UNITED STA 1ES p A 1ENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.gov
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`121110,748
`
`04/28/2008
`
`John Corbitt
`
`10114/2011
`
`7590
`96000
`C. R. Bard, Inc.
`Bard Biopsy Systems
`1415 W. 3rd St.
`Tempe, AZ 85281
`
`297-PDD-10-182 US CIP
`3
`
`6042
`
`EXAMINER
`
`LOGIE, MICHAEL J
`
`ART UNIT
`
`PAPER NUMBER
`
`2881
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`10/14/2011
`
`ELECTRONIC
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
`following e-mail address(es):
`BPVIP.Docket@crbard.com
`J acki.Daspit@ crbard.com
`raust@ austip1aw.com
`
`PTOL-90A (Rev. 04/07)
`
`Focal Exhibit 1009 Page 1
`
`

`

`Office Action Summary
`
`Application No.
`
`Applicant(s)
`
`12/110,748
`
`Examiner
`
`CORBITT ET AL.
`
`Art Unit
`
`2881
`MICHAEL LOGIE
`-- The MAILING DATE 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 ;2 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 t. t 36(a). 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. § t 33).
`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 t .704(b).
`
`Status
`
`1 )IZ! Responsive to communication(s) filed on 24 August 2011.
`2a)IZ! This action is FINAL.
`2b)0 This action is non-final.
`3)0 An election was made by the applicant in response to a restriction requirement set forth during the interview on
`__ ;the restriction requirement and election have been incorporated into this action.
`4)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 Quayle, 1935 C. D. 11, 453 O.G. 213.
`
`Disposition of Claims
`
`5)[8J Claim(s) 1-9 and 14-34 is/are pending in the application.
`5a) Of the above claim(s) __ is/are withdrawn from consideration.
`6)0 Claim(s) __ is/are allowed.
`7)[8J Claim(s) 1-9 and 14-34 is/are rejected.
`8)0 Claim(s) __ is/are objected to.
`9)0 Claim(s) __ are subject to restriction and/or election requirement.
`
`Application Papers
`
`1 0)0 The specification is objected to by the Examiner.
`11 )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).
`12)0 The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PT0-152.
`
`Priority under 35 U.S.C. § 119
`
`13)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) [8J Notice of References Cited (PT0-892)
`2) 0 Notice of Draftsperson's Patent Drawing Review (PT0-948)
`3) 0 Information Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mail Date __ .
`
`4) 0 Interview Summary (PT0-413)
`Paper No(s)/Mail Date. __ .
`5) 0 Notice of Informal Patent Application
`6) 0 Other: __ .
`
`U.S. Patent and Trademark Off1ce
`PTOL-326 (Rev. 03-11)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20110930
`
`Focal Exhibit 1009 Page 2
`
`

`

`Application/Control Number: 12/110,748
`Art Unit: 2881
`
`Page 2
`
`DETAILED ACTION
`
`Response to Amendment
`
`An "Amendment" was received on 24 August 2011, in response to Office Action
`
`of 25 May 2011. Claims 1-9, 14-30 have been amended. Claims 10-13 have been
`
`cancelled. Claims 31-34 have been newly added. Claims 1-9 and 30-34 are now
`
`pending
`
`Response to Arguments
`
`Applicant's arguments with respect to claim 1 -9 and 14-34 have been considered
`
`but are moot in view of the new ground(s) of rejection.
`
`Claim Rejections - 35 USC § 103
`
`Claims 1-8, 14-19 and 31 are rejected under 35 U.S.C. 103(a) as being
`
`unpatentable over Patrick et al. (US pgPub 2005/01 01860) and further in view of Gerow
`
`(USPN 4,795,463) as evidenced by Henley (USPN 5,534,023).
`
`In regards to claim 1, Patrick et al. teach a method of partial breast radiation
`
`therapy (abstract teaches treating surrounding tissue, [0001] teaches treatment of
`
`disorders in the breast by positioning tissue and applying radiation and [0051] teaches
`
`radio opaque expandable surface 20, thus only partial breast irradiation) comprising the
`
`steps of:
`
`directing a radiation beam to said substantially radio-opaque implant serving as a
`
`target for delivery of radiation therapy to margins around the breast cavity such that the
`
`Focal Exhibit 1009 Page 3
`
`

