Patent No. 8,288,745
`Petition For Inter Partes Review
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
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`Focal Therapeutics, Inc.,
`Petitioner
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`v.
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`Senorx, Inc.
`Patent Owner
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`Patent No. 8,288,745
`Issue Date: October 16, 2012
`Title: METHOD OF UTILIZING AN IMPLANT FOR
`TARGETING EXTERNAL BEAM RADIATION
`_______________
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`Inter Partes Review No. ______
`____________________________________________________________
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`DECLARATION OF ROBERT T. CHANG
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`1
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`Focal Exhibit 1017 Page 1
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`
`Petition For Inter Partes Review
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`Focal Therapeutics, Inc.,
`Petitioner
`
`v.
`
`Senorx, Inc.
`Patent Owner
`
`Patent No. 8,288,745
`Issue Date: October 16, 2012
`Title: METHOD OF UTILIZING AN IMPLANT FOR
`TARGETING EXTERNAL BEAM RADIATION
`_______________
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`Inter Partes Review No. ______
`____________________________________________________________
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`DECLARATION OF ROBERT T. CHANG
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`1
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`Focal Exhibit 1017 Page 1
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`I.
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`1.
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`INTRODUCTION
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`I have been retained by Morrison & Foerster LLP in this case as an
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`expert in the relevant art.
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`2.
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`I have been asked to provide my opinions and views on the materials I
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`have reviewed in this case related to U.S. Patent No. 8,288,745 (“the ’745 patent”
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`(Ex. 1001)), and the scientific and technical knowledge regarding the same subject
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`matter as the ’745 patent before and at the earliest effective filing date of April 28,
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`2008. The ’745 patent issued from U.S. Application No. 12/110,748 (the ’748
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`application), which was filed on April 28, 2008 and is the earliest effective filing
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`date of the ’745 patent. The ’745 patent is a continuation—in-part of US
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`Application No. 11/108,785 (“the ’785 application” (EX. 1002)), which ultimately
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`issued as U.S. Patent No. 7,637,948 (“the ’948 patent” (EX. 1003)), and was filed
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`on April 19, 2005.
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`3.
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`My opinions and underlying reasoning for the opinions are set forth
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`below.
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`II.
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`PROFESSIONAL BACKGROUND
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`4.
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`I have been active in industries related to the relevant field of art of
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`device implantation and therapy. I am presently an independent consultant to
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`medical device companies. In this capacity, I primarily provide my clients with
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`guidance on new product development strategy and tactics related to minimally
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`Focal Exhibit 1017 Page 2
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`invasive technology. Immediately prior to this, I was Vice President of Research
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`and Development at Sadra Medical, a subsidiary of Boston Scientific Corporation,
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`in Los Gatos, CA. In this capacity, I was responsible for new product development
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`regarding minimally invasive alternatives to traditional surgical heart valve
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`replacement to treat aortic valve disease. At the same company, I was Executive
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`Vice President and Chief Technology Officer (2009-2011) with responsibility for
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`new product development and operations of a novel percutaneous endovascular
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`aortic valve therapy. Prior to this, I was President, Chief Executive Officer,
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`Director and Co-Founder of Ample Medical of Foster City, CA (2002-2009) where
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`I created and implemented plans for the development of a unique and novel
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`percutaneous endovascular mitral valve regurgitation therapy. Prior to that, I was
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`Chief Operating Officer and Director at Satiety of Redwood City, CA (2000-2001)
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`where I directed development of innovative therapeutic medical devices for the
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`treatment of obesity. From 1995 to 2000, I held numerous positions, including
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`President, Chief Operating Officer/General Manager and other research and
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`development positions at IsoStent of Belmont, CA, where I was responsible for
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`developing a wide range of technologies including stent design and manufacturing,
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`catheter design and development, ion implantation and chemical radiation
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`processing. Further, I identified new applications for radioactive stent technology
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`such as coronary artery disease, gastrointestinal blockage, and pancreatic
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`carcinoma. Prior to that I was an Associate Product Manager and a Senior Project
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`Engineer at Devices for Vascular Intervention of Redwood City, CA (1991-1995).
