Free Declaration in Support - District Court of California - California

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F.T. Alexandra Mahaney, State Bar No. 125984 WILSON SONSINI GOODRICH & ROSATI Professional Corporation 12235 El Camino Real, Suite 200 San Diego, CA 92130 Telephone: (858) 350-2300 Facsimile: (858) 350-2399 Email: [email protected] Bruce R. Genderson (admitted pro hac vice) Aaron P. Maurer (admitted pro hac vice) Rachel Shanahan Rodman (admitted pro hac vice) Adam D. Harber (admitted pro hac vice) WILLIAMS & CONNOLLY LLP 725 Twelfth St. NW Washington, DC 20005 Telephone: (202) 434-5000 Facsimile: (202) 434-5029 Attorneys for Defendant and Counterclaimant SENORX, INC. IN THE UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA SAN JOSE DIVISION HOLOGIC, INC., CYTYC CORPORATION and ) HOLOGIC L.P., ) ) Plaintiffs, ) ) v. ) ) SENORX, INC., ) ) Defendant. ) ) ) ) SENORX, INC., ) ) Counterclaimant, ) ) v. ) ) HOLOGIC, INC., CYTYC CORPORATION and ) HOLOGIC L.P., ) ) Counterdefendants. )

Case No. 08-CV-0133 RMW DECLARATION OF COLIN G. ORTON, Ph.D. IN SUPPORT OF DEFENDANT'S OPENING CLAIM CONSTRUCTION BRIEF AND MOTION FOR PARTIAL SUMMARY JUDGMENT OF NONINFRINGEMENT

Date: June 25, 2008 Time: 2:00 p.m. Courtroom: 6, 4th Floor Judge: Hon. Ronald M. Whyte

DECLARATION OF COLIN G. ORTON, PH.D. IN SUPPORT OF SENORX INC.'S CL. CONSTR. BRIEF AND MOTION FOR PARTIAL SUMMARY JUDGMENT

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I, Colin G. Orton, Ph.D., declare that: BACKGROUND 1. The facts set forth below in this declaration are based on my personal knowledge,

and if called as a witness, I could and would testify competently to those facts. 2. I am a radiation physicist with over three decades of experience specializing in

medical radiation physics and, in particular, brachytherapy. 3. My educational and professional history are summarized in my C.V., attached as

Exhibit 1 hereto. In summary, I graduated from the University of Bristol (UK) in 1959 with a Bachelor of Science degree in Physics. I subsequently obtained a Masters' degree (1961) and Ph.D. (1965) in Radiation Physics from St. Bart's Hospital Medical College, London University. 4. From 1966 through 1975, I practiced as a Medical Radiation Physicist at NYU

Medical Center, including serving as Chief Physicist and Assistant and Associate Professor of Radiology. From 1975 through 1981, I served as the Chief Physicist at Rhode Island Hospital and as an Associate Professor of Radiation Medicine at Brown University. From 1981 through my retirement in 2003, I was the Chief Physicist and a Professor of Radiation Oncology at Harper Hospital and Wayne State University in Detroit, Michigan. 5. I am a member of several professional societies related to medical radiation

physics, including the American Association of Physicists in Medicine ("AAPM") and American Brachytherapy Society ("ABS"). I served as president of AAPM in 1981, and in 1993 I was honored to be awarded the William D. Coolidge Award by the AAPM. The Coolidge Award is AAPM's highest honor, and is presented to a member who has exhibited a distinguished career in medical physics, and who has exerted a significant impact on the practice of medical physics. In addition, I was president of the American College of Medical Physics ("ACMP") in 1985, and received the Marvin M. D. Williams Award from the ACMP, their highest award. In 2002, I served as President of ABS, and prior to that, in 1995, I received ABS's highest honor, the Ulrich Henschke Award. 6. I have never testified as an expert in a patent case and have not testified in any

other matter, as an expert or otherwise, in the last four years.
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7.

I am being compensated for my time in this matter at my usual rate of $450 per

hour, plus expenses. My compensation does not depend on the outcome of this litigation. 8. I have been asked by counsel for SenoRx, Inc. to provide testimony relating to the

three patents at issue in this lawsuit, United States Patent Nos. 5,913,813 ( '813 patent), 6,413,204 ('204 patent), and 6,482,142 ('142 patent). 9. I have been asked to address these issues from the perspective of a "person of

ordinary skill in the art." These patents are addressed primarily to radiation oncologists and radiation physicists. During the 1980s and 1990s, most of the literature, including patent literature, describing new devices in the same field came from radiation physicists or radiation oncologists. Indeed, the inventors of the patents-in-suit include both physicians and radiation physicists. The relevant scientific area is radiation oncology and radiation oncology physics. I understand that the person of ordinary skill is a hypothetical person who can have the skills of multiple individuals working together as a team. Thus, in my opinion, a person of ordinary skill in the art of radiation oncology and radiation physics for purposes of these patents would have the skills of both a radiation oncologist and a medical radiation physicist. Such a person would have a Ph.D. in Physics or Medical Physics with two or more years of clinical experience, or equivalent training and experience (e.g., less education and more experience) and/or an M.D. degree with further training and Board Certification in radiation oncology with at least two years experience practicing as a radiation oncologist, or equivalent training and experience. Such a person would have knowledge of and experience in various forms of irradiation, including external beam treatment and brachytherapy, the history and use of brachytherapy devices (including balloon brachytherapy devices) to treat tumors and tissue remaining after the surgical extraction of all or a portion of a tumor in and around both naturally-occurring and surgicallycreated cavities, the physics of brachytherapy procedures, the principles of radioactivity, and an understanding of the effect of radiation on cells. Such a person would have experience inserting and using brachytherapy devices in a variety of cavities, including the brain, breast, bladder, rectum and vagina. In addition, such a person would be familiar with remote afterloading technology, as well as available radiation sources.
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10.

