Spine v. Biedermann Motech GmbH (684 F. Supp. 2d 68, 2010)

MEMORANDUM OPINION

COLLEEN KOLLAR-KOTELLY, District Judge.

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 gener ally 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.[] 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.

Internet, 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, “[interference 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 — ie., 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. 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).

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”) 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 haying 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, Biedermann 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. (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 Comme’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 Comme’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. 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 patent-ably 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. 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. 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 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. 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 description requirement (i.e., an invention may be enabled even if it is not described). See AR 208-13. The Board also explained that although the Board may determine issues of unpatentability in interference proceedings, it is not required to do so. AR 213-16.

On February 15, 2008, Stryker filed a “Revised Substantive Motion 1” to redefine the interference. See AR 307-59. Four days later, APJ Lee held a telephone conference with counsel for both parties. AR 360. APJ Lee ordered Stryker to file a revised Substantive Motion 2 to fix certain errors in its original filing. AR 364. On February 21, 2008, Stryker filed its “Revised Substantive Motion 2,” contingent upon the granting of Substantive Motion 1, for judgment that Biedermann’s claims pertaining to proposed Count 2 are unpatentable for failing to meet the “written description” requirement of 35 U.S.C. § 112. See AR 365-465.

On April 30, 2008, a panel of the Board (APJs Schafer, Lee, and Moore) issued a Memorandum Opinion and Order. See AR 468-81. The Board denied Stryker’s Revised Substantive Motion 1 to redefine the interference count. AR 469. Because Stryker’s Revised Substantive Motion 2 was contingent on the granting of Motion 1, the Board dismissed the contingent motion. AR 479. The Board then entered judgment against Stryker in the Interference, cancelling claims 1-39 of the '460 Patent. AR 482-84. On May 30, 2008, Stryker filed a “Request for Rehearing of Judgment Based on Denial of Carbone Revised Substantive Motion 1.” AR 485-527. On August 27, 2008, a panel of the Board (APJs Schafer, Lee, and Moore) issued a written decision on Stryker’s request for rehearing. See AR 528-38.

II. LEGAL STANDARD

This action is brought pursuant to 35 U.S.C. § 146, which states in pertinent part that “[a]ny party to an interference dissatisfied with the decision of the Board of Patent Appeals and Interferences on the interference, may have remedy by civil action.... ” Judicial review under section 146 is “described as a hybrid of an appeal and a trial de novo.” Estee Lauder Inc. v. L’Oreal, S.A., 129 F.3d 588, 592 (Fed.Cir.1997). “Questions of law are reviewed de novo, but the underlying factual determinations made by the Board are reviewed for clear error.” Abbott GmbH & Co. KG v. Yeda Research & Dev. Co., Ltd., 576 F.Supp.2d 44, 49 (D.D.C.2008) (citing Winner Int’l Royalty Corp. v. Wang, 202 F.3d 1340, 1348 (Fed.Cir.2000)). An action brought under § 146 is essentially a proceeding to review the action of the Board. Conservolite, Inc. v. Widmayer, 21 F.3d 1098, 1102 (Fed.Cir.1994). “A party may not ... advance new legal theories at the trial court level, even if the overarching legal issue was presented below.” Boston Sci. Scimed, Inc. v. Medtronic Vascular, Inc., 497 F.3d 1293, 1298 (Fed.Cir.2007). The record below may be admitted by either party, but the parties may also “take further testimony.” See 35 U.S.C. § 145; see also Agilent Tech., Inc. v. Affymetrix, Inc., 567 F.3d 1366, 1379 (Fed.Cir.2009). However, the parties’ right to offer new evidence is limited to issues raised by the parties during the proceedings below or by the Board’s decision. Widmayer, 21 F.3d at 1102. If the district court accepts new evidence not previously before the Board, the Court must make de novo factual findings for issues on which the court accepts new evidence. Yeda Research & Dev., 576 F.Supp.2d at 49. In addition to the administrative record, which has been accepted into evidence, the parties have submitted a series of declarations and exhibits in support of their motions for summary judgment. The Court shall consider this evidence where appropriate in the context of a summary judgment motion.