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`5.
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`I earned a B.S. in Mechanical Engineering, magna cum laude, from
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`California Polytechnic State University in 1986. I earned a S.M. in Mechanical
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`Engineering from Massachusetts Institute of Technology in 1988.
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`6.
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`Most of my professional career has focused on developing innovative
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`medical devices for therapeutic treatment of diseases. More specifically, I have
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`developed: (a) radioactive stent technology and delivery systems involving
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`radiation technology such as ion implantation and chemical radiation processing;
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`(b) percutaneous endovascular aortic valve therapy including bovine tissue,
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`catheter delivery and introduction system, user interface system, and implant
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`structure; (c) percutaneous endovascular mitral regurgitation therapy including
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`delivery systems and permanent implants; (d) endoscopically delivered obesity
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`therapy including space occupying and tissue approximation technology; and (e)
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`percutaneous atherectomy catheter systems and accessories involving composite
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`structures and tissue excision technologies.
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`7.
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`My work has resulted in over 20 issued patents, patent applications,
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`and peer—reviewed publications.
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`8.
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`A copy of my curriculum vitae that summarizes my education, Work
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`history and publications is in Appendix A.
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`9.
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`I am being compensated for taking part in this case but have no other
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`relationship to Focal Therapeutics, Inc. My compensation is not dependent on the
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`outcome of this case.
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`III. BASIS FOR OPINION
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`10. My opinions and views set forth in this report are based on my
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`education, training, and experience in the relevant field, as well as the materials I
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`reviewed in this case, and the scientific knowledge regarding the same subj ect’
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`matter that existed prior to the earliest effective filing date of the ’745 patent.
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`IV.
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`PATENT LAW STANDARD
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`ll.
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`It is my understanding that a patent claim is invalid for anticipation if
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`it can be shown that each and every limitation of the claim is disclosed either
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`expressly or inherently in a single prior art reference. It is also my understanding
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`that to establish anticipation by inherency, the extrinsic evidence must be clearly
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`described in the reference.
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`12.
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`It is my understanding that a patent claim is invalid for obviousness if
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`the claimed invention as a Whole would have been obvious to one of ordinary skill
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`in the art at the time the invention was made, in View of a single prior art reference
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`or a combination of prior art references. Specifically, I understand that a
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`determination of whether a claimed invention would have been obvious requires
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`taking into consideration factors which include: (a) assessing the scope and content
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`of the prior art; (b) the differences between the claimed invention and the prior art;
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`and (c) the level of ordinary skill in the art. I further understand that secondary
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`considerations, such as commercial success, the solution of long-recognized but
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`unresolved needs, failures of others, etc. may be considered in a determination of
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`obviousness.
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`13.
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`It is my understanding that when combining two or more references,
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`or when modifying an item disclosed in one reference, so as to arrive at a claimed
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`invention, one should consider whether there is a reason for the proposed
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`combination or modification. For example, when a technology or product is
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`available in one field of endeavor, design incentives and other market forces can
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`prompt variations of it, either in the same field or a different one. For the same
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`reason, if a technique has been used to improve one device, and a person of
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`ordinary skill in the art would recognize that it would improve similar devices in
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`the same way, using the technique is obvious unless its actual application is
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`beyond his or her skill.
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`14.
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`It is my understanding that the claims of a patent are analyzed from
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`the perspective of “a person of ordinary skill in the art” and that the claims of the
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`’745 patent are interpreted as a person of ordinary skill in the art would have
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`understood them at the time the ’748 application, which issued as the ’745 patent,
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`was filed. It is further my understanding that a claim is given the “broadest
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`reasonable construction in light of the specification” in inter partes review. See 37
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`C.F.R. § 42.l0O(b).
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`15.
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`It is my understanding that “prior a ” includes patents and
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`publications in the relevant literature and information that predates the effective
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`priority date of the ’745 patent. It is also my understanding that priority is
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`determined on a claim—by-claim basis. Further, it is my understanding that if a
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`claim in a continuation-in-part application recites a feature that was first introduced
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`or adequately supported in the continuation-in-part application, then that claim is
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`entitled only to the filing date of the continuation-in-part.
