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Spine v. Biedermann Motech GmbH

February 16, 2010

STRYKER SPINE, PLAINTIFF,
v.
BIEDERMANN MOTECH GMBH, ET AL., DEFENDANTS.



The opinion of the court was delivered by: Colleen Kollar-kotelly United States District Judge

MEMORANDUM OPINION

This case involves a dispute between Plaintiff Stryker Spine ("Stryker"), a French corporation, and Defendants Biedermann Motech GmbH ("Biedermann") and DePuy Spine, Inc. ("DePuy"), over a patent interference proceeding at the United States Patent and Trademark Office ("PTO"). Stryker seeks judicial review of decisions made by the PTO's Board of Patent Appeals and Interferences pursuant to 35 U.S.C. § 146. Pending before the Court are a series of dispositive motions. Stryker has filed a [31] Motion for Summary Judgment regarding the PTO's refusal to redefine the interference count ("Redefinition Motion"); a [32] Motion for Summary Judgment regarding Defendants' failure to adequately support their patent claims under 35 U.S.C. § 112 ("§ 112 Motion"); a [33] Motion for Summary Judgment regarding the unpatentability of Defendants' claims over prior art ("Unpatentability Motion"); and a [35] Motion for Summary Judgment regarding the unconstitutionality of the appointment of an Administrative Patent Judge ("Unconstitutionality Motion"). Defendants oppose these motions and have separately filed a single [36] Motion for Summary Judgment. The United States has also intervened and filed an opposition to Stryker's Unconstitutionality Motion. Briefing on these motions is now complete.

For the reasons explained below, the Court shall DENY each of Stryker's motions for summary judgment and GRANT-IN-PART and DENY-IN-PART Defendants' motion for summary judgment. With respect to Stryker's Unconstitutionality Motion, the Court finds that any constitutional defect in the administrative patent judge's appointment was cured by his reappointment prior to the PTO's issuance of a final decision on rehearing. Therefore, the Court shall award judgment to Defendants on this claim. With respect to Stryker's Redefinition Motion, the Court finds that there are genuine issues of material fact that preclude the award of summary judgment to either party. Because the issues raised in the § 112 Motion and Unpatentability Motion are both contingent on Stryker's success on the Redefinition Motion, the Court shall also deny the parties' motions with respect to these issues.

I. BACKGROUND

A. The Patent Process and Interference Proceedings Generally

1. Patent Prosecution

The process of obtaining a patent is known as "prosecution"and begins with the filing of an application with the PTO. See Intervet, Inc. v. Merial Ltd., 643 F. Supp. 2d 97, 99 (D.D.C. 2009); see generally 37 C.F.R. § 1.51. A patent application consists of a specification of the proposed patent as prescribed by 35 U.S.C. § 112, including a claim or claims, an oath or declaration, drawings as may be necessary, and the appropriate filing fee. 37 C.F.R. § 1.51(b). The specification required by 35 U.S.C. § 112 includes both a "written description of the invention" (description) and a written explanation of "the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use" it (enablement). 35 U.S.C. § 112, para. 1. As Judge Henry H. Kennedy, Jr., aptly explained in a recent decision,

At the end of the written description and enablement, a proper specification should conclude with a list of "claims," which identify the specific innovations, components or subparts of the invention, the applicant regards as hers. 35 U.S.C. § 112, para. 2.

A claim is a single sentence description of what the applicant believes to be her invention, setting the boundaries of the invention the applicant wishes the PTO to examine. A single claim can be composed of multiple elements and/or limitations.*fn1 Elements are the previously known physical components that make up the claimed invention. Limitations, on the other hand, usually describe the claim's restrictions.

An application may contain several claims, and each claim usually contains several restrictions. It is these claims that define the scope of patent protection.

Intervet, 643 F. Supp. 2d at 99.

