UNITED STATES INTERNATIONAL TRADE COMMISSION
`WASHINGTON, D.C.
`Before the Honorable Clark S. Cheney
`Administrative Law Judge
`
`In the Matter of
`CERTAIN STRONTIUM-RUBIDIUM
`RADIOISOTOPE INFUSION SYSTEMS,
`AND COMPONENTS THEREOF
`INCLUDING GENERATORS
`
`Investigation No. 337-TA-1110
`
`CORRECTED EXPERT REPORT OF NORBERT J. PELC, Sc.D.
`October 1, 2018
`
`___Oct 1, 2018_______________
`DATE
`
`____________________________
`Norbert J. Pelc, Sc.D.
`
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION
`
`1
`
`Bracco Ex. 2011
`Jubilant v. Bracco
`IPR2018-01449
`
`

`

`CONTAINS CONFIDENTIAL BUSINESS INFORMATION
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`Table of Contents
`
`I.
`
`II.
`
`INTRODUCTION .............................................................................................................. 1 
`
`MY BACKGROUND, QUALIFICATIONS AND COMPENSATION ........................... 1 
`
`A.
`B.
`C.
`
`Background and Qualifications ..................................................................................1 
`Identification Of Expert Testimony In The Last Four Years .....................................3 
`Compensation ............................................................................................................4 
`
`III.
`
`LEGAL PRINCIPLES ........................................................................................................ 4 
`
`A.
`B.
`C.
`D.
`E.
`F.
`G.
`H.
`
`Perspective of a Person of Ordinary Skill in the Art .................................................4 
`Presumption of Validity .............................................................................................6 
`Anticipation................................................................................................................6
`Written Description ....................................................................................................7 
`Non-Obviousness .......................................................................................................8 
`Assignor Estoppel ......................................................................................................9 
`Prosecution Laches ....................................................................................................11 
`Inventorship ...............................................................................................................12 
`
`IV.
`
`PRIORITY DATE AND OVERVIEW OF THE ASSERTED PATENTS ...................... 13 
`
`A.
`B.
`
`Priority Date ...............................................................................................................13 
`Overview Of The Asserted Patents ............................................................................14 
`
`V.
`
`VI.
`
`VII.
`
`THE COMMISSION’S CLAIM CONSTRUCTION ....................................................... 17 
`
`RESPONDENTS ARE ESTOPPED FROM CHALLENGING THE VALIDITY AND
`ENFORCEABILITY OF THE ASSERTED PATENTS .................................................. 18 
`
`THE ASSERTED PATENTS ARE NOT UNENFORCEABLE DUE TO
`PROSECUTION LACHES .............................................................................................. 22 
`
`A.
`
`There Was No Unreasonable And Unexplained Delay .............................................22 
`
`1.
`2.
`3.
`4.
`
`’467 Application ............................................................................................23 
`’200 Application ............................................................................................27 
`’484 Application ............................................................................................27 
`’320 Application ............................................................................................28 
`
`B.
`
`There Was No Prejudice ............................................................................................29 
`
`VIII. RESPONSE TO DR. STONE’S IMPROPER INVENTORSHIP ARGUMENT ............ 31 
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`IX. 
`
`X. 
`
`XI. 
`
`ANTICIPATION REBUTTAL ........................................................................................ 33 
`
`THE ASSERTED PATENTS ARE NOT INVALID AS OBVIOUS .............................. 35 
`
`THE KLEIN THESIS, ALONE OR IN COMBINATION WITH OTHER
`REFERENCES, DOES NOT RENDER THE ASSERTED CLAIMS OF THE
`ASSERTED PATENTS OBVIOUS ................................................................................. 38 
`
`A. 
`
`The Klein Thesis, Alone or in Combination with CardioGen-82, Tate, Medrad
`Intego, Akiyama, or Duchon, Does Not Render The Asserted Claims of the ’826
`Patent Obvious ...........................................................................................................39 
`
`1. 
`2. 
`3. 
`4. 
`5. 
`6. 
`7. 
`8. 
`9. 
`10. 
`11. 
`12. 
`13. 
`14. 
