Patent No. 8,288,745
`Petition For Inter Partes Review
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`Focal Therapeutics, Inc.,
`Petitioner
`
`v.
`
`Senorx, Inc.
`Patent Owner
`
`Patent No. 8,288,745
`Issue Date: October 16, 2012
`Title: METHOD OF UTILIZING AN IMPLANT FOR
`TARGETING EXTERNAL BEAM RADIATION
`_______________
`
`Inter Partes Review No. Unassigned
`____________________________________________________________
`
`
`
`PETITION FOR INTER PARTES REVIEW
`
`UNDER 35 U.S.C. §§ 311-319 AND 37 C.F.R. § 42.100 et seq.
`
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`sf-3267698
`
`
`Petition For Inter Partes Review
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`Focal Therapeutics, Inc.,
`Petitioner
`
`v.
`
`Senorx, Inc.
`Patent Owner
`
`Patent No. 8,288,745
`Issue Date: October 16, 2012
`Title: METHOD OF UTILIZING AN IMPLANT FOR
`TARGETING EXTERNAL BEAM RADIATION
`_______________
`
`Inter Partes Review No. Unassigned
`____________________________________________________________
`
`
`
`PETITION FOR INTER PARTES REVIEW
`
`UNDER 35 U.S.C. §§ 311-319 AND 37 C.F.R. § 42.100 et seq.
`
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`sf-3267698
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`
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`TABLE OF CONTENTS
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`Page
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`EXHIBIT LIST FOR INTER PARTES REVIEW OF U.S. PATENT
`NO. 8,288,745 ................................................................................................ ii
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`I.
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`II.
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`NOTICES AND STATEMENTS ................................................................... 1
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`INTRODUCTION .......................................................................................... 2
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`III. THE ’745 PATENT ........................................................................................ 5
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`A.
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`B.
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`C.
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`Background .......................................................................................... 5
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`The Prosecution History ....................................................................... 6
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`Priority ................................................................................................ 10
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`IV. DETAILED EXPLANATION OF GROUNDS FOR
`INVALIDITY ............................................................................................... 12
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`A.
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`B.
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`C.
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`D.
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`Claim Construction............................................................................. 13
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`Stubbs ................................................................................................. 14
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`Stubbs-Edmundson ............................................................................. 30
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`Patrick-Stubbs .................................................................................... 46
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`V.
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`CONCLUSION ............................................................................................. 59
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`CERTIFICATE OF SERVICE (37 C.F.R. § 42.6(E)(4)) ....................................... 60
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`EXHIBIT LIST FOR INTER PARTES REVIEW OF
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`U.S. PATENT NO. 8,288,745
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`Exhibit Description
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`Exhibit #
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`U.S. Patent No. 8,288,745 to Corbitt et al. (“the ’745 patent”)
`
`U.S. Application No. 11/108,785 (“the ’785 application”), a
`continuation-in-part to the ’745 patent
`
`U.S. Patent No. 7,637,948 (“the ’948 patent”), issued patent from the
`’785 application
`
`Filing Receipt dated May 14, 2008
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`Information Disclosure Statement dated October 20, 2009
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`Preliminary Amendment dated February 23, 2010
`
`Request for Corrected Filing Receipt dated February 23, 2010
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`Office Action dated May 25, 2011
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`Final Rejection dated October 14, 2011
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`Notice of Allowance dated May 15, 2012
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`U.S. Publication No. 2009/0024225 to Stubbs (“Stubbs”)
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`U.S. Provisional Application No. 60/949,963 to Stubbs
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`U.S. Publication No. 2008/0177179 to Stubbs and Edmundson et al.
`(“Stubbs-Edmundson”)
`
`U.S. Provisional Application No. 60/875,776 to Stubbs-Edmundson
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`U.S. Patent No. 6,214,045 (“Corbitt”)
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`U.S. Publication No. 2005/0101860 to Patrick and Stubbs (“Patrick-
`Stubbs”)
`
`Declaration of Robert T. Chang
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`
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`1001
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`1002
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`1003
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`1004
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`1005
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`1006
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`1007
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`1008
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`1009
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`1010
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`1011
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`1012
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`1013
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`1014
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`1015
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`1016
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`1017
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`Petitioner Focal Therapeutics, Inc. (“Petitioner”) respectfully petitions for
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`inter partes review of claims 1-30 of U.S. Patent No. 8,288,745 (“the ’745 patent”
`
`(Ex. 1001)) in accordance with 35 U.S.C. §§ 311-319 and 37 C.F.R. § 42.100 et
`
`seq.
