`to 2017, if the Board concludes that the ’795 Patent can claim priority to November
`
`2, 2017, my opinions would be the same.
`
`A. The Disclosure of the ‘795 Patent
`24. The ’795 Patent generally relates to a stable pharmaceutical syrup
`
`formulation or suspension for oral administration having one or more
`
`pharmaceutical active agent, agave syrup and a dilutant. Ex. 1001, at 1:31-34.1 The
`
`abstract of the ’795 Patent further states that “[t]he formulation or suspension has
`
`viscosity suitable for drinking.” Id., abstract. According to the “Technical Field”
`
`section, the ’795 Patent also relates to “aqueous suspensions and formulations” and
`
`
`1 This citation references to column:line-line. To the extent that a citation
`encompasses multiple columns it will be cited as column:line-column:line.
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`to “a pharmaceutical suspension composed of pharmaceutical active agents,
`
`
`
`suspension agents, sweetening agents and flavoring agents.” Id., at 1:6-9.
`
`25. The ’795 Patent begins by stating that it is desirable to provide drugs in
`
`a chewable solid form or in a liquid form/syrup to children and older persons because
`
`such persons can have problems swallowing tablets and capsules. Id., at 1: 12-14.
`
`The ’795 Patent acknowledges that syrups are well suited for children and that
`
`parents often prefer to give syrups to sick children below the age of 12 years because
`
`the dose, which is in volumes, can be tailored to a child’s weight, and the syrup can
`
`be flavored, which improves intake and compliance by children. Id., at 1: 15-20.
`
`According to the ’795 Patent, the problem with administering liquids that contain
`
`analgesic, antihistamine and dieuretic active pharmaceutical agents is that “[they]
`
`taste terrible and pharmaceutical chemists have turned to unnatural and artificial
`
`ingredients to mask the taste.” Id., at 1:20-24. Additionally, the ’795 Patent contends
`
`that “[n]o liquid medium, primarily of natural ingredients, containing this
`
`combination of active agents are available.” Id., at 1:24-26. Although not stated, it
`
`appears that the ’795 Patent seeks to address this issue by creating an “improved
`
`pharmaceutical suspension or syrup formulation.”2 Id., at 1:27-28.
`
`
`2 As I explain in the “Prior Art Relied Upon” section of my report, others had
`addressed this issue years before the ’795 Patent. See, Section IV.A.
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`Michael M. Crowley Declaration
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`26. The pharmaceutical formulations disclosed in the ’795 Patent are
`
`
`
`stable, syrups or suspensions for oral administration having, at a minimum, one or
`
`more pharmaceutical active agents, agave syrup and a dilutant. Id., 1:31-34; 2:1-4.
`
`The formulations of the ‘795 Patent may also optionally include an acidic
`
`preservative (id., at 1:36-39; 2:4-6), a flavoring or masking agent (id., 1:36-39; 2:4-
`
`6), buffers (id., at 3:1-7), wetting agents (id., at 4:24-35) and, though generally not
`
`preferred, coloring agents (id., 4: 35-41).
`
`27. The ’795 Patent discloses “a pharmaceutical suspension or syrup
`
`formulation that can be used with various active pharmaceutical agents.” Id., at 1:66
`
`-2:1. Pharmaceutical active agents suitable for use in the formulations of the ’795
`
`Patent include, but are not limited to, acetaminophen, ibuprofen, famotidine,
`
`pseudoephedrine, hydrochloride, chlorpheniramine, maleate, dextromethorphan
`
`hydrobromide,
`
`guaifenesin,
`
`diphenhydramine
`
`hydrochloride,
`
`loperamide
`
`hydrochloride and simethicone and suitable combinations thereof. Id., at 1:55-62;
`
`3:26-43. The ’795 Patent discloses suspensions and syrups that include active
`
`pharmaceutical agents in amounts between 0.01 to 4 w/w%, or between 0.01 to 5
`
`grams per 100 mL. Id., at 3: 8-19. The ’795 Patent notes that the amount of the
`
`pharmaceutical active agent in the suspension should be enough to provide a
`
`therapeutic amount and a convenient dosage unit. A person skilled in the art would
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`have also known, or would have been able to discern, the amount that would be
`
`
`
`needed, depending on the active pharmaceutical agent in question. Id., at 2:40-45,
`
`3:10-19.
`
`28. The terms “agave syrup” and “syrup” are defined in the ’795 Patent as
`
`“a processed juice obtained from the agave sp. Plant” and “a formulation that has a
`
`flow without applied pressure and is sticky or tacky to the touch,” respectively. Id.,
`
`at 2:6-11. The ’795 Patent discloses embodiments where the pharmaceutical
`
`suspension or syrup formulation includes between 50 to 98% w/w, between 65 to
`
`98% w/w, or between 75 to 95% w/w/ of agave syrup. Id., at 2:40-57. The
`
`significance of the disclosed agave syrup concentration ranges is not described, but
`
`the ’795 Patent does indicate that agave syrup may be included in the formulation as
`
`a sweetener. Id., at 4:17-21. As I discuss further in section III.B.2, at the relevant
`
`time, agave syrup was a known sweetener that was included in food products and
`
`medicine in amounts ranging from 2-98%. The ’795 Patent further indicates that “the
`
`syrup can have a viscosity of the type used with pharmaceutical suspensions or syrup
`
`formulations, including a viscosity of about 200 and 3500 centipoise (cP) at about
`
`2.5 rpm to about 30 rpm, as determined by a Brookfield viscometer at about 22
`
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` KINDERFARMS Ex. 1003
` KINDERFARMS LLC. v. GENEXA INC.
` PGR2023-00051
`
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`Page 16 of 242
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`