`
`Independent Claim 1 of the ’826 Patent ........................................................39 
`Dependent Claim 2 of the ’826 Patent ...........................................................65 
`Dependent Claim 3 of the ’826 Patent ...........................................................69 
`Dependent Claim 5 of the ’826 Patent ...........................................................71 
`Dependent Claim 9 of the ’826 Patent ...........................................................73 
`Dependent Claim 10 of the ’826 Patent .........................................................80 
`Dependent Claim 11 of the ’826 Patent .........................................................82 
`Dependent Claim 12 of the ’826 Patent .........................................................87 
`Dependent Claim 13 of the ’826 Patent .........................................................89 
`Dependent Claim 14 of the ’826 Patent .........................................................91 
`Dependent Claim 17 of the ’826 Patent .........................................................93 
`Dependent Claim 18 of the ’826 Patent .........................................................94 
`Dependent Claim 19 of the ’826 Patent .........................................................97 
`Dependent Claim 28 of the ’826 Patent .........................................................103 
`
`B. 
`
`The Klein Thesis, Alone or in Combination with CardioGen-82, Tate, Medrad
`Intego, Akiyama, or Duchon, Does Not Render The Asserted Claims of the ’869
`Patent Obvious ...........................................................................................................104 
`
`1. 
`2. 
`3. 
`4. 
`5. 
`6. 
`7. 
`8. 
`9. 
`10. 
`11. 
`12. 
`
`Independent Claim 1 of the ’869 Patent ........................................................104 
`Dependent Claim 2 of the ’869 Patent ...........................................................126 
`Dependent Claim 3 of the ’869 Patent ...........................................................128 
`Dependent Claim 4 of the ’869 Patent ...........................................................130 
`Dependent Claim 5 of the ’869 Patent ...........................................................132 
`Dependent Claim 8 of the ’869 Patent ...........................................................133 
`Dependent Claim 14 of the ’869 Patent .........................................................133 
`Dependent Claim 24 of the ’869 Patent .........................................................135 
`Dependent Claim 27 of the ’869 Patent .........................................................142 
`Dependent Claim 28 of the ’869 Patent .........................................................144 
`Dependent Claim 29 of the ’869 Patent .........................................................147 
`Dependent Claim 30 of the ’869 Patent .........................................................149 
`
`C. 
`
`The Klein Thesis, Alone or in Combination with CardioGen-82, Tate, Medrad
`Intego, Akiyama, or Duchon, Does Not Render Obvious the Asserted Claims of
`the ʼ870 Patent ...........................................................................................................151 
`
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`CONTAINS CONFIDENTIAL BUSINESS INFORMATION
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`1. 
`2. 
`3. 
`4. 
`5. 
`6. 
`7. 
`8. 
`9. 
`10. 
`11. 
`
`Independent Claim 1 of the ’870 Patent ........................................................151 
`Dependent Claim 2 of the ’870 Patent ...........................................................165 
`Dependent Claim 8 of the ’870 Patent ...........................................................168 
`Dependent Claim 9 of the ’870 Patent ...........................................................175 
`Dependent Claim 10 of the ’870 Patent .........................................................177 
`Dependent Claim 11 of the ’870 Patent .........................................................180 
`Dependent Claim 12 of the ’870 Patent .........................................................182 
`Dependent Claim 13 of the ’870 Patent .........................................................184 
`Dependent Claim 16 of the ’870 Patent .........................................................186 
`Dependent Claim 17 of the ’870 Patent .........................................................186 
`Dependent Claim 27 of the ’870 Patent .........................................................189 
`
`XII.  THE CARDIOGEN-82 INFUSION SYSTEM, ALONE OR IN COMBINATION WITH
`OTHER REFERENCES, DOES NOT RENDER THE ASSERTED CLAIMS OF THE
`ASSERTED PATENTS OBVIOUS ............................................................................... 191 
`
`A. 
`
`B. 
`
`There Is No Motivation To Combine The Rubidium-82 Elution System Disclosed
`In CardioGen-82 And The Klein Thesis With The FDG Systems Disclosed In
`Tate And The Intego Operation Manual ....................................................................191 
`CardioGen-82, Alone or in Combination With The Klein Thesis, Tate, Intego
`Operations Manual, or Duchon, Does Not Render Obvious the Asserted Claims of
`the ’826 Patent ...........................................................................................................193 
`
`1. 
