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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 your supervision?
A: Yes.
Q: And what was your purpose in preparing this?
A: If my recollection is correct about this, specifically, file, I don't know if this is exactly the presentation but it's certainly close to the presentation that was given to--after the objections that were raised about the Carol patent, we met with the patent office, described to the representative--
Q: The examiner?
A: --examiner, what our patent was about and how it's differentiated from the Carol patent.
Q: Okay. And was--are the statements that you've made in this document true and accurate to the best of your belief?
A: Yes. Sorry. Yes.
Q: Okay.

ECF No. 168 (SEALED), Ex. 6 221:22 to 223:1-7. During Che January 3, 2013 deposition of UMD's outside counsel Susan Pan, who prosecuted the '008 and '591 patents before the PTO, Pan testified that she could not recall whether the PowerPoint had been given to the examiner:

Q. Ms. Pan, I have handed you what's marked as Pan Exhibit 16 which David Shepard testified was the power point presentation made to the USPTO on October 6, 2005. Feel free to take a look at it and then tell me if you recognize it.
A. I can't say that it's ringing any bells in my mind.
Q. We're going to proceed under the assumption that David Shepard testified accurately.
* * *
Q. Do you know how much time the inventors spent putting this power point together?
A: No. I have no idea.
Q. Do you know if anyone authored this power point other than David Shepard and Matthew Earl as is indicated on the first page?
A. I wouldn't know.
Q. Well, if you had an inkling that someone else participated, would you have inquired?
A. For the power point?
Q. Yes.
A. You mean like if an administrative assistant helped them?
Q. No. If someone had actually authored the substance other than Mr. Shepard and Mr. Earl.
A. I don't believe it would have crossed my mind.
Q. Who made this power point presentation to the examiner?
A. I don't recall.
Q. Fair to assume that you have not seen this power point presentation before you met with the inventors the day of the presentation?
A. I don't see it - it's a very long power point. Very long. And typically examiner interviews are only an hour or so. So I don't know if this was what was presented at the examiner interview. I don't recall seeing this power point.
Q. Well, you saw a reference in the record to the power point, didn't you?
A. Yes. But nothing ties this to the application in any way.
Q. You mean other than Mr. Shepard's testimony?
A. I don't know what Mr. Shepard has testified to.
Q. I'm asking you to assume that he testified he did make this presentation.
A. Okay.
Q. So with that assumption in mind, would you have made this presentation to the USPTO as well as Mr. Shepard?
A. I don't believe I--I don't believe I would have.

ECF No. 168 (SEALED), Ex. 7 119:19 to 121:22.

At the December 14, 2012 claim construction hearing, the Defendants orally moved to supplement the record to include the PowerPoint. ECF No. 149-1 ¶ 8; see Hr'g Tr. 81:3-5. The motion to supplement was filed three days later. ECF No. 14 9. Prowess objects to the motion on three grounds, none of which is persuasive.

First, Prowess argues that the motion is untimely because the PowerPoint was in the Defendants' possession for "weeks" before the claim construction hearing, but "at no point" did the Defendants seek a stipulation from Prowess to supplement their claim construction evidence or move for leave to amend their claim construction statement and chart. ECF No. 168 (SEALED) at 1; see id. at 6. The PowerPoint was produced to the Defendants on November 28, 2012; the Defendants moved orally to supplement the record to include the document just over two weeks later. ECF No. 149-1 ¶ 6; Hr'g Tr. 81:3-5. In a case that has been pending for more than two years, a two-week response time is hardly dilatory.

Next, Prowess argues that the Defendants' motion should be denied because the PowerPoint is not "intrinsic" evidence. ECF No. 168 (SEALED) at 7-9.[52] Specifically, Prowess asserts that Shepard "could not confirm" whether the PowerPoint is the same document he showed to the examiner; Pan did not recall the PowerPoint at all; and the PowerPoint was never released to the public. Id. Because extrinsic evidence is "significantly less useful" than intrinsic evidence, Prowess concludes that the PowerPoint "is not helpful to this Court." Id. at 8-9. Even assuming that the PowerPoint is not intrinsic evidence, Prowess's argument fails: extrinsic evidence is routinely useful to "show what was then old, to distinguish what was new, and to aid the court in the construction of the patent." Markman v. Westview Instruments, Inc., 52 F.3d 967, 980 (Fed. Cir. 1995) (internal quotation marks omitted), aff'd, 517 U.S. 370 (1996).

Prowess's final argument--that supplementation would be "futile" because the PowerPoint "does not show any disavowal of claim scope, and therefore cannot change the plain and ordinary meaning of [the disputed] terms"--is also wrong. ECF No. 168 (SEALED) at 9 (emphasis in original). Reference to the PowerPoint may ultimately be unnecessary. However, the Defendants need only show that the document may aid in the Court's truth-finding function and that consideration of the PowerPoint, to the extent it is warranted, would not prejudice Prowess. Stemcells, 2012 WL 1184545, at *8. The PowerPoint was written by two of the three inventors of the patents in suit, and was presented to the patent examiner during prosecution of one of those patents in support of the inventors' arguments as to DAO's novelty. See ECF No. 149-2 at 29-55; ECF No. 168 (SEALED), Ex. 6 221:22 to 223:1-7. Accordingly, it is--at the very least--extrinsic evidence that could be helpful to the Court. Moreover, Prowess has had access to the PowerPoint since Shepard produced it seven months ago. Thus, the possibility of prejudice to Prowess is de minimis.

The Defendants' motion to supplement the record will be granted.

III. Claim Construction A. Legal Standards

1. Claim Construction Generally

Claim construction is a question of law, to be determined by the court. Markman v. Nestview Instruments, Inc., 517 U.S. 370, 384 (1996). Specifically, "[c]laim construction is a matter of resolution of disputed meanings and technical scope, to clarify and when necessary to explain what the patentee covered by the claims, for use in the determination of infringement. It is not an obligatory exercise in redundancy."[53] Therefore, "district courts are not . . . required to construe every limitation present in a patent's asserted claims." 02 Micro Int'l Ltd. v. Beyond Innovation Tech. Co., 521 F.3d 1351, 1362 (Fed. Cir. 2008). For instance, terms that are "commonplace" or that "a juror can easily use [] in her infringement fact-finding without further direction from the court" need not be construed because they "are neither unfamiliar to the jury, confusing to the jury, nor affected by the specif ication[54] or prosecution history[55] . "[56]

"Although a claim is not to be construed in light of the accused device, it must inevitably be construed in the context of the accused device." Pulse Med. Instruments, Inc. v. Drug Impairment Detection Servs., Inc., No. DKC 07-1388, 2009 WL 6898404, at *2 (D. Md. Mar. 20, 2009). "It is only after the claims have been construed without reference to the accused device that the claims, as so construed, are applied to the accused device to determine infringement." SRI Int'l v. Matsushita Elec. Corp. of Am., 775 F.2d 1107, 1118 (Fed. Cir. 1985) (en banc) (emphasis in original).

