IN THE UNITED STATES PATENT AND TRADEMARK OFFICE

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1 IN THE UNITED STATES PATENT AND TRADEMARK OFFICE In the Inter Partes Review of: U.S. Patent No. 7,965,408 Trial Number: IPR Panel: To Be Assigned Filed: January 3, 2001 Issued: June 21, 2011 Inventor(s): Cyrus Kurosh Samari Assignee: Sorna Corporation Title: MEDICAL DATA RECORDING SYSTEM Mail Stop Inter Partes Review Commissioners for Patents P.O. Box 1450 Alexandria, VA PETITION FOR INTER PARTES REVIEW UNDER 35 U.S.C. 311 AND 37 C.F.R i

2 TABLE OF CONTENTS I. GROUNDS FOR STANDING UNDER 37 C.F.R (a)... 1 II. MANDATORY NOTICES 37 C.F.R. 42.8(A)(1)... 1 A. 37 C.F.R. 42.8(b)(1): Real Party-In-Interest... 1 B. 37 C.F.R. 42.8(b)(2): Related Matters... 1 C. 37 C.F.R. 42.8(b)(3) and (4): Lead and Back-Up Counsel and Service Information... 2 D. PAYMENT OF FEES 37 C.F.R III. SUMMARY OF THE 408 PATENT... 3 A. Brief Description of the Technology at Issue... 3 B. Summary of the Prosecution History of the 408 Patent... 5 C. Claim Construction 37 C.F.R (b)(3) Parsing (Claim 1) and Extracting (Claim 14) DICOM Image Information Recording other files as defined by DICOM Autoloader control software Job Noting... 8 IV. IDENTIFICATION OF CHALLENGE 37 C.F.R (b)... 9 A. 37 C.F.R (b)(1): Claims for Which IPR Is Requested... 9 B. 37 C.F.R (b)(2): The Specific Art and Statutory Ground(s) on Which the Challenge Is Based... 9 V. THERE IS A REASONABLE LIKELIHOOD THAT ONE OR MORE CLAIMS OF THE 408 PATENT IS UNPATENTABLE UNDER 37 C.F.R (b)(4) and (5) A. Person Having Ordinary Skill in the Art (PHOSITA)...10 B. Summary/Historical Understanding of the Art by the PHOSITA...10 C. Alleged Problem Solved by the Inventor Was Already Solved...14 VI. Claim-By-Claim Explanation of Grounds for Unpatentability...15 A. Ground 1 Claims 1-2, 4-11 and are obvious 35 U.S.C. 103(a) over Kahle in view of DICOMView and further in view of MicroTech Summary of Prior Art and Rationale to Combine...16 ii

3 2. Claim Claim Claim Claim Claim Claim Claim Claim Claim Claim Claim Claim Claim Claim B. Ground 2 Claims 3-5, 12 and 13 Are Obvious Under 35 U.S.C. 103(a) over Kahle in view of DICOMView further in view of MicroTech and further in view of Farrell Claim Claim Claim Claim Claim VII. RELIEF REQUESTED...60 iii

4 EXHIBIT LIST Exhibit No. Description 1001 U.S. Patent No. 7,965,408 ( 408 Patent ) 1002 U.S. Patent No. 5,518,325 ( Kahle ) 1003 Heartlab s 1998 DICOMView User s Guide ( DICOMView ) MicroTech User s Manual ( MicroTech ) 1005 U.S. Patent No. 5,717,841 ( Farrell ) 1006 U.S. Patent No. 7,302,164 ( Wright ) 1007 Excerpts from the DICOM Standard 1998 ( DICOM Standard ) 1008 Excerpt from NEMA Standards Publication PS , Digital Imaging and Communications in Medicine (DICOM) Part 8: Network Communication Support for Message Exchange; ( DICOM Artim Timer ) 1009 File History of the 408 Patent 1010 Article: Nissen, Steven Evolution of the Filmless Cardiac Angiography Suite -- Am. J. Cardiology, August Declaration of Steven Horii 1012 Declaration of Corwin Nichols iv

5 1013 Declaration of Robert Petrocelli v

6 Pacsgear, Inc., which recently merged with Perceptive Software LLC (collectively hereinafter referred to as "Petitioner"), respectfully request Inter Partes review ("IPR") of claims 1-19 of U.S. Patent No. 7,965,408 ("the '408 Patent") pursuant to 35 U.S.C. 311 and 37 C.F.R I. GROUNDS FOR STANDING UNDER 37 C.F.R (a) Petitioner hereby certifies that the '408 Patent is available for IPR and the Petitioner and its real parties of interest are not barred or estopped from requesting IPR of claims 1-19 on the grounds identified herein. Petitioner and its real parties of interest are not the owner of the '408 Patent. Petitioner and its real parties of interest have not previously initiated a civil action challenging the validity of any claims of the '408 Patent. Petitioner submits this petition less than one year after Petitioner or any of its real parties of interest were first served with a complaint alleging infringement of the '408 Patent. The estoppel provisions of 35 U.S.C. 315(e)(1) do not prohibit this IPR. II. MANDATORY NOTICES 37 C.F.R. 42.8(A)(1) A. 37 C.F.R. 42.8(b)(1): Real Party-In-Interest Real parties-in-interest for Petitioner are Pacsgear, Inc., Perceptive Software LLC, Lexmark International Technology, S.A., Lexmark International, Inc., and Perceptive Software USA, Inc. B. 37 C.F.R. 42.8(b)(2): Related Matters 1