`2. 
`3. 
`4. 
`5. 
`6. 
`7. 
`8. 
`9. 
`10. 
`11. 
`12. 
`13. 
`14. 
`
`Independent Claim 1 of the ’826 Patent ........................................................194 
`Dependent Claim 2 of the ’826 Patent ...........................................................202 
`Dependent Claim 3 of the ’826 Patent ...........................................................204 
`Dependent Claim 5 of the ’826 Patent ...........................................................205 
`Dependent Claim 9 of the ’826 Patent ...........................................................206 
`Dependent Claim 10 of the ’826 Patent .........................................................209 
`Dependent Claim 11 of the ’826 Patent .........................................................210 
`Dependent Claim 12 of the ’826 Patent .........................................................213 
`Dependent Claim 13 of the ’826 Patent .........................................................214 
`Dependent Claim 14 of the ’826 Patent .........................................................215 
`Dependent Claim 17 of the ’826 Patent .........................................................216 
`Dependent Claim 18 of the ’826 Patent .........................................................217 
`Dependent Claim 19 of the ’826 Patent .........................................................218 
`Dependent Claim 28 of the ’826 Patent .........................................................220 
`
`C. 
`
`CardioGen-82, Alone or in Combination With The Klein Thesis, Tate, Intego
`Operations Manual, or Duchon, Does Not Render Obvious the Asserted Claims of
`the ’869 Patent ...........................................................................................................220 
`
`1. 
`2. 
`3. 
`4. 
`5. 
`
`Independent Claim 1 of the ’869 Patent ........................................................222 
`Dependent Claim 2 of the ’869 Patent ...........................................................234 
`Dependent Claim 3 of the ’869 Patent ...........................................................235 
`Dependent Claim 4 of the ’869 Patent ...........................................................236 
`Dependent Claim 5 of the ’869 Patent ...........................................................238 
`
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`6. 
`7. 
`8. 
`9. 
`10. 
`11. 
`12. 
`
`Dependent Claim 8 of the ’869 Patent ...........................................................238 
`Dependent Claim 14 of the ’869 Patent .........................................................239 
`Dependent Claim 24 of the ’869 Patent .........................................................240 
`Dependent Claim 27 of the ’869 Patent .........................................................245 
`Dependent Claim 28 of the ’869 Patent .........................................................247 
`Dependent Claim 29 of the ’869 Patent .........................................................248 
`Dependent Claim 30 of the ’869 Patent .........................................................249 
`
`D. 
`
`CardioGen-82, Alone or in Combination With The Klein Thesis, Tate, Intego
`Operations Manual, or Duchon, Does Not Render Obvious the Asserted Claims of
`the ’870 Patent ...........................................................................................................251 
`
`1. 
`2. 
`3. 
`4. 
`5. 
`6. 
`7. 
`8. 
`9. 
`10. 
`11. 
`
`Independent Claim 1 of the ’870 Patent ........................................................252 
`Dependent Claim 2 of the ’870 Patent ...........................................................259 
`Dependent Claim 8 of the ’870 Patent ...........................................................260 
`Dependent Claim 9 of the ’870 Patent ...........................................................263 
`Dependent Claim 10 of the ’870 Patent .........................................................264 
`Dependent Claim 11 of the ’870 Patent .........................................................265 
`Dependent Claim 12 of the ’870 Patent .........................................................266 
`Dependent Claim 13 of the ’870 Patent .........................................................268 
`Dependent Claim 16 of the ’870 Patent .........................................................268 
`Dependent Claim 17 of the ’870 Patent .........................................................269 
`Dependent Claim 27 of the ’870 Patent .........................................................271 
`
`XIII.  OBJECTIVE INDICIA OF NONOBVIOUSNESS........................................................ 272 
`
`A. 
`B. 
`C. 
`
`There Was A Long Felt But Unmet Need .................................................................272 
`Copying ......................................................................................................................276 
`Failure Of Others .......................................................................................................281 
`
`XIV.  CONCLUSION ............................................................................................................... 283 
`
`
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`
`I.
