`Entered: April 22, 2014
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`Trials@uspto.gov
`Tel: 571-272-7822
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_______________
`
`FOCAL THERAPEUTICS, INC.,
`Petitioner,
`
`v.
`
`SENORX, INC.,
`Patent Owner.
`_______________
`
`Case IPR2014-00116
`Patent 8,288,745 B2
`_______________
`
`
`Before LORA M. GREEN, FRANCISCO C. PRATS, and
`JACQUELINE WRIGHT BONILLA, Administrative Patent Judges.
`
`
`
`BONILLA, Administrative Patent Judge.
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
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`1
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`AT&T - Exhibit 1003
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`Case IPR2014-00116
`Patent 8,288,745 B2
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`I.
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`INTRODUCTION
`
`A. Background
`
`
`
`Petitioner Focal Therapeutics, Inc. (―Focal Therapeutics‖) filed a Petition
`
`(Paper 1, ―Pet.‖) to institute an inter partes review of claims 1-30 of U.S. Patent
`
`No. 8,288,745 B2 (Ex. 1001 (―the ‘745 patent‖)). 35 U.S.C. § 311. Patent Owner
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`SenoRx, Inc. (―SenoRx‖) filed a Preliminary Response (Paper 6, ―Prel. Resp.‖).
`
`We have jurisdiction under 35 U.S.C. § 314.
`
`The standard for instituting an inter partes review is set forth in 35 U.S.C.
`
`§ 314(a), which provides:
`
`THRESHOLD.—The Director may not authorize an inter
`partes review to be instituted unless the Director determines that the
`information presented in the petition filed under section 311 and any
`response filed under section 313 shows that there is a reasonable
`likelihood that the petitioner would prevail with respect to at least 1 of
`the claims challenged in the petition.
`
`For the reasons set forth below, we conclude that Focal Therapeutics has
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`shown that, under 35 U.S.C. § 314(a), there is a reasonable likelihood that it would
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`prevail with respect to at least one of the challenged claims. We institute an inter
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`partes review of claims 1-12, 14-24, and 26-30 of the ‘745 patent.
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`B. The ’745 Patent (Ex. 1001)
`
`The ‘745 patent relates to a method of cancer therapy that partially radiates
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`the breast. Ex. 1001, 1:23-30. The method uses external beam radiation delivered
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`through a radiation source, such as a breast implant. Id. at 1:64–2:2; 2:23-36, 47-
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`50. The ‘745 patent describes a breast implant, such as the implant disclosed in
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`U.S. Patent No. 6,214,045 B1 (Ex. 1015) (―the Corbitt ‘045 patent‖), which
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`―functions as a radio-opaque target for external beam stereotactic partial breast
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`radiotherapy.‖ Id. at 2:24-32; 4:28-30.
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`Case IPR2014-00116
`Patent 8,288,745 B2
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`C. Illustrative Claims
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`
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`Claims 1 and 18, the only challenged independent claims, are reproduced
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`below.
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`1. A method of partial breast radiation therapy comprising the steps of:
`
`placing within a breast cavity a substantially radio-opaque implant
`constructed of biocompatible and biodegradable material, said
`substantially radio-opaque implant supporting the tissue surrounding
`the breast cavity; and
`
`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 radiation beam does not materially
`irradiate the whole of the breast.
`
`18. A method of partial breast radiation comprising the steps of:
`
`placing within a breast lumpectomy cavity an implant constructed of
`biocompatible and biodegradable material with a substantially radio-
`opaque marker contained within the implant, and said implant
`supporting the tissue surrounding the breast lumpectomy cavity; and
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`directing a radiation beam to said implant, said substantially radio-
`opaque marker within said implant serving as a target for delivery of
`radiation therapy to margins around the breast cavity, such that the
`radiation beam does not materially irradiate the whole of the breast.
`
`Id. at 5:25-35; 6:31-42.
