UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD

Transcription

1 UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD IntroMedic Co., Ltd., Petitioner, v. Given Imaging Ltd., Patent Owner U.S. Patent No. 7,009,634 Issue Date: March 7, 2006 Title: Device for In-Vivo Imaging Inter Partes Review No. Unassigned PETITION FOR INTER PARTES REVIEW UNDER 35 U.S.C AND 37 C.F.R ET SEQ. i

2 LIST OF EXHIBITS Exhibit 1001 U.S. Patent No. 7,009,634 to Iddan, et al., issued on Mar. 7, Exhibit 1002 Exhibit 1003 Exhibit 1004 Exhibit 1005 Exhibit 1006 Exhibit 1007 Exhibit 1008 Exhibit 1009 Exhibit 1010 Exhibit 1011 Exhibit 1012 Exhibit Prosecution History Excerpt: Mar. 8, 2001 Patent Application as filed. 634 Prosecution History Excerpt: Oct. 7, 2005 Request for Continued Examination and Response to Office Action. Japanese Patent No entitled Gastric Camera, published on March 16, 1982 (and translation). U.S. Patent No. 5,929,901 to Adair, et al., entitled Reduced Area Imaging Devices Incorporated Within Surgical Instruments, issued on Jul. 27, Prosecution History Excerpt: Sep. 27, 2004 Office Action. 634 Prosecution History Excerpt: Nov. 22, 2004 Amendment and Response to Office Action. U.S. Patent No. 5,604,531 to Iddan, et al., entitled In Vivo Video Camera System, issued on Feb. 18, U.S. Patent No. 6,240,312 to Alfano entitled Remotecontrollable, Micro-scale Device for use in In Vivo Medical Diagnosis and/or Treatment, issued on May 29, Prosecution History Excerpt: Aug. 4, 2005 Office Action. 634 Prosecution History Excerpt: Oct. 7, 2005 Amendment and Response to Final Office Action. 634 Prosecution History Excerpt: Nov. 3, 2005 Notice of Allowance. 634 Reexamination Excerpt: Sep. 11, 2012, Reexamination Order and Office Action. ii

3 Exhibit 1014 Exhibit 1015 Exhibit 1016 Exhibit 1017 Exhibit 1018 Exhibit 1019 Exhibit 1020 Exhibit 1021 Exhibit 1022 Exhibit 1023 Exhibit 1024 Exhibit 1025 Exhibit Reexamination Excerpt: Jan. 28, 2013 Patentee Response to Office Action. 634 Reexamination Excerpt: Dec. 27, 2012 IntroMedic Petition to the Patent Office. 634 Reexamination Excerpt: Jul. 31, 2013 Patent Office Denial of Petition. 634 Reexamination Excerpt: Jan. 28, 2013 Declaration of Dr. Blair Lewis. 634 Reexamination Excerpt: Jan. 28, 2013 Technical Declaration of Gavriel Iddan. 634 Reexamination Excerpt: Jan. 28, 2013 Declaration of Gavriel Meron. 634 Reexamination Excerpt: Jan. 28, 2013 Amendments to the Claim. 634 Reexamination Excerpt: Feb. 26, 2013 Third Party Requestor Comments. U.S. Patent No. 5,817,015 to Adair, et al., entitled Endoscope with Reusable Core and Disposable Sheath with Passageways, issued on Oct. 06, U.S. Patent No. 4,884,133 to Kanno, et al., entitled Endoscope Light Source Apparatus, issued on Nov. 28, Reexamination Excerpt: Mar. 21, 2013 Patentee Petition to the Patent Office. 634 Reexamination Excerpt: Mar. 27, 2014 Dismisal of Petition. 634 Reexamination Excerpt: May 30, 2014 Action Closing Prosecution. iii

