Paper 8 Tel: Entered: April 22, 2014 UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD

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1 Paper 8 Tel: 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 IPR 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

2 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 ( the 745 patent )). 35 U.S.C Patent Owner SenoRx, Inc. ( SenoRx ) filed a Preliminary Response (Paper 6, Prel. Resp. ). We have jurisdiction under 35 U.S.C 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 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: The method uses external beam radiation delivered through a radiation source, such as a breast implant. Id. at 1:64 2:2; 2:23-36, 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. Id. at 2:24-32; 4:

3 below. C. Illustrative Claims Claims 1 and 18, the only challenged independent claims, are reproduced 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 radioopaque 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 radioopaque 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: D. Prior Art Relied Upon Focal Therapeutics relies upon the following prior art: Stubbs, U.S. Pub. No. 2009/ , published Jan. 22, 2009, claiming priority to a U.S. provisional appl. filed Jul. 16, 2007 (Ex ( Stubbs )); Stubbs, U.S. provisional appl. 60/949,963, filed Jul. 16, 2007 (Ex ( Stubbs Provisional )); Stubbs et al., U.S. Pub. No. 2008/ A1, published Jul. 24, 2008, related to a U.S. provisional appl. filed Dec. 19, 2006 (Ex ( Stubbs-Edmundson Publication )); 3

4 Stubbs et al., U.S. provisional appl. 60/875,776, filed Dec. 19, 2006 (Ex ( Stubbs-Edmundson Provisional )); The Corbitt 045 patent (Ex. 1015), issued Apr. 10, 2001; and Patrick and Stubbs, U.S. Pub. No. 2005/ A1, published May 12, 2005, filed Nov. 7, 2003 (Ex ( Patrick-Stubbs )). E. Alleged Grounds of Unpatentability Focal Therapeutics contends that claims 1-30 of the 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 102(e) 1-30 Stubbs 103(a) 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) 1-30 Stubbs-Edmundson Publication and the Corbitt 045 patent Stubbs-Edmundson Publication and Admitted Prior Art Stubbs-Edmundson Publication, the Corbitt 045 patent, and Admitted Prior Art 103(a) (a) 13, (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

5 II. Case IPR 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.F.R (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 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 745 Patent All alleged grounds of unpatentability asserted by Focal Therapeutics rely on at least one of three references cited as prior art under 35 U.S.C. 102(e) or 102(b): (1) Stubbs, a U.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 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 5

6 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 Filing date 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) 12/110,748 ( the 748 application ) 11/108,785 ( the 785 application ) (Ex.1002) 10/627,718 ( the 718 application ) 09/828,806 ( the 806 application ) Continuation-inpart ( CIP ) 4/28/2008 CIP 4/19/2005 Divisional* 2 7/28/2003 CIP* 4/10/ 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-inpart application of the Corbitt 045 patent. Ex. 2002, 1: 3-10; Ex. 2003, 1:

7 U.S. Patent No. Application No. Type 1 Filing date The Corbitt 045 patent (Ex. 1015) Ex. 1001, 1: /169,351 ( the 351 application ) 60/091,306 ( the 306 provisional ) (Ex. 2001) 60/077,639 (Ex. 2005) 60/061,588 (Ex. 2004) Non-provisional 10/9/1998 Provisional 6/30/1998 Provisional 3/11/1998 Provisional 10/10/1997 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 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. Id. 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. 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. 7

8 (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- 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, Id. 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. Id. 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 102(e) or 102(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

9 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 of 35 U.S.C Hollmer v. Harari, 681 F.3d 1351, 1355 (Fed. Cir. 2012); 35 U.S.C 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 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 CoreValve, 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 of unpatentability. 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

10 situation. See, e.g., Polaris Wireless, Inc. v. TruePosition, Inc., IPR , 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 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, IPR , 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

11 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, Ex 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, asfiled, 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 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, 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

12 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 CoreValve, 741 F.3d at 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