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`D. Prior Art Relied Upon
`
`Focal Therapeutics relies upon the following prior art:
`
`Stubbs, U.S. Pub. No. 2009/0024225, published Jan. 22, 2009, claiming priority
`to a U.S. provisional appl. filed Jul. 16, 2007 (Ex. 1011 (―Stubbs‖));
`
`Stubbs, U.S. provisional appl. 60/949,963, filed Jul. 16, 2007 (Ex. 1012
`(―Stubbs Provisional‖));
`
`Stubbs et al., U.S. Pub. No. 2008/0177179 A1, published Jul. 24, 2008, related
`to a U.S. provisional appl. filed Dec. 19, 2006 (Ex. 1013 (―Stubbs-Edmundson
`Publication‖));
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`Stubbs et al., U.S. provisional appl. 60/875,776, filed Dec. 19, 2006 (Ex. 1014
`(―Stubbs-Edmundson Provisional‖));
`
`The Corbitt ‘045 patent (Ex. 1015), issued Apr. 10, 2001; and
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`Patrick and Stubbs, U.S. Pub. No. 2005/0101860 A1, published May 12, 2005,
`filed Nov. 7, 2003 (Ex. 1016 (―Patrick-Stubbs‖)).
`
`E. Alleged Grounds of Unpatentability
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`Focal Therapeutics contends that claims 1-30 of the ‘745 patent are
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`unpatentable under 35 U.S.C. § 102(e) and § 103(a) based on the following
`
`grounds. Pet. 14, 30, 47.
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`Reference(s)
`
`Basis
`
`Claims Challenged
`
`Stubbs
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`Stubbs
`
`§ 102(e)
`
`1-30
`
`§ 103(a)
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`1-30
`
`Stubbs and ―Admitted Prior Art‖ (Ex. 1001)
`
`§ 103(a)
`
`13, 25
`
`Stubbs-Edmundson Publication
`
`§ 102(e)
`
`1-30
`
`Stubbs-Edmundson Publication
`
`§ 103(a)
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`1-30
`
`Stubbs-Edmundson Publication and the Corbitt
`‘045 patent
`
`
`§ 103(a)
`
`1-30
`
`Stubbs-Edmundson Publication and ―Admitted
`Prior Art‖
`
`§ 103(a)
`
`13, 25
`
`Stubbs-Edmundson Publication, the Corbitt
`‘045 patent, and ―Admitted Prior Art‖
`
`§ 103(a)
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`13, 25
`
`Patrick-Stubbs and the Corbitt ‘045 patent
`
`§ 103(a)
`
`1-30
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`Patrick-Stubbs, the Corbitt ‘045 patent, and
`―Admitted Prior Art‖
`
`§ 103(a)
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`13, 25
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`ANALYSIS
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`II.
`
`A. Claim Construction
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`
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`In an inter partes review, a claim in an unexpired patent shall be given its
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`broadest reasonable construction in light of the specification of the patent in which
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`it appears. See 37 C.F.R. § 42.100(b) (2013). Under the broadest reasonable
`
`construction standard, claim terms are given their ordinary and customary
`
`meaning, as would be understood by one of ordinary skill in the art in the context
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`of the entire disclosure. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed.
`
`Cir. 2007).
`
`Focal Therapeutics offers a claim construction of the phrase ―stereotactic
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`radiation machine‖ recited in certain challenged dependent claims, indicating that
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`the phrase encompasses ―all external beam radiation therapy machines that use
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`multi-directional external radiation beams, such as 3DCRT and selected IMRT
`
`machines.‖ Pet. 13-14. Focal Therapeutics‘ proposed construction, on the record
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`before us, is reasonable in view of the broadest reasonable construction of the
`
`phrase in light of the specification, and we adopt it for the purposes of this
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`decision.
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`B. Effective Filing Date of the’745 Patent
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`All alleged grounds of unpatentability asserted by Focal Therapeutics rely
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`on at least one of three references cited as prior art under 35 U.S.C. § 102(e) or
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`§ 102(b): (1) Stubbs, a U.S. patent application publication with an earliest possible
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`effective filing date of July 16, 2007 (Ex. 1011); (2) Stubbs-Edmundson
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`Publication, a U.S. patent application publication with an earliest possible effective
`
`filing date of December 19, 2006 (Ex. 1013); and (3) Patrick-Stubbs, a U.S. patent
`
`application publication with an earliest possible effective filing date of November
`
`7, 2003, and published on May 12, 2005 (Ex. 1016). If the challenged claims of
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`the ‘745 patent are entitled to the benefit of an effective filing date earlier than
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`November 7, 2003 (the earliest of the possible effective filing dates of the
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`references), for example, then every ground in the Petition would rely on at least
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`one reference that fails to qualify as prior art against the ‘745 patent. We must
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`evaluate, therefore, the priority date, i.e., the effective filing date, of the ‘745
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`patent.