Unless otherwise stated, my opinions as to the '813 and '204 patents are based on

the understanding of a person of ordinary skill in the art as of July 24, 1997, and as to the '142 patent, as of December 16, 1999. Unless stated otherwise, my opinions would be the same if I used the definition of a person of ordinary skill proposed by Dr. Verhey in his Declaration submitted in support of Plaintiffs' Motion for Preliminary Injunction in this case. My primary disagreement with Dr. Verhey's definition is that the patents are not focused only on calculating radiation profiles, the primary responsibility of radiation physicists, but also on the design and use of brachytherapy devices. Radiation oncologists who use, and often implant these devices, are an important part of the team typically involved in the conception and use of new devices, and the skills of radiation oncologists thus should be included in the definition. 11. For purposes of the opinions set forth herein, I have considered the patents-in-suit

and their prosecution histories. Further, I have examined SenoRx's ConturaTM Multi-Lumen Balloon ("Contura"), including its instructions for use. I understand Plaintiffs allege the Contura infringes the patents-in-suit. TECHNOLOGY DESCRIBED IN THE PATENTS-IN-SUIT 12. The administration of radiation within natural and surgically-created body cavities

to treat malignant tumors has been practiced for decades. When administering radiation within a body cavity, the ideal is to deliver 100% of the prescribed radiation dose to 100% of the target tissue. Where the cavity is surgically-created, such as in the brain or breast, the target tissue is usually defined as the tissue situated between the wall of the excised tissue and a specific prescribed distance beyond the wall. 13. Intracavitary radiation presents certain challenges. The absorbed radiation dose in

tissue is inversely proportional to the square of the distance between each point in the radiation source and the tissue. Because of this inverse square relationship, delivering 100% of the prescribed radiation dose to the target tissue at a distance from the cavity wall necessarily means that a dose higher than prescribed will be administered to tissue nearer to the surface of the cavity. This may result in overexposure of healthy tissue near the cavity wall.

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14.

The inventions described in the '813 and '204 patents are closely related and

attempt to solve this problem in the same way. In general, these patents describe an instrument using a radioactive source to deliver the prescribed radiation dose to the target tissue. The patents attempt to accomplish this goal, while minimizing radiation exposure above the prescribed dose to tissue close to the radiation source, by requiring an outer volume, often a balloon, which when inflated, surrounds an inner spatial volume containing the radiation source. As depicted in Figure 7 of the '204 patent, the spacing apart of the inner volume containing the radiation source from the outer volume means the very high dose of radiation close to the source is not being administered to the tissue. Ideally, the slope of the curve of dose versus distance from the source (between the wall of the cavity and the furthest point of the target tissue) would be perfectly flat so that one would deliver 100%, but never more than 100%, of the prescribed dose to the target tissue. While this is not possible, the use of a balloon to space apart the radiation source from the wall of the cavity allows the dose to be delivered to tissue in the flatter portion of the curve shown in Figure 7D. This concept was well known by radiation physicists and oncologists for decades prior to the filing of the patents-in-suit and is a basic concept that I taught to my students when I began teaching the principles of brachytherapy in 1966. 15. Further, the inventions also seek to ensure uniformity of dosing to the target tissue

at points equidistant from the surface of the balloon by requiring that the source is centered within the body cavity. The patents achieve this by requiring that the distance from the wall of the inner spatial volume to the wall of the outer volume be constant over their entire surfaces. That is, the two volumes described in the patents must be the same shape. They also must share the same center and have the same orientation ("concentric"). As discussed in greater detail below, in this way the invention ensures the radiation dose to the target tissue is uniform at all points the same distance from the outer balloon. 16. The '142 patent, on the other hand, claims a device producing a radiation profile

that is asymmetric with the outer volume. This is accomplished by requiring the radiation source either to be a different shape than the outer volume or to be placed within the apparatus asymmetrically (i.e. not in the center of the outer volume).
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THE CONTURA I have been asked by counsel for SenoRx to examine its Contura product. The

Contura is a balloon catheter device for delivering radiation therapy to the surgical margins following lumpectomy for breast cancer. I have worked with interstitial and intracavitary brachytherapy devices to deliver radiation since 1966. Referring to Exhibit 2, the balloon is labeled "A." The balloon is attached to the end of a catheter body, labeled "B." There are a number of lumens that run through the catheter body from one end of the Contura (the proximal end, "C") through to the other end (the distal end, "D"). Five of these lumens are designed to have a radiation source inserted into them; one is positioned in the center of the catheter body, and the other four are offset from the center lumen, and spaced at 90 degree increments (so that one is located above, one below, and one to either side of the central lumen). Another lumen connects to a vacuum port at the far end of the device, assisting physicians in conforming the walls of the lumpectomy cavity to the balloon by removing air and liquids from the cavity. A final lumen connects to the polyurethane balloon, and allows the balloon to be inflated and deflated. 18. In use, the device is inserted into a lumpectomy cavity of a woman, where the

balloon portion is inflated with a contrast fluid. A CT scan of the device in situ is then made, and a radiation oncologist and radiation physicist determine how best to deliver radiation to the patient. Typically, the treatment plan seeks to deliver the prescribed radiation dose (usually 34 gray or "Gy") and dose distribution to target tissue at a predetermined depth (usually 1 cm). The treatment plan also seeks to minimize radiation to particularly sensitive tissues such as the skin, ribs and lungs. This is typically accomplished with the Contura by the use of multiple dwell positions in multiple lumens for different lengths of time. 19. After a dose plan is optimized and approved, an afterloader is connected to the

catheter by the lumen(s) at the proximal end of the device. Afterloaders used with the Contura are shielded machines containing a single radiation source, generally Iridium ("Ir") 192. The radiation source used with the Contura is cylindrically shaped. The radiation source is inserted sequentially by the afterloader into multiple lumens of the Contura, although a single lumen
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could be used on occasion. Radiation is delivered at precise locations along the distal end of each lumen by pausing and moving the radiation source according to the dose plan. The radiation source is withdrawn back into the afterloader after each treatment is delivered along a single lumen. Treatment with the Contura typically takes approximately five treatment days, after which the device is surgically removed from the patient. MEANING OF THE DISPUTED CLAIM TERMS IN THE PATENTS-IN-SUIT 20. I have been asked to discuss, from the viewpoint of a person of ordinary skill in

the art, the meaning of certain claim terms in the '813, '204 and '142 patents. My opinion of the meaning of each of these claim terms as they would be understood by a person of ordinary skill in the art is set forth below. A. 21. Inner Spatial Volume ('813 Claim 1, '204 Claim 1) I understand the Court in a prior litigation concerning the '813 and '204 patents