4 Exhibit 1027 Exhibit 1028 Exhibit 1029 Exhibit 1030 Exhibit 1031 Exhibit 1032 Exhibit 1033 Exhibit 1034 Exhibit 1035 Exhibit 1036 Exhibit 1037 Patent Cooperation Treaty (PCT) No. WO A1 to Iddan, et al., entitled Energy Management of Video Capsule, published on June 24, JP to Adachi, et al., entitled Endoscope published on May 19, 1992 (and translation). Japanese Patent Publication No to Katsunori, entitled Endoscope published on August 18, 1998 (and translation). European Patent No. EP A1 to Wood entitled Compact Video Imaging Assembly published on September 15, U.S. Patent No. 6,277,064 to Yoon, entitled Surgical Instrument with Rotatably Mounted Offset Endoscope, was filed on December 29, 1998 and issued on August 21, U.S. Patent No. 6,324,418 to Crowley, et al., entitled Portable Tissue Spectroscopy Apparatus and Method issued on November 27, U.S. Patent No. 5,734,418 to Danna, entitled Endoscope with Tab Imager Package issued on March 31, German Patent No. 3,440,177, issued on May 15, 1986 (and translation) as filed in Inter Partes Reexamination No. 95/002,175. Japanese Patent Publication No ,927 to Masayuki, et al., entitled Electronic Endoscope Apparatus published on October 4, 1992 (and translation). Declaration of Robert J. Wood and accompanying exhibits. Wireless Transmission of a Colour Television Moving Image from the Stomach Using a Miniature CCD Camera, Light iv

5 Source and Microwave Transmitter, CP Swain, et al., Gastrointestinal Endoscopy, Vol. 45, No. 4 at 62 (1997). Exhibit 1038 Exhibit 1039 Exhibit 1040 Wireless Transmission of a Color Television Moving Image from the Stomach Using a Miniature CCD Camera, Light Source and Microwave Transmitter, Swain CP, et al., Gut 39:A26 (1996). Japanese Patent Publication No to Kenichi, et al., entitled Imaging instrument for capsule endoscope filed on February 2, 2000 (and translation). Request for Inter Partes Reexamination of U.S. Patent No. 7,009,634 dated Sep. 11, Exhibit 1041 Given Imaging s 510(k) Summary to the FDA dated July 29, Exhibit 1042 Imaging Device Makes Chip-Sized Cameras A Real-World Possibility, New York Times (May 27, 1997). v

6 TABLE OF CONTENTS I. NOTICE OF LEAD AND BACKUP COUNSEL...1 II. NOTICE OF EACH REAL PARTY-IN-INTEREST...1 III. NOTICE OF RELATED MATTERS...1 IV. NOTICE OF SERVICE INFORMATION FOR PETITIONER...2 V. SERVICE ON THE PATENT OWNER...2 VI. VII. GROUNDS FOR STANDING...2 THRESHOLD REQUIREMENT FOR INTER PARTES REVIEW...2 VIII. SUMMARY OF THE 634 PATENT...3 A. B. C. Overview of the 634 Patent...3 Summary of the Prosecution History...5 Summary of the Reexamination...7 IX. CONSTRUCTION OF CLAIMS...10 A. B. Applicable Legal Standards...10 Proposed Constructions...11 X. Prior ART REFERENCES RELIED ON BY PETITIONER...11 XI. STATEMENT OF PRECISE RELIEF REQUESTED...13 XII. STATEMENT OF NON-REDUNDANCY...14 A. B. Non-Redundancy of Proposed Grounds in this Proceeding...14 Non-Redundancy with Reexamination...19 XIII. CLAIM-BY-CLAIM EXPLANATION OF GROUNDS FOR UNPATENTABILITY...21 A. Technological Background Applicable to all Grounds...21 vi

7 B. C. D. E. F. Ground I - Claim 1 of the 634 Patent is Obvious Over Yoon in View of Katsunori and in Further View of the Gastric Camera Patent...26 Ground II - Claim 1 of the 634 Patent is Obvious over Welch Allyn in View of the Gastric Camera Patent...31 Ground III Claim 1 is Obvious Over Iddan in view of Welch Allyn, or in view of Katsunori and Danna...36 Ground IV Claim 1 is obvious over Boston Scientific in view of Katsunori and in further view of Danna...42 Ground V Claim 1 of the 634 Patent is invalid as Obvious Over Olympus in view of Katsunori and Danna...47 XIV. SECONDARY CONSIDERATIONS DO NOT SUPPORT THE PATENTABILITY OF CLAIM A. B. C. D. E. Unexpected Results...54 Long Felt Need and Failure of Others...55 Commercial Success...56 Praise and Skepticism of Others...57 Simultaneous Invention...58 XV. CONCLUSION...60 vii