`
`I.
`
`NOTICES AND STATEMENTS
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`Pursuant to 37 C.F.R. § 42.8(b)(1), Petitioner identifies Focal Therapeutics,
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`Inc. as the real party-in-interest. Pursuant to 37 C.F.R. § 42.8(b)(2), there are no
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`related matters. Pursuant to 37 C.F.R. § 42.8(b)(3), Petitioner identifies the
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`following counsel and a power of attorney accompanies this Petition.
`
`Lead Counsel
`
`Backup Counsel
`
`Matthew Kreeger
`MKreeger@mofo.com
`Registration No.: 56,398
`MORRISON & FOERSTER LLP
`425 Market St.
`San Francisco, California 94105-2482
`Tel: (415) 268-6468
`Fax: (415) 268-7522
`
`
`Matthew Chivvis
`MChivvis@mofo.com
`Registration No.: 61,256
`MORRISON & FOERSTER LLP
`425 Market St.
`San Francisco, California 94105-2482
`Tel: (415) 268-7307
`Fax: (415) 268-7522
`
`Pursuant to 37 C.F.R. § 42.8(b)(4), service information for lead and back-up
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`counsel is provided above. Pursuant to 37 C.F.R. § 42.104(a), Petitioner certifies
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`that the ’745 patent is available for inter partes review and that the Petitioner is not
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`barred or estopped from requesting an inter partes review challenging the patent
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`claims on the grounds identified in this Petition.
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`II.
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`INTRODUCTION
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`The ’745 patent was filed on April 28, 2008. It has 2 independent claims
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`and 28 dependent claims, all of which are directed to methods of breast radiation
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`therapy utilizing a biodegradable breast implant that, when placed in a breast
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`cavity, provides a target for delivery of radiation beams to the cavity. These
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`claims are not novel, and never should have been allowed over the prior art.
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`Certain critical prior art submitted by the applicant—in particular
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`publication No. 2009/024225 to Dr. James Stubbs (“Stubbs”)—was not considered
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`on the record by the Examiner. This may have been because the application that
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`issued as the ’745 patent was improperly recorded as a continuation of U.S.
`
`application No. 11/108,785—rather than a CIP of that application. That error was
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`not corrected until the applicant filed an Amendment and a Request for Corrected
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`Filing Receipt on February 23, 2010, over four months after submitting intervening
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`art to the Examiner via an IDS on October 20, 2009. Moreover, the applicant
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`failed to submit another earlier prior art reference—publication No. 2008/0177179
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`to Dr. Stubbs and Gregory Edmundson et al. (“Stubbs-Edmundson”)—on which
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`the same Dr. Stubbs is a named inventor. Thus, the Examiner did not appreciate
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`the significance of either of these references, despite the fact that they pertain to
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`the very concept claimed by the ’745 patent: the use of bioabsorbable breast
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`implants as targets for radiation beam therapy.
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`The Examiner instead relied on only Dr. Stubbs’s earliest work in this field,
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`which is publication No. 2005/0101860 to Timothy Patrick and Dr. Stubbs
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`(“Patrick-Stubbs”) and intervening § 102(b) prior art. However, the Examiner
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`made a clear legal error in examining Patrick-Stubbs and other art. He
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`(1) determined priority for the claims under examination on a limitation-by-
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`limitation basis, (2) awarded certain limitations priority to the parent application,
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`and then (3) rejected intervening prior art disclosures for those limitations. For
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`Patrick-Stubbs, the Examiner improperly ignored important disclosed features of
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`Patrick-Stubbs on the basis that “because these limitations are disclosed in the
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`parent continuation-in-part cases of the present application, Patrick et al. does not
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`qualify as prior art for [this] teaching.” (Non-Final Office Action dated May 25,
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`2011 (Ex. 1008), at 4.)