provided the following construction of inner spatial volume: "A region of space surrounded by an outer spatial volume that is either enclosed by a polymeric film wall or defined by the outside surface of a solid radionuclide sphere." 22. I agree with the Court's definition with one exception. It is my opinion the

polymeric walls described in the '813 and '204 patents must be distensible. The patents disclose that the inner spatial volume either is a volume defined by a polymeric film wall or a solid spherical radionuclide. The specifications and preferred embodiments only describe polymeric walls that are distensible. See, e.g., '813 Abstract; '204 patent, col. 2:56-60. 23. I agree with the Court that the '813 and '204 patents require the solid radionuclide

to be spherical. The specifications and preferred embodiments only describe spherical, solid radionuclides. See '813 patent, col. 2:59-60, fig. 5; '204 patent, col. 4:44-48, figs. 3, 4. And, given that the outer balloon is generally spherical, a spherical radionuclide is required to maintain constant spacing between the surfaces of the inner and outer volumes of the device. Even more importantly, a non-spherical radionuclide disposed in a spherical balloon will not achieve a dose distribution that is the same at all points equidistant from the surface of the outer balloon, as required by the claims, both because of anisotropy (i.e. self-absorption of radiation in
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a non-spherical source), and because some parts of the radiation source would be closer to tissues in some directions, but further from tissues in other directions.1 24. Finally, even if the solid radiation source were non-spherical and the same shape

as the outer surface, it would be unlikely to produce an isodose profile that matched the shape of the outer surface. As a person of ordinary skill in the art would understand, anisotropy of nonspherical solid radiation sources causes the radiation source itself to absorb more radiation in the longitudinal direction than other directions, resulting in an isodose profile that is different in different directions. Thus, the person of ordinary skill in the art would understand the patents to require that the solid inner spatial volume embodiment must be spherical. B. 25. Predetermined Spacing ('813 Claim 1, '204 Claim 3) Claim 1 of the '813 patent requires "predetermined constant spacing" between the

inner spatial volume and the wall of the outer chamber. Likewise, claim 3 of the '204 patent requires "predetermined spacing" between the inner spatial volume and the surface of the outer spatial volume. Although the claim language is different, based on my review of the specification, it is my opinion these terms require the same thing for each patent: fixed spacing, predetermined before administering radiation, between the surfaces of the inner and outer volumes such that, when inflated, the distance from the closest point on the wall or edge of the inner chamber to the closest point on the outer chamber is the same. Put another way, a person of ordinary skill in the art would understand the '813 and '204 patents to require the inner spatial volume to be the same shape and concentric with the outer volume. 26. The specifications for the '813 patent and '204 patent make clear the invention

requires constant spacing between the surfaces of the inner and outer volumes, see '813 Abstract; '813 patent, col. 1:55-57; '204 patent, col. 5:22-27, as do the drawings of the preferred embodiments, see '813 patent, figs. 1, 3; '204 patent, figs. 1, 5. Indeed, the '813 Abstract describes the walls of the two chambers as being "concentric" (for spherical chambers) and

Solid radionuclide sources are only described with respect to spherical outer balloons. See, e.g., '813 patent, fig. 3; '204 patent, fig. 5.
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"spaced equidistant over the entire surfaces thereof" (for non-spherical chambers). This means the two spaces must be concentric and the same shape. 27. Moreover, one of the purposes of the inventions is to create a uniform dose

distribution at points equidistant from the outer surface of the balloon. This necessarily requires concentric volumes of the same shape. If the inner spatial volume containing the radiation source is a different shape than the outer volume or off-center within the outer volume, some portion of the target tissue will receive less radiation than prescribed (cold spots), and other portions of the tissue will receive more radiation than prescribed (hot spots). Thus, the absorbed dose in the target tissue will not be substantially uniform at points equidistant from the surface of the outer chamber. To obtain the desired uniformity using the teachings of these patents, the distance between the wall of the inner spatial volume and the wall of the outer volume necessarily must be fixed and constant as claimed. Thus, a person of ordinary skill in the art would understand "predetermined constant spacing" in the '813 patent and "predetermined spacing" in the '204 patent to mean the inner spatial volume and outer volume are the same shape and concentric. 28. A person of ordinary skill in the art would read "predetermined spacing" of the

'204 patent, claim 3 to require constant spacing for the additional reason that claim 3 further requires a three-dimensional isodose profile that is substantially similar in shape to the expandable surface element. For the reasons discussed in paragraphs 49-51 below, it is clear that this limitation is only satisfied by the invention of the '204 patent if the spacing is "constant." 29. Consistent with my definition described in paragraph 25 above, "spacing"

between two objects means the distance between the two closest points on the objects. The definition proposed by Plaintiffs that the spacing is "constant in all directions" for the spherical embodiment is imprecise. The spacing from any point on one surface is not the same to all points on the other surface. If Plaintiffs mean by "constant in all directions" the same concept as I discuss in paragraph 25, my proposed definition is more precise and will avoid confusion. 30. Plaintiffs also propose that, when the outer chamber is non-spherical, the spacing

is "constant along a radial plane." That construction is also flawed. First, the term "radial plane"
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is imprecise and subject to confusion. I assume that Plaintiffs are referring to planes perpendicular to the longitudinal axis of the non-spherical outer balloon, but there are an infinite number of radial planes that could be constructed. Nowhere does the patent say the spacing needs to be constant only along a single plane ­ let alone a radial plane. In addition, the spacing between the surfaces of the inner and outer volumes can be constant along a radial plane, but result in an isodose profile that is not the same in the target tissue at points equidistant from the outer surface of the balloon. As illustrated below, for example, the distance between the surfaces of a spherical inner volume containing the radiation source and a cylindrical outer volume can be constant along each specific radial plane, but the resulting isodose profile would not give the same dose to all tissue equidistant from the outer surface of the balloon, and would not create a dose profile substantially similar to the shape of the outer volume.



31.

