UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`___________________
`
`Luminex Corporation
`
`Petitioner,
`
`v.
`
`Irori Technologies, Inc.
`
`Patent Owner
`
`___________________
`
`U.S. Patent No. 6,416,714
`
`Issue Date: July 9, 2002
`
`Filed: June 7, 1995
`
`Title: REMOTELY PROGRAMMABLE MATRICES WITH MEMORIES
`
`____________________
`
`Inter Partes Review No.____
`
`____________________
`
`DECLARATION OF MICHAEL L. METZKER REGARDING
`
`U.S. PATENT NO. 6,416,714
`
`Luminex Ex. 1201
`Luminex/Irori - Page 1
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`

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`TABLE OF CONTENTS
`
`Page
`
`I.
`
`II.
`III.
`
`IV.
`
`V.
`
`A.
`B.
`C.
`D.
`
`A.
`B.
`
`C.
`D.
`E.
`F.
`
`A.
`
`INTRODUCTION .............................................................................1
`Engagement .......................................................................................1
`Background And Qualifications.........................................................1
`Compensation And Prior Testimony ..................................................2
`Information Considered .....................................................................3
`LEGAL STANDARDS FOR PATENTABILITY..............................3
`THE ’714 PATENT.........................................................................10
`Effective Filing Date of the ’714 Patent ...........................................10
`Description of the Background Technology Relevant to the
`’714 Patent.......................................................................................10
`The Person Of Ordinary Skill In The Art .........................................14
`Technical Overview of the ’714 Patent ............................................14
`Prosecution History of the ’714 Patent.............................................17
`Claim Construction..........................................................................21
`PRIOR ART REFERENCES...........................................................28
`U.S. Patent No. 6,087,186 “Methods and Apparatus for
`Synthesizing Labeled Combinatorial Chemistry Libraries,”
`(“Cargill”)........................................................................................28
`U.S. Patent No. 4,499,052 “Apparatus For Distinguishing
`Multiple Subpopulations of Cells” (“Fulwyler”) ..............................29
`C. WO 93/06121 “Method of Synthesizing Diverse Collections of
`Oligomers” (“Dower”)....................................................................30
`CARGILL INVALIDATES THE CLAIMS OF THE ’714
`PATENT..........................................................................................31
`Comparison of Terminology Used in the ’714 Patent and
`Cargill..............................................................................................31
`Cargill Anticipates Claim 1 of the ’714 Patent.................................37
`Cargill Anticipates Claim 4 of the ’714 Patent.................................60
`
`B.
`
`A.
`
`B.
`C.
`
`-i-
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`TABLE OF CONTENTS
`(continued)
`
`Page
`
`VI.
`
`VII.
`
`D.
`E.
`F.
`G.
`H.
`
`A.
`
`B.
`C.
`D.
`E.
`F.
`G.
`H.
`
`A.
`
`B.
`
`C.
`
`D.
`
`E.
`
`Cargill Anticipates Claim 6 of the ’714 Patent.................................74
`Cargill Anticipates Claim 8 of the ’714 Patent.................................88
`Cargill Anticipates Claim 9 of the ’714 Patent.................................91
`Cargill Anticipates Claim 13 of the ’714 Patent .............................109
`Cargill Anticipates Claim 14 of the ’714 Patent .............................115
`FULWYLER INVALIDATES THE CLAIMS OF THE ’714
`PATENT........................................................................................119
`Comparison of Terminology Used in the ’714 Patent and
`Fulwyler ........................................................................................119
`Fulwyler Anticipates Claim 1 of the ’714 Patent............................126
`Fulwyler Anticipates Claim 4 of the ’714 Patent............................154
`Fulwyler Anticipates Claim 6 of the ’714 Patent............................170
`Fulwyler Anticipates Claim 8 of the ’714 Patent............................185
`Fulwyler Anticipates Claim 9 of the ’714 Patent............................188
`Fulwyler Anticipates Claim 13 of the ’714 Patent..........................199
`Fulwyler Anticipates Claim 14 of the ’714 Patent..........................205
`FULWYER IN COMBINATION WITH DOWER
`INVALIDATES THE CLAIMS OF THE ’714 PATENT..............210
`Comparison of Terminology Used in the ’714 Patent and
`Dower............................................................................................210
`Fulwyler In Combination With Dower Renders Claim 1 of the
`’714 Patent Obvious.......................................................................217
`Fulwyler In Combination With Dower Renders Claim 4 of the
`’714 Patent Obvious.......................................................................223
`Fulwyler In Combination With Dower Renders Claim 6 of the
`’714 Patent Obvious.......................................................................226
`Fulwyler In Combination With Dower Renders Claim 9 of the
`’714 Patent Obvious.......................................................................230
`
`-ii-
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`TABLE OF CONTENTS
`(continued)
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`Page
`
`F.
