CYTYC Corp. v. TriPath Imaging, Inc. (505 F. Supp. 2d 199, 2007)

MEMORANDUM AND ORDER

WOODLOCK, District Judge.

TABLE OF CONTENTS

I.BACKGROUND..............................................;............207

A. Cytyc’s Technology.......................................’............207

B. TriPath’s Patents____'.................................................208

1. '377 Patent (Rutenberg) .............'..............................208

2. '182 Patent (Luck) ................................................208

3. '327 Patent (Wilhelm)..............................................209

4. '969 Patent (Kamentsky)...........................................209

C. Procedural Posture...................................................209

II. LEGAL FRAMEWORK-..................................................209

A. Standard of Review.....,...................-..........................209

B. Basic Legal Principles.................................................210

III. BELATEDLY-DEVELOPED THEORIES .................................211

A. Theory Of Infringement under the Doctrine of Equivalents ................211

B. Theory of Contributory Infringement of Patent '377.......................213

C. New Infringement Argument of Patent '969..............................213

IV. '377 PATENT (RUTENBERG)............................................214

A. Patent Infringement..................................................214

B. Patent Validity.......................................................218

1. Anticipation of the '377 Patent by Tanaka I and II ....................219

a. Tanaka I and II Technology......\.:...........................219

b. Disclosure of “Interactive Review” by Tanaka I and II

(Claim 11)..................... 220

i. Definition of “Interactive Review”...........................220

ii. “Interactive Review” as Limiting Claim 11...................221

iii. Disclosure of “Interactive Review” (Claim 11).................222

c. Disclosure of “Classifying the Specimen” (Claims 11 and 16)........222

d. Disclosure of “Assigning a Value on a Scale” (Claim 14)............224

e. Disclosure of-“Location Guided Screening” (Claim 16)..............224

f. Disclosure of “Ranking Objects in the Specimen”..................224

g. Conclusion...................................................225

2. Anticipation of the '377 Patent by Husain II and III...................225

a. Husain II....................................................225

b. Husain III................ 226

e. Conclusion...................................................226

3. Anticipation of the '377 Patent by Greenberg.........................226

4. Anticipation of the '377 Patent by CDS-1000 .........................227

V. '182 PATENT (LUCK)................. 227

A. Infringement.....:...............................................:... 228

B. Anticipation of the '182 Patent by Tanaka I and Tanaka II.................228

VI. '327 PATENT (WILHELM)...............................................230

A. Infringement.........................................................230

1. Infringement of Claim 1............................................230

2. Infringement of Claim 5............................................232

B. Anticipation..........................................................233

1. Tucker I.........................................................234

a. The Tucker I Technology ......................................234

b. Disclosure by Tucker I of the Preamble of Claim 1 ................234

e. Disclosure of “Accumulation of Scan Processing Flags” by

Tucker I...................................................235

d. Anticipation by Tucker I of Claims 5 and 6.......................236

2. CDS-1000........................................................236

VII. '969 PATENT (KAMENTSKY)............................................237

A. Infringement.........................................................238

B. Anticipation..........................................................240

1. The HOME Technology............................................240

2. Qualification of the IMPACT and Krief Articles as Prior Art............241

a. IMPACT Article..............................................241

b. Krief Thesis..........................................•........242

3. “Means for Automatically Recording”................................242

4. “Operatively Linked”..............................................243

5. “Means for Computing”............................................243

6. Claim 21.........................................................243

VIII.CONCLUSION..........................................................244

In these consolidated actions, Cytyc Corporation (“Cytyc”) seeks declaratory judgment that its ThinPrep Imaging System (“TIS”) does not infringe four patents owned by TriPath Imaging, Inc. (“TriPath”) regarding the semi-automated screening of biological samples for cancerous cells: United States Patent Nos. 6,327,377 (“'377 patent”), 5,257,182 (“'182 patent”), 5,715,327 (“'327 patent”), and 5,793,969 (“'969 patent”). Cytyc also requests a declaration that the patents are invalid. TriPath, in turn, claims that Cy-tyc’s TIS infringes TriPath’s patents.

Both parties have moved for summary judgment as to certain claims. Cytyc moves for a judgment of noninfringement and invalidity with respect to the '377, '183, and '327 patents and noninfringement with respect to the '969 patent. TriPath moves for a judgment of nonanti-cipation for each patent and literal infringement with respect to the '327 patent. For the reasons stated below, I grant in part and deny in part the motions for summary judgment of both parties.

I. BACKGROUND

The technology in this ease centers around the process of screening biological material for the presence of abnormal or cancerous cells.

A. Cytyc’s Technology

Cervical cancer is screened by examining cervical tissue most often taken in the form of a Papancolaou (“Pap”) smear. The screening of slides of thousands of cells can be tedious and time consuming. Cytyc’s TIS is an automated microscope that aids physicians in identifying whether a slide contains cancerous cells. It uses computer imaging technology to search for the presence of atypical cells, cervical neo-plasia, carcinoma, and other cytologic criteria. The TIS reduces time spent screening slides by presenting the cytologist with the portions of the slide most likely to contain abnormal cells, eliminating the need for the cytologist to review the entire slide.

The TIS consists of two components: the Image Processor Subsystem and the Review Scope. The Image Processor Subsystem is a computer-controlled microscopic imaging device that determines the cells of greatest abnormality and stores their locations in a database for future access. The Subsystem consists of a monitor, keyboard, and mouse, an Image Processor, and an Image Processor Controller, all of which take and process images of slides of biological material measures the nucleus-like blobs or clusters in each image, and using those measurements, weeds out distracting objects such as debris, blood, and mucus to identify normal or abnormal cells. Then, using the size and darkness of the cells, it ranks them in order of likelihood of abnormality and presents them to a cytoteehnologist. The cytoteehnologist is responsible for evaluating the entire field using the Review Scope to assess the abnormality of the cells and specimen.

B. TriPath’s Patents

I describe the technology of the several TriPath patents generally at this point and then address the cross-motions for summary judgment relating to each patent in turn in following sections.