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`There can be no dispute that this approach was improper and that priority
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`determinations are based on the claim as a whole, not limitation-by-limitation. See
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`M.P.E.P. § 201.11 I.B (collecting cases). In fact, a proper analysis of priority
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`would necessarily conclude that the ’745 patent claims are not entitled to the
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`priority of any parent application, thus rendering Patrick-Stubbs § 102(b) prior art.
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`The failure to assess priority using the proper standard pervades the
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`prosecution in this case, and led to the lack of consideration of other relevant art,
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`including issued family members of the ’745 patent. One such family member is
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`U.S. Patent No. 6,214,045 (“Corbitt”). Corbitt is § 102(b) prior art to the
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`continuation-in-part date for the ’745 patent. It discloses bioabsorbable implants
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`that one of ordinary skill in the art would have readily considered for use with
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`targeted external beam radiation therapies.
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`In this Petition for inter partes review, Petitioner presents grounds including
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`Stubbs, Stubbs-Edmundson, and Patrick-Stubbs because the Examiner did not give
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`these references the consideration they were due. Stubbs alone anticipates or
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`renders obvious the independent claims in the ’745 patent because it discloses the
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`claimed methods of breast radiation therapy utilizing a biocompatible and
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`biodegradable breast implant that, when placed in a breast cavity, provides a target
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`for the delivery of a radiation beam to the cavity. Stubbs-Edmundson also
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`anticipates or renders obvious the claims of the ’745 patent for much the same
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`reason. Moreover, either Stubbs-Edmundson or Patrick-Stubbs can be combined
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`with Corbitt to render the claims of the ’745 patent obvious. Combinations
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`involving the admitted prior art disclosed in the ’745 patent render certain
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`dependent claims obvious as well.
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`In this Petition, Part III summarizes the ’745 patent, its prosecution history,
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`and priority, and Part IV sets forth the detailed grounds for invalidity of the ’745
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`patent’s independent and dependent claims in view of the prior art summarized
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`above. Petitioner has established a reasonable likelihood that it will prevail on at
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`least one claim of the ’745 patent, if not all of them. Accordingly, Petitioner
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`respectfully requests a Decision to institute inter partes review.
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`III. THE ’745 PATENT
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`A. Background
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`The ’745 patent is directed to a method of breast radiation therapy using an
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`implant that provides a target for radiation treatment. (See Ex. 1001 at Abstract,
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`Cls. 1, 18.) In the Background of the Invention section, the ’745 specification
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`acknowledges that the concept of using “breast radiation targeting the area of the
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`breast involved by cancer” is known and “is currently gaining popularity.” (Id. at
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`1:28-30.) Indeed, the specification recognizes that “[p]artial breast radiation is
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`currently being delivered through temporarily implanted balloon catheters.” (Id. at
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`1:32-33.) According to the specification, a drawback to the catheter methodology
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`is that it “allows an opening into the cavity[,] which increase[s] the chance of
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`infection.” (Id. at 1:45-46.)
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`The ’745 specification proposes an improved method for the “use of external
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`beam radiation delivered through a multidirectional stereotactic radiation source.”
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`(Id. at 1:65-66.) But the specification again acknowledges that the use of “external
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`beam radiation” in cancer treatment is known, and provides the example of using
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`an implanted gold seed as a guide for focusing the beam. (Id. at 2:2-7.) Because
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`the breast is primarily composed of fatty tissue, however, the specification suggests
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`that known therapies employing a seed to focus the beam of an external radiation
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`source would be inhibited. (Id. at 2:9-16.) To address this issue, the ’745
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`specification proposes a modification to the resorbable implant described in Corbitt
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`to include a more fully defined “x-ray opaque or metallic material for identification
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`of [an] area.” (Id. at 2:26-51.) Like the seeds used in the prior art, this improved
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`implant is purportedly designed to guide the external beam in order to allow a
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`more specific area of the cavity to be radiated. (Id. at 2:47-49.)
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`B.
