_
`
`_
`
`,
`
`‘ ’
`
`’
`
`"
`
`r.
`
`i
`
`”
`
`"or
`
`A
`
`-
`
`, K UNITED STAT!DEPARTMENT OFCOMMERCE
`Patent and Trademark Office
`‘A K
`,6?
`Address: COMMISSIONER OF PATENTS AND TRADEMARKS
`,
`Washington. no. 20231
`
`‘hm 0*
`
` ATTORNEY DOCKET NO.
`
`|._. .
`
`III FEIZ-U1-3
`|— F\'IZiNo’—'-iL-II-
`ENZIII
`1'.1'I»’—\II-3N|Z|EiTIIZI!Ei
`
`IN|'_'I
`
`ENZD E=II:u::HEM INC:
`FIFTH AVENUE 1E€TH FL|:”:|F\.'
`NEH YURK NY 10017
`
` I-{M131 / 1I.E‘E|E=
`-1
`
`vf:»I_+
`
`DATE MAILED:
`
`1
`
`-" '35‘ / '95‘
`
`Please find below and/or attached an Office communication concerning this application or
`proceeding.
`
`commissioner of Patents and Trad marks
`
`\
`
`\\
`
`’
`
`\ \
`
`\
`
`\
`
`\ ‘
`
`.1
`
`i J I iS
`
`9°C (3,, 2,95,
`Page 1 Of 11
`
`HOLOGIC EXHIBIT 1031
`Hologic V. Enzo
`
`.
`
`1_ We copy
`
`Page 1 of 11
`
`HOLOGIC EXHIBIT 1031
`Hologic v. Enzo
`
`

`
`Office Action Summary
`
`Application No.
`08/486,070
`Examiner
`
`App|icant(s)
`
`Stavrianopoulos et al.
`Group Art Unit
`
`Kl Responsive to communication(s) filed on 7/24/98, 8/77/98, and .9/2 7/98
`
`X This action is FINAL.
`
`D 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.
`
`month(s), or thirty days, whichever
`3
`A shortened statutory period for response to this action is set to expire
`is longer, from the mailing date of this communication. Failure to respond within the period for response will cause the
`application to become abandoned.
`(35 U.S.C. § 133). Extensions of time may be obtained under the provisions of
`37 CFR1.136(al.
`
`Disposition of Claims
`
`IX CIaim(s) 48-700 and 702-782
`
` , flaimlsl 7-47 and 707 have been canceled.
`
`I: CIaim(s)
`
`X Claimlsl 48-700 and 702-782
`
`C‘ C|aim(s)
`
`I: Claims
`
`Application Papers
`
`is/are pending in the application.
`
`is/are allowed.
`
`is/are rejected.
`
`is/are objected to.
`
`are subject to restriction or election requirement.
`
`I: See the attached Notice of Draftsperson's Patent Drawing Review, PTO-948.
`
`I: The drawing(s) filed on
`
`is/are objected to by the Examiner.
`
`I: The proposed drawing correction, filed on
`
`is
`
`Chpproved
`
`Ctlisapproved.
`
`C The specification is objected to by the Examiner.
`
`|: The oath or declaration is objected to by the Examiner.
`
`Priority under 35 U.S.C. § 119
`
`I: Acknowledgement is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d).
`
`D All Cl Some* DNone
`
`of the CERTIFIED copies of the priority documents have been
`
`Cl received.
`
`3 received in Application No. (Series Code/Serial Number)
`
`:1 received in this national stage application from the International Bureau (PCT Rule 17.2(a)).
`
`*Certified copies not received:
`
`E] Acknowledgement is made of a claim for domestic priority under 35 U.S.C. § 119(e).
`
`Attachmentlsl
`
`Cl Notice of References Cited, PTO—892
`
`D Information Disclosure Statement(s'), PTO-1449, Paper Nols).
`8 Interview Summary, PTO-413
`I
`C] Notice of Draftsperson's Patent Drawing Review, PTO-948
`
`Cl Notice of Informal Patent Application, PTO-152
`
`U. S. Patent and Trademark Office
`
`PTO-326 (Rev. 9-95)
`
`Page 2 of 11
`
`--- SEE OFFICE ACTION ON THE FOLLOWING PAGES ---
`
`Office Action Summary
`
`part of paper No_
`
`34
`
`Page 2 of 11
`
`

