UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`
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`THERMO FISHER SCIENTIFIC INC.
`Petitioner
`
`v.
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`Bio-Rad Laboratories, Inc.
`Patent Owner
`
`
`Patent No. 8,236,504
`Issued: August 7, 2012
`Filed: June 30, 2010
`Inventors: Kordunsky et al.
`
`Title: SYSTEMS AND METHODS FOR FLUORESCENCE DETECTION
`WITH A MOVABLE DETECTION MODULE
`
`
`Inter Partes Review No. IPR2017-00054
`_______________
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`DECLARATION OF RICHARD MATHIES, PH. D.
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`THERMO FISHER EX. 1002
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`TABLE OF CONTENTS
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`I.
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`Overview and summary of opinions ................................................................ 1
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`II. My background and qualifications .................................................................. 2
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`III. List of documents I considered in formulating my opinions........................... 5
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`IV. Person of ordinary skill in the art .................................................................... 8
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`V.
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`State of the art before May 8, 2003 ................................................................. 9
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`VI. Overview of the '504 Patent...........................................................................10
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`VII. Claim construction .........................................................................................12
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`VIII. Claims 1-3, 6-11, 13-17 and 19-22 are not entitled to priority before their
`actual filing date of June 30, 2010 .................................................................15
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`IX. Basis of my analysis with respect to anticipation ..........................................23
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`X.
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`Basis of my analysis with respect to obviousness and objective indicia of
`nonobviousness ..............................................................................................23
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`XI. Summary of Grounds .....................................................................................25
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`XII. Ground 1: Claims 1-3, 6-11, 13-17, 19, 20 and 22 are anticipated by
`Kordunsky PCT .............................................................................................26
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`XIII. Ground 2: Claim 21 would have been obvious over Kordunsky PCT in
`view of Li .......................................................................................................34
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`XIV. Ground 3: Claims 1-3, 6-7, 9, 13-14, 16 and 19-22 would have been
`obvious over Li ..............................................................................................36
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`XV. Ground 4: Claims 8, 10 and 15 would have been obvious over Li and
`Heffelfinger ....................................................................................................55
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`XVI. Ground 5: Claims 11 and 17 would have been obvious over Li and Miller .56
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`XVII. Objective indicia of nonobviousness .............................................................57
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`XVIII. Conclusion ....................................................................................................59
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`I, Richard Mathies, hereby declare as follows.
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`I.
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`Overview and summary of opinions
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`1.
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`I am over the age of eighteen (18) and otherwise competent to make
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`this declaration.
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`2.
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`I have been retained as an expert witness on behalf of THERMO FISHER
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`SCIENTIFIC INC. for the above-captioned inter partes review (IPR). I am being
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`compensated for my time in connection with this IPR at my standard consulting
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`rate, which is $500 per hour. I understand that the petition for inter partes review
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`involves U.S. Patent No. 8,236,504 ("the '504 Patent"), Ex. 1001. The '504 Patent,
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`entitled "Systems and methods for fluorescence detection with a movable detection
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`module," issued on Aug. 7, 2012, from U.S. App. No. 12/827,521, which was filed
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`on Jun. 30, 2010. Ex. 1001. The '504 Patent claims priority to App. No. 11/555,642
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`filed Nov. 1, 2006, which is a continuation of App. No. 10/431,708, filed May 8,
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`2003. Id., Ex. 1007; Ex. 1031. I further understand that, according to the first page
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`of the patent, the '504 Patent is assigned to Bio-Rad Laboratories, Inc. ("the
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`patentee"). I understand that the earliest asserted priority date for the '504 Patent is
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`May 8, 2003.
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`3.
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`In preparing this Declaration, I have reviewed the '504 Patent, its file
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`history (Ex. 1004), and considered each of the documents cited herein, in light of
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`general knowledge in the art (i.e., field) before May 8, 2003. In formulating my
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`opinions, I have relied upon my more than 40 years' experience, education, and
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`knowledge in the relevant art. In formulating my opinions, I have also considered
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`the viewpoint of a person of ordinary skill in the art ("artisan") before May 8,
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`2003.
