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[email protected] Paper 8
Tel: 571-272-7822 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 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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Patent 8,288,745 B2
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. 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. Id. 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.‖ Id. at 2:24-32; 4:28-30.
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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-
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-
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.
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
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
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
§ 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) 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
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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.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
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’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
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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. Type1 Filing date
The ‘745 patent
(Ex. 1001)
12/110,748
(―the ‘748 application‖)
Continuation-in-
part (―CIP‖)
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)
10/627,718
(―the ‘718 application‖)
Divisional*2 7/28/2003
6,638,308 B2
(―the ‘308 patent‖)
(Ex. 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. 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)
Provisional 6/30/1998
60/077,639
(Ex. 2005)
Provisional 3/11/1998
60/061,588
(Ex. 2004)
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.‖ 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.
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(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, 1998. 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.
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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. § 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 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
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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.
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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
‘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 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
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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
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, 2008. 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)).
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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. 14-30.
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. 1011 ¶ 0004. 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 ¶ 0024.
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
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procedure, for example, the surface may include in its construction a radio opaque
material.‖ Id. at ¶ 0047.
2. 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. 1011
¶ 0001. 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, 2008. In its Petition, Focal Therapeutics
refers to disclosures in both Stubbs and Stubbs Provisional. Pet. 17-30 (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 5:19-21.
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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 12-18 weeks post surgically
and may last 7 weeks, thus requiring an implant that remains fully functional for as
long as 6 months.‖ Id. at 9:11-13.
3. Analysis—claims 1-12, 14-24, and 26-30
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. 14-19, 26-27. 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 15-16 (citing Ex. 1011, ¶¶ 0024 and 0044-47), 17-19 (citing
Ex. 1011, ¶¶ 0015, 0024-27, 0029, 0030, 0033, 0034, 0036, 0040, 0044-47, 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 26-27 (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
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dependent claims, with the exception of claims 13 and 25. Pet. 16, 20-25, 27-30.
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 26-30. 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 26-30 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, 27-30.
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. 1017 ¶ 25 (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. 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 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
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 1:59-63. The passage then states that such
―problems are resolved by use of the proposed method.‖ Id. at 1:63-64.
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. 1017 ¶¶ 25, 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
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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. 30-46.
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 34-46 (referring to Ex. 1014 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. 1013 ¶ 0022; see also Ex. 1014 ¶ 22.
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. 1013 ¶¶ 0012-14, 0019,
0022, 0025, 0026; see also Ex. 1014 ¶¶ 11-13, 18, 20, 23, 24.
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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. 1013 ¶¶ 0016, 0017,
0032, 0037-39; see also Ex. 1014 ¶¶ 15, 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. 1013 ¶ 0039; see also Ex. 1014 ¶ 34.
2. 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. 1013 ¶ 0021). 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. 1013 ¶ 0039). 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. 1013 ¶¶ 0025, 0040); see also id. at 35, 43
(citing Ex. 1013 ¶¶ 0012, 0015, 0016, 0019, 0021, 0022, 0024, 0025, 0053-55,
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
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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. 1013 ¶¶ 0019, 0021; Ex.
1014 ¶¶ 18, 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. 1013 ¶¶ 0015, 0024, 0025, 0039, 0040, 0053-55, 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
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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. 30-46. 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; 2:15-19. 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 4:31-37. 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 3:18-22. Claim 6 of the Corbitt ‘045 patent recites
an implant comprising resorbable material and radiographic markers. Id. at 4:57-
63; 5:5-8.
2. Analysis—claims 1-12, 14-24, and 26-30
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
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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. 1013 ¶ 0019; Ex. 1014 ¶ 18.
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. 32-33.
In view of the above-mentioned contentions, cited Declaration evidence by
Mr. Chang (Ex. 1017 ¶¶ 48, 49), and the claim charts in the Petition (Pet. 34-37,
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, 44-
46. 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
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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 26-30
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. 1013 ¶ 0017; Pet. 40, 45
(citing Ex. 1013 ¶ 0017; see also id. (citing Ex. 1013 ¶ 0054 (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. 1013 ¶ 0017),
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
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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. 46-59. 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. 1016 ¶¶ 0009, 0013. 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
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reference teaches that the ―fiducial markers and their detection systems can be
radio-opaque markers that are imaged radiographically.‖ Id. at ¶ 0012.
2. 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. 47-50, 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 48-49 (citing Ex. 1017 ¶ 55). 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. 1017 ¶ 54).
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‘
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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. 48-50, 56; see also, e.g., Ex 1016
¶¶ 0029, 0051.
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. 48-49 (citing Ex. 1017 ¶¶ 54-55); see, e.g., Ex.
1017 ¶ 55 (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 26-
30 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
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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 26-30 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 26-30 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 26-30 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, 2014. 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
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discuss any proposed changes to the Scheduling Order entered herewith and any
motions the parties anticipate filing during the trial.
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For PETITIONER:
Matthew Kreeger
Matthew Chivvis
For PATENT OWNER:
Michael Fink
Arnold Turk