UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Oflice
`Address: COMMISSIONER FOR PATENTS
`PO. Box I450
`Alexandria, Virginia 223l3-I450
`www.usp!o.g0v
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`APPLICATION NO.
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`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
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`08/486,070
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`06/07/1995
`
`JANNIS G. STAVRIANOPOULOS
`
`ENZ—7(P)(C3)
`
`6279
`
`28171
`
`7590
`
`I I/26/2004
`
`-
`ENZO BIOCHEM, INC.
`527 MADISON AVENUE (9TH FLOOR)
`NEW YORK, NY 10022
`
`EXAMINER
`MARSCHEL, ARDIN H
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`ART UNIT
`
`I631
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`PAPER NUMBER
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`DATE MAILED: I 1/26/2004
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`Please find below and/or attached an Office communication concerning this application or proceeding.
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`PTO—90C (Rev. 10/03)
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`Page 1 of 12
`Page “I of 12
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`BD EXHIBIT 1022
`BD EXHIBIT 1022
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`

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`Application No.
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`08/486,070
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`Examiner
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`
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`AppIicant(s)
` Office Action Summary
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`STAVRIANOPOULOS ET AL.
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`Art Unit
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`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
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`Ardin Marschel
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`1631
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`
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`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE Q MONTH(S) FROM
`THE MAILING DATE OF THIS COMMUNICATION.
`— Extensions of time may be available under the provisions of 37 CFR 1.136(a).
`after SIX (6) MONTHS from the mailing date of this communication.
`if the period for reply specified above is less than thirty (30) days, a reply within the statutory minimum of thirty (30) days will be considered timely.
`-
`if NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication:
`—
`- Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
`Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any
`earned patent term adjustment. See 37 CFR 1.704(b).
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`In no event, however, may a reply be timely filed
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`Status
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`1)[Z| Responsive to communication(s) filed on 30 June 2004.
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`2a)EI This action is FINAL.
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`2b)IXl This action is non-final.
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`3):] Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
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`closed in accordance with the practice under Ex parte Quayle, 1935 C.D. 11, 453 O.G. 213.
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`Disposition of Claims
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`4)[X] Claim(s) 286 is/are pending in the application.
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`4a) Of the above c|aim(s)
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`is/are withdrawn from consideration.
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`5)l:l Claim(s) _ is/are allowed.
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`6)lX] Claim(s) 3144—3286 is/are rejected.
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`7)[:] Claim(s) j is/are objected to.
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`8)E] Claim(s) j are subject to restriction and/or election requirement.
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`Application Papers
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`9)|:] The specification is objected to by the Examiner.
`10)EI The drawing(s) filed on ___ is/are: a)D accepted or b)|:I objected to by the Examiner.
`1
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
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`11)Ij The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PTO-152.
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`Priority under 35 U.S.C. § 119
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`12)E] Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
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`a)|:] All
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`b)I:] Some * c)D None of:
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`1.[:I Certified copies of the priority documents have been received.
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`2.El Certified copies of the priority documents have been received in Application No. __
`31: Copies of the certified copies of the priority documents have been received in this National Stage
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`application from the International Bureau (PCT Rule 17.2(a)).
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`* See the attached detailed Office action for a list of the certified copies not received.
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`Attachment(s)
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`1) D Notice of References Cited (PTO-892)
`2) D Notice of Draftsperson’s Patent Drawing Review (PTO-948)
`3) IX] Information Disclosure Statement(s) (PTO-1449 or PTO/SB/08)
`Paper No(s)/Mail Date (1 sheet).
`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 1-04)
`Page 2 of 12
`Page 2 of 12
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`4) El Interview Summary (PTO-413)
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`Paper N°(S)/M3“ Data _._ -
`5) I:I Notice of Informal Patent Application (PTO—152)
`6) El Other:
`.
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`_
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`Office Action Summary
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`Part of Paper No./Mail Date 111904
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`

