UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box I450
`Alexandria. Virginia 223 I3-I450
`www.uspto.gav
`
`08/486,070
`
`06/07/1995
`
`JANNIS G. STAVRIANOPOULOS
`
`ENZ-7(P)(C3)
`
`6279
`
`28171
`
`7590
`
`09l‘29/2005
`
`ENZO BIOCHEM, INC.
`527 MADISON AVENUE (9TH FLOOR)
`NEW YORK, NY 10022
`
`EXAMINER
`
`MARSCHEL, ARDIN H
`
`I631
`
`DATE MAILED: 09/29/2005
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`PTO-90C (Rev. 10/03)
`
`Page 1 0f12
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`HOLOGIC EXHIBIT 1014
`
`Hologic V. Enzo
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`Page 1 of 12
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`HOLOGIC EXHIBIT 1014
`Hologic v. Enzo
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`

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`Office Action Summary
`
`- plication No.
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`_
`
`Applicant(s)
`
`08/486,070
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`Examine,
`
`Ardin Marschel
`
`STAVRIANOPOULOS ET AL.
`
`M Uni,
`
`1631
`
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address -
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE § MONTH(S) OR THIRTY (30) DAYS,
`WHICHEVER IS LONGER, FROM THE MAILING DATE OF THIS COMMUNICATION.
`- Extensions of time may be available under the provisions of 37 CFR 1.136(3).
`In no event, however, may a reply be timely filed
`after SIX (6) MONTHS from the mailing date of this communication.
`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).
`
`Status
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`1)IZ Responsive to communication(s) filed on 25 May 2005.
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`2a)lZ This action is FINAL.
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`2b)E] This action is non-final.
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`3)EI 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)IX] Claim(s) (See attached list.) is/are pending in the application.
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`4a) Of the above claim(s)
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`is/are withdrawn from consideration.
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`5)E Claim(s) (See attached list.) is/are allowed.
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`6)X Claim(s) (See attached list.) islare rejected.
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`7)E] Claim(s)_ is/are objected to.
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`8)E] Claim(s)
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`are subject to restriction and/or election requirement.
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`Application Papers
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`9)[j The specification is objected to by the Examiner.
`
`.
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`10)l:] The drawing(s) filed on _ is/are: a)EI accepted or b)C] objected to by the Examiner.
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`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)l] 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)[:] Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
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`a)I:] All
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`b)E] Some * c)[j None of:
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`1.Ij Certified copies of the priority documents have been received.
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`2.E] Certified copies of the priority documents have been received in Application No. __
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`3.[] 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)).
`* See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment(s)
`
`4) El Interview Summary (PTO-413)
`Paper N0(S)/Ma“ 9316- ._-
`5) L__I Noiioo of informal Paieni Application (PTO-152)
`5) C] Other:
`.
`
`1) D Notice of References Cited (PTO-892)
`2) D Notice of Drattsperson’s Patent Drawing Review (PTO-948)
`3) E] lnforrnation Disclosure Statement(s) (PTO-1449 or PTOISB/08)
`Paper No(s)/Mail Date
`.
`U.S. Patent and Tradermrk Office
`PTOL-326 (Rev. 7-05)
`Page 2 of 12
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`Office Action Summary
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`Part of Paper No./Mail Date 92005
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`Page 2 of 12
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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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`Claim listings from the attached 326 form:
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`Pending claims 4): 3144-3147, 3150-3155, 3157-3169, 3172-3175, 3179-3183, 3185-
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`3201, 3204-3209, 3211-3224, 3227-3232, 3234-3238, 3240-3248, 3252-3256, 3258-
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`3268, 3271-3277, 3279-3283, and 3287-3407
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`Allowed claims 5): 3144-3146, 3150-3155, 3157-3169, 3172-3174, 3179-3183, 3185-
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`3197, 3222-3224, 3227-3232, 3234-3238, 3240-3247, 3252-3256, 3259-3268, 3271-
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`3274, 3279-3283, 3287-3291, 3294-3299, 3310-3325, 3328-3361, and 3380-3407
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`Rejected claims 6): 3147, 3175, 3198-3201, 3204-3209, 3211-3221, 3248, 3258, 3275-
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`3277,3292, 3293, 3300-3309, 3326, 3327, and 3362-3379
`
`DETAILED ACTION
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`Applicants’ arguments, filed 5/25/05, have been fully considered but they are not
`deemed to be persuasive. Rejections and/or objections not reiterated from previous
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`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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`Page 3 of 12
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`Page 3 of 12
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`