7 Sorna Corporation ("Sorna") has asserted the '408 Patent in Sorna Corp. v. Pacsgear, Inc., Case No. 13-CV ADM/LIB, in the United States District Court, District of Minnesota. This case may affect, or be affected by, a decision in this proceeding. C. 37 C.F.R. 42.8(b)(3) and (4): Lead and Back-Up Counsel and Service Information Pursuant to 37 C.F.R. 42.8(b)(3) and 42.10(a), Petitioner provides the following designation of counsel. Lead Counsel Willmore F. Holbrow, III (Reg. No. 41,845) Postal and Hand-Delivery Address: Blakely, Sokoloff, Taylor & Zafman, LLP Wilshire Boulevard, 7th Floor Los Angeles, California Telephone: (310) Fax: (310) Back-up Counsel Matthew N. Nicholson (Reg. No. 62,889) Postal and Hand-Delivery Address: Blakely, Sokoloff, Taylor & Zafman, LLP 1279 Oakmead Parkway Sunnyvale, California Telephone: (408) Fax: (408)

8 Pursuant to 37 C.F.R (b), several Powers of Attorney accompany this IPR. Service information for lead and back-up counsel is provided in the designation of lead and back-up counsel, above. Service of any documents via hand-delivery may be made at the postal mailing addresses designated above. D. PAYMENT OF FEES 37 C.F.R The undersigned authorizes the Office to charge $24,600 to Deposit Account No for the fee set forth in 37 C.F.R (a) for this Petition for Inter Partes review. Review of nineteen (19) claims is requested, so the undersigned authorizes $9,000 for the Inter Partes Review Request fee and $15,600 for the Inter Partes Review Post Institution fee. The undersigned further authorizes payment for any additional fees that may be due in connection with this Petition to be charged to the above-referenced Deposit Account. III. SUMMARY OF THE 408 PATENT A. Brief Description of the Technology at Issue The 408 Patent is titled Medical Data Recording System. The 408 Patent consists of 19 claims. Claims 1 and 14 are the only independent claims and for purposes of this analysis are essentially identical. The Background of the Invention section identifies the problems the purported invention was designed to overcome: 3

9 In the past medical imaging such as x-rays were recorded on film and digital images were stored on digital film using film laser printers, which is expensive, bulky and difficult to store. Ex at 1: The filing and record keeping of the images thus received is a problem. It is a labor-intensive and error-prone task to gather information about each disc, write out labels and attach the labels to the discs, or write directly on the disc for storing and filing. It is very useful to have the information contained on a disc printed on a disc for reference and filing and for automatically creating a directory of the information stored on all the discs recorded in an office. Ex at 1: The specification of the 408 Patent further identifies a point of novelty as follows: The present invention automatically scans data received for storage on a disc and prints selected fields of information directly on the discs for easy file management. Ex at 1: The 408 Patent claims a method for essentially (i) receiving medical image data in DICOM format for recording on a CD, (ii) retrieving patient and study information from the received data, (iii) recording the medical image data onto a 4

10 CD along with "viewing software (which allows one to view the images at any compatible computer) and (iv) labeling the CD with the patient and study information retrieved from the medical image data. Ex Cols As shown below, the concept of creating CDs containing medical images and viewing software from received medical image data and generating a label from the medical information that includes patient and study information to identify the contents of the CD would have been obvious to a person having ordinary skill in the art (PHOSITA), especially in view of the benefit of the prior art. B. Summary of the Prosecution History of the 408 Patent The patent owner filed the application for the 408 Patent (09/753,792) on January 3, 2001 and it did not issue until June 21, During the intervening 10- plus year period, all the original claims were withdrawn or substantially amended. The claims were not allowed until the addition of a limitation requiring recording on said recording media in response to the job, the medical data image viewing software and the medical data. Ex at pp , and Two of the references relied on in this Petition, Kahle and Farrell, were used in rejections during the prosecution of the 408 Patent. Neither Kahle nor Farrell disclose recording on said recording media in response to the job, the medical data image viewing software and the medical data. However, unbeknownst to the Examiner, recording medical data image viewing software and the medical data on the CD 5

11 was well known prior to the priority date of the 408 Patent (DICOMView, as will be discussed in greater detail below, teaches among other things recording medical data image viewing software and medical data on a CD). A Notice of Allowance issued on May 4, 2011 in which the Examiner essentially recited all the limitations from the independent claims, including the newly added limitation requiring the recording of viewing software. The combination of all such limitations, in the Examiner s opinion, was not disclosed in the prior art. The 408 Patent issued on June 21, C. Claim Construction 37 C.F.R (b)(3) In an IPR, claim terms in an unexpired patent are given their broadest reasonable construction in light of the specification of the patent in which they appear. 37 C.F.R (b). Any terms not included in this discussion are to be given their broadest reasonable interpretation in the context of the disclosure as commonly understood by those of ordinary skill in the art. The claim constructions below are made only for the purposes of this IPR and Petitioner and its real parties in interest reserve the right to present different constructions in the related litigation. 1. Parsing (Claim 1) and Extracting (Claim 14) Claim 1 uses the term parsing and Claim 14 uses the term extracting. The 408 Patent does not specifically define the terms parsing or extracting. 6