`

`Case PGR2023-00051
`U.S. Patent No. 11,617,795
`Michael M. Crowley Declaration
`
`degrees.” Id., at 2: 12-16.3 The ’795 Patent contemplates other viscosities for the
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`syrup, including a viscosity of less than 2,000 cP; less than 1,700 cP; less than 1,500
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`cP; about 1,500 cP; less than 1,000 cP; less than 750 cP; less than 600 cP; or less
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`than 500 cP. Id., at 2:17-27. The ’795 Patent does not explain the importance of these
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`viscosity ranges, but in my experience, they are all typical for orally administered
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`liquids (i.e., solutions, syrups and elixirs) that are pourable and drinkable. Notably,
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`the ’795 Patent does not report the viscosity of the formulations described in
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`Examples 1 and 2.
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`29. With regard to the amount of water or dilutant in the suspension or
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`syrup, the ’795 Patent indicates that the amount may be reduced to optimize the
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`formulation. Id., at 2: 57-60. For example, the ’795 Patent mentions using the
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`minimum amount of water (or diluent) needed to hydrate the agave syrup and to
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`impart the desired degree of viscosity. Id., at 3:20-24; 4:14-18. The ’795 Patent also
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`discloses a method of making the pharmaceutical syrup formulations of the
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`3 I note that the ’795 Patent provides minimal methodological information about
`how the viscosity of formulations of the invention are to be measured using a
`Brookfield viscometer. The range of rpms provided by the ‘795 Patent is very
`broad (2.5 rpm to 30 rpm). Additionally, there is no mention of the spindle size
`that is to be used, nor is there any discussion regarding whether the measurements
`should be taken at a single shear rate or multiple shear rates. The viscosity results
`from the Brookfield viscometer will be influenced by the methodology selected by
`the POSITA.
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`13
`
` KINDERFARMS Ex. 1003
` KINDERFARMS LLC. v. GENEXA INC.
` PGR2023-00051
`
`
`Page 17 of 242
`
`

`

`Case PGR2023-00051
`U.S. Patent No. 11,617,795
`Michael M. Crowley Declaration
`
`invention that involves adding an amount of one or more pharmaceutical active
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`agents to pre-warmed agave, stirring the contents until they are mixed and adding
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`the diluent to achieve a desired viscosity of less than 1,500 cP, 1,000 cP, 600 cP or
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`400 cP. Id., 4:42-53.
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`30. One aspect of the ’795 Patent includes a pharmaceutical suspension that
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`can enhance the taste masking of unpalatable pharmaceutical active agents with
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`generally natural ingredients. Id., at 1:42-44. In some embodiments, clean inactive
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`ingredients that are gluten-free, non-GMO and certified vegan are included in the
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`formulations. In other embodiments, “unnatural” ingredients, such as aspartame,
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`carbomer, EDTA, gelatin, milk, parabens, polyethylene glycol and titanium dioxide,
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`are excluded. Id., at 1: 44-50; 2:28-39. The patent notes that certain embodiments
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`can be designed to provide pharmaceutical suspensions made with the same active
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`ingredients needed for a treatment, but without the artificial ingredients. Id., at 2:36-
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`39. The ’795 Patent does, however, state that artificial flav