“A motion for summary judgment in an action seeking judicial review of an interference proceeding pursuant to 35 U.S.C. § 146 is subject to the same legal standard as other proceedings unrelated to patent law issues.” Sears Ecological Applications Co. v. MLI Assocs., LLC, 652 F.Supp.2d 244, 256 (N.D.N.Y.2009). Summary judgment is proper when “the pleadings, the discovery [if any] and disclosure materials on file, and any affidavits show that there is no genuine issue as to any material fact and that the movant is entitled to judgment as a matter of law.” Fed.R.Civ.P. 56(c). Under the summary judgment standard, the moving party bears the “initial responsibility of informing the district court of the basis for its motion, and identifying those portions of the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, which it believes demonstrate the absence of a genuine issue of material fact.” Celotex Corp. v. Catrett, 477 U.S. 317, 323, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986) (internal quotation marks omitted). In response, the non-moving party must “go beyond the pleadings and by [its] own affidavits, or by the depositions, answers to interrogatories, and admissions on file, designate specific facts showing that there is a genuine issue for trial.” Id. at 324, 106 S.Ct. 2548 (internal quotation marks omitted). All underlying facts and inferences are analyzed in the light most favorable to the nonmoving party. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986).

III. DISCUSSION

There are at least four separate issues raised by the parties’ cross-motions for summary judgment. In no particular order, those issues are: whether the PTO erred by improperly declaring and refusing to redefine the single interference count; whether the PTO erred by failing to conclude that Biedermann’s patent application lacked adequate written specification and enablement; whether the PTO erred by failing to conclude that Biedermann’s claims are unpatentable; and whether the allegedly unconstitutional appointment of one of the administrative patent judges that ruled on the interference renders the decisions made by that APJ null and void. Because a finding that one of the APJs was unconstitutionally appointed would require a remand to the Board for reconsideration of the merits of the interference proceeding, the Court considers that issue first. The Court next addresses the Redefinition Motion because Stryker’s other claims are contingent upon the redefinition of the interference count.

A. Unconstitutional Appointment of the Administrative Patent Judge

Stryker contends that the decisions of the Board that are under review in this action are invalid and void because Administrative Patent Judge James T. Moore, who was a member of the three-judge panel reviewing the merits of the underlying interference proceeding, received his commission in violation of the Appointments Clause of the United States Constitution, Article II, Section 2, cl. 2. Both Defendants and the United States as Intervenor contend that the Board’s decisions below are valid because, among other things, APJ Moore was constitutionally reappointed before the Board issued its final decision on rehearing. Before addressing the merits of the constitutional question, however, the Court must determine whether Stryker has properly presented it to this Court.

1. Procedural Defenses

Defendants argue that Stryker has not properly presented a constitutional challenge to this Court because it did not include a request for declaratory relief in its First Amended Complaint. See [39] Defs.’ Opp’n at 9. While that is technically true, it cannot be said that Stryker failed to plead a constitutional challenge. The First Amended Complaint contains several allegations relating to the unconstitutional appointment of the administrative patent judges, see First Am. Compl. ¶¶ 72, 115, 130, 146, and it specifically requests relief in the form of a remand to the PTO and an order directing the PTO to “reassign the Interference to a new APJ and a lawfully constituted panel of APJs.” Id., Demand for Relief ¶ 3(a). These allegations are sufficient under the notice pleading requirements of Rule 8.

Additionally, Defendants contend that Stryker waived this argument by failing to raise it with the Board until its final May 30, 2008, request for rehearing before the Board. See [39] Defs.’ Opp’n at 9-11. Biedermann relies on In re DBC, 545 F.3d 1373 (Fed.Cir.2008), for the proposition that an argument may be waived in federal court if it is not timely presented to the Board. The DBC court held that the appellant had waived his Appointments Clause challenge by failing to raise the issue before the Board and presenting for the first time on appeal in federal court. Id. at 1377-78. Although there is some language in DBC suggesting that a litigant must present a “timely” claim to the Board in order to preserve review in federal court, the rationale for that rule is to provide the agency an opportunity to correct any errors “before it is haled into federal court.” DBC, 545 F.3d at 1379 (quoting Woodford v. Ngo, 548 U.S. 81, 89, 126 S.Ct. 2378, 165 L.Ed.2d 368 (2006)). That objective is satisfied where, as in this case, the litigant raises the issue in a motion for rehearing. Indeed, the DBC court approved such an approach:

[N]othing prevented DBC from taking steps while this case was before the Board to ascertain the appointment status of the administrative patent judges assigned to its case. Even if DBC did not learn of the judges assigned to its panel until oral argument or until a decision was issued, it still had an opportunity to challenge the composition of the panel in a post-argument submission or in a motion for reconsideration. If DBC had timely raised this issue before the Board, the Board could have evaluated and corrected the alleged constitutional infirmity by providing DBC with a panel of administrative patent judges appointed by the Secretary. Of course, the Board may not have corrected the problem, or even acknowledged that the problem existed. But in that case, DBC would have preserved its right to appeal the issue.

545 F.3d at 1379. Not only did Stryker raise this issue in its request for rehearing, AR 495-96, the Board actually addressed the merits of this argument and rejected it, AR 535. The Court is therefore not persuaded that Stryker waived its Appointments Clause challenge by waiting until its request for rehearing to raise it with the Board.

2. The Appointments Clause

The Appointments Clause of the United States Constitution states:

[The President] shall nominate, and by and with the Advice and Consent of the Senate, shall appoint Ambassadors, other public Ministers and Consuls, Judges of the Supreme Court, and all other Officers of the United States, whose Appointments are not herein otherwise provided for, and which shall be established by Law; but the Congress may by Law vest the Appointment of such inferior Officers, as they think proper, in the President alone, in the Courts of Law, or in the Heads of Departments.

U.S. Const., art. II, § 2, cl. 2. “[A]ny appointee exercising significant authority pursuant to the laws of the United States is an ‘Officer of the United States,’ and must, therefore, be appointed in the manner prescribed by [the Appointments Clause].” Buckley v. Valeo, 424 U.S. 1, 126, 96 S.Ct. 612, 46 L.Ed.2d 659 (1976); see also Officers of the United States within the Meaning of the Appointments Clause, 37 Op. Off. Legal Counsel -, 2007 OLC LEXIS 3, at *11 (2007) (describing officers as those who possess delegated sovereign authority from the federal government). The Supreme Court has held that postmasters, district court clerks, Federal Election Commissioners, and special trial judges in Tax Court are all “inferior Officers.” See Freytag v. Comm’r, 501 U.S. 868, 880-82, 111 S.Ct. 2631, 115 L.Ed.2d 764 (1991); Buckley, 424 U.S. at 126, 96 S.Ct. 612 (citing cases). The difference between an “Officer of the United States” who must be appointed and an “employee” who may be hired is that employees are “lesser functionaries subordinate to officers of the United States.” Buckley, 424 U.S. at 126 n. 162, 96 S.Ct. 612. In explaining why a special trial judge in Tax Court is an inferior officer subject to the Appointments Clause, the Supreme Court noted that the office of special trial judge is established by law, with the duties, salary, and means of appointment specified by statute. Freytag, 501 U.S. at 881, 111 S.Ct. 2631. Moreover, the Court noted, they perform more than merely ministerial tasks, such as taking testimony, conducting trials, and ruling on the admissibility of evidence, and they exercise significant discretion. Id.

The Appointments Clause restricts Congress’s power to vest the appointment of inferior officers to the President, the “Courts of Law,” or the “Heads of Departments.” The Supreme Court has held that “the term ‘Department’ refers only to a part or division of the executive government, as the Department of State, or of the Treasury, expressly created and given the name of a department by Congress.” Freytag, 501 U.S. at 868, 111 S.Ct. 2631 (internal quotation marks and alterations omitted); see also Burnap v. United States, 252 U.S. 512, 515, 40 S.Ct. 374, 64 L.Ed. 692 (1920) (“The term ‘head of a department’ means ... the Secretary in charge of a great division of the executive branch of the government, like the State, Treasury, and War, who is a member of the Cabinet.”) The term does not include inferior commissioners and bureau officers. Id. (citing United States v. Germaine, 99 U.S. 508, 511, 25 L.Ed. 482 (1878)). The term “Courts of Law” has been interpreted to include both Article III courts and legislative courts created pursuant to Article I of the Constitution. Freytag, 501 U.S. at 890, 111 S.Ct. 2631.