`

`Application/Control Number: 12/110,748
`Art Unit: 2881
`
`Page 3
`
`radiation beam does not materially irradiate the whole of the breast (see citations above
`
`and[0014]).
`
`Although, Patrick et al. teach placing a radio-opaque implant within a breast,
`
`because these limitations are disclosed in the parent continuation-in-part cases of the
`
`present application, Patrick et al. does not qualify as prior art for teaching placing within
`
`a breast cavity a substantially radio-opaque implant constructed of constructed of
`
`biocompatible and biodegradable material said implant supporting the tissue
`
`surrounding the breast cavity.
`
`However, Gerow teaches placing within a breast cavity (abstract) a substantially
`
`radio-opaque implant (abstract note: silicone gel) constructed of biocompatible
`
`(inherently biocompatible, since it is intended to remain in the body) and biodegradable
`
`material (col. 2, lines 50-52) said implant supporting the tissue surrounding the breast
`
`cavity (inherent function of a cosmetic implant).
`
`Although Gerow does not specifically teach that silicone gel is radiopaque, this
`
`quality is known to the art as evidenced by Henely (see Col. 1, lines 44-45 of Henley).
`
`Therefore Gerow as evidenced by Henely modifies Patrick et al. by providing a
`
`substantially radiopaque, biodegradable, biocompatible implant.
`
`Since both Patrick et al. and Gerow are concerned with breast implants, one of
`
`ordinary skill in the art would have rational to look for the modifications of Gerow in the
`
`method of Patrick et al. because it would allow for a determination as to whether the
`
`envelop is intact or has an impending fold-fault rupture thus preventing rupture of the
`
`prosthetic envelope (col. 4, lines 7-11 of Gerow). That is a technique for improving a
`
`Focal Exhibit 1009 Page 4
`
`

`

`Application/Control Number: 12/110,748
`Art Unit: 2881
`
`Page 4
`
`particular class of devices was part of the ordinary capabilities of a person of ordinary
`
`skill in the art, in view of the teaching of the technique for other situations (i.e. detection
`
`of implant intactness).
`
`In regards to claim 2, Patrick et al. teach a therapeutically effective dosage of
`
`radiation to said breast tissue surrounding the implant via a stereotactic radiation
`
`machine ([0052]).
`
`In regards to claim 3, Patrick et al. teach multiple therapeutically effective
`
`dosages of radiation to said breast tissue surrounding the implant in a single treatment
`
`via a stereotactic radiation machine ([0006] and [0052]).
`
`In regards to claim 4, Patrick et al. teach therapeutically effective dosages of
`
`radiation to said breast tissue surrounding the implant multiple times in a single
`
`treatment via a stereotactic radiation machine ([0006] and [0052]).
`
`In regards to claim 5, Patrick et al. teach a therapeutically effective dosage of
`
`radiation to said breast tissue surrounding the implant via multidirectional radiation
`
`therapy ([0006]).
`
`In regards to claim 6, Patrick et al. teach a therapeutically effective dosage of
`
`radiation to said breast tissue surrounding the implant via Image guided radiation
`
`therapy ([0006]).
`
`In regards to claim 7, Patrick et al. teach a therapeutically effective dosage of
`
`radiation to said breast tissue surrounding the implant via 3-D conformal radiation
`
`therapy ([0006]).
`
`Focal Exhibit 1009 Page 5
`
`

