`
`Primary Examiner: John S. Brusca
`
`527 Madison Avenue, 9"‘ Floor
`
`New York, NY 10022-4304
`
`August 10, 2007
`
`I I I I I I I I I I I I I I I
`
`Patentees:
`
`Rabbani er al.
`
`U.S. Patent No.2
`
`7,064,197 B1
`
`Issued:
`
`June 20, 2006
`
`Serial No.:
`
`08/486,070
`
`Filed:
`
`June 7, 1995
`
`For:
`
`SYSTEM, ARRAY AND NON-POROUS SOLID
`
`SUPPORT COMPRISING FIXED OR
`
`IMMOBILIZED NUCLEIC ACIDS
`
`FILED VIA EXPRESS MAIL
`
`-- RETURN RECEIPT REOUES TED
`
`Mail Stop -- Box Reconstruction
`Commissioner for Patents
`
`P.0. Box 1450
`
`Alexandria, VA 22313-1450
`
`Attention:
`
`Deborah Dotson (Telephone 571-272-0520)
`
`Technology Center 1600
`
`COMMUNICATION ACCOMPANYING PATENTEES' SUBMISSION OF CERTAIN MISSING
`
`DOCUMENTS FROM U.S. PATENT APPLICATION SERIAL NO. 08/486,070, FILED JUNE 7, 1995
`
`Dear Sirs:
`
`V This Communication accompanies Patentees’ submission of certain missing
`
`documents from the file history of U.S. Patent Application Serial No. 08/486,070,
`
`filed on June 7, 1995. Patentees’ undersigned attorney was informed by a third"
`
`party that these documents were missing. No Notice Under 37 CFR 1.251 or other
`
`formal or informal inquiry is believed to have been issued or made with respect to
`
`these missing documents.
`
`Enz-7(P2)
`
`Page 1 Of 60
`
`HOLOGIC EXHIBIT 1011
`
`Hologic V. Enzo
`
`Page 1 of 60
`
`HOLOGIC EXHIBIT 1011
`Hologic v. Enzo
`
`
`
`Rabbani et al., U.S. Paut No. 7,064,197 B1 (Issued Jun.0, 2006)
`Page 2 [Communication Accompanying Patentees’ Submission Of Certain Missing
`Documents From U.S. Patent Application Serial No. 08/486,070, Filed 6/7/95]
`
`-- August 10, 2007
`
`
`
`EXPRESS MAIL CERTIFICATE
`
`"Express Mail" Label No. EM008701605US
`
`Deposit Date
`AUGUST 10 2007
`I hereby certify that this paper (Communication
`Accompanying Patentees’ Submission Of Certain
`Missing Documents From U.S. Patent Application Serial
`No. 08/486, Filed June 7, 1995) and the attachments
`herein are being deposited with the United States Postal
`Service "Express Mail Post Office to Addressee" service
`under 37 CFR 1.10 on the date indicated above and is
`addressed to the Commissioner of Patents and
`Trademarks, Box Reconstruction, P. 0. Box 1450,
`Al xandria, VA 2313-1450.
`
`
`
`
`
`_}_((_A f AUG /0 2007
`
`
`Ronald C. Fedus
`
`Reg. No. 32,567
`
`Date
`
`
`
`
`
`REMARKS
`
`Earlier this year it came to the undersigned’s attention from a third party that
`
`several documents appeared to be missing from the USPTO’s file wrapper for U.S.
`
`Patent Application Serial No. 08/486,070 ("the ’070 Application), filed on June 7,
`
`1995, the immediate application from which U.S. Patent No. 7,064,197 B1 ("the
`
`'1 97 Patent) issued on June 20, 2006.
`
`In three instances, the exhibits to filed
`
`declarations or a communication appeared to be missing.
`
`In three other instances,
`
`the entire declaration or information disclosure statements appeared to be missing.
`
`According to the third party, the following documents were missing from the
`
`USPTO’s file wrapper for the ’070 Application:
`
`Enz-7(P2)
`
`Page 2 of 60
`
`Page 2 of 60
`
`
`
`Rabbani et aI., U.S. Pa.t No. 7,064,197 B1 (Issued Jun.0, 2006)
`Page 3 [Communication Accompanying Patentees’ Submission Of Certain Missing
`DocumentsFrom U.S. Patent Application Serial No. 08/486,070, Filed 6/7/95]
`
`—- August 10, 2007
`
`1.
`
`Exhibits 5-10 to May 8, 2001 Declaration Of Dr. Cheryl H. Agris,
`
`Attorney At Law (In Support Of The Written Description Of The Invention Claimed
`
`In U.S. Patent Application Serial No. 08/486,070);
`
`2.
`
`Exhibits 1-4 to May 30, 2001 Communication For Transmitting Charts
`
`In Support Of Applicant's Invention Claimed In U.S. Patent Application Serial No.
`
`08/486,070;
`
`3.
`
`June 17, 2002 Declaration Of Dr. Jannis G. Stavrianopoulos with
`
`Exhibits 1-26;
`
`4.
