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Prowess, Inc. v. RaySearch Laboratories, AB

United States District Court, Fourth Circuit

July 10, 2013

PROWESS, INC., Plaintiff,
v.
RAYSEARCH LABORATORIES, AB, et al., Defendants.

MEMORANDUM OPINION

William D. Quarles, Jr., United States District Judge

Prowess, Inc. ("Prowess") sued RaySearch Laboratories, AB ("RaySearch") and others[1] (collectively, the "Defendants") for patent infringement. A claim construction hearing was held on December 14, 2012 ("Hr'g"). Pending are the Defendants' motions for leave to file amended answers to the second amended complaint, and counterclaims, and to supplement the record in support of their opening claim construction brief. Also pending are the disputed claim construction issues. For the following reasons, the Defendants' motion for leave to file amended answers will be denied; the Defendants' motion to supplement the record will be granted; and the disputed claims will be construed as discussed herein.

I. Background[2]

A. The Parties

Prowess is a California healthcare technology company with its principal place of business in Concord, California. Second Am. Compl. ¶ 1. Prowess and RaySearch, a Swedish healthcare technology company, [3] develop software for the optimization of cancer radiation therapy. Second Am. Compl. ¶ 1; RaySearch Answer to Second Am. Compl. ¶ 2. Nucletron manufactures cancer radiation therapy equipment and is allegedly a licensee of RaySearch's software. Second Am. Compl. ¶ 3; Nucletron Answer to Second Am. Compl. ¶ 3. Effective March 1, 2012, Nucletron was merged into Elekta, Inc. ("Elekta"), a Georgia corporation with its principal place of business in Norcross, Georgia. Nucletron Answer to Second Am. Compl. ¶ 3.[4] Philips is a California company with its principal place of business in Cleveland, Ohio. Philips Answer to Second Am. Compl. ¶ 4. Philips manufactures cancer radiation therapy equipment and is allegedly a licensee of RaySearch's software. Second Am. Compl. ¶ 4; Philips Answer to Second Am. Compl. ¶ 4.

B. Radiation Therapy

Radiation therapy for cancer treatment involves shooting a beam of radiation at a tumor to destroy the cancerous cells' ability to reproduce. Second Am. Compl. ¶ 12. The radiation is emitted from a linear accelerator ("linac"), which is mounted on a gantry--essentially, a rotating base--and equipped with a collimator ("MLC") whose moving "fingers" form an aperture[5] to shape the radiation beam, thereby varying the dose received by the tumor. Second Am. Compl. ¶ 15; Joint Claim Constr. Statement (SEALED) at 1; Popple Decl.[6] (SEALED) ¶ 20; Claim Constr. Hr'g Tr. 6:22-25 to 7:1-4, 7:20-22, Dec. 14, 2012 [hereinafter, "Hr'g"].[7] Typically, the gantry remains stationary (in a "fixed-field" position) while the radiation is delivered. Popple Decl. (SEALED) ¶ 21.[8] In intensity-modulated radiotherapy ("IMRT"), the intensity of the radiation[9] is modulated within each delivered field. '008 patent col. 111.64-66. A gantry may also deliver radiation while moving in arcs ("intensity modulated arc therapy, " or "IMAT"). See Id . col. 2 11.55-56. In IMAT, the radiation beam remains "on" while the gantry is moving. See Hr'g 7:14-15.

In the process of delivering radiation, adjacent healthy organs and tissue may suffer collateral damage. Second Am. Compl. ¶ 12. To decrease this risk, physicians use computer software to develop treatment plans that adjust the intensity, shape, and angle of the radiation beam. Id. ¶ 13; see also Hr'g 8:6-14. There are two methods of planning radiation treatment: "forward"[10] and "inverse." Popple Decl. (SEALED) ¶ 23. "Forward" planning describes a manual "trial-and-error" approach, and is "best suited for cases in which the tumor has a simple shape and is not near any critical organs." Id. ¶ 24-25. By contrast, in "inverse" planning, a radiation oncologist "defines a patient's critical organs and target tumor and specifies the target dose and dose limitations to surrounding structures." Id. ¶ 26. The treatment planning system then uses an optimization program to determine optimal treatment "fields" (i.e., beams of radiation from a particular direction). Id.