"It is a bedrock principle of patent law that the claims of a patent define the invention to which the patentee is entitled the right to exclude."[57] Thus, when construing a claim, a court should give its words their "ordinary and customary meaning" as would be understood by "a person of ordinary skill in the art in question at the time of the invention."[58]

"The claim should be read within the context of the entire patent, including the specification." Pulse, 2009 WL 6898404, at *2. The specification "is always highly relevant to the claim construction analysis. Usually it is dispositive; it is the single best guide to the meaning of a disputed term."[59] "The specification functions as a dictionary to explain the claimed subject matter and define the terms used in the claims[, but] is to be used only to interpret words or phrases of a patent claim, not to add to, or detract from, the language of the claims."[60] "In some instances, the ordinary meaning of a claim as understood by a person of skill in the art will be readily apparent from the words themselves and in those situations, general language dictionaries may be of assistance." Pulse, 2009 WL 6898404, at *2 (citing Phillips, 415 F.3d at 1314).

"In addition to consulting the specification ... a court should also consider the patent's prosecution history, if it is in evidence." Phillips, 415 F.3d at 1317 (internal quotation marks omitted). "The prosecution history limits the interpretation of claim terms so as to exclude any interpretation that was disclaimed during prosecution."[61] "Yet because the prosecution history represents an ongoing negotiation between the PTO and the applicant, rather than the final product of that negotiation, it often lacks the clarity of the specification and thus is less useful for claim construction purposes." Phillips, 415 F.3d at 1317.

"In most situations, an analysis of the intrinsic evidence alone will resolve any ambiguity in a disputed claim term. In such circumstances, it is improper to rely on extrinsic evidence." Vitronics, 90 F.3d at 1583. However, extrinsic evidence, including expert and inventor testimony, dictionaries, and learned treatises,

may be helpful to explain scientific principles, the meaning of technical terms, and terms of art that appear in the patent and prosecution history. Extrinsic evidence may demonstrate the state of the prior art at the time of the invention. It is useful to show what was then old, to distinguish what was new, and to aid the court in the construction of the patent.

Markman, 52 F.3d 967, 980 (Fed. Cir. 1995) (internal quotation marks omitted), aff'd, 517 U.S. 370 (1996). "In sum, extrinsic evidence may be useful to the court, but it is unlikely to result in a reliable interpretation of patent claim scope unless considered in the context of the intrinsic evidence." Phillips, 415 F.3d at 1319.

2 . Indefiniteness

The issue of claim indefiniteness is "inextricably intertwined with claim construction." Enargizer Holdings, Inc. v. Int'l Trade Comm'n, 435 F.3d 1366, 1368 (Fed. Cir. 2006) (internal quotation marks omitted). "[D]etermination of claim indefiniteness is a legal conclusion that is drawn from the court's performance of its duty as the construer of patent claims." Exxon Research & Eng'g Co. v. United States, 265 F.3d 1371, 1376 (Fed. Cir. 2001) (internal quotation marks omitted). The Court begins by recognizing that every patent's specification must "conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor . . . regards as the invention." 3 5 U.S.C. § 112(b). "Because the claims perform the fundamental function of delineating the scope of the invention, the purpose of the definiteness requirement is to ensure that the claims delineate the scope of the invention using language that adequately notifies the public of the patentee's right to exclude." Datamize, LLC v. Plumtree Software, Inc., 417 F.3d 1342, 1347 (Fed. Cir. 2005) (internal citations omitted).

"In the face of an allegation of indefiniteness, general principles of claim construction apply." Datamize, 417 F.3d at 134 8. "Only claims 'not amenable to construction' or 'insolubly ambiguous' are indefinite." Id. at 1347. Thus, a construed claim can be indefinite if the construction remains insolubly ambiguous, meaning that it "fails to provide sufficient clarity about the bounds of the claim to one skilled in the art." Star Scientific, Inc. v. R.J. Reynolds Tobacco Co., 655 F.3d 1364, 1373 (Fed. Cir. 2011). But, a claim term may be definite even when discerning the meaning is a "formidable [task] and the conclusion may be one over which reasonable persons will disagree." Source Search Techs., LLC v. LendingTree, LLC, 588 F.3d 1063, 1076 (Fed. Cir. 2009) (internal quotation marks omitted).

B. Analysis

The parties principally dispute whether the relevant claims require participation by a "user, " and availability of a "hybrid" mode of planning and delivery. Because the disputed terms are interspersed throughout the claims of the '008 and '591 patents, [62] the Court's analysis will proceed by term, in the order set forth in the parties' Joint Claim Construction Statement (ECF No. 91 (SEALED)). Differences in proposed constructions will be emphasized by underlining.

1. "radiation output"

Claim Language

Prowess's Proposed Construction

The Defendants' Proposed Construction

radiation output

measure of the rate of radiation delivered by the linac according to the linac's constraints

measure of the rate of radiation delivered by the linac

The term "radiation output" appears in Claim 23 of the '008 patent, which claims "[t]he medium of claim 22, wherein the limitation on operations of the linear accelerator comprise at least one of: a radiation output, a minimal accurate dose amount and a conveyance speed for the linear accelerator."'008 patent col. 12 11.26-29 (emphasis added).[63] The parties agree that radiation output refers to a "rate" of radiation, [64] which is "a measure of unit as a function of time."[65] The parties also agree that "radiation output" refers to a "measure of the rate of radiation delivered by the linac."

