`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O, Box 1450
`Alexandria, Virginia 22313-1450
`wWW.USplO.gov
`
`08/486,070
`
`06/0711995
`
`JANNIS G, STAVRIANOPOULOS
`
`ENZ-7(P)(C3)
`
`6279
`
`11126/2004
`
`28171
`7590
`ENZO BIOCHEM, INC.
`527 MADISON A VENUE (9TH FLOOR)
`NEW YORK, NY 10022
`
`EXAMINER
`
`MARSCHEL, ARDIN H
`
`ART UNIT
`
`PAPER NUMBER
`
`1631
`
`DATE MAILED: 11/26/2004
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`PTO-90C (Rev, 10103)
`
`Exhibit 2123 Page 1
`
`Enzo Exhibit 2123
`Hologic, Inc. v. Enzo Life Sciences, Inc.
`Case IPR2016-00822
`
`
`
`Office Action Summary
`
`Application No,
`
`Applicant(s)
`
`08/486,070
`
`Examiner
`
`STAVRIANOPOULOS ET AL.
`
`Art Unit
`
`1631
`Ardin Marschel
`•• The MAILING DA TE of this communication appears on the cover sheet with the correspondence address .(cid:173)
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE ~ MONTH(S) FROM
`THE MAILING DATE OF THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR 1.136(a). In no event, however, maya reply be timely filed
`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 patentterm adjustment. See 37 CFR 1.704(b).
`
`Status
`
`1)[8] Responsive to communication(s) filed on 30 June 2004.
`2a)0 This action is FINAL.
`2b)[gJ This action is non-final.
`3)0 Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`closed in accordance with the practice under Ex parte Quay/e, 1935 C.D. 11, 453 O,G. 213.
`
`Disposition of Claims
`
`4)[8] Claim(s) 3144-3286 is/are pending in the application.
`4a) Of the above claim(s)
`is/are withdrawn from consideration.
`5)0 Claim(s)
`is/are allowed.
`6)[8] Claim(s) 3144-3286 is/are rejected.
`7)0 Claim(s) __ is/are objected to.
`8)0 Claim(s) __ are subject to restriction and/or election requirement.
`
`Application Papers
`
`9)0 The specification is objected to by the Examiner.
`10)0 The drawing(s) filed on
`is/are: a)O accepted or b)O objected to by the Examiner,
`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).
`11)0 The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PTO-152.
`
`Priority under 35 U.S.C. § 119
`
`12)0 Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`a)O All b)O Some * c)O None of:
`1.0 Certified copies of the priority documents have been received.
`2.0, Certified copies of the priority documents have been received in Application No. __ .
`3.0 Copies of the certified copies of the priority documents have been received in this National Stage
`application from the International Bureau (PCT Rule 17.2(a».
`* See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment(s)
`1) 0 Notice of References Cited (PTO·892)
`2) 0 Notice of Draftsperson's Patent Drawing Review (PTO·948)
`3) [8] Information Disclosure Statement(s) (PTO·1449 or PTO/S6/08)
`Paper No(s)/Mail Date (1 sheet).
`
`4) 0 Interview Summary (PTO·413)
`Paper No(s)/Mail Date. __ .
`5) 0 Notice of Informal Patent Application (PTO·152)
`6) 0 Other: __ "
`
`U.S. Patent and Trademark Office
`PTOL·326 (Rev. 1·04)
`
`Office Action Summary
`
`Part of Paper No.lMaii Date 111904
`
`Exhibit 2123 Page 2
`
`
`
`Application/Control Number: 08/486,070
`Art Unit: 1631
`
`Page 2
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`DETAILED ACTION
`
`Due to the below set forth new grounds of rejection the finality of the office
`
`action, mailed 4/7/04, is hereby withdrawn. Also, due to said withdrawl of finality the
`
`Notice of Appeal, filed 6/30/04, is deemed moot. The amendment, filed 6/30/04, has
`
`been entered.
