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`EX“ib”21°2 P3991
`
`Enzo Exhibit 2102
`BD v. Enzo
`Case |PR2017—00181
`
`Enzo Exhibit 2102
`BD v. Enzo
`Case IPR2017-00181
`
`Exhibit 2102 Page 1
`
`

`

`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Applicant(s):
`
`Stavrianopoulos et al.
`
`Serial No.:
`
`08/486,070
`
` \/é\/\.I%%§
`
`Filed:
`
`FOFZ
`
`June 7, 1995
`
`ARRAYS AND SYSTEMS COMPRISING
`ARRAYS FOR GENETIC ANALYSES AND
`OTHER APPLICATIONS
`
`Group Art Unit: 1631
`
`Ex'r: Ardin H. Marschel, Ph.D.
`
`60 Executive Boulevard
`
`Farmingdale, NY 11735-4716
`
`Mail Stop Non-Fee Amendment
`Commissioner of Patents
`P.O. Box 1450
`
`Alexandria, VA 22313-1450
`
`DECLARATION OF DR. DOLLIE M. W. KIRTIKAR UNDER 37 C.F.R. §1.132
`
`I, Dollie M. W. Kirtikar, hereby declare as follows:
`
`BA CKGROUND
`
`1.
`
`I am presently Senior Scientist for Enzo Biochem, lnc., 60 Executive
`
`Boulevard, Farmingdale, New York 11735-4716, having held that position since 1997.
`
`Prior to my present position, I was Research Scientist for Enzo, having been first hired
`
`in February 1979. During the early 1990s, I held other positions within Enzo or its
`
`subsidiaries, including Production Manager and Supervisor of QA/QC. My professional
`
`experience is listed on my curriculum vitae attached as Exhibit 1.
`
`2.
`
`In terms of my education, I received my Bachelor of Science (B.Sc.) with
`
`honors from the University of Bombay, Bombay, India in 1952, graduating with a major
`
`in microbiology and a minor in chemistry.
`
`In 1957, I received a Master of Science
`
`(M.Sc.) from the Seth C.S. Medical College, University of Bombay.
`
`In 1967, lwas
`
`awarded a Doctor of Philosophy (Ph.D) from the University of Kansas. My doctoral
`
`thesis was titled “Phenotypic Transformation.”
`
`Enz-7(P)(C3)
`
`Exhibit 2102 Page 2
`
`Exhibit 2102 Page 2
`
`

`

`Stavrianopoulos et al.
`Serial No. 08/486,070
`Filed: June 7, 1995
`Page 2 [Declaration of Dr. Dollie M. W. Kirtikar]
`
`3.
`
`From 1969 to 1971, I received a visiting fellowship from the Nucleic Acid
`
`Research Foundation of Netherlands, under which I carried out research on enzymes
`
`and factors involved in DNA transcription in the Biochemistry Department, University of
`
`Netherlands, Croningen, Netherlands. From 1971 to 1977, lwas a research associate
`
`in the Biochemistry Department, Case Western Reserve University School of Medicine,
`Cleveland, Ohio. At Case Western, I conducted research on enzymes involved in DNA
`repair following treatment with cancer-causing physical and chemical agents. From
`
`1977 to 1978, lwas a research associate in the Radiology Department, Stanford
`
`University Medical Center, Stanford, California, where I conducted research on DNA-
`
`repair deficient bacteria. My education and research experience are listed on my CV
`
`(Exhibit 1).
`
`4.
`
`During my education and research spanning the years 1961 to 1978, I
`
`held a number of teaching positions which are listed on my CV (Exhibit 1).
`
`_
`
`5.
`
`lam the author of several scientific publications and the inventor named
`
`on several U.S. and foreign patents and patent applications. My scientific publications
`
`are listed on my CV (Exhibit 1). Representative issued U.S. patents are listed on my A
`
`CV (Exhibit 1).
`
`I am also a co—inventor on the above-identified U.S. Patent Application
`
`Serial No. 08/486,070, filed on June 7, 1995 (hereinafter "the ‘O70 application").
`
`I am
`
`familiar with the specification for the ‘O70 application that was filed on June 7, 1995.
`
`I
`
`have also read the Declaration of Dr. Jannis G. Stavrianopoulos, who is one of my co-
`
`inventors on the ‘O70 application.‘
`
`I have additionally read the Office Action mailed on
`
`July 2, 2003.
`
`6.
`
`As a co—inventor, I am making this Declaration on behalf of and at the
`
`request of the assignee.
`
`‘ I understand that Dr. StavrianopouIos's Declarati n was submitted to the Unit d States Patent
`and Trademark Office in Applicants‘ June 17, 2002 Supplemental Amendment T [Their] April 10,
`2002 Amendment Under 37 C.F.R. §1.1 16.
`
`Enz-7( P)(C3)
`
`Exhibit 2102 Page 3
`
`Exhibit 2102 Page 3
`
`