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`4.
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`It is my opinion that the claims of the '504 Patent would have been
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`obvious in view of prior art as discussed in more detail below.
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`5.
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`Further, I have reviewed the '504 Patent file history (Ex. 1004), and I
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`am not aware of any objective indicia of nonobviousness that would support
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`patentability of the claims of the '504 Patent.
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`II. My background and qualifications
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`6.
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`I am an expert in the design of analytical instruments for fluorescence
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`detection in biological applications, including thermal cyclers. I have been an
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`expert in this field since well before 2003. In particular, I have worked on the
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`development and optimization of fluorescence scanning detectors since 1990 and
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`have extensively applied this technology to the detection of capillary array
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`electrophoresis DNA sequencing and to fluorescence detection of DNA in gels and
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`in microtitre plates. I am also expert in the development of chip-based PCR
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`systems coupled to electrophoresis analysis by fluorescence scanners for fragment
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`sizing and sequencing as illustrated by many publications including 193, 255, 258,
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`334, 341, 348, and 387 in my attached publication list. Ex. 1003.
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`7.
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`I am presently Professor of the Graduate School, University of
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`California, Berkeley, and have been in this position since 2013. I have served at the
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`University of California, Berkeley since 1976, where before my current position I
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`was Dean, College of Chemistry (2008-2013), Director of the Center for Analytical
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`Biotechnology (2003-2008), Professor of Chemistry (since 1986), Associate
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`Professor of Chemistry, (1982-1986), and Assistant Professor of Chemistry, (1976-
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`1982). My prior work experience is listed on my CV. Ex. 1003.
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`8.
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`I earned a B. S. in Chemistry from the University of Washington
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`(1968), an M. S. in Physical Chemistry from Cornell University (1970) and a Ph.
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`D. in Physical Chemistry from Cornell University (1974). Ex. 1003.
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`9.
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`Throughout my career, I have published over 450 scientific articles
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`and books or book chapters on topics such as analytical instrumentation design,
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`including fluorescence detectors and thermal cyclers. I regularly attend scientific
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`and technology conferences where I interact with others in the fields of optics,
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`physics, engineering (e.g., mechanical, electrical or structural), analytical or
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`physical chemistry, chemistry, biology or a related field in the engineering,
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`biological or chemical sciences. A list of my publications and presentations is
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`found in my curriculum vitae. Ex. 1003.
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`10.
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`I have received several honors in my career related to my research and
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`contributions to the field of analytics and instrumentation. For example, I am a
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`Fellow of the National Academy of Inventors (NAI) (2015), G. N. Lewis Professor
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`of Chemistry (2008-2013), G. F. Smith Memorial Lecturer, Univ. of Illinois at
`
`Urbana (2011), ACS Analytical Division Award in Chemical Instrumentation
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`(2010), Dole Lectures in Physical Chemistry, Northwestern Univ. (2010), Fellow
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`of the Society for Applied Spectroscopy (2008), First Dow Harvard-MIT Lecturer
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`(2007), Eli Lilly/Indiana University Distinguished Lecturer (2006), Invited
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`Member, Royal Society of Chemistry (2005), Fellow of Optical Society of
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`America (2004), Kolthoff Lectures, University of Minnesota (2004), Ellis R.
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`Lippincott Award from Optical Society of America (2004), Association for
`
`Laboratory Automation (2001) Research Award (2001), Frederick Conference on
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`Capillary Electrophoresis Award (1998), A. D. Little Lectures, Massachusetts
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`Institute of Technology (1998), Millner Memorial Lecturer, Duke University
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`(1997), First Carl Rollinson Memorial Lecturer, University of Maryland (1996),
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`(1995) Reilly Lecturer in Physical Chemistry, University of Notre Dame (1995).
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`Ex. 1003.
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`11. Thus, throughout my career, I have had extensive experience in the
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`design or manufacture of biological analysis instruments, including optical
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`components for fluorescence detection, for example in thermocyclers and scanners.
