Trials@uspto. gov
`Tel: 571-272-7822
`
`Paper 8
`Entered: April 22, 2014
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`FOCAL THERAPEUTICS, INC.,
`Petitioner,
`
`v.
`
`SENORX, INC.,
`Patent Owner.
`
`Case IPR20 14-00 116
`Patent 8,288, 7 45 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.P.R. § 42.108
`
`Verizon Wireless
`Exhibit 1036-0001
`
`

`

`Case IPR20 14-00 116
`Patent 8,288, 7 45 B2
`
`I.
`
`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
`
`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
`
`shown that, under 35 U.S.C. § 314(a), there is a reasonable likelihood that it would
`
`prevail with respect to at least one of the challenged claims. We institute an inter
`
`partes review of claims 1-12, 14-24, and 26-30 of the '745 patent.
`
`B. The '745 Patent (Ex. 1001)
`
`The '745 patent relates to a method of cancer therapy that partially radiates
`
`the breast. Ex. 1001, 1:23-30. The method uses external beam radiation delivered
`
`through a radiation source, such as a breast implant. !d. at 1:64-2:2; 2:23-36, 47-
`
`50. The '745 patent describes a breast implant, such as the implant disclosed in
`
`U.S. Patent No. 6,214,045 B1 (Ex. 1015) ("the Corbitt '045 patent"), which
`
`"functions as a radio-opaque target for external beam stereotactic partial breast
`
`radiotherapy." !d. at 2:24-32; 4:28-30.
`
`2
`
`Verizon Wireless
`Exhibit 1036-0002
`
`

`

`Case IPR20 14-00 116
`Patent 8,288, 7 45 B2
`
`C. Illustrative Claims
`
`Claims 1 and 18, the only challenged independent claims, are reproduced
`
`below.
`
`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(cid:173)
`opaque marker contained within the implant, and said implant
`supporting the tissue surrounding the breast lumpectomy cavity; and
`directing a radiation beam to said implant, said substantially radio(cid:173)
`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.
`!d. at 5:25-35; 6:31-42.
`
`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 AI, published Jul. 24, 2008, related
`to a U.S. provisional appl. filed Dec. 19, 2006 (Ex. 1013 ("Stubbs-Edmundson
`Publication"));
`
`3
`
`Verizon Wireless
`Exhibit 1036-0003
`
`

`

`Case IPR20 14-00 116
`Patent 8,288, 7 45 B2
`
`Stubbs et a1., 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
`
`Patrick and Stubbs, U.S. Pub. No. 2005/0101860 AI, published May 12, 2005,
`filed Nov. 7, 2003 (Ex. 1016 ("Patrick-Stubbs")).
`
`E. Alleged Grounds of Unpatentability
`
`Focal Therapeutics contends that claims 1-30 ofthe '745 patent are
`
`unpatentable under 35 U.S.C. § 102(e) and§ 103(a) based on the following
`
`grounds. Pet. 14, 30, 47.
`
`Reference( s)
`
`Basis
`
`Claims Challenged
`
`Stubbs
`
`Stubbs
`
`§ 102(e)
`
`§ 103(a)
`
`1-30
`
`1-30
`
`Stubbs and "Admitted Prior Art" (Ex. 1001)
`
`§ 103(a)
`
`13,25
`
`Stubbs-Edmundson Publication
`
`Stubbs-Edmundson Publication
`
`Stubbs-Edmundson Publication and the Corbitt
`'045 patent
`
`§ 102(e)
`
`§ 103(a)
`
`§ 103(a)
`
`1-30
`
`1-30
`
`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)
`
`13,25
`
`Patrick-Stubbs and the Corbitt '045 patent
`
`§ 103(a)
`
`1-30
`
`Patrick-Stubbs, the Corbitt '045 patent, and
`"Admitted Prior Art"
`
`§ 103(a)
`
`13,25
`
`4
`
`Verizon Wireless
`Exhibit 1036-0004
`
`