13 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 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, 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 SenoRx s contentions suggest that relevant disclosure exists in the 306 Here, provisional, but not in later filed applications, until it reappears in the 745 patent itself. In view of the priority chain break at the 226 patent, SenoRx has not shown, on this record, that the 745 patent is entitled to any priority date earlier than the actual filing date of the 745 patent of April 28, Consequently, based on the 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

14 record before us, and for the purposes of institution, Stubbs, Stubbs-Edmundson Publication, and Patrick-Stubbs each qualify as prior art under 35 U.S.C. 102(e), and Patrick-Stubbs also qualifies as prior art under 102(b). C. Alleged Grounds Based on Stubbs Focal Therapeutics contends that Stubbs anticipates, or renders obvious, claims 1-30, either alone, or, with respect to dependent claims 13 and 25, in further view of Admitted Prior Art presented in the 745 patent (Ex. 1001). Pet For the purposes of institution, for the reasons discussed above, Stubbs qualifies as prior art under 35 U.S.C. 102(e). 1. Stubbs (Ex. 1011) In its background section, Stubbs states that [e]xternal beam radiation therapy (EBRT) is one of the most common adjuvant therapies for cancer patients. Ex In relation to the disclosed invention, Stubbs describes a bioabsorbable implant placed within a tissue cavity, such as the breast. Id. at 0013, 0034, 0045; see also id. at Fig. 4. Stubbs describes using such implants to provide 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. Id. at In addition, Stubbs describes that the disclosed implant and system greatly improve[] the effectiveness of radiation therapy by facilitating radiation dosing and improving its accuracy, where the result is a treatment method which concentrates radiation on target tissue and helps to preserve the surrounding healthy tissue. Id. at 0046; see also id. at claims 1, 5 (reciting a bioabsorbable implant, treating surrounding tissues, and using external beam radiation). Stubbs further describes that [t]o aid with visualization, device 10 [i.e., implant 10] can be constructed of materials which highlight its surface during the imaging 14

15 procedure, for example, the surface may include in its construction a radio opaque material. Id. at Stubbs Provisional (Ex. 1012) Stubbs indicates that it claims priority to Stubbs Provisional, i.e., U.S. Provisional Appl. No. 60/949,963, filed on July 16, 2007 (Ex. 1012). Ex Stubbs states that Stubbs Provisional is incorporated herein by reference in its entirety. Id. We consider disclosures in Stubbs Provisional because Stubbs was published on January 22, 2009, and was filed on July 16, 2008, i.e., after the filing date of the 745 patent on April 28, In its Petition, Focal Therapeutics refers to disclosures in both Stubbs and Stubbs Provisional. Pet (referring to Stubbs Provisional as Provisional ). Stubbs Provisional describes implantable devices that provide a means of more accurately targeting external beam radiation to the region of tissue that is to be treated, where the implants provide a reproducibly-shaped 3-dimensional target that is used to focus the radiation therapy treatment beams directly onto the targeted tissue, such as breast tissue. Ex. 1012, 1:25-28; 8:1-6. Stubbs Provisional describes a bioabsorbable surgical implant with at least one integral radiographic (or ultrasonic) visualization (targeting) property. Id. at 5:14-15; see also id. at 10:5-8. Stubbs Provisional further describes fiducial markers having different radiographic properties than that of surrounding tissue (e.g., bone, and soft tissue), such as radio-opaque markers (e.g., permanently implanted foreign bodies). Id. at 4:26 5:2. In addition, Stubbs Provisional describes that the implant can be visualized, and its contours (and thus the contours of the target tissue to be treated typically marginal regions surrounding an excised tumor) readily determinable. Id. at 5:

16 Stubbs Provisional also describes radiation therapy that spans a wide range of time intervals. Id. at 9:5-9. Stubbs Provisional refers to patients who receive a hypofractionated radiation therapy, where resorption can start as early as 3 weeks post implant. Id. at 9:9-11. Stubbs Provisional also describes other patients, where radiation therapy may not start for weeks post surgically and may last 7 weeks, thus requiring an implant that remains fully functional for as long as 6 months. Id. at 9: Analysis claims 1-12, 14-24, and Focal Therapeutics contends that Stubbs, as well as Stubbs Provisional (collectively the Stubbs references ), disclose all the elements of challenged independent claims 1 and 18. Pet , For example, in relation to claim 1, Focal Therapeutics contends that Stubbs describes biocompatible and biodegradable implants used in targeted external beam radiation therapy, and identifies where both Stubbs references disclose an implant that is (1) substantially radio-opaque; (2) constructed of biocompatible and biodegradable materials; (3) placed within a breast cavity; (4) used to support the tissue surrounding the breast cavity; and (5) used as a target for delivery of radiation beam therapy to margins around the breast cavity; such that (6) the radiation beam does not irradiate the whole breast. Id. at (citing Ex. 1011, 0024 and ), (citing Ex. 1011, 0015, , 0029, 0030, 0033, 0034, 0036, 0040, , 0051, 0054; claim 13; Figs. 1, 5-7; Ex. 1012, 1:25-28; 2:1-3; 5:14-22; 6:4-9; 8:3-13, 22-23; 10:5-6); see also id. at (citing similar disclosures in relation to claim 18). Focal Therapeutics identifies reasonably where Stubbs and Stubbs Provisional 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

17 dependent claims, with the exception of claims 13 and 25. Pet. 16, 20-25, In the Petition, including the claim charts, Focal Therapeutics identifies reasonably where Stubbs and Stubbs Provisional disclose, or at least suggest, the different steps and elements of dependent claims 2-12, 14-17, 19-24, and Id. Focal Therapeutics has demonstrated that there is a reasonable likelihood that it would prevail on the grounds that claims 1-12, 14-24, and of the 745 patent are anticipated by, or alternatively, would have been obvious over, Stubbs. 4. Analysis claims 13 and 25 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, relying on a Declaration by Robert T. Chang (Ex. 1017). Pet. 16, 20-25, Specifically, Focal Therapeutics contends that the 745 patent describes that aspirating air from a lumpectomy cavity after implant placement was well-known. Id. at 16 (citing Ex. 1001, 1:54-60; Ex (citing same)). Focal 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 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. Id. (citing Ex , 50, 56); see also id. at 24, 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 burns and other undesirable side effects. Id. at 1:

18 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. Id. at 1: The passage then states that such problems are resolved by use of the proposed method. Id. at 1: That passage of the 745 patent, however, does not indicate adequately what an ordinary artisan (rather than inventors of the 745 patent) would have known about the stated drawback, especially in relation to air present after placing an implant (rather than a catheter) within a breast cavity, as disclosed in Stubbs. In its Petition, Focal Therapeutics does not establish sufficiently what an ordinary artisan would have known about the drawback in any context, much less in relation to an implant made of biocompatible and biodegradable material, in the absence of reading the 745 patent itself. Pet. 16. The paragraphs of Mr. Chang s Declaration cited by Focal Therapeutics do not persuade us otherwise. Id. Those paragraphs rely on the same passage in the 745 patent itself and/or Mr. Chang s conclusory statement that a person having ordinary skill in the art would have considered balloon catheters to be comparable to Stubbs s biocompatible and biodegradable implants: both implants fill the breast cavity and are surrounded by air without providing further explanation or citation to additional evidence. Ex , 44, 50, 56. Such evidence does not establish sufficiently a reasonable likelihood that an ordinary artisan would have known about a drawback in relation to air in a lumpectomy cavity when placing an implant, such as described in Stubbs, within a breast cavity. We are not persuaded that Focal Therapeutics has demonstrated that there is a reasonable likelihood that it would prevail on the grounds that claims 13 and 25 18