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`16.
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`It is my understanding that a patent application can disclose prior
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`technologies as prior art in its specification, and the admitted prior information can
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`be used as “prior art” against its claims.
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`V.
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`A PERSON OF ORDINARY SKILL IN THE ART
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`17. A person of ordinary skill in the art relevant to the ’745 patent would
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`have had at least a bachelor’s degree in mechanical engineering, biomedical
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`engineering, or a similar field of engineering, and at least five years of experience
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`developing or researching therapeutic device implants.
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`VI. OVERVIEW OF THE APPLICABLE TECHNOLOGIES
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`18.
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`Following is an overview of the applicable technologies and the state
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`of the art before and at the earliest effective filing date of the application that
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`Focal Exhibit1017 Page7
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`issued as the ’745 patent. The ’745 patent issued from U.S. Application No.
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`12/110,748 (the ’748 application), which was filed on April 28, 2008 and is the
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`earliest effective filing date ofthe ’745 patent. The ’745 ‘patent is a continuation-
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`in-part of U.S. Application No. 11/ 108,785 (the ’785 application), which ultimately
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`issued as U.S. Patent No.'7,637,948 (the ’948 patent), and was filed on April 19,
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`2005. However, the ’745 patent adds substantial new matter to the ’948 patent.
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`19.
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`The ’745 patent generally relates to methods of breast radiation
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`therapy utilizing a biocompatible and biodegradable breast implant that provides a
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`target for the delivery of a radiation beam to the cavity.
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`20.
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`The use of radiation as a treatment for breast cancer therapy is not
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`new. As stated in the Background of the Invention portion of the ’745 patent,
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`before the filing ofthe ’748 application, it was known that radiation therapy could
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`expose the entire breast to radiation. (Ex. 1001 at 1:23-25.) Moreover, such
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`therapy could also expose the surrounding healthy structures and organs to
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`radiation. (Id. at 1:25-28.) It was therefore understood that, to minimize the
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`radiation of healthy tissue, partial breast radiation therapy may be used to target the
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`radiation at the desired area. (Id. at 1:28-32.)
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`21.
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`Partial breast radiation therapy may be implemented in various ways.
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`One way that was known before the filing of the ’748 application was
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`brachytherapy, which places radioactive material into the body to serve as the
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`concentrated source of radiation. (Id. at 1:32-37.) For brachytherapy, the
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`radiation is implanted directly into the tissue to be treated. (Ex. 1016 at 11 3.)
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`22. Another way to conduct partial breast radiation therapy that was
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`known before the filing of the ’748 application was to use external beam radiation
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`therapy (EBRT), which directs one or more beams of high-energy x-rays from
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`outside of the patient’s body to a targeted location inside the patient’s body.
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`(Ex. 1016 at 1] 5; Ex. 1011 at 1} 4.) As further stated in the Background of the
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`Invention portion of the ’745 patent, before the filing of the ’748 application, it
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`was known that a seed could be implanted as a target for the external beam
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`radiation therapy on solid organs. (Ex. 1001 at 2:2-9.) However, a person having
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`ordinary skill in the art would not have understood the use of brachytherapy to
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`describe or enable the use of external beam radiation therapy.
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`23.
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`It was also known that advances in technology improved EBRT’s
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`ability to “shape the radiation therapy beams to better avoid nearby sensitive
`structures.” (Ex. 1011 at 1] 7.) Itwas therefore understood that a technique called
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`intensity-modulated radiation therapy (IMRT) could improve the beam shape and
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`minimize the radiation of the surrounding healthy tissue. (Id. at 1[ 7.) It was
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`further understood that a technique called image guided radiation therapy (IGRT)
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`used radiographic imaging to better target the radiation to the desired area. (Id.) In
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`particular, both of the techniques “use[d] numerous, smaller and better focused
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`beams that intersect at the target volume.” (Id. at 11 8.)
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`24.
