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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`INARI AGRICULTURE, INC.,
`Petitioner,
`
`v.
`
`PIONEER HI-BRED INTERNATIONAL, INC.,
`Patent Owner.
`_____________
`
`Case No. PGR2024-00023
`Patent No. 11,696,545
`_____________
`
`DECLARATION OF RAYMOND D. RILEY, PH.D.
`
`
`
`Inari Exhibit 1003
`Inari v. Pioneer
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`TABLE OF CONTENTS
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`INTRODUCTION ............................................................................................. 1
`I.
`II. BACKGROUND AND QUALIFICATIONS ................................................... 2
`A. Academic Training ...................................................................................... 2
`B. Selected Professional Experience ................................................................ 3
`C. Patents .......................................................................................................... 6
`III. LEVEL OF ORDINARY SKILL IN THE ART ............................................... 7
`IV. MATERIALS CONSIDERED AND RELIED UPON ................................... 10
`V. LEGAL STANDARDS ................................................................................... 10
`A. Obviousness ............................................................................................... 10
`B. Claim Construction .................................................................................... 16
`C. Utility ......................................................................................................... 16
`D. Written Description ................................................................................... 18
`E. Enablement ................................................................................................ 19
`VI. DESCRIPTION OF THE RELEVANT FIELD AND TIMEFRAME ........... 22
`VII. OVERVIEW OF THE ’545 PATENT ............................................................ 22
`A. Subject Matter of the ’545 Patent .............................................................. 22
`VIII. TECHNICAL BACKGROUND AND STATE OF THE ART ...................... 26
`IX. GROUNDS 1-3: CLAIMS 1-20 ARE UNPATENTABLE AS
`OBVIOUS OVER THE PRIOR ART ............................................................. 29
`A. Graham Factor Analysis Relevant to Grounds 1-3 ................................... 30
`1. Scope and Content of the Prior Art ..................................................... 30
`2. Differences Between the Prior Art and the Claimed Invention .......... 45
`3. Level of Ordinary Skill in the Art ....................................................... 76
`4. Secondary Considerations ................................................................... 84
`B. Ground 1: Claims 1-20 Are Unpatentable as Obvious Over Smalley
`(EX1005) and the Corresponding PVPA Certificate (EX1008) ............... 85
`1. Claim 1: Variety PH4CYJ ................................................................... 87
`2. Claims 2-20: Variations and Hybrids Related to PH4CYJ ................. 92
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`a. Claim 2: Ovule or Pollen From the Inbred Line of Claim 1 ....... 95
`b. Claims 3-8: Hybrids and Related Uses Derived From
`1PFHC43 ..................................................................................... 95
`c. Claim 9: Nucleic Acids Isolated From PH4CYJ ........................ 99
`d. Claims 10-17: Converted Seeds of PH4CYJ ............................ 100
`e. Claims 18-20: F1 Hybrid Derived From Variety PH4CYJ
`with a Transgene ....................................................................... 103
`C. Ground 2: Claims 1-20 Are Unpatentable as Obvious Over Benson
`(EX1006) .................................................................................................104
`1. Claim 1 ..............................................................................................106
`2. Claims 2-20 .......................................................................................108
`D. Ground 3: Claims 1-20 Are Unpatentable As Obvious Over
`Longenberger (EX1007) ..........................................................................114
`1. Claim 1 ..............................................................................................116
`2. Claims 2-20 .......................................................................................119
`X. GROUND 4: CLAIMS 1-20 LACK SPECIFIC UTILITY ...........................123
`A. Analysis of Patents at Issue in J.E.M. Ag Supply ....................................128
`XI. GROUNDS 5-6: THE ’545 PATENT FAILS TO STAISFY SECTION
`112..................................................................................................................151
`A. The Minimal Differences Between the ’545 Patent’s Specification
`and the Prior Art Are At Best Consistent with the Disclosures
`Required for PVP Certificates .................................................................151
`B. The Minimal Differences Between the ’545 Patent’s Specification
`and the Prior Art Do Not Adequately Describe or Enable Claims 1-
`20 154
`1. Lack of Written Description ..............................................................158
`2. Lack of Enablement...........................................................................158
`C. The Minimal Differences Between the ’545 Patent’s Specification
`and the Prior Art Stand in Contrast to PO’s Earlier Plant Utility
`Patents the Supreme Court Considered in J.E.M. ...................................159
`1. Unlike the ’545 Patent, PO’s Earlier Patents Had Highly
`Customized Specifications Highlighting Distinctive Properties
`of the Claimed Inbred Lines ..............................................................159
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`2. Unlike the ’545 Patent, PO’s Earlier Patents Had Narrower
`Claims Specifically Linked to PO’s Deposits and/or “All”
`Disclosed Characteristics of the New Varieties ................................161
`XII. CONCLUSION ..............................................................................................163
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`I, Raymond D. Riley, Ph.D., hereby declare under penalty of perjury:
`
`I.