19 are anticipated by, or would have been obvious over, Stubbs in view of cited statements in the 745 patent. D. Alleged Grounds Based on Stubbs-Edmundson Publication Focal Therapeutics contends that Stubbs-Edmundson Publication anticipates, or renders obvious, claims 1-30, either alone, or, with respect to dependent claims 13 and 25, in further view of Admitted Prior Art in the 745 patent. Pet For the purposes of institution, for the reasons discussed above, Stubbs- Edmundson Publication qualifies as prior art under 35 U.S.C. 102(e). 1. Stubbs-Edmundson Publication (Ex. 1013) and Stubbs-Edmundson Provisional (Ex. 1014) On the face of the publication, Stubbs-Edmundson Publication (Ex. 1013) indicates that it is related to U.S. Provisional Appl. No. 60/875,776, filed on December 19, 2006 (Ex. 1014). In its Petition, Focal Therapeutics refers to disclosures in both applications. Petition (referring to Ex as Provisional ). Below, we refer to the published non-provisional application (Ex. 1013) and provisional application (Ex. 1014) collectively as Stubbs-Edmundson. Stubbs-Edmundson describes systems and methods for treating proliferative tissue disorders, such as malignant breast tumors, by resecting at least a portion of the proliferative tissue to create a resection cavity, followed by external radiation therapy of residual tumor margin. Ex ; see also Ex Stubbs-Edmundson describes using a tissue fixation device having an expandable surface, where the device may comprise a balloon catheter or, alternatively, an introduction device for the placement of biocompatible materials, (foam, plastic, etc.) to occupy a resected tissue or natural cavity. Ex , 0019, 0022, 0025, 0026; see also Ex , 18, 20, 23,

20 In this context, Stubbs-Edmundson describes the tissue fixation device as having a catheter body member or an elongate body member... for delivering an expandable surface element into a resection cavity. Ex , 0017, 0032, ; see also Ex , 16, 28, 33, 34. Stubbs-Edmundson states that body members can be constructed of a variety of materials, in one embodiment the body member material is silicone, preferably a silicone that is at least partially radio-opaque, thus facilitating x-ray location of body member after insertion of device. Ex ; see also Ex Analysis Independent claim 1 of the 745 patent recites a substantially radio-opaque implant constructed of biocompatible and biodegradable material. Claim 18 recites an implant constructed of biocompatible and biodegradable material with a substantially radio-opaque marker contained within the implant. Focal Therapeutics contends Stubbs-Edmundson Publication discloses the use of breast implants made of biocompatible materials that are bioabsorbable. Pet. 31 (citing Ex ). Focal Therapeutics further contends that Stubbs- Edmundson Publication discloses that [t]he breast implant may be constructed of a radio-opaque material (e.g., silicone) to facilitate the identification of the location of the implant after it is inserted into the breast. Id. (citing Ex ). In addition, Focal Therapeutics contends that other embodiments in Stubbs- Edmundson Publication use radio-opaque fiducial markers to determine the location of the implant. Id. (citing Ex , 0040); see also id. at 35, 43 (citing Ex , 0015, 0016, 0019, 0021, 0022, 0024, 0025, , 0061, 0062). We are not persuaded by Focal Therapeutics contentions in relation to a biodegradable implant that is also substantially radio-opaque (as recited in claim 20

21 1) or with a substantially radio-opaque marker contained within the implant (as recited in claim 18) based on disclosures in Stubbs-Edmundson alone. Stubbs- Edmundson describes an introduction device for the placement of biocompatible materials, (foam, plastic, etc.) to occupy a resected tissue or natural cavity, where such biocompatible materials may be bioabsorbable. Ex , 0021; Ex , 19. Focal Therapeutics does not explain, however, where Stubbs- Edmundson describes, or suggests, that the introduction device, itself, comprises biodegradable materials, as required by claims 1 and 18. Notably, Focal Therapeutics discusses fiducial markers, imaging, radiographic imaging, and radio opaque material in relation to a tissue fixation device, such as one comprising an expandable surface (e.g., balloon) and/or a body member. Ex , 0024, 0025, 0039, 0040, , 0061, 0062). Focal Therapeutics does not explain sufficiently how Stubbs-Edmundson describes or suggests that the tissue fixation device (or introduction device) is, or should be, constructed of the biodegradable materials, such as foam, plastic, etc. Id. at 0019, 0021; Pet. 31. Nor does Focal Therapeutics explain sufficiently how Stubbs-Edmundson describes or suggests biodegradable materials (placed in a cavity using a device) that are substantially radio-opaque or contain a substantially radio-opaque marker. In other words, Focal Therapeutics does not explain adequately how Stubbs- Edmundson discloses or suggests an implant constructed of biodegradable material, where the implant also is substantially radio-opaque or contains a substantially radio-opaque marker, as required in challenged independent claims 1 and 18. In addition, with respect to dependent claims 13 and 25, Focal Therapeutics does not explain sufficiently how cited disclosures in the 745 patent, i.e., Admitted Prior Art, overcome the above-mentioned deficiencies in this 21