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`To assist with the targeting of external beam radiation therapy, it was
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`well known at the time that the ’748 application was filed that imaging radio-
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`opaque markers could help delineate the target tissue from healthy tissue and
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`provide for better targeted radiation therapy. (Id.) Many different ways for
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`implanting radio-opaque materials were known, such as placing fiducial markers
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`on the breast implant, or constructing the breast implant with radio-opaque
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`material. (Ex. 1016 at 1111 12, 36-38, 51, 55.) As stated in the Background of the
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`Invention portion of the ’745 patent, before the filing of the ’748 application, it
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`was known that bioabsorbable implants, including Corbitt’s breast implants, may
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`serve as radio-opaque targets. (Ex. 1001 at 2:26-39.) Further, it was known that
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`chemotherapy could be initiated prior to delivering radiation therapy—an approach
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`that is termed neoadjuvant chemotherapy. (See Ex. 1011 at 1111 53, 5 5.) However, a
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`person having ordinary skill in the art would know it is preferable to wait until
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`neoadjuvant chemotherapy is completed before initiating external beam radiation
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`therapy.
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`25.
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`It was well known at the time that the ’748 application was filed that
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`the technique of aspirating air from the lumpectomy cavity improved radiation
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`therapy involving balloon catheters. (Id. at 1:54-59.) To the extent that any
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`10
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`additional advantages exist for “aspirating air” prior to external beam radiation
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`therapy, those advantages could include further stabilizing the breast implant to
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`improve targeting of the desired areas in need of radiation therapy. Further, it was
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`known that the most common Way to aspirate or remove air from the lumpectomy
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`cavity was with a syringe and needle. (Id. at 1:59-60.)
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`VII. THE ’745 PATENT
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`26.
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`The ’745 patent includes two independent claims, claims 1 and 18,
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`which recite:
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`l. A method of partial breast radiation therapy comprising the steps of:
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`a) placing within a breast cavity a substantially radio-opaque implant
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`constructed of biocompatible and biodegradable material, said substantially
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`radio-opaque implant supporting the tissue surrounding the breast cavity;
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`and
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`b) directing a radiation beam to said substantially radio-opaque implant
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`serving as a target for delivery of radiation therapy to margins around the
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`breast cavity, such that the radiation beam does not materially irradiate the
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`Whole of the breast.
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`18. A method of partial breast radiation comprising the steps of:
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`a) placing within a breast lumpectomy cavity an implant constructed of
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`biocompatible and biodegradable material with a substantially radio-opaque
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`ll
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`marker contained within the implant, and said implant supporting the tissue
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`surrounding the breast lumpectomy cavity; and
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`b) directing a radiation beam to said implant, said substantially radio-
`opaque marker within said implant serving as a target for delivery of
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`radiation therapy to margins around the breast cavity, such that the radiation
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`beam does not materially irradiate the whole of the breast.
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`27. Dependent claims 2 and 19 add delivery of a therapeutically effective
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`dosage of radiation via a stereotactic radiation machine. Dependent claims 3, 4
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`and 20 add delivery of multiple therapeutically effective dosages of radiation via a
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`stereotactic radiation machine. Dependent claims 6 and 21 add delivery of a
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`therapeutically effective dosage of radiation via multidirectional radiation therapy.
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`Dependent claims 8 and 22 add delivery of a therapeutically effective dosage of
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`radiation via image guided radiation therapy. Dependent claims 10 and 23 add
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`delivery of a therapeutically effective dosage of radiation via 3-D conformal
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`radiation therapy. Dependent claims 12 and 24 add delivery of a therapeutically
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`effective dosage of radiation via intensity-modulated radiation therapy. Dependent
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`claims 13 and 25 add aspirating air. Dependent claims 5, 7, 9, 11, 14, 26 and 27
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`add beginning radiation therapy 1-90 days after placement of implant. Dependent
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`claims 15 and 28 add the step of initiating chemotherapy up to 120 days after
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`placement of implant. Dependent claims 16 and 29 add the implant’s shape to
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`guide radiation therapy. Dependent claim 17 requires the radio—opaque implant to
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`12
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`be constructed of a porous material. Dependent claim 30 requires the radio-opaque
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`marker to be constructed of material different from the implant.