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`In view of my education, experience, and expertise described above, I am an expert
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`in the field of optical detection devices, including in thermal cyclers.
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`III. List of documents I considered in formulating my opinions
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`12.
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`In formulating my opinions, I considered all of the references cited in
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`this Declaration, including the documents listed below.
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`Exhibit No.
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`Description
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`1001
`
`1002
`1003
`1004
`1005
`
`1006
`
`1007
`
`1008
`
`1009
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`1010
`
`1011
`
` Kordunsky et al., “Systems and methods for fluorescence detection
`with a movable detection module” U.S. Patent No. 8,236,504
`(Filed: Jun. 30, 2010; Issued: Aug. 7, 2012)
` Declaration of Professor Richard Mathies
` Curriculum Vitae of Professor Richard Mathies
` File History for U.S. Patent No. 8,236,504
` Li, et al. “Fluorescence quantitative PCR analyzing system”
`Chinese Publication No. CN1379236 (Filed: Apr. 12, 2001;
`Published: Nov. 13, 2002)
` Certified Translation of Li, et al. “Fluorescence quantitative PCR
`analyzing system” Chinese Publication No. CN1379236 (Filed:
`Apr. 12, 2001; Published: Nov. 13, 2002) (Certification Document
`Included)
` U.S. Patent Application No. 11/555,642 filed Nov. 1, 2006
`Kordunsky et al., “Systems and methods for fluorescence detection
`with a movable detection module”
` Mitoma, et al., “Fluorescence detecting apparatus” U.S. Patent
`6,144,448 (Filed: Oct. 30, 1996; Issued: Nov. 7, 2000)
` Kordunsky, et al. “Systems and methods for fluorescence detection
`with a movable detection module” International Publication No.
`WO2004/104547 (Filed: May 10, 2004; Published: Dec. 2, 2004)
` Pantoliano, et al., “Method for identifying lead compound”
`U.S. Patent 6,303,322 (Filed: Jan. 5, 2000; Issued: Oct. 16,
`2001)
` Oldham, et al. “Scanning system and method for scanning a
`plurality of samples” International Publication No.
`WO02/06796 (Filed: Jul. 13, 2001; Published: Jan. 24,
`2002)
`
`
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`Exhibit No.
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`Description
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`1012
`
`1013
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`1024
`
`1025
`1026
`
` Ririe, et al. “Thermal cycling system and method of use”
`International Publication No. WO03/007677 (Filed: Jul. 16,
`2002; Published: Jan. 30, 2003)
` Wittwer, et al. “Multiplex genotyping using fluorescent
`hybridization probes” U.S. Patent 6,140,054 (Filed: Sep. 30,
`1998; Issued: Oct. 31, 2000)
` Berndt, et al. “System for detecting bacterial growth in a
`plurality of culture vials” U.S. Patent 5,595,708 (Filed: Nov.
`18, 1994; Issued: Jan. 21, 1997)
` Heffelfinger, et al., “Multi parameter scanner” U.S. Patent No.
`6,043,506 (Filed: Dec. 30, 1997; Issued: Mar. 28, 2000)
` Iwasaki, et al., “DNA chip reading head and DNA chip reader”
`Japanese Publication No. JP2001-242081 (Filed: Feb. 29, 2000;
`Published: Sep. 7, 2001)
` Certified Translation of Iwasaki, et al., “DNA chip reading head
`and DNA chip reader” Japanese Publication No. JP2001-242081
`(Filed: Feb. 29, 2000; Published: Sep. 7, 2001) (Certification
`Document Included)
` Perov, et al. “Biochip scanner device” U.S. Patent 6,329,661
`(Filed: Feb. 29, 2000; Issued: Dec. 11, 2001)
` Cunanan, et al. “Scan head microplates” U.S. Patent 6,024,920
`(Filed: Apr. 14, 1999 Issued: Feb. 15, 2000)
` Giebeler, et al. “Optical system for a scanning fluorometer”
`U.S. Patent 6,316,774 (Filed: Mar. 23, 1999; Issued: Nov. 13,
`2001)
` Hueton, et al. “High-speed fluorescence scanner” U.S. Patent
`5,459,325 (Filed: Jul. 19, 1994; Issued: Oct. 17, 1995)
` Fernandes, et al. “Mutli[sic.]-functional photometer with movable
`linkage for routing optical fibers” U.S. Patent 5,436,718 (Filed: Jul.