`
`INTRODUCTION
`1. My name is Raymond D. Riley, and I have been retained by counsel
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`for Petitioner Inari Agriculture, Inc. (“Inari” or “Petitioner”) as an expert witness
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`to provide analysis regarding U.S. Patent No. 11,696,545 (the “’545 Patent”),
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`which I understand has been designated as EX1001. Specifically, I have been
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`asked to consider the validity of claims 1-20 of the ’545 Patent (the “Challenged
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`Claims”) in view of prior art, the non-obviousness and utility requirements, and the
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`understanding of a person of ordinary skill in the art at the time of the invention as
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`it relates to the ’545 Patent. I have personal knowledge of the facts and opinions
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`set forth in this declaration and believe them to be true. If called upon to do so, I
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`would testify competently thereto.
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`2.
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`I am being compensated for my time at my standard consulting rate. I
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`am also being reimbursed for expenses that I incur during the course of this work.
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`My compensation is not contingent upon the results of my study, the substance of
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`my expert opinions, or the outcome of any proceeding involving the challenged
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`claims. I have no financial interest in the outcome of this matter or on the pending
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`litigation between Petitioner and Patent Owner. My analysis here is based on my
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`years of education, research, and experience, as well as my investigation and study
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`of relevant materials, including those cited herein.
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`3.
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`I may rely upon these materials, my knowledge and experience,
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`and/or additional materials to rebut arguments raised by the Patent Owner.
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`Further, I may also consider additional documents and information in forming any
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`necessary opinions, including documents that may not yet have been provided to
`
`me.
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`4. My analysis of the materials produced in this proceeding is ongoing
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`and I will continue to review any new material as it is provided. This declaration
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`represents only those opinions I have formed to date. I reserve the right to revise,
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`supplement, and/or amend my expert opinions stated herein based on new
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`information and on my continuing analysis of the materials already provided.
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`II. BACKGROUND AND QUALIFICATIONS
`5.
`I am an expert in the field of plant breeding and genetics. I have
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`studied, taught, practiced, and researched in this field for over 45 years. I have
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`summarized in this section my educational background, work experience, and
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`other relevant qualifications. My curriculum vitae, which I understand has been
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`designated EX1004, describes my background and experience.
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`A. Academic Training
`6.
`I earned my Bachelor of Science degree in Soil & Crop Science with a
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`second major in Agribusiness Management from the University of Wisconsin –
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`Platteville in 1977. I earned a Master of Science degree in Plant Breeding and
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`Genetics from the University of Nebraska in 1980. In 1981, I earned a Doctor of
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`Philosophy degree, in Plant Breeding and Genetics with a minor in Organization
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`Behavior and Performance, also from the University of Nebraska. My dissertation
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`entitled “Heritability of Mature Plant Traits in Sand Bluestem,” was directed to
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`studies on inheritance of certain agronomically important traits in sand bluestem, a
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`perennial tall-grass native to the Great Plains.
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`B.
`7.