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`Application/Control Number: O8/486,070
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`Page 2
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`Art Unit: 1631
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`DETAILED ACTION
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`Due to the below set forth new grounds of rejection the finality of the office
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`action, mailed 4/7/04, is hereby withdrawn. Also, due to said withdrawl of finality the
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`Notice of Appeal, filed 6/30/04, is deemed moot. The amendment, filed 6/30/O4, has
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`been entered.
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`Applicants‘ arguments, filed 6/30/O4, have been fully considered but they are not
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`deemed to be persuasive. Rejections and/or objections not reiterated from previous
`office actions are hereby withdrawn. The following rejections and/or objections are
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`either reiterated or newly applied. They constitute the complete set presently being
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`applied to the instant application.
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`NEW MATTER
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`Claims 3147-3150, 3164-3166, 3170, 3171, 3175-3178, 3192-3194, 3198-3245,
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`3248-3251, 3265, 3266, 3269, 3270, and 3278 are rejected under 35 U.S.C. 112, first
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`paragraph, as failing to comply with the written description requirement. The claim(s)
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`contains subject matter which was not described in the specification in such a way as to
`reasonably convey to one skilled in the relevant art that the inventor(s), at the time the
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`application was filed, had possession of the claimed invention.
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`NEW MATTER has been amended into the claims via claim 3147 which cites the
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`following solid supports which have not been found as filed: “a plate”, “depressions”,
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`“beads", " a set of plates”, “a set of...depressions”, or “a set of...beads”. The closest
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`citation to these is set forth in the bridging paragraph between pages 13 and 14 as filed
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`which cites plastic or glass wells which are not the generic wells as in instant claim
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`Page 3 of 12
`Page 3 of 12
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`

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`Application/Control Number: 08/486,070
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`Art Unit: 1631
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`’
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`A Page 3
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`3147. This citation also cites “arrangements of wells, tubes or cuvettes” which includes
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`an arrangement limitation which is more limited than the above cites sets because the
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`sets of claim 3147 lack any arrangement limitation(s) and thus contain NEW MATTER
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`due to broadening to sets vs. arrangements. On page 16, lines 9-14, cites a glassplate
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`with an array of depressions or wells but not the generic plate or plates as now set forth V
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`in claim 3147 nor depressions or wells without their presence in a glass plate as now
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`set forth in claim 3147. On page 23, line 17, conventional microtiter well plates are set
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`forth but not the generic plate or set of plates as now set forth in instant claim 3147.
`Open plate(s) incubation is cited on page 23, lines 25-27, but are reasonably interpreted
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`as describing said conventional microtiter plates and not generic plate(s) as now
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`claimed in claim 3147. This NEW MATTER is also present in claims 3175, 3201, and
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`3248.
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`Although applicants point to a previous claim regarding the “more than one
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`surface” type of solid support in claim 3148, a review of the instant disclosure as filed
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`has failed to reveal any such “more than one surface” limitation. This phrase thus adds
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`NEW MATTER compared to the instant disclosure as filed. This NEW MATTER is also
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`present in claims 3176, 3202, 3249, 3150, and 3278.
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`Although applicants point to previous claims regarding the “to one of said
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`reactive sites or binding sites” as now set forth in claim 3149, a review of the instant
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`disclosure as filed has failed to reveal any citation regarding the particular "to one or
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`limitation within said phrase. This “to one of” phrase thus adds NEW MATTER
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`compared to the instant disclosure as filed.
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`it is acknowledged that several chemical
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`Page 4 of 12
`Page 4 of 12
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`

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`Application/Control Number: 08/486,070
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`Art Unit: 1631
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`’
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`Page 4
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`5
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`surface treatments have been disclosed as filed, such as providing alkylamine (page 16,
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`line 1) and epoxy glue (page 23, line 3). Such surface treatment(s), however, lack any
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`localization of nucleic acid attachment “to one of’ any sites on the various surfaces or
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`solid supports as now set forth in claim 3149 which therefore contains NEW MATTER
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`due to said "to one of” limitation. This NEW MATTER is also present in claims 3177,
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`3178, 3250, and 3251.
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`Although applicants point to previous claims regarding claims 3164 and 3165, a
`review of the instant disclosure as filed has failed to reveal any written support as filed
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`for the quantitation limitation directed to “proportional to”. The specification at page 13,
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`lines 11-28, cite quantitation of signal but not that such quantitation is via a signal which
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`is “proportional to" an amount of label etc. This phrase thus adds NEW MATTER 1
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`A
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`V compared to the instant disclosure as filed. This NEW MATTER is also present in
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`N claims 3192, 3193, 3218, 3219, 3242, 3243, 3265, and 3266.
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`Although applicants point to a previous claim regarding claim 3165, a review of
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`the instant disclosure as filed has failed to reveal any written support as filed for
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`quantifiability of a label “in or from a fluid or solution’’ either “in” or “through” a “non-
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`porous solid support” as now set forth in claim 3165.
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`lt is acknowledged that a fluid or
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`solution is cited as filed as well as non-porous solid supports of various types, but not
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`that quantifiability is practiced either “in" or “through" a non-porous support as now set
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`forth in claim 3165. This phrase thus adds NEW MATTER compared to the instant
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`disclosure as filed.
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`Page 5 of 12
`Page 5 of 12
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`