Because both the '813 and '204 patents require constant spacing, the person of

ordinary skill in the art would understand the patents also to require the spacing to be fixed and unchanging. The outer balloon is fixed once it is inflated. As a result, the distance between the outer balloon and the inner spatial volume can remain constant only if the inner spatial volume also remains fixed and unchanging during dosing. See '813 patent, col. 3:6-9; '204 patent, col. 5:10-12 (both requiring "exact positioning" of "individual radiation sources"). 32. Thus, it is my opinion the person of ordinary skill in the art would understand the

claim term "predetermined constant spacing" and "predetermined spacing" between the inner spatial volume and the radiation transparent wall or expandable surface element to mean fixed spacing, predetermined by one skilled in the art before administering radiation, between the wall
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or edge of the inner spatial volume and the wall of the outer chamber, when inflated, which for each point on the wall or edge of the inner spatial volume, the distance to the closest point on the outer chamber is the same (i.e., the inner spatial volume and outer chamber have the same shape and are concentric). 33. I understand Plaintiffs have made various contentions regarding why the Contura

infringes the '813 and '204 patents. I understand Plaintiffs contend the portion of each of the five treatment lumens inside the Contura balloon is an inner spatial volume, that the five treatment lumens and the area within the balloon between and surrounding the five treatment lumens constitutes the inner spatial volume, and that the radionuclide is an inner spatial volume. Even if this is correct (and I disagree that any of these three alternatives are inner spatial volumes), in my opinion, the Contura still would not satisfy the "predetermined constant spacing" and "predetermined spacing" elements of the '813 and '204 patents as I have construed those claim elements. 34. First, none of the Contura lumens are arranged so that their entire surfaces are the

same distance from the outer balloon. Because they are arranged roughly parallel to the longitudinal axis of the device, the distance from the surface of the lumen to the surface of the balloon changes as one moves down the axis. Thus, they are not arranged to have the same spacing as required by the claim element. In addition, none of these lumens have the same shape as the surface of the outer balloon when inflated. Therefore, there is no "predetermined constant spacing" or "predetermined spacing" between the inner spatial volume and the outer balloon. Moreover, the four offset lumens do not share a common center with the outer balloon, and thus there is no "predetermined constant spacing" or "predetermined spacing" between each of the four offset lumens and the outer balloon. 35. Second, the irregular, unbounded region within the balloon between and

surrounding the five "treatment" lumens similarly has a different shape from the outer balloon and is not spaced a constant distance from the outer balloon. Therefore, there is no "predetermined constant spacing" or "predetermined spacing" between this region and the outer balloon.
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36.

Third, the radionuclide source (Ir-192) used with the Contura is cylindrical, not

spherical. As a result, it is not the same shape as the Contura's spherical balloon, and the "predetermined constant spacing" or "predetermined spacing" limitation is not met. Further, the Contura also does not meet this limitation because the radionuclide source used with the Contura is not fixed. The radionuclide, as used by physicians with the Contura, is moved to multiple dwell positions during treatment. In addition, four of the Contura's lumens are offset from the center, and thus a radionuclide source placed within them would not be concentric with the outer balloon. As for the central lumen, it has multiple dwell positions, only one of which is centered within the outer balloon. C. 37. Means . . . For Rendering Uniform ('813 Claim 1) Claim 1 of the '813 patent requires a "means disposed in the other of the inner

spatial volume and outer chamber for rendering uniform the radial absorbed dose profile" generated by the radiation source. The means for performing this function is either "a low radiation absorbing material, e.g., air[,] or even a more absorptive material, such as an x-ray contrast fluid." '813 patent, col. 1:60-62. Unlike Ir-192 (the source used with the Contura), some of the radiation sources identified in the '813 patent are low enough energy sources for which x-ray contrast fluid or other radiation absorbing or attenuating material can significantly affect the dose versus distance curve at higher concentrations. See '813 patent, col. at 2:51-55, 3:42-8 (mentioning I-125, Y-90 and Yb-169). The person of ordinary skill in the art would understand this claim language to mean that radiation absorbing or attenuating materials cause the absorbed dose to be significantly2 more uniform between the surface of the outer chamber and the target tissue by absorbing or attenuating radiation.

The claim itself uses the word "uniform" without qualification. The person of ordinary skill would understand that it would be virtually impossible to render the dose versus distance curve completely flat between the edge of the balloon and the predetermined depth in the target tissue, but as explained in this section, it is possible to render the profile significantly more uniform. Thus, in my opinion, the person of ordinary skill would understand the term to mean significantly more uniform.
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38.

This interpretation is further required by the embodiment described at col. 3:51-65

of the '813 patent, in which the radiation source is in the outer volume and the radiation absorbing material is in the inner volume. In this embodiment, which is within the scope of claim 1, the radiation attenuating material is not used to space apart the radiation source from the tissue, but to attenuate the amount of radiation delivered to the tissue. Indeed, the patent already teaches spacing apart the inner and outer chambers in a different claim element ­ claim 1(c). Claim 1(e), on the other hand, would be understood by a person of ordinary skill in the art to teach that the structure described in the patent ­ radiation absorbing or attenuating material ­ performs the function of rendering the dose significantly more uniform by absorbing or attenuating radiation. D. 39. Inner Closed Chamber ('813 Claim 2) A person of ordinary skill in the art would understand the term "inner closed

chamber" to mean an inner chamber completely closed off within the outer, closed, inflatable chamber. E. 40. Plurality of Solid Radiation Sources ('813 Claim 12, '204 Claim 17, '142 Claim 6) A person of ordinary skill in the art would understand "plurality of solid radiation

particles" and "plurality of radioactive solid particles" as used in the patents-in-suit to mean two or more separate radioactive solid particles placed in the inner spatial volume at the same time. 41. This is the clear meaning of "plurality" to a person of ordinary skill in the art.

Such a person would not understand "plurality of solid radiation sources" to include a single solid radionuclide, and the patents expressly distinguish between a single solid sphere and a plurality of radioactive particles. See, e.g., '813 patent, col. 2:64-66; '204 patent, col. 5:1-4; '142 patent, col. 2:65-67, 3:7-10. 42. The person of ordinary skill in the art would also understand that the claim term

requires that the multiple radiation sources be present in the device at the same time. For example, claim 6 of the '142 patent provides that the plurality of radiation sources are on at least two elongate members (described as wires or rods) extending into the apparatus volume. This
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would be understood to mean the radiation sources were on at least two such wires at the same time. Further, the '142 specification teaches that the "resulting asymmetric isodose curve 40 can be further tailored by using solid radioactive particles 36 having differing specific activities to achieve the desired dosing." See '142 patent, col. 5:32-35 (emphasis added). The person of ordinary skill in the art would understand from this that the multiple radiation sources would be in the device at the same time. The only reason to use solid radiation sources with "differing specific activities" would be because they were used at the same time. A single solid radionuclide inserted sequentially would have the same specific activity each time it was inserted. 43. The specifications of the '204 and '813 patents teach the same thing. Both refer