`
`Fulwyler In Combination With Dower Renders Dependent
`Claims 8, 13 and 14 of the ’714 Patent Obvious ............................233
`CONCLUSION .............................................................................234
`
`VIII.
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`-iii-
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`I.
`
`INTRODUCTION
`
`A.
`
`1.
`
`Engagement
`
`I have been retained by counsel for Luminex Corporation as an expert
`
`witness in the above-captioned proceeding. I have been asked to render an opinion
`
`regarding the validity of Claims 1, 4, 6, 8-9, and 13-14 of U.S. Patent No.
`
`6,416,714 (the “’714 Patent”) (Exhibit 1003). The following is my written
`
`declaration that sets forth my opinion that Claims 1, 4, 6, 8-9, and 13-14 of the
`
`’714 Patent are invalid.
`
`B.
`
`2.
`
`Background And Qualifications
`
`I have been working in the fields of molecular biology and chemistry
`
`since 1984. I received a B.S. degree in Biochemistry & Biophysics in 1984 from
`
`the University of California, Davis. From 1984-1987, I worked as a Research
`
`Chemist at Bio-Rad Laboratories. Between 1987 and 1991, I worked as an
`
`Associate Scientist, Applied Biosystems, Inc. (ABI). I received a Ph.D. in
`
`Molecular & Human Genetics from Baylor College of Medicine in 1996.
`
`3.
`
`I am presently Founder, President & Chief Executive Officer of
`
`RedVault Biosciences, LP (“RedVault”). RedVault is a new biotechnology
`
`company committed to creating innovative technologies to advance genomic
`
`medicine, which I founded in April 2013. In starting RedVault, I have transitioned
`
`into an Adjunct Associate Professor in the Department of Molecular and Human
`
`1
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`Genetics and at the Human Genome Sequencing Center, both at the Baylor College
`
`of Medicine. Additionally, I am an Adjunct Associate Professor, Department of
`
`Chemistry at Rice University.
`
`4.
`
`From January 2009 to February 2014, I have been an Associate
`
`Professor in the Department of Molecular & Human Genetics & Human Genome
`
`Sequencing Center, both at the Baylor College of Medicine. I also hold an
`
`appointment as an Adjunct Associate Professor in the Department of Cell &
`
`Molecular Biology at Baylor College of Medicine. Prior to my Associate positions
`
`at the Baylor College of Medicine and Rice University, I held the position of
`
`tenure-track Assistant Professor in Molecular and Human Genetics and Senior
`
`Manager at the HGSC since November 1999 and the position of Adjunct Assistant
`
`Professor in Chemistry since July 2001.
`
`5.
`
`My Curriculum Vitae, including my publications and patents, is
`
`submitted herewith as Attachment A.
`
`C.
`
`6.
`
`Compensation And Prior Testimony
`
`I am being compensated at a rate of $600 per hour for my study and
`
`testimony in this matter. I am also being reimbursed for reasonable and customary
`
`expenses associated with my work and testimony in this investigation. My
`
`compensation is not contingent on the outcome of this matter or the specifics of my
`
`testimony.
`
`2
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`7.
`
`I have served as an expert witness prior to this matter and a list of
`
`matters in which I have provided expert testimony at trial or deposition during the
`
`last four years is included in my Curriculum Vitae (Attachment A).
`
`D.
`
`8.
`
`Information Considered
`
`My opinions are based on my years of education, research and
`
`experience, as well as my investigation and study of relevant materials. In forming
`
`my opinions, I have considered the materials referred to herein or listed in
`
`Appendix A. I may rely upon these materials and/or additional materials to rebut
`
`arguments raised by the patentee. Further, I may also consider additional
`
`documents and information in forming any necessary opinions — including
`
`documents that may not yet have been provided to me.
`
`9.
`
`My analysis of the materials produced in this investigation is ongoing,
`
`and I will continue to review any new material as it is provided. This declaration
`
`represents only those opinions I have formed to date. I reserve the right to revise,
`
`supplement, and/or amend my opinions stated herein based on new information,
`
`including the testimony of Irori’s experts, and on my continuing analysis of the
`
`materials already provided.