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`Application/Control Number: 08/486,070
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`Page 5
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`Art Unit: 1631
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`Although applicants point to a previous claim regarding claim 3166, a review of
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`the instant disclosure, however, as filed has failed to reveal any written support forthe
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`“iminobiotin”, “hapten", or “|igand” limitations therein. These limitations thus add NEW
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`MATTER compared to the instant disclosure as filed. This NEW MATTER is also
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`present in claims 3194, 3220, and 3244.
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`A Although applicants point to previous claims regarding instant claims 3170 and
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`3171, a review of the instant disclosure as filed, however, has failed to reveal any
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`written description of any “set“ regarding comprising a support as set forth in either of
`claims 3170 or 3171. These set limitations thus add NEW MATTER compared to the
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`instant disclosure as filed. This NEW MATTER is also present in claims 3269 and
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`3270.
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`Although applicants point to previous claims regarding instant claims 3198 etc., a
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`review of the instant disclosure as filed, however, has failed to reveal any written
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`description of a generic “array“ comprising “various” nucleic acids. These generic .
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`various nucleic acid array limitations thus add NEW MATTER compared to the instant
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`disclosureas filed. Applicants argue in REMARKS, filed 6/30/04, that plural sequences
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`of analytes and DNA are cited in the specification at several instances.
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`in response, the
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`immobilization or fixation disclosures, including examples, as filed immobilize or fix a
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`plurality of sequences but not specifying any variousness or differences between such
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`pluralities unless also accompanied by requiring depressions or wells. That is, no
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`generic description of arrays as in claim 3198 has been found as filed wherein any
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`specificity as to sequence characterization is set forth without depressions or wells
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`Page 6 of 12
`Page 6 of 12
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`

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`Application/Control Numbers‘ 08/486,070
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`Page 6
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`Art Unit: 1631,
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`required therefor. For example, in Example 1, with usage thereof in Example 2, on
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`pages 15-18 of the specification cites arrays with depressions or wells for depositing of
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`1 various denatured analytes. Instant claim 3198 lacks any corresponding limitation
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`regarding what deposition is practiced for such various samples in contrast to the
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`depressions or wells as in Example 1 which are reasonably interpreted as being
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`directed to separation of such various denatured analytes into depressions or wells.
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`In
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`Example 3 on pages 18-19, at page 18, lines 23-25, “the analyte” (singular) was
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`described as immobilized on an activated glass surface. This is neither an array
`disclosure nor cites the practice of various nucleic acidsbas now in claim 3198.
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`Applicants further argue in said REMARKS that exemplified sequences are set forth in
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`the specification on pages 10, 20, 21, 22, and 23. Consideration of these citations
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`reveals that no array disclosure has been found nor pointed to nor any written support
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`for any array (singular) as claimed in claim 3198 whereon “various” nucleic acids are
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`fixed or immobilized. Applicants further submit a Declaration from Dr. Alexander A.
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`Waldrop, Ill. Consideration of said Declaration reveals that, after reviewing of scientific
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`background and filter assay practice of the Grunstein and Hogness types, item # 9
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`therein discusses advantages of non-porous solid supports, none of which, however,
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`are disclosed as filed.
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`In said Declaration in items # 10 and 11 a NEW MATTER
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`rejection is summarized plus Declarant’s substantial experience and background. Said
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`items 3 10 and 11 however, lack any discussion of written support contrary to this NEW
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`MATTER rejection. Declarant then further sets forth in item # 12 array subject matter
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`but without specifying any written description as instantly filed regarding this NEW
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`Page 7 of 12
`Page 7 of 12
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`