3. Administrative Patent Judge Moore’s Appointment

The law regarding the appointment of administrative patent judges has changed several times within the last dozen years. Prior to March 29, 2000, administrative patent judges were appointed by the Secretary of Commerce. See 35 U.S.C.A. § 3(a) (West 1999) (“The Secretary of Commerce, upon the nomination of the Commissioner [of Patents and Trademarks], in accordance with law, shall appoint all other officers and employees.”). However, effective March 29, 2000, the law provided that administrative patent judges should be appointed by the Director of the PTO. See 35 U.S.C.A. § 6(a) (West 2000) (“The administrative patent judges shall be persons of competent legal knowledge and scientific ability who are appointed by the Director.”) In 2008, the law was changed again. See Act of August 12, 2008, Pub.L. No. 110-313, 122 Stat. 3014 (2008). The law now provides that administrative patent judges shall be “appointed by the Secretary of Commerce, in consultation with the Director.” 35 U.S.C.A. § 6(a) (West 2009). The 2008 Act also added two additional subsections relating to appointments previously made by the PTO Director:

(c) Authority of the Secretary. — The Secretary of Commerce may, in his or her discretion, deem the appointment of an administrative patent judge who, before the date of the enactment of this subsection, held office pursuant to an appointment by the Director to take effect on the date on which the Director initially appointed the administrative patent judge.

(d) Defense to challenge of appointment. — It shall be a defense to a challenge to the appointment of an administrative patent judge on the basis of the judge’s having been originally appointed by the Director that the administrative patent judge so appointed was acting as a de facto officer.

35 U.S.C.A. § 6 (West 2009).

The parties agree that Administrative Patent Judge James T. Moore was appointed to his position on November 5, 2001. See Stmt. (Unconstitutionality) ¶ 13; [47] Defs.’ Corrected Resp. Stmt. (Unconstitutionality) Mot. ¶ 13. This falls within the statutory time period during which APJ appointments were being made by the PTO Director. Although Defendants do not concede that APJ Moore was appointed by the PTO Director, they do concede that Moore was not appointed by the Secretary of Commerce. See [47] Defs.’ Corrected Resp. Stmt. (Unconstitutionality) ¶ 13. Stryker was unable to obtain discovery from the PTO to confirm that Moore was appointed in this manner, but exhibits provided by the United States provide clear evidence that APJ Moore was in fact appointed by the PTO Director on November 5, 2001. See [53] Intervenor United States’ Mem. Supp. Constitutionality of APJ Moore, Ex. 1 (Mem. Re: Ratification of the Director’s Administrative Patent and Trademark Judge Appointments) at 2-3. On August 12, 2008 — the day that the law was changed — the Secretary of Commerce reappointed APJ Moore and deemed the appointment to take effect on the date that the Director initially appointed him. Id., Ex. 1 at 6; id., Ex. 2, at 1.

4. Constitutionality of APJ Moore’s Initial Appointment

The Appointments Clause provides that administrative patent judges, as inferior officers of the United States, may only be appointed by either the President, a “Court of Law,” or a “Head of Department.” Because APJ Moore was appointed by the PTO Director, his initial appointment would have been unconstitutional unless the Director of the PTO can be considered either a “Court of Law” or a “Head of Department.” Defendants advance theories as to why the PTO Director may belong to either of these categories. The United States, as Intervenor, while not explicitly conceding the point, does not argue that APJ Moore was constitutionally appointed by the PTO Director. Rather, both Defendants and the United States argue that even if APJ Moore was unconstitutionally appointed in the first instance, his reappointment on August 12, 2008, cures any constitutional defect because (1) the Board issued its final decision on rehearing after the reappointment; (2) APJ Moore’s appointment was deemed retroactive by the Secretary of Commerce; and/or (3) APJ Moore’s prior actions were legitimate under the de facto officer doctrine.