1. '377 Patent (Rutenberg)

The '377 Patent (Rutenberg), issued December 4, 2001, claims a “semi-automated” method for screening and classifying cytological specimens. In the preferred embodiment, the Rutenberg device includes an automated microscope, a camera, and a computer. '377 patent at col. 4, 11. 44-47. Rutenberg describes the process of classification of a slide as comprising at least three steps of screening. The first screening (or “primary classifier”) of the cells consists of a low resolution scan in which the image processor screens out objects that are too small, too dark, or too light to be malignant. Id. at col. 11, 11. 13-15. The secondary screening (“secondary classifier”) is a higher resolution scan performed by a computer that identifies suspicious looking cells within the slide. Id. at col. 11, 11. 24-25. The computer assigns the suspicious looking cells a number from 0.1, for likely benign cells, to 0.9, for likely malignant cells. Id. at col. 16, 11. 57-col. 17,1. 2. The computer then presents the 64 most suspect cells to a cytoteehnologist for final classification of the slide. Id. at col. 17,11.14-15.

2. '182 Patent (Luck)

The '182 patent claims a method of classifying cells based on their morphology, designed to improve the original approach set forth in the '377 patent by providing a better image for the cytotechnician to evaluate. In its preferred embodiment, the device performs three scans of the specimen slides. First, the camera automatically focuses and captures an image of the slide at low magnification. '182 patent, col. 7,11. 10-13. The image processor then digitizes the image. Id. at col. 3, 11. 55-57. In this first scan, the image processor identifies the portions of the slide that contain biological material. Id. at col. 7,11. 14-21. For the second scan, the camera captures at high resolution a second image of the cells identified in the first scan. Id. at col. 4, 11. 6-26. The image processor locates the centers of those cells that might be malignant, and a computer assigns the cells a value indicating the likelihood of malignancy. Id. Finally, in a high resolution rescan, the camera obtains high resolution images of the sixty-four cells identified in the second scan as the most suspect. Id. at col. 4, 11. 27-39. A summary screen displays these images for review by a cytoteehnologist. Id. at col. 4, 11. 40-43.

3. '327 Patent (Wilhelm)

The '327 patent describes a method and apparatus for determining whether a slide is suitable for processing. '327 patent at col. 2, 11. 3-5. Specifically, the invention determines whether there were errors in specimen collection, slide preparation, slide handling, or machine processing that might lead to an inaccurate diagnosis. Id. at col. 2, 11. 8-15. The central computer controls the microscope, camera, and image processor in order to acquire a digital image of the slide. Id. at col. 4, 11. 23-26. Then it conducts thirteen suitability tests and computes a score that indicates whether a slide has passed. Id. at col. 4, 11. 37-40. In order to produce reliable results, a slide must pass each of the tests. Id.

4. '969 Patent (Kamentsky)

The '969 patent describes a network system for review and analysis of computer encoded microscope slides and specimens. '969 patent at col. 5, 11. 10-14. During the initial examination of a slide, a microscope equipped with an encoder device encodes information, such as parts of the slide that have been viewed, events of interest for diagnosis, and, for quality control purposes, the manner in which the initial slide examination was conducted. Id. at col. 5, 11. 10-19. This information is stored on a networked file server. Id. at col. 5,11.14-17.

Users can access this information at a series of microscope stations linked by a modem or local access network (“LAN”). Id. at col. 5, 11. 19-22. In addition, the invention allows users to access images from an online library and patient information while simultaneously viewing a slide, either directly through a microscope or as a stored digital image. Id. at col. 5,11. 19-34.

C. Procedural Posture

Plaintiff Cytyc Corporation filed its declaratory judgment action against Defendant TriPath Imaging in this court in June 2003, seeking a finding of invalidity and non-infringement with respect to six TriPath patents. That action, No. 03-11142, which has been designated the lead case, was later consolidated with an infringement action TriPath initially filed against Cytyc in North Carolina and which was transferred to this court as No. 03-12630.

Following a three-day Markman hearing, I issued a Memorandum and Order construing disputed claim terms in all four patents-in-suit. Memorandum and Order, November 28, 2005, 2005 WL 3177877 (“Markman Order”).

II. LEGAL FRAMEWORK

A. Standard of Review

Summary judgment is appropriate when “the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to judgment as a matter of law.” Fed.R.Civ.P. 56(c). A judgment as a matter of law is as appropriate in a patent case as it is in any other matter; it is appropriate when no reasonable jury could reach a verdict for the nonmoving party. Barmag Barmer Maschinenfabrik, AG v. Murata Machinery, Ltd., 731 F.2d 831, 835 (Fed.Cir.1984).

B. Basic Legal Principles

The parties have filed cross motions for summary judgment on issues of patent infringement and patent validity.

An infringement analysis entails two steps: (1) determining the meaning and scope of the patent claims asserted to. be infringed and, (2) comparing the properly construed claims to the device accused of infringing. Markman v. Westview Instruments, Inc., 52 F.3d 967, 976 (Fed.Cir. 1995), aff'd, 517 U.S. 370, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996). Because I have already construed the meaning and scope of claims in the disputed patents in the Markman Order of November 28, 2005, the bulk of the remaining infringement analysis involves the second step,

In order to prove infringement, a patent owner must show that an accused device “incorporates every limitation of a claim, either literally or under the doctrine of equivalents.” MicroStrategy, Inc. v. Business Objects, S.A., 429 F.3d 1344, 1352 (Fed.Cir.2005). To find literal infringement, each claim limitation must be present in the accused device; any deviation precludes such a finding. Telemac Cellular Corp. v. Topp Telecom, Inc., 247 F.3d 1316, 1330 (Fed.Cir.2001). With respect to methods, “infringement arises when all of the steps of a claimed method are performed, whether or not the infringer also performs additional steps.” Smith & Nephew, Inc. v. Ethicon, Inc., 276 F.3d 1304, 1311 (Fed.Cir.2001). In the absence of literal infringement, the doctrine of equivalents allows patentees “to claim those insubstantial alterations that were not captured in drafting the original patent claim but which could be created through trivial changes.” Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722, 733, 122 S.Ct. 1831, 152 L.Ed.2d 944 (2002).

An accused technology cannot infringe a patent that is invalid. Patents, however, are presumed to be valid. 35 U.S.C. § 282. In order to overcome this presumption, the opposing party must come forward with clear and convincing evidence of invalidity in order to prevail. Perricone v. Medicis Pharmaceutical Corp., 432 F.3d 1368, 1372 (Fed.Cir.2005).