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`The Specification of the ’745
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`28.
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`The ’745 patent issued from U.S. Application No. 12/110,748 (the
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`’748 application), which was filed on April 28, 2008 and is the earliest effective
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`filing date of the ’745 patent. The ’745 patent is a continuation—in-part of U.S.
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`Application No. 11/108,785 (the ’785 application) that adds new subject matter,
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`which ultimately issued as U.S. Patent No. 7,637,948 (the ’948 patent), and was
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`filed on April 19, 2005. The ’745 patent is directed to a method of breast radiation
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`therapy that uses an implant to provide a target for the radiation treatment. (See
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`Ex. 1001 at Abstract, Cls. 1, 18.) In the Background of the Invention section, the
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`’745 specification acknowledges that the concept of using “breast radiation
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`targeting the area of the breast involved by cancer” is known and “is currently
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`gaining popularity.” (Id. at 1:28-30.) Indeed, the specification recognizes that
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`“[p]artial breast radiation is currently being delivered through temporarily
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`implanted balloon catheters.” (Id. at 1:32-33.)
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`29.
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`The ’745 specification proposes an improved method for the “use of
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`external beam radiation delivered through a multidirectional stereotactic radiation
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`source.” (Id. at 1:65-66.) The specification acknowledges that the use of “external
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`beam radiation” in cancer treatment is known, such as using an implanted gold
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`13
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`seed to guide the focusing of the beam. (Id. at 2:2-7.) The specification suggests
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`that, because the breast is primarily composed of fatty tissue, known therapies
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`employing a seed to focus the beam of an external radiation source would be
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`inhibited. (Id. at 219-16.) To address this issue, the ’745 specification proposes a
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`modification to the resorbable implant described in Corbitt to include a more fully
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`defined “x—ray opaque or metallic material for identification of [an] area.” (Id. at
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`2:26-51.) Like the seeds used in the prior art, this improved implant is purportedly
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`designed to better guide the external beam and minimize the irradiation of healthy
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`tissue. (Id. at 2:47-49.)
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`The File I-Iistog
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`30.
`The ’745 patent was filed on April 28, 2008. It is a continuation-in-
`part ofApplication No. 1 1/108,785, which was filed on April 19, 2005 and issued
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`as the ’948 patent. However, the ’745 patent adds substantial new matter to the
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`’948 patent. Via an additional continuation-in-part, a continuation, and a
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`divisional, the ’745 patent traces its parentage back to U.S. Patent No. 6,214,045
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`which was filed October 9, 1998 (“Corbitt” (Ex. 1015)). Yet, the ’745 patent
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`specification consists almost entirely of new matter. Besides an incorporation by
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`reference, the only disclosure that the specification of the ’745 patent has in
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`common with Corbitt is a single quoted phrase: “X—ray opaque or metallic material
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`14
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`for identification of the area.” (Ex. 1001 at 2:33-34; Ex. 1015 at 4:36-37.) The
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`same is true regarding the ’948 patent. (Ex. 1003 at 5:18-19.)
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`31. Despite the presence of substantial new matter, the May 14, 2008
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`Filing Receipt incorrectly listed the application as a direct continuation of the
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`application that issued as the ’948 patent. (Filing Receipt dated May 14, 2008
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`(Ex. 1004).) An ID8 was submitted that listed Publication No. 2009/024225 to
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`Stubbs (“Stubbs” (Ex. 1011)) While the examiner treated the application as a direct
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`continuation. (Information Disclosure Statement dated October 20, 2009 (Ex.
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`1005).) Though it was filed on July 16, 2008, Stubbs claims priority to a lengthy
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`provisional application (U.S. Application No. 60/949,963 (Ex. 1012)) filed on July
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`16, 2007. Although Stubbs is prior art under § 102(e) to the filing date of the
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`application for the ’745 patent, it is not prior art to the parent filing dates. On
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`February 23, 2010, the applicant sought to fix the ’745 patent’s related application
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`data by submitting a Preliminary Amendment and Request for Corrected Filing
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`Receipt. (Preliminary Amendment dated February 23, 2010 (Ex. 1006); Request
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`for Corrected Filing Receipt dated February 23, 2010 (Ex. 1007).)
