WILLIAM D. QUARLES, JR., District Judge.
Prowess, Inc. ("Prowess") sued RaySearch Laboratories, AB ("RaySearch") and others
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,
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
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"
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.
On January 9, 2007 and February 19, 2008, U.S. Patent Nos. 7,162,008 (the "'008
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 l. 67 to col. 3 l.3. "Hybrid IMRT" "provides the ability to incorporate into each treatment plan the dosimetric advantages of both IMRT and IMAT." Id. col. 3 ll. 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.
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
On September 7, 2012, the parties filed a Joint Claim Construction Statement. ECF No. 91 (SEALED).
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).
Before reaching the merits of the claim construction issues, the Court will address the Defendants' pending motions.
The Defendants seek leave to file amended answers to the second amended complaint, and counterclaims, on the
The Federal Rules of Civil Procedure create "tension" over the standard applicable to motions to amend pleadings
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 30 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]ll unamended portions of the Scheduling Order ... remain in full effect." Id. at 3.
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. 1 (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).
"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."
"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
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.
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."]
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 et al., 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.
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.
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.
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).
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 et al., 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.
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
The Defendants allege that Yu "disclosed the claimed invention'"
The Defendants allege that the above disclosures of "the claimed invention" are "but-for material" to the patentability of "the '008 and '591 patents"
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"
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,
The Defendants move to supplement the record in support of their opening claim construction brief to include a PowerPoint presentation (the "Power-Point")
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).
ECF No. 168 (SEALED), Ex. 6 221:22 to 223:1-7. During the 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 Power-Point had been given to the examiner:
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. 149. 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 Power-Point 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.
Prowess's final argument — that supplementation would be "futile" because the PowerPoint "does not show
The Defendants' motion to supplement the record will be granted.
Claim construction is a question of law, to be determined by the court. Markman v. Westview Instruments, Inc., 517 U.S. 370, 384, 116 S.Ct. 1384, 134 L.Ed.2d 577 (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."
"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."
"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."
"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."
Markman, 52 F.3d 967, 980 (Fed.Cir.1995) (internal quotation marks omitted), aff'd, 517 U.S. 370, 116 S.Ct. 1384, 134 L.Ed.2d 577 (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.
The issue of claim indefiniteness is "inextricably intertwined with claim construction." Energizer 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." 35 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 1348. "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. Lending-Tree, LLC, 588 F.3d 1063, 1076 (Fed.Cir. 2009) (internal quotation marks omitted).
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,
Prowess's Proposed The Defendants'
Claim Language Construction Proposed Construction
radiation output measure of the rate of radiation measure of the rate of radiation
delivered by the linac according to delivered by the linac
the linac's constraints
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 ll. 26-29 (emphasis added).
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
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."
Prowess's Proposed The Defendants'
Claim Language Construction Proposed Construction
minimal accurate minimum amount of dose to produce minimum amount of dose to
dose amount an accurate beam according produce an accurate beam
to the linac's constraints
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 ll. 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
Prowess's Proposed The Defendants'
Claim Language Construction Proposed Construction
objective function mathematical function expressing a a mathematical function expressing
set of conditions to be optimized a set of user-defined clinical
objectives of the treatment plan to
be optimize
The term "objective function" appears in Claims 1, 7, 9, 10, 12, 14, 16-18, 20, and 25.
'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
Although the Figure does not expressly indicate what steps, if any, involve user participation, the text of the patent's specification does:
See '008 patent col. 6 ll. 23-49 (italicized emphases added). Of particular relevance here, the specification continues:
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 ll. 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 ll. 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,
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 ll. 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 ll. 51-54. The Defendants' proposed construction incorporates this express limitation; Prowess's does not.
Prowess's Proposed The Defendants'
Claim Language Construction Proposed Construction
providing a No construction required — plain Cannot be construed — insolubly
signal and ordinary meaning 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." '008 patent col. 10 ll. 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 ll. 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
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:
'008 patent col. 5 ll. 48-59 (emphasis added). The prosecution history also supports Prowess's position: although the PTO issued four office actions
Prowess's Proposed The Defendants'
Claim Language Construction Proposed Construction
reiterative No construction required — plain Cannot be construed — insolubly
evaluation and ordinary meaning 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. 11 ll. 28-31 (emphasis added). Claim 18 asserts "[t]he method of claim 17, wherein the radiation source includes a
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:
'008 patent col. 7, ll. 40-50. The patent examiner never objected to the term on grounds of indefiniteness. Popple Decl. (SEALED) 1169. 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.
Prowess's Proposed The Defendants'
Claim Language Construction Proposed Construction
designating No construction required — plain indication made by a user
and ordinary meaning
"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." '008 patent col. 9 ll. 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 ll. 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. 11 ll. 42-19 (emphasis added).
Prowess argues that no construction of "designating" is required, because the term has a plain and ordinary meaning:
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. 11 ll. 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 1
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.