The parties dispute whether the rate is delivered by the linac "according to the linac's constraints." Prowess principally argues that the intrinsic record supports adding "according to the linac's constraints" to the construction because the claim language is "directed to a term on the operations of the linear accelerator, " and one of ordinary skill in the art would "understand" that linacs "differ in their ability to dynamically adjust dose rates." Prowess's Opening Br. (SEALED) at 47. The Defendants contend that "[t]hose familiar with radiation treatment planning . . . understand that the user or planner can freely designate parameters, such as the radiation output, when creating a plan." Defendants' Opening Br. (SEALED) at 30.

The Defendants' construction is correct. That linacs are subject to delivery constraints is a central focus of the '008 and '591 patents. According to the '008 patent specification, prior art did not account for the delivery constraints "imposed by" the design of various components of the linac. '008 patent col. 2 11.48-52. Its failure to do so resulted in "complex" and often "inefficient" treatment plans. Id. col. 2 11.51-52. The "purpose" of the claimed invention was to "enable a single planning system to plan for different modes of IMRT delivery and to simplify the planning and delivery of IMRT." Id. col. 3 11.15-17. Accordingly, the invention considers "all delivery constraints" in the process of optimizing the shapes and corresponding weights of the apertures. Id. col. 3 11.20-26.[66]The output of the algorithm is a set of deliverable apertures and their weights, which are transferred to the linac's control system for delivery to the patient. Id. col. 3 11.58-61.

In other words, the invention incorporates--rather than eliminates--the delivery constraints to which all linacs are subject. By definition, a linac can only deliver radiation that meets these constraints; it cannot, by contrast, deliver what it cannot deliver. Because "radiation output" refers to a "measure of the rate of radiation delivered by the linac, " and linacs are necessarily subject to the very delivery constraints that the invention claims to directly take into account, Prowess's proposed construction is redundant. The Court will construe "radiation output" to mean "measure of the rate of radiation delivered by the linac."

2. "minimal accurate dose amount"

Claim Language

Prowess's Proposed Construction

The Defendants' Proposed Construction

minimal accurate dose amount

minimum amount of dose to produce an accurate beam according to the linac's constraints

minimum amount of dose to produce an accurate beam

The phrase "minimal accurate dose amount" also appears in dependent Claim 23 of the '008 patent, which asserts: "[t]he medium of claim 22, wherein the limitation on operations of the linear accelerator comprise at least one of: a radiation output, a minimal accurate dose amount and a conveyance speed for the linear accelerator." '008 patent col. 12 11.26-29 (emphasis added). The parties agree that "minimal accurate dose amount" refers to the "minimum amount of dose to produce an accurate beam."

The parties dispute whether the minimum amount of dose to produce an accurate beam must be delivered "according to the linac's constraints." Prowess argues that claim language supports adding "according to the linac's constraints" to the construction because the claim is "directed to a term on the operations of the linear accelerator, " and linacs "differ in their ability to dynamically adjust dose rates." Prowess's Opening Br. (SEALED) at 49. The Defendants contend that "[t]hose familiar with radiation treatment planning . . . understand that a user or planner can freely designate parameters, such as the minimum dose rate setting, when creating a plan." Defendants' Opening Br. (SEALED) at 30.

The Defendants' construction is correct. Namely, Prowess's construction is unnecessary because the newness of the claimed optimization method--emphasized throughout the specification--is that it directly considers "all delivery constraints" in generating a treatment plan. E.g., "008 patent col. 3 11.15-27. Accordingly, the minimum amount of dose to produce an accurate beam, delivered by the linac, must necessarily meet the linac's limitations. The Court will construe "minimal accurate dose amount" to mean "minimum amount of dose to produce an accurate beam."

3. "objective function"

Claim Language

Prowess's Proposed Construction

The Defendants' Proposed Construction

objective function

mathematical function expressing a set of conditions to be optimized

a mathematical function expressing a set of user-defined clinical objectives of the treatment plan to be optimized

The term "objective function" appears in Claims 1, 7, 9, 10, 12, 14, 16-18, 20, and 25.[67] Claim 1 asserts

[a] method for planning radiation treatment of a target area . . . said method comprising evaluating the initial radiation to the patient against an objective function; altering the initial aperture configuration based on the geometric constraints of the collimator; calculating an altered radiation dose distribution to the patient based on the altered aperture configuration and re-evaluating the altered radiation output against the objective function; re-altering the altered aperture configuration; re-calculating the altered radiation dose distribution to the patient and re-evaluating the altered radiation output for the re-altered aperture configuration until the objective function is satisfied, wherein the objective function scores the radiation treatment plan quality and is a function of the altered radiation dose distribution at a given iteration ....

'008 patent cols. 9-10 (emphases added). The parties agree that "objective function" relates to a "mathematical function" reflecting certain conditions (or "objectives") "to be optimized." They dispute whether the set of conditions expressed by the mathematical function, to be optimized by that function, is necessarily user-defined.

Prowess contends that: (1) "nothing in the claims" requires "anything" to be performed by a user; (2) when the applicants intended a claim element to require a "user, " they expressly included such a term; and (3) Claim 20 of the '008 patent "makes clear" that a computer-readable medium can be encoded with a computer program to execute the claimed steps. Prowess's Opening Br. (SEALED) at 14. The Defendants object that "[t]hose of ordinary skill in the art of radiation treatment planning understand an objective function to be a function that is to be minimized during the treatment plan optimization process, and is defined by the clinical objectives as set forth by the planner." Defendants' Opening Br. (SEALED) at 24.