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`Selected Professional Experience
`After completing my Doctor of Philosophy degree, I worked at
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`Pioneer Hi-Bred International, Inc. (“PHI”), beginning in 1981. From 1981 to
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`1990, I was a research program manager and corn breeder. I was responsible for
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`management of an integrated research program directed toward development of
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`commercial corn. I was also responsible for commercial research interactions to
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`effectively focus research efforts, communicate research results and enhance
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`commercial success.
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`8.
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`In that role, I developed several inbred and hybrids of commercial and
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`germplasm significance. I was the co-inventor of a patent (U.S. Patent No.
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`5,491,295) for corn hybrid 3394, which at one point was the largest selling corn
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`hybrid. PHI has stated that hybrid 3394 “became so dominant by the mid-90s that,
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`by itself, it outsold the entire hybrid lineups of all competitor seed companies.”
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`EX1019, “A Brief History of Corn – From Domestication to 1995,” PHI (Dec. 19,
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`2022), https://www.pioneer.com/us/agronomy/domestication-of-corn.html.
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`9.
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`From 1991 to 2000, I was a research director for PHI and, after
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`DuPont’s acquisition of PHI in October 1999, for DuPont. I was initially the
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`research commercial liaison and director of corn breeding and product
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`development efforts for Africa/Middle East/Pacific Rim. Later, I was responsible
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`for North Central Corn-Belt corn product development. Later still, I was
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`responsible for product characterization and commercialization (PCC) of corn for
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`South America, Africa, Middle East, Asia and China. Each of these roles
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`involved, among other things, working with or directing the activities of teams
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`breeding and/or developing new inbred and hybrid corn varieties.
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`10.
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`I then moved to Syngenta Seeds, where I worked from 2000 to 2015.
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`From 2000 to 2003, I was Syngenta’s Global Corn Seed Production Head based in
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`Toulouse, France. From 2003 to 2004, I was the Global Head of Field Crops
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`Research and Development. In these roles, I again worked directly with and/or
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`directed the activities of teams breeding varieties of corn and other crops.
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`11. From 2004 to 2010, I was the head of NAFTA corn and soybean seeds
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`research and development, based in Minnetonka, Minnesota. In that role, I
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`developed a high-performance corn and soybean research and development team
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`that has repositioned Syngenta’s corn and soybean product offerings to be among
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`the best in the industry.
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`12. From 2010 to 2011, I was the global head, corn seeds research and
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`development. In that role, I represented seeds research and development in the
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`establishment of a global corn seeds strategy and managed Syngenta’s global corn
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`breeding and trait development portfolio.
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`13. From 2011 to 2014, I was the global head of germplasm technology.
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`In that role, I led the establishment of a global cross crop plant breeding technical
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`excellence program for application of breeding, statistical and emerging molecular
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`biology technologies. I also established the “Syngenta Plant Breeding Academy”
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`to enable ongoing state of the art skill development and networking of Syngenta
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`scientists and our key collaborators.
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`14. From 2013 to 2014, I was the head of Traits Research, leading traits
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`research teams responsible for GM (genetically modified) and non-GM traits for
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`insect and disease resistance, yield, and stress tolerance. From 2014 to 2015, I was
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`the Head of Computational Biology. In that role I established an integrated
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`Computational Biology team to support Syngenta’s research and development
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`efforts spanning breeding, trait development (GM and Native) and chemistry.
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`15. From 2015 to 2018, I was the Senior Vice President of Product
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`Development at Indigo Ag Inc. At Indigo, I led teams and projects focused on
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`product development of microbiome-based crop production enhancing products.
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`16. Since 2018, I have worked as a consultant to a range of Ag Tech
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`startups in areas spanning crop genetics, AI assisted breeding, gene editing, seed
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`business strategy, biotech, microbial seed treatments, soil carbon sequestration and
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`environmentally sustainable practices. Beginning in 2020 to present, I have also
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`served as a member of the global Loam Bio Management Team at Loam Bio LLC,
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`with a focus on research and development. Loam Bio develops programs to
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`remove carbon from the atmosphere and store it in the soil, improving agricultural
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`productivity.