`
`
`INTRODUCTION
`
`1.
`
`I have been retained as an independent expert witness by the law firms Greenberg
`
`Traurig, LLP and Goodwin Procter LLP on behalf of Complainant Bracco Diagnostics Inc.
`
`(“Bracco”) in the above-captioned proceeding.
`
`2.
`
`I have been asked to provide my opinions about the state of the art of the
`
`technology described in U.S. Patent Nos. 9,750,869 (the “’869 patent”), 9,750,870 (the “’870
`
`patent), and 9,814,826 (the “’826 patent”) (collectively, the “Asserted Patents”). I understand
`
`that Bracco has accused Jubilant DraxImage, Inc., Jubilant Pharma Limited, and Jubilant Life
`
`Sciences Limited (collectively “Respondents”) of infringing claims 1-5, 8, 14, 24, and 29-30 of
`
`the ’869 patent, claims 1-2, 8, 10-12, 16-17, and 27 of the ’870 patent, and claims 1-3, 5, 9, 11-
`
`14, 17-19, and 28 of the ’826 patent (collectively, the “Asserted Claims”).
`
`3.
`
`I have also been asked by counsel for Bracco to respond to the September 17,
`
`2018 Report of Robert T. Stone, Ph.D. (“Stone Report”) and to provide my opinions on the
`
`validity of the claims of the Asserted Patents.
`
`II. MY BACKGROUND, QUALIFICATIONS AND COMPENSATION
`
`
`Background and Qualifications
`
`I am a Professor of Bioengineering, Radiology, and, by courtesy, of Electrical
`
`A.
`
`4.
`
`Engineering at Stanford University in Stanford, California.
`
`5.
`
`In 1974, I received my B.S. in Applied Mathematics, Engineering and Physics
`
`from the University of Wisconsin in Madison and I started my graduate studies at Harvard
`
`University. While a student at Harvard, I was a research assistant at the Massachusetts General
`
`Hospital (“MGH”). I received my S.M. in Medical Radiological Physics in 1976 and my Sc.D.
`
`in Medical Radiological Physics in 1979, both from Harvard University.
`NY 247663659v1
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`NY 247663246v6
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`CONTAINS CONFIDENTIAL BUSINESS INFORMATION
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`6.
`
`I have worked in diagnostic imaging for more than 40 years. My graduate
`
`research while at Harvard and MGH focused on tomographic imaging with radioisotope sources
`
`(what is now called “Positron Emission Tomography” or PET), as well as tomographic imaging
`
`using x-ray sources (both “Computed Tomography” or CT, and what is now called
`
`“tomosynthesis”). From 1978 until 1990 I worked at GE Medical Systems as a Senior Physicist
`
`in the Radiological Sciences Laboratory, and as the manager of that group. While at GE, I
`
`contributed to the development of CT, Digital Radiography, Magnetic Resonance Imaging
`
`(MRI), and other advanced diagnostic imaging devices, and I collaborated with radiologists at
`
`leading medical centers on the development of new applications of these technologies.
`
`7.
`
`I joined Stanford University as an Associate Professor of Radiology in 1990 and
`
`became a Professor of Radiology in 1997, a position I still hold. In 2002, I was named the
`
`Associate Chair for Research in the Department of Radiology. In 2004, I was appointed
`
`Professor of Bioengineering, a position I also still hold. Since 1990 I have also held a courtesy
`
`faculty appointment in Electrical Engineering at the same rank as my appointments in Radiology
`
`and Bioengineering. In 2012, I was named the Chair of the Department of Bioengineering and
`
`gave up the position of Associate Chair of the Department of Radiology. I completed my term as
`
`Chair of Bioengineering in 2017.
`
`8.
`
`I am named as an author on more than 200 published peer-reviewed journal
`
`articles and over 350 research papers presented at scientific conferences, essentially all in the
`
`field of diagnostic imaging, including Positron Emission Tomography. I am also named as an
`
`inventor on 95 issued U.S. Patents. Among these are contributions related to Positron Emission
`
`Tomography.