`30, 1993; Issued: Jul. 25, 1995)
` Diggle, et al. “Automation of Fluorescence-Based PCR for
`Confirmation of Meningococcal Disease” Journal of Clinical
`Microbiology, Vol. 39, No. 12, 2001, pp. 4518-4519
` Bio-Tek FL600 “Fluorescence Plate Reader” Hardware Guide,
`Bio-Tek Instruments, Inc., Part No. 6001000, Jun. 1998, Revision
`D
` File History for U.S. Patent No. 8,835,118
` Kordunsky, et al. “Systems and methods for fluorescence detection
`
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`Exhibit No.
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`Description
`
`with a movable detection module” U.S. Patent 7,148,043 (Filed:
`May 8, 2003; Issued: Dec. 12, 2006)
` Reid, et al. “Side-wall heater for thermocycler device” U.S.
`Publication No. 2003/0106682 (Filed: Oct. 1, 2002; Published: Jun.
`12, 2003)
` Higuchi, et al. “Monitoring multiple reactions simultaneously and
`analyzing same” European Patent No. EP0640828 (Filed: Aug. 16,
`1994; Issued: Jun. 10, 2000)
` Miller, et al., “Compact scan head with multiple scanning
`modalities” U.S. Patent No. 5,528,050 (Filed: Jul. 24, 1995;
`Issued: Jun. 18, 1996)
` Constans, A. “Some Like It Hot: A Thermal Cycler Roundup” The
`Scientist, Vol. 15, Issue 24, Dec. 10, 2001, pp. 32-35
` U.S. Patent Application No. 10/431,708 filed May 8, 2003
`Kordunsky et al., “Systems and methods for fluorescence detection
`with a movable detection module”
` Heffelfinger, et al. “Tunable excitation and/or tunable detection
`microplate reader” U.S. Patent 5,784,152 (Filed: Oct. 11, 1996;
`Issued: Jul. 21, 1998)
` Woudenberg, et al. “System for real time detection of nucleic acid
`amplification products” U.S. Patent No. 5,928,907 (Filed: Dec. 2,
`1996; Issued: Jul. 27, 1999)
` Fitzgerald, D. “Up to Speed on PCR” The Scientist, Vol. 14, Issue
`23, Nov. 27, 2000, pp. 31-33
` Lauermann, L. “Advances in PCR Technology” Animal Health
`Research Reviews, Vol. 5, Issue 2, Dec. 2004, pp. 247-248
` Meisenholder, G. “New Lids on the Block - LabConsumer Annual
`Review of Thermal Cyclers” The Scientist, Vol. 13, Issue 23, Nov.
`22, 1999, pp. 17-19
` Ackley, et al. “Generic handheld symbology scanner with modular
`optical sensor” U.S. Patent 6,003,775 (Filed: Jun. 11, 1997; Issued:
`Dec. 21, 1999)
` Kawakami, H. “Carriage and recording apparatus” U.S. Patent
`6,520,625 (Filed: Aug. 17, 2000; Issued: Feb. 18, 2003)
`
`1027
`
`1028
`
`1029
`
`1030
`
`1031
`
`1032
`
`1033
`
`1034
`
`1035
`
`1036
`
`1037
`
`1038
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`IV. Person of ordinary skill in the art
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`
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`13. A person of ordinary skill in the art ("artisan") is a hypothetical
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`person who is presumed to be aware of all pertinent art, thinks along conventional
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`wisdom in the art, and is a person of ordinary creativity. An artisan in the technical
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`field of the '504 Patent –optical detection devices, including in thermal cyclers –
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`would have had knowledge of the scientific literature concerning the design and
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`manufacture of analytical instruments for biological applications, which included
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`optical detection devices and scanning assemblies, including but not limited to
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`thermal cyclers, sequencers, microarray readers, fluorimeters, plate readers and
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`scanners, before May 8, 2003.