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`17. As a leader of corn breeding teams and programs, it was my
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`responsibility to ensure that investments in this area were delivering utility and
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`supporting the commercial success of the company I was employed with, as well
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`as the customers who utilized the developed product.
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`C.
`18.
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`Patents
`I am the inventor or a co-inventor of a number of patents in corn
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`breeding and related fields including:
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`a.
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`U.S. Patent No. 5,159,133 (EX1092) entitled “Inbred Corn Line
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`PHV37;”
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`b.
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`U.S. Patent No. 5,491,295 (EX1080) entitled “Hybrid Corn Plant and
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`Seed;”
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`c.
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`U.S. Patent No. 10,624,351 entitled “Modulated Nutritional Quality
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`Traits in Seeds” (related patents: US 11,178,876; US 11,766,045);
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`d.
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`U.S. Patent No. 10,640,783 entitled “Endophyte Compositions and
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`Methods of Improvement of Plant Traits” (related patents: US
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`11,516,989); and
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`e.
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`U.S. Patent No. 10,645,938 entitled “Endophyte Composition and the
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`Methods for Improvement of Plant Traits.”
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`III. LEVEL OF ORDINARY SKILL IN THE ART
`19.
`In rendering the opinions set forth in this declaration, I was asked to
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`consider the patent claims and the prior art through the eyes of one of ordinary skill
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`at the time of the claimed invention, which I understand to be July 2, 2021—the
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`filing date of the application that issued as the ’545 Patent, and the earliest priority
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`date to which the claims of the issued patent are entitled. I understand that the
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`factors considered in determining the ordinary level of skill in a field of art include
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`the level of education and experience of persons working in the field; the types of
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`problems encountered in the field; the teachings of the prior art, and the
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`sophistication of the technology at the time of the claimed invention. I understand
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`that one of ordinary skill is not a specific real individual, but rather is a
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`hypothetical individual having the qualities reflected by the factors above. I
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`understand that one of ordinary skill would also have knowledge from the
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`teachings of the prior art, including the art cited below.
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`20. Taking these factors into consideration, on or before July 2, 2021, one
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`of ordinary skill relating to the technology of the ’545 Patent would have had a
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`high level of skill. In particular, a POSA would have had a doctoral degree in
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`plant breeding or a related field, at least five years of experience with corn
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`breeding, and additional experience interfacing with laboratory-side personnel
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`(including a computational biologist along with genetics specialists) as well as
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`field-side personnel. Alternatively, additional experience could take the place of
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`an advanced degree.
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`21.
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`It has long been expected that substantial academic preparation was
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`important to work as a corn breeder. For example, in a widely cited 1991 text
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`entitled Principles of Cultivar Development, Walter Fehr described the academic
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`experience expected for a plant breeder in terms that also applied in 2021:
`
`To be capable of planning and conducting an effective plant breeding
`research program, a person needs an appropriate undergraduate and
`graduate education. The education includes a mixture of formal
`courses, independent research experience in working with an active
`research program, and informal interaction with students and faculty.
`Academic courses include plant breeding and those disciplines that
`contribute to cultivar development. Independent research gives
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`experience in planning, conducting, and interpreting experiments.
`Participation in an active research program is a means of obtaining
`practical experience with breeding techniques and methods. Informal
`interaction with students and faculty provides the opportunity to
`evaluate new ideas and concepts.
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`EX1016, Fehr, 8 (internal citation omitted). Indeed, the amount of education and
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`experience required to run a successful breeding program has only increased over
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`the years, especially as genetics, genomics, data science, and computational
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`techniques have become increasingly important to breeding programs. In addition,
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`an important aspect of the breeder’s role is the ability to use breeding skills to create
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`value for the company and enable business and customer (i.e., farmer) success.
