United States District Court, S.D. California
ORDER DENYING ALPHATEC SPINE, INC.'S MOTION FOR SUMMARY JUDGMENT
[Docket No. 51]
ROGER T. BENITEZ, District Judge.
Presently before the Court is Alphatec Spine, Inc.'s Motion for Summary Judgment. (Docket No. 51.) For the reasons stated below, the Motion is DENIED.
Plaintiff Samy Abdou, M.D., alleges that Defendant Alphatec Spine, Inc. willfully infringed U.S. Patent Nos. 7, 951, 153 ("the '153 patent") and 8, 172, 855 ("the '855 patent"), both of which are entitled, "Devices and Methods for Inter-Vertebral Orthopedic Device Placement." The patents at issue are directed toward the treatment of diseases of the spine.
The spine consists of a vertebral column and a spinal cord. The vertebral column provides support for the body and protects the spinal cord. Posterior to the vertebral column is the spinal cord, and anterior to the vertebral column is the aorta and vena cava, the body's two major blood vessels. The vertebral column is made up of individual vertebral bones, which are separated by an intervertebral disc space. The disc space permits movement between vertebral bones and absorbs shock from the load transmitted through the vertebral column. Many medical problems involving the spine result from a problem of the disc (e.g., herniation) or compression of surrounding nerves. Treatment of these issues include implanting devices between vertebrae in order to adjust, align, and maintain the spatial relationship between them.
The '153 and '855 patents teach and claim devices and methods to target, access, and perform surgical work in the intervertebral space with minimal tissue dissection, including to place a sizable orthopedic device within. The '153 patent discloses devices by which a surgeon may access the intervertebral space by using a curved or arced portal ("insertion device") that allows for placement of a sizeable implant. The curved portal contains an internal bore or guide shaft, which extends from the proximal opening (nearest the surgeon) toward the distal end (at the disc space). An orthopedic implant is advanced through the bore and into the targeted disc space. The '855 patent discloses methods for targeting and accessing a targeted location within the spinal column, including between vertebrae, and for delivering an orthopedic implant into a target location, using devices similar to those described in the '153 patent.
A claim construction hearing was held on January 17, 2014. The Court declined to construe the ten sets of disputed claim terms found in the '153 and '855 patents, finding that they had a plain and ordinary meaning. (Docket No. 74.) Presently before the Court is Alphatec's Motion for Summary Judgement. (Docket No. 51.)
Alphatec argues that because the Court has previously construed the claims as permitting the mounting of the devices outside of the body, the asserted claims are invalid for failure to meet the written description and enablement requirements of 35 U.S.C. § 112(a).
Summary judgment is appropriate when "after opportunity for discovery and upon motion, there is no genuine dispute of material fact for trial and one party is entitled to judgment as a matter of law." Novartis Corp. v. Ben Venue Labs., Inc., 271 F.3d 1043, 1046 (Fed. Cir. 2001); FED. R. CIV. P. 56(c). All facts must be viewed in the light most favorable to the non-moving party, and all doubts must be resolved in the non-movant's favor. Helifix Ltd. v. Blok-Lok, Ltd., 208 F.3d 1339, 1345-46 (Fed. Cir. 2000).
"Under 35 U.S.C. § 282, a patent is presumed valid, and the one attacking validity has the burden of proving invalidity by clear and convincing evidence." Atlas Powder Co. v. E.I. du Pont de Nemours & Co., 750 F.2d 1569, 1573 (Fed. Cir. 1984). "Thus, a moving party seeking to invalidate a patent at summary judgment must submit such clear and convincing evidence of invalidity so that no reasonable jury could find otherwise." Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955, 962 (Fed. Cir. 2001).
A. WRITTEN DESCRIPTION
"The specification shall contain a written description of the invention, and of the manner and process of making and using it." 35 U.S.C. § 112(a). "Specifically, the description must clearly allow persons of ordinary skill in the art to recognize that the inventor invented what is claimed. In other words, the test for sufficiency is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date." Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc) (internal quotation marks, citation, and alteration omitted). "Put another way, one skilled in the art, reading the original disclosure, must immediately discern the limitation at issue in the claims." Purdue Pharma L.P. v. Faulding, Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000).