With respect to patent validity, the arguments raised in summary judgment discuss only whether TriPath’s four patents were anticipated by prior art. Patent law invalidates claims that have been anticipated by prior art, as defined in 35 U.S.C. § 102. A claim is anticipated “if each and every limitation is found either expressly or inherently in a single prior art reference.” IPXL Holdings, L.L.C. v. Amazon.com, Inc., 430 F.3d 1377, 1381 (Fed.Cir.2005). The touchstone of anticipation analysis is “whether one skilled in the art would reasonably understand or infer from the prior art reference’s teaching that every claim [limitation] was disclosed in that single reference.” Id.

With these principles as reference, I address the parties’ respective claims after disposition of certain preliminary questions regarding the theories and evidence properly raised in this case.

III. BELATEDLY-DEVELOPED THEORIES

A. Theory of Infringement under the Doctrine of Equivalents

Late in the discovery of this litigation and in contravention of the operative scheduling order, TriPath attempted to introduce the theory of infringement under the doctrine of equivalents for all seventeen asserted claims of the patents-in-suit, including the '182 Luck patent. TriPath first raised the contention explicitly in a “response” expert report on May 2, 2005, two and a half weeks after rebuttal expert reports were due. By Memorandum and Order dated June 21, 2005, I granted Cy-tyc’s motion to strike that portion of the response reports that related to a doctrine of equivalents theory because it was too fundamental a theory not to have been advanced in the initial expert reports. See Docket No. 107.

My construction of the word “image” in the November 28, 2005 Markman Order appears to have undercut TriPath’s claim of literal infringement on the '182 patent. As a result, TriPath filed a motion to reconsider my July 21, 2005 order (Docket No. 239), arguing (1) that TriPath introduced the doctrine of equivalents theory earlier in litigation than my order states (iethat Cytyc had adequate notice), (2) that it would be unduly harsh, prejudicial, and “draconian” for me to prohibit TriPath from proceeding on the equivalents theory of infringement, (3) that any prejudice to Cytyc can be cured by allowing Cytyc to engage in extra discovery, and (4) that as a result TriPath should be able to produce non-expert evidence supporting the doctrine of equivalents.

I will deny TriPath’s motion for reconsideration. First, Cytyc did not have adequate notice that TriPath would be advancing a theory of infringement based upon the doctrine of equivalents. I recognize (and noted in 2005) that Cytyc did not ask TriPath in its interrogatories whether it would be pursuing a doctrine of equivalents theory. Thus I believe that the interrogatories and their respective responses are not relevant to whether Cytyc had or should have had notice. TriPath, however, had the entire length of expert discovery to develop a theory under the doctrine of equivalents. TriPath did make limited reference to the doctrine of equivalents in its initial expert report, by way of legal boilerplate and a few stray references to whether two things were “equivalent” for the purpose of claim construction. See TriPath’s Motion to Reconsider at 5 (Argument); TriPath’s Post-Hearing Supplemental Brief, Exhibit 4 (Initial Expert Report). TriPath claims that raising the theory in this oblique manner constitutes notice. But, as I stated in the July 21, 2005 order, TriPath needed to develop the theory explicitly to place it at issue in the case.

Furthermore, even if my July 21, 2005 order was in some fashion severe, Cytyc has relied upon that judgment through the remaining discovery period. TriPath failed to file a motion to reconsider even after my Markman Order entered November 21, 2005. I decline to authorize the parties to engage in additional discovery at this point in the litigation, with trial on the horizon. TriPath claims that any additional discovery Cytyc needs to perform could be completed and briefed without affecting the trial date but I am not persuaded by this bare assertion. Substantial additional discovery will be necessary. Cytyc would have to be allowed to obtain fact discovery on the equivalence of digital and non-digital images, depose TriPath’s experts, and serve rebuttal expert reports. Perhaps more importantly, it would ennervate the integrity of case management deadlines to indulge TriPath’s argument that the parties might be able to work harder to remedy the default now that the deadline has passed.

TriPath argues that it should at least be able to present non-expert testimony supporting the doctrine of equivalents. My July 21, 2005 order precluded TriPath from using any evidence at all, not just expert evidence, to advance a theory of doctrine of equivalents. I decline to accept TriPath’s suggestion that it can proceed on the equivalents theory using lay testimony. The evidence TriPath wishes to submit is offered to prove whether looking through a microscope is equivalent to looking at a digital image for purposes of the '182 patent. TriPath tenders its experts to testify as “lay witnesses” to this equivalence. Although it is arguable that TriPath does not need expert testimony to prove its claim, I will not allow TriPath to circumvent my June 21, 2005 order by calling an expert to testify under the guise of fact witness testimony.

I realize that the doctrine of equivalents has apparently emerged as TriPath’s best argument for infringement of the '182 patent. That development, however, was always a possibility. TriPath did not promptly file a motion to reconsider, not even after it had notice that the Markman construction excluded a claim for literal infringement. Instead, TriPath waited until filing for summary judgment to raise the doctrine of equivalents theory anew. Meanwhile, in the months after I issued an order striking the theory, Cytyc has relied upon that order and has had no reason to pursue or request additional factual or expert discovery regarding the theory. In order to prevent any possible prejudice Cytyc would suffer by having to respond to a foundational theory of infringement at this late stage of litigation and to maintain the integrity of case management orders and the deadlines they import, I decline to alter my July 21, 2005 order and will deny the motion to reconsider. (Docket No. 239).

Accordingly, Cytyc’s corollary motion (Docket No. 214) to strike ¶ ¶ 3-4 and 19-21 of the Reynolds Declaration (Docket No. 201) and ¶ ¶ 5-9 of the Gahm Declaration (Docket No. 188), which TriPath claims is factual testimony as to equivalence, will be granted.

B. Theory of Contributory Infringement of Patent '377

TriPath argued in its moving papers that even if Cytyc has not itself infringed the '377 patent, it is a contributory infringer or an infringer by active inducement. Cytyc seeks to strike this theory as waived because TriPath made no mention of it in its interrogatory responses or expert reports and Cytyc has had no fact or expert discovery on this issue.'