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`As presented in its ―Statement of Priority,‖ the ‘745 patent claims priority to
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`a series of patent documents as follows:
`
`U.S. Patent No.
`
`Application No.
`
`Type1
`
`The ‘745 patent
`(Ex. 1001)
`
`12/110,748
`Continuation-in-
`
`(―the ‘748 application‖) part (―CIP‖)
`
`Filing date
`
`4/28/2008
`
`7,637,948 B2
`(―the ‘948 patent‖)
`(Ex. 1003)
`
`11/108,785
`(―the ‘785 application‖)
`(Ex.1002)
`
`CIP
`
`4/19/2005
`
`6,881,226 B2
`(―the ‘226 patent‖)
`(Ex. 2002)
`
`6,638,308 B2
`(―the ‘308 patent‖)
`(Ex. 2003)
`
`10/627,718
`(―the ‘718 application‖)
`
`Divisional*2
`
`7/28/2003
`
`09/828,806
`(―the ‘806 application‖)
`
`CIP*
`
`4/10/2001
`
`
`1 Designations in this column indicate that the patent document is a ―type‖ of
`application in relation to the patent document in the row just below it. For
`example, the ‘745 patent (Ex. 1001) is a continuation-in-part application of the
`‘785 application (Ex. 1002), which issued as the ‘948 patent (Ex. 1003).
`2 Regarding the ―*‖ designations above, we note that the ‘745 patent states that the
`‘226 patent is a continuation application of the ‘308 patent, and that the ‘308 patent
`is a ―division‖ application of the Corbitt ‘045 patent. Ex. 1001, 1:6-19. The ‘226
`patent indicates, however, that it is a divisional application of the ‘308 patent, and
`the ‘226 and ‘308 patents both indicate that the ‘308 patent is a continuation-in-
`part application of the Corbitt ‘045 patent. Ex. 2002, 1: 3-10; Ex. 2003, 1:3-10.
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`U.S. Patent No.
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`Application No.
`
`Type1
`
`Filing date
`
`
`
`The Corbitt ‘045
`patent‖ (Ex. 1015)
`
`09/169,351
`(―the ‘351 application‖)
`
`Non-provisional 10/9/1998
`
`
`
`
`
`
`
`60/091,306
`(―the ‘306 provisional‖)
`(Ex. 2001)
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`60/077,639
`(Ex. 2005)
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`60/061,588
`(Ex. 2004)
`
`Provisional
`
`6/30/1998
`
`Provisional
`
`3/11/1998
`
`Provisional
`
`10/10/1997
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`Ex. 1001, 1:4-19.
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`As to priority, Focal Therapeutics contends that the challenged claims of the
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`‘745 patent are not entitled to the filing date of the Corbitt ‘045 patent (filed
`
`October 9, 1998), or the ‘948 patent (filed April 19, 2005), because independent
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`claims 1 and 18 of the ‘745 patent ―are neither disclosed nor enabled by the parent
`
`specifications.‖ Pet. 10-11.
`
`Specifically, Focal Therapeutics points out that the independent claims
`
`require a step of ―directing a radiation beam‖ to the implant, ―such that the
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`radiation beam does not materially irradiate the whole of the breast.‖ Id. at 11.
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`Focal Therapeutics contends that this step corresponds to a ―targeted beam
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`radiation procedure‖ known as ―external-beam radiation therapy, which directs one
`
`or more beams of high-energy x-rays from outside of the patient‘s body to a
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`targeted location inside the patient‘s body.‖ Id. Focal Therapeutics further
`
`contends that neither the Corbitt ‘045 patent, nor the ‘948 patent, describes the use
`
`of external-beam radiation therapy, but instead only mentions brachytherapy,
`
`―which is a type of local radiation therapy that is delivered by internally
`
`implanting radioactive material to a specific tissue area within a given patient.‖ Id.
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`(emphasis in original). Thus, according to Focal Therapeutics, all claims of the
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`‘745 patent must be accorded the filing date of the ‘748 application, that is, April
`
`28, 2008, and, therefore, Stubbs, Stubbs-Edmundson Publication, and Patrick-
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`Stubbs all qualify as prior art. Id.