to "plurality of radiation emitting particles" that are "mounted on the distal ends of a plurality of wires . . . and exit a plurality of ports" and explain that the particular "arrangement allows the exact positioning of the individual radiation sources 44 to be positioned so as to generate a desired resultant profile." See '204 patent, col. 5:6-12 (emphasis added); '813 patent, col. 3:3-9 (emphasis added). A person of ordinary skill would understand from this that the term "plurality" refers to multiple "individual radiation sources" positioned at the same time so that their combined radioactive activity creates a "resultant" isodose profile. 44. The person of ordinary skill would not consider a single source which is moved

around inside the inner spatial volume to be a "plurality" of radiation sources. Such a person would understand "plurality" to exclude "one" source. Indeed, such a person would recognize that the inventors went out of their way to distinguish between a single source and the use of multiple sources at the same time. The invention focuses on the use of fixed sources and constant spacing to accomplish the goals of the inventions described in the patents. A device that had a single source that was moved around in the inner spatial volume would be viewed by a person of ordinary skill as a very different approach from the invention described in the patentsin-suit, where radiation is administered by two or more sources simultaneously. 45. My opinion that the invention described in the patents-in-suit does not include

moving a single source around in the inner spatial volume is further supported by the fact that
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afterloaders had been available since at least the early 1990s to move a single radiation source to multiple dwell positions inside a catheter, as, for example, in gynecological oncology use. The person of ordinary skill in the art would have been aware of this use of afterloaders, and would have concluded from the description in the patents and the use of the term "plurality" that the claims did not encompass this known use of moving a single radionuclide source into different positions, and that the invention was attempting to solve the problems of obtaining desired isodose curves by instead using multiple radiation sources in fixed positions at the same time. Indeed, at the time of filing of the '142 and '204 patent applications, the inventors themselves were aware of afterloaders that had the ability to insert solid radiation particles into a brachytherapy apparatus. See '142 patent, col. 5:8-10 ("solid radiation emitting material 36 can be inserted through lumen 14 on a wire 34, for example using an afterloader"); '204 patent, col. 4:54-56. 46. The Instructions For Use for the Contura state that the Contura is compatable with

the VariSource 200, VariSource ID, and Nucletron HDR afterloaders and the GammaMedPlus afterloader. None of these afterloaders can place more than one radiation source into the Contura device at any one time. To my knowledge, none of the commercially available afterloaders in the United States today are capable of placing more than one radiation source at a time. 47. As used by physicians, the Contura device utilizes only one radioactive solid

source. In fact, a single source is almost always used for the entire treatment of an individual patient. The existing afterloaders used with the Contura are able to hold only one source at a time. Each radiation source remains in the afterloader for approximately 90 days before it is replaced, which is far longer than the duration of a course of Contura therapy. 48. In my opinion, the Contura device as used by physicians does not satisfy the

"plurality" limitation of '813 claim 12, '204 claim 17 or '142 claim 6. F. 49. Three-Dimensional Isodose Profile That Is Substantially Similar in Shape to the Expandable Surface Element ('204 Claim 1) Claim 1 of the '204 patent claims a radiation source disposed in the inner spatial

volume "generating a three-dimensional isodose profile that is substantially similar in shape to
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the expandable surface element." A person of ordinary skill in the art would understand this phrase to mean the final resulting isodose profile is substantially similar in shape to the outer spatial volume expandable surface and is concentric with the outer spatial volume expandable surface. 50. Radiation dosing is almost always administered in "fractions" or individual doses.

Before delivering the first fraction, the radiation physicist typically determines the isodose distribution, which reflects the final, cumulative dose of radiation delivered to the patient at different distances in all directions. The patent claim uses the term "isodose profile" to mean this isodose distribution. This isodose profile is then used to determine a treatment plan, in which each fraction typically delivers the same dose distribution. The isodose profile, therefore, represents the sum of the fractions, which is the final, cumulative dose of radiation administered from the apparatus. The specification describes the dose to be delivered as the "absorbed dose," '204 patent, col. 2:46-48, and the person of ordinary skill in the art would understand this to mean the "final" or total resulting dose from the delivery of radiation to the tissue. For example, the specification discusses achieving a "predetermined dose range" in the target tissue, which is the dose "between a minimum prescribed absorbed dose for delivering therapeutic effects to tissue that may include cancer cells, and a maximum prescribed absorbed dose above which healthy tissue necrosis may result." '204 patent, 2:46-55; see also, e.g., '204 patent, 2:21-26 ("It is desirable to keep the radiation that is delivered to the tissue in the target treatment region within a narrow absorbed dose range . . . ."). The person of ordinary skill in the art would understand this to be referring to the final, cumulative absorbed dose, and thus would understand the term "isodose profile" to mean the profile created from the total dose of radiation delivered by the device. 51. From my review of the specification and prosecution history, the inventors clearly

defined what isodose profile meets the "substantially similar in shape" limitation ­ one that is substantially similar in shape and concentric with the surface of the outer volume. See '204 patent, col. 2:21-26, 2:46-55, 5:13-19. For example, the specification states that:

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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 53.

As illustrated in Fig. 5, it is not essential to the invention that the volumes 30 and 34 have spherical walls, so long as the resultant dosing profile is consistent with the shape of the outer volume 34. That is, the absorbed dose within the target tissue at points equidistant from the surface 36 of the outer spatial volume 34 should be substantially uniform in substantially every direction. '204 patent, col. 5:13-19. A person of ordinary skill in the art would necessarily understand that to accomplish an absorbed dose distribution within the target tissue that is uniform in every direction at points equidistant from the surface of the outer spatial volume, the isodose profile must be both the same shape and concentric with the outer expandable surface. See also, supra, § B. 52. The applicants' statements in the prosecution history make this requirement even

clearer. In the prosecution history, the inventors distinguished U.S. Patent No. 5,429,582 (the "Williams '582 patent") by stating that the two balloons in the apparatus of Figure 7 were not "equally spaced apart," and therefore could not generate an isodose profile that has "substantially the same shape as the outer element." December 20, 2000 Am. to '204 patent at 15-16. Figure 7 of the Williams '582 patent is shown below:

Figure 7 of the Williams '582 patent has an inner and outer balloon of the same

shape, but the inner balloon is asymmetrically located within the outer balloon. A person of ordinary skill in the art would understand that the isodose profile generated by this arrangement would be the same shape as the outer spatial volume, but would not be concentric with the outer spatial volume. As a result, such a person would understand the only reason the applicants could assert that the isodose curve created in Figure 7 was not "substantially the same shape as the
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outer element" is that the isodose curve would not be concentric with respect to the outer spatial volume. As such, a person of ordinary skill in the art would understand "substantially the same shape as the outer element" to require an isodose curve that is both the same shape as and concentric with the outer spatial volume. G. 54. Controlled Dose To Reduce or Prevent Necrosis ('204 Claim 2) Claim 2 of the '204 patent specifically refers to "reduce or prevent necrosis." A

person of ordinary skill in the art would understand the term to have the meaning proposed by SenoRx: controlling the ratio of the dose at the expandable surface of the outer spatial volume to the prescribed dose at the depth of interest in the target tissue so as to reduce or eliminate the risk of damage to healthy tissue in contact with the expandable surface as compared to devices in which the tissue is directly adjacent to the radiation source. The construction proposed by Plaintiffs would require avoiding any death to cells in healthy tissue, which is inconsistent with how a person of ordinary skill would understand "reduce or prevent necrosis in healthy tissue" within the meaning of the claim. H. 55. Apparatus Volume ('142 Claim 1) Claim 1 of the '142 patent discloses an instrument comprising "an expandable

outer surface defining a three-dimensional apparatus volume configured to fill an interstitial void created by the surgical extraction of diseased tissue and define an inner boundary of the target tissue being treated." A person of ordinary skill in the art would understand "apparatus volume" as it is plainly described in claim 1: a three-dimensional region of space within the expandable outer surface that completely fills the void created by surgical removal of the tumor. This is how the term is explicitly defined in the claim itself. 56. SenoRx's proposed construction of apparatus volume is consistent with the last

clause of the claim term: "define an inner boundary of the target tissue being treated." The "volume" defined by the expandable outer surface itself defines the boundary of what is outside the volume ­ here the target tissue being treated. Thus, it is perfectly consistent with my understanding of the claim's definition of "apparatus volume" that the apparatus volume also defines the inner boundary of the target tissue being treated ­ that boundary is the outside surface
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of the volume. Because the volume is itself defined by the expandable outer surface, it necessarily follows that the expandable outer surface also could be said to define the inner boundary of the target tissue. 57. I understand Plaintiffs propose that "apparatus volume" means "a three-

dimensional geometric solid composed of an expandable outer surface." That term is not found in the patent and would not provide any guidance to a person of ordinary skill in the art as to what is encompassed by the claim term. Plaintiffs' construction is also at odds with the claim language and specification, which consistently and repeatedly refer to the apparatus volume as just that ­ a volume of space into which radiation sources are inserted. See, e.g., '204 patent, claims 1, 6; col. 3:1-11. A person of ordinary skill in the art would understand that while the "expandable outer surface defin[es] a three-dimensional apparatus volume," the "expandable outer surface" and the "three-dimensional apparatus volume" are different things. To conflate the surface with the volume, as Plaintiffs do in their proposed construction, in my opinion would read out of the claim altogether the explicit definition of "apparatus volume" as a volume that fills the interstitial void. It would also essentially define a surface to be a volume, which is inconsistent with basic principles of geometry as would be understood by the person of ordinary skill. I. 58. Located So As To Be Spaced Apart from the Apparatus Volume ('142 Claim 1) The phrase "located so as to be spaced apart from the apparatus volume" would

be understood by a person of ordinary skill in the art to mean the radiation source must be located outside of, and not within, the apparatus volume. J. 59. Asymmetrically Located and Arranged Within the Expandable Surface ('142 Claim 1) Claim 1 of the '142 patent requires the radiation source to be "asymmetrically

located and arranged within the expandable surface." A person of ordinary skill in the art would understand this phrase to mean the radiation source cannot be concentric with the expandable outer surface. I understand that Plaintiffs seek to define "asymmetrically located and arranged" to mean asymmetric with respect to the longitudinal axis of the device. Claim 1, however, does
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not reference the longitudinal axis, nor would a person of ordinary skill in the art import that limitation into the claim. Instead, claim 1 states the asymmetry is with respect to the arrangement of the radiation sources anywhere within the expandable surface, indicating to a person of ordinary skill in the art that the radiation sources must be off-center within the expandable surface. K. 60. Predetermined Asymmetric Isodose Curves ('142 Claim 1, 6) Claims 1 and 6 of the '142 patent require the invention to produce "predetermined

asymmetric isodose curves." A person of ordinary skill in the art would understand that phrase to mean isodose curves that are not substantially the same shape as the apparatus volume and/or not concentric with the apparatus volume. 61. Plaintiffs again seek to construe "asymmetric" to mean asymmetric with respect

to the longitudinal axis of the apparatus volume. But neither claim 1 nor claim 6 references the longitudinal axis when describing the isodose curves, nor would a person of ordinary skill in the art import that limitation into the claims. Claim 1 states the invention provides predetermined asymmetric isodose curves "with respect to the apparatus volume," and claim 6 states the predetermined asymmetric isodose curves are provided "within the target tissue." Plaintiffs' construction is also at odds with the patent's preferred embodiments. Figures 3A and 4 are clearly intended to represent "asymmetric isodose curves." See '142 patent, figs. 3A and 4; col. 6:30-40, 6:52-63; see also '142 patent, col. 2:56-3:11. This is consistent with SenoRx's proposed construction because the profiles are not the same shape as the apparatus volume. Plaintiffs' construction, however, conflicts with the specification. Because Figures 3A and 4 depict isodose profiles that are symmetric with respect to the longitudinal axis of the apparatus volume, Plaintiffs' proposed construction would render the isodose curves in these embodiments symmetric. L. 62. Being Provided On At Least Two Elongate Members Extending into the Apparatus Volume ('142 Claim 6) Claim 6 of the `142 patent provides that the plurality of radiation sources are

"provided on at least two elongate members extending into the apparatus volume." This phrase means the radiation sources are attached to at least two separate elongate members ­ e.g., wires
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or rods ­ that are contained within the outer surface at the same time. See, e.g., '142 patent, Figs. 3 and 4. 63. A person of ordinary skill in the art would understand the term "provided on . . .

elongate members" to mean the radiation sources are physically attached to the elongate members. This construction is consistent with the plain meaning of the claim, each embodiment of the '142 patent containing a plurality of radiation sources on elongate members, and the specification. //

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1 2 3 4

I declare under penalty of perjury that the foregoing is true and correct.