`

`Application/Control Number: 12/110,748
`Art Unit: 2881
`
`Page 5
`
`In regards to claim 8, Patrick et al. teach a therapeutically effective dosage of
`
`radiation to said breast tissue surrounding the implant via intensity modulated radiation
`
`therapy ([0006]).
`
`In regards to claims 14-18, Patrick et al. teach initiating targeting of a radiation
`
`beam about 1-90 days subsequent placement of the implant ([0053]).
`
`In regards to claim 19, Patrick et al. teach initiating chemotherapy and thereafter,
`
`initiating targeting of a radiation beam up to 120 days subsequent placement of the
`
`implant ([0053]).
`
`In regards to claim 31, Patrick et al. teach wherein said substantially radio-
`
`opaque implant has a shape selected to guide the delivery of radiation therapy to the
`
`margins around said breast cavity ([0014]).
`
`Claims 9, 20-30 and 33-34 are rejected under 35 U.S.C. 1 03(a) as being
`
`unpatentable over the combined invention of Patrick et al. (US pgPub 2005/01 01860)
`
`and Gerow (USPN 4,795,463) as evidenced by Henley (USPN 5,534,023) and further in
`
`view of Bouck et al. (USPN 5, 192,744).
`
`In regards to claims 9 and 27, Patrick et al. teach aspirating air from the
`
`lumpectomy cavity at any time after placement of the implant ([0014], [0051] and [0053],
`
`note: lumpectomy cavity, inflation with air and collapse of expandable surface).
`
`Although Patrick et al. teach that the cavity is a lumpectomy cavity, because
`
`these limitations are disclosed in the parent continuation-in-part cases of the present
`
`Focal Exhibit 1009 Page 6
`
`

`

`Application/Control Number: 12/110,748
`Art Unit: 2881
`
`Page 6
`
`application, Patrick et al. does not qualify as prior art for teaching wherein the breast
`
`cavity is a lumpectomy cavity.
`
`However, Bouck et al. teaches the breast cavity it a lumpectomy cavity (col. 5,
`
`lines 31-41 teach applicable to all forms of internal solid tumors and removing a tumor
`
`(i.e. lumpectomy cavity in a breast) and implant placed at the site of the removed tumor.
`
`Further col. 5, lines 50-64 teaches observing the result of the inhibitor via radiological
`
`measurements of breast tumors, thus implying a lumpectomy procedure).
`
`Bouck et al. modifies the combined invention by placing the implant in the
`
`lumpectomy cavity.
`
`Since all inventions are directed towards breast implantation, it would have been
`
`obvious to one of ordinary skill at the time of the invention to have the implant placed in
`
`the lumpectomy cavity because it would provide inhibitors of the implant, which inhibit
`
`the angiogenesis of any reforming tumor at the same site of the removal (col. 5, lines
`
`31-41)
`
`In regards to claim 20, Patrick et al. teach a method of partial breast radiation
`
`therapy (abstract teaches treating surrounding tissue, [0001] teaches treatment of
`
`disorders in the breast by positioning tissue and applying radiation and [0051] teaches
`
`radio opaque expandable surface 20, thus only partial breast irradiation) comprising the
`
`steps of:
`
`directing a radiation beam to said substantially radio-opaque implant serving as a
`
`target for delivery of radiation therapy to margins around the breast cavity such that the
`
`Focal Exhibit 1009 Page 7
`
`

`

`Application/Control Number: 12/110,748
`Art Unit: 2881
`
`Page 7
`
`radiation beam does not materially irradiate the whole of the breast (see citations above
`
`and [0014]).
`
`Although, Patrick et al. teach placing a radio-opaque implant within a breast,
`
`because these limitations are disclosed in the parent continuation-in-part cases of the
`
`present application, Patrick et al. does not qualify as prior art for teaching placing within
`
`a breast cavity a substantially radio-opaque implant constructed of constructed of
`
`biocompatible and biodegradable material said implant supporting the tissue
`
`surrounding the breast cavity.
`
`However, Gerow teaches placing within a breast cavity (abstract) an implant
`
`(abstract note: silicone gel within envelope) constructed of biocompatible (inherently
`
`biocompatible, since it is intended to remain in the body) and biodegradable material
`
`(col. 2, lines 50-52) with a substantially radio-opaque marker contained within the
`
`implant (silicone gel is radio-opaque see below) said implant supporting the tissue
`
`surrounding the breast cavity (inherent function of a cosmetic implant).
`
`Although Gerow does not specifically teach that silicone gel is radiopaque, this
`
`quality is known to the art as evidenced by Henely (see Col. 1, lines 44-45 of Henley).
`
`Therefore Gerow as evidenced by Henely modifies Patrick et al. by providing a
`
`substantially radiopaque, biodegradable, biocompatible implant.
`
`Since both Patrick et al. and Gerow are concerned with breast implants, one of
`
`ordinary skill in the art would have rational to look for the modifications of Gerow in the
`
`method of Patrick et al. because it would allow for a determination as to whether the
`
`envelop is intact or has an impending fold-fault rupture thus preventing rupture of the
`
`Focal Exhibit 1009 Page 8
`
`