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`Application/Control Number: O8/486,070
`Art Unit: 1631
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`Page 7
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`MATTER rejection.
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`Item # 13 then summarizes various understandings but again
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`without any description regarding written basis contrary to this NEW MATTER rejection.
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`Then item # 14 sets forth an opinion and conclusion but only verifies that a page 16
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`citation in the instant specification as filed cites an array with both various nucleic acids
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`as well as having depressions and wells.
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`Item # 15 repeats the page 16 array
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`disclosure wherein various nucleic acids are cited with also the array having
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`depressions or wells and then gives a contrary opinion. This is non-persuasive in that
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`the factual basis on said page 16 corresponds to written support for connecting various
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`nucleic acids with an array having depressions or wells and is thus directed tothe
`limiting written support whereas the opinion expressed in said item # 15 is an allegation
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`which lacks any such factual support. Declarant then argues that the phrase “For
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`example” conveys what is illustrative or exemplary of an array. This does not negate
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`the fact that written basis for an array with various nucleic acids ‘‘only’' is disclosed as
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`filed wherein the array has depressions or wells. Declarant goes on to state that fixation
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`or immobilization in the disclosure is not dependent on the shape or conformation of the
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`support.
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`In response, it has been noted above that such generic fixation or
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`immobilization lacks any indication of “various” nucleic acids as set forth in the citation
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`on page 16 as well as lacking in array disclosure as on page 16. Thus, the non-porous
`support descriptions lack any description of conception of an array type of invention.
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`I
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`When an array invention is cited on page 16 it is only cited with various nucleic’ acids as
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`well as with depressions or wells. Declarant then describes a Petrie dish plate, tube,
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`cuvette, etc. as conventional apparatus as conveyed via Example 1. Such conveyance
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`Page 8 of 12
`Page 8 of 12
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`

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`Application/Control Number: O8/486,070
`Art Unit: 1631
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`Page 8
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`is also lacking in written support as Example 1 does not cite any Petrie dish plate etc.
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`Additionally, what is conveyed in Dec|arant’s understanding clearly is not written.
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`Declarant then summarizes Examples in the specification but none of them cite an array
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`with various nucleic acids thereon independent of depressions or wells thus failing to
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`provide written support for the generic array as claimed instantly in claims 3198 etc.
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`In
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`particular Example 7 is discussed regarding a conventional microtiter plate but
`acknowledging the fixing of “the polynucleotide analyte” (singular) thereto. Such a
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`singular analyte fixation to a microtiter plate both provides written description for a
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`single (not various) analyte and such a plate which is well known to contain depressions
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`or wells.
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`In items # 17-23 Declarant discusses the definition of analyte but fails to
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`indicate their disposition on an array therein which also fails to provide written basis for
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`the array of claims 3198 etc.
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`In summary, Dec|arant’s opinion/understanding
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`Declaration fails to provide support for the written description of an array as now
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`claimed in instant claims 3198-3221 which contain embodiments which are not limited
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`to the combined limitations of various nucleic acids and depressions or wells thereon.
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`Claims 3222 etc. which cite an array comprising various sing|e—stranded nucleic
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`acids fixed or immobilized to a non-porous support having depression or wells also
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`contains a limitation regarding cell a cell fixed in situ to said wells or depressions. This
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`cell fixation in situ in wells or depressions or not has not been found as filed. This NEW .
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`MATTER is also present in claims 3223-3245.
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`Page 9 of 12
`Page 9 of 12
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`

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`Application/Control Number: 08/486,070
`Art Unit: 1631
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`Page 9
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`VAGUENESS AND lNDEFlNITENESS
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`Claims 3144-3286 are rejected under 35 U.S.C. 112, second paragraph, as
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`being indefinite for failing to particularly point out and distinctly claim the subject matter
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`which applicant regards as the invention.
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`In claims 3170, 3171, 3269, and 3270; a set is claimed but with only one support
`cited therein regarding said set. Thus, the metes and bounds of the claims are vague
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`and indefinite as to whether the set is defined by one support or whetherthe metes and
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`bounds are defined by the set limitation. Additionally, there is no indication in these
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`claims as to what would be meant if the set includes one or more item(s) other than the
`cited solid support. Clarification via clearer claim wording is requested.
`1
`I
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`All of the presently pending claims, either directly or indirectly via dependence
`from another claim cite either the phrase “directly or indirectly fixed or immobilized" or
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`“indirectly fixed or immobilized”.
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`In the first phrase, it is unclear whether one, both, or
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`neither of the limitations “directly” or “indirectly" applies to modify “immobilized”.
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`lnthe
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`second phrase the limitation “indirectly” may or may not modify “immobilized". The lack
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`of clear and concise metes and bounds of these phrases supports this rejection. Similar
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`phrases, such as “indirect fixation or immobilization" in line 6 of claim 3173 also contain
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`this unclarity.
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`PRIOR ART
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`The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that
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`form the basis for the rejections under this section made in this Office action:
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`A person shall be entitled to a patent unless —
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`Page 10 of 12
`Page 10 of 12
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`