The word "user" does not appear in any of the '008 or '591 patent claims. See generally '008 and '591 patents. However, the claims "should be read within the context of the entire patent, including the specification." Pulse, 2009 WL 6898404, at *2. Contrary to Prowess's suggestion, see Prowess's Opening Br. (SEALED) at 16, the specification refers to user partici- pation. Figure 1 of the '008 patent, which "shows a flow chart of the DAO procedure, "[68] is illustrative:

(Image Omitted)

Although the Figure does not expressly indicate what steps, if any, involve user participation, the text of the patent's specification does:

In a first step 60, the mode of delivery is selected. The modes of delivery include IMRT, IMAT, or hybrid IMRT. If fixed field IMRT or hybrid IMRT is selected, in a step 61, the user must select the delivery angles and the number of apertures assigned to each angle. Then one proceeds to step 62a if one selected hybrid IMRT in a step 60. Otherwise, if one selected fixed field IMRT in a step 60, then one proceeds immediately to a step 63. If the user selects IMAT in a step 60, then the user proceeds immediately to step 62a.
In a step 62a, one must select the number of arcs and the range for each arc. After the consideration factors (the delivery angles and number of apertures assigned to each angle for DIRT or the number of arcs and range for each arc for IMAT) are entered, in a step 62b, the treatment planning system automatically calculates evenly spaced radiation beams to approximate the range of rotation of the gantry. Hybrid IMRT required both steps 61 and 62 to account for the combined use of fixed field and arced delivery.
In a step 63, each field is divided into a grid of discrete pencil beams and the dose distribution for each pencil beam is computed. The MLC delivery constraints for fixed field delivery are determined in a step 64. For rotation delivery in a step 64, the constraints associated with rotational delivery are also determined to ensure not only coordination of MLC movement with radiation delivery, but also the synchronization of radiation delivery and gantry rotation.

See '008 patent col. 6 11.23-49 (italicized emphases added). Of particular relevance here, the specification continues:

In a step 65, the user defines the clinical objectives of the treatment plan. These clinical objectives are used to score the quality of the treatment plan throughout the optimization process. The treatment plan quality can be scored by an objective function that reduces the treatment plan into a single numerical value. The objective function can be, by way of example only, a least-square dose difference objective between the desired dose and the achieved dose. The objective function can also be based on dose volume histograms (DVH) or biological based parameters.
The optimization process begins in a step 66, where the treatment planning system assigns an initial aperture shape for each beam angle.

Id. col. 6 11.50-62 (italicized emphases added). Before reciting the claims, the specification provides, "[w]hile the disclosure above describes the invention in detail ... it will be apparent to one of ordinary skill in the art that various changes and modifications can be made therein without departing from [its] spirit and scope." Id. col. 9 11.32-36.

"When consulting the specification to clarify the meaning of claim terms, courts must take care not to import limitations into the claims from the specification." Abbott Labs. v. Sandoz, Inc., 566 F.3d 1282, 1288 (Fed. Cir. 2009). Thus, when the specification describes a single embodiment to enable the invention, the Court will not limit broader claim language to that application "unless the patentee has demonstrated a clear intention to limit the claim scope using words or expressions of manifest exclusion or restriction." Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 906 (Fed. Cir. 2004) (internal quotation marks omitted); see Id . at 907-08 (citing Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1301 (Fed. Cir. 1999), Gen. Am. Transp. Corp. v. Cryo-Trans, Inc., 93 F.3d 766, 770 (Fed. Cir. 1996), and Modine Mfg. Co. v. U.S. Int'l Trade Comm'n, 75 F.3d 1545, 1551 (Fed. Cir. 1996) as examples where the Federal Circuit "interpreted the pertinent claim language narrowly, not merely because the specification did not describe a broader embodiment, but because the specification . . . made clear that the invention was limited to a particular structure").

Here, the description of the invention, as it pertains to how the "objective function" is generated, is detailed and unequivocal. Step 65 of the DAO procedure--entitled "Decide upon clinical objectives"--is explained as follows: "In a step 65, the user defines the clinical objectives of the treatment plan." '008 patent col. 6 11.50-51 (italicized emphasis added). These user-defined clinical objectives are, in turn, used to score the quality of the treatment plan by the objective function. Id. col. 6 11.51-54. The Defendants' proposed construction incorporates this express limitation; Prowess's does not.[69] Thus, the Defendants' construction is correct. The Court will construe "objective function" to mean "a mathematical function expressing a set of user-defined clinical objectives of the treatment plan to be optimized."

4 . "providing a signal"

Claim Language

Prowess's Proposed Construction

The Defendants' Proposed Construction

providing a signal

No construction required--plain and ordinary meaning

Cannot be construed-- insolubly ambiguous

The term "providing a signal" appears in Claims 9 and 10. Both depend from Claim 8, which in turn depends from Claim 1. Claim 9 asserts "[t]he method of claim 8, further comprising providing a signal for at least one optimized aperture size once the objective function is satisfied." l 008 patent col. 10 11.42-44 (emphasis added). Claim 10 asserts "[t]he method of claim 8, further comprising providing a signal for at least one optimized aperture weight once the objective function is satisfied. Id. col. 10 11.45-47 (emphasis added).

Prowess argues that "providing a signal" requires no construction because it has a plain and ordinary meaning. Prowess's Opening Br. (SEALED) at 26. The Defendants assert that neither patent "describes" any such signal, and it is unclear what would provide the signal and to what or to whom it would be provided. Defendants' Opening Br. (SEALED) at 40. The Defendants conclude that the term is "insolubly ambiguous and not amenable to construction." Id.

A claim is definite if "one skilled in the art would understand the bounds of the claim when read in light of the specification." Exxon Research & Eng'g, 265 F.3d at 1375. A construed claim can be indefinite if the construction remains insolubly ambiguous, meaning that it "fails to provide sufficient clarity about the bounds of the claim to one skilled in the art." Star Scientific, 655 F.3d at 1373. A claim is not indefinite merely when discerning the meaning poses a "formidable [task]" and the conclusion "may be one over which reasonable persons will disagree." Source Search Techs., 588 F.3d at 1076 (internal quotation marks omitted).

Claims 9 and 10 do not define "providing a signal"; however, the specification sheds light on the term's meaning. The detailed description of the invention explains:

[a] t a given time during the delivery of radiation to a patient, the [Linac Control System, or "LCS"] is receiving information on dose delivery from the dose control unit. The LCS also receives information in real-time from the MLC position sensors. The LCS compares the dose delivery information from both the MLC controller and the dosimetry system controller with the prescription. Depending on the result of the comparison, the LCS may respond in a variety of manners. For example, the LCS may send a signal to the beam triggering system to pause the radiation so that the MLC can advance to the proper location.

'008 patent col. 5 11.48-59 (emphasis added). The prosecution history also supports Prowess's position: although the PTO issued four office actions[70] during the prosecution history, Claims 9 and 10 were ultimately issued in the same form as initially filed by the inventors. Popple Decl. (SEALED) ¶ 61. See generally Prowess's Opening Br. (SEALED), Ex. E (file history for '008 patent). Thus, the Court agrees with Prowess that the term "providing a signal" has a plain and ordinary meaning--to supply an indication or notification--and, when read in light of the specification, is not insolubly ambiguous.