12 For purposes of this IPR, the broadest reasonable interpretation of parsing and extracting is retrieving data from a data source. Ex at DICOM Image Information Independent claims 1 and 14 both use the term DICOM image information, which is not specifically defined in the 408 Patent. For purposes of this IPR, the broadest reasonable interpretation of DICOM image information is image data stored in DICOM format. Ex at Recording other files as defined by DICOM Independent claims 1 and 14 both use the term recording other files as defined by DICOM. Other files as defined by DICOM is not specifically defined in the 408 Patent. The 408 Patent also does not specifically define what the term other files means. In the context of claim 1 with respect to the term files, claim 1 includes receiving medical data information in DICOM format the medical data further comprising one or more files;. storing DICOM image information coming from the one or more files;.storing the parsed patient identification information and parsed study information coming from the one or more files; and recording said DICOM image information from the one or more files. For purposes of this IPR, the broadest reasonable interpretation of recording other files as defined by DICOM is recording at least two files that are in DICOM format (such as at least two files with image data stored in DICOM 7

13 format) that are not the one or more files referenced in claims 1 and 14. Ex at Autoloader control software Independent claims 1 and 14 both refer to autoloader control software, which is described as an existing, off-the-shelf product, named Buzzsaw in the patent specification. Ex at 5: The 408 Patent describes functions of Buzzsaw as instructing a CD autoloader to pick up a new CD and put it into the drive; and after recording data onto the CD, instructing the CD autoloader to place the CD into the printer. Ex at 5: Accordingly, for purposes of this IPR the broadest reasonable interpretation of autoloader control software is software that automatically facilitates the moving and recording of a CD and printing a label thereon. Ex at Job Claims 1 and 14 include the term job (e.g., creating a job ; and submitting the job ). For purposes of this IPR, the broadest reasonable interpretation of job is a specified amount of processing by a computer. Ex at Noting Claims 1 and 14 include the term noting the end of the received medical data information. Other than in the claims, the specification of the 408 Patent 8

14 does not include the term noting or note. For purposes of this IPR, the broadest reasonable interpretation of noting is observing. Ex at 40. Therefore, the broadest reasonable interpretation of the claim limitation noting the end of the received medical data information is observing the end of the received medical data information. IV. IDENTIFICATION OF CHALLENGE 37 C.F.R (b) A. 37 C.F.R (b)(1): Claims for Which IPR Is Requested Petitioner requests IPR of claims 1-19 of the 408 Patent. B. 37 C.F.R (b)(2): The Specific Art and Statutory Ground(s) on Which the Challenge Is Based IPR of claims 1-19 is requested in view of the following references: Ex U.S. Patent No. 5,518,325 ( Kahle ). Ex Heartlab s 1998 DICOMView User s Guide ( DICOMView ). Ex MicroTech User s Manual ( MicroTech ). Ex U.S. Patent No. 5,717,841 ( Farrell ). Ground Proposed Statutory Rejections for the 408 Patent 1 Claims 1-2, 6-11, and are obvious over Kahle in view of DICOMView and further in view of MicroTech 2 Claims 3-5 and are obvious over Kahle in view of DICOMView in view of MicroTech and further in view of Farrell 9

15 V. THERE IS A REASONABLE LIKELIHOOD THAT ONE OR MORE CLAIMS OF THE 408 PATENT IS UNPATENTABLE UNDER 37 C.F.R (b)(4) and (5). A. Person Having Ordinary Skill in the Art (PHOSITA) The 408 Patent relates to the design of systems implementing the electronic transfer and copying of data, namely DICOM medical image data, onto a CD and extracting data (e.g., patient and study information from the DICOM medical image data) and placing it on to the label of the CD. Ex A person of ordinary skill in the art would have had (i) several years of experience or education in computer programming, including use of the DICOM Standard, (ii) at least two years of experience at a medical facility relating to medical imaging (e.g., X-rays) (iii) at least three years of experience in the design, use and/or implementation of computer systems and software designed to receive, store and transfer data, and (iv) familiarity with the technology relating to recording data on a CD-R using a CD recorder capable of also printing a label on the CD-R. Ex at 30. B. Summary/Historical Understanding of the Art by the PHOSITA Dr. Steven Horii became board certified in diagnostic radiology in He joined the American College of Radiology National Electrical Manufacturers Association (ACR-NEMA) Digital Imaging and Communications in Medicine 10

16 Committee shortly after it was formed in 1983 and served as clinical co-chairman of the ACR-NEMA, subsequently re-named the DICOM Standards Committee, from 1987 through During that time, he was Chairman of Working Group V (WG V) on Exchange Media from 1988 to WG V is responsible for the development of standards for exchanging DICOM images on various media. For his work on DICOM, he was named One of the Twenty Most Influential People in Radiology by Diagnostic Imaging magazine in Ex at 4-7. Dr. Horii describes the state of the art from a historical perspective as follows. For close to a century, radiologists used film to capture, view, transfer and store the images. If patients were transferred to other facilities, or if they needed their films for a second opinion, film libraries also provided the films (or copies) to patients for their patient folders. The organization of film libraries included the creation of film jackets that held a number of folders. The jacket served as a master folder and had space on the outside to record what folders were included. The folders themselves were typically organized by the type of image or by imaging technique and would contain subfolders if the patient had more than one of that particular imaging study along with any diagnostic reports. Ex at Early electronic medical systems were designed for communication of radiological images within hospitals, for the diagnosis and monitoring of a 11