`

`Case IPR20 14-00 116
`Patent 8,288, 7 45 B2
`
`II.
`
`ANALYSIS
`
`A. Claim Construction
`
`In an inter partes review, a claim in an unexpired patent shall be given its
`
`broadest reasonable construction in light of the specification of the patent in which
`
`it appears. See 37 C.P.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
`
`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
`
`radiation machine" recited in certain challenged dependent claims, indicating that
`
`the phrase encompasses "all external beam radiation therapy machines that use
`
`multi-directional external radiation beams, such as 3DCRT and selected IMRT
`
`machines." Pet. 13-14. Focal Therapeutics' proposed construction, on the record
`
`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
`
`decision.
`
`B. Effective Filing Date of the '7 45 Patent
`
`All alleged grounds ofunpatentability asserted by Focal Therapeutics rely
`
`on at least one ofthree references cited as prior art under 35 U.S.C. § 102(e) or
`
`§ 1 02(b ): ( 1) Stubbs, aU. S. patent application publication with an earliest possible
`
`effective filing date of July 16, 2007 (Ex. 1011); (2) Stubbs-Edmundson
`
`Publication, a U.S. patent application publication with an earliest possible effective
`
`filing date ofDecember 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
`
`5
`
`Verizon Wireless
`Exhibit 1036-0005
`
`

`

`Case IPR20 14-00 116
`Patent 8,288, 7 45 B2
`
`the '745 patent are entitled to the benefit of an effective filing date earlier than
`
`November 7, 2003 (the earliest of the possible effective filing dates of the
`
`references), for example, then every ground in the Petition would rely on at least
`
`one reference that fails to qualify as prior art against the '745 patent. We must
`
`evaluate, therefore, the priority date, i.e., the effective filing date, of the '745
`
`patent.
`
`As presented in its "Statement of Priority," the '745 patent claims priority to
`
`a series of patent documents as follows:
`
`U.S. Patent No.
`
`Application No.
`
`Type 1
`
`The '745 patent
`(Ex. 1001)
`7,637,948 B2
`("the '948 patent")
`(Ex. 1003)
`6,881,226 B2
`("the '226 patent")
`(Ex.2002)
`6,638,308 B2
`("the '308 patent")
`(Ex.2003)
`
`Continuation-in-
`12/110,748
`("the '7 48 application") part ("CIP")
`11/108,785
`CIP
`("the '785 application")
`(Ex.1002)
`10/627,718
`("the '718 application")
`
`Divisional *2
`
`09/828,806
`("the '806 application")
`
`CIP*
`
`Filing date
`
`4/28/2008
`
`4/19/2005
`
`7/28/2003
`
`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 ofthe 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(cid:173)
`part application ofthe Corbitt '045 patent. Ex. 2002, 1: 3-10; Ex. 2003, 1:3-10.
`
`6
`
`Verizon Wireless
`Exhibit 1036-0006
`
`

`

`Case IPR20 14-00 116
`Patent 8,288, 7 45 B2
`
`U.S. Patent No.
`
`Application No.
`
`Type1
`
`Filing date
`
`The Corbitt '045
`patent" (Ex. 10 15)
`
`09/169,351
`("the '3 51 application")
`
`Non-provisional
`
`10/9/1998
`
`60/091,306
`("the '306 provisional")
`(Ex.2001)
`60/077,639
`(Ex.2005)
`60/061,588
`(Ex.2004)
`
`Provisional
`
`6/30/1998
`
`Provisional
`
`3/11/1998
`
`Provisional
`
`10/10/1997
`
`Ex. 1001, 1:4-19.
`
`As to priority, Focal Therapeutics contends that the challenged claims of the
`
`'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
`
`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
`
`radiation beam does not materially irradiate the whole of the breast." !d. at 11.
`
`Focal Therapeutics contends that this step corresponds to a "targeted beam
`
`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
`
`targeted location inside the patient's body." !d. 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." !d.
`
`7
`
`Verizon Wireless
`Exhibit 1 036-0007
`
`