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`14. With respect to the subject matter of the '504 Patent, an artisan would
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`typically have had (i) an undergraduate degree (e.g., B.Sc. or B.A.) in optics,
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`physics, engineering (e.g., mechanical, electrical or structural), analytical or
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`physical chemistry, chemistry, biology or a related field in the engineering,
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`biological or chemical sciences, and have had at least about one year of experience
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`in the design or manufacture of biological analysis instruments, including optical
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`components for fluorescence detection, for example in thermocyclers and scanners.
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`Also, an artisan may have worked as part of a multidisciplinary team and drawn
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`upon not only his or her own skills, but of others on the team, e.g., to solve a given
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`problem. For example, a physicist, biologist, chemist and/or an optical engineer
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`may have been part of a team.
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`V.
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`State of the art before May 8, 2003
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`15.
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`I understand that the face of the '504 Patent claims priority to U.S.
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`patent App. No. 11/555,642 filed Nov. 1, 2006, which is a continuation of App.
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`No. 10/431,708, filed May 8, 2003. Ex. 1001, p. 1, section (60). Therefore, the
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`following overview and discussion throughout this Declaration presents the state of
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`the art before May 8, 2003.
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`16. Before May 8, 2003, the skill level and knowledge of an artisan was
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`exceptionally deep and rich with respect to the use of optics heads and scanning
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`assemblies in real-time cyclers. Thermal cyclers were not merely a matter of
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`academic interest, but part of everyday life to artisans since advent of "end point"
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`PCR in the mid-1980s, and of real-time PCR in the 1990s (i.e., quantitative PCR
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`involving optical detection during the course of the reaction). Ex. 1034, 1; Ex.
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`1035, 1; Ex. 1036, 17; Ex. 1030, 1. Thermal cyclers were found in every lab and
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`clinic, and typically were one of the most-used instruments there. Id.
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`17. Artisans familiar with real-time cyclers would have found it obvious
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`that the support should be attached to the cycler in order to work effectively as a
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`support for a moving head. More than a dozen prior-art references disclosed
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`scanning assemblies for moving an optical detector. Ex. 1010, Figs. 30-36, cols.
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`35-36; Ex. 1011, 9:23-32; Ex. 1012, 17:13-24, Fig. 5-6; Ex. 1013, 11:24-34, Fig.
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`10; Ex. 1014, 2:1-3:65, Fig. 1B; Ex. 1015, 9:27-60, Figs. 1, 4; Ex. 1016, Fig. 6; Ex.
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`1017, ¶¶72-75, Fig. 6; Ex. 1018, Abstract, 4:39-41, Fig. 1; Ex. 1019, 3:1-4:65,
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`Figs. 1-2; Ex. 1020, 11:6-12:65, Figs. 11-15; Ex. 1021, 3:1-65, Fig. 1; Ex. 1022,
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`4:13-26, Fig. 1; Ex. 1023, 4518; Ex. 1024, p. 3-10, Fig. 3-6. Five of these prior-art
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`scanning assemblies were used to move an optical module to scan samples in a
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`thermal cycler. Ex. 1010, Figs. 30-36, cols. 35-36; Ex. 1011, 9:23-32; Ex. 1012,
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`17:13-24, Fig. 5-6; Ex. 1013, 11:24-34, Fig. 10; Ex. 1023, 4518; Ex. 1024, p. 3-10,
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`Fig. 3-6. Scanning assemblies were readily available on the market for routine
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`combination with a detector of choice. Ex. 1018, Fig. 1, Abstract, 4:39-41; Ex.
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`1022, 4:13-26, Fig. 1. Thus, it was a well-known and even typical practice to
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`mount a movable shuttle on a support to provide a convenient attachment site for
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`an optics head for scanning sample wells in a thermal cycler.