It is true that TriPath pled contributory infringement in its counterclaim and its answer to Cytyc’s complaint. TriPath made no explicit reference to the theory, however, after the pleadings until briefing the motion for summary judgment. In order to proceed on this claim, TriPath should have developed the theory during discovery and explicitly outlined a theory of contributory infringement in its expert reports. Introducing a new theory at this stage of litigation — where factual and expert discovery has closed — with no' explanation for the delay is unacceptable. See Powell v. Storz Opthalmics, Inc., 34 U.S.P.Qüd 1136, 1139-40 (M.D.Fla.Í994), aff'd, 53 F.3d 347 (Fed.Cir.1995) (precluding patentee from introducing theory of infringement not disclosed during discovery after accused infringer had conducted discovery, prepared its case, and submitted dispositive motions).

TriPath should not be materially prejudiced by my decision on this issue. As stated below, I have denied Cytyc’s motion for summary judgment with respect to literal infringement of the '377 patent; consequently, TriPath’s direct infringement claim is alive and well. TriPath argues that pursuing a theory of contributory infringement will aid in emphasizing the fact that Cytyc’s technology requires a human user. Concern for trial-presentation choreography, however, is not a valid reason for raising a new theory of contributory infringement post-discovery. TriPath will have an adequate opportunity at trial to provide evidence that Cytyc’s technology prepares biological samples for human review.

C. TriPath’s New Infringement Argument of Patent '969

Cytyc moves to strike as untimely TriPath’s argument and supporting expert testimony that the TIS Review Scope (as opposed to the TIS Image Processor Subsystem) infringes claim 16 of the '969 Patent. Cytyc’s motion to strike will be denied, but I will allow Cytyc to pursue additional discovery to rebut TriPath’s argument.

TriPath first developed the Review Scope theory of infringement in expert report updates filed in March 2006. I had allowed the parties to submit the updated expert reports for the sole purpose of reflecting the claim construction adopted in the November 2005 Markman Order. Cy-tyc claims that TriPath’s new argument is, not a response to the Markman order and that TriPath should have been able to make an argument that the Review Scope infringed claim 16 as early as August 2005 when the parties stipulated to a claim construction of the element “location information of interest” found in claim 16(b)(iii). Claiming undue prejudice, Cytyc has moved to strike the expert reports upon which TriPath relies for its argument that the Review Scope contains “means for automatically recording location information of interest” on the grounds that the argument should have been made in the initial round of expert reports. Specifically, Cy-tyc seeks to exclude ¶¶ 3, 5, and 9-12 of the Russ Updated Report. See Cytyc Motion to Strike, Ex. 4 (Docket # 142).

Perhaps TriPath could have developed its infringement argument earlier than it did. But while the parties might have agreed to the relevant claim construction before the Markman hearing, they did so after the close of expert discovery. Thus, TriPath might not have been prompted to make the argument before the initial expert reports were due in March 2005. I dó not conclude that TriPath could not or should not have made the argument in its initial expert report. But I also do not view the existence of the August 2005 stipulation, which was executed well after the last expert reports were circulated, as determinative of whether TriPath knew enough to raise the argument in its initial expert report.

■ I will allow TriPath to pursue its infringement argument. The Review Scope infringement theory was introduced late but it was introduced well before the- summary judgment briefing was due. Further, because it is not an ■ entirely new fundamental theory of infringement, like the doctrine of equivalents, it should not widen-the scope of discovery so much as to cause a delay in trial.

In summary, Cytyc’s motion to strike the Review Scope infringement argument and supporting testimony will be denied. TriPath has agreed to withdraw paragraph 12 of the Russ updated expert report. Paragraphs 3, 5, and 9 are allowed. I will grant Cytyc’s request for additional discovery to respond to the argument that the Review Scope infringes claim 16.

IV. '377 PATENT (RUTENBERG)

TriPath’s '377 Patent describes technology that, like the TIS, screens and classifies biological material for the purpose of determining whether the material contains abnormal cells. Cytyc has filed a motion for summary judgment with respect to this patent on both noninfringement and patent invalidity. Specifically, Cytyc requests judgment as a matter of law that (1) its technology, TIS, does not infringe '377’s independent claims 11 and 16 or dependent claims 13, 15, 17-18, 20, and 22-26, and (2) TriPath’s patent was anticipated .by two pieces of prior art, both authored by Tana-ka. TriPath has filed a cross motion for summary judgment on patent validity with respect to all the prior art at issue in the case.

A. Patent Infringement

Given some additional claim construction I provide in this section, I cannot find noninfringement as a matter of law with respect to independent claims 11 and 16 of the '377 patent., In order for a technology to infringe a patent, it must infringe every limitation embodied in the patented claim. See Section IIB, supra. Because accepting Cytyc’s sole argument would exclude the preferred embodiment of the patented technology from the patent, I deny Cytyc’s motion for summary judgment.

The single disputed issue for infringement regarding both claims 11 and 16 is whether 'Cytyc’s technology “classifies the specimen,” as opposed to “objects within the specimen.” There is no dispute that Cytye’s TIS meets the other limitations of the claims. Cytyc argues, however, that the TIS does not “classify specimens” because the TIS never places specimens into one of two or more groups. See Markman Order at 66 (defining classifying as placing something into “one of two or more groups”). Instead, the TIS, Cytyc argues, merely facilitates human classification of the specimen by placing objects within the specimen into one of two or more groups. Docket No. 160 at 10. It is the human, not the machine, that Cytyc claims classifies the slide or entire specimen as normal or abnormal. Cytyc points to the following testimony by TriPath’s technical expert:

Q: And so it is accurate to say that the TIS machine may classify objects within a specimen but does not classify the specimen itself?

A: Yes, that’s correct.

Q: And only the human being classifies the specimen?

A: Yes.

Russ Dep. at 91 (Shannon Deck, Ex. 15).

The TIS does not infringe the '377 patent insofar as “classifying the specimen,” on its face, does not include “classifying objects within the specimen.” In the Markman Order, I construed “classifying the specimen” to mean “classifying the specimen into one of two ór more groups, including [by] primary and secondary classifiers, but not [by] a classifier, human or otherwise, that provides'a final diagnosis.” See Markman Order at 10-13. Neither the parties nor I, however, addressed the definition of the term “specimen” or whether “classifying the specimen” could include classifying objects within the specimen. Cytyc suggests that classifying the specimen involves assigning the entire specimen to one of two or more groups, whatever the specimen consists of. That reading would exclude Cytyc’s technology because the TIS primary and secondary screens do not assign the entire specimen into one of two or more groups “for further classification,” but rather, do so only for objects or cells within a specimen.