`
`June 28, 2002 Supplemental Information Disclosure Statement Under
`
`37 C.F.R. §§1.56 & 1.97-1.98 with Exhibits 1-16;
`
`5.
`
`July 30, 2002 Second Supplemental Information Disclosure Statement
`
`Under 37 C.F.R. §§1.56 & 1.97-1.98 with Exhibits 1-28; and
`
`6.
`
`Eight (8) Charts attached to December 31, 2002 Communication For
`
`» Submitting Eight Charts In Support Of Applicant's Invention Claimed In U.S. Patent
`
`Application Serial No. 08/486,070.
`
`Upon receiving this information from the third party, the undersigned
`
`immediately reviewed the contents of the instant Assignee’s (Enzo Life Sciences,
`
`Inc.) files to determine whether the above-listed documents were present. These
`
`documents were found to be present in the Assignee’s ’070 Application file.
`
`Before preparing this Communication and submitting the above-listed
`
`documents, however, the undersigned contacted Landon-IP, Inc. of Alexandria,
`
`Virginia, to request that they undertake to examine the contents of the ’070
`
`Application file maintained by the USPTO. Landon—lP later informed the
`
`undersigned that an inspection of the publicly available papers for the file history
`
`revealed that the requested papers could not be located. Landon-IP suggested,
`
`however, that the next option would be to order an electronic copy of the entire file
`
`with cited references on CD-Rom, and to conduct a further examination. According
`
`Enz-7(P2)
`
`Page 3 of 60
`
`Page 3 of 60
`
`
`
`Rabbani et al., U.S. Pa.t No. 7,064,197 B1 (Issued Jun.0, 2006)
`Page 4 [Communication Accompanying Patentees’ Submission Of Certain Missing
`Documents From U.S. Patent Application Serial No. 08/486,070, Filed 6/7/95]
`
`-- August 10, 2007
`
`to Landon-IP, this option would cover the situation where the missing papers may
`
`have been incorrectly scanned in the non-patent literature. The undersigned
`
`proceeded to order the electronic copy of the entire file for the ’070 Application
`
`with cited references on CD-Rom. A short time later, Landon-IP confirmed with the
`
`undersigned that the requested papers (above—|isted documents) are missing from
`
`the official USPTO copy of the file history for the '1 97 Patent.
`
`Having thus confirmed that the above-listed documents are missing from the
`’070 Application and '1 97 Patent file, the undersigned proceeded to check the
`
`Code of Federal Regulations (notably 37 CFR 1.251 Unlocatable File), the Manual
`
`of Patent Examining Procedure (MPEP) §508.04 (MPEP Pages 500-32 through 500-
`
`34), and the USPTO website for information on handling the matter of incomplete
`
`file wrapper papers, but not a complete file wrapper.
`
`In the MPEP (page 500-34,
`
`left column, last paragraph, through right column, first paragraph), it states:
`
`37 CFR 1.251 generally applies only to situations in which the
`file of an application or patent
`(not
`just certain documents)
`is
`unlocatable. When a document is missing from an application, Office
`practice
`is
`to call
`the
`applicant's
`representative
`and
`request
`submission (generally by facsimile) of a copy of the missing document.
`While the Office will generally treat missing documents
`in this
`relatively informal manner (rather than issuing a notice under 37 CFR
`1.251), the Office may issue a notice under 37 CFR 1.251 to obtain a
`copy of a missing document if the Office's informal attempts to obtain
`a copy of the document are unsuccessful. The notice under 37 CFR
`1.251 will include a printout of the contents entries from the Office's
`
`PALM system.
`
`The undersigned also checked the Public PAIR for the ’070 Application and
`
`the ’197 Patent to determine whether a Notice Under 37 CFR 1.251 had been
`
`recently issued. No such notice was listed.
`
`Lastly, before filing this Communication and submitting the above-listed
`
`documents, the undersigned also attempted to obtain information by contacting the
`
`USPTO at various numbers, including the Reconstruction Section (Tel. Nos. 571-
`
`Enz-7(P2)
`
`Page 4 of 60
`
`Page 4 of 60
`
`
`
`Rabbani et al., U.S. Pa.t No. 7,064,197 B1 (Issued Jun.0, 2006)
`Page 5 [Communication Accompanying Patentees’ Submission Of Certain Missing
`Documents From U.S. Patent Application Serial No. 08/486,070, Filed 6/7/95]
`
`-- August 10, 2007
`
`272-3150 and 571-272-1000) and Document Services (an option from the menu
`for Tel. No. 571-272-3150). A call was made on August 9, 2007 to Deborah
`
`Dotson, Technology Center 1600 (Telephone 571-272-0520) who suggested that
`
`the missing documents could be sent to her attention for proper scanning into the
`
`USPTO’s system.1 The undersigned acknowledges with appreciation the time and
`
`courtesy extended by Ms. Dotson in handling his inquiry about these missing
`
`documents.