`

`Stavrianopoulos et al.
`Serial No. 08/486,070
`Filed: June 7, 1995
`Page 3 [Declaration of Dr. Dollie M. W. Kirtikar]
`
`EXPERIMENTS UNDERLYING THE '070 APPLICATION
`
`7.
`
`In connection with the present invention, my co-inventors and I discovered
`
`that nucleic acids could be fixed to non-porous solid supports and remain available for
`
`hybridization and detection.
`
`In our research and experiments that led to the present
`
`invention and the filing of the first application in January 1983, my co-inventors and I
`
`investigated different support materials, shapes, surfaces and treatments with respect to
`
`fixing nucleic acids to supports in hybridizable form.
`
`In at least two separate instances,
`
`we constructed an array of different nucleic acids fixed or immobilized to two different
`
`kinds of solid supports. Amongvthe different solid supports I investigated prior to 1983
`
`are those listed below in chronological order (most recent at the bottom). Copies of
`
`pages from my laboratory notebook are also included herewith as Exhibits 2-9.
`
`TITLE OF LABORATORY NOTEBOOK PAGE(S)
`
`EXHIBIT NO.
`
`
`
`2
`
`glass tubes
`
`Concentration curve for DNA binding to
`activated glass tubes
`Con A bindin to DNA on the lass surface
`
`DNA binding to activated surfaces — plastic
`Activated plastic plates —- Detection of glycosylated DNA by con A-- alkaline
`
`plastic plates
`
`wells treated with eoxy lue
`
`
`
`
`
`hoshatase
` DNA binding to activated glass surface
`- lass fiber filters
`Pre aration of - lass fibre filter
`
`glass tubes/slides
`
`Prearation of Silanized glass
`
`5
`
`
`
`7
`
`
`2 My laboratory notebook refers to “microscope slides with slots." In common parlance, “slots"
`may suggest rectangular channels, troughs or indentations. In the context of my experiments,
`h wever, “slots" refers t
`the flat circles that are preprinted onto flat microscope slides.
`It is
`known in th art that ‘slots’ is a synonym for the circles on preprinted slides, also known as
`cytology slides.
`
`Enz-7( P)(C3)
`
`Exhibit 2102 Page 4
`
`lass tubes
`
`
`
`[flat] microscope slides with
`Detection of glucosylated DNA with
`slots
`fluorescent Con-A on slides
`T-rerinted slides 2
`microscoe slides with slots
`,
`lass tubes - Bindin of DNA to lassT 3
`
`Exhibit 2102 Page 4
`
`

`

`Stavrianopoulos et al.
`Serial No. 08/486,070
`Filed: June 7, 1995
`Page 4 [Declaration of Dr. Dollie M. W. Kirtikar]
`
`A
`
`8.
`
`Since the focus of our investigations was attachment of nucleic acids to
`
`ostensibly inert materials, such as glass and plastic, I focused upon surface treatments
`
`for glass and plastic that would permit such binding. Because the shape of these
`
`materials is irrelevant to their surface chemistry, I used a variety of differently shaped
`
`supports to carry out these experiments, including microscope slides, glass fibers, test
`
`tubes, microtitre plates and wells.
`
`FLAT MICROSCOPE SLIDES WERE USED IN OUR EXPERIMENTS
`
`9.
`
`As indicated above and as shown in my laboratory notebook pages
`
`(Exhibits 2 and 9), on at least two separate occasions I fixed nucleic acids to flat
`
`microscope slides.
`
`ARRAYS OF DIFFERENT NUCLEIC ACIDS WERE CONSTRUCTED
`ON SEPARATE OCCASIONS VVITH DIFFERENT SOLID SUPPORTS
`
`10.
`
`As shown in my laboratory notebook pages (Exhibits 2 and 8), l
`
`constructed two nucleic acid arrays3, one using preprinted microscope slides and the
`
`other using glass fiber filters. See the second page of both Exhibits 2 and 8.
`
`A.
`
`In the first array (Exhibit 2, second page), T4 and A DNA were
`
`spotted on twelve locations on the same fiat microscope glass slide. The flat
`
`microscope slide was a preprinted glass slide, also called a cytology slide.
`
`B.
`
`In the second array (Exhibit 8, second page), T4 and A DNA were
`
`each spotted three times on the same glass fiber filter.
`
`In fact, two such arrays in
`
`the form of glass fiber filters were taped to my original laboratory notebook page
`
`3 This is true under a restrictive definition of “nucleic acid array” as meaning a plurality of various
`nucleic acids arranged on a solid support. Under the plain definition - a plurality of (various or
`identical) nucleic acids arranged on a solid support - more of my experiments could be
`charact rized as involving construction of nucleic acid arrays.
`
`Enz-7( P)(C3)
`
`Exhibit 2102 Page 5
`
`Exhibit 2102 Page 5
`
`