17 patient s condition. These Picture Archiving and Communication Systems (PACS) were the early versions of the modern day PACS. However, because such PACS were hospital-based, most physicians outside the hospital did not have electronic access to patient images. For this reason, a very early method of distributing images from a PACS to non-hospital doctors was to print the images directly from the modality or other storage device on film and deliver them for viewing on the traditional lightbox. Ex at 17. The progress and development of digital media came from the consumer electronics industry. Vinyl analog records were replaced by digital Compact Discs (CD). Makers of personal computers took advantage of the large storage capacity of CDs and began to advocate for using the recordable CD for storage and distribution of digital information. Other medical specialties that used imaging, particularly cardiology, also made the transition to digital imaging. Conventional cardiac x-ray imaging used 35mm motion picture (cine) film, so cardiology film libraries contained many canisters of such films. Ex at 18. In 1983, the American College of Radiology and National Electrical Manufacturers Association (ACR-NEMA) formed an interdisciplinary committee of radiologists, members from industry and computer engineering experts to develop a uniform protocol to enable completely filmless distribution of radiological images. That effort ultimately led to the DICOM standard. The 12

18 images originate with a variety of modalities including CT Scans, MRI s, Ultrasound, etc. The DICOM standard provides infrastructure so that these components can operate irrespective of the imaging equipment manufacturer, so long as the imaging equipment conforms to DICOM. In order to identify the medical images, the DICOM standard requires that image data contain a DICOM image and a header. The header consists of specific, accessible information relating to the image including patient name and study information, etc. See e.g., Ex at p. 58. The identifying information was placed in the header so that it could be easily accessed and extracted, as needed. Ex at 20 and 23. The DICOM committee selected the recordable CD (CD-R) as the medium for which to generate a standard. This led to the CD being selected as a portable storage medium of choice, as explicitly stated in the DICOM standard, specifically Part 10. Ex at 24. In 1996 the American College of Cardiology (ACC) took the opportunity at their annual meeting to demonstrate the benefits of the DICOM standard by providing a CD containing various DICOM medical images from a number of studies including angiograms, ultrasound images, several nuclear studies, and medical image viewing software on the CD, which enabled the recipients to review the images on any Windows based personal computer. The CD also featured a label with patient and study information on it. Ex at p. 3; Ex at

19 Importantly, the DICOM standard enabled a wide array of equipment manufacturers to make imaging devices (MRI, CT, etc.), PACS themselves, CD readers/writers, workstations and storage systems all speak the same language. Ex at 26. This enabled the performance of key tasks such as comparing a current study with a prior one or a study from a different type of modality to determine if a disease is getting worse or improving. Ex at 27. DICOM s adoption of the CD-R as the preferred portable recording medium shifted the industry to CD-Rs. Ex at 27. Labeling CDs with patient and study information was a natural, obvious development, as it would otherwise be essentially impossible to use, file, store and retrieve CDs because there would be no practical way of knowing their contents from a visual inspection. Ex at 28. C. Alleged Problem Solved by the Inventor Was Already Solved In light of the state of the art and its historical development, the concept of burning medical images onto CDs with viewing software and labeling the CDs was clearly well known. In addition to the discussion above: (i) in 1994 Rolf Kahle had developed a system which would record any type of received data on a CD and extract data ( title information ) from the received data for automatic placement on the label of a CD (Ex. 1002), (ii) in 1998, Robert Petrocelli s Heartlab company had developed a product specifically designed to extract patient and study 14

20 information and burn medical images and viewing software onto CDs (Ex. 1003) and (iii) in 1998, MicroTech had developed a system for recording data onto CDs, which used a timeout methodology to ensure that all the data was burned on the CD. Ex at p As discussed in more detail below, the prior art of record combined with the common sense and knowledge of a PHOSITA render all the claims of the 408 Patent unpatentable. VI. Claim-By-Claim Explanation of Grounds for Unpatentability As detailed below, claims 1-19 of the 408 Patent are unpatentable as being obvious. In support of the findings below, Petitioner submits a declaration by Dr. Steven Horii (Ex. 1011) explaining the perspective of a PHOSITA. A. Ground 1 Claims 1-2, 4-11 and are obvious 35 U.S.C. 103(a) over Kahle in view of DICOMView and further in view of MicroTech Claims 1-2, 4-11 and of the 408 Patent are obvious over Kahle in view of DICOMView and further in view of MicroTech. Kahle (Ex. 1002) issued on May 21, 1996 and therefore qualifies as prior art at least under 35 USC 102(b). DICOMView (Ex. 1003) was published in 1998 (Ex. 1013) and therefore also qualifies as prior art at least under 35 USC 102(a) and 35 USC 102(b). 1 MicroTech 1 A declaration from Robert Petrocelli (Ex. 1013) provides evidence that DICOMView qualifies as prior art. 15