`
`Accordingly, the above—listed documents are attached as exhibits to this
`
`Communication as follows:
`
`1.
`
`Exhibits 5-10 to May 8, 2001 Declaration Of Dr. Cheryl H. Agris,
`
`Attorney At Law (In Support Of The Written Description Of The Invention Claimed
`
`In U.S. Patent Application Serial No. 08/486,070) [Exhibit 1];
`
`2.
`
`Exhibits 1-4 to May 30, 2001 Communication For Transmitting Charts
`
`In Support Of Applicant's Invention Claimed In U.S. Patent Application Serial No.
`
`08/486,070 [Exhibit 2];
`
`3.
`
`June 17, 2002 Declaration Of Dr. Jannis G. Stavrianopoulos with
`
`Exhibits 1-26 [Exhibit 3];
`
`4.
`
`June 28, 2002 Supplemental Information Disclosure Statement Under
`
`37 C.F.R. §§1.56 & 1.97-1.98 with Exhibits 1-16 [Exhibit 4];
`
`5.
`
`July 30, 2002 Second Supplemental Information Disclosure Statement
`
`Under 37 C.F.R. §§1.56 & 1.97-1.98 with Exhibits 1-28 [Exhibit 5]; and
`
`6.
`
`Eight (8) Charts attached to December 31, 2002 Communication For
`
`Submitting Eight Charts In Support Of Applicant's Invention Claimed In U.S. Patent
`
`Application Serial No. 08/486,070 [Exhibit 6].
`
`‘ In responding to a November 18, 2005 Office Communication initiating reconstruction pursuant to
`37 C.F.R. §1.251 of U.S. Patent Application Serial No. 06/461,469, filed on January 27, 1983 Ithe
`first-filed application in the family leading to the ‘O70 Application), the undersigned filed a
`Communication on December 8, 2005 directed to the attention of Deborah Dotson, Technology
`Center 1600.
`
`Enz-7(P2)
`
`Page 5 of 60
`
`Page 5 of 60
`
`
`
`Rabbani et aI., U.S. Pa.t No. 7,064,197 B1 (Issued Jun.0, 2006)
`Page 6 [Communication Accompanying Patentees’ Submission Of Certain Missing
`Documents From U.S. Patent Application Serial No. 08/486,070, Filed 6/7/95]
`
`-- August 10, 2007
`
`Including the cover sheets (but not the tabs) for each of the six above-listed
`
`exhibits, a total of 880 pages are being submitted herewith to complete the
`
`USPTO’s file history for the ‘O70 Application.
`
`No fee or fees are believed to be due in connection with this Communication.
`
`In the event that any fee or fees are due, however, The Patent and Trademark
`
`Office is hereby authorized to charge the amount of any such feels) to Deposit
`
`Account No. 05-1 135, or to credit any overpayment thereto.
`
`If a telephone conversation would further the prosecution of the present
`
`application, Applicants’ undersigned attorney requests that he be contacted at the
`
`number provided below.
`
` ctfully submitted,
`
`onald C.
`
`edus
`
`Registration No. 32,567
`
`Attorney for Patentees
`
`ENZO LIFE SCIENCES, INC.
`
`c/o ENZO BIOCHEM, INC.
`
`527 Madison Avenue, 9"‘ Floor
`New York, NY 10022-4304
`
`Telephone: (212) 583-0100
`Facsimile: (212) 583-0150
`
`Enz-7(P2)
`
`Page 6 of 60
`
`Page 6 of 60
`
`
`
`U.S. PAT. NO.7,064,197
`(ussN 08 1486,070l.
`EXHIBIT 6 TO
`AUGUST 10,2OO7
`COMMUNICATION
`MISSING F/W ITEM NO. 6
`EIGHT (8} CHARTS ATTACHED
`TO DECEMBER 31 ] 2OO2
`COMMUNICATION FOR
`SUBMITTING EIGHT CHARTS
`IN SUPPORT OF APPLICANT'S
`INVENTION CLAIMED IN U.S.
`PATENT APPLICATION SERIAL
`NO. 08 1486,070
`
`Page 7 of 60
`
`
`
`
`
`Applicant(s):
`
`Stavrianopoulos et al.
`
`Serial No.:
`
`08/486,070
`
`Filed:
`
`FOF2
`
`June 7, 1995
`
`ARRAYS AND SYSTEMS COMPRISING
`ARRAYS FOR GENETIC ANALYSES AND
`
`OTHER APPLICATIONS
`
`IAS PREVIOUSLY AMENDED)
`
`——*—*—*—*—§—\,§—__,s.,s.,s.,
`
`.....a{'‘
`
`RECEIVED
`JAN b 6 2003
`
`TECH CENTER 1600/2900
`
`Group Art'Unit: 1631
`
`Ex'r: Ardin H. Marschel, Ph.D.