It is well settled that courts should avoid deciding constitutional questions where it is not necessary to do so. See generally Ashwander v. Tenn. Valley Auth., 297 U.S. 288, 347, 56 S.Ct. 466, 80 L.Ed. 688 (1936) (Brandeis, J., concurring). Accordingly, the Court shall not decide whether APJ Moore’s appointment by the PTO Director was unconstitutional unless none of the three theories above cures the alleged constitutional defect. For purposes of the analysis below, the Court shall assume arguendo that APJ Moore’s initial appointment was unconstitutional.

5. The Board’s Decision on Rehearing After APJ Moore’s Reappointment

Defendants and Intervenor United States argue that APJ Moore’s reappointment by the Secretary of Commerce on August 12, 2008, cured any constitutional defect in the prior Board actions because the Board did not issue its final decision denying Stryker’s motion for rehearing until August 27, 2008. However, Stryker contends that the Board’s decision on rehearing could not ratify the prior rulings made by an unlawfully-constituted panel because the Board’s standard of review on rehearing is narrow in scope. Before examining the scope of the Board’s review in the context of a motion for rehearing, the Court shall examine the legal authorities cited by each party.

In support of their argument that a lawfully appointed officer can ratify the decisions of an unlawfully appointed officer, Defendants and Intervenor cite Andrade v. Regnery, 824 F.2d 1253 (D.C.Cir.1987). In Andrade, federal employees challenged the acts of agency officials who were implementing a reduction in force program (RIF) on the grounds that the officials had not been constitutionally appointed to their positions. See 824 F.2d at 1255. However, the court rejected the employees’ challenge because the official responsible for hiring agency employees was constitutionally appointed three days before the RIF formally went into effect. Id. at 1256-57. The court rejected the employees’ argument that the actions should be set aside because the RIF was planned and conceived before the officer was appointed, reasoning that the harm was not legally cognizable until it was formally implemented, which occurred only after an official was duly appointed. Id. at 1257. Defendants analogize the Board’s August 2008 decision on rehearing to the Andrade officer’s ratification of the earlier decisions. The United States also cites Olympic Federal Savings & Loan Association v. Director, Office of Thrift Supervision, No. 90-482, 1990 WL 134841 (D.D.C. Sept. 6, 1990). In Olympic, the court held that the plaintiffs Appointments Clause challenge was moot because the plaintiff: (a) did not oppose the government’s mootness argument, (b) did not identify any actions it sought to have invalidated, (c) did not contest the government’s representation that the properly appointed successor had ratified the prior director’s acts, and (d) did not argue that the de facto officer doctrine was inapplicable. Id. at *3.

In support of its view that a ruling on rehearing is not equivalent to ratification, Stryker cites Ryder v. United States, 515 U.S. 177, 115 S.Ct. 2031, 132 L.Ed.2d 136 (1995). In Ryder, the Supreme Court reviewed an Appointments Clause challenge brought by a Coast Guard enlistee convicted by a court-martial whose conviction was upheld on appeal, first by the Coast Guard Court of Military Review and then by the Court of Military Appeals. 515 U.S. at 179-80, 115 S.Ct. 2031. Two judges on the former court had been unconstitutionally appointed, but the Court of Military Appeals — despite realizing the constitutional violation — affirmed the judgment on the ground that the judges’ actions were valid de facto. Id. at 180, 115 S.Ct. 2031. The Supreme Court rejected this application of the de facto officer doctrine, id. at 183-84, 115 S.Ct. 2031, and went on to consider the government’s argument that any constitutional defect in the first court’s composition was effectively cured by the review available in the Court of Military Appeals, id. at 186, 115 S.Ct. 2031. The Court found that after “[e]xamining the difference in function and authority between the Coast Guard Court of Military Review and the Court of Military Appeals, it is quite clear that the former had broader discretion to review claims of error, revise factual determinations, and revise sentences than did the latter.” Id. at 187. Thus, the Court held that the Court of Military Appeals’ review did not cure the constitutional defect because it did not “g[i]ve petitioner all the possibility for relief that review by a properly constituted Coast Guard Court of Military Review would have given him.” Id. at 187-88, 115 S.Ct. 2031. Stryker analogizes the Board sitting in August 2008 to the Court of Military Appeals in Ryder — properly appointed but limited by a narrow standard of review.