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`32.
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`On May 25, 2011, the Examiner issued a first Office Action rejecting
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`the ’745 patent’s independent claims as obvious over Patrick-Stubbs in View of
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`U.S. Patent No. 6,228,055 (“Foerster”), explaining that:
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`In regards to claim 1, Patrick et al. teach a method of partial breast
`radiation (abstract teaches treating surrounding tissue, [0001] teaches
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`15
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`treatment of disorders in the breast by positioning tissue and applying
`radiation and [0051] teaches radio opaque expandable surface 20, thus only
`partial breast irradiation) comprising the steps of:
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`targeting a radiation beam to said breast tissue surrounding the
`implant such that the radiation beam does not materially
`irradiate the whole of the breast (see citations above).
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`Although, Patrick et al. teach placing a radio-opaque implant within a
`breast, because these limitations are disclosed in the parent continuation-in-
`part cases of the present application, Patrick et al. does not qualify as prior
`art for teaching placing within a breast cavity, a substantially radio-opaque
`implant constructed of constructed of [sic] biocompatible and biodegradable
`material said implant supporting the tissue surrounding the breast cavity.
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`However, Foerster et al. teaches placing within a breast cavity, a
`substantially radio-opaque implant (col. 5, lines 63-67 and col. 1, lines 8-13)
`constructed of constructed of [sic] biocompatible and biodegradable material
`(col. 5, lines 63-67 and col. 13, lines 30-3 6) said implant supporting the
`tissue surrounding the breast cavity (wherein a implant [sic] will inherently
`support the surrounding tissue).
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`(Non—Final Office Action dated May 25, 2011 (Ex. 1008), at 4.) Even though
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`Patrick-Stubbs is § 102(b) prior art to the ’745 patent filing date, the Examiner
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`dismissed significant disclosed features of this reference because they related to
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`limitations that were “disclosed in the parent continuation-in-part cases of the
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`present application.” (Id.)
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`33.
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`The Examiner appears to have made this statement based on the single
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`shared phrase between the ’745 patent and Corbitt: “X-ray opaque or metallic
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`material for identification of the area.” (Ex. 1001 at 2:33-34; Ex. 1015 at 4:36-37.)
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`While the Examiner maintained his rejections over Patrick-Stubbs in View of
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`Foerster in a final office action, he withdrew them after the applicant filed its brief
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`on appeal. In the notice of allowance, the Examiner noted that “the parent
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`continuation-in-part inventions of the present application pre-date the filing date of
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`Patrick and teach a radio-opaque breast implant.” (Notice of Allowance dated May
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`16, 2012 (Ex. 1010), at 2-3.)
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`VIII. THE PRIOR ART
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`34.
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`Following are brief summaries of the prior art references applied
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`against the claims of the ’745 patent in this declaration. The prior art references
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`are exhibits to the accompanying Petition and are referred to in my declaration by
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`their exhibit numbers.
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`U.S. Patent Publication No. 2009/0024225 (Stubbs) (Ex. 1011 1
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`35.
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`Stubbs is a published United States patent application that claims
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`priority to a provisional application (U.S. Provisional Application No. 60/949,963
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`(Ex. 1012)) filed on July 16, 2007. I understand that, although listed in an IDS by
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`the applicant, that Stubbs was not considered on the record during prosecution of
`
`the ’745 patent. Stubbs relates to biocompatible and biodegradable implants for
`
`use in targeted external beam radiation therapy. Stubbs discloses an implant that
`
`is: (1) substantially radio-opaque (Ex. 1011 at 1[ 47 (“the surface may include in
`
`its construction a radio opaque materia ”)), (2) constructed ofbiocompatible and
`
`biodegradable materials (Id. at 1] 24 (“[t]he device can be formed of an absorbable
`
`17
`
`Focal Exhibit1017 Page17
`
`Focal Exhibit 1017 Page 17
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`
`
`material that is implanted at the time of tumor resection and requires no second
`
`procedure to remove (it dissolves in situ leaving no foreign material in the patient’s
`
`body)”)), (3) placed within a breast cavity (Id. at 1] 44 (“[f] ollowing tumor
`
`resection .