`

`Stavrianopoulos et al.
`Serial No. 08/486,070
`Filed: June 7, 1995
`Page 5 [Declaration of Dr. Dollie M. W. Kirtikar]
`
`(Exhibit 8, second page) at the time the experiment was performed and both
`
`arrays are still taped there.
`
`MY EXPERIMENTAL WORK IS IN THE ’070 APPUCATION AS FILED
`
`11.
`
`The ‘O70 application as originally filed is completely consistent with the
`
`experiments discussed above in that it reasonably conveys that ( 1) the invention
`
`resided in the attachment of nucleic acids to the surface of a non-porous solid support;
`
`and that (2) the shape of that surface of the non-porous solid support was irrelevant to
`
`the invention; and, therefore, (3) that a person skilled in the art at the time the
`
`application was filed would not have viewed arrays as being limited to those including
`
`wells or depressions because of the irrelevance of the shape of the surface or solid
`
`support to which the nucleic acid was bound.
`
`The first conclusion is manifest from page 10 of the ‘O70 application, stating that:
`
`In accordance with the practice of this invention, analytes in a biological
`sample are .
`.
`. directly fixed to a suitable solid support. .
`.
`. It is preferred
`that the solid support to which the analyte is fixed be non-porous.
`
`The second conclusion, that the shape of the solid support is irrelevant, is likewise
`
`made manifest on page 10, which states that:
`
`.
`.
`[l]t is preferred that the solid support to which the analyte is fixed be .
`glass,
`or
`alternatively,
`plastic,
`polystyrene,
`polyethylene,
`dextran,
`polypropylene, and the like.
`
`It will be appreciated that the above cited passage makes no reference to the shape of
`
`the solid support. Certainly, had the shape been critical, it would have been specified.
`
`Indeed, only later in the specification at page 13, as a preferred embodiment, solid
`
`supports with wells or depressions are cited:
`
`Enz-7(P)(C3)
`
`Exhibit 2102 Page 6
`
`Exhibit 2102 Page 6
`
`

`

`Stavrianopoulos et al.
`Serial No. 08/486,070
`Filed: June 7, 1995
`Page 6 [Declaration of Dr. Dollie M. W. Kirtikar]
`
`invention involves
`Yet another aspect of the method of the present
`generating the soluble signal .
`.
`. in a device capable of transmitting light
`therethrough for
`the detection of
`the signal by spectrophotometric
`techniques. .
`.
`. Examples of the devices useful in the spectrophotometric
`analysis of the signal
`included conventional apparatus employed in
`diagnositic laboratories,
`i.e., plastic or glass wells,
`tubes, cuvettes or
`arrangements of wells, tubes or cuvettes.
`
`Accordingly, point 3 is clearly conveyed, that a person skilled in the art was told by the
`
`‘070 application that the invention resided in attaching nucleic acids to a solid support
`
`without any reference to the shape of that solid support; and that solid supports with
`
`wells or depressions were but a preferred embodiment, THEREFORE, the ‘070
`
`application conveyed that an array as disclosed need not be limited to one with wells or
`
`depressions.
`
`I hereby declare that all statements made herein of my own knowledge are true and
`
`that all statements made on information and belief are believed to be true; and
`
`further that these statements are made with the knowledge that willful false statements
`
`and the like so made are punishable by fine or imprisonment, or both, under Section
`
`1001 of Title 18 of the United States Code, and that any such willful false statements
`
`may jeopardize the validity of the application or any patent issued thereon.
`
`Oct. 281% smog
`Date
`
`filo/L; <£7>[/cow
`Dollie M. W. Kirtikar, Ph.D.
`
`=|=***#*¥
`
`Enz-7( P)(C3)
`
`Exhibit 2102 Page 7
`
`Exhibit 2102 Page 7
`
`