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`22. Before July 2, 2021, my level of skill in the art was at least that of one
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`of ordinary skill. I am very familiar with the experience and knowledge of a
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`POSA as of 2021. I held comparable positions to a POSA in the 1980s-90s. More
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`recently, I have held positions in which I directed and/or worked with people who
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`would be considered POSAs, including in leadership roles at PHI and Syngenta
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`and in consulting roles. I am qualified to provide opinions concerning what one of
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`ordinary skill would have known and understood at that time, and my analysis and
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`conclusions herein are from the perspective of one of ordinary skill as of that date.
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`IV. MATERIALS CONSIDERED AND RELIED UPON
`23.
`In reaching the conclusions described in this declaration, I have relied
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`on the ’545 Patent, the prior art, and other documents and materials cited herein.
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`For ease of reference, the full list of documents that I have considered is included
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`in Appendix A.
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`24. These materials comprise patents, related documents, and printed
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`publications. Each of these materials is a type of document that experts in my field
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`would have reasonably relied upon when forming their opinions.
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`25.
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`I have also relied on my education, training, research, knowledge, and
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`personal and professional experience in the relevant technologies and systems that
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`were already in use prior to, and within the timeframe of the earliest priority date
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`of the claimed subject matter in the ’545 Patent, which is July 2, 2021.
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`V. LEGAL STANDARDS
`26.
`I am not a lawyer and do not provide any legal opinions, but I have
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`been advised that certain legal standards are to be applied by technical experts in
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`forming opinions regarding meaning and validity of patent claims. I have applied
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`the legal standards described below, which were provided to me by counsel for
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`Petitioner.
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`A. Obviousness
`27.
`I have been informed that a claim may be unpatentable under 35
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`U.S.C. § 103(a) if the subject matter described by the claim as a whole would have
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`been obvious in view of a prior art reference or in view of a combination of
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`references at the time the alleged invention was made. I have been informed that
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`obviousness is determined from the perspective of a hypothetical person of
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`ordinary skill in the art (“POSA” or “person of ordinary skill”) and that the
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`challenged claims of the patent should be read from the point of view of such a
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`person at the time the alleged invention was made. I have been informed that a
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`hypothetical person of ordinary skill is assumed to know and to have all relevant
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`prior art in the field of endeavor covered by the patent in suit, and would thus have
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`been familiar with each of the references cited herein, as well as the background
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`knowledge in the art, and the full range of teachings they contain.
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`28.
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`I have been informed that there are two criteria for determining
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`whether prior art is analogous and thus can be considered prior art: (1) whether the
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`art is from the same field of endeavor, regardless of the problem addressed, and (2)
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`if the reference is not within the field of the patentee’s endeavor, whether the
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`reference still is reasonably pertinent to the particular problem with which the
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`patentee is involved. I have also been informed that the field of endeavor of a
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`patent is not limited to the specific point of novelty, the narrowest possible
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`conception of the field, or the particular focus within a given field. I have also
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`been informed that a reference is reasonably pertinent if, even though it may be in
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`a different field from that of the patentee’s endeavor, it is one which, because of
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`the matter with which it deals, logically would have commended itself to a
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`patentee’s attention in considering the problem.
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`29.
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`I have also been informed that an analysis of whether an alleged
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`invention would have been obvious should be considered in light of the scope and
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`content of the prior art, the differences (if any) between the prior art and the
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`alleged invention, and the level of ordinary skill in the pertinent art involved. I
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`have been informed as well that a prior art reference should be viewed as a whole.
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`30.