`
`II.
`
`LEGAL STANDARDS FOR PATENTABILITY
`
`10.
`
`I have been informed of and understand the following legal principles,
`
`and I have applied these to my analyses herein.
`
`3
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`11.
`
`It is my understanding that for an invention claimed in a patent to be
`
`found patentable, it must be, among other things, new and not obvious in light of
`
`what came before it (the “prior art”).
`
`12.
`
`It is my understanding that in the context of this proceeding, the party
`
`asserting unpatentability bears the burden to prove unpatentability by “a
`
`preponderance of the evidence.” It is my understanding that a preponderance of
`
`the evidence is evidence sufficient to show that a fact is more likely than not.
`
`13.
`
`It is my understanding that in the context of this proceeding, the
`
`claims of the patent must be given their broadest reasonable interpretation
`
`consistent with the specification. The claims are then to be compared to the
`
`information in the prior art.
`
`14.
`
`It is my understanding that for purposes of this proceeding, the
`
`information that may be evaluated as prior art is limited to patents and printed
`
`publications. My analysis herein compares prior art patents and printed
`
`publications to the claims of the’714 Patent.
`
`15.
`
`It is my understanding that one way in which prior art may render a
`
`patent claim unpatentable is when prior art can be shown to “anticipate” the claim.
`
`It is also my understanding that in addition to anticipation, the prior art can be
`
`shown to “render obvious” the claim alone, or in combination with other prior art.
`
`4
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`16. Anticipation: It is my understanding that, for a patent claim to be
`
`“anticipated” by the prior art, each and every element or limitation recited in the
`
`claim must be found, expressly or inherently, in a single prior art reference. It is
`
`my understanding that claim limitations that are not expressly found in a prior art
`
`reference are inherent if the prior art necessarily functions in accordance with, or
`
`includes, the claim limitations. It is my understanding that extrinsic evidence, that
`
`is evidence outside of the anticipatory prior art reference, may be used in the
`
`analysis of whether a feature is inherently present in the prior art reference.
`
`Additionally, the prior art reference must enable one of ordinary skill in the art to
`
`make the claimed invention without undue experimentation.
`
`17. Obviousness: It is my understanding that a patent claim may be
`
`obvious even though it is not identically disclosed or described in a single prior art
`
`reference. An invention may be obvious “if the differences between the subject
`
`matter sought to be patented and the prior art are such that the subject matter as a
`
`whole would have been obvious at the time the invention was made to one person
`
`having ordinary skill in the art to which the subject matter pertains.”
`
`18.
`
`It is my understanding that the ’714 Patent was granted from U.S.
`
`Patent Application No. 08/484,486 (“the ’486 Application”) that was filed on
`
`June 7, 1995, and claims priority to April 25, 1995. I have used the latter date as
`
`the earliest “date the invention was made” in my analysis.
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`5
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`19.
`
`It is my understanding that obviousness may be shown by one or more
`
`items of prior art including combinations of prior art references. It is also my
`
`understanding that the relevant inquiry into obviousness requires consideration of
`
`four factors: (a) the scope and content of the prior art; (b) the differences between
`
`the prior art and the claims at issue; (c) the knowledge of one of ordinary skill in
`
`the pertinent art; and (d) objective factors indicating obviousness or non-
`
`obviousness.
`
`20.
`
`It is my understanding that the objective factors indicating
`
`obviousness or nonobviousness (i.e., secondary considerations) may include: (a)
`
`commercial success of products covered by the patent claims; (b) the taking of
`
`licenses under the patent by others; (c) a long-felt but unmet need for the
`
`invention; (d) failed attempts by others to make the invention; (e) praise by others
`
`(particularly following initial skepticism); (f) copying of the invention by others in
`
`the field; (g) unexpected results achieved by the claimed invention; (h) and the
`
`patentee’s approach being contrary to the accepted wisdom of the prior art.
`
`21.
`
`It is my understanding that the obviousness inquiry should not be
`
`done in hindsight, but should be done through the eyes of one of ordinary skill in
`
`the relevant art at the time the subject patent was filed. For purposes here, I have
`
`applied my analyses to that understood by one of ordinary skill in the art as of
`
`April 25, 1995.
`
`6
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`22.