Prowess alleges that inverse planning treatment was historically "limit[ed], " because optimization programs did not account for specific equipment limitations, or--with respect to the IMAT mode of delivery--the velocity of the MLC leaves and gantry. Second Am. Compl. ¶ 15; see Popple Decl. ¶¶ 27-28. Manual reconfiguration by the individual radiologist was required to render the treatment plan deliverable. See generally Hr'g 9-10.

C. The '008 and '591 Patents

On January 9, 2007 and February 19, 2008, U.S. Patent Nos. 7, 162, 008 (the "'008 patent") and 7, 333, 591 (the "'591 patent") were issued to inventors Matt A. Earl, David M. Shepard, and Xingsheng (Cedric) Yu (collectively, the "inventors"). See generally '008 patent; '591 patent (ECF No. 87-2 (SEALED)).[11]According to Prowess, the patents "disclose[] and claim[] innovative and valuable improvements in the process of developing treatment plans using IMAT and IMRT." Second Am. Compl. ¶¶ 18, 24; see also Hr'g 6:21-22. Specifically, the patents are "directed to methods and software of directly taking machine parameters (i.e., MLC motion speed, gantry speed, and the range of dose rates) into account." ECF No. 92 (SEALED) at 14 (bold and italic emphasis in original). This technique-- which the inventors named "direct aperture optimization" ("DAO")[12]

requires just one step: the treatment planner simply enters in the dose prescriptions for the tumor and restrictions for surrounding structures, and the output of the inventors' patented algorithm is an aperture configuration that is automatically generated by the computer software, . . . which is readily deliverable.

ECF No. 92 (SEALED) at 14 (emphasis in original). The invention "allows for" the planning for IMRT, IMAT, or a "new type" of intensity-modulated radiotherapy that combines IMRT and IMAT. '008 patent col. 2 1.67 to col. 3 1.3. "Hybrid IMRT" "provides the ability to incorporate into each treatment plan the dosimetric advantages of both IMRT and IMAT." Id. Col. 3 11.4- 6.

The '008 and '591 patents were assigned to the University of Maryland ("UMD") and exclusively licensed to Prowess. E.g., Hr'g 6:15-20.

D. Procedural History

On May 18, 2011, Prowess filed suit for patent infringement against Nucletron, RaySearch, and Philips Healthcare Informatics, Inc. ECF No. 1. On June 3, 2011, Prowess amended the complaint to add Philips as a defendant. ECF No. 5. On August 19 and 22, 2011, the Defendants answered the amended complaint and counterclaimed. ECF Nos. 13, 14, 17. On September 8, 2011, Prowess answered. ECF Nos. 29-31.

On March 15, 2012, Prowess filed a second amended complaint alleging that RaySearch "has been and is offering" certain software[13] that employs algorithms which infringe upon "most, if not all" of the '008 and '591 patent claims. Second Am. Compl. ¶¶19, 25. Prowess further alleged that RaySearch has contributed to infringement of the patents by providing the SmartArc module to radiation therapy equipment manufacturers like Nucletron and Philips. Id. Prowess alleged that Nucletron and Philips are infringing the patents by selling radiation therapy equipment that "includes and employs" RaySearch's software. Id. ¶¶ 20, 26. Finally, Prowess alleged that the Defendants willfully infringed the patents by "continuing their acts of infringement after having been provided notice of the Patent by Prowess." Id. ¶¶ 21, 27.[14] On April 4, 2012, the Defendants answered and counterclaimed, seeking declarations of noninfringement and patent invalidity. ECF Nos. 66-68. On April 30, 2 012, Prowess answered. ECF Nos. 70-72.

On September 7, 2012, the parties filed a Joint Claim Construction Statement. ECF No. 91 (SEALED).[15] Also on September 7, the parties filed their respective opening claim construction briefs (individually, "opening brief"). ECF Nos. 87 (SEALED), 92 (SEALED). On October 12, 2012, the parties filed their respective responsive claim construction briefs (individually, "responsive brief"). ECF Nos. 105 (SEALED), 106 (SEALED). On October 22, 2012, Prowess moved to strike the Defendants' responsive brief and requested an expedited briefing schedule. ECF No. 114 (SEALED).[16] On November 5, 2012, the Defendants opposed the motion to strike. ECF No. 116. On November 15, 2012, Prowess replied. ECF No. 121.