`
`Applicants' arguments, filed 6/30/04, have been fully considered but they are not
`
`deemed to be persuasive. Rejections and/or objections not reiterated from previous
`
`office actions are hereby withdrawn. The following rejections and/or objections are
`
`either reiterated or newly applied. They constitute the complete set presently being
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`applied to the instant application.
`
`NEW MATTER
`
`Claims 3147-3150, 3164-3166, 3170, 3171, 3175-3178, 3192-3194, 3198-3245,
`
`3248-3251, 3265, 3266, 3269, 3270, and 3278 are rejected under 35 U.S.C. 112, first
`
`paragraph, as failing to comply with the written description requirement. The claim(s)
`
`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.
`
`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",
`
`"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
`
`which cites plastic or glass wells which are not the generic wells as in instant claim
`
`Exhibit 2123 Page 3
`
`
`
`Application/Control Number: 08/486,070
`Art Unit: 1631
`
`Page 3
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`3147. This citation also cites "arrangements of wells, tubes or cuvettes" which includes
`
`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
`
`due to broadening to sets vs. arrangements. On page 16, lines 9-14, cites a glass plate
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`with an array of depressions or wells but not the generic plate or plates as now set forth
`
`in claim 3147 nor depressions or wells without their presence in a glass plate as now
`
`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
`
`as describing said conventional microtiter plates and not generic plate(s) as now
`
`claimed in claim 3147. This NEW MATTER is also present in claims 3175,3201, and
`
`3248.
`
`Although applicants point to a previous claim regarding the "more than one
`
`surface" type of solid support in claim 3148, a review of the instant disclosure as filed
`
`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 dis~losure as filed. This NEW MATTER is also
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`present in claims 3176, 3202, 3249, 3150, and 3278.
`
`Although applicants point to previous claims regarding the "to one of said
`
`reactive sites or binding sites" as now set forth in claim 3149, a review of the instant
`
`disclosure as filed has failed to reveal any citation regarding the particular "to one of'
`
`limitation within said phrase. This "to one of' phrase thus adds NEW MATTER
`
`compared to the instant disclosure as filed. It is acknowledged that several chemical
`
`Exhibit 2123 Page 4
`
`
`
`Application/Control Number: 08/486,070
`Art Unit: 1631
`
`Page 4
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`surface treatments have been disclosed as filed, such as providing alkylamine (page 16,
`
`line 1) and epoxy glue (page 23, line 3). Such surface treatment(s), however, lack any
`
`localization of nucleic acid attachment "to one of' any sites on the various surfaces or
`
`solid supports as now set forth in claim 3149 which therefore contains NEW MATTER
`
`due to said "to one of' limitation. This NEW MATTER is also present in claims 3177,
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`3178,3250, and 3251.
`
`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
`
`for the quantitation limitation directed to "proportional to". The specification at page 13,
`
`lines 11-28, cite quantitation of signal but not that such quantitation is via a signal which
`
`is "proportional to" an amount of label etc. This phrase thus adds NEW MATTER
`
`compared to the instant disclosure as filed. This NEW MATTER is also present in
`
`claims 3192,3193,3218,3219,3242,3243,3265, and 3266.
`
`Although applicants point to a previous claim regarding claim 3165, a review of
`
`the instant disclosure as filed has failed to reveal any written support as filed for
`
`quantifiability of a label "in or from a fluid or solution" either "in" or "through" a "non-
`
`porous solid support" as now set forth in claim 3165. It 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
`
`that quantifiability is practiced either "in" or "through" a non-porous support as now set
`
`forth in claim 3165. This phrase thus adds NEW MATTER compared to the instant
`
`disclosure as filed.
`
`Exhibit 2123 Page 5
`
`
`
`Application/Control Number: 08/486,070
`Art Unit: 1631
`
`Page 5
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`Although applicants point to a previous claim regarding claim 3166, a review of
`
`the instant disclosure, however, as filed has failed to reveal any written support for the
`
`"iminobiotin", "hapten", or "ligand" limitations therein. These limitations thus add NEW
`
`MATTER compared to the instant disclosure as filed. This NEW MATTER is also
`
`present in claims 3194,3220, and 3244.
