`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`PO. Box 1450
`Alexandria1 Virginia 22313- 1450
`www.uspto.gov
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`APPLICATION NO.
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` F ING DATE
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`FIRST NAMED INVENTOR
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`ATTORNEY DOCKET NO.
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`
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`CONF {MATION NO.
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`12/110,748
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`04/28/2008
`
`John Corbitt
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`SENOP— 08900
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`6042
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`EXAMINER
`CRBamnc. —
`05’2“)“ —
`7590
`96000
`Bard Biopsy Systems
`LOGIE, MICHAEL J
`1415 W. 3rd St.
`PAPER NUMBER
`Tempe, AZ 85281
`
`ART UNIT
`2881
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`
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`NOT *ICATION DATE
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`DELIVERY MODE
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`05/25/201 1
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`ELECTRONIC
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`Please find below and/or attached an Office communication concerning this application or proceeding.
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`The time period for reply, if any, is set in the attached communication.
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`Notice of the Office communication was sent electronically on above—indicated "Notification Date" to the
`following e—mail address(es):
`BPVIP.Docket@crbard.com
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`JackiDaspit @ crbard.com
`rau st @ au stiplaw.com
`
`PTOL—90A (Rev. 04/07)
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`Focal Exhibit 1008 Page 1
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`Focal Exhibit 1008 Page 1
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`

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`Application No.
`Applicant(s)
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`Office Action Summary
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`12/110,748
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`Examiner
`MICHAEL LOGIE
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`CORBITT ET AL.
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`Art Unit
`2881
`
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
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`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE 3 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( a).
`In no event however may a reply be timely filed
`after SIX () 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).
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`Status
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`1)|Zl Responsive to communication(s) filed on 28 Ami/2008.
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`a)I:l This action is FINAL.
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`2b)IZ| This action is non-final.
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`3)|:l 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 Exparte Quay/e, 1935 CD. 11, 453 O.G. 213.
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`Disposition of Claims
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`4)IXI Claim(s) fl) is/are pending in the application.
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`4a) Of the above claim(s) _ is/are withdrawn from consideration.
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`5)I:I Claim(s) _ is/are allowed.
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`6)|Zl Claim(s
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`1_3-0 is/are rejected.
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`)
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`)
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`(
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`(
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`Application Papers
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`is/are objected to.
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`are subject to restriction and/or election requirement.
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`9)I:I The specification is objected to by the Examiner.
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`0)|Z| The drawing(s) filed on 28 AQI’i/ 2008 is/are: a)IZI accepted or b)|:l 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).
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`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)I:I Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
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`a)|:l All
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`b)I:l Some * c)|:l None of:
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`1.|:I Certified copies of the priority documents have been received.
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`2.|:I Certified copies of the priority documents have been received in Application No. _
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`3.|:I 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) X Notice of References Cited (PTO-892)
`2) D Notice of Draftsperson‘s Patent Drawing Review (PTO-948)
`3) IZI Information Disclosure Statement(s) (PTO/SB/08)
`
`Paper No(s)/Mai| Date 10/20/2009 03/19/2010 04/01/2010.
`US. Patent and Trademark Office
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`4) D Interview Summary (PTO-413)
`Paper N°(5 )/Mai| Date. _
`5)I:I Notice of Informal Patent Application
`)6|:| Other:
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`PTOL-326 (Rev. 08-06)
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`Office Action Summary
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`Part of Paper No./Mai| Date 20110519
`Focal Exhibit 1008 Page 2
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`
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`Focal Exhibit 1008 Page 2
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`

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`Application/Control Number: 12/110,748
`Art Unit: 2881
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`Page 2
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`DETAILED ACTION
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`Claim Objections
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`Claims 1, 20 and 24 objected to because of the following informalities:
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`Claims 1 and 20 recite "Placing" and "Targeting", the "P" and the "T" should not
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`be capitalized.
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`Claims 6 and 24 recites "Image", the "I" should not be capitalized.
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`Appropriate correction is required.
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`Claim Rejections - 35 USC § 102
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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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`(b) the invention was patented or described in a printed 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.
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`Claims 1 and 20 are rejected under 35 U.S.C. 1 02(b) as being anticipated by
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`Gerow (USPN 4,795,463).