On November 30, 2012, the Defendants moved for leave to file amended answers and defenses to the second amended complaint, and counterclaims. ECF Nos. 126, 127 (SEALED). On December 13, 2012, the Court denied Prowess's motion to strike the Defendants' responsive brief on claim construction. ECF Nos. 146 (SEALED), 147 (SEALED). On December 14, 2012, the Court held a claim construction hearing. ECF No. 148. On December 17, 2012, the Defendants moved to supplement the record in support of their opening brief. ECF No. 14 9. Also on December 17, Prowess opposed the Defendants' motion for leave to file amended answers. ECF No. 151 (SEALED). On January 7, 2013, the Defendants replied. ECF No. 164 (SEALED). That day, Prowess opposed the Defendants' motion to supplement the record. ECF No. 168 (SEALED). On January 24, 2013, the Defendants replied. ECF No. 179 (SEALED).

II. The Defendants' Motions

Before reaching the merits of the claim construction issues, the Court will address the Defendants' pending motions.

A. Motion for Leave to File Amended Answers and Defenses to the Second Amended Complaint, and Counterclaims

The Defendants seek leave to file amended answers to the second amended complaint, and counterclaims, on the grounds that they have "recently learned of facts" that support adding as affirmative defenses and counterclaims inequitable conduct, unclean hands, and infectious unenforceability. See ECF No. 126 at 1. See generally ECF Nos. 126-4, 126-5, 126-6. Prowess contends that the Defendants' motion "fail[s] to satisfy" the Federal Circuit's "heightened" standard for proving inequitable conduct, and the Defendants' other amendments--which are "based entirely" on the inequitable conduct allegations--should be rejected for the same reason. See ECF No. 151 (SEALED) at 1 n.l, 2-3. Prowess further argues that the Defendants' evidence of inequitable conduct is insufficient "as a matter of law, " rendering amendment futile. Id. at 3.

The Federal Rules of Civil Procedure create "tension" over the standard applicable to motions to amend pleadings[17] when a scheduling order sets a deadline for amendment.[18] Specifically, Rule 15(a)(2) instructs the Court to "freely give leave [to amend a pleading] when justice so requires"; under the Rule, a motion to amend should be denied only when "the amendment would be prejudicial to the opposing party, there has been bad faith on the part of the moving party, or the amendment would be futile."[19] On the other hand, Rule 16(b) requires the Court to issue a scheduling order that "limit[s] the time to join other parties, amend the pleadings, complete discovery, and file motions." Fed.R.Civ.P. 16(b)(1), (3)(A). The schedule "may be modified only for good cause and with the judge's consent." Fed.R.Civ.P. 16(b)(4). Although the interplay between these rules is unclear, the Fourth Circuit has clarified that a party must first demonstrate good cause to modify scheduling order deadlines, before also satisfying the Rule 15(a)(2) standard for amendment.[20]

Here, the November 16, 2011 scheduling order required motions for amendment of pleadings to be filed within 60 days. ECF No. 43 (I.A.6). On February 28, 2012, the Court granted the parties' joint motion for leave to extend all deadlines by 3 0 days. ECF No. 58. The scheduling order was modified for the third time on March 22, 2012. ECF No. 65. The amended order required Prowess to file and serve a second amended complaint on March 21, 2012, and required the Defendants to answer the second amended complaint by April 4, 2012. Id. at 1. The order further provided that, " [a]11 unamended portions of the Scheduling Order . . . remain in full effect." Id. at 3.[21]

Accordingly, the deadline for motions to amend remained 90 days after entry of the initial scheduling order, or February 14, 2012. The Defendants' motion was filed more than nine months later, on November 30, 2012. ECF No. 126. Thus, the motion may be granted only if the Defendants have--as an initial matter—shown good cause. Nourison, 535 F.3d at 298; see also Cook, 484 F.App'x at 814-15.

Rule 16(b) good cause exists when, inter alia, a party "uncover[s] previously unknown facts during discovery that would support an additional cause of action." Forstmann v. Culp, 114 F.R.D. 83, 86 n.l (M.D. N.C. 1987) (quoted and cited in In re Lone Star Indus., Inc. Concrete R.R. Cross Ties Litig., 19 F.3d 1429 (Table), 1994 WL 118475, at *11 (4th Cir. 1994)).