`

`EDUCATION:
`
`Bachelor of Science B.Sc.
`
`Master of Science M.Sc.
`
`Doctor of Philosophy Ph.D.
`
`RESEARCH EXPERIENCE:
`
`March 1969 to March 1971
`
`May 1971 to September 1977
`
`Dollie M.W.Kirtikar
`
`71—30 162"‘ Street, Unit #3
`Fresh Meadow, NY 11373
`(415) 327-3442
`
`April 1952 with Honors.
`Microbiology as Major; Chemistry as minor.
`St.Xavier's College, Bombay,lndia.
`University of Bombay.
`
`February 1957 (three years with research
`Microbiology as major; Biochemistry as minor.
`Seth G.S.Medical College, Eombay, lndia.
`University of Bombay.
`Thesis: Typing of Salmonella Paratyphi A Strains For All
`Over The World
`
`June 1967.
`University of Kansas. Kansas (U.S.)
`Title of Doctorial Thesis: Phenotypic Transformation
`
`Visiting fellowship from Nucleic Acid Research
`Foundation of Nederlands
`
`Biochemistry Department, University of Nederlands at
`Groningen, Nederlands
`
`Molecular biology with emphasis on enzyme, and
`factors involved in DNA transcription
`
`Research Associate at Biochemistry Department,
`Case Western Reserve University
`School of Medicine, Cleveland, OH 44106
`
`Molecular biology with emphasis on enzyme
`involved in DNA repair after treatment with physical and
`chemical agents known to cause cancer.
`
`October 1977 to June 1978
`
`Research Associate at Radiology Department
`Stanford University Medical Center,
`Stanford, CA 94305
`
`February 1979 to February 1997
`
`Molecular biology and genetics with emphasis on DNA-
`repair deficient bacteria
`
`Research scientist at Enzo Biochem, Inc. and its
`subsidiary, Enzo Life Sciences, Inc.
`(formerly Enzo Diagnostics, Inc.)
`
`Exhibit 2102 Page 8
`
`Exhibit 2102 Page 8
`
`

`

`Dollie M.W. Kirtikar
`
`Page 2
`
`February 1997 to Present
`
`TEACHING EXPERIENCE:
`
`Also held position as Production Manager and
`Supervisor of OA/QC
`
`Senior Scientist at Enzo Life Sciences, Inc.
`(formerly Enzo Diagnostics, Inc.)
`
`1961-1963
`
`Teaching Assistantship at Microbiology Department, University School of Kansas
`Medical Center, Kansas City, Kansas.
`
`General laboratory assistance in various courses offered to medical and graduate
`students. Preparation of course material, supervision of students conducting
`experiments, assistance in lab experiments, conferences with students, etc.
`
`1965
`
`Laboratory Instructor in Department of Pathology and Bacteriology at Topiwalla
`National Medical College, Bomoay, India.
`
`Supervision of clinical laboratory staff.
`Training of research personnel such as technicians, graduate students. Conferences
`with students etc. on particular research projects. .
`
`Biochemistry Department, University of Nederlands at Groningen, (March) Nederlands.
`
`Training of graduate students and technicians. Conferences and discussions with
`graduate students on particular research project
`
`Biochemistry Department, Case Western Reserve University School of Medicine,
`Cleveland, OH 44106
`
`1969-1971
`
`1972-1977
`
`General supervision of laboratory personnel; training and supervision of technicians,
`graduate and college students; iniation of new personnel in the laboratory group in
`various techniques. Conferences and discussions and suggestions to various personnel
`about specialized techniques in molecular biology.
`
`Jan.1978 to
`June 1978
`
`Radiology Department,Stanford University Medical Center, Stanford, CA 94305
`
`Training and supervision of one technician in molecular genetics with particular
`emphasis on mapping of bacterial mutants. Preparation of phage lysate, transduction
`and conjugation expts, construction of strains etc.
`
`Exhibit 2102 Page 9
`
`Exhibit 2102 Page 9
`
`