8 I. NOTICE OF LEAD AND BACKUP COUNSEL Lead Counsel: David Cotta (Reg. No. 52,771); Tel.: ; Fax: ; Address: Mintz Levin Cohn Ferris Glovsky and Popeo PC, One Financial Center, Boston, MA Backup Counsel: Peter Cuomo (Reg. No. 58,481); Tel.: ; Fax: ; Address: Mintz Levin Cohn Ferris Glovsky and Popeo PC, One Financial Center, Boston, MA 02111; Kongsik Kim (Reg. No. 63,867); Tel.: ; Fax: ; Address: Mintz Levin Cohn Ferris Glovsky and Popeo PC, One Financial Center, Boston, MA Pursuant to 37 C.F.R (b), a Power of Attorney accompanies this Petition. II. NOTICE OF EACH REAL PARTY-IN-INTEREST The real party-in-interest for this petition to institute inter partes review is IntroMedic Co., Ltd. III. NOTICE OF RELATED MATTERS Pursuant to 37 C.F.R. 42.8(b)(2), Petitioner states that U.S. Patent No. 7,009,634 ( the 634 patent ) is the subject of currently pending inter partes reexamination proceeding No. 95/002,175. Petitioner is unaware of any other related judicial or administrative matters involving the 634 patent. 1

9 IV. NOTICE OF SERVICE INFORMATION FOR PETITIONER Please address all correspondence to Lead Counsel at the address shown above. Petitioner also consents to electronic service by at: and V. SERVICE ON THE PATENT OWNER Given Imaging Ltd., is the owner by patent assignment of U.S. Patent No. 7,009,634 ( the 634 patent ). Pursuant to 37 C.F.R. 105(a), service of this Petition has been made simultaneously with this filing to the current correspondence address for the 634 patent as shown in the Certificate of Service. VI. GROUNDS FOR STANDING Petitioner hereby certifies that the patent for which review is sought is available for inter partes review and that Petitioner is not barred or estopped from requesting an inter partes review challenging the patent claims on the grounds identified in this Petition. VII. THRESHOLD REQUIREMENT FOR INTER PARTES REVIEW A petition for inter partes review must demonstrate a reasonable likelihood that the Petitioner would prevail with respect to at least one of the claims challenged in the petition. 35 U.S.C. 314(a). This Petition meets that threshold. All of the elements of claim 1 of the 634 patent are taught and/or disclosed in the prior art as explained below, and reasons to combine the prior art 2

10 teachings and/or disclosures, where necessary, are established for each proposed ground under 35 U.S.C. 103(a). VIII. SUMMARY OF THE 634 PATENT A. Overview of the 634 Patent The 634 patent relates to a swallowable capsule for in-vivo imaging of the gastrointestinal tract. The only issued claim of the 634 patent reads as follows: 1. A swallowable capsule for in-vivo imaging of the gastrointestinal tract, said capsule comprising: a housing, said housing including at least a dome type optical viewing window portion disposed along a longitudinal axis of said capsule, said dome type optical viewing window portion being part of the external surface of said housing, said housing enclosing at least: at least one CMOS or CCD imaging camera; at least two white LED illuminating sources for illuminating said gastrointestinal tract site only through said optical viewing window; an optical system comprising at least one lens for collecting light from said gastrointestinal tract site through said optical viewing window onto said CMOS or CCD imaging camera for imaging said gastrointestinal tract site onto said CMOS or CCD imaging camera, said optical system being separated from said dome type optical viewing window portion, which is not part of said optical system, by a gap, the at least two white LED illuminating sources positioned in the vicinity 3