"Inequitable conduct is an equitable defense to patent infringement that, if proved, bars enforcement of a patent." Therasense, Inc. v. Becton, Dickinson & Co., 649 F.3d 1276, 1285 (Fed. Cir. 2011) (en banc), [22] "Each individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the [PTO], which includes a duty to disclose . . . all information known to that individual to be material to patentability . . . . "[23] "A patent applicant's duty to disclose is not limited to disclosing prior art. A patent applicant must disclose any material information to the PTO." Critikon, Inc. v. Becton Dickinson Vascular Access, Inc., 120 F.3d 1253, 1258 (Fed. Cir. 1997).

"To establish unenforceability based on inequitable conduct in the PTO, it must be shown that information material to patentability was withheld from the PTO, or material misinformation was provided to the PTO, with the intent to deceive or mislead the patent examiner into granting the patent."[24] Allegations of inequitable conduct must be pled with particularity. Fed R. Civ. P. 9(b);[25] see Exergen Corp. v. Wal-Mart Stores, Inc., 575 F.3d 1312, 1318 (Fed. Cir. 2009).

"Whether inequitable conduct has been pleaded with particularity under Rule 9(b) is a question governed by Federal Circuit law." Exergen, 575 F.3d at 1318. "[I]n pleading inequitable conduct in patent cases, Rule 9(b) requires identification of the specific who, what, when, where, and how of the material misrepresentation or omission committed before the PTO." Id. at 1327. The pleading "must [also] include sufficient allegations of underlying facts from which a court may reasonably infer that a specific individual (1) knew of the withheld material information or of the falsity of the material misrepresentation, and (2) withheld or misrepresented this information with a specific intent to deceive the PTO." Id. at 1328-29 (emphases added). "A reasonable inference is one that is plausible and that flows logically from the facts alleged, including . . . objective indications of candor and good faith." Id. at 1329 n.5.

The Defendants argue that the proposed amended answers adequately plead inequitable conduct in "over [50] paragraphs of specific details describing multiple material references and prior disclosures of the invention that were . . . withheld from the PTO." ECF No. 127 (SEALED) at 6 (citing ECF Nos. 126-1 to -3, ¶¶10-62). The Defendants further argue that the answers "provide enough details regarding the materiality of the references and prior disclosures to enable a court to reasonably infer that the withholding parties acted with the requisite state of mind." Id. Prowess contends that the Defendants' motion ignores the "new, strict evidentiary standards" for proving inequitable conduct set forth in Therasense, Inc. v. Becton, Dickinson & Co., 649 F.3d 1276 (Fed. Cir. 2011) (en banc). ECF No. 151 (SEALED) at 2.[26] Prowess further argues that the Defendants have failed to plead inequitable conduct with particularity, and amendment would be futile. Id. at 2-3, 6.

As a preliminary matter, the issue before the Court is whether the Defendants have pled--not proven--inequitable conduct. See Delano Farms, 655 F.3d at 1350; Therasense, 649 F.3d at 1285 (addressing appeal from district court's award of summary judgment due to inequitable conduct); Pfizer Inc. v. Teva Pharm. USA, Inc., 803 F.Supp.2d 409, 432 (E.D. Va. 2011) ("[A]t the pleading stage[, ] a party is not required to meet the clear and convincing evidence standard that applies on the merits."). However, the Court also recognizes its duty after Therasense to "take an active role in examining the propriety of inequitable conduct claims"--a function that "cannot [be] perform[ed]" without "incorporating allegations of the specific elements to be proven on the merits at the pleading stage, albeit at a lower standard of plausibility." Teva Pharm. USA, 803 F.Supp.2d at 432.

Here, the Defendants seek leave to allege two bases of inequitable conduct in prosecution of the '008 and '591 patents: withholding of references, and withholding of prior "disclosures" of the claimed invention that would anticipate the patent claims. See generally ECF No. 126-1, Countercls. ¶¶10-61 [hereinafter, "Countercls."][27] The Court will address each in turn.