`
`Although applicants point to previous claims regarding instant claims 3170 and
`
`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
`
`instant disclosure as filed. This NEW MATTER is also present in claims 3269 and
`
`3270.
`
`Although applicants point to previous claims regarding instant c!aims 3198 etc., a
`
`review of the instant d,isclosure 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
`
`disclosure as 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. 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 unle.ss 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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`Exhibit 2123 Page 6
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`
`
`Application/Control Number: 08/486,070
`Art Unit: 1631
`
`Page 6
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`required therefor. For example, in Example 1, with usage thereof in Example 2, on
`
`pages 15-18 of the specification cites arrays with depressions or wells for depositing of
`
`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
`
`depressions or wells as in Example 1 which are reasonably interpreted as being
`
`directed to separation of such various denatured analytes into depressions or wells. In
`
`Example 3 on pages 18-19, at page 18, lines 23-25, "the analyte" (singular) was
`
`described as immobilized on an activated glass surface. This is neither an array
`
`disclosure nor cites the practice of various nucleic acids as now in claim 3198.
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`Applicants further argue in said REMARKS that exemplified sequences are set forth in
`
`the specification on pages 1 0, 20, 21, 22, and 23. Consideration of these citations
`
`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.
`
`Waldrop, III. Consideration of said Declaration reveals that, after reviewing of scientific
`
`background and filter assay practice of the Grunstein and Hogness types, item # 9
`
`therein discusses advantages of non-porous solid supports, none of which, however,
`
`are disclosed as filed. 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
`
`items 3 10 and 11 however, lack any discussion of written support contrary to this NEW
`
`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
`
`Exhibit 2123 Page 7
`
`
`
`Application/Control Number: 08/486,070
`Art Unit: 1631
`
`Page 7
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`MATTER rejection. 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
`
`as well as having depressions and wells. Item # 15 repeats the page 16 array
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`disclosure wherein various nucleic acids are cited with also the array having
`
`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
`
`nucleic acids with an array having depressions or wells and is thus directed to the
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`limiting written support whereas the opinion expressed in said item # 15 is an allegation
`
`which lacks any such factual support. Declarant then argues that the phrase "For
`
`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
`
`filed wherein the array has depressions or wells. Declarant goes on to state that fixation
`
`or immobilization in the disclosure is not dependent on the shape or conformation of the
`
`support. In response, it has been noted above that such generic fixation or
`
`immobilization lacks any indication of "various" nucleic acids as set forth in the citation
`
`on page 16 as well as lacking in array disclosure as on page 16. Thus, the non-porous
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`support descriptions lack any description of conception of an array type of invention.
`
`When an array invention is cited on page 16 it is only cited with various nucleic acids as
`
`well as with depressions or wells. Declarant then describes a Petrie dish plate, tube,
`
`cuvette, etc. as conventional apparatus as conveyed via Example 1. Such conveyance
`
`Exhibit 2123 Page 8
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`
`
`Application/Control Number: 08/486,070
`Art Unit: 1631
`
`Page 8
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`is also lacking in written support as Example 1 does not cite any Petrie dish plate etc.
`
`Additionally, what is conveyed in Declarant's understanding clearly is not written.
`
`Declarant then summarizes Examples in the specification but none of them cite an array
`
`with various nucleic acids thereon independent of depressions or wells thus failing to
`
`provide written support for the generic array as claimed instantly in claims 3198 etc. In
`
`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
`
`single (not various) analyte and such a plate which is well known to contain depressions
`
`or wells. In items # 17-23 Declarant discusses the definition of analyte but fails to
`
`indicate their disposition on an array therein which also fails to provide written basis for
`
`the array of claims 3198 etc. In summary, Declarant's opinion/understanding
`
`Declaration fails to provide support for the written description of an array as now
`
`claimed in instant claims 3198-3221 which contain embodiments which are not limited
`
`to the combined limitations of various nucleic acids and depressions or wells thereon.