Whether this case is governed by Andrade or Ryder depends upon the scope of the Board’s authority in the context of a motion for rehearing. If the Board had only limited authority on rehearing, then the properly constituted Board could not fully ratify its earlier decisions, even if they were not final for purposes of judicial review until a decision had been issued on rehearing. Requests for a rehearing are governed by Board Rule 125(e), which states in pertinent part:

(3) Burden on rehearing. The burden of showing a decision should be modified lies with the party attacking the decision. The request must specifically identify:

(i) All matters the party believes to have been misapprehended or overlooked, and

(ii) The place where the matter was previously addressed in a motion, opposition, or reply.

37 C.F.R. § 41.125(c)(3). The Board’s Standing Order also has a provision relating to requests for rehearings:

A request for rehearing is, in form, a miscellaneous motion, but no prior conference call is required. The argument responsive to the decision must be made with particularity in the following manner:

On page • — •, lines-, the opinion states —. The opinion is believed to have overlooked [or misapprehended] —. This point was set forth in — Motion [or Opposition or Reply] — at page —, lines

The request must include as an appendix an evidence list setting forth a list (in numerical order by exhibit number) of each exhibit that the party believes was overlooked or misapprehended.

AR 53 (Standing Order ¶ 125.2). As a miscellaneous motion, a request for rehearing is limited to 10 pages in length (excluding tables and appendices). AR 30 (Standing Order ¶ 121.2). The Standing Order further states that “[e]vidence not already of record at the time of the decision will not be admitted absent a showing of excusable neglect for the belated submission.” AR 53 (Standing Order ¶ 125.4). Stryker argues that these provisions authorize only a narrow standard of review on rehearing, limiting the Board to consideration of matters that have been “misapprehended or overlooked.” Stryker further claims, albeit without factual support, that the Board’s review on rehearing is akin to a district court’s review on a motion for reconsideration. See [55] Pl.’s Reply Mem. Resp. to United States’ Mem. at 4-5. Defendants and Intervenor dispute this interpretation of the Board’s regulations, construing the phrase “misapprehended or overlooked” as permitting the Board to consider on rehearing the substance of any issues that were previously before the Board.

There is admittedly some ambiguity in the Board’s regulations regarding the meaning of “misunderstood or overlooked.” However, the procedural limitations on briefing and the evidence in the record appear to be aimed at preventing an unsuccessful claimant from simply taking a second bite at the apple. And nothing in the regulations prohibits the Board from reconsidering the merits of the Board’s original decision, as long as the party properly includes the issues in its request. Here, the record shows that Stryker explicitly sought a full review on the merits in its May 30, 2008, request for rehearing of the Board’s denial of its Revised Substantive Motion l. See AR 488 (“[Stryker] respectfully requests that the Board ... rehear and reconsider the Board’s denial of Carbone Revised Substantive Motion 1 to Redefine the Interference by dividing Count 1 into two separate counts Although limited to ten pages by the rules, Stryker’s request discusses the arguments and facts raised in its Revised Substantive Motion, explaining why, in Stryker’s view, the inventions in proposed counts 2 and 3 are distinguishable from each other in view of prior art, discussing the level of ordinary skill in the art, and reviewing the legal authority cited by the Board in its April 30, 1998, opinion. See AR 488-94. Stryker also reattached the declaration of Charles L. Bush, Jr., which it had included in support of its Revised Substantive Motion 1. See AR 497-520.

The record indicates that the Board, sitting on rehearing as a constitutionally appointed panel, did address the merits of Stryker’s request for rehearing. The Board’s opinion on rehearing demonstrates that its analysis was detailed and thorough. See AR 532 (“Substantively, we have reviewed Carbone Revised Motion 1 anew on a page-by-page basis for a discussion of the specific elements of each count as compared to those of the other and how the differences are such that the subject matter of one count would not have been obvious over the subject matter of the other.”) The decision also reveals that it specifically reconsidered the merits of the analysis it previously conducted. See AR 532-33 (“The Board recognizes now and recognized when it wrote the initial decision that Carbone may have a theory on why these ‘inventions’ are conceptually different. ... The problem was and is that Carbone has failed to make the final, vital analysis — given the subject matter of one count why the subject matter of the other count would not have been obvious to one of ordinary skill in the art.”) In doing so, the Board reaffirmed its April 30, 2008, decision that Stryker had not established that the single count of the Interference embodied two patentably distinct inventions. See AR 469; AR 530-34. While the Board did not have occasion to revisit the January 22, 2008, decision regarding preliminary rulings by APJ Lee, those rulings involved motions that were contingent upon the success of the motion to redefine the Interference. Therefore, the denial of Revised Substantive Motion 1, upheld on rehearing, renders any constitutional defect in the January panel irrelevant.