11 of said optical system and not on the longitudinal axis of said optical system so that the at least two white LED illuminating sources illuminate said gastrointestinal tract site directly through said optical viewing window and not through said optical system, and said CMOS or CCD imaging camera imaging said gastrointestinal tract site via said optical viewing window and via said optical system; and a transmitter for transmitting the signal of the CMOS or CCD imaging camera to a receiving system. Ex (9:33-62). The basic components of the claimed capsule can be seen in Figure 1 of the 634 patent (reproduced below), including: a camera for imaging the gastrointestinal tract (element 24), a lens for focusing light on the camera (element 22), two LED lights for illuminating the area to be imaged (element 23), a dome shaped window through which the camera can image the gastrointestinal track (element 21) and a transmitter (element 26) for transmitting images taken by the camera. 4

12 B. Summary of the Prosecution History The 634 patent claims priority from a provisional patent application filed on March 8, Ex The 634 patent application, as filed, included 55 claims directed to a swallowable capsule, device or system for in vivo imaging, and methods of using the same. Ex (Mar. 8, 2001 Patent Application as filed). During the course of the prosecution, five additional claims were added. Ultimately, only one claim (claim 60) was allowed. This claim was based on an amended version of original claim 15. Ex (Oct. 7, 2005 Request for Continued Examination and Response to Office Action). Claim 15 as initially filed was directed to a swallowable capsule and read: 15. A swallowable capsule for in vivo imaging of the gastrointestinal tract, said capsule having an optical window and comprising: at least one CMOS imaging camera; at least one illumination source for illuminating a gastrointestinal tract site; an optical system for imaging the gastrointestinal tract site onto the CMOS imaging camera; and a transmitter for transmitting video output of the CMOS imaging camera. In an initial office action, Claim 15 was rejected as obvious over JP ( Gastric Camera patent ) (Ex. 1004), in view of U.S. Patent No. 5,929,901 ( Adair ) (Ex. 1005). The examiner found that the swallowable capsule disclosed 5

13 in the Gastric Camera patent included: an imaging camera, at least one illumination source for in vivo imaging, an optical system for in vivo imaging (the lens), and a transmitter for transmitting video output of the imaging camera. Ex (Sep. 27, 2004 Office Action). The examiner further found that the one element not disclosed in the Gastric Camera patent, a CMOS imaging camera, was obvious in view of the disclosure of this element in Adair. Id. p. 5. In response to the examiner s initial rejection, the patentee amended claim 15 to require two illumination sources, to require a gap between the optical system and the optical window, and to require that the illumination sources illuminate the target site directly through the optical window and not through the optical system. Ex (November 22, 2004 Response to Office Action). The examiner then rejected amended claim 15 as obvious over U.S. Patent No. 5,604,531 (Ex. 1008) ( the 531 patent ), in view of U.S. Patent No. 6,240,312 (Ex. 1009) ( Alfano ). Ex (Aug. 4, 2005 Office Action) p. 7. The examiner found that the swallowable capsules disclosed in the 531 patent included: a housing with an optical window, an imaging camera, an illumination source, an optical system, a gap between the optical window and the optical system, a transmitter, and light transmitted directly through the optical window not through the optical system. Id. The examiner further concluded that the one element from claim 15 not disclosed in Iddan, at least two illumination sources, was obvious in 6

14 view of Alfano s disclosure of this element. Id. p. 8; see also Ex (Alfano) 6: On October 7, 2005, the patentee submitted new claim 60 which the patentee represented as being based on prior claim 15. Ex (Oct. 7, 2005 Amendment and Response to Final Office Action). Claim 60 added limitations requiring a dome type optical window and two white LED illuminating sources. On November 3, 2005, the examiner issued a Notice of Allowance, allowing claim 60 as the only claim of the 634 patent. Ex (Notice of Allowance). C. Summary of the Reexamination Seven years after the issuance of the 634 patent, the patent office ordered reexamination in response to a request filed by Petitioner, IntroMedic. As discussed in more detail below, the examiner ultimately found the challenged claim to be patentable, a decision IntroMedic is currently appealing. On September 11, 2012, the examiner ordered reexamination based upon the combination of Mullick in view of Toshiba and Olympus. Ex IntroMedic had initially proposed four grounds of rejection. The examiner, however, declined to institute reexamination on three of the four grounds, including the following three rejected combinations: 1) Toshiba taken with Olympus and/or the German 177 patent; 2) Olympus taken with Toshiba, and 3) the German 177 patent taken 7

