Zap Surgical Systems, Inc. v. Elekta Ltd.

• Decision Date: 30 March 2021
• Docket Number: Patent 7,295,IPR2019-01659,648 B2
• Parties: ZAP SURGICAL SYSTEMS, INC., Petitioner, v. ELEKTA LIMITED, Patent Owner.
• Court: Patent Trial and Appeal Board

ZAP SURGICAL SYSTEMS, INC., Petitioner,
v.
ELEKTA LIMITED, Patent Owner.

IPR2019-01659

Patent 7, 295, 648 B2

United States Patent and Trademark Office, Patent Trial and Appeal Board

March 30, 2021

James Isbester John Alemanni KILPATRICK TOWNSEND & STOCKTON LLP

PATENT OWNER Frank Bernstein Tamara Fraizer David Prueter SQUIRE PATTON BOGGS

Before BRYAN F. MOORE, JENNIFER S. BISK, and NORMAN H. BEAMER, Administrative Patent Judges.

JUDGMENT FINAL WRITTEN DECISION DETERMINING ALL CHALLENGED CLAIMS UNPATENTABLE DENYING PATENT OWNER'S REVISED MOTION TO AMEND DENYING PATENT OWNER'S MOTION TO EXCLUDE 35 U.S.C. § 328(A)

BEAMER, ADMINISTRATIVE PATENT JUDGE.

I. INTRODUCTION

In response to a Petition filed by ZAP Surgical Systems, Inc. ("Petitioner"), we instituted inter partes review of claims 1-4, 7-13, 16-18, 20, and 22-23 of U.S. Patent No. 7, 295, 648 B2 (Ex. 1001, "the 648 patent"). Paper 1 ("Pet."); Paper 7 ("Dec."). Elekta Limited ("Patent Owner") filed a Response to the Petition, Petitioner filed a Reply, and Patent Owner filed a Sur-Reply. Paper 14 ("PO Resp."); Paper 19 ("Reply"); Paper 24 ("Sur-Reply"). Patent Owner also filed a Motion to Amend the claims, Petitioner filed an Opposition to that Motion, and we provided Preliminary Guidance under the Board's Motion to Amend Pilot Program. Papers 13, 18, 20.

Thereafter, Patent Owner filed a Revised Motion to Amend, Petitioner filed an Opposition, Patent Owner filed a Reply, and Petitioner filed a Sur-Reply. Paper 22 ("RMTA"); Paper 25 ("Opp. RMTA"); Paper 35 ("Reply RMTA"); Paper 43 ("Sur-Reply RMTA"). The Revised Motion to Amend states that it is contingent upon a finding that challenged independent claims 1 and/or 18 are unpatentable. RMTA 1.

In addition, Patent Owner filed a Motion to Exclude evidence, which Petitioner opposed, and in support of which Patent Owner filed a Reply. Papers 37, 38, 41.

An oral hearing took place on January 27, 2021. The Hearing Transcript ("Tr.") is included in the record as Paper 47. After considering the parties' arguments and supporting evidence, we determine that Petitioner has demonstrated by a preponderance of the evidence that claims 1-4, 7-13, 16-18, 20, and 22-23 are unpatentable. Also, we determine that Patent Owner's Revised Motion to Amend should be denied. In addition, for the reasons explained below, we deny Patent Owner's Motion to Exclude evidence.

II. BACKGROUND

A. The '648 Patent

The '648 patent, titled "Method And Apparatus For Treatment By Ionizing Radiation," was filed on October 21, 2004, issued on Novembe 2007, and cites Great Britain priority applications filed October 23, 200: November 4, 2003. Ex. 1001, codes (54), (22), (45), (30). The patent describes a radiation therapy/surgery device for treatment of, e.g., tumor the brain. Id. at code (57). Figure 5 of the '648 patent, annotated by the panel to show a "rotation axis" and a "support axis," is reproduced below.

(Image Omitted)

Figure 5 illustrates a perspective view of the internal structure of an exemplary apparatus of the '648 patent. Ex. 1001, 5:8-9. A sturdy mounting ring 20 supports rotatable ring 24, which can rotate around patient 18 lying on a table. Id. at 7:5-14. The table support can be adjusted via a patient positioning system (not shown). Id. at 8:33-39. Mounting brackets 26 and 28 are attached to ring 24, which include pivotable mounting points 30 (only the upper such point is visible in Figure 5) spaced transversely from the plane of the ring, wherein an imaginary line drawn through the points 30 (the "rotation axis" shown above) would pass directly through the axis of rotation of the ring (the "support axis" shown above), and which point of intersection is at the same height as a patient lying on the patient table. Id. at 7:14-23.

A linear accelerator (linac) 32 is mounted on the pivotal mounting points 30 in a suitable housing 34. A motor 36 is provided to allow the linac housing 34, and thus the linac 32, to be rotated about the pivotal mounting points 30. The height of the linear accelerator 32 and its direction are set so that its beam axis passes through the intersection point referred to above. Id. at 7:24-30. This intersection point is referred to as the "isocentre." Id. at 6:44-49.

The linac can thereby rotate about the ring axis and the pivotable mounting point axis, allowing the beam to come from many directions and always pass through the intersection point, which is where the patient's head (for example) is positioned. Id. at 7:31-40. In operation, the patient is subjected to multiple radiation doses from multiple directions, with each dose at a relatively low level so as not to damage the undiseased tissue through which the beam passes, but with the cumulative doses at the target intersection high enough to destroy the diseased tissue. Id. at 1:11-36, 7:41-44.