`
`In its Preliminary Response, SenoRx contends that each application in the
`
`chain of priority of the ‘745 patent (see table above) properly claims priority to all
`
`earlier applications. Prel. Resp. 9. According to SenoRx, each patent/application
`
`in the chain ―specifically incorporate[s] by reference‖ the earlier disclosures,
`
`including the disclosure in the ‘306 provisional, filed on June 30, 1998. Id.
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`SenoRx further contends that Focal Therapeutics does not discuss the ‘306
`
`provisional, and incorrectly fails to recognize that the ‘745 patent is entitled to the
`
`filing date of the ‘306 provisional. According to SenoRx, the ‘306 provisional
`
`adequately supports and enables the independent claims and ―provides the exact
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`disclosure which [Focal Therapeutics] asserts is missing, i.e., ‗external-beam
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`radiation.‘‖ Id. at 12 (citing Ex. 2001, 3:7), 14 (citing Ex. 2001, 3:4-7), 13-16; see
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`also Ex. 2001, 2:26–3:7.
`
`Hence, SenoRx contends that every application in the chain specifically
`
`incorporates by reference each and every earlier filing in the chain, and the ‘306
`
`provisional provides any necessary 35 U.S.C. § 112 support for the challenged
`
`claims in the ‘745 patent by virtue of those incorporations by reference.
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`Consequently, according to SenoRx, the ‘745 patent has an effective filing date of
`
`June 30, 1998 (of the ‘306 provisional), and, therefore, Stubbs, Stubbs-Edmundson
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`Publication, and Patrick-Stubbs fail to qualify as prior art under § 102(e) or
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`§ 102(b). Accordingly, SenoRx contends that we must deny the Petition because
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`every ground relies on at least one of those references. Prel. Resp. 8.
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`1. Principles of Law
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`
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`A claim in a patent application is entitled to the benefit of the filing date of
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`an earlier filed, related application if it meets the requirements of 35 U.S.C. § 120.
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`Hollmer v. Harari, 681 F.3d 1351, 1355 (Fed. Cir. 2012); 35 U.S.C. § 120. Such
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`requirements include, inter alia, that: (1) the written description of the earlier filed
`
`application provides support for the claim as of its earlier filing date, as required
`
`under 35 U.S.C. § 112; and (2) the later application ―contains or is amended to
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`contain a specific reference to the earlier filed application.‖ 35 U.S.C. § 120; In re
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`NTP, Inc., 654 F.3d 1268, 1277 (Fed. Cir. 2011); PowerOasis, Inc. v. T-Mobile
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`USA, Inc., 522 F.3d 1299, 1306 (Fed. Cir. 2008).
`
`In relation to (1), as stated by the Federal Circuit, ―if any application in the
`
`priority chain fails to make the requisite disclosure of subject matter [under § 112],
`
`the later-filed application is not entitled to the benefit of the filing date of
`
`applications preceding the break in the priority chain.‖ Hollmer, 681 F.3d at 1355.
`
`Likewise, in relation to (2), the ―specific reference‖ requirement in § 120
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`―mandates ‗each [intermediate] application in the chain of priority to refer to the
`
`prior applications.‘‖ Medtronic CoreValve, LLC v. Edwards Lifesciences Corp.,
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`741 F.3d 1359, 1363 (Fed. Cir. 2014) (quoting Encyclopaedia Britannica, Inc. v.
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`Alpine Elecs. of Am., Inc., 609 F.3d 1345, 1352 (Fed. Cir. 2010)). Thus, if any one
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`of the applications in an asserted priority chain fails to meet the requirements of
`
`either (1) or (2), a break in the chain exists at that point.
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`In an inter partes review, the burden is on the petitioner to show a
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`reasonable likelihood that it would prevail on a ground of unpatentability. 35
`
`U.S.C. § 314(a). With respect to entitlement to any earlier effective filing date,
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`however, a patent owner is not presumed to be entitled to the earlier filing dates of
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`ancestral applications that do not share the same disclosure, such as in a CIP
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`situation. See, e.g., Polaris Wireless, Inc. v. TruePosition, Inc., IPR2013-00323,
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`Paper 9, 29. Nonetheless, a petitioner first must raise the issue by identifying,
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`specifically, the features, claims, and ancestral applications allegedly lacking § 112
`
`support for the claims based on the identified features. See id. Then, the patent
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`owner must make a sufficient showing of entitlement to earlier filing date(s), in a
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`manner that is commensurate in scope with the specific points and contentions
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`raised by the petitioner. See id.