21 (Ex. 1004) was published February 1998 (Ex. 1012) also qualifies as prior art at least under 35 USC 102(a) and 35 USC 102(b). 2 Kahle, DICOMView, and MicroTech are each analogous art to the 408 Patent. A reference is analogous art to the claimed invention if: (1) the reference is from the same field of endeavor as the claimed invention (even if it addresses a different problem); or (2) the reference is reasonably pertinent to the problem faced by the inventor (even if it is not in the same field of endeavor as the claimed invention). In re Bigio, 381 F. 3d 1320, 1325 (Fed. Cir. 2004). Here, the above references and the claimed invention are analogous art as they are all (i) from the same field of endeavor, namely each disclose a computer-based system including a computer and a CD recorder that allows for recording received data on a CD and (ii) the references are all very pertinent to the problem faced by the inventor, namely burning received data onto a CD. Ex at 53 and Summary of Prior Art and Rationale to Combine Kahle, entitled Disk Label Printing, discloses a generic methodology for automatically labeling a recordable CD with information obtained directly from the data that will be recorded on the CD. Ex at 1:7-11; 5:45-6:7. The teachings 2 A declaration from Corwin Nichols (Ex. 1012) provides evidence that MicroTech qualifies as prior art. 16

22 of Kahle are not limited to any particular type of information being recorded on the CD nor any type of information to put on the CD s label, and thus are applicable to medical data information such as DICOM image information and medical data identification information such as patient identification information and study information. Ex at Kahle refers to the information recorded on the CD as digital information. Ex at 3: The digital information is not limited to any particular type of information. For example, Kahle provides an example of digital information as being customer records (Ex at 3:62-4:2) and also states that [o]ther examples are almost limitless. Ex at 4:2 (emphasis added). In addition, Kahle states: Digital information includes any kind of information that can be communicated by a person by sight or sound that has been put in the form of digital quanta, typically in binary form. Ex at 4:41-47 (emphasis added). Clearly, medical data information such as DICOM image information qualifies as any kind of information and would be in binary form. Ex at Kahle also does not limit the type of information obtained from the digital information for the CD s label. Kahle refers to the obtained information for labeling as title information. Ex at 2:13-18; 5: The title information identifies the information to be recorded on the CD and is not limited to any particular information. For example, Kahle explicitly states: 17

23 The title information will uniquely identify the information recorded on the CD-R. The title information can include, but is not limited to, the name of the particular database file being recorded on the CD-R, a brief description of the type of information recorded on the CD-R, a table of contents, or the like. Further, the title information can contain information relating to distribution, mailing, filing, retrieval, security, controlled copy number, etc. Ex at 4:11-18 (emphasis added). It is not surprising that Kahle does not limit the title information to any particular information because the specific type of information to include on the label would depend, at least in part, on the type of data being recorded on the CD. Ex at 55. Since the purpose of labeling a CD is to reflect its contents (see Ex at 1:28-30; and Ex at 1:29-36), in the case of medical data such as DICOM image information being recorded to a CD, a PHOSITA at the time of the alleged invention would have recognized that information to put on the label would include patient identification information and study information because it would allow for easy visual recognition of which patient and study and their associated DICOM images, are stored on the CD. Ex at 55 and 96. Thus, although Kahle does not explicitly describe recording medical data information to a CD or that the label includes medical identification information, it would have been obvious to a PHOSITA at the time of the alleged invention that 18

24 the teachings of Kahle, including automatically retrieving a portion of the digital stream to be recorded on the CD for use in printing a label for the CD, are applicable to any type of data to be recorded on the CD including medical data information such as DICOM image information and any type of desired information of the DICOM image information may be retrieved from the data for the CD s label. Ex at 47. A PHOSITA at the time of the alleged invention would, of course, recognize the importance of uniquely labeling a recordable CD to easily identify the contents of the recordable CD since the information recorded on the CD is typically unique and it otherwise would be difficult to file, store, and retrieve CDs with no other practical way of knowing the contents of the CDs. Ex at 28 and 49; See also Ex at 2:58-3:7. Moreover, the 408 Patent itself recognizes that the alleged invention is not unique to data for medical imaging. Ex at 1:45-47 (emphasis added): Although the invention is described in terms of storing medical imaging data any data imbedded with information useful for filing and label printing can be used with the invention. Although a PHOSITA at the time of the alleged invention would understand the teachings of Kahle to apply to medical data information such as DICOM image information and patient identification and study information, Kahle does not explicitly describe burning image viewing software on the CD. 19

25 DICOMView discloses a system where medical image data in DICOM format is written to a CD along with viewing software for viewing the images on any computer. Ex at pp. 14 and DICOMView also discloses retrieving patient identification information and study information from the medical data information in connection with selecting which images to record on a CD. Ex at pp DICOMView and Kahle are easily combinable under the expansive and flexible approach to obviousness articulated in KSR Int l Co. v. Teleflex Inc., 27 S. Ct. 1727, 1739 (2007). DICOMView and Kahle are each analogous to the alleged invention as described above. Ex at 53. It would have been obvious to a PHOSITA at the time of the alleged invention to use the combined teachings of Kahle and DICOMView to write DICOM image information onto a CD, along with software to view the images, and extract patient identification information and study information from that data for the CD s label. Ex at 55. In short, this combination would allow for the highly desirable result of directly obtaining the label information from the digital information that is to be recorded on the CD without human intervention, thereby improving product quality and integrity as well as improving production cycle time. Ex at 6:2-7; 1: In addition, a PHOSITA would be motivated to make the combination so as to include image viewing software on the CD to allow the DICOM image information to be viewed on any compatible computer thereby increasing the 20