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`Application/Control Number: 08/486,070
`Art Unit: 1631
`'
`
`A
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`Page 3
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`New MATTER
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`Claims 3147, 3175, 3198-3201, 3204-3209, 3211-3221, 3248, 3302-3309, 3326,
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`3327, and 3362-3379 are rejected under 35 U.S.C. 112, first paragraph, as failing to
`comply with the written description requirement. The c|aim(s) contains subject matter
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`which was not described in the specification in such a way as to reasonably convey to
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`one skilled in the relevant art that the inventor(s), at the time the application was filed,
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`had possession of the claimed invention.
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`The NEW MATTER rejection based on NEW MATTER being amended into
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`instant claim 3147 etc. directed to "beads" is maintained and reiterated from the
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`previous office action, mailed 11/26/04, due to these limitations still being present in
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`certain claims and not supported by written disclosure as filed. Applicants havenewly
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`added the limitation "a bead" (e.g., claim 3147, line 4) which also is NEW MATTER due
`to not being found as filed regarding written description. This "a bead" rejection basis is
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`necessitated by amendment. The NEW MATTER directed to "a bead" or "beads" was
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`not addressed as to written description specifically as filed by applicants in their
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`response, filed 5/25/05.
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`In an appendix applicants point to pages 13-14; page 14, lines
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`19-20; page 16, lines 10-11; Examples 1-3 and 5-7; and claims 17 and 21 as originally
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`filed; of the specification for written support for claim 3147, for example, but neither a
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`bead or beads is found therein. These NEW MATTER limitations are present in claims ’
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`3147, 3175,3201, and 3248.
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`The NEW MATTER rejection directed to a lack of written description as filed for a
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`generic "array" comprising "various" nucleic acids is maintained and reiterated from the
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`Page 4 of 12
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`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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`Page 4
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`‘
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`previous office action, mailed 11/26/04.
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`In contrast, the arrays with depressions or wells
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`for depositing of various denatured analytes has written basis in Example 1 as filed.
`Thus, the "various" nucleic acids limitation is connected as filed to depressions or wells
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`for depositing of various analytes. Applicants argue that plural sequences in the
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`specification supports generic arrays with various nucleic acids thereon. This has been
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`responded to previously and the response is repeated that plural sequences may either
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`be the same or different and that the phrase "plural sequences" lacks written support for
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`different or various as a particular type of plural sequences. Applicants again also note
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`a Declaration of Dr. Alexander A. Waldrop, III, which has been responded to previously
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`as being non-persuasive. Applicants further argue that the novelty of the invention
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`resides in fixing nucleic acids in hybridizable form to the surface of a substrate
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`regardless of its shape.
`
`In response, this NEW MATTER rejection basis is not directed
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`to claims which cite plural sequences or surface(s) of a substrate regardless of shape.
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`This rejection is directed to claims which specifically cite "various" nucleic acids which
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`indicates some type of variation of nucleic acid type which as filed is only described
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`wherein depressions or wells are practiced apparently to separate one variant from
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`another therebetween the depressions or wells. Such a consideration is not required
`
`when plural nucleic acid molecules or sequences are utilized without any distinction as
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`to type or variousness. When applicants, as filed, describe various nucleic acids they
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`also reasonably indicate depressions or wells for separation of the various nucleic acid
`types. Applicants then argue that In re Peters is analogousin that tapered and non-
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`tapered tips has written support and note that the CCPA indicated that the tip
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`Page 5 of 12
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`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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`configuration was non-critical.
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`In response, this fact pattern is distinguished over that of
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`the instant claims because the nucleic acid hybridization practice includes an enabling
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`usage of detection of analyte targets specific to the nucleic acid probe utilized and
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`therefore separation in depressions or wells of variants of nucleic acid for detection
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`purposes is critical when variants are utilized in order to maintain whatever desired
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`target specificity is present regarding various probe nucleic acids. Various training
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`materials are then set forth by applicants but again supporting only non-critical elements
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`as having written basis where no relationship is required in contrast to the instant
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`invention wherein hybridization probe specificity distinguishes various or different
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`nucleic acid targets which would be obscured and useless if separations of some type,
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`such as wells or depressions, were not envisioned by applicants as filed to separate
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`various analyte detection elements. No other separation practice was disclosed as filed
`
`between various nucleic acids. Applicants argue further regarding "non-porous solid
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`support" support. This section again ignores the hybridization probe specificity
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`regarding target detection which is a critical feature thereof and only described as filed
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`wherein various nucleic acids_are immobilized in wells or depressions in order to obtain
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`a detection result separated between various or different nucleic acid probes. This
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`argument also seems to be directed to instant broad claims which do not require various
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`nucleic acids which argument is moot regarding this basis for rejection because it is
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`directed only to claims containing the "various...nuc|eic acids" limitation. Applicants go
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`on to argue that Bilstad v. Wakalopulos explained two commonly recognized exceptions
`
`regarding "plurality". The Federal Circuit was cited as determining that disclosure of a
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`Page 6 of 12
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`Page 6 of 12
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`