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`Application/Control Number: O8/486,070
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`‘
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`Page 10
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`Art Unit: 1631
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`(e) the invention was described in (1) an application for patent, published under section 122(b), by
`another filed in the United States before the invention by the applicant for patent or (2) a patent ,
`granted on an application for patent by another filed in the United States before the invention by the
`applicant for patent, except that an international application filed under the treaty defined in section
`351(a) shall have the effects for purposes of this subsection of an application filed in the United States
`only if the international application designated the United States and was published under Article 21(2)
`of such treaty in the English language.
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`Claims 3144-3148, 3151 , 3155, 3156-3163, 3166-3176, 3179, 3183-3191 , 3194-
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`3197, 3246-3249, 3252, 3256-3264, and 3267-3286 are rejected under 35
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`U.S.C. 102(e)(2)' as being clearly anticipated by Stuart et al. (P/N 4,732,847).
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`Stuart et al. summarizes the usage of monoclonal antibodies for distinguishing
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`DNA-RNA hybrids on a solid surface as disclosed in the abstract. The sample nucleic
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`acid being detected is described in Stuart et at. as being inclusive of detection of
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`specific sequences “from a wide variety of sources" as cited in column 2, lines 30-33.
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`In
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`column 2, lines 48-53, the detection of both naturally occurring as well as synthetic
`fragments is disclosed. These synthetic analytes are reasonably interpreted as being
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`within the analyte scope of the instant claims because they are not “cell fixed in situ”
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`type as negated in the above listed instant claims. Both covalent and non—covalent
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`fixation of single stranded polynucleotide is cited in column 3, lines 31-40, inclusive also
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`of glass slides which are reasonably interpreted as the commonly utilized non-porous
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`microscope type slides which are well known in the art. Said column 3, lines 31-40,
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`citation also includes disclosure of surface treatment as in instant claim 3151, for
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`example. RNA probes which hybridize to said sample single-stranded nucleic acids are
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`disclosed in column 3, lines 10-21. Antibody detection complexes including non-
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`radioactive labels for detection of hybridized DNA-RNA hybrids are described in column
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`Page 11 of 12
`Page 11 of 12
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`

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`Application/Control Number: 08/486,070
`Art Unit: 1631
`I
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`Page 11
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`4, lines 24-55. Thus, the instant claims directed to hybridizable nucleic acids on a non-
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`porous support wherein
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`No claim is allowed.
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`Papers related to this application may be submitted to Technical Center 1600 by
`facsimile transmission. Papers should be faxed to Technical Center 1600 via the
`Central PTO Fax Center. The faxing of such papers must conform with the notices
`published in the Official Gazette, 1096 0G 30 (November 15, 1988), 1156 OG 61
`(November 16, 1993), and 1157 OG 94 (December 28, 1993)(See 37 CFR § 1.6(d)).
`The Central PTO Fax Center number is (703) 872-9306.
`
`Any inquiry concerning this communication or earlier communications from the
`examiner should be directed to Ardin Marschel, Ph.D., whose telephone number is
`(571) 272-0718. The examiner can normally be reached on Monday-Friday from 8 A.M.
`to 4 P.M.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
`supervisor, Michael Woodward, Ph.D., can be reached on (571)272-0722.
`
`Any inquiry of a general nature or relating to the status of this application should
`be directed to Legal Instrument Examiner, Tina Plunkett, whose telephone number is
`(571) 272-0549.
`‘
`
`Information regarding the status of an application may be obtained from the
`Patent Application Information Retrieval (PAIR) system. Status information for
`published applications may be obtained from either Private PAIR or Public PAIR.
`Status information for unpublished applications is available through Private PAIR only.
`For more information about the PAIR system, see http://pair-direct.uspto.gov. Should
`you have questions on access to the Private PAIR system, contact the Electronic 1
`Business Center (EBC) at 866-217-9197 (tol|—free).
`
`November 19. 2004
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`ARDIFI H. M RSCHE
`
`PRIMARY lEQAt’ltllE?El%'l.
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`Page 12 of 12
`Page 12 of 12