15 with Toshiba and/or Olympus. 1 On December 27, 2012, Intromedic petitioned the Patent Office to review the examiner s decision that Intromedic had not established a reasonable likelihood of prevailing on the other proposed grounds. Ex The Patent Office denied this petition on July 31, Ex On January 28, 2013, the patentees submitted written comments (Ex. 1014) along with seven declarations and twenty articles. Each of the four named inventors of the 634 patent offered a declaration swearing behind Mullick under 37 C.F.R by alleging that an embodiment of the purported invention had been tested in a human subject on October 17, The patentees also introduced a declaration from Dr. Blair Lewis, formerly the Chairman of Given Imaging s Medical Advisory Board and currently a paid consultant for Given Imaging, addressing secondary considerations. Ex ( 10 and 51). Two of the inventors, Gavriel Iddan and Gavriel Meron filed additional declarations arguing that the claimed capsule was not obvious and offering purported evidence of secondary considerations. Exs and The patentees also amended claim 1 In a nullity action before the German Federal Patent Court, Utility Model 201,22,489 (a foreign counterpart to the 634 patent that claims priority to the same provisional patent application as does the 634 patent) was found invalid in view of the German 177 Patent. Ex pp

16 1 by changing at least one CMOS or CCD imaging camera to at least one CMOS imaging camera. Ex (Jan. 28, 2013 Amendments to the Claim). Following the patentees response to the Office Action, IntroMedic provided third-party comments on February 26, Ex (Feb. 26, 2013 Third Party Requestor Comments). Pursuant to 37 CFR 1.948, IntroMedic submitted two new prior art references, U.S. Patent No. 5,817,015 to Adair ( Adair ) (Ex. 1022) and U.S. Patent No. 4,884,133 to Kanno ( Kanno ) (Ex. 1023), as well as additional proposed grounds of rejection incorporating the new references into the grounds previously proposed. 2 On March 21, 2013, the patentees petitioned the Patent Office to strike certain of IntroMedic s comments and newly proposed grounds of rejection. Ex The Patent Office dismissed this petition on March 27, Ex On May 30, 2014, the examiner issued an Action Closing Prosecution rejecting all of the pending proposed grounds of rejection. Ex The examiner first accepted the patentees assertion of an actual reduction to practice as of October 17, 1999, which eliminated Mullick as a prior art reference. Id. p The proposed additional grounds of rejection were: 1) Toshiba taken with Olympus, Adair and Kanno; 2) Toshiba taken with the German 177 patent, Adair and Kanno, 3) Olympus taken with Toshiba, Adair and Kanno, and 4) the German 177 patent taken with Toshiba, Adair and Kanno. Ex

17 The Examiner then concluded that without Mullick, the proposed obviousness rejection of claim 1 over Mullick in view of Toshiba and Olympus could no longer be adopted. Id. pp The Examiner declined to adopt any of the other proposed grounds. In each case, the examiner found that the proposed combination lacked the white LED of claim 1 of the 634 patent, which the examiner had construed to mean white light produced by a blue LED refracted through a crystal. Id. p. 7. IntroMedic is currently appealing the Examiner s conclusion not to adopt any of the proposed grounds of rejection. IX. CONSTRUCTION OF CLAIMS A. Applicable Legal Standards A claim in inter partes review is given the broadest reasonable construction in light of the specification of the patent in which it appears. See 37 C.F.R (b); see also, Office Patent Trial Practice Guide, 77 Fed. Reg , (Aug. 14, 2012). Accordingly, and solely for purposes of this review, Petitioner construes the claim language such that the claim terms are given their broadest reasonable interpretation. Also, the claim terms are given their ordinary and customary meaning, as would be understood by one of ordinary skill in the art at the time of the invention and in the context of the entire patent disclosure. In re Translogic Technology, Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). A patentee may rebut the presumption of applying the plain and ordinary meaning by acting as 10