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`The Prosecution History
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`The ’745 patent was filed on April 28, 2008. It is a continuation-in-part of
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`application No. 11/108,785 (“the ’785 application” (Ex. 1002)), which was filed on
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`April 19, 2005 and issued as U.S. Patent No. 7,637,948 (“the ’948 patent”
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`(Ex. 1003)). Via an additional continuation-in-part, a continuation, and a
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`divisional, the ’745 patent traces its parentage back to Corbitt. Yet, the connection
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`between the ’745 patent and its parents—including Corbitt—is threadbare, as its
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`specification consists almost entirely of new matter. Besides an incorporation by
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`reference, the only disclosure that the specification of the ’745 patent has in
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`common with Corbitt is a single quoted phrase: “x-ray opaque or metallic material
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`for identification of the area.” (Ex. 1001 at 2:33-34; Ex. 1015 at 4:36-37.) The
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`same is true regarding the ’948 patent. (Ex. 1003 at 5:18-19.) Despite the fact that
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`the ’745 application contained primarily new matter, the May 14, 2008 Filing
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`Receipt incorrectly listed the application as a direct continuation of the ’785
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`application (issued as the ’948 patent). (Filing Receipt dated May 14, 2008
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`(Ex. 1004).)
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`Before this error was corrected, an IDS was submitted that listed U.S.
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`publication No. 2009/024225 to Stubbs (“Stubbs” (Ex. 1011)). (Information
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`Disclosure Statement dated October 20, 2009 (Ex. 1005).) Though it was filed on
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`July 16, 2008, Stubbs claims priority to a lengthy provisional application filed on
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`July 16, 2007. (U.S. Provisional Application No. 60/949,963 (Ex. 1012).) Thus,
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`Stubbs is intervening art that is prior art under § 102(e) to the filing date of the
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`application for the ’745 patent, but not the filing dates of its parents. On February
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`23, 2010, the applicant sought to fix the ’745 patent’s related application data by
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`submitting a Preliminary Amendment and a Request for Corrected Filing Receipt.
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`(Preliminary Amendment dated February 23, 2010 (Ex. 1006); Request for
`
`Corrected Filing Receipt dated February 23, 2010 (Ex. 1007).)
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`On May 25, 2011, the Examiner issued a first Office Action rejecting the
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`’745 patent’s independent claims as obvious over Patrick-Stubbs in view of U.S.
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`Patent No. 6,228,055 (“Foerster”), explaining that:
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`In regards to claim 1, Patrick et al. teach a method of partial
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`breast radiation (abstract teaches treating surrounding tissue, [0001]
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`teaches treatment of disorders in the breast by positioning tissue and
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`applying radiation and [0051] teaches radio opaque expandable
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`surface 20, thus only partial breast irradiation) comprising the steps
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`of: targeting a radiation beam to said breast tissue surrounding the
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`implant such that the radiation beam does not materially irradiate the
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`whole of the breast (see citations above).
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`Although, Patrick et al. teach placing a radio-opaque implant
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`within a breast, because these limitations are disclosed in the parent
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`continuation-in-part cases of the present application, Patrick et al.
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`does not qualify as prior art for teaching placing within a breast
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`cavity, a substantially radio-opaque implant constructed of
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`constructed of [sic] biocompatible and biodegradable material said
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`implant supporting the tissue surrounding the breast cavity.
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`However, Foerster et al. teaches placing within a breast cavity,
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`a substantially radio-opaque implant (col. 5, lines 63-67 and col. 1,
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`lines 8-13) constructed of constructed of [sic] biocompatible and
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`biodegradable material (col. 5, lines 63-67 and col. 13, lines 30-36)
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`said implant supporting the tissue surrounding the breast cavity
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`(wherein a implant [sic] will inherently support the surrounding
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`tissue).
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`(Non-Final Office Action dated May 25, 2011 (Ex. 1008), at 4.) As this passage
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`shows, even though Patrick-Stubbs is § 102(b) prior art to the filing date for the
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`’745 patent, the Examiner dismissed significant disclosed features of this reference
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`because they related to limitations that were “disclosed in the parent continuation-
`
`in-part cases of the present application.” (Id.)
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`The Examiner appears to have made this statement based on the single
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`shared phrase between the ’745 patent and Corbitt: “x-ray opaque or metallic
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`material for identification of the area.” (Ex. 1001 at 2:33-34; Ex. 1015 at 4:36-37.)