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`I have also been informed that in considering whether an invention for
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`a claimed combination would have been obvious, I may assess whether there are
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`apparent reasons to combine known elements in the prior art in the manner claimed
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`in view of interrelated teachings of multiple prior art references, the effects of
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`demands known to the design community or present in the market place, and/or the
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`background knowledge possessed by a person of ordinary skill. I have been
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`informed that other principles may be relied on in evaluating whether an alleged
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`invention would have been obvious, and that these principles include the
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`following:
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` A combination of familiar elements according to known methods is likely
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`to be obvious when it does no more than yield predictable results;
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` When a device or technology is available in one field of endeavor, design
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`incentives and other market forces can prompt variations of it, either in
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`the same field or in a different one, so that if a person of ordinary skill
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`can implement a predictable variation, the variation is likely obvious;
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` If a technique has been used to improve one device, and a person of
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`ordinary skill would recognize that it would improve similar devices in
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`the same way, using the technique is obvious unless its actual application
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`is beyond his or her skill;
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` An explicit or implicit teaching, suggestion, or motivation to combine
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`two prior art references to form the claimed combination may
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`demonstrate obviousness, but proof of obviousness does not depend on or
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`require showing an explicit teaching, suggestion, or motivation to
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`combine;
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` Market demand, rather than scientific literature, can drive design trends
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`and may show obviousness;
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` In determining whether the subject matter of a patent claim would have
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`been obvious, neither the particular motivation nor the avowed purpose
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`of the named inventor controls;
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` One of the ways in which a patent’s subject can be proved obvious is by
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`noting that there existed at the time of invention a known problem for
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`which there was an obvious solution encompassed by the patent’s claims;
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` Any need or problem known in the field of endeavor at the time of
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`invention and addressed by the patent can provide a reason for combining
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`the elements in the manner claimed;
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` “Common sense” teaches that familiar items may have obvious uses
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`beyond their primary purposes, and in many cases a person of ordinary
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`skill will be able to fit the teachings of multiple patents together like
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`pieces of a puzzle;
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` A person of ordinary skill is also a person of ordinary creativity, and is
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`not an automaton;
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` A patent claim can be proved obvious by showing that the claimed
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`combination of elements was “obvious to try,” particularly when there is
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`a design need or market pressure to solve a problem and there are a finite
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`number of identified, predictable solutions such that a person of ordinary
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`skill would have had good reason to pursue the known options within his
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`or her technical grasp; and
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` One should be cautious of using hindsight in evaluating whether an
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`alleged invention would have been obvious.
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`31.
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`I have further been informed that, in making a determination as to
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`whether or not the alleged invention would have been obvious to a person of
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`ordinary skill, the Board may consider certain objective factors if they are present,
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`such as: commercial success of products practicing the alleged invention; long-felt
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`but unsolved need; teaching away; unexpected results; copying; and praise by
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`others in the field. These factors are generally referred to as “secondary
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`considerations” or “objective indicia” of nonobviousness. I have been informed,
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`however, that for such objective evidence to be relevant to the obviousness of a
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`claim, there must be a causal relationship (called a “nexus”) between the claim and
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`the evidence and that this nexus must be based on what is claimed and novel in the
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`claim rather than something in the prior art. I also have been informed that even
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`when they are present, secondary considerations may be unable to overcome
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`primary evidence of obviousness (e.g., motivation to combine with predictable
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`results) that is sufficiently strong.
`
`32.
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`I have been asked to consider the patentability of claims 1-20 (the
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`“Challenged Claims”) of the ’545 Patent that are challenged in the Petition.
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`33.
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`I have been informed that for PGRs, unpatentability must be shown
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`under a preponderance of the evidence. I have been informed that to establish
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`something by a preponderance of the evidence one needs to prove it is more likely
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`true than not true. I have concluded that the Challenged Claims are unpatentable
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`under 35 U.S.C. § 103 (for obviousness) as described below, under both the
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`preponderance of the evidence standard as well as the higher standard of clear and
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`convincing evidence. The same is true for my conclusion, as also described below,
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`that the Challenged Claims are unpatentable under 35 U.S.C. § 101 for lack of
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`specific utility as well as under 35 U.S.C. § 112 for lack of written description or
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`enablement.
`
`B. Claim Construction
`34.
`I have been informed that patent claims are construed from the
`
`viewpoint of a person of ordinary skill at the time of the alleged invention. I have
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`been informed that patent claims generally should be interpreted consistent with
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`their plain and ordinary meaning as understood by a person of ordinary skill in the
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`relevant time period (i.e., at the time of the purported invention, or the so called
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`“effective filing date” of the patent application), after reviewing the patent claim
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`language, the specification and the prosecution history (i.e., the intrinsic record)
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`C. Utility
`35.