Because the Board conducted the same analysis and reached the same conclusion on rehearing as it did in its initial decision on Stryker’s Revised Substantive Motion 1 (to redefine the Interference), Stryker cannot credibly argue that it was denied the opportunity to have its substantive claims considered by a properly constituted panel. Unlike in Ryder, the constitutionally-appointed rehearing panel gave Stryker all the possibility of relief that a properly constituted panel would have given it initially. Therefore, any constitutional defect in APJ Moore’s initial appointment was cured in this particular instance by the substantive decision on the merits on rehearing by a properly constituted panel.

In light of the substantive nature of the Board’s review on rehearing, a remand to the Board for de novo consideration is unnecessary. Although Stryker seeks a remand to a completely new panel of APJs, it has not provided the Court with any reason — other than administrative inertia — for ordering the Board to appoint a different panel of judges to rehear Stryker’s claims. See Pl.’s Unconstitutionality Br. at 16-17. That is inconsistent with the principle that a new judge should only be assigned on remand where there is some allegation of bias or impropriety by the prior judge. See, e.g., 28 U.S.C. § 144 (requiring recusal where judge has personal bias or prejudice against a party); Armco, Inc. v. United Steelworkers of Am., 280 F.3d 669, 683 (6th Cir.2002) (holding that factors to be considered before reassigning a different judge are (1) whether the original judge likely would have difficulty setting aside previously-expressed views on remand, (2) whether reassignment is advisable to preserve the appearance of justice, and (3) whether reassignment would be excessively wasteful and duplicative). Stryker fears that the same panel on remand might simply issue the same rulings that it did before. But such a result would not be unconstitutional. See Andrade, 824 F.2d at 1256-57 (holding that Appointments Clause is satisfied when constitutionally-appointed officer implements and ratifies the acts of prior, unappointed officers). Moreover, Stryker has not identified any reason to believe that a different panel would reach a different conclusion.

Accordingly, the Court shall deny Stryker’s Unconstitutionality Motion and grant-in-part Defendants’s motion for summary judgment with respect to the allegedly unconstitutional appointment of APJ Moore. Because the Court finds that the Board’s decision on rehearing cures the constitutional defect in its earlier decisions, it does not reach the parties’ alternative arguments regarding the 2008 statutory provisions permitting retroactive appointment and a defacto officer defense.

B. Redefining the Interference Count

The Court shall now address the parties’ cross-motions for summary judgment on the issue of whether the Board erred by failing to redefine the interference count as two separate counts — one for the “intersecting axes” invention and another for the “intersecting planes” invention. Stryker claims that these inventions are distinctly patentable and that the Board erred as a matter of law by declaring an interference based on a single count containing both inventions. Stryker now asks this Court to reverse the Board’s decision and either remand for further proceedings or rule on Stryker’s contingent motions for summary judgment as to unpatentability and lack of written specification or enabling disclosure. See Pl.’s Redefinition Br. at 43-44. Defendants claim that, based on the record before the Board and before this Court, Stryker cannot establish that its two proposed interference counts are distinctly patentable and therefore Defendants are entitled to judgment as a matter of law.

Stryker raises three primary claims of error by the Board in its motion for summary judgment. First, Stryker claims that the Board erred as a matter of law by declaring a single interference count consisting of multiple independent claims. Second, Stryker claims that the Board’s declaration of interference was arbitrary and capricious because the Board did not provide any rational explanation for declaring only a single claim. And third, Stryker claims that the Board erred by failing to redefine the interference as having two separate counts, one for each of Stryker’s patentably distinct inventions. After reviewing the evidence presented to the Board and the relevant standards that apply, the Court shall address each of the parties’ contentions.