A patent examiner then reviews the application to determine whether a patent should issue. "On taking up an application for examination or a patent in a reexamination proceeding, the examiner shall make a thorough study thereof and shall make a thorough investigation of the available prior art relating to the subject matter of the claimed invention." 37 C.F.R. § 1.104(a)(1). If the patent examiner determines that the applicant is entitled to a patent under the law, a "Notice of Allowance" is issued. Id. § 1.311(a). If, however, the patent examiner determines that there are deficiencies or problems with the application, the examiner will issue an "Office Action" advising the applicant as to the "reasons for any adverse action or any objection or requirement." Id. § 1.104(a)(2). Upon receipt of an Office Action, an applicant may amend the claims, argue as to the merits of the examiner's findings, or both. See id. § 1.111. This back and forth between the applicant and the patent examiner continues until a patent is issued or a final rejection occurs.

2. Patent Interference Practice

United States patent law, unlike much of the rest of the world, is premised on the principle that the first to invent-rather than the first to file a patent application-is granted the patent right. ROBERT L. HARMON, PATENTS AND THE FEDERAL CIRCUIT, 1151 (2009). As a consequence of this rule, there must be a mechanism for determining who among multiple patent applicants, or, as in this case, among an applicant and a patentee, was the first to invent the claimed subject matter. That mechanism is known as an interference, which is a "proceeding [] principally declared to permit a determination of priority." Minnesota Mining and Mfg. Co. v. Norton Co., 929 F.2d 670, 674 (Fed. Cir. 1991). As is oft-repeated, "[i]nterference practice is highly arcane and specialized," Conservolite, Inc. v. Widmayer, 21 F.3d 1098, 1100 (Fed. Cir. 1994), and can be "virtually incomprehensible to the uninitiated," PATENTS AND THE FEDERAL CIRCUIT,supra, at 1152.

"An interference exists if the subject matter of a claim of one party would, if prior art, have anticipated or rendered obvious the subject matter of a claim of the opposing party and vice versa." 37 C.F.R. § 41.203. Either the patent applicant or the patent examiner may suggest an interference. See id. § 41.202. If the Director of the PTO agrees that an interference is warranted- i.e., that "an application is made for a patent which would interfere with any pending application, or with any unexpired patent"-he may declare an interference and provide notice of such declaration to the applicants, or applicant and patentee, as the case may be. 35 U.S.C. § 135(a); see also 37 C.F.R. § 41.203.*fn2 The notice declaring an interference identifies the interfering subject matter; the involved applications, patents, and claims; the accorded benefit for each count; and the claims corresponding to each count. 37 C.F.R. § 41.203(b). An administrative patent judge (APJ) may change the declaration of interference, and a party may suggest an additional interference. Id. § 41.203(c)-(d). The Board of Patent Appeals and Interferences (the "Board") determines questions of priority of the inventions and may determine questions of patentability as well. 35 U.S.C. § 135(a).*fn3

Interference proceedings are governed by the PTO's regulations for contested cases. See 37 C.F.R. § 41.200(a). An interference proceeding may involve one or more counts; a count is the Board's description of the interfering subject matter that sets the scope of admissible proofs on priority. Id. § 41.201. Each count must describe a patentably distinct invention. Id. Parties are presumed to have invented interfering subject matter in the order of the dates of their accorded benefit for each count. Id. § 207(a)(1). The "accorded benefit" is the Board's recognition that a patent application provides a proper written description and enablement. Id. § 41.201. The party with the earlier accorded benefit is deemed the senior party, while the other party is the junior party. Id. Priority may be proved by a preponderance of the evidence. Id. § 41.207(a)(2). The parties may file substantive and responsive motions. Substantive motions must (1) raise a threshold issue (i.e., an issue that, if resolved in favor of the movant, would deprive the opponent of standing in the interference); (2) seek to change the scope of the definition of the interfering subject matter or the correspondence of claims to the count; (3) seek to change the benefit accorded for the count; or (4) seek judgment on derivation or on priority. See 37 C.F.R. §§ 41.208, 41.200. "To be sufficient, a motion must provide a showing, supported with appropriate evidence, such that, if unrebutted, it would justify the relief sought." 37 C.F.R. § 41.208(b).