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`While the Examiner maintained his rejections over Patrick-Stubbs in view of
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`Foerster in a final office action, he withdrew them after the applicant filed its brief
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`on appeal. In the notice of allowance, the Examiner again noted that “the parent
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`continuation-in-part inventions of the present application pre-date the filing date of
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`Patrick and teach a radio-opaque breast implant.” (Notice of Allowance dated
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`May 15, 2012 (Ex. 1010), at 2-3.)
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`It was improper for the Examiner to assess priority for individual limitations.
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`The M.P.E.P. clearly discloses that priority is determined on a claim-by-claim—
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`not on a limitation-by-limitation—basis. See M.P.E.P. § 201.11 I.B (“[I]f a claim
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`in a continuation-in-part application recites a feature which was not disclosed or
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`adequately supported by a proper disclosure under 35 U.S.C. [§] 112 in the parent
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`non-provisional application, but which was first introduced or adequately
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`supported in the continuation-in-part application, such a claim is entitled only to
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`the filing date of the continuation-in-part application.”) (emphasis added). This
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`error not only affected the Examiner’s analysis of Patrick-Stubbs, but also makes
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`plain that he would not have considered Corbitt itself as prior art. Id. It also may
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`explain the Examiner’s failure to use Stubbs or Stubbs-Edmundson in any
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`rejections.
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`C.
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`Priority
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`While the Examiner’s approach to priority was flawed, his analysis confirms
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`that certain limitations in the ’745 patent’s independent claims lack support in the
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`earlier filed applications from the same family. The Examiner relied on Patrick-
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`Stubbs as a prior art reference for some claim limitations even though it was both
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`filed and published after the filing date of Corbitt, the ’745 patent’s earliest parent.
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`(Ex. 1008 at 4-6; see also Ex. 1010 at 2-3.) Thus, the Examiner recognized that
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`certain limitations in these claims were not supported by the ’745 patent’s
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`continuation-in-part specification. This finding was correct. As noted above, the
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`specification of the ’745 patent consists almost entirely of new matter, sharing only
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`a single quoted phrase with Corbitt and the ’948 patent. (Ex. 1001 at 2:33-34;
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`Ex. 1015 at 4:36-37; Ex. 1003 at 5:18-19.)
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`What the Examiner failed to appreciate is that this finding shows that none
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`of the ’745 patent claims are entitled to the filing date of the parent applications.
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`Under 35 U.S.C. § 120, a claim in an application is entitled to the benefit of the
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`filing date of an earlier filed application only if the subject matter of the claim as a
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`whole is disclosed in the earlier filed application in the manner required by
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`35 U.S.C. § 112(1). M.P.E.P. 201.11 I.B. Using this standard, the independent
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`claims are not entitled to the filing date of Corbitt or the ’948 patent because
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`limitations in these claims are neither disclosed nor enabled by the parent
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`specifications. Indeed, both of the independent claims require a step of “directing
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`a radiation beam” to the implant, “such that the radiation beam does not materially
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`irradiate the whole of the breast.” (Ex. 1001 at Cls. 1, 18.) This type of targeted
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`beam radiation procedure is commonly referred to as external-beam radiation
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`therapy, which directs one or more beams of high-energy x-rays from outside of
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`the patient’s body to a targeted location inside the patient’s body. (Ex. 1016 at ¶ 5;
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`Ex. 1011 at ¶ 4.) Nothing in either Corbitt or the ’948 patent teaches the use of
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`external-beam radiation therapy. Rather, the only radiation therapy mentioned in
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`their disclosures is brachytherapy (Ex. 1015 at 4:35-36; Ex. 1003 at 5:17-18),
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`which is a type of local radiation therapy that is delivered by internally implanting
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`radioactive material to a specific tissue area within a given patient. (Chang
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`(Ex. 1017), ¶ 21.) One of ordinary skill in the art would not have understood this
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`statement about the possible use of brachytherapy to describe or enable the
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`application of external beam radiation to a bioabsorbable implant. (Chang
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`(Ex. 1017), ¶ 22.)
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`Accordingly, the disclosure in Corbitt and the ’948 patent does not even
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`come close to satisfying the requirements in § 112(1) for the independent claims,
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`and all of the claims in the ’745 patent must be accorded its actual filing date of
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`April 28, 2008.