Prowess's Proposed The Defendants'
Claim Language Construction Proposed Construction
selecting No construction required __ plain choice made by a user
and ordinary meaning
"Selecting" appears in Claims 1, 13, 16, 25, 26, and 28.
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 1 — 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 ll. 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 ll. 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,"
Prowess's Proposed The Defendants'
Claim Language Construction Proposed Construction
receiving a selected a mode receiving a selected mode of receiving from a user a selected
radiation treatment including radiation treatment, where mode of radiation treatment,
one of: a fixed the modes of delivery include where the available
field intensity modulated a fixed field intensity modulated modes of delivery include a
radiotherapy, an intensity radiotherapy, an intensity fixed field intensity modulated
modulated arc therapy, modulated arc therapy, and radiotherapy, an intensity
and a hybrid treatment of a hybrid treatment of intensity modulated arc therapy, and a
intensity modulated radiotherapy modulated radiotherapy hybrid treatment of intensity
and intensity and intensity modulated are modulated radiotherapy and
modulated are therapy therapy intensity modulated are
therapy
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 ll. 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 ll. 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."
Prowess's Proposed The Defendants'
Claim Language Construction Proposed Construction
selecting at least one of a No construction required — A user choosing a set of parameters
set of parameters a) and b) plain and ordinary meaning wherein the parameters
available for selection
include a), b), and a
combination of a) and b)
selecting at least one of a)
and b)
selecting at least one of the
set of parameters a) and b)
The phrase "selecting at least one of a set of parameters a) and b)" — and variations thereof — appears in independent
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,
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),
Prowess's Proposed The Defendants'
Claim Language Construction Proposed Construction
aperture configuration for No construction required — aperture configuration, which
passing the radiation beam plain and ordinary meaning takes into account the machine
parameters, for passing
the radiation beam such that
the beam is deliverable
aperture configuration for
the radiation beam
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 ll. 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 ll. 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 ll. 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 '008 patent defines "configuration." See supra. No further construction is required.
Prowess's Proposed The Defendants' Claim Language Construction Proposed Construction receiving a No construction required — plain receiving from a user a designation designation and ordinary meaning
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 ll. 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
Prowess's Proposed The Defendants'
Claim Language Construction Proposed Construction
until the objective function No construction required — Cannot be construed —
is satisfied plain and ordinary meaning insolubly ambiguous
that satisfies an objective
function
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 ... recalculating the altered radiation dose distribution to the patient and re-evaluating the altered radiation output for the realtered 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. (SEALED) 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
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 1339. 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., 477F.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;
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." Internet 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.
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 receiving a selected mode of radiation treatment,
treatment including one of: a fixed field where the modes of delivery include a
intensity modulated radiotherapy, an intensity fixed field intensity modulated radiotherapy,
sity modulated arc therapy, and a hybrid an intensity modulated arc therapy, and a
treatment of intensity modulated hybrid treatment of intensity modulated radiotherapy
radiotherapy and intensity modulated and intensity modulated arc
therapy therapy
selecting at least one of a set of parameters Plain and ordinary meaning
a) and b); selecting at least one of a) b)
and selecting at least one of the se
parameters a) and b)
aperture configuration for passing the radiation Plain and ordinary meaning
beam; aperture configuration for the
radiation beam
receiving a designation Plain and ordinary meaning
until the objective function is satisfied; that Plain and ordinary meaning
satisfies an objective function
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.
For the reasons discussed in the accompanying Memorandum Opinion, it is, this 9th day of July, 2013, ORDERED that:
Therasense generated a split among district courts about the effect — if any — of its holding on Exergen's pleading requirements. Cutsforth, Inc. v. LEMM Liquidating Co., No. 12cv-1200 (SRN/JSM), 2013 WL 2455979, at *4 n. 9 (D.Minn. June 6, 2013) (collecting cases). The Federal Circuit resolved this uncertainty in Delano Farms Co. v. California Table Grape Commission, 655 F.3d 1337 (Fed.Cir.2011), which held that, to survive a motion to dismiss, an inequitable conduct counterclaim need only recite facts "from which the court may reasonably infer that a specific individual both knew of invalidating information that was withheld from the [PTO] and withheld that information with a specific intent to deceive the [PTO]." Id. at 1350.
The Defendants note that, "[t]o the extent that the Court concludes that a claim-by-claim analysis is required," they attached to their reply brief the invalidity charts provided to Prowess as part of the Defendants' Initial Disclosure of Invalidity Contentions. ECF No. 164 (SEALED) at 7 n. 4. To the extent the Defendants are capable of adequately pleading inequitable conduct, it is their burden to file a proposed amended complaint that does so. The Court will not write additional allegations into the amended pleading before it.
At his October 22, 2012 deposition, Yu admitted to having read De Gersem in 2001. ECF No. 127 (SEALED), Ex. 4 (SEALED) 67:13-18.