`

`Application/Control Number: 12/110,748
`Art Unit: 2881
`
`Page 8
`
`prosthetic envelope (col. 4, lines 7-11 of Gerow). That is a technique for improving a
`
`particular class of devices was part of the ordinary capabilities of a person of ordinary
`
`skill in the art, in view of the teaching of the technique for other situations (i.e. detection
`
`of implant intactness).
`
`Although Patrick et al. teach that the cavity is a lumpectomy cavity, because
`
`these limitations are disclosed in the parent continuation-in-part cases of the present
`
`application, Patrick et al. does not qualify as prior art for teaching wherein the breast
`
`cavity is a lumpectomy cavity.
`
`However, Bouck et al. teaches the breast cavity it a lumpectomy cavity (col. 5,
`
`lines 31-41 teach applicable to all forms of internal solid tumors and removing a tumor
`
`(i.e. lumpectomy cavity in a breast) and implant placed at the site of the removed tumor.
`
`Further col. 5, lines 50-64 teaches observing the result of the inhibitor via radiological
`
`measurements of breast tumors, thus implying a lumpectomy procedure).
`
`Bouck et al. modifies the combined invention by placing the implant in the
`
`lumpectomy cavity.
`
`Since all inventions are directed towards breast implantation, it would have been
`
`obvious to one of ordinary skill at the time of the invention to have the implant placed in
`
`the lumpectomy cavity because it would provide inhibitors of the implant, which inhibit
`
`the angiogenesis of any reforming tumor at the same site of the removal (col. 5, lines
`
`31-41)
`
`Focal Exhibit 1009 Page 9
`
`

`

`Application/Control Number: 12/110,748
`Art Unit: 2881
`
`Page 9
`
`In regards to claim 21, Patrick et al. teach a therapeutically effective dosage of
`
`radiation to said breast tissue surrounding the implant via a stereotactic radiation
`
`machine ([0052]).
`
`In regards to claim 22, Patrick et al. teach multiple therapeutically effective
`
`dosages of radiation to said breast tissue surrounding the implant in a single treatment
`
`via a stereotactic radiation machine ([0006] and [0052]).
`
`In regards to claim 23, Patrick et al. teach a therapeutically effective dosage of
`
`radiation to said breast tissue surrounding the implant via multidirectional radiation
`
`therapy ([0006]).
`
`In regards to claim 24, Patrick et al. teach a therapeutically effective dosage of
`
`radiation to said breast tissue surrounding the implant via Image guided radiation
`
`therapy ([0006]).
`
`In regards to claim 25, Patrick et al. teach a therapeutically effective dosage of
`
`radiation to said breast tissue surrounding the implant via 3-D conformal radiation
`
`therapy ([0006]).
`
`In regards to claim 26, Patrick et al. teach a therapeutically effective dosage of
`
`radiation to said breast tissue surrounding the implant via intensity modulated radiation
`
`therapy ([0006]).
`
`In regards to claims 28 and 29, Patrick et al. teach initiating targeting of a
`
`radiation beam about 1-90 days subsequent placement of the implant ([0053]).
`
`Focal Exhibit 1009 Page 10
`
`