1. Withheld References

The Defendants allege that the '008 and '591 patents' inventors--Earl, Shepard, and Yu--withheld four publications from the PTO during the patents' prosecution: (1) J. Tervo & P. Kolmonen, A Model for the Control of a Multileaf Collimator in Radiation Therapy Treatment Planning, 16 Inverse Problems 1875 (2000) ("Tervo"); (2) Werner De Gersem, Leaf Position Optimization for Step-and-Shoot IMRT, 51 Int'l J. Radiation Oncology 1372 (2001) ("De Gersem"); (3) Paul S. Cho & Robert J. Marks II, Hardware-Sensitive Optimization for Intensity Modulated Radiotherapy, 45 Physics Med. & Biology 429 (2000) ("Cho & Marks"); and (4) Johan Lof, Development of a General Framework for Optimization of Radiation Therapy, Stockholm (2000) (the "Lof thesis") (collectively, the "withheld references"). Countercls. ¶¶ 11-14. The Defendants assert that they did not learn of this alleged misconduct until the inventors' October and November 2012 depositions. See generally ECF No. 127 (SEALED) at 2-3.

a. Materiality

The Defendants allege that the withheld references are "but-for material" to the patentability of "the claims of the '008 and '591 patents" because--like the patents--the references are "related to" the optimization of radiation treatment plans wherein the constraints of the machine are directly considered. Countercls. ¶¶ 21, 26, 33. The Defendants further allege that the withheld references "directly contradict" statements made to the PTO during prosecution of the '008 patent, in that "[i]t was repeatedly argued" to the Office that prior art did not disclose one-step optimization. Id. ¶¶ 21, 28; see also Id . ¶¶ 29-33. The Defendants conclude that the PTO "would not have allowed the claims of" either patent had it been aware of these withheld references. E.g., Id . ¶¶ 24, 26.

As discussed above, Rule 9(b) requires allegations of inequitable conduct to include "identification of the specific who, what, when, where, and how" of the material omission committed before the PTO. Exergen, 575 F.3d at 1327. To satisfy the first element, the pleading must name the person who knew of the material information and deliberately withheld or misrepresented it. See id. at 1329. To plead the "what" and "where" of the material omissions, the pleading must identify "which claims, and which limitations in those claims, the withheld references are relevant to, and where in those references the material information is found." Id.[28]To allege "why" the withheld information was material and not cumulative--and "how" an examiner would have used the information in assessing patentability--the pleading must also indicate "the particular claim limitations, or combination of claim limitations, " that are supposedly absent from the information of record. Id.[29] Factual deficiency as to any of the above elements is "fatal under Rule 9(b)." Id. at 1330.

Assuming that the withheld disclosures are prior art, [30] the Defendants have not identified which patent claims the references are relevant to, or which claim limitations are absent from the information of record. Cf. Exergen, 575 F.3d at 1329.[31] Further, that the withheld references arguably "contradict" statements made during prosecution of the '008 patent, see Countercls. ¶¶ 21, 28-33, does not salvage the Defendants' motion. In support of this argument, the Defendants cite sections of the Manual of Patent Examining Procedures (the "MPEP") regarding the duty to disclose information material to patentability, [32] as well as 37 C.F.R. § 1.56[33] (Rule 56). E.g., Countercls. ¶ 10. But the MPEP is not binding on this Court, [34] and the Federal Circuit has expressly declined to adopt Rule 56 as a definition for inequitable conduct. See Therasense, 64 9 F.3d at 1295 ("Because Rule 56 sets such a low bar for materiality, adopting this standard would inevitably result in patent prosecutors continuing the existing practice of disclosing too much prior art of marginal relevance and patent litigators continuing to charge inequitable conduct in nearly every case as a litigation strategy.").

Thus, the Defendants have failed to plausibly allege, with particularity, that the withheld references are material. Their motion fails for this reason alone. Exergen, 575 F.3d at 1330.

b. Knowledge and Intent

In addition to showing materiality, the pleading "must include sufficient allegations of underlying facts from which a court may reasonably infer that a specific individual (1) knew of the withheld material information or of the falsity of the material misrepresentation, and (2) withheld or misrepresented this information with a specific intent to deceive the PTO." Exergen, 575 F.3d at 1328-29 (emphases added).

The Defendants allege that the inventors "knew of" Tervo and De Gersem "at least as early as September 26, 2001, " as they cited the publications in an article they coauthored that was received on that date;[35] the inventors "knew of" Cho Sc Marks by February 4, 2003, as they cited the publication in an article "created" for an American Association of Physicists in Medicine ("AAPM") summer program (the "Summer School Paper")[36]; and "at least" Shepard and Yu "knew of" the Lof thesis at some time "before the issuance of the '008 and '591 patents." Countercls. ¶¶ 15-17.[37] The '008 patent application was filed on December 3, 2002; the '591 patent application was filed on October 27, 2006. See generally '008 and '591 patents.