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`IV. DETAILED EXPLANATION OF GROUNDS FOR INVALIDITY
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`Pursuant to 37 C.F.R. §§ 42.22(a)(1) and 42.104(b), Petitioner respectfully
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`requests the cancellation of claims 1-30 of the ’745 patent based on the grounds of
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`invalidity as set forth in this Petition.
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`Specifically, Petitioner submits that independent claims 1 and 18 of the ’745
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`patent are anticipated or rendered obvious by art that was known to those of
`
`ordinary skill well before the ’745 patent was filed. As demonstrated in Part IV.B,
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`Stubbs is an anticipatory reference that teaches all the elements of the claimed
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`methods for partial breast radiation therapy. Alternatively, Stubbs renders the
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`claims obvious. In Part IV.C, this Petition establishes that Stubbs-Edmundson is
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`also anticipatory, because it discloses the limitations of the claimed methods as
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`well. In addition, Stubbs-Edmundson renders the claims obvious alone or in view
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`of Corbitt, a parent of the ’745 patent that issued in 2001 and describes
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`bioabsorbable implants. When properly considered, Patrick-Stubbs also renders
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`the claims obvious in view of Corbitt, as discussed in Part IV.D. Finally, the
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`dependent claims at issue merely recite variations of the claimed methods that
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`were well within the knowledge of the skilled artisan, as further demonstrated by
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`the admitted prior art described in the ’745 specification.
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`In each of the following sections, Petitioner sets forth the specific art and
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`statutory grounds on which the challenge is based in a table at the start of the
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`section. 37 C.F.R. §§ 42.22(a)(2) and 42.104(b)(2). Petitioner then presents a
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`discussion of how the claims are unpatentable under the statutory grounds raised.
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`37 C.F.R. § 42.104(b)(4). Finally, Petitioner sets forth a claim chart that specifies
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`where each element of a challenged claim is met by the prior art. 37 C.F.R.
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`§ 42.104(b)(4). The showing in these sections establishes a reasonable likelihood
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`of prevailing as to each ground of invalidity with respect to the challenged claims
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`as to that ground.
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`The grounds for invalidity set forth below are supported by the declaration
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`of Robert T. Chang, who provides testimony regarding the prior art and the
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`understanding of one of ordinary skill in the art. Robert T. Chang’s declaration is
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`attached as Ex. 1017.
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`A. Claim Construction
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`Petitioner notes that a claim is given the “broadest reasonable construction in
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`light of the specification” in inter partes review. See 37 C.F.R. § 42.100(b).
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`Claims 2-4 and 19-20 recite a “stereotactic radiation machine” for use with
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`the method of partial breast radiation therapy disclosed in claims 1 and 18. The
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`’745 patent proposes “the use of external beam radiation delivered through a
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`multidirectional stereotactic radiation source such as but not limited to the
`
`CYBERKNIFE, the BRAINLAB, and other external beam sources.” (Ex. 1001 at
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`1:64-2:1 (emphasis added).) Further, Figure 3 of the ’745 patent discloses “an
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`sf-3267698
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`13
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`
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`example of multi-directional (stereotactic) radiation therapy.” (Id. at 4:58-59.) To
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`ensure that “stereotactic radiation machine” is accorded the broadest reasonable
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`construction in light of the ’745 patent specification, a person having ordinary skill
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`in the art would consider all external beam radiation therapy machines that use
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`multi-directional external radiation beams, such as 3DCRT and selected IMRT
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`machines, to be “stereotactic radiation machines.” (Chang (Ex. 1017), ¶ 41.)
`
`B.
`
`Stubbs
`
`Grounds 1-3 are based on Stubbs (Ex. 1011) and are addressed together
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`below.