`
`Serial No. 08/486,070
`
`- 2 -
`
`Art Unit: 1634
`
`Applicants’ arguments; filed 7/24/98, 8/17/98, and 9/21/98,
`
`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 newly applied.
`
`They constitute
`
`the complete set presently being applied to the instant
`
`application.
`
`Claims 60, 63, 77-99, 114, 118, 133, 136, 141, 144-161, 164,
`
`and 180-182 are rejected, as discussed below, under 35 U.S.C.
`
`112, first paragraph, as containing subject matter which was not
`
`described in the specification is such a way as to reasonably
`
`convey to one skilled in the relevant art that the inventor(s),
`
`at the time the application was filed, had possession of the
`
`claimed invention.
`
`Consideration of the disclosure as filed has failed to
`
`reveal the limitation of instant claims 60 and 114 directed to
`
`the support and system being composed of different materials.
`
`This limitation is therefore NEW MATTER. Consideration of the
`
`arguments and Declaration of Dr. Dean Engelhardt reveals that
`
`many alternatives were disclosed as filed directed to both porous
`
`and non—porous substrates or supports but that the citations
`
`pointed to lack any characterization wherein broadly different
`
`materials as given now in claims 60 and 114 are disclosed. This
`
`rejection is reiterated from the previous office action, mailed
`
`1/21/98.
`
`Page3 ofll
`
`Page 3 of 11
`
`

`
`Serial No. 08/486,070
`
`- 3 -
`
`Art Unit: 1634
`
`Claims 63, 86, 118, 146, 152, 164, and 180-182 have been
`
`amended to cite "a combination of any of the foregoing" or
`
`"combinations thereof" which are directed to DNA etc. This is
`
`NEW MATTER as written basis as filed for such combination
`
`practice has neither been pointed to by applicants nor been found
`
`by consideration of the instant disclosure as filed. This
`
`rejection is necessitated by amendment.
`
`Claims 77-85, 87-99, 133, 136, and 141 contain NEW MATTER
`
`because the oligonucleotide or polynucleotide is cited as fixed
`
`or immobilized to the system rather than being limited to being
`fixed or immobilized to the solid support within such a system.
`
`Consideration of the disclosure as filed has not revealed fixing
`
`or immobilizing to a system as now cited in claims 77 etc.
`
`Applicants argue that original claims 20 and 23 give written
`
`support
`
`to said system immobilization of oligonucleotides etc.
`
`In response the written basis in these claims clearly contain
`
`"means" within devices or apparati thus not supporting the
`
`generic "system" limitation that has been noted above as NEW
`
`MATTER. This rejection is therefore maintained and reiterated
`
`from the previous office action, mailed 1/21/98, and necessitated
`
`by amendment due to newly added claims that contain the NEW
`
`MATTER either directly or via dependence from other claims.
`
`Claims 144-161 and 180-182 contain NEW MATTER directed to
`
`enhancement of fixtation or immobilization with several
`
`treatments cited which have not been found as to written basis as
`
`Page 4 of 11
`
`Page 4 of 11
`
`

`
`Serial No. 08/486,070
`
`- 4 -
`
`Art Unit: 1634
`
`filed either.
`
`For example,
`
`the written basis for "a dispersive
`
`compound" of claim 148 has not been found as filed.
`
`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 --
`
`the invention was known or used by others in this
`(a)
`country, or patented or described in a printed publication
`in this or a foreign country, before the invention thereof
`by the applicant for a patent.
`
`the invention was patented or described in a printed
`(b)
`publication in this or a foreign country or in public use or
`on sale in this country, more than one year prior to the
`date of application for patent in the United States.
`
`the invention was described in a patent granted on an
`(e)
`application for patent by another filed in the United States
`before the invention thereof by the applicant for patent, or
`on an international application by another who has fulfilled
`the requirements of paragraphs (1),
`(2), and (4) of section
`371(c) of this title before the invention thereof by the
`applicant for patent.
`
`Claims 48-50, 53-56, 59, 61, 63-81, 84, 86-100, 102-104,
`
`107-109, 113, and 115-132, 135-143, 152, 155, 156, 158, and 160-
`
`182 are rejected under 35 U.S.C. § 102(b) as being clearly
`
`anticipated by Kourilsky et al.
`
`(UK 2,019,408).
`
`This rejection is reiterated and maintained from the
`
`previous office action, mailed 1/21/98, and necessitated by
`
`amendment regarding newly added claims. Applicants argue that
`
`ultracentrifugation is not
`
`immobilization or fixation.
`
`In
`
`response it is noted that resuspension as a distinct act is
`
`required in order to resuspend the pellet from said
`
`Page 5 of 11
`
`Page 5 of 11
`
`