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`Application/Control Number: O8/486,070
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`Page 6
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`Art Unit: 1631
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`specie may be sufficient written description support for a later claimed genus including
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`that specie.
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`In response, this argument is again apparently directed to the broad instant
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`claims which lack a "various...nuc|eic acids" limitation and therefore is moot regarding
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`this rejection. Additionally, there is no indication as filed that the specie of
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`"various...nuc|eic acids" with its well known probe specificity character may or should be
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`generically applied to surfaces other than those with depressions or wells, especially
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`since the depressions or well as discussed above reasonably effect a separation of
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`probes for detection facilitation of each ‘probes specific target detection capability.
`Again applicants argue that Dr. Waldrop's Declaration should be given relevant weight
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`and is not an opinion Declaration.
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`In response, this Declaration was discussed in the
`
`record previously as being a Declaration which failed to provide written basis as filed for
`the generic array containing "various'...nucleic acids". Also, contrary to applicants’
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`argument, Item 14 in said Declaration clearly states that it is an "opinion" Declaration.
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`In particular Item 15 of said Declaration cites an example providing glass plates with an
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`array of depressions or wells with "various denatured analytes" and then confusingly,
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`and in direct conflict, declares that the reference is not limited to depressions or wells.
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`Additionally, the Declaration fails to indicate what disclosure as filed supports the
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`various nucleic acids with their hybridization specificity as to any detection practice
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`corresponding thereto generic array surfaces which is a reasonable summaryof the
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`remainder of said Declaration.
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`It is reiterated that such a Declaration is not written basis
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`as filed. Applicants further argued missing several points in said Declaration but
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`confusingly fail to indicate what those points are. Thus, such points cannot be
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`Page 7 of 12
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`Page 7 of 12
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`

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`Application/Control Number: 08/486,070
`Art Unit: 1631
`
`0
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`Page 7
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`responded to. Applicants then argue regarding In re Alton.
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`in response, the fact pattern
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`in In re Alton is different from the instant disclosure as filed and therefore non-
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`persuasive.
`
`In the consideration of In re Alton, the persuasive Declaration indicated an
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`independence of different IFN amino acid substitutions/alterations wherein an amino
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`terminus alteration did not functionally relate to another amino acid substitution well
`
`within the polypeptide. Thus, there was an independence of amino acid substitution
`
`and/or deletion which supported the analysis of the therein discussed Declaration as
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`being persuasive. The Declaration of Dr. Waldrop, III, in contrast, sets forth the
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`argument that the disclosure as filed describes a number of surfaces or substrates but
`
`lacks any indication of the independence on which the In re Alton decision relies thus
`
`making this argument non-persuasive. Also, the locating of various nucleic acids is
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`. functionally important for specific target or analyte detection in theinstant disclosure
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`example which is not required or even significant in the In re Alton case.
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`It is also noted
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`that there is no indication of plural sequencesbeing located with any particularity on any
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`generic array in the instant disclosure as filed nor even that there is any separation
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`whatsoever between any of the plural sequences so as to functionally result in specific
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`and separate detection which is the only hybridization probe use that may relate to
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`plural sequences if they were, in particular, inclusive of variants or different types.
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`Thus, there is no generic array that has written support as filed on which various nucleic
`
`acids are attached or immobilized etc. This rejection applies to instant claims 3198-
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`3201, 3204-3209, 3211-3221, 3302-3309, 3326, 3327, and 3362-3379; either as
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`reiterated or necessitated by amendment for newly added claims.
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`Page 8 of 12
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`Page 8 of 12
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`