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`VI. Overview of the '504 Patent
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`18.
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`I understand that this Declaration is being submitted together with a
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`petition for inter partes review of claims 1-3, 6-11, 13-17 and 19-22 of the '504
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`Patent. I have reviewed the '504 Patent, its file history, and the applications to
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`which the '504 Patent claims priority. Ex. 1001, Ex. 1004, Ex. 1007, Ex. 1031. In
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`assessing the '504 Patent, I have considered the teachings of the scientific literature
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`before May 8, 2003, in light of general knowledge in the art before that date.
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`19. The '504 Patent claims are directed to a thermal cycler with a movable
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`detection module which contains an internal light generator and a detector
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`(hereafter, "optics head"), attached to a shuttle movably mounted on a support,
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`where the optics head views sample wells through openings in a heating element.
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`20. The '504 Patent has 22 claims. Claims 1 and 13 are the only
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`independent claims. Each claim of the '504 Patent requires the presence of a self-
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`contained movable "detection module" ("optics head") which contains both a light
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`generator and a detector within its housing. Claim 1 is exemplary and is provided
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`below:
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`1. A fluorescence detection apparatus for analyzing samples
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`located in a plurality of wells in a thermal cycler, the apparatus
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`comprising:
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`a support structure attachable to the thermal cycler;
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`a shuttle movably mounted on the support structure; and
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`a detection module attached to the shuttle, the detection
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`module including:
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`a housing having an opening oriented toward the plurality
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`of wells;
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`an excitation light generator disposed within the housing;
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`and
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`an emission light detector disposed within the housing,
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`wherein, when the support structure is attached to the
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`thermal cycler, a heating element is disposed between the
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`detection module and the sample wells and the shuttle is
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`movable
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`to position
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`the detection module
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`in optical
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`communication with different wells of the plurality of wells
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`through a plurality of openings extending through the heating
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`element.
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`21.
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`Independent claim 13 is similar to claim 1, but indicates that the
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`cycler has an "exterior housing." Ex. 1001, claim 13.
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`Ex. 1001, claim 1.
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`22.
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`I understand that claims 2 to 12 are "dependent" from claim 1 because
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`they refer directly to claim 1. Ex. 1001. I also understand that claims 4 and 5 are
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`dependent from claim 3 because each of these claims refers directly to claim 3.
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`VII. Claim construction
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`23.
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`I understand that terms of the claims are to be given their broadest
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`reasonable interpretations in light of the '504 Patent's specification. I also
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`understand that the prosecution history of the patent should be consulted in
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`determining claim meaning. I further understand that these terms should be given a
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`meaning consistent with how they would be viewed by an artisan before May 8,
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`2003, and my analyses below are presented from such a viewpoint. Any term I
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`have not expressly interpreted below, I have given its broadest reasonable
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`interpretation consistent with the patent’s specification and the prosecution history.
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`24. Claim 1(h) recites "a heating element" with a plurality of openings,
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`and claim 13(b) recites a "heater" with a plurality of transparent portions, which
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`can be holes (see claim 22). The ‘504 specification only discusses one component
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`which has a plurality of openings or transparent portions - a “lid heater” with
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`“holes.” In particular, “[l]id heater 204 has holes 220 therethrough …and
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`electronically controlled heating elements (not shown).” Ex. 1001, 5:1-3. For
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`purposes of the instant petition only under the broadest reasonable interpretation,
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`the terms "heating element" (claim 1) and "heater" (claim 13) are treated as
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`equivalent. Under
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`the broadest
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`reasonable
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`interpretation,
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`this heating
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`element/heater includes but should not be limited to the "lid heater" discussed in
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`the '504 patent as part of an "exemplary" apparatus. Ex. 1001, 4:7-15, 4:37-66. The
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`'504 Patent discusses two components that have a heating function – namely, a
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`sample unit (i.e., thermal cycling block) and a "lid heater" placed on top of sample
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`tubes. Id. Under the broadest reasonable interpretation, either component could act
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`as a "heating element" (claim 1) or "heater" (claim 13) if it meets all the claim
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`requirements for this element. Claim 21 confirms that the "heater" (claim 13) or
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`"heating element" (claim 1) is not limited to the so-called "lid heater" which is only
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`described as placed on top of wells in the '504 Patent and its parent 11/555,642, as
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`discussed further in the section below regarding lack of priority. Ex. 1001, 4:37-39,
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`5:1-17, Figs. 2, 6. Claim 21 requires that (1) the optics head opening must be below
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`THERMO FISHER EX. 1002
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`the sample wells and (2) the optics head must view sample wells "through ... the
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`heater." Artisans would have understood that an optics head placed below sample
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`wells as required by claim 21 could not view the wells "through" the lid heater,
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`which is only described as necessarily placed on top of the wells. Thus, artisans
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`would have understood that the "heater" element of claims 13-22, and thus the
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`equivalent "heating element" of claims 1-12, have a broader reasonable
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`interpretation than the lid heater discussed in the '504 Patent, and are not limited to
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`such a lid heater. Id.