`
`2. Analysis
`
`Focal Therapeutics contends that neither the Corbitt ‘045 patent, nor the
`
`‘948 patent, provides adequate § 112 support for the step of ―directing a radiation
`
`beam‖ to an implant, ―such that the radiation beam does not materially irradiate the
`
`whole of the breast,‖ as recited in independent claims 1 and 18 of the ‘745 patent.
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`Pet. 10-11. We conclude that Focal Therapeutics has identified sufficiently the
`
`features, claims, and ancestral applications allegedly lacking § 112 support. We
`
`need evaluate, therefore, whether SenoRx makes a sufficient showing of
`
`entitlement to earlier filing dates, in a manner that is commensurate in scope with
`
`the specific points and contentions raised by Focal Therapeutics. Polaris,
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`IPR2013-00323, Paper 9, 29.
`
`SenoRx correctly notes that the ‘745 patent, itself, expressly incorporates by
`
`reference the disclosures of each priority application/patent in the relevant chain.
`
`Prel. Resp. 7; Ex. 1001, 1:3-20 (listing priority documents and stating ―disclosures
`
`of which are incorporated herein by reference‖ at the end). Our analysis does not
`
`end there, however. We must consider, going back to the ‘306 provisional,
`
`whether each and every one of the related priority documents provides the requisite
`
`disclosure under § 112, i.e., whether ―each incorporate[s] by reference the earlier
`
`disclosures in the chain,‖ as asserted by SenoRx. Prel. Resp. 9.
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`In this capacity, SenoRx contends that ―each of the ‘948 patent, the ‘226
`
`patent, the ‘308 patent and the Corbitt ‘045 patent specifically incorporate by
`
`reference the disclosures of the earlier applications in the chain, including the
`
`disclosure of the ‘306 Provisional.‖ Id. SenoRx points to a ―priority statement‖
`
`relevant to the ‘226 patent, citing Exhibit 2006, which SenoRx contends is the first
`
`page of the specification of the ‘718 application (the ‘226 patent) as-filed on July
`
`28, 2003. Ex. 2006. This statement, as-filed, however, includes no reference to
`
`the immediate parent, i.e., the ‘806 application (the ‘308 patent), but rather only
`
`mentions its grandparent, the ‘351 application (the Corbitt ‘045 patent) and earlier
`
`filed provisional applications. Thus, the specification of the ‘718 application, as-
`
`filed, does not meet the requirements of § 120.
`
`To satisfy § 120, applicants must submit ―an amendment containing the
`
`specific reference to the earlier filed application‖ during pendency of the later filed
`
`application. 35 U.S.C. § 120. Because the specification of the ‘718 application,
`
`as-filed, did not reference its immediate parent (the ‘806 application, the ‘308
`
`patent), applicants filed an amendment containing such a reference. Ex. 2006; Ex
`
`2002, 1:3-11. Applicants amended the specification of the ‘718 application (the
`
`‘226 patent), however, to read as follows.
`
`This application is a divisional of application Ser. No.
`09/828,806, filed on Apr. 10, 2001 now U.S. Pat No. 6,638,308,
`incorporated herein by reference which was a continuation-in-part of
`U.S. patent application Ser. No. 09/169,351 filed Oct. 9, 1998 now
`U.S. Pat No. 6,214,045, which claimed the benefit of U.S. provisional
`application Ser. Nos. 60/061,588 filed Oct. 10, 1997; 60/077,639 filed
`Mar. 11, 1998 and 60/091,306 filed Jun. 30, 1998.
`
`Ex 2002, 1:3-11 (emphasis added). Thus, applicants amended the specification to
`
`incorporate by reference the immediate parent, i.e., the ‘806 application (the ‘308
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`patent), but not any earlier filed patent documents in the chain, i.e., the Corbitt
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`‘045 patent, or provisional applications, including the ‘306 provisional.