`
`527 Madison Avenue (9"‘ Floor)
`
`New York, New York 10022-4304
`
`December 31, 2002
`
`FILED BY EXPRESS MAIL
`
`Honorable Commissioner of Patents and Trademarks
`
`Washington, D.C. 20231
`
`COMMUNICATION FOR SUBMITTING EIGHT CHARTS IN SUPPORT OF
`
`APPL|CANT'S INVENTION CLAIMED IN
`U.S. PATENT APPLICATION SERIAL NO. 08/486 070
`
`Dear Sirs:
`
`This Communication follows the PTO interview held on December 17,
`
`2002 in connection with the above—identified application. This
`
`Communication also follows Applicants‘ December 6, 2002 Communication
`
`and their December 3, 2002 Amendment Under 37 C.F.R. §1.115. No
`
`communication or office action is outstanding in this application. Thus, no
`
`extension request or fee is believed due in connection with this
`
`Communication which is being timely filed.
`
`Enz-7(P)(C3I
`
`Page 8 of 60
`
`Page 8 of 60
`
`
`
`Stavrianopoulos et al.
`
`Serial No.: 08/486,070
`
`Filed: June 7, 1995
`
`Page 2 [Communication For Submitting Eight Charts In Support Of Applicants’
`Invention Claimed In U.S. Patent Application Serial No. 08/486,070)
`
`December 31, 2002]
`
`EXPRESS MAIL CERTIFICATE
`
`"Express Mail" Label No. EV205342237US
`Deposit Date
`December 31 2002
`I hereby certify that this paper and the attachments
`herein are being deposited with the United States Postal
`Service "Express Mail Post Office to Addressee" service
`under 37 CFR 1.10 on the date indicated above and is
`addressed to the Commissioner of Patents and
`T a emarks, W shington DC 20231.
`
`Reg. No. 32,567
`
`Ronald C. Fedus
`
`
`
`II
`I
`
`Enz-7IPI(C3I
`
`Page 9 of 60
`
`Page 9 of 60
`
`
`
`
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFIC
`
`' "‘—j—:—_RECEIVED
`“‘”—"‘-I
`pplicant(s):
`Stavrianopoulos et al.
`JAN 0 6 2003
`
`/
`./ \.
`
`Serial No.
`Filed:
`Title:
`
`Q
`
`Group Art Unit: 1631
`08/486,070
`Examiner: Ardin H. Marschel, Ph.D.
`June 7, 1995
`ARRAYS AND SYSTEMS COMPRISING ARRAYS FOR GENETIC ANALYSES
`AND OTHER APPLICATIONS
`
`(As Previously Amended)
`
`FILED BY EXPRESS MAIL
`
`Honorable Commissioner of
`
`Patents and Trademarks
`
`Washington, D. C. 20231
`
`Sir:
`
`Transmitted herewith is a Communication For Submitting Eight Charts In
`Support Of Applicants‘ Invention Claimed In U.S. Patent Application Serial No.
`08/486,070.
`
`The fee has been calculated as shown below:
`
`CLAIMS
`REMAINING
`AFTER
`
`HIGHEST NUMBER
`PREVIOUSLY PAID
`
`PRESENT
`EXTRA
`
`RATE
`
`ADDITIONAL
`
`AMENDMENT of Multiple
`
`Dependent Claims
`TOTAL
`ADDITIONAL FEE
`
`
`
`(
`
`(
`
`)
`
`)
`
`Charge Deposit Account No. 05-1135 in the amount of $
`
`A check in the amount of $
`
`is attached.
`
`The Commissioner is hereby authorized to charge payment of the following
`(X)
`fees associated with this communication or credit any overpayment to Deposit
`
`Account No. 05-1135: any filing fees under 37 C.F.R. §1.16 for the presentation
`of extra claims and any patent application processing fees ,under 37 C.F.R. §1.17.
`
`Enz-7lP)lC3)
`
`Page 10 of 60
`
`Page 10 of 60
`
`
`
`shington DC 20231.
`
`
`
`Ronald C. Fedus
`
`Reg. No. 32,567
`
`DC; 3/ Z002
`Date
`
`
`
`
`
`
`
`
`Stavrianopoulos et al.
`Serial No. 08/486,070
`
`Filed: June 7, 1995
`
`Page 2 [Transmittal —— December 31, 2002]
`
`EXPRESS MAIL CERTIFICATE
`
`
`
`
`
`
`"Express Mail" Label No. EV205342237US
`Deposit Date
`December 31 2002
`I hereby certify that this paper and the attachments
`herein are being deposited with the United States Postal
`Service "Express Mail Post Office to Addressee" service
`under 37 CFR 1.10 on the date indicated above and is
`ressed to the Commissioner of Patents and
`
`
`
`Tra emarks,
`
`
`
`
`
`
`
`Enz-7(P)(C3)
`
`Page 11 of 60
`
`Page 11 of 60
`
`
`
`Stavrianopoulos et al.
`Serial No. 08/486,070
`
`Filed: June 7, 1995
`
`.
`
`Page 3 [Transmittal —- December 31, 2002]
`
`Copies are being provided in triplicate.