26 number of recipients that are able to view the images. Ex at pp Moreover, it is simply a matter of applying the known techniques of the prior art (e.g., (i) recording DICOM image information onto a CD along with image viewing software as disclosed by DICOMView (Ex at pp. 6, 14, and 44-46); and (ii) labeling the CD with identifying information that is retrieved directly from the data being recorded on the CD as disclosed by Kahle (Ex at 5:45-6:7)) to improve the CD recording process so that the CD is accurately labeled. Ex at 49. A PHOSITA at the time of the alleged invention would have recognized that the combination of Kahle and DICOMView would have the predictable result of writing DICOM image information and image viewing software on a CD and generating/printing a label with patient identification information and study information for the CD. Ex at 50. The independent claims further require noting the end of the received medical data information through the software module for each patient. The 408 Patent states that its alleged invention relates to determining [the] end of [an] incoming data stream in order to create jobs for recording and printing file information on a disc taken from the electronically stored information on the disc. Ex at 2: The 408 Patent describes using a timer and timeout period. Ex. 1001, 3:54-67: Timer_1 60 is programmed to check if an end-of-patient-data 21

27 timeout (MaxTime) 65 has occurred Max Time 65 is also user configurable via FilmX.ini and is set to 30 seconds for default. ; see also claim 7 of the 408 Patent. Although Kahle discloses a controller downloading the information to be written to the CD and then sending the information to the CD recorder for recording (Ex at 7:21-31) and DICOMView discloses a Copy Study function that allows a study to be copied from a source to a destination including onto a CD (Ex at p. 14), neither Kahle nor DICOMView explicitly discloses using a timer and timeout period to note the end of the received medical data information. MicroTech, however, discloses the use of a timer and a timeout period to observe the end of received data prior to recording the data onto the CD. For example, MicroTech states: There is usually nothing on an audio DAT which indicates the end of recording on the tape. Therefore AUDIODAT looks for several things which may signal where the end is. A long period of silence has passed, at least equal to the amount required to indicate the end-of-recording. This length of time is 30 seconds by default; it can be changed by using the e command-line option. Ex at p In fact, MicroTech discloses that the length of time of the timeout period is the same default value (30 seconds) as the default value of the MaxTime timer of the 408 Patent. 22

28 MicroTech does not disclose using its timer and timeout period for noting the end of received medical data information for each patient. MicroTech is analogous to the 408 Patent as it discloses a system that receives data, records it on a CD, and automatically labels the CD. Ex at pp A PHOSITA would be motivated to use the teachings of MicroTech related to a timer and timeout period to note the end of received medical data information for each patient. As noted by Dr. Horii, timeout periods are used quite often to ensure that a task is completed before moving onto another task. Ex at 58. In fact, he identified a timer and timeout period used in the DICOM standard, called the Artim Timer, which checks to see if a coupling is completed in a certain time period. Ex at 58. A PHOSITA, when faced with wanting to determin[e] [the] end of [an] incoming data stream in order to create jobs for recording (Ex. 1001, 2:14-16), would recognize that a timer and timeout period is a known technique to solve that problem. Ex at 59. Using MicroTech s teaching of the timer and timeout in the combination of Kahle and DICOMView would simply have been a matter of selecting an obvious design choice for the PHOSITA to obtain the predictable result of being able to presume whether the end of the data stream has been reached. Ex at

29 The obviousness of the claims will become even more apparent in light of the following comparison between the prior art references and the claims on a limitation by limitation basis to establish that all the claims are obvious: 2. Claim 1 a) A medical data recording method comprising: receiving medical data information in DICOM format through a software module and parsing patient identification information and study information from the received medical data information, the medical data further comprising one or more files Kahle discloses a controller receiving a data stream of a file for recording on a CD, parsing the data stream, extracting certain information from the data, and composing the information for labeling the CD. Ex at 5:45-6:7. This allows the CD to be labeled with information directly obtained from the data being recorded on the CD, without human intervention. Id. As discussed above, Kahle refers to the information being parsed and extracted for labeling as title information and does not limit the title information to any particular type of information. Ex at 4: Also as discussed above, Kahle also does not limit the source of the information from which the title information is parsed and extracted (the digital information ). Ex at 3:62-24