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`In other words, the ‘718 application, as-filed, failed to satisfy § 120, but
`
`applicants later fulfilled the ―specific reference‖ requirement of § 120 by amending
`
`the specification during prosecution. Notably, however, SenoRx does not show
`
`sufficiently that, upon that amendment, the specification continued to provide
`
`adequate § 112 support of the challenged claims by incorporating by reference the
`
`‘306 provisional. SenoRx does not point us to a version of the ‘718 application
`
`(as-filed, or as the ‘226 patent) that both satisfies § 120 and provides adequate
`
`§ 112 support at the same time.
`
`As discussed above, if any application in a priority chain fails to meet either
`
`(1) the written description requirement under § 112, or (2) the ―specific reference‖
`
`requirement under § 120, the later-filed application is not entitled to the benefit of
`
`the filing date of any applications preceding the break in the priority chain.
`
`Hollmer, 681 F.3d at 1355; Medtronic CoreValve, 741 F.3d at 1363. Because the
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`‘718 application (and its issued ‘226 patent) failed to meet both (1) and (2) at the
`
`same time, i.e., failed to meet either (1) or (2) at a given point in time, a break in
`
`the priority chain occurred at this point. In re Hogan, 559 F.2d 595, 609 (CCPA
`
`1977) (stating ―[t]here must be continuing disclosure through the chain of
`
`applications, without hiatus, to ultimately secure the benefit of the earliest filing
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`date‖). Thus, the ‘745 patent is not entitled to claim priority to the filing date of
`
`the Corbitt ‘045 patent or the ‘306 provisional, i.e., patent documents filed earlier
`
`than the ‘806 application (the ‘308 patent) incorporated by reference in the ‘226
`
`patent.
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`We consider next whether SenoRx provides a sufficient showing that
`
`challenged claims of the ‘745 patent are entitled to the filing dates of the ‘308
`
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`patent or later filed applications in the chain. That is, even though the ‘745 patent
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`may not be entitled to an effective filing date based on the filing date of the Corbitt
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`‘045 patent, or the ‘306 provisional, it still may be entitled to an effective filing
`
`date after those dates, but before the actual filing date of the ‘748 application,
`
`which matured into the ‘745 patent. SenoRx contends that the ‘306 provisional
`
`and the Corbitt ‘045 patent provide adequate § 112 support for claims 1 and 18.
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`Prel. Resp. 13-23. SenoRx does not explain adequately, however, how the ‘308
`
`patent, the ‘226 patent, or the ‘948 patent provides such support. In relation to
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`support for the recited step of ―directing a radiation beam‖ to an implant, ―such
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`that the radiation beam does not materially irradiate the whole of the breast,‖
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`SenoRx relies only on disclosures in the ‘306 provisional. See, e.g., Prel. Resp. 14,
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`16, 20, 22-23. Especially because the ‘745 patent, the ‘948 patent, and the ‘308
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`patent are all CIP applications, we must assess whether SenoRx shows sufficiently
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`where earlier filed applications provide the § 112 support in question.3 Here,
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`SenoRx‘s contentions suggest that relevant disclosure exists in the ‘306
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`provisional, but not in later filed applications, until it reappears in the ‘745 patent
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`itself.
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`In view of the priority chain break at the ‘226 patent, SenoRx has not shown,
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`on this record, that the ‘745 patent is entitled to any priority date earlier than the
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`actual filing date of the ‘745 patent of April 28, 2008. Consequently, based on the
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`3 As noted by the Federal Circuit, determining the effective filing date of each
`claim in a CIP application ―can be quite complex,‖ because ―CIPs generally add
`new matter.‖ PowerOasis, 522 F.3d at 1305 n.4. Specifically, different claims in a
`CIP application may receive different effective filing dates, because ―[s]ubject
`matter that arises for the first time in the CIP application does not receive the
`benefit of the filing date of the parent application.‖ Augustine Med., Inc. v.
`Gaymar Indus., Inc., 181 F.3d 1291, 1302 (Fed. Cir. 1999) (citing Waldemar Link
`v. Osteonics Corp., 32 F.3d 556, 558 (Fed. Cir. 1994)).
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`record before us, and for the purposes of institution, Stubbs, Stubbs-Edmundson
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`Publication, and Patrick-Stubbs each qualify as prior art under 35 U.S.C. § 102(e),
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`and Patrick-Stubbs also qualifies as prior art under § 102(b).