18 a lexicographer and providing a special definition of the term that is laid out with reasonable clarity, deliberateness, and precision. In re Scroggie, 442 Fed. Appx. 547, 550 (Fed. Cir. 2011). For terms not specifically construed below, Petitioner interprets them for purposes of this review in accordance with their plain and ordinary meaning under the required broadest reasonable construction in light of the patent specification. 37 C.F.R (b). Because that legal standard for claim construction differs from the one applied in U.S. District Court litigation, see In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1364, 1369 (Fed. Cir. 2004), Petitioner expressly reserves the right to advocate a different construction in any subsequent litigation for any term found in the 438 patent. B. Proposed Constructions 1. white LED (claim 1) Proposed construction: White light produced by a blue LED chip (emitting light in the blue spectrum range) and a refracting crystal. See, Ex at 2:5-8. X. PRIOR ART REFERENCES RELIED ON BY PETITIONER 1. Japanese Patent No , entitled Gastric Camera ( Gastric Camera Patent ) (Ex. 1004) was published on March 16, It is therefore prior art under pre-aia 35 U.S.C. 102(b). 2. Patent Cooperation Treaty (PCT) No. WO A1 to Iddan ( Iddan ) (Ex. 1027), entitled Energy Management of Video Capsule, has an 11

19 international filing date of December 15, 1998 and published on June 24, It is therefore prior art under pre-aia 35 U.S.C. 102(a). 3. JP to Adachi, et al., entitled Endoscope and assigned to Olympus Optical ( Olympus ) (Ex. 1028), was filed on October 5, 1990 and published on May 19, It is therefore prior art under pre-aia 35 U.S.C. 102(b). 4. Japanese Patent Publication No to Katsunori ( Katsunori ) (Ex. 1029), entitled Endoscope was filed on June 2, 1997 and published on August 18, It is therefore prior art under pre-aia 35 U.S.C. 102(b). 5. European Patent No. EP A1 to Wood, entitled Compact Video Imaging Assembly and assigned to Welch Allyn ( Welch Allyn ) (Ex. 1030), claims priority to a U.S. Provisional filed on November 3, 1998 and was published on September 15, It is therefore prior art under pre-aia 35 U.S.C. 102(a). 6. U.S. Patent No. 6,277,064 to Yoon ( Yoon ) (Ex. 1031), entitled Surgical Instrument with Rotatably Mounted Offset Endoscope, was filed on December 29, 1998 and issued on August 21, It is therefore prior art under pre-aia 35 U.S.C. 102(e). 12

20 7. U.S. Patent No. 6,324,418 to Crowley, et al., entitled Portable Tissue Spectroscopy Apparatus and Method and assigned to Boston Scientific ( Boston Scientific ) (Ex. 1032), was filed on September 29, 1997 and issued on November 27, It is therefore prior art under pre-aia 35 U.S.C. 102(e). 8. U.S. Patent No. 5,734,418 to Danna ( Danna ) (Ex. 1033), entitled Endoscope with Tab Imager Package, was filed on July 17, 1996 and issued on March 31, It is therefore prior art under pre-aia 35 U.S.C. 102(b). XI. STATEMENT OF PRECISE RELIEF REQUESTED Petitioner respectfully requests that claim 1 of the 634 patent (Ex. 1001) be invalidated based on the following grounds of unpatentability, explained in greater detail below. Ground 1 Obvious over Yoon in view of Katsunori and the Gastric Camera Patent Ground 2 Ground 3 Obvious over Welch Allyn in view of the Gastric Camera Patent Obvious over Iddan in view of Welch Allyn or in view of Katsunori and Danna Ground 4 Ground 5 Obvious over Boston Scientific in view of Katsunori and Danna Obvious over Olympus in view of Katsunori and Danna 13