But under Cytyc’s reading, the preferred embodiment of the patented technology would also not “infringe” the asserted claims. In the preferred embodiment, as TriPath points out, the first two screenings identify only objects within the specimen as normal or abnormal without classifying the specimen as a whole. The '377 specification seems to use “classifying the specimen” interchangeably with “classifying portions of the specimen.” See, e.g., col. 2, 11. 31-37 (“[T]he invention includes an initial classifier ... to classify a cytological specimen and a subsequent classifier ... to classify those portions of the cytological specimen selected by the initial classifier for subsequent classification.”). It seems clear, as well, that the primary and secondary classifiers that Rutenberg describes classify only objects within one biological sample. See, e.g., col. 17, 11. 34-52:

Fig. 5 shows the screening of a typical Pap smear which contains approximately 100,000 benign cells and other objects. Through erosion/dilation and IDO filters, the primary classifier 400 will filter out 99% of these objects, passing approximately 1,000 objects to the secondary classifier 420. Classifier 420 ... in turn filters out 80% of these 1,000 objects, passing the images of approximately 200 residual objects deemed to be the most suspect of pathology to the output monitor for tertiary human inspection.

If a Pap smear is the same as a “specimen,” then the '377 specification clearly calls for a method of screening out objects within that specimen. In other words, because “classifying the specimen,” according to my construction, must refer to the classification by only the primary and secondary classifiers, “classifying the entire specimen” is something that neither Cytyc’s TIS nor '377’s methods 11 and 16 perform.

To avoid the untenable result that the patent claim excludes the preferred embodiment of the patented technology, I must construe “classifying the specimen” to include classifying objects within a specimen in an overall process falling short of classifying the entire specimen. Under this construction, Cytyc’s TIS “classifies the specimen ... for further review by a human” insofar as it screens objects within the specimen and assigns them to groups. Cytyc does not dispute that its technology classifies objects within a specimen. Thus, Cytyc’s current motion for summary judgment is denied with respect to the asserted claims.

B. Patent Validity

Cytyc has moved for summary judgment asserting that claims of the '377 patent are invalid as anticipated by prior art. Specifically, Cytyc claims that over a year before the '377 patent application was filed, Dr. Noboru Tanaka published two articles describing the CYBEST Model 4, an automated cytological screening system (herein referred to as Tanaka I and II). Dr. Tanaka’s articles, it contends, disclose each element of and therefore anticipate the asserted claims of the '377 patent pursuant to 35 U.S.C. § 102.

TriPath has, in turn, filed a cross-motion for summary judgment, seeking a declaration that its patent was not anticipated by Tanaka I or Tanaka II. Additionally, TriPath seeks a declaration of nonanticipation with respect to four additional references: (1) two articles describing a cervical specimen screening device developed by O.A.N. Husain in the United Kingdom (herein referred to as Husain II and III); (2) an article by S. Donald Greenberg describing a system for analyzing abnormalities in lung cells (“Greenberg”); and (3) a cervical specimen screening device developed by Cytyc in the late 1980s known as the CDS-1000.

1. Anticipation of the '377 Patent by Tanaka I and II

Cytyc contends that the Tanaka references anticipate each element of the asserted claims. TriPath argues that the Tanaka references are nonanticipatory because they fail to disclose the following six claim limitations: (1) “interactive review” (claim 11); (2) “classifying the specimen” (claims 11 and 16); (3) locating and identifying objects for “further classification by a human” (claims 11 and 16); (4) “assigning a value on a scale” (claim 14); (5) “location guided screening” (claim 16); and (6) “ranking objects in the specimen” (claim 16). For the reasons below, I will deny both parties’ motions for summary judgment with respect to anticipation of claims 11 and 16 of the '377 patent because there is a disputed issue of whether Tana-ka’s CYBEST Model 4 discloses a method for “further classification by a human.”

a. Tanaka I and II Technology

Tanaka I and II describe the CYBEST Model 4, an automated cytologic screening system for uterine cancer that - “utilize[s] image analysis technology for the automated prescreening of cervical cytology specimens.” Tanaka II at 449. After 14 years of research, Dr. Noboru Tanaka developed the CYBEST Model 4 in 1981. I note at the outset that the Tanaka references were not listed as cited references on the face of the '377 patent, and there is no evidence that the Patent and Trademark Office considered Tanaka I or II during the prosecution of '377. The PTO did, however, consider an older Tanaka model, the CYBEST Model 3, and determined that it did not anticipate TriPath’s claimed methods.

The CYBEST Model 4 system scanned specimen slides to obtain digital images of individual cells and cell specimens. Id. at 451. It then analyzed the cells using five parameters: nuclear size, nuclear-cytoplasmic ratio, nuclear optical density, nuclear shape, and chromatin pattern. Id. These parameters were weighted according to their importance and used to generate an “atypicality grade” for individual cells. Id. at 452. Each cell was assigned one of 19 rankings between +1 and -1, with +1 the highest grade (definitely malignant) and -1 the lowest (definitely benign). Id. The atypicality grades for each cell were accumulated into a ranking for the overall specimen slide, on the same 19-point scale. Id.

As an “optional feature,” the CYBEST Model 4 allowed for post-screening human review of the ten cells with the highest atypicality rank. Id. This “10-cell system” displayed all of the measurement data, the atypicality grade, and the final specimen assessment (normal, suspicious, or reject) on the screen for the reviewer. Id. The primary purpose of this feature was to “confirm[ ] the machine assessment by direct manual optical observation and for evaluation of the accuracy of the automated system.” Id.

b. Disclosure of “Interactive Review” by Tanaka I and II (Claim 11)

For the reasons stated below, I conclude that Tanaka I and II disclosed a method providing for “interactive review.” Before reaching the question of disclosure, however, I must address: (1) the definition of interactive review, and (2) whether the term “interactive review” limits claim 11 of the '377 patent.

i. Definition of “Interactive Review”

As discussed below, I construe “interactive review” as used in claim 11 to mean “review by a human of the results from an initial classification.” TriPath defines the term as “subsequent human examination of selected objects within a specimen via interaction with a machine, such as by a series of human commands and associated machine responses.” Docket No. 218 at 2. Cytyc proposes no definition, but it insists that the term does not incorporate human classification of a specimen. That question was resolved, it claims, by the Markman Order, which excluded human review from the definition of “classifying the specimen.”