`
`I have been informed of and understand that in 2007, the United
`
`States Supreme Court issued its decision in KSR Int’l Co. v. Teleflex, Inc. which
`
`governs many of the principles concerning obviousness, and I have set out these
`
`understandings in the following paragraphs.
`
`23.
`
`It is my understanding that the combination of familiar elements
`
`according to known methods is likely to be obvious when it does no more than
`
`yield predictable results. It is my understanding that when a work is available in
`
`one field of endeavor, design incentives, and other market forces can prompt
`
`variations of that work, either in the same field or a different one. If one of
`
`ordinary skill in the art can implement a predictable variation the change would
`
`have been considered obvious. For example, a predictable variation of prior art is
`
`obvious, for example, if the claimed structure in a patent only substitutes one
`
`element for another element that is known in the field, unless the result is
`
`unexpected.
`
`24.
`
`It is my understanding that if a technique has been used to improve
`
`one device, and one of ordinary skill in the art would have recognized that it would
`
`improve similar devices in the same way, using that technique to improve the other
`
`device would have been obvious, unless its actual application yields unexpected
`
`results or challenges in implementation.
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`7
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`25.
`
`It is my understanding that the obviousness analysis does not require
`
`precise teachings directed to the specific subject matter of the claim or claims at
`
`issue, but also can take account of the “ordinary innovation” that does no more
`
`than yield predictable results, which are inferences and creative steps that one of
`
`ordinary skill in the art would normally employ.
`
`26.
`
`It is my understanding that one can consider factors such as
`
`interrelated teachings of multiple patents, the effects of demands known to the
`
`design community or present in the marketplace, and the background knowledge
`
`possessed by one of ordinary skill in the art to determine whether there was an
`
`apparent reason to have combined the known elements in the fashion claimed by
`
`the patent at issue. It is my understanding that a motivation that would have been
`
`known to one of ordinary skill in the art, including common sense, or derived from
`
`the nature of the problem to be solved, is sufficient to explain why prior art
`
`references would have been combined. It is my understanding that common sense
`
`teaches that familiar items may have obvious uses beyond the particular
`
`application being described in a reference. The prior art considered can be directed
`
`to any need or problem known in the field of endeavor at the time of the invention
`
`and can provide a reason for combining the elements of the prior art in the manner
`
`claimed in the patent.
`
`8
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`27. When there is such a design need or market pressure to solve a
`
`problem, and there are a finite number of identified, predictable solutions, one of
`
`ordinary skill in the art would have had good reason to pursue the known options
`
`within their technical grasp. If this leads to the anticipated success, it is likely the
`
`product of ordinary skill and common sense. The fact that a particular
`
`combination of prior art elements was “obvious to try” may indicate that the
`
`combination was obvious even if no one attempted the combination.
`
`28.
`
`It is my understanding that a reference may “teach away” from the
`
`claimed inventions and therefore preclude a determination that the reference
`
`renders the claimed invention obvious. It is my understanding a reference that
`
`“teaches away” one of ordinary skill in the art, upon reading the reference, would
`
`be discouraged from following the path set out in the reference. Said in another
`
`way, a reference that “teaches away” would have led one of ordinary skill in the art
`
`in a direction divergent from the path that was taken by the patentee. However, it
`
`is also my understanding that the mere disclosure of alternative designs in a
`
`reference does not necessarily teach away, nor does teaching away apply simply
`
`because a combination may be inferior as compared to better alternatives in the
`
`prior art.
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`III. THE ’714 PATENT
`
`A.
`
`29.
`
`Effective Filing Date of the ’714 Patent
`
`The ’714 Patent was filed as the ’486 Application on June 7, 1995.
`
`The face of the ’714 Patent states that it is a continuation-in-part of application No.
`
`08/428,662 (“the ’662 Application), filed April 25, 1995.
`
`30.
`
`It is my understanding based on this chain of priority that the earliest
`
`effective filing date to which the ’714 Patent can claim is April 25, 1995. It is my
`
`understanding that the claims of the ’714 Patent are only entitled to this date if the
`
`’662 Application provides sufficient disclosure of the claimed invention. For
`
`purposes of my analyses herein, I have used April 25, 1995 as the effective filing
`
`date of the ’714 Patent for purposes of determining whether a reference in prior art.
`
`B.
`
`Description of the Background Technology Relevant to the ’714
`Patent
`
`31.