`

`Application/Control Number: 12/110,748
`Art Unit: 2881
`
`Page 10
`
`In regards to claim 30, Patrick et al. teach initiating chemotherapy and thereafter,
`
`initiating targeting of a radiation beam up to 120 days subsequent placement of the
`
`implant ([0053]).
`
`In regards to claim 33, Patrick et al. teach wherein said implant has a shape
`
`selected to guide the delivery of radiation therapy to the margins around said breast
`
`lumpectomy cavity ([0014]).
`
`In regards to claim 34, Patrick et al. differs from the claimed invention by not
`
`disclosing wherein the substantially radio-opaque marker is a radio-opaque element
`
`centrally located within said implant, said radio-opaque element being constructed from
`
`a material different from the material from which said implant is constructed.
`
`However, Gerow teaches wherein the substantially radio-opaque marker is a
`
`radio-opaque element centrally located within said implant, said radio-opaque element
`
`being constructed from a material different from the material from which said implant is
`
`constructed (abstract, silicon-gel within silicone elastomer envelope).
`
`Therefore Gerow as evidenced by Henely modifies Patrick et al. by providing a
`
`substantially radiopaque, biodegradable, biocompatible implant.
`
`Since both Patrick et al. and Gerow are concerned with breast implants, one of
`
`ordinary skill in the art would have rational to look for the modifications of Gerow in the
`
`method of Patrick et al. because it would allow for a determination as to whether the
`
`envelop is intact or has an impending fold-fault rupture thus preventing rupture of the
`
`prosthetic envelope (col. 4, lines 7-11 of Gerow). That is a technique for improving a
`
`particular class of devices was part of the ordinary capabilities of a person of ordinary
`
`Focal Exhibit 1009 Page 11
`
`

`

`Application/Control Number: 12/110,748
`Art Unit: 2881
`
`Page 11
`
`skill in the art, in view of the teaching of the technique for other situations (i.e. detection
`
`of implant intactness).
`
`Claim 32 is rejected under 35 U.S.C. 1 03(a) as being unpatentable over the
`
`combined invention of Patrick et al. (US pgPub 2005/01 01860) and Gerow (USPN
`
`4,795,463) as evidenced by Henley (USPN 5,534,023) and further in view of Lynn et al.
`
`(USPN 5, 147,398).
`
`In regards to claim 32, the combined invention differs from the claimed invention
`
`by not disclosing wherein said substantially radio-opaque implant is constructed of a
`
`porous material.
`
`However, Lynn et al. teach wherein said substantially radio-opaque implant is
`
`constructed of a porous material (col. 2, lines 14-17).
`
`Lynn et al. modifies the combined invention by providing the implant with a
`
`porous envelope.
`
`Since all inventions are directed towards breast implantation, it would be obvious
`
`to one of ordinary skill in the art at the time of the invention to have the porous envelope
`
`of Lynne in the combined method because it reduces capsular contracture and
`
`therefore reduce the perception of excessive firmness (col. 2, lines 17-21 ).
`
`Conclusion
`
`Applicant's amendment necessitated the new ground(s) of rejection presented in
`
`this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP
`
`Focal Exhibit 1009 Page 12
`
`

`

`Application/Control Number: 12/110,748
`Art Unit: 2881
`
`Page 12
`
`§ 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37
`
`CFR 1.136(a).
`
`A shortened statutory period for reply to this final action is set to expire THREE
`
`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.
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to MICHAEL LOGIE whose telephone number is (571 )270-
`
`1616. The examiner can normally be reached on 7:00 to 3:30.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
`
`supervisor, Robert Kim can be reached on 571-272-2293. The fax phone number for
`
`the organization where this application or proceeding is assigned is 571-273-8300.
`
`Focal Exhibit 1009 Page 13
`
`

`

`Application/Control Number: 12/110,748
`Art Unit: 2881
`
`Page 13
`
`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 PAl R or Public PAl R.
`
`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). If you would like assistance from a
`
`USPTO Customer Service Representative or access to the automated information
`
`system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
`
`/M. L./
`Examiner, Art Unit 2881
`
`/ROBERT KIM/
`
`Supervisory Patent Examiner, Art Unit 2881
`
`Focal Exhibit 1009 Page 14
`
`