B. Stryker Spine's Patent

Stryker Spine is the assignee of U.S. Patent No. 6,974,460 ("the '460 Patent"), which is titled "Biased Angulation Bone Fixation Assembly." See Admin. Record ("AR")*fn4 4; Defs.' Mot. for Summ. J., Shaw Decl. Ex. 7 (the '460 Patent) at 1. The '460 Patent was issued on December 13, 2005, and was based on U.S. Patent Application No. 10/091,068 ("the '068 Application"), which was filed on March 5, 2002. AR 4. The '068 Application claimed the benefit of Provisional Application No. 60/322,042, filed on September 14, 2001. First Am. Compl. ("FAC") ¶ 19; Answer ¶ 19. The named inventors of the '460 Patent are John Carbone, Aaron Markworth, Michael Horan, and Yves Crozet. AR 4.

The device described by the '460 Patent is intended for spinal fixation, i.e., securing a spinal rod to the bones of the vertebrae. The abstract of the '460 Patent reads as follows:

A bone fixation assembly including a coupling element having an inner surface defining a first bore coaxial with a first longitudinal axis, and a second bore coaxial with a second longitudinal axis, whereby the second longitudinal axis intersects the first longitudinal axis. The coupling element has a seat adjacent the lower end of the coupling element, the seat being defined by the inner surface of the coupling element. The assembly includes an anchoring element assembled with the coupling element, the anchoring element having a first end for insertion into bone and a head spaced from the first end, the head being in contact with the seat of the coupling element. The assembly provides sufficient angulation between adjacent anchoring elements securing a common orthopedic rod, and is particularly useful for assemblies mounted in spines having abnormal curvatures and in the cerivicothoracic region of the spine.

'460 Patent at 1.

The '460 Patent contains 39 claims, five of which are independent (claims 1, 18, 24, 33, and 38). FAC ¶ 20; '460 Patent cols. 15-18. According to Stryker, claims 1 and 18 represent two distinctly patentable inventions. Claim 1, which Stryker calls the "intersecting axes" invention, is described in the '460 Patent as follows:

1. A bone fixation assembly comprising: a coupling element having an inner surface defining a first bore coaxial with a first longitudinal axis and a second bore coaxial with a second longitudinal axis, wherein first said first and second longitudinal axes intersect and are in communication with one another; said coupling element including a seat adjacent said lower end of said coupling element, said seat being defined by the inner surface of said coupling element; and an anchoring element assembled with said coupling element, said anchoring element having a first end for insertion into bone and a head spaced from the first end, said head being in contact with seat of said coupling element.

'460 Patent col. 15:42-55.

Claim 18, which Stryker calls the "intersecting planes" invention, is described in the '460 Patent as follows:

18. A bone fixation assembly comprising: a coupling element having an upper end defining a first plane, a lower end defining a second plane, and at least one bore extending from said upper end toward said lower end, wherein said first and second planes intersect one another; an anchoring element assembled with said coupling element, said anchoring element being adapted for insertion into bone; and said coupling element having a U-shaped opening that extends from the upper end of said coupling element toward the lower end of said coupling element, wherein said U- shaped opening is adapted to receive a stabilizing rod.

'460 Patent col. 16:50-63.

C. Defendants' Patent Application & Suggestion of Interference

Defendant Biedermann is the assignee of U.S. Patent Application No. 10/763,431 ("the '431 Application"), which is titled "Bone Screw." FAC ¶ 16; Answer ¶ 16. Defendant DePuy has been identified as the exclusive licensee of the '431 Application. Answer ¶ 18. The '431 Application was filed on January 22, 2004. FAC ¶ 23; Answer ¶ 23. The '431 Application claimed to be a continuation of Application No. 10/037,698, filed November 9, 2001, which claimed priority from German Application No. 10055888.7, filed November 10, 2000, and German Application No. 10065397.7, filed December 27, 2000. FAC ¶ 23; Answer ¶ 23. The named inventors of the '431 Application are Lutz Biedermann and Jurgen Harms. Defs.' Mot. for Summ. J., Shaw Decl. Ex. 6 (the '431 Application) at 1.