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`In regards to claim 1, Gerow teaches a method of partial breast radiation (col. 7,
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`line 48 teaches mammography of breasts and the abstract teaches a radiopaque
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`prosthesis for the breast cavity, thus partial irradiation) comprising the steps of:
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`placing within a breast cavity (abstract), a substantially radio-opaque implant
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`(abstract) constructed of biocompatible (inherently biocompatible, since its intended to
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`remain in the body) and biodegradable material (col. 2, lines 50-52), said implant
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`supporting the tissue surrounding the breast cavity (inherent function of a cosmetic
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`breast implant); and
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`Focal Exhibit 1008 Page 3
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`

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`Application/Control Number: 12/110,748
`Art Unit: 2881
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`Page 3
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`targeting a radiation beam to said breast tissue surrounding the implant such that
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`the radiation beam does not materially irradiate the whole of the breast (since the
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`implant has radiopaque markers, the entire breast cannot be irradiated during the
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`mammography, thus only partial irradiation of the breast).
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`In regards to claim 20, Gerow teaches a method of partial breast radiation (col. 7,
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`line 48 teaches mammography of breasts and the abstract teaches a radiopaque
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`prosthesis for the breast cavity, thus partial irradiation) comprising the steps of:
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`placing within a breast cavity (abstract), an implant constructed of biocompatible
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`(inherently biocompatible, since its intended to remain in the body) and biodegradable
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`material (col. 2, lines 50-52), said implant containing a substantially radio-opaque
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`marker (abstract) and said implant supporting the tissue surrounding the breast cavity
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`(inherent function of a cosmetic breast implant); and
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`targeting a radiation beam to said breast tissue surrounding the implant such that
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`the radiation beam does not materially irradiate the whole of the breast (since the
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`implant has radiopaque markers, the entire breast cannot be irradiated during the
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`mammography, thus only partial irradiation of the breast).
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`Claim Rejections - 35 USC § 103
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`The following is a quotation of 35 U.S.C. 1 03(a) which forms the basis for all
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`obviousness rejections set forth in this Office action:
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`(a) A patent may not be obtained though the invention is not identically disclosed or described as set
`forth in section 1 02 of this title, if the differences between the subject matter sought to be patented and
`the prior art are such that the subject matter as a whole would have been obvious at the time the
`invention was made to a person having ordinary skill in the art to which said subject matter pertains.
`Patentability shall not be negatived by the manner in which the invention was made.
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`Focal Exhibit 1008 Page 4
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`Application/Control Number: 12/110,748
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`Page 4
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`Art Unit: 2881
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`Claims 1-30 are rejected under 35 U.S.C. 103(a) as being unpatentable over
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`Patrick et al. (US ngub 2005/0101860) and further in view of Foerster et al. (USPN
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`6,228,055).
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`In regards to claim 1, Patrick et al. teach a method of partial breast radiation
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`(abstract teaches treating surrounding tissue, [0001] teaches treatment of disorders in
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`the breast by positioning tissue and applying radiation and [0051] teaches radio opaque
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`expandable surface 20, thus only partial breast irradiation) comprising the steps of:
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`targeting a radiation beam to said breast tissue surrounding the implant such that
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`the radiation beam does not materially irradiate the whole of the breast (see citations
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`above).
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`Although, Patrick et al. teach placing a radio-opaque implant within a breast,
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`because these limitations are disclosed in the parent continuation-in-part cases of the
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`present application, Patrick et al. does not qualify as prior art for teaching placing within
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`a breast cavity, a substantially radio-opaque implant constructed of constructed of
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`biocompatible and biodegradable material said implant supporting the tissue
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`surrounding the breast cavity.
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`However, Foerster et al. teaches placing within a breast cavity, a substantially
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`radio-opaque implant (col. 5, lines 63-67 and col. 1, lines 8-13) constructed of
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`constructed of biocompatible and biodegradable material (col. 5, lines 63-67 and col.
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`13, lines 30-36) said implant supporting the tissue surrounding the breast cavity
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`(wherein a implant will inherently support the surrounding tissue).
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`Focal Exhibit1008 Page5
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`Focal Exhibit 1008 Page 5
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`Application/Control Number: 12/110,748
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`Page 5
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`Art Unit: 2881
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`Foerster et al. modifies Patrick et al. by providing a radio opaque insert for the
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`breast.