`

`Case IPR20 14-00 116
`Patent 8,288, 7 45 B2
`
`(emphasis in original). Thus, according to Focal Therapeutics, all claims of the
`
`'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(cid:173)
`
`Stubbs all qualify as prior art. !d.
`
`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. !d.
`
`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
`
`disclosure which [Focal Therapeutics] asserts is missing, i.e., 'external-beam
`
`radiation."' !d. at 12 (citing Ex. 2001, 3:7), 14 (citing Ex. 2001, 3:4-7), 13-16; see
`
`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.
`
`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
`
`Publication, and Patrick -Stubbs fail to qualify as prior art under § 1 02( e) or
`
`§ 1 02(b ). Accordingly, SenoRx contends that we must deny the Petition because
`
`every ground relies on at least one of those references. Prel. Resp. 8.
`
`8
`
`Verizon Wireless
`Exhibit 1036-0008
`
`

`

`Case IPR20 14-00 116
`Patent 8,288, 7 45 B2
`
`1. Principles of Law
`
`A claim in a patent application is entitled to the benefit of the filing date of
`
`an earlier filed, related application if it meets the requirements of35 U.S.C. § 120.
`
`Hollmer v. Harari, 681 F.3d 1351, 1355 (Fed. Cir. 2012); 35 U.S. C. § 120. Such
`
`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
`
`contain a specific reference to the earlier filed application." 35 U.S. C. § 120; In re
`
`NTP, Inc., 654 F.3d 1268, 1277 (Fed. Cir. 2011); PowerOasis, Inc. v. T-Mobile
`
`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
`
`"mandates 'each [intermediate] application in the chain of priority to refer to the
`
`prior applications."' Medtronic Core Valve, LLC v. Edwards Lifesciences Corp.,
`
`741 F.3d 1359, 1363 (Fed. Cir. 2014) (quoting Encyclopaedia Britannica, Inc. v.
`
`Alpine Elecs. of Am., Inc., 609 F.3d 1345, 1352 (Fed. Cir. 2010)). Thus, if any one
`
`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.
`
`In an inter partes review, the burden is on the petitioner to show a
`
`reasonable likelihood that it would prevail on a ground ofunpatentability. 35
`
`U.S. C. § 314(a). With respect to entitlement to any earlier effective filing date,
`
`however, a patent owner is not presumed to be entitled to the earlier filing dates of
`
`ancestral applications that do not share the same disclosure, such as in a CIP
`
`9
`
`Verizon Wireless
`Exhibit 1036-0009
`
`

`

`Case IPR20 14-00 116
`Patent 8,288, 7 45 B2
`
`situation. See, e.g., Polaris Wireless, Inc. v. TruePosition, Inc., IPR2013-00323,
`
`Paper 9, 29. Nonetheless, a petitioner first must raise the issue by identifying,
`
`specifically, the features, claims, and ancestral applications allegedly lacking § 112
`
`support for the claims based on the identified features. See id. Then, the patent
`
`owner must make a sufficient showing of entitlement to earlier filing date( s ), in a
`
`manner that is commensurate in scope with the specific points and contentions
`
`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.
`
`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,
`
`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.
`
`10
`
`Verizon Wireless
`Exhibit 1036-0010
`
`

`

`Case IPR20 14-00 116
`Patent 8,288, 7 45 B2
`
`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." !d. 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(cid:173)
`
`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
`
`11
`
`Verizon Wireless
`Exhibit 1036-0011
`
`

`

`Case IPR20 14-00 116
`Patent 8,288, 7 45 B2
`
`patent), but not any earlier filed patent documents in the chain, i.e., the Corbitt
`
`'045 patent, or provisional applications, including the '306 provisional.
`
`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 Core Valve, 741 F.3d at 1363. Because the
`
`'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
`
`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.
`
`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
`
`12
`
`Verizon Wireless
`Exhibit 1036-0012
`
`