5. "reiterative evaluation"

Claim Language

Prowess's Proposed Construction

The Defendants' Proposed Construction

reiterative evaluation

No construction required--plain and ordinary meaning

Cannot be construed-- insolubly ambiguous

The term "reiterative evaluation" appears in dependent Claims 17 and 18. Claim 17 asserts "[t]he method of claim 16, wherein after said objective function is satisfied, reiterative evaluation in reference to geometric and physical constraints of the collimator is not performed." '008 patent col. 1111.28-31 (emphasis added). Claim 18 asserts "[t]he method of claim 17, wherein the radiation source includes a linear accelerator, said method further comprising: designating a limitation on operation of the linear accelerator prior to calculating the initial radiation output, wherein after said objective function is satisfied, reiterative evaluation in reference to the limitations on the operation of the linear accelerator is not performed." Id. col. 1111.32-38 (emphasis added).

Prowess argues that no construction is required, because "reiterative evaluation" has a plain and ordinary meaning: i.e., repeated or successive evaluation. Prowess Opening Br. (SEALED) at 23. The Defendants argue that the term "does not have a widely accepted meaning or a particular meaning in the field, " and is insolubly ambiguous. Defendants' Opening Br. (SEALED) at 41.

As discussed above, a claim is definite if "one skilled in the art would understand the bounds of the claim when read in light of the specification." Exxon Research & Eng'g, 265 F.3d at 1375. Here, the specification--citing Figure 1, see supra Page 49--explains:

[i]n the preferred embodiment of this invention, a simulated annealing algorithm is used in steps 67 through 7 0 to determine the optimal aperture shapes and corresponding weights. The optimization algorithm randomly selects a variable from the set of variables considered in the optimization process, i.e., the MLC leaf positions and the weights of the aperture shape. For the selected variable, a change of random size is sampled from a probability distribution. For instance, a Gaussian distribution could be used. In addition, the shape of the curve could change with successive iteration of the procedure.

'008 patent col. 7, 11.40-50. The patent examiner never objected to the term on grounds of indefiniteness. Popple Decl. (SEALED) ¶ 69. See generally Prowess's Opening Br. (SEALED), Ex. E (file history for '008 patent).

Thus, the Court agrees with Prowess that "reiterative evaluation" has a plain and ordinary meaning--repeated or successive evaluation--and, when read in light of the specification, is not insolubly ambiguous.

6. "designating"

Claim Language

Prowess's Proposed Construction

The Defendants' Proposed Construction

designating

No construction required--plain and ordinary meaning

indication made by a user

"Designating" appears in Claims 1, 4, 18, 20, 25, 27, and 28, in reference to geometric constraints on the collimator or linac. For instance, Claim 1 asserts "[a] method for planning radiation treatment of a target area . . . said method comprising: designating geometric constraints for the collimator."l008 patent col. 9 11.38-44 (emphasis added). Dependent Claim 4 asserts "[t]he method of claim 1, wherein the radiation source comprises a linear accelerator, said method further comprising: designating a limitation on operations of the linear accelerator prior to calculating the initial radiation dose distribution to the patient." Id. col. 10 11.22-27 (emphasis added). Independent Claim 20 claims "[a] computer readable medium" that is "encoded with a computer program for executing: designating geometric constraints for the collimator." Id. col. 1111.42-49 (emphasis added).

Prowess argues that no construction of "designating" is required, because the term has a plain and ordinary meaning: "the act of identifying or indicating." Prowess Opening Br. (SEALED) at 23, 28 (emphasis in original). The Defendants argue that "[t]hose of ordinary skill in the art of radiation treatment planning understand that a planner, such as a dosimetrist or physicist, designates or selects the constraints and parameters in the treatment planning system." Defendants' Opening Br. (SEALED) at 27.

The Court agrees with Prowess. First, the claim language clearly indicates that a program--as opposed to an individual--is capable of "designating" linac and collimator constraints. See '008 patent col. 1111.46-49 (Claim 20 asserts a "computer readable medium encoded with a computer program for executing: designating geometric constraints for the collimator"). Ambiguity in the specification cautions against inserting a "user" requirement into the construction. See Abbott Labs., 566 F.3d at 1288; Liebel-Flarsheim, 358 F.3d at 906. Namely, in describing Step 64 of Figure l[71] ("Define geometric constraints for delivery mode and linac"), the specification provides: "The MLC delivery constraints for fixed field delivery are determined in a step 64. For rotation delivery in a step 64, the constraints associated with rotational delivery are also determined . . . ." '008 patent col. 6 11.46-49 (italicized emphases added). The specification's failure to indicate whether an individual must designate the constraints of the linac and collimator is conspicuous in light of Step 65 ("Decide upon clinical objectives"), wherein "the user defines the clinical objectives of the treatment plan." Id. col. 6 11.50-51 (emphasis added).

Because the claim language clearly indicates that "designating" can be performed by a computer program as well as an individual, the Defendants' construction will not be adopted.

7. "selecting"

Claim Language

Prowess's Proposed Construction

The Defendants' Proposed Construction

selecting

No construction required--plain and ordinary meaning

choice made by a user

"Selecting" appears in Claims 1, 13, 16, 25, 26, and 28.[72]For instance, independent Claim 1 asserts "[a] method for planning radiation treatment of a target area . . . said method comprising . . . assigning an initial aperture configuration for passing the radiation beam based on the designated geometric constraints of the collimator comprising selecting a number of delivery angles for the radiation beam towards the target area and a number of apertures through which the radiation beam is directed; and selecting a number and range of arcs for the gantry . . . ." '008 patent col. 9 11.38-51 (emphases added). Independent Claim 2 5 asserts: "[a] method for planning radiation treatment of a target area . . . said method comprising: selecting at least one of a set of parameters a) and b), wherein a) comprises a number of delivery angles for the radiation beam toward the target area and a number of apertures through which the radiation beam is directed, and wherein b) comprises a number and range of arcs for the gantry . . . ." Id. col. 12 11.36-46. Prowess argues that "selecting" does not require a user term; the Defendants contend that it does. See Prowess's Opening Br. (SEALED) at 36; Defendants' Opening Br. (SEALED) at 27.