A fully-automated system cannot infringe the asserted claims of the Ruten-berg '377 patent. For clarity, I should briefly rehearse the conclusions of the Markman order. Although I did not explicitly state it then, I construe claims 11 and 16 to patent a method that must include some further human classification of the specimen. See claims ll(b)(ii); 16(b)(ii) (“further classification by a human”). Nonetheless, I concluded in the Markman hearing that a machine, rather than a human, might perform the final classification in the technology that the '377 patent claims. That conclusion is consistent with the fact that claims 11 and 16 contemplate at least some — not necessarily final — human classification.

With this in mind, I will construe “interactive review” as stated in the '377 patent as “review by a human of the results from an initial classification.” The word “interactive” in common usage suggests influence or reciprocity between two different entities. See Webster’s Third New International Dictionary (1986). Given the language in the claim stating that the method provides for “interactive review ... including identifying objects ... for further classification by a human,” at least one of the interacting entities should be a human.

The term “review” denotes an examination. Technically, a review is the examination of something that has already been examined in one form or another. The common usage of the term may sometimes be broader; some portion of the population will often use the term “review” to denote an initial examination. In the context of this claim, however, there is no dispute that the interactive review occurs subsequent to an initial examination by a machine. Thus, I adopt-a modified version of TriPath’s proposed definition for “interactive review”: examination by a human of the results of an initial examination.

Contrary to Cytyc’s argument, the definition of “interactive review” is not limited by the claimed steps of claims 11 and 16. Claims 11 and 16 describe methods (including classifying the specimen) that merely “provide” for further interactive review. Claim 11 reads, “A method for providing interactive review of objects in a specimen indicative of the highest likelihood of abnormality ... comprising ... obtaining the specimen” and “classifying the specimen.” Thus, the definition of “classifying the specimen,” which here is only a method of preparing a slide for interactive review, is not relevant to the definition of “interactive review.”

ii. “Interactive Review” as Limiting Claim 11

I also construe the term “interactive review,” which occurs in the preamble of claim 11, as claim-limiting. A preamble “limits the invention if it recites essential structure- or steps, or if it is ‘necessary to give life, meaning, and vitality’ to the claim.” Catalina Marketing Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir.2002) (quoting Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305 (Fed.Cir.1999)). “Conversely, a preamble is not limiting “where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use of the invention.’ ” Id. (quoting Rowe v. Dror, 112 F.3d 473, 478 (Fed.Cir.1997)).

I concur with Cytyc that “interactive review” is an introductory descriptive term that does not add meaning to the body of,claim 11. As stated above, the claimed method only prepares the specimen for interactive review. Ordinarily, where the preamble describes the purpose of the method, as it does here, it is not considered limiting. See Catalina Marketing, 289 F.3d at 809.

There is, however, an exception to the life-and-vitality test when the applicant has explicitly relied upon a feature in the preamble during prosecution to distinguish it from prior art. Id. at 808 (“[C]lear reliance on the preamble during prosecution to distinguish the claimed invention from the prior art transforms the preamble into a claim limitation because such reliance indicates use of the preamble to define, in part, the claimed invention.”). TriPath argues that the exception applies here, and I agree.

The evidence shows that the patentee attempted to distinguish his invention from fully automated systems during the prosecution process. See Amendment, at 8 (March 14, 1994) (Daniel Decl. Ex. 13, Tab 30). The premise of the '377 invention, as explained by the applicant, is that humans are more adept than machines at visual recognition and classification. Id. at 6. The purpose of the method is not to analyze or categorize a specimen completely, but merely to save the cytotechnologist’s time in the overall analysis. Id. Because the claim contemplates some manual review, the applicant described his invention as “semi-automated,” specifically making use of the term “interactive.” Id. at 7. The applicant claimed that this “interactive” feature of his invention was contrary to the trend of prior art classifiers, which sought to remove the human factor from the classification process altogether. Id.

The applicant relied “clearly and unmistakably” upon the interactive nature of the invention to distinguish it over the prior art. See Catalina Marketing, 289 F.3d at 809. Thus, “interactive review” is a claim limitation, and it must be present in the Tanaka references in order to prove anticipation.

iii. Disclosure of “Interactive Review” (Claim 11)

Given the above construction, I find the Tanaka references disclose a method providing for “interactive review.” A claim is anticipated “if each and every limitation is found either expressly or inherently in a single prior art reference.” IPXL Holdings, L.L.C. v. Amazon.com, Inc., 430 F.3d 1377, 1381 (Fed.Cir.2005). The Tanaka references describe a system that allows for some form of human review of the initial classification. The 10-cell system, although optional, provides humans the opportunity to examine a specimen. This optional human interaction after initial examination by a machine anticipates the “method providing for interactive review” in claim 11. See Upsher-Smith Laboratories, Inc. v. Pamlab, LLC, 412 F.3d 1319, 1322 (Fed.Cir.2005) (stating that technology that “optionally includes” an item anticipates a claim that expressly includes it).

c. Disclosure of “Classifing the Specimen ...” (Claims 11 and 16)

There is a genuine dispute of fact as to whether Tanaka I and II disclose the methods of Claims 11 and 16. TriPath argues that the CYBEST Model 4, unlike their claimed method, is a fully-automated system that produces a final diagnosis at the completion of the screening process. Any additional human review, it contends, is merely an optional quality control feature unrelated to classification. TriPath essentially argues that the CYBEST model 4 does not anticipate “classifying a specimen ... for ... further classification by a human.” I agree the references are ambiguous as to this issue. Cytyc argues that Tanaka’s 10-cell system provides a human operator the opportunity to retain or correct the initial classification, and consequently, in cases where the human reviews the results, the human does make the final diagnosis.