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`CONTAINS CONFIDENTIAL BUSINESS INFORMATION
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`9.
`
`I have received many awards for my contributions to medical imaging. I was
`
`elected to the National Academy of Engineering in 2012. In 2016, I received an Honorary
`
`Doctor of Medicine from Friedrich Alexander University of Erlangen-Nuremberg. I received the
`
`Edith H. Quimby Award from the American Association of Physicists in Medicine (AAPM) and
`
`the Outstanding Researcher Award from the Radiological Society of North America (RSNA),
`
`both in 2013. Among other honors, I am a Fellow of the AAPM, the International Society for
`
`Magnetic Resonance in Medicine, the Institute for Medical and Biological Engineering, and
`
`SPIE (international society for optics and photonics).
`
`10.
`
`I have also served as a reviewer for the National Institutes of Health (NIH),
`
`including as a member of the Radiology and Nuclear Medicine Study Section of NIH from 1991-
`
`1997, and for other grant funding agencies. My additional NIH service, includes serving as a
`
`member of the National Advisory Council of the National Institute of Biomedical Imaging and
`
`Bioengineering and of the Council of Councils. I have served as a reviewer and on the editorial
`
`boards for many journals. I am currently the Editor-in-Chief of the Journal of Medical Imaging.
`
`11.
`
`A copy of my Curriculum Vitae (“CV”) is submitted herewith as Exhibit 1,
`
`which describes my education, training and experience in greater detail. Attached to my CV is a
`
`list of publications I have authored, including publications I have authored within the past ten
`
`years.
`
`B.
`
`12.
`
`Identification Of Expert Testimony In The Last Four Years
`
`Separate from my role as an employee of Stanford University, I have worked as a
`
`consultant, including on intellectual property matters. In the last 4 years, I provided expert
`
`testimony in the following cases:
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`
`
`
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`
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`
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`
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`
`
`
`
`
`
`
`United States District Court for the District of Delaware C.A. No. 13-846, Sarif
`Biomedical LLC v. Brainlab, Inc., Brainlab AG, Brainlab Medizinishe Computer
`Systeme GMBH, and Varian Medical Systems, Inc.
`
`United States District Court for the Western District of Virginia, Charlottesville
`Division, CA 3:14-cv-00051-NKM-JCH, University of Virginia Patent Foundation v.
`General Electric Company D/B/A GE Healthcare
`
`United States Patent and Trademark Office, Cases No. IPR 2016-00357, IPR 2016-
`00358, IPR 2016-00359, and IPR2017-00109, General Electric Company v.
`University of Virginia Patent Foundation
`
`United States International Trade Commission, Inv. No. 337-TA-1063 Hologic, Inc v.
`FUJIFILM Corporation, FUJIFILM Medical Systems USA, Inc, and FUJIFILM
`Techno Products Co, Ltd.
`
`Arizona Superior Court Pima County, Joseph Dagher v. Lathrop Gage LLP, et al
`Civil Action No. 1:17-cv-01746-CMA-KMT
`
`C.
`
`13.
`
`Compensation
`
`I am billing my work in this matter at $575 per hour, with reimbursement for
`
`actual expenses. My payment is not contingent upon my testimony or the outcome of the case. I
`
`have no personal interest in the outcome of the case.
`
`III. LEGAL PRINCIPLES
`
`
`14.
`
`I am not an attorney and I will offer no opinions on the law. I have, however,
`
`been instructed by counsel regarding the following legal principles related to my opinions.
`
`Based on these instructions, I have developed and applied the following understandings in
`
`arriving at my stated opinions and stated conclusions in this Report.
`
`A.
`
`15.
`
`Perspective of a Person of Ordinary Skill in the Art
`
`I understand that the content of patents and prior art should be interpreted the way
`
`a person of ordinary skill in the art (“POSITA”) would have interpreted the information at the
`
`time of invention.
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`CONTAINS CONFIDENTIAL BUSINESS INFORMATION
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`16.
`
`I understand that, to determine the appropriate level of one of ordinary skill in the
`
`art, the following four factors may be considered: (a) the types of problems encountered by those
`
`working in the field and prior art solutions thereto; (b) the sophistication of the technology in
`
`question, and the rapidity with which innovations occur in the field; (c) the educational level of
`
`active workers in the field; and (d) the educational level of the inventor.