`
`Serial No. 08/486,070
`
`- 5 -
`
`Art Unit: 1634
`
`ultracentrifugation.
`
`Such a required resuspension clearly
`
`supports the immobilized character of said pellet and supports
`
`this rejection. Applicants also argue that the signal of the
`
`reference is prevented from the pelleted product. This is non-
`
`persuasive because the instant claims do not contain any
`
`limitation that requires that the signal be generated while the
`
`nucleic acids are yet fixed or immobilized. That is,
`
`they can be
`
`resuspended as in the reference and capable of generating a
`
`soluble signal as this is not negated by any instant claim
`
`wording.
`
`Applicants argue the below art rejections in that the
`
`practice of in—situ hybridization is a very specialized type of
`
`methodology and different from the soluble signal generation
`
`practice as instantly claimed.
`
`In response applicants are
`
`reminded that compositions, apparati, and systems are claimed and
`
`not methods. Therefore,
`
`if a reference meets the composition,
`
`apparatus, or system limitations, it anticipates the instant
`
`invention even if a number of uses can be practiced for the
`
`claimed invention.
`
`In other words patentable weight is not given
`
`to use limitations if they do not limit the actual composition
`
`etc.
`
`limitations.
`
`Claims 48-54, 56, 59, 61-79, 84-100, 102-108, 113, 115-134,
`
`138-143, 152-158, and 162-182 are rejected under 35 U.S.C.
`
`§ 102(e) as being clearly anticipated by Stuart et al.
`
`Applicants argue that Stuart et al.
`
`is concerned with in
`
`Page 6 of 11
`
`Page 6 of 11
`
`

`
`Serial No. 08/486,070
`
`- 6 -
`
`Art Unit: 1634
`
`situ hybridization and not applicable. This is non-persuasive as
`
`already discussed above. Applicants then argue that the instant
`
`invention requires chemically labeled nucleic acid for one of the
`
`strands. This is also non-persuasive because there is therein no
`
`limitation regarding whether a label may or may not also interact
`
`with the second strand in a hybrid formed during a hybridizatino
`
`assay. This rejection is reiterated and necessitated by
`
`amendment due to the newly added claims.
`
`Claims 48-54, 56, 59, 61-79, 84-100, 102-108, 113, 115-134,
`
`138-143, 152-158, and 162-182 are rejected under 35 U.S.C.
`
`§ 102(a) as being clearly anticipated either by Langer—Safer et
`
`al. or Manuelidis et al.
`
`The listed claims are anticipated either by Langer—Safer et
`
`al. or Manuelidis et al.
`
`in the same manner as the above
`
`rejection based on Stuart et al. because both references also
`
`discussed the performance of in situ hybridization of chromosome
`
`spreads on microscope slides etc. as summarized above: This
`
`rejection is reiterated and necessitated by amendment due to the
`
`newly added claims.
`
`Claims 48-100 and 102-182 are rejected under 35 U.S.C.
`
`§ lO2(e) as being anticipated by Ward et al.
`
`Ward et al. disclose via the "GENERAL PROTOCOL" and with
`
`connected discussion elsewhere at the bottom of columns 19 and 20
`
`in situ hybridization where immobilized double-stranded nucleic
`
`acid is shown visualized with a biotinylated probe bound to
`
`Page 7 of 11
`
`Page 7 of 11
`
`

`
`‘Serial No. 08/486,070
`
`- 7 —
`
`Art Unit: 1634
`
`avidin—peroxidase. This reads on the listed claims as the
`
`peroxidase is capable of generating a soluble signal as discussed
`
`above and therefore still reads on the instant invention even
`
`though Ward et al. discloses insoluble signal generation. This
`
`rejection is reiterated and necessitated by amendment due to the
`
`newly added claims.
`
`The non-statutory double patenting rejection, whether of the
`obviousness-type or non—obviousness-type,
`is based on a
`judicially created doctrine grounded in public policy (a policy
`reflected in the statute) so as to prevent the unjustified or
`improper timewise extension of the "right to exclude" granted by
`a patent.
`In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA
`1969);
`In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970);
`In re
`Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982);
`In re Longi,
`759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); and In re Goodman,
`29 USPQ2d 2010 (Fed. Cir. 1993).
`
`A timely filed terminal disclaimer in compliance with 37
`CFR 1.32l(b) and (c) may be used to overcome an actual or
`provisional rejection based on a non-statutory double patenting
`ground provided the conflicting application or patent is shown to
`be commonly owned with this application.
`See 37 CFR 1.78(d).
`
`Effective January 1, 1994, a registered attorney or agent of
`record may sign a terminal disclaimer.
`A terminal disclaimer
`signed by the assignee must fully comply with 37 CFR 3.73(b).
`
`Claims 100, 102-108, 110-132, 134, 139, and 142-182 are
`
`rejected under the judicially created doctrine of obviousness-
`
`type double patenting as being unpatentable over claim 17 of U.S.
`
`Patent No. 4,994,373. Although the conflicting claims are not
`
`identical,
`
`they are not patentably distinct from each other
`
`because they contain common embodiments regarding devices.
`
`It is
`
`noted that a terminal disclaimer was filed in the immediate
`
`parent
`
`to the instant application, however, when a new
`
`Page 8 of 11
`
`Page 8 of 11
`
`