I must emphasize that Tanaka I and II do not need to disclose the human as the final classifier in order to anticipate TriPath’s technology. As discussed in the previous section addressing “interactive review,” TriPath’s technology does not require a human as the final classifier. It is true that in the preferred embodiment described in the '377 specification, the human is the final classifier. It is also true that claims 11 and 16 require some form of human classification of the specimen. The final classification, however, as the specification implies, could be automated. Thus, in order for Tanaka I and II to disclose “classifying the specimen,” there need only be some form of “further classification by a human.”

Tanaka I and II disclose a system that provides fully-automated classification with the option of subsequent human review of the 10 most atypical cells. The question is whether the optional human review includes any classification of the specimen. The description of the 10-cell system explains that the purpose of the human review as a “useful ... confirmation of the machine assessment” and an opportunity to evaluate “the accuracy of the automated system.” The words “assessment,” “accuracy,’? and “automated” as they are used in Tanaka II could support an . inference that the human’s role is solely that of general quality control to confirm that the machine is not broken, i.e., that the human would never engage in “classification.” In other words, it is unclear from the Tanaka literature whether, during the 10-cell review, the human assigns the specimen or portions of the specimen into one of two or more groups.

TriPath points to considerable evidence that Tanaka discloses a fully-automated process, but this evidence does not exclude the possibility of optional human classification. It is true that Tanaka’s articles refer to the invention as an “automated” — as opposed to “semi-automated” — process. It is also true that the Tanaka computer assigns each specimen a “final assessment” of “normal,” “suspicious,” or “rejected.” Contrast this to the '377 patent, which does not label the entire specimens at all, but leaves that diagnostic function to the (possibly-human) reviewer in the tertiary classification.

But the Tanaka references also contain language supporting the inference that it has disclosed a semi-automated system. First, the Tanaka I abstract describes the invention as an automated “prescreening” process. One could similarly describe TriPath’s methods claimed in 11 and 16 as embodying a fully-automated pre-screen-ing process that allows a human to perform additional classification. Second and more importantly, Tanaka’s 10-cell system, read literally, is a form of human review or examination of the most atypical specimens. It allows a human to analyze the specimen, and perhaps, although it is not quite clear, override the classification provided by the machine, allowing for a “super-final” classification by a human. Finally, the description of the CYBEST system in the Husain III article suggests that human review is an integral part of the CYBEST invention: “[The CYBEST] uses an exclusive algorithm for clusters and overlaps and produces an atypicality index or ranking of abnormal signals which are then submitted for operator review.” Husain III at 200. This evidence is sufficient to support an inference that Tanaka discloses a method that “classifies the specimen ... for further classification by a human.”

I must deny both parties’ motions for summary judgment on the issue of anticipation of ¡claim 11 and 16 (and, mutatis mutandis, on their dependent claims). The question for the jury will be whether Tanaka I or II disclosed a method providing for subsequent human review that amounts to “classification,” or whether the review performed by the human after looking at the 10-cell system falls short of assigning the specimen or portions of the specimen into one of two or more groups.

d.Disclosure of “Assigning a Value on a Scale” (Claim 14)

Tanaka I and II disclose a method “assigning a value on a scale” as claimed in claim 14 of the '377 patent. Claim 14 depends on claim 11 and adds the limitation of “assigning value on a scale between a first output value associated with a first condition and a second output value associated with a second condition.” The CY-BEST model 4 classifies cells by assigning them one of 19 values between -1 and +1, with +1 indicating “definitely malignant” and -1 indicating “definitely benign.” Ta-naka I at 3302. Thus, the Tanaka technology assigns a value on a scale between a first output value (-1) associated with a first condition (benign) and a second output value (-I-1) associated with a second condition (malignant).

TriPath argues that Tanaka I and II do not assign values “on a scale” because the scale is not continuous. Claim 14, however, does not require that the scale be continuous, and I will not construe it as such. Relatedly, TriPath argues that because the CYBEST assigns only one of 19 values between -1 and +1 to each cell, allowing for the possibility that two cells could share the same value, it does not amount to assigning values on a scale. This argument also fails. TriPath’s patent does not require that each object have a unique value.

e. Disclosure of “Location Guided Screening” (Claim 16)

The parties have not agreed to nor proposed definitions for “location-guided screening”; nor have they asked me to construe the term. Though “location-guided screening” could be a self-explanatory term of common usage, it is possibly a technical term. Additionally, the parties have not provided argument beyond bare assertion about whether the term, located in the preamble of claim 16, is claim-limiting. Consequently, I cannot determine whether the Tanaka references anticipate this element for purposes of summary judgment.

f. Disclosure of “‘Ranking Objects in the Specimen”

There is no doubt that Tanaka I and II- disclose a method that “ranks objects in a specimen in an order according to the likelihood that an object has attributes of cell abnormality.” To quote from the Tanaka I article: “Ten cells can be called out ... in the order of highest atypical rank.” Tanaka I at 3305; see also Figure 11 (showing the 10-cell ranking of “most malignant cell review”).

TriPath’s various arguments that Tana-ka I and II fail to disclose a method of ranking are not persuasive. TriPath first argues that Cybest Model 4 does not rank objects because after it assigns values it does not place them in order. First, Figure 11 in the Tanaka article shows a ranking of -the ten most atypical cells in order of their atypicality. Perhaps TriPath has ignored the 10-cell system because it is an “optional” feature, but the case law has established that optional facets of a technology are fully capable of anticipating TriPath’s claims. See TJpsher-Smith, 412 F.3d at 1322.

Second, assigning values to objects on a numerical scale is equivalent to putting them in order. The values themselves certainly have an order, and assigning objects to values with an inherent order is equivalent to ranking. The parties previously agreed that “ranking” means “placing objects in a row, or order in such a manner that the first ranked object is the one with the greatest probability of exhibiting a particular characteristic, and the second ranked object is the object with the second greatest probability of exhibiting a particular characteristic, etc.” Markman Order at 68. Under my construction and this stipulated definition, the Tanaka 10-cell output anticipates a method of ranking because it prints out the 10 most malignant cells “in order.”