Like the '460 Patent, the '431 Application describes a device that connects a bone screw to a coupling element for the receipt of an anchoring rod. The abstract of the '431 Application reads as follows:

A bone screw having a screw member (1) possessing a threaded section (2) and a head (3) and a receiving part (5) at the head end for receiving a rod to be connected to the bone screw is provided. The receiving part (5) has on [sic] open first bore (6) and a substantially U-shaped cross-section having two free legs provided with a thread. Furthermore, the receiving part has a second bore (7) on the end opposite to the first bore (6) whose diameter is greater than that of the threaded section (20 and smaller than that of the head (3). On the bottom of the first bore a seat for the head (3) is provided. In order that the screw member can be pivoted to at least one side by an enlarged angle, the edge bounding the free end of the second bore (7) viewed relative to the axis of the first bore (6) is of asymmetric construction.

'431 Application at 1 (figure omitted).

On July 9, 2004, Beidermann filed a "Request for Declaration of Interference Under 37 CFR 1.604(a)" between the '431 Application and the '460 Patent. See Pl.'s Redefinition Mot., Ex. B. Biedermann proposed two interference counts, one of which was directed to an "assembly or coupling element" as addressed in 33 claims in the '460 Patent (which were copied by Biedermann), and the other of which was directed to a "method" as defined in four other claims in the '460 Patent (also copied by Biedermann). Pl.'s Stmt.*fn5 (Redefinition) ¶ 4. On January 10, 2006, Biedermann filed a "Suggestion of Interference Under 37 CFR 41.202(a)" proposing only a single count of interference directed toward an assembly or coupling element. Defs.' Resp. Stmt. (Redefinition) ¶ 4; Pl.'s § 112 Mot., Exs. U-V. On April 13, 2007, the examiner in charge of the '431 Application issued an action acknowledging Biedermann's suggestion of interference. Pl.'s Stmt. (Redefinition) ¶ 5; Pl.'s Redefinition Mot., Ex. C ("4/13/07 PTO Commc'n"). Among other things, the PTO indicated that Biedermann had "list[ed] a variety of claims as being the proposed count" and informed Biedermann that "[r]espectfully, a count cannot consist of more than one claim." 4/13/07 PTO Commc'n at 2. The PTO stated that Biedermann had one month to correct any deficiencies. Id.

On May 16, 2007, Biedermann filed a "Supplemental Suggestion of Interference" with the PTO. Defs.' Resp. Stmt. (Redefinition) ¶ 6; Pl.'s Redefinition Mot., Ex. D ("Supp. Sugg. Interf."). Biedermann explained that in its view, the PTO's statement that a count cannot consist of more than one claim is incorrect. See Supp. Sugg. Interf. at 2. Biedermann explained that its proposed count was known as a "McKelvey count" and that such counts have been proposed by the Board in many interferences and are therefore acceptable.*fn6 Id. at 2-3. Biedermann then proposed what it called a "Simplified McKelvey Count," defined as "[t]he assembly or coupling element of Carbone claims 1, 18, 24, 33, or 38, or the assembly or coupling element of Biedermann claims 6, 18, 28, 33 or 35." Id. at 4. Biedermann explained that the simplified McKelvey count "has the advantage of combining the parties' independent claims, which are not patentably distinct from one another, while sweeping in the remaining dependent claims, which do not add features that render their subject matter as a whole each separately patentable over the parties' combined independent claims." Id.

D. The Interference Proceeding

On October 10, 2007, Patent Interference No. 105,578 was declared involving the '460 Patent and the '431 Application. Defs.' Stmt. ¶ 1. Administrative Patent Judge (APJ) Jameson Lee was assigned to manage the interference proceeding. Id. ¶ 3. Biedermann and Harms, the inventors of the '431 Application, were identified as the senior party, whereas the inventors of the '460 Patent (Carbone et al.) were identified as the junior party.*fn7 Id. The interference was declared on the basis of a single count, which read "Carbone's patent claim 1, 18, 24, 33, or 38 or Biedermann's claim 6, 18, 28, 33, or 35." AR 5.*fn8 The declaration of interference scheduled an initial conference call for December 5, 2007. Id. ¶ 5. Under the Board's Standing Order governing procedures in interference proceedings, each party must file a list of the substantive motions it intends to file prior to this initial conference call. AR 29 (Standing Order ¶ 104.2.1), 71 (Standing Order ¶ 204).