`
`Also enclosed:
`
`December 31 , 2002
`Date
`
`ENZO LIFE SCIENCES, INC.
`
`(formerly named Enzo Diagnostics, Inc.)
`c/0 Enzo Biochem, Inc.
`527 Madison Avenue (9‘“ Fl.)
`New York, New York 10022
`Tel. (212) 583-0100
`
`Attorney's Docket No.: Enz-7(P)(C3l
`
`pectfully
`
` onald C. Fedus
`
`Registration No. 32,567
`
`Attorney for Applicants
`
`Enz-7(P)(C3l
`
`Page 12 of 60
`
`Page 12 of 60
`
`
`
`Stavrianopoulos et al.
`
`Serial No.: 08/486,070
`
`Filed: June 7, 1995
`
`Page 3 [Communication For Submitting Eight Charts In Support Of Applicants’
`-
`Invention Claimed In U.S. Patent Application Serial No. 08/486,070)
`
`December 31, 2002]
`
`REMARKS
`
`Claims 1576-2160 as amended previously by Applicants’ December 3, 2002
`
`Amendment Under 37 C.F.R. §1.115 are still pending and remain under
`
`examination in this application. No claim changes have been effected by this
`
`Communication.
`
`As indicated by the title, the purpose of this Communication is to submit
`
`eight charts in support of Applicants‘ array invention that is claimed in the present
`
`application. These eight charts are attached as Exhibits 1-8, respectively.
`
`With minor_ changes, Charts 1-4 (Exhibits 1-4) correspond to the charts
`
`presented in Applicants‘ May 30, 2000 Communication.
`
`In Charts 5 and 6 (Exhibits 5 and 6), Applicants have illustrated the various
`
`embodiments of non—porous supports or substrates disclosed in the specification.
`
`Such non-porous supports or substrates fall into flat surfaces and curved surfaces.
`
`Chart 6 (Exhibit 6) contains citations to the specification for each listed
`
`embodiment.
`
`Charts 7 and 8 (Exhibits 7 and 8) are also new. Chart 7 (Exhibit 7) illustrates.
`
`the reactive groups or binding sites in Applicants’ claimed array invention. Such
`
`reactive groups or binding sites can take at least three forms: amines, epoxides and
`
`hydroxyls. Also listed in Chart 7 (Exhibit 7) are examples of such amines, epoxides
`
`and hydroxyls.
`
`Chart 8 (Exhibit 8) is a Venn diagram illustrating the relationship between
`
`treated plastic and treated glass as disclosed in the specification. As shown in the
`
`Venn diagram, certain treatments are specific to plastic and others are specific to
`
`glass.
`
`In the case of two treatments, epoxy glue or solution, and ammonium
`
`Enz-7(Pl(C3l
`
`Page 13 of 60
`
`Page 13 of 60
`
`
`
`Stavrianopoulos et al.
`
`Serial No.: 08/486,070
`
`Filed: June 7, 1995
`Page 4 [Communication For Submitting Eight Charts In Support Of Applicants’
`Invention Claimed In U'.S. Patent Application Serial No. 08/486,070)
`December 31, 2002]
`
`acetate (NH4OAc), these are applicable to both plastic and glass, as shown in the
`
`intersecting portion of the two circles in the Venn diagram of Chart 8 (Exhibit 8).
`
`Applicants respectfully request that full consideration be given to each of the
`
`eight charts (Exhibits 1-8) that are being submitted in support of Applicants‘
`
`claimed array invention.
`
`Favorable action is respectfully requested.
`
`*-X--X-****
`
`Enz-7(P)(C3)
`
`Page 14 of 60
`
`Page 14 of 60
`
`
`
`Stavrianopoulos et al.
`
`Serial No.: 08/486,070
`
`Filed: June 7, 1995
`
`Page 5 [Communication For Submitting Eight Charts In Support Of Applicants’
`Invention Claimed In U.S. Patent Application Serial No. 08/486,070)
`
`December 31, 2002]
`
`SUMMARY AND CONCLUSIONS
`
`Claims 1576-2160 continue to be presented for further examination in
`
`this application. No changes to the claims have been effected by this
`
`Communication, the purpose of which is to present eight charts bearing on
`
`the written description of Applicants‘ claimed array subject matter.
`
`No fee or fees are believed to be due in connection with this
`
`Communication.
`
`In the event that any other fee or fees are due, however,
`
`authorization is hereby given to charge the amount of any such feels) to
`
`Deposit Account No. 05-1 135, or to credit any overpayment thereto.
`
`If a telephone conversation would further the prosecution of the
`
`present application, Applicants’ undersigned attorney request that he be
`
`contacted at the number provided below.
`
`pectfully ubmitted,
`
`R/onald C. Fedus
`
`Registration No. 32,567
`
`Attorney for Applicants
`
`ENZO LIFE SCIENCES, INC.
`
`(formerly named Enzo Diagnostics, Inc.)
`c/o ENZO BIOCHEM, INC.