`
`Serial No. 08/486,070 ’
`
`— 8 —
`
`Art Unit: 1634
`
`application serial number is utilized due to the instant
`
`application being a continuation of said parent a new terminal
`
`disclaimer must be filed.
`
`It is noted that applicants‘ arguments'
`
`have been persuasive for the instant composition claims but that
`
`claim 17 of the patent is a device which falls into the same
`
`restriction group as the above rejected instant claims.
`
`The disclosure is objected to because of the following
`
`informalities:
`
`The specification has been amended at pages 18, 24, and 25
`
`to indicate that the generic name for TRITON X-100 is "octoxymol”
`
`which conflicts with the Merck Index spelling of "octoxymol”.
`
`Appropriate correction is required.
`
`No claim is allowed.
`
`Applicants‘ amendment necessitated the new grounds of
`
`rejection. Accordingly, THIS ACTION IS MADE FINAL.
`
`See M.P.E.P.
`
`§ 706.07(a). Applicants are reminded of the extension of time
`
`policy as set forth in 37 C.F.R. § l.l36(a).
`
`A SHORTENED STATUTORY PERIOD FOR RESPONSE TO THIS FINAL
`ACTION IS SET TO EXPIRE THREE MONTHS FROM THE DATE OF THIS
`ACTION.
`IN THE EVENT A FIRST RESPONSE 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 C.F.R. § l.l36(a) WILL BE CALCULATED FROM THE
`MAILING DATE OF THE ADVISORY ACTION.
`IN NO EVENT WILL THE
`STATUTORY PERIOD FOR RESPONSE EXPIRE LATER THAN SIX MONTHS FROM
`THE DATE OF THIS FINAL ACTION.
`
`This application is subject to the provisions of Public Law
`
`Page 9 of 11
`
`Page 9 of 11
`
`

`
`Serial No. 08/486,070
`
`- 9 —
`
`Art Unit: 1634
`
`103-465, effective June 8, 1995. Accordingly, since this
`
`application has been pending for at least two years as of June 8,
`
`1995,
`
`taking into account any reference to an earlier filed
`
`application under 35 U.S.C. 120, 121 or 365(c), applicant, under
`
`37 CFR 1.129(a),
`
`is entitled to have a first submission entered
`
`and considered on the merits if, prior to abandonment,
`
`the
`
`submission and the fee set forth in 37 CFR l.l7(r) are filed
`
`prior to the filing of an appeal brief under
`
`37 CFR 1.192. Upon
`
`the timely filing of a first submission and the appropriate fee
`
`for a large entity under 37 CFR l.l7(r),
`
`the finality of the
`
`previous Office action will be withdrawn.
`
`In View of 35 U.S.C.
`
`132, no amendment considered as a result of payment of the fee
`
`set forth in 37 CFR l.l7(r) may introduce new matter into the
`
`disclosure of the application.
`
`If applicant has filed multiple proposed amendments which,
`
`when entered, would conflict with one another, specific
`
`instructions for entry or non—entry of each such amendment should
`
`be provided upon payment of any fee under 37 CFR l.l7(r).
`
`Papers related to this application may be submitted to Group
`1600 by facsimile transmission.
`Papers should be faxed to Group
`1600 via the PTO Fax Center located in Crystal Mall 1.
`The
`faxing of such papers must conform with the notice published in
`the Official Gazette, 1096 0G 30 (November 15, 1989).
`The CM1 Fax Center number is (703) 308-4242.
`
`Any inquiry concerning this communication or earlier
`communications from the examiner should be directed to
`
`Ardin Marschel, Ph.D., whose telephone number is (703) 308-3894.
`The examiner can normally be reached on Monday-Friday from 8 A.M.
`to 4 P.M.
`
`Page N)of11
`
`Page 10 of 11
`
`

`
`Serial No. 08/486,070
`
`- 10 —
`
`Art Unit: 1634
`
`If attempts to reach the examiner by telephone are
`unsuccessful,
`the examiner's supervisor, W. Gary Jones, can be
`reached on (703) 308-1152.
`
`Any inquiry of a general nature or relating to the status of
`this application should be directed to the Chemical Matrix
`receptionist whose telephone number is (703) 308-0196.
`
`December 7, 1998
`
`AJAAMML4
`
`ARDIN H. MARSCHEL
`PRIMARY EXAMINER
`
`Page llofll
`
`Page 11 of 11