30 4:2; and 4: That being said, Kahle does not explicitly disclose that the received data is medical data in DICOM format nor that the information parsed from the received data is patient identification information and study information. However, a PHOSITA at the time of the alleged invention would understand that the teachings of Kahle including receiving a data stream of a file for recording on a CD, and parsing and extracting data fields from the data stream for generating the label are applicable to any type of data to be recorded on the CD including medical data information such as DICOM image information and any type of desired information of the DICOM image information may be parsed from the data for the CD s label. Ex at 47, 54, and 70. Moreover, receiving medical data information in DICOM format and parsing patient identification information and study information for a label on the CD is obvious in view of Kahle and DICOMView. Ex at DICOMView discloses a system in which patient and study information is retrieved from medical data information in DICOM format in connection with selecting which images are to be written to a CD. Ex at pp. 6 and 14. For example, DICOMView discloses software that receives medical data information in DICOM format when a user selects the Open Study or Copy Study function. The Copy Study function allows for the copying of a medical study from any available source media including a DICOM source to a CD writer. Ex at p. 25

31 14. As part of selecting a study, a user may search using patient identification information (e.g., patient name, patient ID, data of birth) and study information (e.g., procedure date, procedure physician, study status), thereby separating and retrieving the patient identification information and study information from the DICOM files. Ex at p. 22, Copy Study Dialog; see also table on p. 21. The medical data information includes one or more files as the Copy Study dialog allows you to copy any number of studies from any listed source to any listed destination. Ex at p. 25. It would be obvious to a PHOSITA that in the case of medical data, information desired to be put on the label would be patient identification information and study information (and thus parsed from the medical data). Ex at 28, 55, and 96. It would be obvious and simple for a PHOSITA to retrieve patient identification information and study information from the DICOM information in a data stream in view of Kahle and DICOMView for ultimate placement on the label of the CD containing the patient s study. Ex at 49. As discussed above, Kahle teaches retrieving desired data fields from a data stream and placing those on a label. Moreover, any difference between the data extracted in Kahle for labeling ( title information ) and the claimed patient identification information and study information (claim 1) is nothing more than the type of information and is therefore nothing more than merely dictated by the intended 26

32 use. Since the purpose of labeling a CD is to reflect its contents (see Ex at 1:28-30; and Ex at 1:29-36), it would have been simple for a PHOSITA recording medical data information onto a CD to apply the teachings of Kahle to automatically retrieve desired fields such as patient identification information and study information from the medical data being recorded on the CD without human intervention. Ex at 49. Moreover, the 408 Patent itself recognizes that the alleged invention is not unique to data for medical imaging. Ex at 1:45-47 (emphasis added): Although the invention is described in terms of storing medical imaging data any data imbedded with information useful for filing and label printing can be used with the invention. b) storing the parsed patient identification information and parsed study information, the stored parsed study information and patient information coming from the one or more files Kahle discloses software that uses parameter tables to parse[] the data stream, extract data fields, and compose the title information. Ex at 5:64-6:2. The parsed information must necessarily be stored at least temporarily for the software to extract the data fields and compose the title information. Ex at 73. Thus Kahle discloses storing the parsed information that was parsed from the data stream of at least one file. Again, as described above, Kahle does not explicitly disclose that the parsed information is patient identification 27

33 information or study information. However any such difference would have been obvious to a PHOSITA in view of DICOMView which, as previously described, focuses on creating CDs featuring medical images in DICOM format that has patient identification information and study information. It would have been obvious to a PHOSITA at the time of the alleged invention to store the patient identification information and study information prior to using that information when generating the label. Ex at 74. c) storing DICOM image information coming from the one or more files Kahle discloses the controller storing the information to be written on the CD. Ex at 7: Again, as described above, Kahle does not explicitly disclose that the information stored is DICOM image information. It would have been obvious to a PHOSITA at the time of the alleged invention that in the case of medical data, DICOM image information would be stored for writing on the CD. Ex at 76 and 96. For example, DICOMView discloses that a study includes DICOM image information. Ex at p. 14 ( The copying of images can take a while depending on how many studies were selected ); p. 25 ( The Copy Study dialog allows you to copy any number of studies from any listed source to any listed destination. The Copy button will copy all images in the selected series from the selected source to 28

34 the selected destination. ). Prior to writing the image information to a CD, DICOMView discloses that the image information is stored on a local hard disk to prepare the image files for writing to the CD. Ex at p. 45 ( In order to write a CD, DICOMView must have a staging area on a local hard disk to prepare the image files for writing to the CD-R media.this means that your c:drive must have enough free space on it to write the image files to the staging area on your c:drive. ) d) noting the end of the received medical data information through the software module for each patient The 408 Patent states that its alleged invention relates to determining [the] end of [an] incoming data stream in order to create jobs for recording and printing file information on a disc taken from the electronically stored information on the disc. Ex at 2: The 408 Patent describes using a timer and timeout period. Ex. 1001, 3:54-67: Timer_1 60 is programmed to check if an endof-patient-data timeout (MaxTime) 65 has occurred Max Time 65 is also user configurable via FilmX.ini and is set to 30 seconds for default. ; see also claim 7 of the 408 Patent; Ex at 7: Although Kahle discloses a controller downloading the information to be written to the CD and then sending the information to the CD recorder for recording (Ex at 7:21-31) and DICOMView discloses a Copy Study 29