`

`Dollie M.W. Kirtikar
`
`Page 3
`
`PUBLICATIONS:
`
`1.
`
`Mridula W. Kirtikar, Typing of Salmonella Paratyphi A Strains For All Over The World.
`J. Post Graduate Medicine of India (1957)
`
`Mridula W. Kirtika, D.D. Banker, and N.W. Purandare, Bacteriophage Typing of 371 Strains of
`Salmonella Paratyphi A. J. Post-Grad. Med., Vol. VI, 6 (1960)
`
`N.Veeraraghavan and M.W. Kirtikar, Biologicial Characteristics of Influenza virus Strains
`Isolated at the Government of India Influenza Centre, Coonoor, during 1950-69, Bull. World
`Hlth.0rg., 24, 687 (1961)
`
`N.Veeraraghavan, M.W. Kirtikar and T. Sreevalsan, Studies on the Cultivation of Influenza
`Virus in vitro. Bull. World H/th. Org., 24, 71 7 (1961)
`
`Mridula W. Kirtikar, Phenotypic Transformation. Dissertation Abs Int/., 28 (7), 2708 (1967)
`
`Mridula W. Kirtikar and Jacob D. Duerksen, A Penicillinase-Specific Ribonucleic Acid
`Component from Bacillus Cereus. I. Ribonucleic Acid Extraction and Definition of the in Vivo
`Test System. Biochemistry, 7, 7172 (1968)
`
`Mridula W. Kirtikar and Jacob D. Duerksen, A Pencillinase-Specific Ribonucleic Acid
`Component from Bacillus Cereus. ll. Partial Characterization of the Active Component.
`Biochemistry, 7, 7183 (1968)
`
`Dollie M. W. Kirtikar and Akira Kaji, Stimulation of Phage Ribonucleic Acid-dependent
`Incorporation of Amino Acids by 5 S Ribonucleic Acid. J.Bio/.Chem., 243, 5345 (1968)
`
`Shelk-Mumtaz Hadi, D. M. Kirtikar, and D.A. Goldthwait, (Endonuclease ll of Escherichia coli.
`Degradation of Double- and Single-Stranded Deoxyribonucleic Acid. Biochemistry, 72, 2747
`(1973)
`
`10.
`
`11.
`
`12.
`
`13.
`
`14.
`
`D.M. Kirtikar and D.A. Goldthwait, The Enzymatic Release of O°—methylguanine and 3-
`methyladenine from DNA Reacted with the Carcinogen N-methyl-N—nitrosourea. Proc. Nat.
`Acad. Sci., 77, 2022 (1974)
`
`D.A. Goldthwait, D.M. Kirtikar, S.M.Hadi, and E.C. Friedberg, Molecular Mechanisms for repair
`of DNA, Part A. Plenum Publishing Company, p. 791-796 (1975)
`
`D.M. Kirtikar, J. Slaughter and D.A. Goldthwait, Endonuclease ll of Escherichia coll:
`Degradation of y—lrradiated DNA. Biochemistry, 74, 1235 (1975)
`
`Dollie M. Kirtikar, Anthony Dipple and David A. Goldthwait, Endonuclease II of Escherichia coliz
`DNA Reacted with 7-Bromomethyl-12—methylbenz[a]anthracene as a Substrate. Biochemistry,
`74, p.5548 (1975)
`
`D.M. Kirtikar, J.P. Kuebler, A. Dipple, and D.A. Goldthwait, Endonuclease II of Escherichia coli
`and Related Enzymes, Fundamentals in Cancer Prevention: 6th Int. Symp. of the Princess
`Takamatsu Cancer Research Fund. University of Tokyo Press, p.349 (1975)
`
`Exhibit 2102 Page 10
`
`Exhibit 2102 Page 10
`
`

`

`Dollie M.W. Kirtikar
`
`Page 4
`
`15.
`
`D.M. Kirtikar, J.P.KuebIer, A. Dipple, a.nd D.A. Goldthwait, Enzymes Involved in Repair of DNA
`Damaged By Chemical Carcinogens and y—lrradiation. Cancer Enzymo/ogy (eds. J. Schultz and
`F. E. Ahmed, Eighth Miami Winter Symposium, Academic Press, p. 7 39 (1976)
`
`16.
`
`Dollie M. Kirtikar and David A. Goldthwait, Endonuclease II and the Apurinic Acid
`Endonuclease of E. Coli. Fed. Proc., 35, 158.9 (1976)
`
`PATENTS:
`
`U.S.
`
`5,241,060
`0
`5,260,433
`0
`0 4,994,373
`
`*1-‘I-*-I>**
`
`Exhibit 2102 Page 11
`
`Exhibit 2102 Page 11
`
`

`

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`Exhibit 2102 Page 12
`
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`Exhibit 2102 Page 13
`
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`Exhibit 2102 Page 14
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`Exhibit 2102 Page 15
`
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`Exhibit 2102 Page 16
`
`Exhibit 2102 Page 16
`
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`Exhibit 2102 Page 17
`
`Exhibit 2102 Page 17
`
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`Exhibit 2102 Page 18
`
`Exhibit 2102 Page 18
`
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`
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