`

`Case IPR20 14-00 116
`Patent 8,288, 7 45 B2
`
`patent or later filed applications in the chain. That is, even though the '745 patent
`
`may not be entitled to an effective filing date based on the filing date of the Corbitt
`
`'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.
`
`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
`
`support for the recited step of "directing a radiation beam" to an implant, "such
`
`that the radiation beam does not materially irradiate the whole of the breast,"
`
`SenoRx relies only on disclosures in the '306 provisional. See, e.g., Prel. Resp. 14,
`
`16, 20, 22-23. Especially because the '745 patent, the '948 patent, and the '308
`
`patent are all CIP applications, we must assess whether SenoRx shows sufficiently
`where earlier filed applications provide the § 112 support in question. 3 Here,
`
`SenoRx's contentions suggest that relevant disclosure exists in the '306
`
`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 April28, 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)).
`
`13
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`Verizon Wireless
`Exhibit 1036-0013
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`

`

`Case IPR20 14-00 116
`Patent 8,288, 7 45 B2
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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 § 1 02(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 ]xtemal 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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`I d. 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." I d. 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." I d. 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
`
`14
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`Verizon Wireless
`Exhibit 1036-0014
`
`

`

`Case IPR20 14-00 116
`Patent 8,288, 7 45 B2
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`procedure, for example, the surface may include in its construction a radio opaque
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`material." I d. at ~ 004 7.
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`2. Stubbs Provisional (Ex. 1 012)
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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." !d. 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 April28, 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." !d. 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)." !d. 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." !d. at 5:19-21.
`
`15
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`Verizon Wireless
`Exhibit 1036-0015
`
`

`

`Case IPR20 14-00 116
`Patent 8,288, 7 45 B2
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`Stubbs Provisional also describes radiation therapy that "spans a wide range
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`of time intervals." !d. 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
`
`weeks post implant." !d. 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." !d. 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 ofbiocompatible 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. !d. at 15-16 (citing Ex. 1011, ~~ 0024 and 0044-4 7), 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).
`
`Focal Therapeutics identifies reasonably where Stubbs and Stubbs Provisional
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`disclose the different elements of independent claims 1 and 18.
`
`Focal Therapeutics likewise contends that the Stubbs references disclose, or
`
`render obvious, processes including all steps and elements of the challenged
`
`16
`
`Verizon Wireless
`Exhibit 1036-0016
`
`

`

`Case IPR20 14-00 116
`Patent 8,288, 7 45 B2
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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
`
`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. !d. 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 ofthe '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
`
`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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`!d. 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
`
`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." !d. (citing Ex. 1017 ~~ 44, 50, 56); see also id. at 24,
`
`28-29.
`
`The passage cited by Focal Therapeutics as "Admitted Prior Art" in the '745
`
`patent states that "[a]n additional drawback to the catheter methodology is the need
`
`to aspirate air from the lumpectomy cavity." Ex. 1001, 1:54-56 (emphasis added).
`
`In this context, the passage further states that "[a]ir in a lumpectomy cavity creates
`
`'hot spots' or high heat conditions within the cavity when subjected to radiation
`
`therapy, thereby causing bums and other undesirable side effects." !d. at 1:54-59.
`
`17
`
`Verizon Wireless
`Exhibit 1036-0017
`
`

`

`Case IPR20 14-00 116
`Patent 8,288, 7 45 B2
`
`The passage also states that "it is desirable to aspirate or remove the air, most
`
`commonly with a syringe and needle," but notes that a "catheter may be punctured
`
`by the needle during aspiration, creating problems for its subsequent use and
`
`effectiveness in treatment." I d. at 1:59-63. The passage then states that such
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`"problems ar