Because the target tissue can have an irregular shape, as the beam is directed to the target from different directions, its cross section is adjusted using a collimator at the output of the linac. Id. at 8:7-14. Also, the intensity of the beam, the speed of rotation of the linac about the axes of the system, and the position of the table supporting the patient can be varied during treatment. Id. at 8:1-13, 23-27, 33-37. The linac can also be used at lower intensities as an imaging device to calibrate the position of the patient or locate anatomical areas of the patient. Id. at 8:14-23. A control means can control the collimation, beam intensity and movement, and patient position, using, inter alia, feedback from the imaging device. Id. at 4:35-59.

The '648 patent asserts that the above-described arrangement has the advantage of accurately positioning the linac over a wide variety of approach angles, using only rotatable joints, such that the linac is suitably balanced around those joints, avoiding imprecision problems of prior art techniques that were less able to accommodate the heavy linac apparatus. Id. at 3:3-31, 5:36-46, 7:50-56. In addition, spacing the pivotable mounting points transversely from the plane of the ring allows the linac to pivot without fouling the support or irradiating unintended areas such as the patient's shoulder. Id. at 4:21-28, 8:67-9:1.

B. Illustrative Claim

Independent claim 1 of the '648 patent is illustrative of the challenged claims, and is reproduced below.

1. A device for treating a patient with ionising radiation comprising

a ring-shaped support, on which is provided a mount

a radiation source attached to the mount

the support being rotateable about an axis coincident with the centre of the ring; the source being attached to the mount via a rotateable union having a [sic] an axis of rotation axis [sic] which is non-parallel to the support axis

wherein the rotation axis of the mount passes through the support axis of the support and the radiation source is collimated so as to produce a beam which passes through the co-incidence of the rotation and support axes.

Ex. 1001, 9:54-67 (British standard spelling in original).

C. References

Petitioner relies on the following references (Pet. iv):

• Grady et al, U.S. 4, 649, 560, issued March 10, 1987. Ex. 1009 ("Grady").

• K J Ruchala et al, "Megavoltage CT image reconstruction during tomotherapy treatments," Phys. Med. Biol. 45, 3545-3562 (2000). Ex. 1010 ("Ruchala").

• Lam et al, U.S. 5, 945, 684, issued Aug. 31, 1999. Ex. 1013 ("Lam").

• Adler, U.S. 5, 207, 223, issued May 4, 1993. Ex. 1012 ("Adler").

• Valentin, WO 01/12262 A1, pub. Feb. 22, 2001. Ex. 1014 ("Valentin").

• Roder, DE 3321057 A1, pub. Dec. 13, 1984. Ex. 1015 ("Roder").

• Winter, U.S. 4, 998, 268, issued March 5, 1991. Ex. 1016 ("Winter").

• Schonberg, Russell G., "The History of the Portable Linear Accelerator," AAPM Meeting (2001). Ex. 1011 ("Schonberg").

Petitioner also relies on the declarations of J. Michael McCarthy and George Asmerom. Ex. 1003 ("McCarthy Decl."); Ex. 1026 (McCarthy MTADecl."); Ex. 1028 (McCarthy Reply Decl."); Ex. 1036 (McCarthy RMTA Decl."); Ex. 1027 ("Asmerom Decl.").

Patent Owner relies on the declarations of K. David Steidley and Phillip Beron, M.D. Ex. 2001 ("Steidley Decl."); Ex. 2007 ("Steidley 2nd Decl."); Ex. 2040 ("Steidley 3^rd Decl."); Ex. 2008 ("Beron Decl").

D. Asserted Grounds of Unpatentability

Petitioner challenges the patentability of claims 1-4, 7-13, 16-18, 20, and 22-23 of the '648 patent on the following grounds (Pet. 3)^[1]:

Claims Challenged	35 U.S.C. §	References
1-4, 7-8, 11-12, 17-18, 20, 23	103(a)	Grady, Ruchala
9, 10, 13, 16, 22	103(a)	Grady, Ruchala, Lam
1-4, 7-8, 11-12, 17-18, 20, 23	103(a)	Adler, Grady
9, 10, 13, 16, 22	103(a)	Adler, Grady, Lam
1-4, 7-8, 11-12, 17-18, 20, 23	103(a)	Valentin, Roder
9, 10, 13, 16, 22	103(a)	Valentin, Roder, Lam

Petitioner also relies on Winter, Schonberg, and Adler as background art in connection with Grounds 1-4. Pet. 20-21, 46-50.

E. Real Parties in Interest

Petitioner identifies itself as the real party in interest. Pet. 77. Patent Owner identifies itself, and Elekta, Inc. as real parties in interest. Paper 5, 2.

F. Related Proceedings

The parties identify Elekta Limited andElekta, Inc. v. Zap Surgical Systems, Inc., Case No. 4:19-cv-02269 (N.D. Cal.) as a related proceeding. Pet. 78; Paper 5, 2.

III. ANALYSIS

A. Legal Standards

A claim is unpatentable for obviousness if, to one of ordinary skill in the pertinent art, "the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made." KSR Int V Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007)...