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`Ground 35 U.S.C. § Claims
`
`References
`
`1
`
`2
`3
`
`
`
`102(e)
`
`1-30
`
`103(a)
`103(a)
`
`1-30
`13, 25
`
`U.S. Patent Publication No. 2009/0024225
`(“Stubbs”) (Ex. 1011)
`Stubbs (Ex. 1011)
`Stubbs in view of “Admitted Prior Art”
`(Ex. 1001)
`
`Stubbs is a published United States patent application that claims priority to
`
`provisional application No. 60/949,963 (Ex. 1012) filed on July 16, 2007. As
`
`discussed above, the claims in the ’745 patent should be accorded an effective
`
`filing date of April 28, 2008 (the filing date for CIP application from which the
`
`’745 issued) due to the substantial new matter in that application. (See supra at
`
`Part III.C.) Thus, Stubbs qualifies as prior art under § 102(e). The Examiner,
`
`however, failed to appreciate the significance of Stubbs—likely because he
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`sf-3267698
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`14
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`improperly analyzed priority—so he did not discuss Stubbs on the record during
`
`the prosecution of the ’745 patent.
`
`Stubbs is clearly relevant to the patentability of the claims of the ’745 patent,
`
`as it describes biocompatible and biodegradable implants for use in targeted
`
`external beam radiation therapy. Exactly like the methods of the ’745 patent’s
`
`independent claims, the preferred embodiment of the implant disclosed in Stubbs
`
`is: (1) substantially radio-opaque (Ex. 1011 at ¶ 47 (“the surface may include in
`
`its construction a radio opaque material”)); (2) constructed of biocompatible and
`
`biodegradable materials (Id. at ¶ 24 (“[t]he device can be formed of an absorbable
`
`material that is implanted at the time of tumor resection and requires no second
`
`procedure to remove (it dissolves in situ leaving no foreign material in the patient’s
`
`body)”)); (3) placed within a breast cavity (Id. at ¶ 44 (“[f]ollowing tumor
`
`resection . . . an implant of the invention 10 is placed into the tumor resection
`
`cavity”)); (4) used to support the tissue surrounding the breast cavity (Id. at ¶ 45
`
`(“the implant occupies the tissue cavity 102 and supports the surrounding target
`
`tissue 112 until such time as it resorbs or biodegrades”)); and (5) used as a target
`
`for delivery of radiation beam therapy to margins around the breast cavity (Id. at
`
`¶ 24 (“a reproducibly-shaped 3-dimensional target that is used to focus the
`
`radiation therapy treatment beams directly onto the targeted tissue—for example,
`
`the tissue surrounding a resected tumor cavity”)), such that (6) the radiation beam
`
`sf-3267698
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`15
`
`
`
`
`
`does not irradiate the whole breast (Id. at ¶ 46 (“[t]he result is a treatment method
`
`which concentrates radiation on target tissue and helps to preserve the surrounding
`
`healthy tissue”)). Thus, the disclosure in Stubbs anticipates or renders obvious
`
`independent claims 1 and 18.
`
`The remaining dependent claims at issue merely claim routine variations that
`
`are anticipated or rendered obvious by Stubbs alone, or would have been obvious
`
`in view of the admitted prior art (APA). For example, claims 13 and 25 further
`
`limit the independent claims to require “aspirating air” from the cavity. (Ex. 1001
`
`at Cls. 13, 25.) In the ’745 specification, however, the patentee admits that the
`
`“need to aspirate air from the lumpectomy cavity” was well-known. (Id. at 1:54-
`
`60.) Indeed, “it is desirable to aspirate or remove the air, most commonly with a
`
`syringe and needle.” (Id. 1:59-60.) Advantages of “aspirating air” surrounding an
`
`implant would have included the prospect of better conformation of the implant to
`
`the tissue surrounding the cavity to improve targeting of the desired areas. (Chang
`
`(Ex. 1017), ¶ 25.) The known technique of “aspirating air” could have been
`
`readily implemented by a person having ordinary skill in the art to improve
`
`Stubbs’s method for external beam radiation therapy in the same way that it is used
`
`to improve methods employing balloon catheters—by removing the air
`
`surrounding the implants. (Chang (Ex. 1017), ¶¶ 44, 50, 56.)
`
`sf-3267698
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`16
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`
`
`
`
`Thus, Petitioner has set forth above a discussion of how the claims are
`
`unpatentable. 37 C.F.R. § 42.104(b)(4). Petitioner sets forth below a claim chart
`
`that specifies where each element of a challenged claim is met by prior art in this
`
`section. 37 C.F.R. § 42.104(b)(4).