`
`.
`
`. an implant of the invention 10 is placed into the tumor resection
`
`cavity”)), (4) used to support the tissue surrounding the breast cavity (Id. at 1[ 45
`
`(“the implant occupies the tissue cavity 102 and supports the surrounding target
`
`tissue 112 until such time as it resorbs or biodegrades”)), and (5) used as a target
`
`for delivery ofradiation beam therapy to margins around the breast cavity (Id. at
`
`11 24 (“a reproducibly-shaped 3-dimensional target that is used to focus the
`
`radiation therapy treatment beams directly onto the targeted tissue—for example,
`
`the tissue surrounding a resected tumor cavity”)), such that (6) the radiation beam
`
`does not irradiate the whole breast (Id. at 11 46 (“[t]he result is a treatment method
`
`which concentrates radiation on target tissue and helps to preserve the surrounding
`
`healthy tissue”)).
`
`Applicant Admitted Prior Art (Ex. 1001 2
`
`36.
`
`In the ’745 specification, the patentee admits that the “need to aspirate
`
`air from the lumpectomy cavity” was well—known. (Ex. 1001 at 1:54-56.) Indeed,
`
`“it is desirable to aspirate or remove the air, most commonly with a syringe and
`
`needle.” (Id. at 1:59-60.)
`
`18
`
`Focal Exhibit1017 Page18
`
`Focal Exhibit 1017 Page 18
`
`
`
`. U.S. Publication No. 2008/0 1 77 1 79 g Stubbs-Edmundson) (Ex. 1013 2
`
`37.
`
`Stubbs-Edmundson is a United States patent application that was
`
`published on July 24, 2008 and claims priority to a provisional application (U.S.
`
`Provisional Application No. 60/875,776 (Ex. 1014)) filed on December 19, 2006. I
`
`understand that Stubbs-Edmundson was not cited during the prosecution of the
`
`’745 patent, and therefore was not considered by the Examiner of the ’745 patent.
`
`Stubbs-Edmundson relates to systems and methods for treating early stages of
`
`breast cancer by resecting a lesion and using an implant to enhance targeted
`
`external radiation therapies by stabilizing the tissue and serving as a target.
`
`(Ex. 1013 at 1111 22-23.) Stubbs-Edmundson discloses breast implants made of
`
`biocompatible materials that are bioabsorbable. (Id. at 11 21.) In one embodiment,
`
`the breast implant is constructed of a radio-opaque material (e.g., silicone) to
`
`facilitate the identification of the location of the implant after it is implanted into
`
`the breast. (Id. at 1] 39.) Other embodiments use radio-opaque fiducial markers
`
`that are placed on or within the breast implant to help locate the targeted tissue for
`
`radiation therapy. (Id. at 1111 25, 40.) Stubbs-Edmundson also discloses external
`
`beam radiation therapies for using one or more high energy x-rays to radiate the
`
`targeted tissue area surrounding the resected tissue cavity, including 3-D conformal
`
`radiation therapy and intensity—modulated radiation therapy. (Id. at 1111 8, 13, 5 6.)
`
`In one example, Stubbs-Edmundson discloses the method of using a radio-opaque
`
`19
`
`Focal Exhibit1017 Page19
`
`Focal Exhibit 1017 Page 19
`
`
`
`implant to improve accuracy of the external beam radiation therapy. (Id. at 111] 15,
`
`54-55, 61-62.)
`
`U.S. Patent No. 6,214,045 (Corbitt) (EX. 1015 Q
`
`38.