As with the term "designating, " claim language strongly suggests that a user--though capable of "selecting"--is not required. Specifically, Claim 13--which depends from independent Claim l--provides, "[t]he method of claim 1, wherein the selecting of the number of delivery angles and the selecting of the number and range of arcs are selected by an operator." '008 patent col. 10 11.56-58 (italicized emphases added). Similarly, Claim 26--which depends from independent Claim 25--asserts, "[t]he method of claim 25, wherein selecting at least one of a) and b) is provided by an operator." Id . col. 12 11.66-67 (italicized emphasis added). The only distinction between the above-cited dependent claims and their independent counterparts is the additional requirement that a "user" perform the selecting. Cf. Wenger Mfg., 239 F.3d at 1233. Because each claim in a patent is "presumptively different in scope, " id., this language supports Prowess's argument that a user may--but need not--do the "selecting." See also SunRace Roots Enter. Co. v. SRAM Corp., 336 F.3d 1298, 1303 (Fed. Cir. 2003) (presumption is "especially strong" when "the limitation in dispute is the only meaningful difference between an independent and dependent claim, and one party is urging that the limitation in the dependent claim should be read into the independent claim").

Although the doctrine of claim differentiation creates only a presumption, which can be overcome by "strong contrary evidence such as definitional language in the patent or a clear disavowal of claim scope, "[73] no such evidence is present here. Specifically, although the specification suggests that a user is required to make certain selections, [74] "a simulated annealing algorithm is used in steps 67 through 70 to determine the optimal aperture shapes and corresponding weights. The optimization algorithm randomly selects a variable from the set of variables considered in the optimization process." '008 patent col. 7 11. (italicized emphases added). Thus, the Defendants' proposed construction of "selecting"—defined as a "choice made by a user"--cannot stand.

8. "receiving a selected a [sic] mode for radiation treatment including one of: a fixed field intensity modulated radiotherapy, an intensity modulated arc therapy, and a hybrid treatment of intensity modulated radiotherapy and intensity modulated arc therapy"

Claim Language

Prowess's Proposed Construction

The Defendants' Proposed Construction

receiving a selected a mode for radiation treatment including one of: a fixed field intensity modulated radiotherapy, an intensity modulated arc therapy, and a hybrid treatment of intensity modulated radiotherapy and intensity modulated arc therapy

receiving a selected mode of radiation treatment, where the modes of delivery include a fixed field intensity modulated radiotherapy, an intensity modulated arc therapy, and a hybrid treatment of intensity modulated radiotherapy and intensity modulated arc therapy

receiving from a user a selected mode of radiation treatment, where the available modes of delivery include a fixed field intensity modulated radiotherapy, an intensity modulated arc therapy, and a hybrid treatment of intensity modulated radiotherapy and intensity modulated arc therapy

The above-quoted term appears in independent Claim 20, which asserts "[a]computer readable medium for planning radiation treatment of a target area [that is] encoded with a computer program for executing . . . receiving a selected a [sic] mode for radiation treatment including one of: a fixed field intensity modulated radiotherapy, an intensity modulated arc therapy, and a hybrid treatment of intensity modulated radiotherapy and intensity modulated arc therapy . . . ." '008 patent col. 1111.42-54.

Prowess argues that, "[a]s written, the claim simply requires receiving a selected mode of radiation treatment including fixed field, arc, and a hybrid (or combination) of both." Prowess's Opening Br. (SEALED) at 34. The Defendants contend that "receiving a selected [] mode" "require[s] that more than one option of the type of treatment planning delivery systems must be available for selection by the planner. Otherwise, no selection could be made." Defendants' Opening Br. (SEALED) at 17.

Claim 20 does not contain the word "user." As discussed above, other claim language supports Prowess's argument that "selecting, " as a general matter, can be performed by a user or a program. The question is whether a user is required to select, at the outset, the mode of delivery of the radiation treatment. The detailed description of the invention states that, "[d]uring treatment planning, a user is allowed to set the mode of treatment including IMRT or IMAT or a hybrid thereof." '008 patent col. 5 11.27-29. Citing Figure 1, the specification further provides, "[i]n a first step 60, the mode of delivery is selected. The modes of delivery include IMRT, IMAT, or hybrid IMRT." Id. col. 6 11.23-25. Thus, the patentee has not "demonstrated a clear intention to limit the claim scope using words or expressions of manifest exclusion or restriction." Liebel-Flarsheim, 358 F.3d at 906 (internal quotation marks omitted). This being the case, Prowess's construction is correct. The Court will not construe the claim to require a "user."

9. "selecting at least one of a set of parameters a) and b)" and variations thereof

Claim Language

Prowess's Proposed Construction

The Defendants' Proposed Construction

selecting at least one of a set of parameters a) and b) selecting at least one selecting at least one of the set of parameters a) and b)

No construction required--plain and ordinarymeaning

A user choosing a set of parameters wherein the parameters available for of a) and b)selection include a), b), and a combination of a) and b)

The phrase "selecting at least one of a set of parameters a) and b)"--and variations thereof --appears in independent Claim 25 and dependent Claim 26.[75] Claim 25 asserts, in relevant part, "[a] method for planning radiation treatment of a target area . . . said method comprising: selecting at least one of a set of parameters a) and b), wherein a) comprises a number of delivery angles for the radiation beam toward the target area and a number of apertures through which the radiation beam is directed, and wherein b) comprises a number and range of arcs for the gantry." '008 patent col. 12 11.36-46. Claim 26 claims "[t]he method of claim 25, wherein selecting at least one of a) and b) is provided by an operator." Id. col. 12 11.66-67.

Prowess argues that the phrase requires no construction, because it has a plain and ordinary meaning. Prowess's Opening Br. (SEALED) at 38. As with the preceding claim term, the Defendants argue that the plain and ordinary meaning of "select"--and as one of skill in the art would understand the term--requires "more than one option of the type of treatment planning delivery systems" to be available for selection "by the planner"; "[o]therwise, no selection could be made." Defendants' Opening Brief (SEALED) at 17.