`I have been informed that the statutory basis for the utility
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`requirement is found in 35 U.S.C. § 101, which provides:
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`Whoever invents or discovers any new and useful process, machine,
`manufacture, or composition of matter, or any new and useful
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`improvement thereof, may obtain a patent therefor, subject to the
`conditions and requirements of this title. (emphasis added)
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`36.
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`I have been informed by counsel that the Supreme Court has
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`interpreted the statute to mean that “one may patent only that which is ‘useful.’”
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`Brenner v. Manson, 383 U.S. 519, 528-29 (1966). Specifically, the utility must be
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`(i) specific, practical, and substantial. Grunenthal GMBH v. Alkem Lab'ys Ltd.,
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`919 F.3d 1333, 1345 (Fed. Cir. 2019). The utility must be “substantial” meaning a
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`utility that “provides a specific benefit in currently available form.” Ex parte
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`Fisher, 72 U.S.P.Q.2d 1020, 1025 (B.P.A.I. 2004).
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`37. Counsel has informed me that the courts have held that “inventions do
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`not meet the utility requirement if they are ‘objects upon which scientific research
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`could be performed with no assurance that anything useful will be discovered in
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`the end.’” In re ’318 Pat. Infringement Litig., 583 F.3d 1317, 1324 (Fed. Cir.
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`2009). For example, an application for a proposed drug to treat dementia was held
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`unpatentable where the applicant’s argument for utility was based only on
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`“analytic reasoning” about the drug without any results of testing in animals or
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`people. Id., 1326-28.
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`38. Further, I also understand from counsel that the Supreme Court has
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`cautioned that “a patent is not a hunting license,” meaning that “[u]nless and until a
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`process is refined and developed to [the] point—where specific benefit exists in
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`currently available form—there is insufficient justification for permitting an
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`applicant to engross what may prove to be a broad field” by obtaining a patent.
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`Brenner, 383 U.S. at 534-36. Counsel has informed me that, for example, in a case
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`involving expressed sequence tags (“ESTs”) in maize, the courts held that claims
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`to specific ESTs were not patentable where the applicant’s only alleged utility
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`were general uses of ESTs and the claimed ESTs were not tied to any specific
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`utility, nor differentiate the claimed ESTs from any other ESTs. In re Fisher, 421
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`F.3d 1365, 1365-68 (Fed. Cir. 2005). Because the applicant “only disclosed
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`general uses for its claimed ESTs, not specific ones that satisfy §101,” the claims
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`were not patentable. Id. at 1374.
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`39. Finally, I understand that utility is determined as of the application
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`filing date. In re Brana, 51 F.3d 1560, 1567 n.19 (Fed. Cir. 1995).
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`D. Written Description
`40.
`I have been informed that the statutory basis for the written
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`description requirement is found in 35 U.S.C. § 112(a), which provides in relevant
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`part:
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`
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`(a) IN GENERAL.—The specification shall contain a written
`description of the invention…
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`41.
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`I have been informed by counsel that a claim in a granted patent must
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`be sufficiently supported by the disclosure in the patent’s specification, read in the
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`context of what a person of ordinary skill in the art would have known at the time
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`of the claimed invention. I understand that the basic inquiry for written description
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`is whether the specification provides sufficient information for the person or
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`ordinary skill to recognize that the named inventors possessed the full scope of the
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`claimed invention.
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`42.
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`In particular, I understand that “[t]he essence of the written
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`description requirement is that a patent applicant, as part of the bargain with the
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`public, must describe his or her invention so that the public will know what it is
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`and that he or she has truly made the claimed invention.” AbbVie Deutschland
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`GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1298 (Fed. Cir. 2014).
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`E.
`43.
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`Enablement
`I have been informed that the statutory basis for the enablement
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`requirement, which is an additional