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`C. Alleged Grounds Based on Stubbs
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`Focal Therapeutics contends that Stubbs anticipates, or renders obvious,
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`claims 1-30, either alone, or, with respect to dependent claims 13 and 25, in further
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`view of ―Admitted Prior Art‖ presented in the ‘745 patent (Ex. 1001). Pet. 14-30.
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`For the purposes of institution, for the reasons discussed above, Stubbs qualifies as
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`prior art under 35 U.S.C. § 102(e).
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`1. Stubbs (Ex. 1011)
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`In its background section, Stubbs states that ―[e]xternal beam radiation
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`therapy (EBRT) is one of the most common adjuvant therapies for cancer
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`patients.‖ Ex. 1011 ¶ 0004. In relation to the disclosed invention, Stubbs
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`describes a bioabsorbable implant placed within a tissue cavity, such as the breast.
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`Id. at ¶¶ 0013, 0034, 0045; see also id. at Fig. 4. Stubbs describes using such
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`implants ―to provide a reproducibly-shaped 3-dimensional target that is used to
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`focus the radiation therapy treatment beams directly onto the targeted tissue—for
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`example, the tissue surrounding a resected tumor cavity.‖ Id. at ¶ 0024.
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`In addition, Stubbs describes that the disclosed implant and system ―greatly
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`improve[] the effectiveness of radiation therapy by facilitating radiation dosing and
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`improving its accuracy,‖ where the ―result is a treatment method which
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`concentrates radiation on target tissue and helps to preserve the surrounding
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`healthy tissue.‖ Id. at ¶ 0046; see also id. at claims 1, 5 (reciting a bioabsorbable
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`implant, treating surrounding tissues, and using external beam radiation). Stubbs
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`further describes that ―[t]o aid with visualization, device 10 [i.e., implant 10] can
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`be constructed of materials which highlight its surface during the imaging
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`procedure, for example, the surface may include in its construction a radio opaque
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`material.‖ Id. at ¶ 0047.
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`2. Stubbs Provisional (Ex. 1012)
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`Stubbs indicates that it claims priority to Stubbs Provisional, i.e., U.S.
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`Provisional Appl. No. 60/949,963, filed on July 16, 2007 (Ex. 1012). Ex. 1011
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`¶ 0001. Stubbs states that Stubbs Provisional ―is incorporated herein by reference
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`in its entirety.‖ Id. We consider disclosures in Stubbs Provisional because Stubbs
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`was published on January 22, 2009, and was filed on July 16, 2008, i.e., after the
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`filing date of the ‘745 patent on April 28, 2008. In its Petition, Focal Therapeutics
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`refers to disclosures in both Stubbs and Stubbs Provisional. Pet. 17-30 (referring
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`to Stubbs Provisional as ―Provisional‖).
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`Stubbs Provisional describes ―implantable devices that provide a means of
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`more accurately targeting external beam radiation to the region of tissue that is to
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`be treated,‖ where the implants ―provide a reproducibly-shaped 3-dimensional
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`target that is used to focus the radiation therapy treatment beams directly onto the
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`targeted tissue,‖ such as breast tissue. Ex. 1012, 1:25-28; 8:1-6. Stubbs
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`Provisional describes ―a bioabsorbable surgical implant with at least one integral
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`radiographic (or ultrasonic) visualization (targeting) property.‖ Id. at 5:14-15; see
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`also id. at 10:5-8. Stubbs Provisional further describes ―fiducial markers having
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`different radiographic properties than that of surrounding tissue (e.g., bone, and
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`soft tissue),‖ such as ―radio-opaque markers (e.g., permanently implanted foreign
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`bodies).‖ Id. at 4:26–5:2. In addition, Stubbs Provisional describes that ―the
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`implant can be visualized, and its contours (and thus the contours of the target
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`tissue to be treated – typically marginal regions surrounding an excised tumor)
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`readily determinable.‖ Id. at 5:19-21.
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`Stubbs Provisional also describes radiation therapy that ―spans a wide range
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`of time intervals.‖ Id. at 9:5-9. Stubbs Provisional refers to patients who ―receive
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`a hypofractionated radiation therapy,‖ where ―resorption can start as early as 3
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`weeks post implant.‖ Id. at 9:9-11. Stubbs Provisional also describes other
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`patients, where ―radiation therapy may not start for 12-18 weeks post surgically
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`and may last 7 weeks, thus requiring an implant that remains fully functional for as
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`long as 6 months.‖ Id. at 9:11-13.