As discussed at length above, [76] the Defendants' proposed "user" requirement is foreclosed by the doctrine of claim differentiation. Namely, Claim 26--which depends from independent Claim 25--asserts, "[t]he method of claim 25, wherein selecting at least one of a) and b) is provided by an operator." Id . col. 12 11.66-67 (italicized emphases added). Because the only distinction between Claim 2 6 claims and its independent counterpart is the additional requirement that a "user" perform the selecting--and each claim in a patent is presumed different in scope--the Court will not import a user requirement into the independent language. Cf. Nenger Mfg., 239 F.3d at 1233; see also SunRace, 336 F.3d at 1303.

Neither will the Court construe the claim to expressly require a "combination" of a) and b). First, unlike Claim 20--which specifically lists three "mode[s]" of radiation treatment (IMRT, IMAT, and hybrid), [77] Claim 25 does not. More importantly, the Defendants' proposed "combination" language is unnecessary because the phrase "at least" already indicates that parameters a) (a number of delivery angles and apertures) and b) (a number and range of arcs) can be selected at the same time. See '008 patent col. 12 11.30.[78] Otherwise, the claim would simply read "a) or b)". See Chef Am., Inc. v. LambWeston, Inc., 358 F.3d 1371, 1373 (Fed. Cir. 2004) ("[O]rdinary, simple English words whose meaning is clear and unquestionable . . . mean exactly what they say."). The term requires no construction.

10. "aperture configuration for passing the radiation beam"

Claim Language

Prowess's Proposed Construction

The Defendants' Proposed Construction

aperture configuration for passing the radiation beam aperture configuration for the radiation beam

No construction required—plain and ordinary meaning

aperture configuration, which takes into account the machine parameters, for passing the radiation beam such that the beam is deliverable

“Aperture configuration for passing the radiation beam" appears in independent Claims 1, 16, and 25.[79] By way of example, Claim 1 asserts "[a] method for planning radiation treatment of a target area . . . said method comprising: designating geometric constraints for the collimator; [and] assigning an initial aperture configuration for passing the radiation beam based on the designated geometric constraints of the collimator comprising selecting a number of delivery angles for the radiation beam towards the target area and a number of apertures through which the radiation beam is directed." '008 patent col. 9 11.38-50 (emphasis added). "Aperture configuration" is expressly defined in Claim 1 as "a plurality of aperture shapes delivered from the selected delivery angles, selected number of apertures through which the radiation beam is directed, and the selected number and range of arcs for the gantry to the target area." Id. col. 10 11.4-8.

Prowess argues that the term is "readily understood to a lay person and one of skill in the art." Prowess Opening Br. (SEALED) at 43. The Defendants assert that the ordinary meaning is "not readily apparent, " and argue that a "review of the specification" leads to their proposed construction. Defendants' Opening Br. (SEALED) at 22. Prowess objects that there is "no credible justification for injecting these limitations into the terms, and Defendants' positions are self-contradicting." Prowess's Responsive Br. (SEALED) at 13.

The Defendants cite two portions of the specification in support of their proposed construction. First, in summarizing the invention, the specification provides that, "[t]he output of the algorithm is a set of deliverable apertures and their weights, which can be transferred to the control system or a linear accelerator and delivered to a patient." '008 patent col. 3 11.59-62. Second, in describing a MLC, the specification notes that "static and dynamic geometric constraints determine the kind of aperture shapes that a particular MLC can form." Id. col. 4 11.46-48.

Neither supports the proposed construction. As to the requirement that the configuration "take[] into account the machine parameters, " this language is unnecessary because Claim 1 expressly states that the aperture configuration must be "based on the designated geometric constraints of the collimator." See Id . col. 9 11.46-47. As for the requirement that the beam be deliverable, the cited portion of the specification (the "output" of the claimed algorithm is a set of "deliverable" apertures) has no application to the claim language at issue: the term appears in Claims 1, 16, and 25 solely in reference to "initial" planning steps that precede the algorithmic output. The parties agree that "aperture" means "shaped opening." Joint Claim Constr. Statement (SEALED) at 1. The '00 8 patent defines "configuration." See supra. No further construction is required.

11. "receiving a designation"

Claim Language

Prowess's Proposed Construction

The Defendants' Proposed Construction

receiving a designation

No construction required—plain and ordinary meaning

receiving from a user a designation

The term "receiving a designation" appears in dependent Claim 22, which asserts "[t]he medium of claim 20, wherein the radiation source comprises a linear accelerator, said computer readable medium encoded with a computer program for executing, further executes: receiving a designation of a limitation on operations of the linear accelerator prior to calculating the radiation dose distribution." '008 patent col. 12 11.19-25 (italicized emphasis added). Prowess argues that the term is "readily understood to a lay person and one of skill in the art." Prowess's Opening Br. (SEALED) at 51. The Defendants contend that "[t]hose of ordinary skill in the art of radiation treatment planning understand that a planner, such as a dosimetrist or physicist, designates or selects the constraints and parameters in the treatment planning system." Defendants' Opening Br. (SEALED) at 27.

Claim 22 depends from Claim 20, which--as discussed above[80]--expressly contemplates that a computer program designate geometric constraints for the collimator. See '008 patent col. 11, 11.46-49. The Court, accordingly, concluded that a user is not required to perform the act of "designating." Supra Page 60. Claim 22 similarly asserts, on its face, a computer program that is capable of receiving the designation once made. No construction is required.

12. "until the objective function is satisfied"; "that satisfies an objective function"

Claim Language

Prowess's Proposed Construction

The Defendants' Proposed Construction

until the objective function is satisfied that satisfies an objective function

No construction required--plain and ordinary meaning

Cannot be construed-- insolubly ambiguous

Finally, the parties dispute the definiteness of "until the objective function is satisfied" and "that satisfies an objective function." The former term appears in Claims 1, 16, 20, and 25; the latter appears in '591 patent Claims 3 and 4. For instance, Claim 1 asserts "[a] method for planning radiation treatment of a target area . . . said method comprising . . . re-calculating the altered radiation dose distribution to the patient and re-evaluating the altered radiation output for the re-altered aperture configuration until the objective function is satisfied, wherein the objective function scores the radiation treatment plan quality and is a function of the altered radiation dose distribution at a given iteration." '008 patent cols. 9-10 (emphasis added).