In addition to alleging prior knowledge of the existence of the withheld references, the Defendants allege that the inventors knew the references contained material information. Specifically, the Defendants allege that the inventors "knew" Tervo and De Gersem were material to the patentability of the '008 and "591 patent claims, because the 2002 Turnkey article referenced Tervo and De Gersem in addition to T. Bortfeld, X-Ray Compensation with Multileaf Collimators, 28 Int'l J. Radiation Oncology 713 (1994) ("Bortfeld"), but only disclosed the latter to the PTO. Countercls. ¶¶ 22-24.[38] The Defendants also allege that the Summer School Paper evidences knowledge of materiality as to Cho & Marks, because page 3 of the Summer School Paper cited Cho & Marks in noting that, "[b]ecause the leaf-sequencing is constrained by the delivery hardware, a large number of complex field shapes are often needed, " which could "lead to a loss in efficiency and an increase in collimator artifacts." Id. ¶ 25. Finally, "[a]t least" Shepard and Yu knew the Lof thesis was material, because the Lof thesis was cited as the first reference in the White Papers describing the technology at issue here (direct machine parameter optimization) . Id. ¶ 27.

The Court will assume, for purposes of this analysis, that the Defendants have adequately alleged the inventors' knowledge of the withheld material information. Without elaboration, the Defendants assert that "the only reasonable inference" to be drawn from the above facts[39] is that the references were withheld "with the specific intent to deceive the [PTO]." Countercls. ¶¶ 34, 36, 38, 40.[40] However, "[t]he mere fact that an applicant disclosed a reference during prosecution of one application, but did not disclose it during prosecution of a related application, is insufficient to meet the threshold level of deceptive intent required to support an allegation of inequitable conduct." 575 F.3d at 1331. It follows, then, that the mere fact that an inventor cited a reference in a publication predating a patent, but did not disclose the reference as prior art regarding the patent, is insufficient to show that the inventor acted with the specific intent to deceive. Certainly, no facts suggest that the specific intent to deceive is "the single most reasonable inference" to be drawn from the facts alleged. See Therasense, 649 F.3d at 1290.[41]

2. Prior "Disclosures" of the Claimed Invention that Would Anticipate the Patents

The Defendants allege that Yu "disclosed the claimed invention"[42] to Elekta "several times" before the '008 and '591 patent applications were filed, including at an IMRT Consortium in "April or May" 1999 and during a July 21, 1999 presentation (the "1999 Elekta disclosures"). Countercls. ¶ 41. Yu--acting alone "or" with Shepard--also "disclosed the claimed invention" to Philips and Elekta employees, including Doctor Todd McNutt, at ASTRO and AAPM Annual Meetings in "either 2000 or 2001" (the "2000/2001 Philips and Elekta disclosures"). Id. ¶¶ 46, 50. Yu and Shepard "disclosed the claimed invention" to Nucletron employees Jaap Pijpelink and Kate Driggers during a September 13, 2001 presentation at the University of Maryland (the "2001 Nucletron disclosures"). Id. ¶ 54. Finally, "[u]pon information or belief, " Yu--alone "or" with Doctor Sarfaraz--"disclosed the claimed invention" to Dean Renner, the owner of Math Resolu- tions, sometime "before the patent applications . . . were filed" (the "Math Resolutions disclosures"). Id. ¶ 58.

a. Materiality

The Defendants allege that the above disclosures of "the claimed invention" are "but-for material" to the patentability of "the '008 and '591 patents"[43] because they were not the subject of any nondisclosure or confidentiality agreements and would anticipate the claims of the patents for purposes of 35 U.S.C. § 102(a).[44] Countercls. ¶¶ 43-44, 47-48, 51-52, 55-56, 59-60.