The Court finds that Alphatec has failed to prove a lack of written description by clear and convincing evidence. As discussed in the Claim Construction Order, the "mount, " "anchor device, " "fixation member, " and "first member" limitations of the claimed devices are mountable, positionable, or attachable both inside and outside of the body. (Docket No. 74, at 4.) The claim language is agnostic as to whether the point of attachment is inside or outside of the body. ( See, e.g., '153 patent, at 7:35-37 ("a first mount... mountable to a defined anatomical position relative to the target space"); id. at 8:31-33 ("a mount that is positionable at a defined anatomical relationship relative to the target space between the skeletal segments"); id. at 8:61-65 ("anchor device having... a second region [that] attaches onto a surface with defined spatial relationship to the disc space"); '855 patent, at 15:38-40 ("positioning an implant insertion assembly in proximity to the target location"); id. at 17:1-2 ("positioning... a first member of a targeting apparatus in proximity to the first vertebral bone").) In addition, the specifications indicate that no particular attachment location is required. ( See, e.g., '153 patent, at 5:45-49 ("The coupler 110 of the device 100 is then attached to an attachment point. It should be appreciated that the attachment point need not be the disc space itself. The coupler 110 can be attached directly to one of the vertebrae or to some other reference location."); '855 patent, at 13:66-14:1 ("In other embodiments, one or more anchors may be placed into the inter-spinous ligament, lateral to the inter-spinous space, into the pedicles or any other suitable anchor point.").)
This action is similar to Gen-Probe Inc. v. Becton Dickinson & Co., 899 F.Supp.2d 971 (S.D. Cal. 2012). One of the patents at issue in Gen-Probe claimed a seal or seals on a collection vessel that are penetrated by a fluid transfer device. Id. at 976. The defendant moved for summary judgment of invalidity of the asserted claims of the patent, on the basis that the patent specification failed to convey that the inventors invented a penetrable cap without a filter because the specification only described a patent with a filter. Id. at 978-79. This Court denied summary judgment because: (1) the embodiments with a filter were preferred embodiments, (2) an embodiment in the Summary of the Invention could "fairly be interpreted" as a cap lacking a filter, and (3) "the entire Summary of the Invention section [was] a series of paragraphs that describe various embodiments of the invention." Id. at 979-80. Gen-Probe is analogous to the present action in that the Court has found in the Claim Construction Order that the embodiments that describe the devices as attaching inside of the body are preferred embodiments, and the patents claim devices that are mountable, positionable, or attachable both inside and outside of the body. As in Gen-Probe, "the Court cannot find that [Alphatec] has met it[s] burden to provide such clear and convincing evidence of invalidity that no reasonable jury could find otherwise." Id. at 980 (internal quotation marks omitted).
Alphatec's arguments to the contrary are not convincing. First, Alphatec argues that summary judgment should be granted because the patents at issue fail to provide any examples of the distal end of the mounting device attaching outside of the body. Alphatec is correct that "the lack of any disclosure of examples may be considered when determining whether the claimed invention is adequately described." Boston Scientific Corp. v. Johnson & Johnson, 647 F.3d 1353, 1364 (Fed. Cir. 2011). However, "examples are not always required to satisfy the written description requirement." Id. Although relevant to the Court's analysis, this factor is not determinative.
Second, Alphatec cites TurboCare Division of Demag Delaval Turbomachinery Corp. v. General Electric Co., 264 F.3d 1111, 1119 (Fed. Cir. 2001), for the proposition that vague references in the patents referring to "other locations" cannot provide the requisite written description support. The patent at issue in TurboCare claimed a shaft seal used in fluid-driven devices such as steam turbines. Id. at 1113. On an appeal of the district court's granting of summary judgment for failure to meet the written description requirement, the plaintiff argued that "one of ordinary skill in the art would recognize that the only viable location for mounting a spring adjacent to said rings' would be between the casing shoulders and the shoulders of the outer ring portion of the segment, and therefore that the claimed subject matter was inherent in the original disclosure." Id. at 1119. However, the plaintiff conceded that the only support in the original disclosure for the location of a claimed spring was the language, "spring located... adjacent to said rings, " from one of the original, rejected claims. Id. The court upheld the district court's granting of summary judgment, finding that the "original disclosure [was] completely lacking in any description of an embodiment in which the spring is located between the casing shoulders and the inner surface of the outer ring portion of the ring segment." Id. TurboCare, however, is distinguishable from the present action. In TurboCare, the plaintiff attempted to limit the mounting location for the spring to between the casing shoulders and the shoulders of the outer ring portion of ...