`
`The ’714 Patent is directed to “the application of data storage
`
`technology to molecular tracking and identification.” ’714 Patent col. 1, ll. 11-12.
`
`Examples of known assays or analyses that employ molecular tracking and
`
`identification include hybridization reactions, immunoassays, and the
`
`characterization of combinatorial libraries. ’714 Patent col. 1, l.58 to col. 4, l. 36.
`
`32. Hybridization assays were a known method to detect or quantify
`
`target nucleic acid in a sample. ’714 Patent col. 1, ll. 59-61. In a nucleic acid
`
`hybridization assay, detection oligonucleotides having a particular nucleic acid
`
`10
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`sequence will hybridize to a complementary target oligonucleotide, if present in
`
`the sample. ’714 Patent col. 1, ll. 59-63. A reporter agent or label, such as a
`
`radioisotope, a fluorogenic molecule, a chromogenic molecule, or an enzyme can
`
`be attached to either the detection or target oligonucleotide. ’714 Patent col. 1, l.
`
`63 to col. 2, l. 4. The ’714 Patent also teaches that it was known to immobilize the
`
`target or detection nucleic acid on solid supports, such as polystyrene latex
`
`microspheres, in order separate the hybridized complex from the reaction mixture
`
`and any unhybridized components. ’714 Patent col. 2, ll. 5-23. The ’714 Patent is
`
`critical of known prior art hybridization techniques that “ . . . must be subject to
`
`analyses, such as sequencing,” to identify the target nucleic acid sequence. ’714
`
`Patent col. 1, l. 59 to col. 2, l. 29.
`
`33. However, as of the earliest priority date for the ’714 Patent, which I
`
`have assumed to be April 25, 1995 for purposes of this declaration, one of ordinary
`
`skill in the art would have been familiar with a variety of methods for identifying a
`
`target sequence using a detection oligonucleotide of known sequence and a
`
`technique for uniquely identifying a solid support associated with the target
`
`sequence. For example, two prior art references are U.S. Patent No. 6,087,186
`
`(“Cargill”) and publication WO 93/06121 (“Dower), both of which disclose a solid
`
`synthesis support that uses an identifier tag to identify a molecule linked to the
`
`11
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`support, such as a detection oligonucleotide used in hybridization assays, within a
`
`complex biological sample or used for multianalyte analysis.
`
`34.
`
`Immunoassays were known methods to detect and/or quantitate
`
`antigens found in a biological sample, such as blood. ’714 Patent col. 2, l. 31 to
`
`col. 3, l. 11. Similar to the hybridization assay, an immunoassay involves two
`
`complementary molecules that bind to form a complex: in this case, it is an
`
`antigen-antibody pair. ’714 Patent col. 2, l. 43 to col. 3, l. 1. Immunoassays
`
`typically involve contacting known, labelled antibodies with a sample and
`
`determining whether any antibody-antigen pairs formed. ’714 Patent col. 2, l. 43
`
`to col. 3, l. 1. The ’714 Patent is critical of known prior art immunoassay
`
`techniques as not providing for the simultaneous quantitation of multiple analytes.
`
`35. However, as of the earliest priority date for the ’714 Patent, which I
`
`have assumed to be April 25, 1995 for purposes of this declaration, one of ordinary
`
`skill in the art would have been familiar with a variety of methods for uniquely
`
`identifying and quantifying the specific antigen-antibody pairs in a sample
`
`contacted with multiple antibodies. For example, Cargill discloses linking antigens
`
`to memory devices in order to track which of multiple antigens have bound to
`
`antibodies in the sample. Cargill col. 23, ll. 12-25. As another example, U.S.
`
`Patent No. 4,499,052 (“Fulwyler”) describes the use of solid supports with unique
`
`12
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`pre-selected ratios of fluorescent dyes to track which of multiple antibodies bind to
`
`antigens in the sample.
`
`36.
`
`The ’714 Patent also relates to the known field of combinatorial
`
`libraries. ’714 Patent col. 3, l. 13 to col. 4, l. 48. Combinatorial libraries are
`
`mixtures of thousands or millions of synthesized compounds, usually peptide or
`
`nucleic acid oligomers, that may interact with a target of interest. ’714 Patent col.
`
`3, ll. 22-37. The libraries are usually synthesized on solid supports, but each
`
`individual library member is present in very low concentrations, such that
`
`identifying the structure of an individual library member is very difficult. ’714
`
`Patent col. 4, ll. 4-8.