`
`527 Madison Avenue, 9"‘ Floor
`
`New York, New York 10022
`
`Telephone: (212) 583-0100
`
`Facsimile: (212) 583-0150
`
`Enz-7(P)(C3)
`
`Page 15 of 60
`
`Page 15 of 60
`
`
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`' ant(s):
`
`Filed:
`
`Title:
`
`08/486,070
`
`June 7, 1995
`
`Group Art Unit: 1631
`
`Examiner: Ardin H. Marschel, Ph.D.
`
`ARRAYS AND SYSTEMS COMPRISING ARRAYS FOR GENETIC ANALYSES
`
`AND OTHER APPLICATIONS (As Previously Amended)
`
`FILED BY EXPRESS MAIL
`
`Mail Stop -- Non-Fee Amendments
`Commissioner for Patents
`P. 0. Box 1450
`Alexandria, VA 22313-1450
`
`Sir:
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`MAY 1 4 2003
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`TECH CENTER 1600/2900
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`Transmitted herewith is a Supplemental Amendment To Applicants‘
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`December 3, 2002 Amendment Under 37 C.F.R. §1.115 in the above-identified
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`patent application.
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`The fee has been calculated as shown below:
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`Stavrianopoulos et al. Serial No.
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`PRESENT
`EXTRA
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`RATE
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`ADDITIONAL
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`+ $270
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`$
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`$
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`0
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`0
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`AMENDMENT First Presentation
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`REMAINING
`AFTER
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`HIGHEST NUMBER
`PREVIOUSLY PAID
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`of Multiple
`Dependent Claims
`TOTAL
`ADDITIONAL FEE
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`(
`(
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`)
`)
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`Charge Deposit Account No. 05-1135 in the amount of $
`A check in the amount of $
`is attached.
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`(X)
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`The Commissioner is hereby authorized to charge payment of the following
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`fees associated with this communication or credit any overpayment to
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`Deposit Account No. 05-1135: any filing fees under 37 C.F.R. §1.16 for the
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`presentation of extra claims and any patent application processing fees under
`37 C.F.R. §1.17.
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`I
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`Paoie 16 of60
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`pectfull
`C”
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`submitted,
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`onald C. Fedus
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`Registration No. 32,567
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`Attorney for Applicant(s)
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`A
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`MAY 1 4 2003
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`TECH CENTER 1000/2900
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`Stavrianopoulos et al.
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`Serial No. 08/486,070
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`Filed: June 7, 1995
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`Page 2 (Transmittal -— May 8, 2003)
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`Copies are being provided in triplicate.
`Also enclosed:
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`May 8, 2003
`Date
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`ENZO LIFE SCIENCES, INC.
`
`(formerly Enzo Diagnostics, Inc.)
`c/o Enzo Biochem, Inc.
`527 Madison Avenue (9"‘ Fl.)
`New York, New York 10022-4304
`Tel. (212) 583-0100
`Attorney's Docket No.: Enz-7(P)(C3)
`
`EXPRESS MAIL CERTIFICATE
`
`"Express Mail" Label No. EL634886271US
`Deposit Date
`May 8, 2003
`I hereby certify that this paper and the attachments
`herein are being deposited with the United States Postal
`Service "Express Mail Post Office to Addressee" service
`under 37 CFR 1.10 on the date indicated above and is
`addressed to the Commissioner of Patents and
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`Reg. No. 32,567
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`shington DC 20231.
`/W 2? 2003
`Date
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`Ronald C. Fedus
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`Enz-7(P)(C3)
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`Pave 17 of 60
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`Page 17 of 60
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`Group Art Unit: 1631
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`Ex'r: Ardin H. Marschel, Ph.D.
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`527 Madison Avenue (9"‘F|oor)
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`New York, NY 10022-4304
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`May 8, 2003
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`MAY 1 4 2003
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`TECH GENTERIBOOIZ9
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`00
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`) ) l ) ) ) ) l ) l ) l
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`App|icant(s):
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`Stavrianopoulos et al.
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`Serial No.:
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`08/486,070
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`Filed:
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`June 7, 1995
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`For:
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`ARRAYS AND SYSTEMS COMPRISING
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`ARRAYS FOR GENETIC ANALYSES AND
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`OTHER APPLICATIONS
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`(As Previously Amended)
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`FILED BY EXPRESS MAIL
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`Mai|Stop.—— Non-Fee Amendments
`Commissioner for Patents
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`P. O. Box 1450
`Alexandria, VA 22313-1450
`
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`SUPPLEMENTAL AMENDMENT TO APPLICANTS‘ DECEMBER 3 2002
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`AMENDMENT UNDER 37 C.F.R. §1.115
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`(FOLLOWING THEIR DECEMBER 31, 2002 COMMUNICATION FOR SUBMITTING EIGHT
`CHARTS IN SUPPORT OF APPLICANTS‘ INVENTION CLAIMED IN U.S. PATENT
`
`APPLICATION SERIAL NO. 08/486,070)
`
`Dear Sirs:
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`This is a supplemental response to Applicants‘ December 3, 2002
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`Amendment Under 37 C.F.R. §1.115, and it follows their December 21, 2002
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`Communication For Submitting Eight Charts In Support Of Applicants’ Invention
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`Claimed ln U.S. Patent Application Serial No. 08/486,070. No deadline is believed
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`to be pending for taking action in this case, a Request Under 37 C.F.R. §1.129(a)
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`For Withdrawal Of The Finality Of The October 10, 2001 Office Action having been
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`filed on November 8, 2001. Accordingly, no extension request or fee is believed
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`due in connection with this response.