Dated: May 21, 2008 Colin G. Orton, Ph.D.

5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28
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Exhibit 1

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Date of Preparation: 5/21/08 COLIN GEORGE ORTON, Ph.D.

Address:
15810 Lakeview Court Grosse Pointe Park, MI 48230 Telephone: (313) 823-8079 E-mail: [email protected]

Personal Data:
Place of Birth: Date of Birth: Marital Status: Citizenship: London, England June 4, 1938 Married U.S.

Education:
1956-1959 1959-1961 1961-1965 University of Bristol, B.Sc. (Hons.) Physics University of London, M.Sc. Radiation Physics University of London, Ph.D. Radiation Physics

Faculty Appointments:
1959-1961 1961-1966 1966-1971 1971-1975 1973-1975 1975-1981 1981-2003 Research Physicist, St. Bartholomew's Hospital Medical College, London University Instructor, St. Bartholomew's Hospital Medical College, London University Assistant Professor of Radiology, NYU Medical Center Associate Professor of Radiology, NYU Medical Center Adjunct Professor, Biology Dept., Fairleigh Dickinson University, Madison, New Jersey Associate Professor, Section on Radiation Medicine, Div.of Biological and Medical Sciences, Brown University Professor, Radiation Oncology and Radiology, Wayne State University School of Medicine, Detroit, MI (Professor Emeritus, 2003 - )

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HOSPITAL OR OTHER PROFESSIONAL APPOINTMENTS:
1966-1975 1969-1975 1975-1981 1977-1979 1980-1981 1981-2003 1981-2000 1981-2003 1982-2000 1982-2000 1982-2000 1984 1985- 2003 2000-2003 Senior Physicist, New York University Medical Center Consultant, Morristown Memorial Hospital, Morristown New Jersey Chief Physicist, Rhode Island Hospital, Providence, RI Medical Staff, Women and Infants Hospital, Providence, RI Medical Staff, Rhode Island Hospital Chief Physics Division, Radiation Oncology Center, Harper-Grace Hospitals, Detroit, MI Associate Medical Staff, Harper-Grace Hospitals, Detroit, MI Professional Staff, Radiation Oncology Research and Development Center, Harper Hospital, Detroit, MI Associate Medical Staff, Hutzel Hospital, Detroit, MI Associate Medical Staff, Children's Hospital, Detroit, MI Associate Medical Staff, Detroit Receiving Hospital, Detroit, MI Acting Director, Radiological Physics Graduate Program, Wayne State University School of Medicine, Detroit, MI Director, Medical Physics Graduate Programs, Wayne State University School of Medicine, Detroit, MI Associate Staff, Detroit Medical Center

MAJOR PROFESSIONAL SOCIETIES:
American Association of Physicists in Medicine, (President, 1981) American Institute of Physics British Institute of Radiology Institute of Physics & The Physical Society, London Health Physics Society American Society of Therapeutic Radiology and Oncology American Brachytherapy Society (Treasurer, 1998-1999, Secretary, 1999-00, President- Elect, 2000-01, President, 2001-02).

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International Organization for Medical Physics (Secretary-General, 1988-94; PresidentElect, 1994-97, President, 1997- 2000, Past-President, 2000-2003) Great Lakes Chapter, AAPM Great Lakes Chapter, HPS (President, 1983-84) American College of Medical Physics (Chairman, 1985) European Society of Therapeutic Radiology and Oncology American College of Radiology Michigan Radiological Society Radiation Research Society Michigan Society of Therapeutic Radiology Int'l Union of Physical and Engineering Sciences in Medicine (President, 2003-06) Radiological Society of North America

BOARD CERTIFICATION:
1983 1989 American Board of Radiology (Therapeutic Radiological Physics) American Board of Medical Physics (Radiation Oncology Physics)

HONORS AND AWARDS:
1976 1976 1987 1988 1989 1989 1991 1993 1993 1993 1995 1995 1997 1998 1998 1999 1999 1999 2003 Elected Fellow of the Institute of Physics & The Physical Society Awarded MA (ad eundem), Brown University Marie Curie Gold Medal Award, HPS Great Lakes Chapter Solomon Padam Singh Annual Orator, Calcutta, India Elected Fellow of the American College of Medical Physics Elected Fellow - American Assoc. of Physicists in Medicine Elected Honorary Member, Romanian Medical Physicists Association Elected Fellow of the American College of Radiology Oettlé Memorial Lecturer, The Cancer Association of South Africa William D. Coolidge Award, American Association of Physicists in Medicine Hartman Orator, American College of Medical Physics Ulrich Henschke Lecturer, American Brachytherapy Society Marvin M.D. Williams Professional Achievement Award, American College of Medical Physics 1998 Giaoacchino Failla Memorial Lecturer, Radiological and Medical Physics Society Ramaiah Naidu Oration, Association of Medical Physicists of India, New Delhi Keynote Speaker, Radiology 1999, Birmingham, UK (May 1999) Nagalingam Suntharalingam Annual Orator, Philadelphia (May 1999) Eastman Kodak Annual Memorial Lecturer, Rochester, NY (October 1999) Award of Merit, Int'l. Union of Physical and Engineering Sciences in Medicine

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SERVICE:
Professional Consultation 1976-1979, 1981 Coordination Consultant, Centers for Radiological Physics

Journal/Editorial Activity 1971-1973 1971-1973 1974-1976 1978-1986 1980-1987 1980-1986 1982-1985 1984 1985-1988 1987-1995 1991199219951997-2004 1997-2004 Editor, Bulletin of the American Association of Physicists in Medicine Member, Editorial Board, American Institute of Physics Associate Editor, Medical Physics Editor, Progress in Medical Radiation Physics (Plenum Publishing Corp.) Associate Editor, Int. Journal of Radiation Oncology Biology Physics Board of Editors, Encyclopedia of Physics in Medicine and Biology Associate Editor, Medical Physics World Editor, Bulletin of the American College of Medical Physics Editor, Medical Physics World Board of Editors, International Journal of Radiation Oncology, Biology, Physics Editor (North America), IOPP Medical Science Series Editorial Board, Radiation Oncology Investigations Advisory Board, International Journal of Radiation Oncology Biology Physics Editor, Medical Physics Medical Physics Board of Editors (Chairman)