Under 35 U.S.C. § 102(a), a person shall be entitled to a patent unless, inter alia, the invention was "known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for patent." 35 U.S.C. § 102(a)(1); see also supra note 44. To be anticipatory, a single prior art reference must "expressly or inherently disclose each claim limitation." Finisar Corp. v. DirecTV Grp., Inc., 523 F.3d 1323, 1334 (Fed. Cir. 2008). Anticipation further requires the presence of "all elements of a claimed invention arranged as in the claim." Id . at 1334-35. "[T]he dispositive question regarding anticipation [is] whether one skilled in the art would reasonably understand or infer from a [prior art reference]" that every claim element is disclosed in that reference. In re Baxter Travenol Labs., 952 F.2d 388, 390 (Fed. Cir. 1991).

Here, the Defendants have failed to allege the form--let alone the content--of the information allegedly disclosed by the inventors to Elekta, Philips, and Nucletron employees between 1999 and 2001. See generally Countercls. ¶¶ ¶¶ 41, 46, 50, 54, 58. The Defendants' conclusionary statement that the disclosures "anticipate[d] the claims of the patents"[45] does not suffice, for "[a] pleading that simply avers the substantive elements of inequitable conduct, without setting forth the particularized factual bases for the allegation, does not satisfy Rule 9(b)." Exergen, 575 F.3d at 1326-27. Without any specific factual allegations as to what was said or shared, this Court cannot reasonably infer that the disclosures are but-for material because they anticipated the patents in suit,

b. Knowledge and Intent

Without elaboration, the Defendants assert that "the only reasonable inference" to be drawn from the above facts is that the inventors did not disclose to the PTO the 1999 Elekta disclosures, the 2000/2001 Philips and Elekta disclosures, the 2001 Nucletron disclosures, or the Math Resolutions disclosures to "deceive the [PTO]." Countercls. ¶¶ 45, 49, 53, 57, 61. As discussed above, the Defendants' conclusionary assertion that the inventors intended to deceive the PTO is insufficient under Rule 9(b).

Contrary to Prowess's suggestion, [46] the Defendants need not prove--at this stage in the proceedings--that inequitable conduct occurred. However, the Defendants must satisfy their burden of pleading, with particularity, the who, what, when, where, and how of the alleged misconduct, as well as facts from which this Court could infer that the inventor(s) who allegedly withheld or misrepresented the relevant information did so knowingly and with the specific intent to deceive. See generally Exergen, 575 F.3d at 1327-29. The Defendants have failed to carry this burden. Accordingly, they have not shown good cause to amend the scheduling order. See Fed. R. Civ. P. 16(b)(4); Cook, 484 F.App'x at 814-15; Forstmann, 114 F.R.D. at 86 n.l.[47] Their motion for leave to amend will be denied.[48]

B. Motion to Supplement the Record in Support of Opening Brief

The Defendants move to supplement the record in support of their opening claim construction brief to include a PowerPoint presentation (the "PowerPoint")[49] produced by counsel for Shepard and Prowess during Shepard's November 28, 2012 deposition. See generally ECF Nos. 149, 149-1. The Defendants argue that supplementation is appropriate because Prowess--which had control over the PowerPoint through its representation of Shepard--would not be prejudiced by the document's addition to the record, and because the PowerPoint--which was presented to the PTO examiner during prosecution of the '008 patent--is relevant to claim construction. ECF No. 149-1 ¶10. Prowess objects that the motion is "untimely and improper, " and "will only serve to delay judicial proceedings and prejudice Prowess." ECF No. 168 (SEALED) at 1-2.

When ruling on a motion to supplement, courts should consider the harm, if any, that would result from supplementation, and whether the proposed evidence "enhances the Court's truth-finding function." StemCells, Inc. v. Neuralstem, Inc., Nos. 8:06-CV-01877-AW, 8:08-CV-02664-AW, 8:08-CV-01173-AW, 2012 WL 1184545, at *8 (D. Md. Apr. 6, 2012).[50]

Shepard was first made available for deposition on November 28, 2012. ECF No. 149-1 ¶6. The PowerPoint was produced during the afternoon session. Id.[51]At the deposition, Shepard testified about the origins and purpose of the PowerPoint, id. ¶ 7:

Q: You have been handed, Dr. Shepard, Exhibit Number 25, which bears the Bates stamp number SHEP876 through 929. This was provided to us a short while ago today during the deposition. Do you recognize this?
A: Yes.
Q: And this is what you presented to the U.S. PTO at one of your meetings with the examiner, isn't that correct?
A: I believe that's correct, yes.
Q: And this is something that was prepared by you or under ...

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