`
`37. However, as of the earliest priority date for the ’714 Patent, which I
`
`have assumed to be April 25, 1995 for purposes of this declaration, one of ordinary
`
`skill in the art would have been familiar with a variety of methods for identifying
`
`and tracking individual members of a combinatorial library. For example, Cargill
`
`and Dower both disclose a solid synthesis support that uses an identifier tag to
`
`identify each step of the synthesis of a molecule associated with that support.
`
`Individual library members can thus be identified and tracked by reading the
`
`information stored in the identifier tag.
`
`13
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`C.
`
`The Person Of Ordinary Skill In The Art
`
`38. One of ordinary skill in the art at the time of the alleged invention of
`
`the ’714 Patent would have had at least a bachelor’s degree in chemistry,
`
`biochemistry, molecular biology, engineering or an equivalent discipline, and at
`
`least two years of experience in the laboratory with chemical synthesis and/or
`
`molecular biology assays and/or immunoassays, or the like that involve tags such
`
`as fluorescent dyes and/or microchips.
`
`D.
`
`39.
`
`Technical Overview of the ’714 Patent
`
`The ’714 Patent “relates to the application of data storage technology
`
`to molecular tracking and identification.” ’714 Patent col. 1, ll. 11-12.
`
`Specifically, the ’714 Patent purports to teach combining a matrix with a recording
`
`device to label molecules or biological particles by programming a memory in the
`
`recording device with information that identifies a molecule or biological particle
`
`that is in proximity or physical contact with the combination. See ’714 Patent,
`
`abstract.
`
`40.
`
`To understand the application of data storage technology to molecular
`
`tracking and identification, the ’714 Patent provides definitions and examples for a
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`number terms. For example, the ’714 Patent describes the combination of a
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`“matrix with memory,” (also referred to as a “matrix with a memory”) or
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`combinations of “matrices with memories.” ’714 Patent at abstract; col. 4, ll. 51-
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`56; col. 5, l. 59 to col. 6, l. 3; col. 11, ll. 18-26; col. 32, ll. 39-62.
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`41.
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`The ’714 Patent expressly defines a “matrix with a memory” as “a
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`combination of a matrix with a miniature recording device that stores multiple bits
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`of data by which the matrix may be identified, preferably in a non-volatile memory
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`that can be written to and read from by transmission of electromagnetic radiation
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`from a remote host, such as a computer.” ’714 Patent col. 11, ll. 20-25.
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`42.
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`The ’714 Patent describes the linking of a “molecule” and “biological
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`particle” or “molecules and biological particles” to one or more combinations of
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`matrices with memories. ’714 Patent at abstract, col. 6, ll. 19-41; col. 9, l. 50 to
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`col. 10, l. 11; col. 12, l. 62 to col. 13, l. 6; col. 27, ll. 4-8; col. 31, ll. 40-67; col. 32,
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`ll. 39-62; col. 34, ll. 19-25; Figures 1-4.
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`43.
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`The ’714 Patent further describes “programming,” by which
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`information or data—regarding the identity of the molecule or biological particle
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`linked to the matrix with memory or the tracking of the synthetic history of the
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`molecule linked to the matrix with memory—is entered and stored in memory.
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`’714 Patent at abstract; col. 1, 11-33; col. 4, ll. 51-56; col. 7, l. 24 to col. 8, l. 3;
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`col. 8, l. 66 to col. 9, l. 8; col. 12, ll. 45-54; col. 21, ll. 37-56; col. 32, ll. 1-8; col.
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`34, ll. 7-35. For example, the ’714 Patent discloses a matrix with memory linked
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`to an organic monomer, followed by stepwise addition of functional groups R1, R2
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`and R3. Corresponding information 1, 2, and 3 can be programmed into the
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`memory to record the addition of R1, R2, and R3, respectively. ’714 Patent col. 9, l.
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`66 to col. 10, l. 11. Accordingly, the memory can be programmed to store bits of
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`data that identify the specific molecule attached thereto.
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`44.
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`The ’714 Patent describes a “data storage unit with programmable
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`memory” (the unit is also referred to as “data storage device,” “data storage
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`memory,” or “memory device”) that records information or data to a storage unit
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`regarding the identity or synthetic history of the molecule or biological particle
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`linked to the matrix with memory. ’714 Patent at abstract; col. 1, 11-33; col. 4, ll.