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Chairman, AIP Advisory Committee on Serials Associate Editor, Brachytherapy Moderator, Medical Physics Point/Counterpoint Series

National and International Boards and Committees 1968-1970 1969-1973 1970-1972 1970-1973 1980-1982 1971-1974 1972-1976 1974-1975 1974-1975 1974-1977 1974-1977 1974-1984 1975-1976 1975-1978 1976 Radiological and Medical Physics Society RAPHEX Committee (Chairman, 1970) Member, Board of Directors, Radiological & Medical Physics Society, New York (Chairman, 1970-1972) President, Radiological & Medical Physics Society Member, Board of Directors, American Association of Physicists in Medicine American Association of Physicists in Medicine, Budget and Finance Committee American Association of Physicists in Medicine, Journal Editorial Committee Radiological and Medical Physics Society, Radiotherapy Committee Uranium Filter Review Committee (Varian) American Association of Physicists in Medicine, Chairman, Computer Applications Committee American Association of Physicists in Medicine, Science Council Coordinating Committee for the New York Center for Radiological Physics (CRP) American Association of Physicists in Medicine, "Medical Physics" Review Committee New England Society of Radiation Oncology, Committee on Basic Science Practice (Chairman, 1977-78) Dartmouth-Hitchcock Medical Center-Scientific Review Committee

Case 5:08-cv-00133-RMW Colin G. Orton, Ph.D. Curriculum Vitae Page 6 1976-1977 1976-1978 1976-1978 1976-1979 1976-1979 1976-1979 1977-1978 1977-1978 1977-1979 1977-1981 1978 1978-1979 1978-1981 1979-1981 1979-1982 1980 1980-1981 1980-1982 1981

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CRP Task Group on Leukemia and Lymphoma Dosimetry Protocol CRP Subcommittee on International Activities American Association of Physicists in Medicine, New England Chapter, Nominations Committee Physics Today Advisory Committee American Association of Physicists in Medicine, Publications Committee CRP Subcommittee on Evaluation (Chairman) Member, Board of Directors, AAPM New England Chapter Member, Executive Committee, New England Society of Radiation Oncology CRP Report Series Subcommittee American Association of Physicists in Medicine, New England Chapter, Scientific Committee AAPM Farrington Daniels Awards Subcommittee CRP Coordination Program Budget Committee American Association of Physicists in Medicine, New England Chapter, Educational Committee Executive Committee, Center for Energy Studies, Brown University Bureau of Radiological Health, Mammographic Phantom Committee Consultant with NAS Committee on Federal Research on Biological and Health Effects of Ionizing Radiation President-Elect and President, American Association of Physicists in Medicine Member, Executive Committee, American Association of Physicists in Medicine (Chairman, 1981) Member, Physics Panel, Radio Graphics

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Chairman, AAPM Nominating Committee Chairman, AAPM ad hoc Committee on Radiation Policy Chairman, AAPM ad hoc Committee on Professionalism Constituting Panel, American College of Medical Physics ASTR Committee on Membership Chairman, Board of Directors, American Association of Physicists in Medicine RTOG Physics Committee RTOG Lung Committee Member, Awards Committee, HPS Great Lakes Chapter (Chairman, 1982-83) Co-Chairman, Symposium Committee, HPS Great Lakes Chapter ACMP Certification Committee, Chairman President, Great Lakes Chapter, Health Physics Society ACMP Board of Chancellors (Vice-Chairman, 1984, Chairman 1985) AAPM Biological Effects Committee Symposium Committee, HPS Great Lakes Chapter (Chairman 1983/84) Chairman, AAPM Educational Council AAPM Nominating Committee RSNA Educational Council ACMP Annual Meeting Program Committee (Chairman 1984) AAPM Task Group on Lung Corrections in Radiotherapy (Chairman 1984-86) AAPM Great Lakes Chapter, Program Committee AAPM Task Group on Evaluation of Models for Dose Response in Radiation

Case 5:08-cv-00133-RMW Colin G. Orton, Ph.D. Curriculum Vitae Page 8 Oncology 1985-1990 1985-1993 1985-1987 1985-1988 1986-1991 1986-1989 1986-1989 1986-1989 1986-1987 1986-1990 1986-1990 1986-1987 1986-1987 1986-1989 1986-1989 1986-1994 1987-1989 1987-1990 1987-1991 1987-1992

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AAPM Awards and Honors Committee Board of Directors, American Board of Medical Physics (Vice-Chairman 1992-93) American Board of Medical Physics Constituting Panel (Chairman, 1985). ACR Committee on Computers RSNA Refresher Course Committee AAPM Nominating Committee AAPM ad-hoc Committee on Guidelines and Protocols for AAPM Publications. AAPM Liaison for Africa HPS Great Lakes Chapter, Chairman, Educational Committee HPS Great Lakes Chapter, Finance Committee AAPM International Affairs Committee (Chairman 1987-90) AAPM Annual Meeting, Technical Exhibits Committee (Chairman) AAPM Annual Meeting Local Arrangements Executive Committee ABMP Constitution and Bylaws Committee ABMP Credentialling Subcommittee (Chairman) AAPM Subcommittee on Research Databases ABR Guest Examiner AAPM ad hoc Committee on Organizational Relations with the Canadian Medical Physicists Inter-Society Council for Radiation Oncology (ISCRO) AAPM Task Group on Clinical Radiation Responses of Normal Tissues

Case 5:08-cv-00133-RMW Colin G. Orton, Ph.D. Curriculum Vitae Page 9 1987-1992 1987-1990 1987-1988 1987-1989 1987-1991 198819881988-2003 1988-2003 1988-1990 1988-1990 1988-1990 1988-1992 1988-1994 1989 1989-2003 19891989-1992 19891989-1992 1990-

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AAPM Task Group on the Role of the Medical Physicist in Radiation Oncology AAPM Task Group on International Publications Support. Steer