1. The Significance of the Interference “Count”

According to PTO regulations, a “count” is “the Board’s description of the interfering subject matter that sets the scope of admissible proofs on priority.” 37 C.F.R. § 41.201. “Where there is more than one count, each count must describe a patent-ably distinct invention.” Id. The parties agree that to prevail on its motion to redefine the interference count to include two separate counts, Stryker must show that the inventions in proposed Counts 2 and 3 are patentably distinct from each other. See [41] Defs.’ Redefinition Opp’n at 15; [31] Pl.’s Redefinition Br. at 28. In proceedings before the Board, a party filing a motion to redefine the interference has the burden of proof to establish it is entitled to the relief requested. 37 C.F.R. § 41.121(b).

For one claim to be patentably distinct from another, the first claim must not be obvious based on the subject matter of the second claim. “A patent may not be obtained ... if 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 to a person having ordinary skill in the art to which said subject matter pertains.” 35 U.S.C. § 103(a). There are several basic factual inquiries associated with determining whether an invention is obvious: (1) the scope and content of prior art; (2) the differences between the claimed subject matter and the prior art; and (3) the level of ordinary skill in the pertinent art. Graham v. John Deere Co. of Kansas City, 383 U.S. 1, 17, 86 S.Ct. 684, 15 L.Ed.2d 545 (1966). Where appropriate, a court should also look to secondary factors that may be relevant to the obviousness analysis, such as commercial success, long felt but unsolved needs, and failure of others. Id. at 17-18, 86 S.Ct. 684; see also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406-07, 127 S.Ct. 1727, 167 L.Ed.2d 705 (2007) (reaffirming Graham). Whether a claim is patentably distinct from another is a question of law that is reviewed de novo. In re DBC, 545 F.3d 1373, 1377 (Fed.Cir.2008).

2. Stryker’s Motion to Redefine the Interference

In Stryker’s Revised Substantive Motion 1 (“Motion 1”), Stryker sought to persuade the Board that Count 1 of the interference actually contained two patentably distinct inventions and should therefore be redefined into two counts: Count 2 (pertaining to the “intersecting axes” invention) and Count 3 (pertaining to the “intersecting planes” invention). Stryker explained in Motion 1 that the '460 Patent is directed to spinal fixation devices for altering the alignment of adjacent vertebral bodies relative to each other, known as “pedicle screw systems.” AR 312-13. Stryker further explained that the prior art for these systems (including U.S. Patent No. 6,537,-276, the “Metz Patent”) captured a spine rod but did not work when the rod capturing assemblies needed to be rotated to extreme angles. AR 313. Stryker argued that to solve this problem, the '460 Patent encompassed two distinct bone fixation assembly inventions, exemplified by claims 1 and 18 of the '460 Patent. The first invention, described by claim l, creates greater angulation by having a pair of bores with longitudinal axes that intersect each other, thus biasing the head of a fastener to one side. AR 314. This “intersecting axes” invention also has a seat at the lower end of the coupling element and an anchoring element with a head in contact with that seat. Id. Stryker explained that the advantage of claim 1 over prior art is the much greater angulation of the fastener with respect to the coupling element, allowing the spinal rod to be situated closer to the bone. AR 315. Stryker uses the “intersecting axes” invention in a commercial product called the OASYS implant system. AR 314.

By contrast, Stryker explained in Motion 1 that claim 18 of the '460 Patent was directed to a bone fixation assembly “in which the coupling element has only a single bore extending from the upper end to the lower end,” but with the upper and lower ends defining first and second planes which intersect each other. AR 316. This “intersecting planes” invention also has an anchoring element and a coupling element with a U-shaped opening to receive a stabilizing rod. Id. Stryker argued that the “intersecting planes” invention was exemplified by all of the embodiments in Biedermann’s '431 Application and is also used in a commercial product sold by Defendant DePuy as the MOUNTAINEER OCT spinal system. Id. Stryker argued that although the “intersecting planes” invention also results in greater angulation compared to the prior art, it does so in a “very different manner” from the “intersecting axes” invention. AR 317. Stryker analyzed the products shown in the '431 Application and the c