Stryker*fn9 did not seek to contest the priority of invention per se in the interference proceeding. Pl.'s Unpatentability Br. at 3-4. Rather, Stryker viewed the single interference count as encompassing two distinct inventions: the first based on claims 1, 24, and 38 of the '460 Patent (the "intersecting axes" invention) and the second based on claims 18 and 33 of the '460 Patent (the "intersecting planes" invention). Stryker also thought that Biedermann's claims lacked support and were unpatentable based on prior art. Accordingly, Stryker filed the following list of motions on November 29, 2007:

1. Carbone Miscellaneous Motion 1 (No Interference in Fact) based on Biedermann's lack of support for the invention of the count;

2. Carbone Miscellaneous Motion 2 (to redefine the interfering subject matter) proposing a substitute count;

3. Carbone Miscellaneous Motion 3 (for judgment based on prior art) based on the unpatentability of the count;

4. Carbone Miscellaneous Motion 4 (to designate Carbone claims not corresponding to the proposed new substitute count)

Defs.' Stmt. ¶ 7. On November 30, 2007, APJ Lee issued an Order dismissing Stryker's motions as being "so vague as to be not useful for reasonable preparation of the scheduled telephone conference call on December 5, 2007." Id. ¶ 8; AR 148-49. APJ Lee gave Stryker until the end of the day to file a revised motions list to explain more specifically (1) why there is no interference in fact; (2) why a substitute count is needed and what substitute count is proposed; (3) which of Biedermann's claims are unpatentable and on what grounds; and (4) which of Biedermann's claims do not correspond to Stryker's proposed substitute count and why. AR 148-49. Stryker filed a revised list of motions. AR 150-52. Biedermann also filed a list of motions pertaining to priority. AR 144-45.

During the motions conference call held on December 5, 2007, Stryker's counsel discussed its revised motions list and informed APJ Lee that Stryker would not be filing a priority motion in the interference.*fn10 Defs.' Stmt. ¶¶ 11-12. On December 6, 2007, APJ Lee issued an Order authorizing substantive motions. AR 156-61. The Order authorized Stryker to file a motion to redefine the Interference by replacing the current count with two new counts: Count 2 (consisting of Stryker's claim 1 or 24 or 38 or Biedermann's claim 6 or 28 or 35) and Count 3 (consisting of Stryker's claim 18 or 33 or Biedermann's claim 22 or 33). AR 160. The Order also authorized Stryker to file a contingent motion (i.e., contingent upon granting of the motion to redefine the Interference) for judgment against Biedermann's claims in proposed Count 2, for lack of written description in the specification. AR 161. However, the Order denied authorization for Stryker to file a motion attacking Biedermann's claims in proposed Count 2 for lack of enabling disclosure. AR 157-58. The Order also denied authorization for Stryker to file a motion attacking Biedermann's claims in proposed Count 3 as unpatentable over prior art. AR 159, 161.

On December 20, 2007, Stryker filed a request for rehearing of APJ Lee's ruling that Stryker was not authorized to file a motion based on lack of enabling disclosure. AR 169-187. Stryker also filed a request for rehearing of APJ Lee's ruling that Stryker was not authorized to file a motion based on unpatentability. AR 188-96. On January 22, 2008, a three-judge panel of the Board (APJs Schafer, Lee, and Moore) issued a decision denying rehearing and affirming APJ Lee's rulings. AR 202-17. The Board noted that Interference proceedings are actively managed by the APJ, and the APJ has discretion to disallow motions that will not serve the interests of achieving a speedy, just, and inexpensive resolution of the Interference. AR 204-06. The Board explained that Stryker's basis for its proposed motion as to lack of enabling disclosure was the purported lack of written description, and the Board rejected this theory as not viable because the enablement requirement is distinct from the written ...


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