There is no evidence for TriPath’s assertion that the 10-cell system’s ranking of “Most Malignánt Cells” was not actually a ranking of the most malignant cells. TriPath asserted at hearing that the label on Tanaka’s Figure 11 is inaccurate and that the Tanaka technology disclosed only a method for ranking by one parameter (the N/C ratio), rather than by atypicality. TriPath argues that, as a result, the disclosure of a ranking method is at least ambiguous. I do not find ambiguity. Tanaka II states specifically that the 10-cell system can provide a print out of the “ten most atypical cells in a specimen.” Tanaka II at Figure 7. An example of this list is presented in Figure 11 of Tanaka I and labeled “10 Most Malignant Cells.” The literature discloses that it determines atypicality by using a weighted average of five different parameters, only one of which is the N/C parameter. See Tanaka I at Figure 5. Given the formula for the weighted average, it is not surprising that the ranking of the cells in Figure 11 happens to track the ranking of the N/C ratio. I have no reason to doubt the accuracy of the Tanaka figures and assertions, and TriPath has submitted no evidence or expert testimony regarding the alleged ambiguity of the references.

g. Conclusion

In sum, although Tanaka I and II disclose the elements of “interactive review,” “assigning a value,” and “ranking,” there is a genuine dispute of fact as to whether it also includes “classifying the specimen ... for further classification by a human.” In addition, given the lack of briefing, whether “location-guided screening” is a claim limitation, how it should be construed, and whether it is anticipated are still open to debate. Consequently, both parties’ motions for summary judgment will be denied on the question of anticipation by the Ta-naka references.

2. Anticipation of the '377 Patent by Husain II and III

I find that neither Husain II or III anticipate, the '377 patent, for reasons discussed below.

a. Husain II

Husain II discusses the development of a semi-automated screening device. The device operates by scanning a prescribed region of a slide and registering the location of suspicious cells. Husain II at 353. These cells are then recalled under computer control for operator viewing and classification. Id. The machine identifies suspicious cells by calculating the area, integrated optical density, aspect ratio, circularity, and convexity or concavity of the outline of the objects. Id. Objects with an optical density greater than 1.8 times the mode are considered “suspicious.” Id. The automatic scanning continues until the device identifies 100 suspicious cells or scans the entire area. Id. The human operator than classifies the selected cells as “abnormal,” “inflammatory,” “normal,” or “artifact.” Id.

Husain II is not anticipatory because it does not disclose an enabling method for ranking cells according to their abnormality. The authors state that they “are currently investigating the use of ranking the abnormal susps [sic] detected in conjunction with high resolution texture analysis,” Husain II at 354, but they stop there. This vague suggestion does not constitute an enabling disclosure for purposes of 35 U.S.C. § 102(b). See Motorola, Inc. v. Interdigital Tech. Corp., 121 F.3d 1461, 1471 (Fed.Cir.1997) (stating that prior art must be enabling to anticipate).

b. Husain III

Husain III is an article describing in very general terms the operation of the Cytoscan automated cervical cancer screening system that was under development at the Charing Cross Hospital in England in the late 1980s. The Cytoscan scanned slides and presented “a hierarchic classification of cells and artefacts” based on cell size, shape, integrated optical density, and nuclear mass. Husain III at 199. A human operator then reviewed the suspect objects. Id.

Husain III is also not sufficiently enabling to be anticipatory. The article mentions that “suspicious signals” are identified by the machine and “ranked in order of severity for operator review.” Id. at 200. These vague references, however, are the only indication of any ranking feature. It does not disclose whether those suspect cells are assigned values and ranked along a numeric scale and whether they are located or mapped. There is also no evidence that the disclosed machine classifies the specimen or reviews a preset number of cells, as disclosed in Husain II. Without more information, Husain III cannot be an enabling disclosure that anticipates the asserted claims.

c. Conclusion

In sum, there is not enough evidence to support an inference that either Husain II or III is anticipatory. Consequently, I grant TriPath’s motion for summary judgment of nonanticipation with respect to these references.

3. Anticipation of the '377 Patent by Greenberg

The Greenberg reference does not anticipate TriPath’s claims because it discloses a fully-automated system. Green-berg discloses a system for assigning numerical values to the various stages of lung cancer cells. The cells are scanned and classified by computer, using the Atypia Status Index (“ASI”) developed by the authors. Greenberg at 171. The ASI is an objective measurement of atypicality scaled from minima of 0.5 (least abnormal) to 5.5 (malignant). Id. Depending on which ASI value a cell is assigned, it can be classified into one of five diagnoses: squamous metaplasia (0.5-1.4), mild atypia (1.5-2.4), moderate atypia (2.5 — 3.4), severe atypia (3.5-4.4), and carcinoma (4.5-5.5). Id. The ASI is computed mathematically by using a combination of parameters derived from analysis of fourteen features of the nucleus and cytoplasm of the cells. Id. at 171-72. It is designed to “identify, classify, and quantify the degree of cellular atypia.” Id. at 171.

The Greenberg technology is fully-automated and thus nonanticipatory. Some human classification is, as discussed above, an essential part of Rutenberg technology. A fully-automated technology allowing for no human review cannot infringe or anticipate TriPath’s claims. The ASI ranking provides a preliminary measure of atypi-cality, but then it places the cells into one of five final categories with diagnostic significance. No subsequent human review is contemplated and thus the technology cannot anticipate the Rutenberg methods.

Cytyc argues that the fact that the authors of the Greenberg study conducted “visual inspection of slides” to compare the machine results with clinical diagnoses in Greenberg is sufficient to disclose human classification. I disagree. The fact that the authors of the article took steps to confirm that their technology produced results similar to clinical evaluation does not support an inference that human review was disclosed as a part of the classification process. Consequently, TriPath’s motion for summary judgment of nonanticipation with respect to this reference is granted.

4. Anticipation of the '377 Patent by CDS-1000

I will grant TriPath’s motion for summary judgment with respect to nonan-ticipation by CDS-1000 because the CDS-1000 does not qualify as prior art. First, the CDS-1000 system is not prior art under 35 U.S.C. §§ 102(a) or (b). In order to anticipate a patent under those sections, the technology must be known, used, or described in a printed publication before the applicant invented the anticipated technology, or publicly displayed more than one year before the filing of the anticipated patent. 35 U.S.C. §§ 102(a), 102(b). The CDS-1000 was a computer screening system designed by Cytyc that analyzed slides o