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`Since both Patrick and Foerster are directed towards marking the breast, it would
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`have been obvious to one of ordinary skill in the art at the time the invention was made
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`to have the radio opaque insert of Foerster et al. in the method of Patrick et al. because
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`it would provide for marking the location of a surgery for the purpose of identification.
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`In regards to claims 2 and 21, Patrick et al. teach targeting a therapeutically
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`effective dosage of radiation to said breast tissue surrounding the implant via a
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`stereotactic radiation machine ([0052]).
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`In regards to claims 3 and 22, Patrick et al. teach targeting multiple
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`therapeutically effective dosages of radiation to said breast tissue surrounding the
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`implant in a single treatment via a stereotactic radiation machine ([0006] and [0052]).
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`In regards to claim 4, Patrick et al. teach targeting therapeutically effective
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`dosages of radiation to said breast tissue surrounding the implant multiple times in a
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`single treatment via a stereotactic radiation machine ([0006] and [0052]).
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`In regards to claims 5 and 23, Patrick et al. teach targeting a therapeutically
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`effective dosage of radiation to said breast tissue surrounding the implant via
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`multidirectional radiation therapy ([0006]).
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`In regards to claims 6 and 24, Patrick et al. teach targeting a therapeutically
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`effective dosage of radiation to said breast tissue surrounding the implant via Image
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`guided radiation therapy ([0006]).
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`Focal Exhibit1008 Page6
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`Focal Exhibit 1008 Page 6
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`Application/Control Number: 12/110,748
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`Page 6
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`Art Unit: 2881
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`In regards to claims 7 and 25, Patrick et al. teach targeting a therapeutically
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`effective dosage of radiation to said breast tissue surrounding the implant via 3-D
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`conformal radiation therapy ([0006]).
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`In regards to claims 8 and 26, Patrick et al. teach targeting a therapeutically
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`effective dosage of radiation to said breast tissue surrounding the implant via intensity
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`modulated radiation therapy ([0006]).
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`In regards to claims 9-13 and 27, Patrick et al. teach aspirating air from the
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`lumpectomy cavity at any time after placement of the implant ([0014], [0051] and [0053],
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`note: lumpectomy cavity, inflation with air and collapse of expandable surface).
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`In regards to claims 14-18 and 2829, Patrick et al. teach initiating targeting of a
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`radiation beam about 1-90 days subsequent placement of the implant ([0053]).
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`In regards to claims 19 and 30, Patrick et al. teach initiating chemotherapy and
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`tmyeafieninMafingtmgeflngofarawafionbeaniupto120dayssubsequentmacement
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`oftheinuflantq0053D.
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`Claim 20 is similar to claim 1 and is therefore rejected as discussed herein
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`above.
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`Focal Exhibit 1008 Page 7
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`Focal Exhibit 1008 Page 7
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`Application/Control Number: 12/110,748
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`Page 7
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`Art Unit: 2881
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`Relevant Art of interest to the applicant:
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`0
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`Silver et al. (USPN 4,937,323) teaches a therapeutic method for treating wounds
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`by dressing the wound with a biocompatible biodegradable collagen tissue
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`product.
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`. Good (USPN 6,099,457) teaches radioactive implants having a radiopaque core.
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`Conclusion
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to MICHAEL J. LOGIE whose telephone number is
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`(571 )270-1 61 6. The examiner can normally be reached on 8:00 to 4:30.
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
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`supervisor, Robert Kim can be reached on 571-272—2293. The fax phone number for
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`the organization where this application or proceeding is assigned is 571-273-8300.
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`Information regarding the status of an application may be obtained from the
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`Patent Application Information Retrieval (PAIR) system. Status information for
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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.
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`For more information about the PAIR system, see http://pair-direct.uspto.gov. Should
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`you have questions on access to the Private PAIR system, contact the Electronic
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`Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a
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`USPTO Customer Service Representative or access to the automated information
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`system, call 800-786-9199 (IN USA OR CANADA) or 571-272—1000.
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`/M. L./
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`Focal Exhibit1008 Page8
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`Focal Exhibit 1008 Page 8
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`Application/Control Number: 12/110,748
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`Page 8
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`Art Unit: 2881
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`Examiner, Art Unit 2881
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`Focal Exhibit1008 Page9
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`Focal Exhibit 1008 Page 9
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