Prowess contends that the terms do not require construction because they carry plain and ordinary meaning, Prowess's Opening Br. (SEAELD) at 55; the Defendants argue that the terms are "not amenable to construction" and insolubly ambiguous, Defendants' Opening Br. (SEALED) at 37. Specifically, the Defendants note that "each of the asserted claims fails to state or suggest what criteria a person of ordinary skill in the art would use to determine whether the objective function has been 'satisfied, ' if in fact satisfying an objective function were even possible." Defendants' Opening Br. (SEALED) at 38. Instead, "[a] user of the claimed method or computer readable medium would be free to select any criteria for satisfying an objective function, and accordingly, determining whether the objective function were satisfied, again if that were possible, would vary from user to user." Id. Because the objective function is "necessary" to practice the alleged invention, the Defendants conclude that all of the '008 patent claims are invalid. Id. at 39-40.

The Defendants rely on Honeywell International, Inc. v. International Trade Commission, 341 F.3d 1332 (Fed. Cir. 2003) in support of their invalidity contention. The patent in Honeywell required that yarn produced by the claimed process "fall within a specified MPE range at some point during the process." Id. at 1335. The patent defined "MPE" as "the difference between the specimen melting point (M.P.) and the melting point (M.P.Q.) of a specimen after subsequent rapid liquid nitrogen quenching of an encapsulated [differential scanning calorimeter] sample from the melt." Id. (internal quotation marks omitted). However, neither the claims, the written description, nor the prosecution history referenced any of the four known preparation methods that could be used to measure the MPE. Id. at 133 9. The Federal Circuit agreed with the Commissioner that the claims were insolubly ambiguous, and hence indefinite, with respect to a required sample preparation method. Id. at 1340.

According to Prowess, the '008 patent does not specify satisfaction criteria "in an absolute sense" because the criteria are necessarily different for each treatment plan, depending on, among other things, tumor location, dose prescription, linac limitations, tissue type, etc. Prowess Responsive Br. (SEALED) at 23. Prowess argues that the claims are not invalid as indefinite because "[a] person having ordinary skill in the art would readily understand how to define termination criteria for satisfying the objective function." Id. (citing Marley Mouldings v. Mikron Indus., Inc., 417 F.3d 1356, 1360-61 (Fed. Cir. 2005) (§ 112 ¶ 2 is satisfied when the relevant values can be calculated, measured, or "easily obtained")). Prowess's expert, Doctor Popple, asserts that "[o]bjective functions and optimization have known methodologies to those having ordinary skill [in] the art." Popple Supplemental Decl. (SEALED) ¶ 33.

Critically, the Defendants do not object to the term "objective function" as insolubly ambiguous;[81] indeed, for the reasons stated above, the Court will adopt the Defendants' proposed construction of the term to denote "a mathematical function expressing a set of user-defined clinical objectives of the treatment plan to be optimized." See supra Page 53. The Defendants challenge the definiteness of determining when that function has been "satisfied." However, the specification explains that the optimization procedure "ceases" "[b]ased on pre-defined termination criteria which are dictated by the optimization algorithm." '008 patent col. 8 11.3-5; id. col. 8, 11.6-10 ("The plan with the optimal value of the objective function is deemed the optimal plan. This optimum treatment plan is a set of deliverable aperture shapes and the intensities associated with each aperture shape."). Thus, the term is not insolubly ambiguous.

13. Additional Invalidity Contentions

In addition to arguing that certain terms are insolubly ambiguous, the Defendants assert that several of the asserted claims are invalid. Defendants' Opening Br. (SEALED) at 33-37, 41-43. Specifically, the Defendants argue that Claims 16-19 and 25-27 do not "particularly point out and distinctly claim the subject matter which the patentee regards as his invention, " and Claims 2 and 20-24 are indefinite. Id. "Ambiguity, undue breadth, vagueness, and triviality are matters which go to claim validity for failure to comply with 35 U.S.C. § 112 ¶ 2, not to interpretation or construction." Intervet Am., Inc. v. Kee-Vet Labs., Inc., 887 F.2d 1050, 1053 (Fed. Cir. 1989); see also Rhine v. Casio, Inc., 183 F.3d 1342, 1346 (Fed. Cir. 1999) (defendants "cannot avoid a full-blown validity analysis by raising the specter of invalidity during the claim construction phase"). Because the Defendants' arguments as to claim invalidity are premature, the Court will not consider them here.

C. Construed Terms

For the reasons stated above, the disputed claim terms will be construed as follows:

Term

Construction

radiation output

measure of the rate of radiation delivered by the linac

minimal accurate dose amount

minimum amount of dose to produce an accurate beam

objective function

a mathematical function expressing a set of user-defined clinical objectives of the treatment plan to be optimized

providing a signal

Plain and ordinary meaning

reiterative evaluation

Plain and ordinary meaning

designating

Plain and ordinary meaning

selecting

Plain and ordinary meaning

receiving a selected a mode for radiation treatment including one of: a fixed field intensity modulated radiotherapy, an intensity modulated arc therapy, and a hybrid treatment of intensity modulated radiotherapy and intensity modulated arc therapy

receiving a selected mode of radiation treatment, where the modes of delivery include a fixed field intensity modulated radiotherapy, an intensity modulated arc therapy, and a hybrid treatment of intensity modulated radiotherapy and intensity modulated arc therapy

selecting at least one of a set of parameters a) and b); selecting at least one of a) and b); and selecting at least one of the set of parameters a) and b)

Plain and ordinary meaning

aperture configuration for passing the radiation beam; aperture configuration for the radiation beam

Plain and ordinary meaning

receiving a designation

Plain and ordinary meaning

until the objective function is satisfied; that satisfies an objective function

Plain and ordinary meaning

III. Conclusion

For the reasons stated above, 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.

ORDER

For the reasons discussed in the accompanying Memorandum Opinion, it is, this 9th day of July, 2013, ORDERED that:

1. The Defendants' motion for leave to file amended answers and defenses to the second amended complaint, and counterclaims (ECF No. 126) BE, and HEREBY IS, DENIED;

2. The Defendants' motion for leave to supplement the record in support of their opening claim construction brief (ECF No. 14 9) BE, and HEREBY IS, GRANTED;

3. The claims as defined in the Memorandum Opinion will govern this litigation; and

4. The Clerk of the Court shall send copies of this Memorandum Opinion and Order to counsel for the parties.


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