`
`Claims 3222 etc. which cite an array comprising various single-stranded nucleic
`
`acids fixed or immobilized to a non-porous support having depression or wells also
`
`contains a limitation regarding cell a cell fixed in situ to said wells or depressions. This
`
`cell fixation in situ in wells or depressions or not has not been found as filed. This NEW.
`
`MATTER is also present in claims 3223-3245.
`
`Exhibit 2123 Page 9
`
`
`
`Application/Control Number: 08/486,070
`Art Unit: 1631
`
`Page 9
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`VAGUENESS AND INDEFINITENESS
`
`Claims 3144-3286 are rejected under 35 U.S.C. 112, second paragraph, as
`
`being indefinite for failing to particularly point out and distinctly claim the subject matter
`
`which applicant regards as the invention.
`
`In claims 3170, 3171,3269, and 3270; a set is c1aime~ but with only one support
`
`cited therein regarding said set. Thus, the metes and bounds of the claims are vague
`
`and indefinite as to whether the set is defined by one support or whether the metes and
`
`bounds are defined by the set limitation. Additionally, there is no indication in these
`
`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.
`
`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
`
`"indirectly fixed or immobilized". In the first phrase, it is unclear whether one, both, or
`
`neither of the limitations "directly" or "indirectly" applies to modify "immobilized". In the
`
`second phrase the limitation "indirectly" mayor 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
`
`this unclarity.
`
`PRIOR ART
`
`The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that
`
`form the basis for the rejections under this section made in this Office action:
`
`A person shall be entitled to a patent unless -
`
`Exhibit 2123 Page 10
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`
`
`Applicatien/Centrol Number: 08/486,070
`Art Unit: 1631
`
`Page 10
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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.
`
`Claims 3144-3148, 3151, 3155, 3156-3163, 3166-3176, 3179, 3183-3191, 3194-
`
`3197,3246-3249,3252,3256-3264. and 3267-3286 are rejected under 35
`
`u.s.c. 1 02(e)(2) as being clearly anticipated by Stuart et al. (P/N 4,732,847).
`
`Stuart et al. summarizes the usage ef meneclenal antibedies fer distinguishing
`
`DNA-RNA hybrids en a selid surface as disclesed in the abstract. The sample nucleic
`
`acid being detected is described in Stuart et al. as being inclusive ef detectien ef
`
`specific sequences "frem a wide variety ef seurces" as cited in celumn 2, lines 30-33. In
`
`celumn 2, lines 48-53, the detectien ef beth naturally eccurring as well as synthetic
`
`fragments is disclesed. These synthetic analytes are reasenably interpreted as being
`
`within the analyte scepe ef the instant claims because they are net "cell fixed in situ"
`
`type as negated in the abeve listed instant claims. Beth cevalent and nen-cevalent
`
`fixatien ef single stranded pelynucleetide is cited in celumn 3, lines 31-40, inclusive also.
`
`ef glass slides which are reasenably interpreted as the cemmenly utilized nen-perous
`
`microscepe type slides which are well knewn in the art. Said celumn 3, lines 31-40,
`
`citatien also. includes disclesure ef surface treatment as in instant claim 3151. fer
`
`example. RNA prebes which hybridize to' said sample single-stranded nucleic acids are
`
`disclesed in celumn 3, lines 10-21. Antibedy detectien cemplexes including nen-
`
`radieactive labels fer detectien ef hybridized DNA-RNA hybrids are described in column
`
`Exhibit 2123 Page 11
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`
`
`Application/Control Number: 08/486,070
`Art Unit: 1631
`
`Page 11
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`4, lines 24-55. Thus, the instant claims directed to hybridizable nucleic acids on a non-
`
`porous support wherein
`
`No claim is allowed.
`
`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 OG 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
`supeNisor, 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
`Business Center (EBC) at 866-217-9197 (toll-free).
`
`November 19, 2004
`
`~VJ1f~ ,/~I
`ARDm H. MAASCHEl / V "'"'1 0 'f
`PRIMARY e>CJ\.Mlru~R
`
`Exhibit 2123 Page 12