`
`17.
`
`I am well acquainted with the level of ordinary skill applicable to the subject
`
`matter of the Asserted Patents as of their filing dates.
`
`18.
`
`The Asserted Patents describe the art of the inventions as follows:
`
`TECHNICAL FIELD
`
`infuse
`that generate and
`to systems
`invention pertains
`The present
`radiopharmaceuticals, and more particularly, to systems including computer-
`facilitated maintenance and/or operation.
`
`
`BACKGROUND
`
`Nuclear medicine employs radioactive material for therapy and diagnostic
`imaging. Positron emission tomography (PET) is one type of diagnostic imaging,
`which utilizes doses of radiopharmaceuticals, for example, generated by elution
`within a radioisotope generator, that are injected, or infused into a patient.
`
`’869 patent at 1:22-36; ’870 patent at 1:25-39; ’826 patent at 1:25-39.
`
`19.
`
` I understand that Dr. Steven Bergmann has provided an opinion that a POSITA at
`
`the time of the inventions claimed in the Asserted Patents would generally have a graduate
`
`degree in medicine and/or in a medical related science, including physics, chemistry, biology,
`
`physiology, and/or biophysics, or a related field, and would generally have at least some clinical,
`
`research, and/or design experience with respect to PET imaging and/or PET imaging systems.
`
`20.
`
`I agree with Dr. Bergmann, that the POSITA would generally have an advanced
`
`degree. In addition, I note that an individual with an undergraduate degree along with significant
`
`experience could also be sufficiently skilled. The amount of experience following an
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`undergraduate degree would depend on the level of formal education and amount of experience
`
`working with radiopharmaceuticals. Such a person may be working as part of a team.
`
`21.
`
`I was at least a POSITA at the time of each of Bracco’s inventions. Since that
`
`time, I have gained significantly more knowledge and experience in this field.
`
`22.
`
`I note that Dr. Stone presents an alternative definition of a POSITA, but does not
`
`explain which definition he applies in his report. Stone Rpt. ¶ 163. Additionally, I disagree with
`
`Dr. Stone’s definition because it makes no mention of the relevant technology. Dr. Stone
`
`recognizes that the Asserted Patents relate to “systems and methods for computer-controlled
`
`safety systems for radioactive materials,” however this is omitted from his definition of a
`
`POSITA. Stone Rpt. ¶ 162.
`
`B.
`
`23.
`
`Presumption of Validity
`
`I have been instructed by counsel that a patent only issues after an Examiner from
`
`the U.S. Patent and Trademark Office (“USPTO”) reviews the patent application and compares
`
`the subject matter of the claims to the prior art. If the Examiner determines that the claims are
`
`patentable, the patent that issues is entitled to a presumption that it is valid.
`
`24.
`
`I also have been instructed by counsel that after a patent issues, a party may
`
`challenge its validity. To prove invalidity, I have been instructed by counsel that the challenging
`
`party must show by clear and convincing evidence that the claim is invalid.
`
`C.
`
`25.
`
`Anticipation
`
`I have been instructed by counsel that a patent or printed publication qualifies as
`
`prior art if it was published prior to the priority date of the asserted patent. I have also been
`
`instructed by counsel that the publication date of a printed publication is the date it was made
`
`available to the extent that a POSITA, exercising reasonable diligence, could have located it.
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`26.
`
`I have been instructed by counsel that in order for a claim to be anticipated, the
`
`challenger must show by clear and convincing evidence that each and every element as set forth
`
`in the claim is found, either expressly or inherently, in a single prior art reference, before the date
`
`of patent owner’s invention. I have further been instructed by counsel that a claim element is
`
`inherently described if it must always be present; in other words, it must inevitably result when
`
`the method described in the reference is carried out.
`
`D. Written Description1
`
`I have been instructed by counsel that a patent claim must comply with the
`
`27.