`
`Corbitt was patented on April 10, 2001. Corbitt relates to a
`
`bioabsorbable breast implant. I understand that Corbitt was not cited during the
`
`prosecution of the ’745 patent, and therefore was not considered by the Examiner
`
`of the ’745 patent. Corbitt teaches the use of biocompatible implants, such as
`
`those constructed with polyglycolic acid, because the biocompatible material
`
`makes the implant resorbable into the human body and tissue.
`
`(EX. 1015 at 1:58-
`
`65, 2241-47, Cls. 9, 18.) Corbitt also discloses breast implants that have a porous
`
`structure and can be used with chemotherapy. (Id. at 4:31-41.) Further, Corbitt
`
`discloses breast implants that contain “x-ray opaque or metallic material for
`
`identification of the area[.]” (Id. at 4:33-41, claims 6, -8, 11, and 24.)
`
`U.S. Patent Publication No. 2005/01 01 860 (Patrick—Stubbs) (Ex. 1016 2
`
`39.
`
`Patrick—Stubbs is a United States patent application that was published
`
`on May 12, 2005. Patrick—Stubbs was previously considered on the record during
`
`prosecution of the ’745 patent, and the Examiner found that the reference discloses
`
`most of the elements of the independent claims, including “a method of partial
`
`breast radiation therapy,” “placing within a breast cavity a substantially radio-
`
`opaque implant,” and “directing a radiation beam.” (Final Rejection dated October
`
`20
`
`Focal Exhibit1017 Page 20
`
`Focal Exhibit 1017 Page 20
`
`
`
`14, 2011 (Ex. 1009), at 2-3.) According to the Examiner, Patrick-Stubbs is only
`
`missing a biodegradable breast implant. The Examiner further found that the ’745
`
`patent improperly claimed priority to the biodegradable breast implant claim
`
`limitation, and unlike the other claim limitations, Patrick-Stubbs cannot be
`
`considered as prior art for that limitation. (Id.)
`
`40.
`
`Patrick-Stubbs relates to treating breast cancer with improved external
`
`beam radiation therapies. Patrick-Stubbs discloses systems and methods that
`
`improve the treatment of breast cancer by using radio-opaque implants to improve
`
`stability and the targeting of the desired tissue with external beam radiation
`
`therapy. (Ex. 1016 at 11 27.) Further, to improve accuracy of external beam
`
`radiation therapy, Patrick-Stubbs teaches the use of radio-opaque materials in the
`
`breast implants, such as implants constructed with silicone components or
`
`containing radio-opaque fiducial markers. (Id. at W 12, 36, 51.) Patrick-Stubbs
`
`discloses various types of external beam radiation therapies including 3-D
`
`conformal radiation therapy and intensity-modulated radiation therapy. (Id. at
`
`1111 6-7, 30, 52.)
`
`IX.
`
`PROPOSED CONSTRUCTION
`
`41.
`
`Claims 2-4 and 19-20 require the use of a “stereotactic radiation
`
`machine.” The ‘745 patent proposes “the use of external beam radiation delivered
`
`through a multidirectional stereotactic radiation source such as but not limited to
`
`21
`
`Focal Exhibit1017 Page 21
`
`Focal Exhibit 1017 Page 21
`
`
`
`the CYBERKNIFE, the BRAINLAB, and other external beam sources.” (Ex. 1001
`
`at 1:64-2:1 (emphasis added).) Further, Figure 3 of the ‘745 patent discloses “an
`
`example of multi-directional (stereotactic) radiation therapy.” (Id. at 4:58-59.) A
`
`person having ordinary skill in the art would have understood that “stereotactic
`
`radiation machine,” as used in the context of claims 2-4 and 19-20, refers to
`
`machines that provide multi-directional radiation beams, such as 3-D conformal
`
`radiation therapy and selected intensity-modulated radiation therapy machines.
`
`X.
`
`VALIDITY
`
`42.
`
`I have found that claims 1-30 are anticipated by, or obvious in View
`
`of, the prior art references discussed above separately or in combination, for the
`
`reasons discussed below.
`
`Stubbs
`
`43.
`
`Claims 1-30 are anticipated by Stubbs or obvious in view of Stubbs
`
`alone or in combination with
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