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`Page 18 of 60
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`Stavrianopoulos et al.
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`Serial No.: 08/486,070
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`Filed: June 7, 1995
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`Page 2 [Supplemental Amendment To Applicants‘ December 3, 2002 Amendment
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`Under 37 C.F.R. §1.115 -- May 8, 2003]
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`EXPRESS MAIL CERTIFICATE
`
`"Express Mail" Label No. EL634886271US
`Deposit Date
`May 8, 2003
`I hereby certify that this paper and the attachments
`herein are being deposited with the United States Postal
`Service "Express Mail Post Office to Addressee" service
`under 37 CFR 1.10 on the date indicated above and is
`addressed to the Commissioner of Patents and
`
`hington DC 20231.
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`/My 9 2003
`Date
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`
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`Ronald C. Fedus
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`Reg. No. 32,567
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`Stavrianopoulos et al.
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`Serial No.: 08/486,070
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`'ed: June 7, 1995
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`.
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`
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`3 [Supplemental Amendment To Applicants’ December 3, 2002 Amendment
`Under 37 C.F.R. §1.115 -- May 8, 2003]
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`
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`In The Claims:
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`Please enter replacement claims 1576 and 1670 as follows:
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`1576.
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`(Twice Amended) An array comprising a non-porous substrate having
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`surfaces, each surface comprising at least one doub|e—stranded nucleic acid fixed or
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`immobilized to one or more reactive groups or binding sites on said surface,
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`wherein at least one nucleic acid strand or a sequence therefrom comprises one or
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`more non-radioactive chemical labels which comprise a non-radioactive signaling
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`moiety or moieties which are quantifiable or detectable, and wherein said non-
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`porous substrate comprises siliceous matter or polymeric material.
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`1670.
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`(Twice Amended) An array comprising a non-porous substrate having
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`surfaces, each surface comprising at least one nucleic acid strand fixed or
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`immobilized to one or more reactive groups or binding sites on said surface, and
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`wherein said non-porous substrate comprises siliceous matter or polymeric material.
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`Add new claims 2161-2162 as follows:
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`-- 2161.
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`(NEW) The array of claim 1576, wherein at least one nucleic acid strand
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`or a sequence therefrom in one of said surfaces is different from at least one other
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`nucleic acid strand or a sequence therefrom in another surface. --
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`Page 20 of 60
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`Stavrianopoulos et al.
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`Serial No.: 08/486,070
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`Filed: June 7, 1995
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`Page 4 [Supplemental Amendment To Applicants’ December 3, 2002 Amendment
`Under 37 C.F.R. §1.115 -- May 8,2003]
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`—- 2162.
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`(NEW) The array of claim 1670, wherein at least one nucleic acid strand
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`or a sequence therefrom in one of said surfaces is different from at least one other
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`nucleic acid strand or a sequence therefrom in another surface. --
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`-X-***-I-**
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`Stavrianopoulos et al.
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`Serial No.: 08/486,070
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`Filed: June 7, 1995
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`Page 5 [Supplemental Amendment To Applicants’ December 3, 2002 Amendment
`Under 37 C.F.R. §1.115 -- May 8, 2003]
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`REMARKS
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`Reconsideration of this application is respectfully requested.
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`Claims 1576-2160 were previously pending in this application. Claims 1576
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`and 1670 have been amended and new claims 2161 and 2162 have been added.
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`No claims have been canceled by this paper. Accordingly, as amended and added
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`above, claims 1576-2162 are being presented for further examination in this
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`application.
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`Claim Amendments
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`In a further sincere effort to define their invention more clearly, Applicants
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`have entered new replacement claims 1576 and 1670, both of which are
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`independent and are directed to their claimed array invention. As set forth above,
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`replacement claim 1576 now recites "[a]n array comprising a non-porous substrate
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`having surfaces, each surface comprising at least one double-stranded nucleic acid
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`fixed or immobilized to one or more reactive groups or binding sites on said surface,
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`wherein at least one nucleic acid strand or a sequence therefrom comprises one or
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`more non—radioactive chemical labels which comprise a non—radioactive signaling
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`moiety or moieties which are quantifiable or detectable, and wherein said non-
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`porous substrate comprises siliceous matter or polymeric material." In the case of
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`claim 1670, Applicants are now claiming "[a]n array comprising a non-porous
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`substrate having surfaces, each surface comprising at least one nucleic acid strand
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`fixed or immobilized to one or more reactive groups or binding sites on said surface,
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`and wherein said non-porous substrate comprises siliceous matter or polymeric
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`material." The changes to claims 1576 and 1670 are believed to better reflect the
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`Page 22 of 60
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`Stavrianopoulos et al.