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`25. Claims 1 and 13 also recite that the cycler has “wells.” The ‘504
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`Patent does not define “wells” or otherwise place any constraints upon the exact
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`format of the well. The prior-art reference “Li” applied herein discloses a cycler in
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`which the sample wells have optical holes at the bottom (shown as element 21 in
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`Fig. 3) to allow Li's optics head to view samples through Li's cycling block. Ex.
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`1006. Under the broadest reasonable interpretation, the term “wells” includes
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`open-ended wells which have a “plurality of openings” that are optical holes at the
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`bottom. Under the broadest reasonable interpretation, the “wells” can be in
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`structural continuity or structural overlap with the openings. Id. Fig. 6 of the '504
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`Patent depicts wells (feature 210) forming a continuous channel with the openings
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`(feature 220) of the heating element, consistent with this interpretation. Ex. 1001,
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`Fig. 6.
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`VIII. Claims 1-3, 6-11, 13-17 and 19-22 are not entitled to priority before their
`actual filing date of June 30, 2010
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`26.
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`I understand that the face of the '504 Patent claims priority to U.S.
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`App. No. 11/555,642 filed Nov. 1, 2006 ("the Parent"). I also understand that, for
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`the '504 Patent to effectively claim priority to the Parent, the Parent must describe
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`the manner and process of making and using the invention in full, clear, concise,
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`and exact terms so that an artisan would have been able to make and use the
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`invention ("§112 support"). I also understand that the invention must be adequately
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`described in the Parent to convey to an artisan that the patent applicant actually
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`invented what is now claimed, i.e., had "possession" of the invention claimed in
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`the patent at the time the Parent was filed.
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`27. The '504 Patent was filed on June 30, 2010, and claims priority to
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`May 8, 2003, as a continuation of App. No. 11/555,642 filed Nov. 1, 2006, which
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`is a continuation of App. No. 10/431,708, filed May 8, 2003.
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`28. But claims 1-3, 6-11, 13-17 and 19-22 are not entitled to the priority
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`benefit of App. No. 11/555,642 filed Nov. 1, 2006 (hereafter, the "Parent"), and
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`thus are not entitled to any priority before their actual filing date of June 30, 2010.
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`This is because the Parent does not provide a written description of the claimed
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`apparatus that is commensurate with the '504 claims, and only describes a
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`particular embodiment that is narrower and differs from what is now claimed.
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`1) The term "heating element" (claim 1) or "heater" (claim 13)
`lacks written description support in the parent
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`29. All '504 claims recite an apparatus with a "heating element" (claim 1)
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`or "heater" (claim 13). These terms were introduced on March 12, 2012 – nearly
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`two years after the ’504 Patent was filed. The claims require that the heating
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`element is "disposed between the detection module and the sample [unit] wells"
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`(claim 1) or the heater has the sample unit/wells on one side and a support structure
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`with a detection module "on an opposite side" of the heater (claim 13). The claims
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`further specify that the heating element contains a "plurality of openings extending
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`through" it (claim 1) or a "plurality of transparent portions" (claim 13).