`
`“written description requirement.” I have been instructed by counsel that to satisfy the written
`
`description requirement, the patent’s specification must describe the claimed invention
`
`sufficiently to convey to a POSITA that the inventors had possession of the claimed invention at
`
`the time of application for the patent. In other words, the specification must describe, expressly
`
`or implicitly, an invention in a manner understandable to the ordinarily skilled artisan, and show
`
`that the applicant invented the claimed invention. I have been instructed by counsel that
`
`consideration of the adequacy of the written description is an objective inquiry into the
`
`disclosure contained within the four corners of the patent, from the perspective of a POSITA.
`
`28.
`
`I have been instructed by counsel that, while a patent’s specification must
`
`describe an invention understandably to a POSITA and show that the inventors actually invented
`
`the invention claimed in the patent, no particular form of disclosure is required. For example, it
`
`is not always necessary for a patent’s written description to use the same language that is used in
`
`its claims, or to provide examples.
`
`
`1 The Stone Report purports to disclose the law on written description, but does not offer any
`written description opinions. Stone Rpt. ¶ 51-53, 63-65. I reserve the right to supplement my
`opinions if Dr. Stone subsequently attempts to provide an opinion concerning written
`description.
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`29.
`
`I have been instructed by counsel that the written description requirement may be
`
`satisfied in a variety of ways, for example: by including a description of an actual reduction to
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`practice; by showing that the invention was ready for patenting, such as by the disclosure of
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`drawings, charts, formulas, or words that show that the invention was complete; or by describing
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`distinguishing characteristics sufficient to show that the applicant was in possession of the
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`claimed invention. I have been instructed by counsel that it is not necessary for the specification
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`to include an example that has all the elements of a claim. I have further been instructed by
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`counsel that the level of detail required to satisfy the written description requirement depends in
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`large part on the nature of the claims and the complexity of the technology.
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`E.
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`30.
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`Non-Obviousness
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`I have been instructed by counsel that “nonobviousness” means not obvious,
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`namely that the subject matter of the invention, taken as a whole, including the results obtained,
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`considered in light of the prior art as a whole, would not have been obvious to a person of
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`ordinary skill in the art at the time the invention was made.
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`31.
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`I have been instructed by counsel that to invalidate a patent for obviousness, the
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`challenger must prove by clear and convincing evidence that the differences between the
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`patented invention and the prior art are such that the subject matter as a whole would have been
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`obvious at the time the invention was made to a person having ordinary skill in the art.
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`32.
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`I have been instructed by counsel that, for an invention that is composed of
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`several elements, it is not enough to demonstrate that each limitation was independently known
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`in the art. I have been instructed by counsel that there must be a reason to combine the elements
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`in the manner claimed by the patent, and there must have been a reasonable expectation of
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`success in doing so.
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`8
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`CONTAINS CONFIDENTIAL BUSINESS INFORMATION
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`33.
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`I have further been instructed by counsel that the obviousness inquiry should not
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`be performed with the benefit of hindsight, but instead based on the knowledge at the time of the
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`invention.
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`34.
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`I have been instructed by counsel that relevant considerations include the level of
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`ordinary skill in the art; the scope and content of the prior art; differences between the prior art
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`and the claims at issue; and objective factors indicating nonobviousness.
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`35.
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`I have been instructed by counsel that objective factors bearing on the question of
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`nonobviousness may include, for example, commercial success; long-felt but unmet need in the
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`art; failures of others to meet a need met by the invention; unexpected results achieved by the
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`invention; and praise of the invention by others.
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`F.
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`36.
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`Assignor Estoppel
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`I have been instructed by counsel that under the doctrine of assignor estoppel, one
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`who assigns a patent to another party is barred from contesting the validity of that patent when
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`sued for infringement. I have been instructed by counsel that assignor estoppel is an equitable
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`doctrine that bars defenses of invalidity and unenforceability.
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`37.
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`I have been instructed by counsel that the existence of an assignment and an
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`inventor’s oath are by themselves enough to support application of assignor estoppel.
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`Furthermore, I have been instructed by counsel that the doctrine is presumed to apply absent
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`exceptional circumstances, such as an express reservation by the assignor of the right to
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`challenge the validity of the patent.
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`38.
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`I have been instructed by counsel that assigno