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`Serial No.: 08/486,070
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`Filed: June 7, 1995
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`Page 6 [Supplemental Amendment To Applicants’ December 3, 2002 Amendment
`Under 37 C.F.R. §1.115 —— May 8, 2003]
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`patentable nature of Applicants‘ claimed array which, among other things,
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`comprises a non-porous substrate comprising siliceous matter or polymeric
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`material.‘
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`A marked-up version of amended claims 1576 and 1670 is attached as
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`Exhibit 1. This marked-up version is entitled "Marked-Up Version Of Amended
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`Claims."
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`Reference to Applicants‘ claimed array subject matter taken in its historical
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`context might be helpful to understanding the basis for the above amendments to
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`claims 1576 and 1670. Array claims (143-182) were first added to this application
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`by Applicants‘ July 21, 1998 Amendment Under 37 C.F.R. §1.115. Claim 143
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`was independent and recited "[a]n array of substrate surfaces, said array
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`comprising a plurality of nucleic acid strands fixed or immobilized to said substrate
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`surfaces." Later, in their May 18, 1999 Third Supplemental Amendment,
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`Applicants canceled their array claims 143-182 in favor of new claims 325-3763
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`In this later set, claim 325 was independent and it recited "[a]n array of substrate
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`surfaces, each substrate surface comprising at least one doub|e—stranded nucleic
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`1 In effect, the following language has been deleted from claims 1576 and 1670:
`. wherein at least one nucleic acid strand or a sequence therefrom in one of said
`surfaces is different from at
`least one other nucleic acid strand or a sequence
`therefrom in another surface .
`.
`
`.
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`2 Other array embodiments were included among claims 325-373. For example, claim 374 was
`directed to "[a] collection or set comprising the array of any of claims 325 to 373, wherein said
`substrate surface is porous or non-porous." Further, claim 375 was directed to "[a] transparent
`non-porous or translucent non-porous system capable of retaining or containing a fluid or solution,
`which system comprises the array of any of claims 325 to 373." Lastly, claim 376 depended from
`claim 375. and it recited "[t]he system of claim 375, wherein said substrate surfaces are contained
`within the transparent non-porous or translucent non-porous system."
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`Page 23 of 60
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`Stavrianopoulos et al.
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`Serial No.: 08/486,070
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`Filed: June 7, 1995
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`Page 7 [Supplemental Amendment To Applicants‘ December 3, 2002 Amendment
`Under 37 C.F.R. §1.115 —— May 8, 2003]
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`acid fixed or immobilized thereto, wherein at least one strand comprises one or
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`more chemical labels which comprises a signaling entity or entities which are
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`quantifiable or detectable, and wherein at least one nucleic acid strand or a
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`sequence therefrom in one of said substrate surfaces is different from at least one
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`other nucleic acid strand or a sequence therefrom in another substrate surface."
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`The subject of these later array claims was listed as item no. 4 among the issues
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`discussed at the March 23, 1999 interview (see page 53 in Applicants’ May 18,
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`1999 Third Supplemental Amendment). The array claims were also discussed on
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`the next page (54) in the same paper.
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`More recently, in Applicants’ April 10, 2002 Amendment Under 37 C.F.R.
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`§1.116, array claims 1266-1424 were added in which the claimed subject matter
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`recited that "said [array substrate] surfaces comprise siliceous matter or polymeric
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`material." In Applicants’ June 17, 2002 Supplemental Amendment to their April
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`10, 2002 Amendment, array claims 1576-1761 were added in place of claims
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`1266-1424. Like their predecessor claims, array claims 1576-1761 were also
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`limited to "siliceous matter or polymeric material." Unlike their predecessor claims,
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`however, array claims 1576-1761 were further limited to "an array comprising a
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`non-porous substrate having surfaces .
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`.
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`In summary, since the first presentation of their array claims in July 1998,
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`Applicants have seen fit to add two features to their claimed array subject matter.
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`First, the claimed subject matter is now defined both in the preamble and in the
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`body of the claim as "[a]n array comprising a non-porous substrate having
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`surfaces." Second, the non-porous substrate in their claimed array subject matter
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`is further defined as comprising siliceous matter or polymeric material.
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`It is believed that prior to the introduction of the presently claimed array
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`subject matter, the recitation that "wherein at least one nucleic acid strand or a
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`Stavrianopoulos et al.
`Serial No.: 08/486,070
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`Filed: June 7, 1995
`Page 8 [Supplemental Amendment To Applicants‘ December 3, 2002 Amendment
`Under 37 C.F.R. §1.115 -- May 8, 2003]
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`sequence therefrom in one of said surfaces is different from at least one other
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`nucleic acid strand or a sequence therefrom in another surface" was helpful if not
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`important to distinguish Applicants‘ array invention from the p