`
`Text of Claim
`
`Stubbs
`
`1.1 A method of partial
`breast radiation therapy
`comprising the steps of:
`
`Stubbs discloses a method of partial breast radiation
`therapy. (See, e.g., ¶¶ 15, 24, 34, 46, Cl. 13; see also
`Provisional at 1:25-28, 8:3-11.)
`
`For example, Stubbs discloses the use of a “system
`for targeting therapeutic rays to target tissue
`surrounding a tumor resection cavity.” ¶ 15. This
`method “use[s] implantable devices that can allow for
`more accurate targeting of external beam radiation to
`the region of tissue that is to be treated,” which can
`“focus the radiation therapy treatment beams directly
`onto the targeted tissue—for example, the tissue
`surrounding a resected tumor cavity.” ¶ 24. As
`Stubbs notes, “[t]he result is a treatment method
`which concentrates radiation on target tissue and
`helps to preserve the surrounding healthy
`tissue.” ¶ 46 (emphasis added).
`
`Stubbs discloses placing an implant within a breast
`cavity. (See, e.g., ¶¶ 26, 34, 40, 44, Cl. 13; see also
`Provisional at 6:4-5, 8:3-6, 10:5-6.)
`
`For example, Stubbs discloses that “[f]ollowing
`tumor resection . . . an implant of the invention 10 is
`placed into the resection cavity 104.” ¶ 44 (emphasis
`added). Stubbs explains that the implant can be
`placed within the breast cavity by “insert[ing] [it] at
`the time of surgical resection of the tumor” or by
`using “a minimally invasive procedure at some time
`period following surgery.” ¶ 26; see also ¶ 40 (“The
`implant [would] be ideally inserted upon completion
`
`
`
`1.2 placing within a
`breast cavity
`
`sf-3267698
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`17
`
`
`
`
`
`Text of Claim
`
`Stubbs
`
`of the tumor resection, but prior to closing of the
`surgical wounds.”).
`
`1.3 a substantially radio-
`opaque implant
`
`Stubbs discloses implants that are substantially radio-
`opaque. (See, e.g., ¶¶ 25, 33, 47, 51, Fig. 1; see also
`Provisional at 5:14-15.)
`
`1.4 constructed of
`biocompatible and
`biodegradable material,
`
`For example, Stubbs discloses that the implant “can
`be constructed of materials which highlight its
`surface during the imaging procedure, for example,
`the surface may include in its construction a radio
`opaque material.” ¶ 47 (emphasis added). Indeed,
`Stubbs discloses that the implant “may be
`impregnated with x-ray media (e.g., barium sulfate,
`Iohexol™, [or] Omnipaque™ . . . ).” ¶ 33.
`
`Stubbs discloses implants that are constructed of
`biocompatible and biodegradable material. (See, e.g.,
`¶¶ 24-26, 29-30, 33; see also Provisional at 2:1-3,
`5:14-15.)
`
`For example, Stubbs provides that the implant “can
`be formed of an absorbable material that is
`implanted at the time of tumor resection and requires
`no second procedure to remove (it dissolves in situ
`leaving no foreign material in the patient’s body).”
`¶ 24 (emphasis added). Stubbs similarly discloses
`that the implant “may be impregnated with . . .
`biocompatible high density matter” and will occupy
`the resection cavity “until such time as it resorbs or
`biodegrades.” ¶¶ 33, 45 (emphasis added).
`
`sf-3267698
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`18
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`
`
`Text of Claim
`
`1.5 said substantially
`radio-opaque implant
`supporting the tissue
`surrounding the breast
`cavity; and
`
`1.6 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,
`
`Stubbs
`
`Stubbs discloses placing the implant within the breast
`cavity to support the tissue surrounding the breast
`cavity. (See, e.g., ¶¶ 34, 36, 45-46, Figs. 5-6; see also
`Provisional at 8:3-6, 8:22-23.)
`
`For example, Stubbs discloses that “[f]ollowing
`insertion of the implant 10 . . . the implant occupies
`the tissue cavity 102 and supports the surrounding
`target tissue 112 until such time as it resorbs or
`biodegrades.” ¶ 45 (emphasis added); see also ¶ 46
`(“With device 10 in place, it supports the target
`tissue 112 surrounding the tissue cavity and
`reduce[s
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