22 regard. Pet. 40, 45. Thus, we are not persuaded that Focal Therapeutics has demonstrated that there is a reasonable likelihood that it would prevail on the grounds that Stubbs-Edmundson Publication anticipates, or renders obvious, independent claims 1 and 18 or any dependent challenged claims. E. Alleged Grounds Based on Stubbs-Edmundson Publication and the Corbitt 045 Patent Focal Therapeutics contends that Stubbs-Edmundson Publication renders claims 1-30 obvious in view of the Corbitt 045 patent (Ex. 1015), or, with respect to dependent claims 13 and 25, in further view of Admitted Prior Art in the 745 patent. Pet For the purposes of institution, for the reasons discussed above, the Corbitt 045 patent qualifies as prior art under 102(b). 1. The Corbitt 045 patent (Ex. 1015) The Corbitt 045 patent describes a bioabsorbable breast implant. Ex. 1015, 1:58-65; 2: The Corbitt 045 patent describes that one can instill the implants with agents, such as chemotherapies, as well as x-ray opaque or metallic material for identification of the area. Id. at 4: In one embodiment, the implant, which preferably is entirely biodegradable, has a porous structure which supports the surrounding tissue and provides a framework for the in-growth of fibrous tissue material. Id. at 3: Claim 6 of the Corbitt 045 patent recites an implant comprising resorbable material and radiographic markers. Id. at 4:57-63; 5: Analysis claims 1-12, 14-24, and Focal Therapeutics contends that [s]imilar to Stubbs-Edmundson, Corbitt describes a bioabsorbable and radiographic breast implant. Pet. 32. Focal Therapeutics also contends that it would have been obvious to substitute Stubbs- Edmundson s biocompatible breast implants with the bioabsorbable breast 22

23 implants described in Corbitt for use with Stubbs-Edmundson s methods for treating breast cancer with external beam radiation therapy, because Stubbs- Edmundson suggests the use of implants such as those described in Corbitt. Id. Thus, according to Focal Therapeutics, an ordinary artisan would have had reason to use the Corbitt 045 patent s bioabsorbable breast implants as biocompatible materials when using an introduction device for the placement of biocompatible materials, (foam, plastic, etc.) to occupy a resected tissue or natural cavity, as taught in Stubbs-Edmundson. Ex ; Ex Consequently, Focal Therapeutics contends, the subject matter of independent claims 1 and 18 would have been obvious to an ordinary artisan over Stubbs- Edmundson Publication in view of the Corbitt 045 patent. Pet In view of the above-mentioned contentions, cited Declaration evidence by Mr. Chang (Ex , 49), and the claim charts in the Petition (Pet , 42-44), we are persuaded that Focal Therapeutics has demonstrated that there is a reasonable likelihood that it would prevail on the ground that Stubbs-Edmundson Publication and the Corbitt 045 patent would have rendered independent claims 1 and 18 obvious. We are persuaded that Focal Therapeutics establishes sufficiently why and how an ordinary artisan would have used the Corbitt 045 patent implants, i.e., as biocompatible materials in an introduction device, in methods disclosed in Stubbs-Edmundson Publication. Focal Therapeutics likewise contends that Stubbs-Edmundson Publication and the Corbitt 045 patent would have rendered obvious processes including all elements and steps of the challenged dependent claims. Pet. 30, 33-34, 37-42, Beyond the biocompatible and biodegradable aspect disclosed in the Corbitt 045 patent, we are persuaded that Focal Therapeutics identifies sufficiently where Stubbs-Edmundson discloses or suggests the steps and elements recited in the 23