35 function that allows a study to be copied from a source to a destination including onto a CD (Ex at p. 14), neither Kahle nor DICOMView explicitly discloses using a timer and timeout period to note the end of the received medical data information. However using a timer and timeout period to note the end of the received medical data information is obvious in light of the teachings of MicroTech. Ex at 79. MicroTech discloses the use of a timer and a timeout period to assess the end of received data prior to recording the data onto the CD. For example, MicroTech states: There is usually nothing on an audio DAT which indicates the end of recording on the tape. Therefore AUDIODAT looks for several things which may signal where the end is A long period of silence has passed, at least equal to the amount required to indicate the end-of-recording. This length of time is 30 seconds by default; it can be changed by using the e command-line option. Ex at p In fact, MicroTech discloses that the length of time of the timeout period is the same default value (30 seconds) as the default value of the MaxTime timer of the 408 Patent. MicroTech does not disclose using its timer and timeout period for noting the end of received medical data information for each patient. However, a PHOSITA would be motivated to use the teachings of MicroTech related to a timer and timeout period to note the end of received medical data information for each 30

36 patient. Ex at 79. As noted by Dr. Horii, timeout periods are used quite often to ensure that a task is completed before moving onto another task. Ex at In fact, he identified a timer and timeout period used in the DICOM standard at least no later than 1996, called the Artim Timer, which checks to see if a coupling is completed in a certain time period. Ex at 58. A PHOSITA, when faced with wanting to determin[e] [the] end of [an] incoming data stream in order to create jobs for recording (Ex. 1001, 2:14-16), would recognize that a timer and timeout period is a known technique to solve that problem. Ex at 60. Using MicroTech s teaching of the timer and timeout in the combination of Kahle and DICOMView would simply have been a matter of selecting an obvious design choice for the PHOSITA to obtain the predictable result of being able to presume whether the end of the data stream has been reached. Ex at e) creating a job containing medical data for a patient, and medical data image viewing software, and Kahle discloses creating a job for writing data to a CD. Ex at 7:22-27; and 7: Kahle, however, does not explicitly disclose that the job contains medical data or medical data image viewing software. However, creating a job containing medical data for a patient and medical data image viewing software is obvious in view of the teachings of DICOMView. 31

37 DICOMView discloses creating a job for burning both the medical data for a patient (e.g., the DICOM medical images) and viewing software that allows the images burned on the CD to be viewed. Ex at pp ( In addition to writing the DICOM information onto the CD-R media, DICOMview also writes a program which will enable the CD to play itself back on any Windows 95/NT PC. You can therefore distribute the media and be sure any recipient with a Windows 95/NT PC will be able to view the images."). DICOMView does not use the term job. Although Kahle and DICOMView do not use the term job, writing data to a CD is a specified amount of processing by a computer and is therefore a job. Ex at 42 and 79. It would have been obvious to a PHOSITA to modify the teachings of Kahle to explicitly write medical data information and medical data image viewing software to a CD because it would allow the images on the CD to be viewed on any compatible computer, thereby increasing the number of recipients that are able to view the images. Ex at pp ; Ex at 82. f) providing print information for an autoloader control software, the print information having selected fields obtained from an automatic scan of the stored parsed patient identification information and the stored parsed study information, 32

38 Kahle discloses a controller with software that uses parameter tables to parse the data stream, extract data fields, and compose title information for printing on a label. Ex at 5:57-6:2. As discussed above with respect to limitation 1(b), the parsed information must necessarily be stored at least temporarily in order for the software to obtain the data fields and compose the title information. Ex at 83. Thus Kahle describes obtaining fields of the parsed information (using parameter tables) to generate the information for the title information. The title information is sent to the printer for printing the label on the CD. Ex at 5: This allows the CD to be labeled with information obtained directly from the information recorded on the CD without human intervention. Ex at 6:2-7. Kahle further discloses that a controller that controls a CD recorder that automatically delivers a blank CD to the recorder, records the digital information to the CD, ejects the CD, and then automatically delivers the CD to the printer to be labeled, thereby facilitating printing of the label. Ex at 8:63-9:6. Kahle also discloses that the CD recorder can extract the title information and deliver the title information to the printer. Ex at 6:19-27; 7: Kahle does not explicitly disclose that the print information for the label is patient identification information and study information. However, as discussed above, retrieving patient identification information and study information for the print information for the label on the CD is obvious in view of Kahle and DICOMView, and 33

39 therefore providing print information that includes patient identification information and study information obtained from the parsed information of the data stream is obvious in view of Kahle and DICOMView. Ex at 84 and 87. g) submitting the job to the autoloader control software, and Kahle discloses a job in the form of selecting the data that is written to the CD and identifying information for the label of the CD. Kahle discloses submitting the job to the CD recorder that automatically provides a blank disk to the recorder, records the digital information, ejects the CD, and automatically delivers the CD to the printer for labeling. Ex at 8:65-9:6. Kahle, however, does not explicitly disclose that the job contains medical data or medical data image viewing software. However, submitting a job containing medical data for a patient and medical data image viewing software is obvious in view of the teachings of DICOMView which discloses a job for burning both the medical data for a patient (e.g., the DICOM medical images) and viewing software that allows the images to be viewed. Ex at pp It would have been obvious to a PHOSITA to modify the teachings of Kahle to explicitly write medical data information and medical data image viewing software to a CD because it would allow the images on the CD to be viewed on any compatible computer, thereby increasing the number of recipients that are able to view the images. Ex at pp ; Ex at