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`Application/Control Number: 08/486,070
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`'
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`Page 8
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`Art Unit: 1631
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`VAGUENESS AND INDEFINITENESS
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`Claims 3258, 3275-3277, 3292, and 3293 are rejected under 35 U.S.C. 112,
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`second paragraph, as being indefinite for failing to particularly point out and distinctly
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`claim the subject matter which applicant regards as the invention.
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`This rejection based on "indirectly" fixed or immobilized is reiterated and
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`maintained from the previous office action, mailed 11/26/04. Applicants only argument
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`regarding this rejection basis is that claim amending has removed the unclear direct or
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`indirect wording. Review of the instant claims, however, reveal that several claims still
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`contain the limitation "indirectly" as related to fixed or immobilized limitations as listed
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`above. Certain newly added claims contain this limitation as necessitated by
`
`amendment, for example, as claim 3292 which contains this unclarity due to depending
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`from claims 3275 or 3276.
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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
`
`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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`(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 3300-3302, 3306, 3308, 3362, 3366-3370, 3373, and 3376-3378 are
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`rejected under 35 U.S.C. 102(e)(2) as being clearly anticipated by Stuart et al. (P/N
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`4,732,847).
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`Page 9 of 12
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`Page 9 of 12
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`

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`Application/Control Number: 08/486,070
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`Page 9
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`Art Unit: 1631
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`This rejection is reiterated from the previous office action, mailed 11/26/04, as
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`necessitated by amendment regarding newly added claims as listed above directed to
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`single stranded polynucleotides fixed or immobilized in hybridizable form to a non-
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`porous solid support, such as a glass slide as set forth previously regarding this
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`rejection. The above listed claims are disclosed in the reference via previously set forth
`
`disclosure in Stuart et al. whereby supports were listed as well as detection via various
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`labels that are colored etc. and quantifiable via said color detection. Applicants argue
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`that the amendments directed to supports comprising amine(s), hydroxy|(s), or
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`epoxide(s) are distinguished over this prior art reference.
`
`In response, such instant
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`claims as being so limited are not rejected hereinunder. The above listed claims,
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`however, are broader in scope and do not require such specifically functionalized
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`supports. No other argument was set forth by applicants that pertains to this rejection.
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`Applicants‘ amendment necessitated the new ground(s) of rejection presented in
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`this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP
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`§ 706.07(a). Applicants are reminded of the extension of time policy as set forth in 37
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`CFR 1.136(a).
`
`A shortened statutory period for reply to this final action is set to expire TH REE
`MONTHS from the mailing date of this action.
`In the event a first reply is filed within
`TWO MONTHS of the mailing date of this final action and the advisory action is not
`mailed until after the end of the THREE-MONTH shortened statutory period, then the
`shortened statutory period will expire on the date the advisory action is mailed, and any
`extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of
`the advisory action.
`In no event, however, will the statutory period for reply expire later
`than SIX MONTHS from the date of this final action.
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`Page 10 of 12
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`Page 10 of 12
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`

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`Application/Control Number: 08/486,070
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`Page 10
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`Art Unit: 1631
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`Since the fee set forth in 37 CFR 1.17(r) for a first submission subsequent to a
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`final rejection has been previously paid, applicant, under 37 CFR 1.129(a), is entitled to
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`have a second submission entered and considered on the merits if, prior to
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`abandonment, the second submission and the fee set forth in 37 CFR 1.17(r) are filed
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`prior to the filing of an appeal brief under 37 CFR 41.37. Upon the timely filing of a
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`second submission and the appropriate fee for a large entity under 37 CFR 1.17(r), the
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`finality of the previous Office action will be withdrawn.
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`If a notice of appeal and the
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`appeal fee set forth in 37 CFR 41 .20(b) were filed prior to or with the payment of the fee
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`set forth in 37 CFR 1.17(r), the payment of the fee set forth in 37 CFR 1.17(r) by
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`applicant will be construed as a request to dismiss the appeal and to continue
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`prosecution under 37 CFR 1.129(a).
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`In view of 35 U.S.C. 132, no amendment
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`considered as a result of payment of the fee set forth in 37 CFR 1.17(r) may introduce
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`new matter into the disclosure of the application.
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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 0G 94 (December 28, 1993)(See 37 CFR § 1.6(d)).
`The Central PTO Fax Center number is (571) 273-8300.
`
`Any inquiry concerning this communication or earlier communications from the
`examiner should be directed to Ardin Marschel, Ph.D., AU 1631 Supervisory Patent
`Examiner, whose telephone number is (571)272-0718. The examiner can normally be
`reached on Monday-Friday from 8 A.M. to 4 P.M.
`
`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
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`Page 11 of 12
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`Application/Control Number: 08/486,070
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`Page 11
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`Art Unit: 1631
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`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).
`
`September 20, 2005
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`U W9/27/0;
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`Page 12 of 12
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