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`3. Analysis—claims 1-12, 14-24, and 26-30
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`Focal Therapeutics contends that Stubbs, as well as Stubbs Provisional
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`(collectively the ―Stubbs references‖), disclose all the elements of challenged
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`independent claims 1 and 18. Pet. 14-19, 26-27. For example, in relation to claim
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`1, Focal Therapeutics contends that Stubbs describes biocompatible and
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`biodegradable implants used in targeted external beam radiation therapy, and
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`identifies where both Stubbs references disclose an implant that is (1) substantially
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`radio-opaque; (2) constructed of biocompatible and biodegradable materials; (3)
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`placed within a breast cavity; (4) used to support the tissue surrounding the breast
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`cavity; and (5) used as a target for delivery of radiation beam therapy to margins
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`around the breast cavity; such that (6) the radiation beam does not irradiate the
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`whole breast. Id. at 15-16 (citing Ex. 1011, ¶¶ 0024 and 0044-47), 17-19 (citing
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`Ex. 1011, ¶¶ 0015, 0024-27, 0029, 0030, 0033, 0034, 0036, 0040, 0044-47, 0051,
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`0054; claim 13; Figs. 1, 5-7; Ex. 1012, 1:25-28; 2:1-3; 5:14-22; 6:4-9; 8:3-13, 22-
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`23; 10:5-6); see also id. at 26-27 (citing similar disclosures in relation to claim 18).
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`Focal Therapeutics identifies reasonably where Stubbs and Stubbs Provisional
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`disclose the different elements of independent claims 1 and 18.
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`Focal Therapeutics likewise contends that the Stubbs references disclose, or
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`render obvious, processes including all steps and elements of the challenged
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`dependent claims, with the exception of claims 13 and 25. Pet. 16, 20-25, 27-30.
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`In the Petition, including the claim charts, Focal Therapeutics identifies reasonably
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`where Stubbs and Stubbs Provisional disclose, or at least suggest, the different
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`steps and elements of dependent claims 2-12, 14-17, 19-24, and 26-30. Id. Focal
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`Therapeutics has demonstrated that there is a reasonable likelihood that it would
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`prevail on the grounds that claims 1-12, 14-24, and 26-30 of the ‘745 patent are
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`anticipated by, or alternatively, would have been obvious over, Stubbs.
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`4. Analysis—claims 13 and 25
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`Focal Therapeutics contends that dependent claims 13 and 25 would have
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`been obvious over Stubbs in view of ―Admitted Prior Art‖ in the ‘745 patent,
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`relying on a Declaration by Robert T. Chang (Ex. 1017). Pet. 16, 20-25, 27-30.
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`Specifically, Focal Therapeutics contends that the ‘745 patent describes that
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`aspirating air from a lumpectomy cavity after implant placement was well-known.
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`Id. at 16 (citing Ex. 1001, 1:54-60; Ex. 1017 ¶ 25 (citing same)). Focal
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`Therapeutics also states that the ―known technique of ‗aspirating air‘ could have
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`been readily implemented by a person having ordinary skill in the art to improve
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`Stubbs‘s method for external beam radiation therapy in the same way that it is used
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`to improve methods employing balloon catheters—by removing the air
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`surrounding the implants.‖ Id. (citing Ex. 1017 ¶¶ 44, 50, 56); see also id. at 24,
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`28-29.
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`The passage cited by Focal Therapeutics as ―Admitted Prior Art‖ in the ‘745
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`patent states that ―[a]n additional drawback to the catheter methodology is the need
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`to aspirate air from the lumpectomy cavity.‖ Ex. 1001, 1:54-56 (emphasis added).
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`In this context, the passage further states that ―[a]ir in a lumpectomy cavity creates
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`‗hot spots‘ or high heat conditions within the cavity when subjected to radiation
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`therapy, thereby causing burns and other undesirable side effects.‖ Id. at 1:54-59.
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`The passage also states that ―it is desirable to aspirate or remove the air, most
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`commonly with a syringe and needle,‖ but notes that a ―catheter may be punctured
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`by the needle during aspiration, creating problems for its subsequent use and