24 challenged dependent claims, with the exception of claims 13 and 25 (discussed below). Id. Thus, Focal Therapeutics has demonstrated that there is a reasonable likelihood that it would prevail on the grounds that claims 1-12, 14-24, and of the 745 patent would have been obvious over Stubbs-Edmundson Publication and the Corbitt 045 patent. 3. Analysis claims 13 and 25 Focal Therapeutics contends that claims 13 and 25 would have been obvious over Stubbs-Edmundson Publication and the Corbitt 045 patent. Pet. 30. Focal Therapeutics contends that Stubbs-Edmundson Publication suggests aspirating air from a lumpectomy cavity after placement of the implant when disclosing that an expandable surface element in tissue fixation device is size[d] to fill a tissue cavity created in a breast during a lumpectomy. Ex ; Pet. 40, 45 (citing Ex ; see also id. (citing Ex (stating expanding the expandable surface ), 0057 (stating that the expandable surface can be expanded, collapsed, or maintained at a generally constant volume of expansion/inflation ). Focal Therapeutics does not establish sufficiently, however, how sizing, expanding, or inflating an expandable surface element, such as one disposed at a distal end of an elongated body member (see Ex ), would have suggested aspirating air from the lumpectomy cavity, as recited in claims 13 and 25, to an ordinary artisan. Focal Therapeutics also contends that claims 13 and 25 would have been obvious over Stubbs-Edmundson Publication (alone or in view of the Corbitt 045 patent) in further view of Admitted Prior Art disclosed in the 745 patent. Pet. 30, 33-34, 40, 45. Focal Therapeutics does not contend that the Corbitt 045 patent describes or suggests aspirating air from a lumpectomy cavity, as recited in claims 24

25 13 and 25. Id. In addition, for the reasons previously discussed, we are not persuaded that Stubbs-Edmundson discloses or suggests this element. The passage in the 745 patent cited by Focal Therapeutics as Admitted Prior Art is discussed above. For the same reasons discussed above, we are not persuaded that Focal Therapeutics establishes sufficiently what an ordinary artisan would have known about the disclosed drawback in any context, much less in relation to an implant made of biodegradable material, in the absence of reading the 745 patent itself. Thus, we are not persuaded that Focal Therapeutics has demonstrated that there is a reasonable likelihood that it would prevail on the grounds that claims 13 and 25 would have been obvious over Stubbs-Edmundson Publication and the Corbitt 045 patent by themselves, or also in view of cited statements in the 745 patent. F. Alleged Grounds Based on Patrick-Stubbs and the Corbitt 045 Patent Focal Therapeutics contends that claims 1-30 would have been obvious over Patrick-Stubbs in view of the Corbitt 045 patent, or, in relation claims 13 and 25, also in view of Admitted Prior Art in the 745 patent. Pet For the purposes of institution, for the reasons discussed above, Patrick-Stubbs qualifies as prior art under 35 U.S.C. 102(b). 1. Patrick-Stubbs (Ex. 1016) Patrick-Stubbs discloses systems and methods for treating proliferative tissue disorders using a tissue fixation device having an expandable surface, and applying external radiation. See, e.g., Ex , Patrick-Stubbs discloses that fiducial markers can be positioned on the tissue fixation device to determine the spatial location of the device and the surrounding PTV. Id. at 0012, 0006 (defining PTV as planning target volume ). In addition, the 25