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`51-56; col. 5, ll. 29-50; col. 9, l. 49 to col. 10, l. 17; col. 11, ll. 27-29; col. 11, ll.
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`48-54; col. 16, l. 63 to col. 18, l. 30; col. 21, l. 5 to col. 22, l. 5; Figures 1-6.
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`45.
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`The ’714 Patent describes a “recording device,” which is an apparatus
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`that includes a data storage unit with programmable memory and is also capable of
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`receiving information and transmitting information that has been recorded. ’714
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`Patent at abstract; col. 4, ll. 51-56; col. 5, l. 1 to col. 7, l. 10; col. 10, ll. 12-17; col.
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`11, ll. 38-47; col. 12, ll. 9-15; col. 23, l. 12 to col. 28, l. 52; Figures 5 & 6.
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`46.
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`The ’714 Patent describes assays that are performed on one or more
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`matrices with memories that are linked with molecules and biological particles
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`with programmed memories. ’714 Patent at abstract; col. 7, ll. 31-35; col. 8, ll.
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`4-10; col. 8, ll. 21-44; col. 9, ll. 34-47; col. 13, ll. 23-31; col. 13, ll. 57-63; col. 31,
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`ll. 10-39; col. 33, l. 36 to col. 37, l. 50.
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`47.
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`The ’714 Patent teaches that such matrices with memory linked to
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`different molecules can be used in applications such as immunoassays, drug
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`screening assays, combinatorial chemistry protocols, high throughput screening
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`applications and multianalyte analyses. ’714 Patent col. 8, ll. 25-27.
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`48.
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`The ’714 Patent describes systems and methods for recording and
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`reading or retrieving the information in the data storage units regarding the identity
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`or synthesis history of molecules or biological particles linked to matrices with
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`memories. ’714 Patent col. 8, ll. 45-65; col. 10, ll. 15-24; col. 21, ll. 16-27; col. 29,
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`l. 1 to col. 30, l. 17; col. 30, ll. 43-67; Figures 7 & 8.
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`E.
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`49.
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`Prosecution History of the ’714 Patent
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`The ’714 Patent issued from the ’486 Application filed on June 7,
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`1995 as a continuation-in-part of the ’662 Application that was filed on April 25,
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`1995. In a first office action, all claims were rejected on multiple grounds. In
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`particular, the Examiner issued a 35 U.S.C. §112 first paragraph rejection, stating
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`in relevant part:
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`Applicant claims and discloses a method for electromagnetically
`tagging molecules comprising contacting the molecules with a matrix
`combination which is disclosed as a matrix with remotely addressable
`or remotely programmable recording devices that contain at least one
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`data storage unit . . . . A critical feature of the invention as disclosed
`in the abstract is that ‘By virtue of this combination, molecules and
`biological particles, . . . that are in proximity or in physical contact
`with the matrix combination can be labelled by programming the
`memory with identifying information and can be identified by
`retrieving the stored information.”
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`Ex. 1203, p. 163, April 9, 1996 Office Action (emphasis added). But the Examiner
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`concluded that the specification did not disclose what the labeling was or how it
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`occurred.
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`The specification teaches that antennae at the recording device may
`receive and store information but it is not clear what information is
`provided by an antigen’s binding and how this in [sic] translated to
`the to the [sic] recording device (and indeed what the information is
`– is it provided in the form of a label?)
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`Ex. 1203, p. 165, April 9, 1996 Office Action (emphasis added).
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`Many claims, including Claim 1, were also rejected, among other grounds,
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`under 35 U.S.C. §102 over U.S. Patent No. 5,252,962 to Urbas (“the ’962 Patent”)
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`(Exhibit 1008). Then-pending Claim 1 recited:
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`1. A combination of a matrix with memory, comprising:
`(A) a recording device, comprising a data storage unit; and
`(B) a matrix material, wherein:
`the device is less than about 10 mm3 in size;
`the matrix material is either comprised of particles of a size
`such that at least dimension is no more than 100 mm or the
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`matrix material is in the form of a container used for chemical
`syntheses; and
`the recording device is in contact with the matrix or in a
`solution that is in contact with the matrix.
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`Ex. 1203, p. 74, ’662 Application. The Examiner concluded that the ’962 Patent
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`disclosed, among other things, that
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`Urbas et al. teaches a passive transponder which includes a receive
`antenna for receiving an input signal. A frequency generator and
`modulator receives the input signal and outputs a data car