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`30.
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`In contrast to the claims which broadly cover an apparatus with any
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`heating element or heater, the Parent only discusses two structures with a heating
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`function – a thermal cycling block, termed "sample unit" by the Parent, and a "lid
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`heater." Ex. 1007, ¶¶26-32, 51, Figs. 2, 6. As explained below, the sample unit
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`described in the Parent does not meet the requirements of the claims, and the "lid
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`heater" does not provide commensurate support. Id..
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`31. The cycling block or "sample unit" discussed in the Parent clearly
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`does not match the claimed "heating element" (claim 1) or heater (claim 13). For
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`example, the Parent does not mention that the sample unit has a plurality of holes
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`(claim 1) or transparent portions (claim 13) through which the optics head can
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`view the wells. The Parent only discusses how the sample unit is part of "[l]id
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`assembly 112," and can contain "sample wells 210," as well as "heating elements."
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`Id.. The Parent further states that the sample unit "may be of conventional design"
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`and that "the base and sample unit may be designed as an integrated system or
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`separated," and that the optics head "may interrogate sample wells from any
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`direction (e.g., above or below) in accordance with the design of a particular
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`instrument." Id. at 31, 51, 80. None of these teachings discloses or suggests that the
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`sample unit has openings or transparent portions, or that wells can be viewed
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`through the sample unit as the claims require.
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`32.
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`In addition, the sample unit as described by the Parent does not have
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`the placement required by
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`the claims. The claims require
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`the heating
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`element/heater to be placed between the detection module and wells (claim 1) or to
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`be placed between the support and wells (claim 13). But the sample unit discussed
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`by the Parent is under all three structures – the sample wells, detection module and
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`support – and not between them. Ex. 1007, Figs. 2, 3.
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`33. The Parent also discusses an entirely different component within the
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`context of an exemplary apparatus – a "lid heater" – which is a single narrow
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`example of the generic heating element/heater recited in the claims. Ex. 1007,
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`¶¶27-32. In particular, the Parent does not support broad claims to any generic
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`heating element or heater since it only discloses a "lid heater" having one particular
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`structure and never suggests that this can be varied in any way.
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`34. Under its plain meaning, the term "lid heater" indicates that the heater
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`also serves as a lid, and this is specifically confirmed in the Parent. The Parent
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`unequivocally states that when present, the lid heater "is in place on the sample
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`unit" in order "to control the temperature of the sample caps" of reaction tubes and
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`thus "prevent condensation … on the caps." Ex. 1007, ¶¶29, 30, Figs. 2, 6.
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`Consistent with its stated function of heating tube caps, the lid heater is invariably
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`depicted as being directly on top of the sample unit directly over and in contact
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`with the tube caps, both in figures and words. Id. The Parent treats both the
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`positioning and contact as integral features of the lid heater, not merely optional or
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`even preferable. Id.
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`35.
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`In contrast, the '504 claims omit any mention of the heater acting as a
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`"lid heater" or otherwise being on top of the sample unit. This broadening in the
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`'504 claims is a material change, since the '504 claims now cover other different
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`heating elements, such as the thermal cycling block of the Li reference, discussed
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`below, in a manner that was not contemplated by the Parent. The Parent only
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`mentions in passing that the fluorometer assembly, which is described as including
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`the support, shuttle and detection module but not the heating element, can be
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`"adapted ... [to] interrogate sample wells from ... below." Ex. 1007, ¶¶ 27, 29, 32,
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`80. This narrow disclosure would not have conveyed what is now more broadly
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`claimed. Id.
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`THERMO FISHER EX. 1002
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`36. The claims now cover cyclers such as Li's which include new and
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`different types of heating elements, such as Li's perforated cycling block which
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`includes the claimed "openings" to allow wells to be viewed through it. In contrast,
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`the Parent describes the lid heater and the "sample unit"(i.e., cycling block) as two
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`separate components, never suggesting that the sample unit can pass as the claimed
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`heating element. Although the Paren