26 reference teaches that the fiducial markers and their detection systems can be radio-opaque markers that are imaged radiographically. Id. at Analysis Focal Therapeutics contends that Patrick-Stubbs discloses nearly all elements recited in the challenged claims, but relies on the Corbitt 045 patent as teaching a relevant implant that is biodegradable. Pet , 56. Specifically, in relation to a substantially radio-opaque implant constructed of biocompatible and biodegradable material (claim 1) and an implant constructed of biocompatible and biodegradable material with a substantially radio-opaque marker contained within the implant (claim 18), Focal Therapeutics contends it was well known that Corbitt s bioabsorbable breast implants support[] the surrounding tissue after implantation, and permit[] the in-growth of fibrous replacement tissue without encapsulation or with reduced scarring. Pet. 48 (quoting Ex. 1015, 1:61-65). Focal Therapeutics contends that an ordinary artisan would have used Corbitt s technique of making breast implants biodegradable to improve the implants disclosed in Patrick-Stubbs for treating breast cancer with external beam radiation therapy. Id. at (citing Ex ). Alternatively, according to Focal Therapeutics, an ordinary artisan would have substituted Patrick-Stubbs s implants with Corbitt s bioabsorbable breast implants for use with Patrick-Stubbs s external beam radiation therapy. Id. at 49 (citing Ex ). Notably, however, Focal Therapeutics does not explain adequately why one would have had reason to use the Corbitt 045 patent s bioabsorbable breast implants in Patrick-Stubbs device comprising a tissue fixation device (such as a balloon catheter) having an expandable surface element. See, e.g., Pet. 50 (regarding 1.4), 56 (regarding 18.3). Focal Therapeutics conclusory statements, e.g., that an ordinary artisan would have done so to improve Patrick-Stubbs 26

27 device, does not provide sufficient explanation, especially when Patrick-Stubbs discloses that its tissue fixation device and expandable surface expand to position and support surrounding tissue, and that the device or expandable surface itself is constructed of radio-opaque material. Pet , 56; see also, e.g., Ex , Focal Therapeutics does not explain sufficiently why would an ordinary artisan would have wanted to improve Patrick-Stubbs device, or why would one have done so by using the implants disclosed in the Corbitt 045 patent in Patrick- Stubbs device. In addition, Focal Therapeutics does not explain sufficiently how one could have used the Corbitt 045 patent s implants as part of Patrick-Stubbs disclosed methods/systems involving a tissue fixation device. The paragraphs of the Chang Declaration cited by Focal Therapeutics provide insufficient additional explanation in this regard. Pet (citing Ex ); see, e.g., Ex (stating that Corbitt s and Patrick-Stubbs s breast implants are comparable to each other without explanation). III. CONCLUSION For the foregoing reasons, we are persuaded that Focal Therapeutics has demonstrated that there is a reasonable likelihood that it would prevail on the grounds that Stubbs anticipates and renders obvious, and Stubbs-Edmundson Publication and the Corbitt 045 patent render obvious, claims 1-12, 14-24, and of the 745 patent. We are not persuaded that Focal Therapeutics has demonstrated that there is a reasonable likelihood that it would prevail on the grounds that any cited prior art anticipates or renders obvious claims 13 and 25 of 27

28 the 745 patent. The Board has not made a final determination on the patentability of the challenged claims. IV. ORDER For the reasons given, it is ORDERED that the Petition is granted with respect to the challenge, under 35 U.S.C. 102, that Stubbs anticipates claims 1-12, 14-24, and of the 745 patent; FURTHER ORDERED that the Petition is granted with respect to the challenge, under 35 U.S.C. 103, that claims 1-12, 14-24, and of the 745 patent would have been obvious over Stubbs; FURTHER ORDERED that the Petition is granted with respect to the challenge, under 35 U.S.C. 103, that claims 1-12, 14-24, and of the 745 patent would have been obvious over Stubbs-Edmundson Publication and the Corbitt 045 patent; FURTHER ORDERED that pursuant to 35 U.S.C. 314(a), inter partes review of the ʼ475 patent is hereby instituted commencing on the entry date of this Order, and pursuant to 35 U.S.C. 314(c) and 37 C.F.R. 42.4, notice is hereby given of the institution of a trial; FURTHER ORDERED that the other grounds presented in Focal Therapeutics Petition are denied, and no ground other than that specifically granted above is authorized for the inter partes review as to claims 1-30; and FURTHER ORDERED that an initial conference call with the Board is scheduled for 11:00 AM Eastern Time on May 23, The parties are directed to the Office Patent Trial Practice Guide, 77 Fed. Reg. at 48,765-66, for guidance in preparing for the initial conference call, and should be prepared to 28

29 discuss any proposed changes to the Scheduling Order entered herewith and any motions the parties anticipate filing during the trial. 29

30 For PETITIONER: Matthew Kreeger Matthew Chivvis For PATENT OWNER: Michael Fink Arnold Turk 30