21 XII. STATEMENT OF NON-REDUNDANCY A. Non-Redundancy of Proposed Grounds in this Proceeding The grounds raised in the below sections are meaningfully distinct from each other and rely upon fundamentally different combinations of prior art. Ground 1 relies on Yoon as the primary reference. Yoon teaches the distal imaging portion of a traditional endoscope that lends itself to use in a capsule endoscope (see below figure). Yoon discloses an optical window with a lens and CMOS camera separated from the window by a gap. Yoon further discloses the use of one or more light sources, which may be light emitting diodes (LEDs). Katsunori teaches an endoscope using white LEDs positioned around the optical system. The Gastric Camera Patent teaches the use of a transmitter to allow the imaging system of Yoon to be untethered and used in a capsule endoscope. Ground 2 relies on Welch Allyn as the primary reference. Welch Allyn discloses the imaging portion of a traditional endoscope that lends itself to use in a capsule endoscope (see figure reproduced below). 14

22 Welch Allyn discloses the use of white LEDs surrounding a CMOS camera. Welch Allyn also teaches that these elements can be placed behind an optical window, which would create a gap. The Gastric Camera patent teaches the encapsulation of such an imaging system with a transmitter to create a capsule endoscope. Ground 2 differs from Ground 1 principally due to the differences between Welch Allyn and Yoon. Welch Allyn discloses the use of white LEDs and further discloses where the white LEDs are positioned relative to the optical system, features that Ground 1 draws from Katsunori. Welch Allyn also differs from Yoon in that the optical window in Welch Allyn is described in the text but not expressly shown to be dome shaped, whereas Yoon s Figure 5 expressly depicts a domeshaped optical window separated from the lens by a gap. Welch Allyn further differs from Yoon in that Welch Allyn is 102(a) prior art that predates the date the patentee purportedly tested its invention by only one month, while Yoon is 102(e) prior art that predates that alleged invention date by more than two years. 15

23 Ground 3 relies on Iddan as the primary reference. Iddan discloses a capsule endoscope with a dome shaped optical viewing window and an imaging unit spaced behind the window by a gap (see figure 4 reproduced below). Iddan also discloses light emitters, a camera, and a transmitter. Katsunori teaches the use of white LEDs and the positioning of the LEDs around the optical system. Danna teaches the interchangeability of solid state imagers based on CCD and CMOS technologies in endoscopes. Ground 3 differs from Grounds 1 and 2 in that the primary reference is a capsule endoscope rather than a traditional endoscope. The obviousness analysis thus involves modification of a capsule endoscope rather than the encapsulation of traditional endoscope. Ground 4 relies on Boston Scientific as the primary reference. Boston Scientific discloses a swallowable capsule including a wireless transmitter and light sources and light detectors separated from a dome shaped optical window by a gap (see figure reproduced below). 16

24 Ground 4 differs from Grounds 1 and 2 in that the primary reference is a capsule endoscope rather than a traditional endoscope. Ground 4 differs from Ground 3 in that the figures in Boston Scientific more clearly show the gap between the window and the sensors and emitters than does the figure in Iddan. Iddan also expressly describes a video camera, while the preferred embodiment described in Boston Scientific is for tissue spectroscopy. Conversely, Iddan does not expressly disclose more than one light source while Boston Scientific discloses the use of multiple light sources. Ground 4 further differs from Ground 3 in that Iddan is 102(a) prior art that predates the date the patentee purportedly tested its invention by four months, while Boston Scientific is 102(e) prior art that predates the same that date by more than two years. Ground 5 relies on Olympus as the primary reference. Olympus discloses a swallowable capsule with LED lights, a lens, a camera, and a transmitter (see figure below). 17

25 Katsunori teaches the use of white LEDs. Danna teaches the interchangeability of solid state imagers based on CCD and CMOS technologies in endoscopes. Ground 5 differs from Grounds 1 and 2 in that the primary reference is a capsule endoscope rather than a traditional endoscope. Ground 5 differs from Grounds 3 and 4 in that Olympus expressly discloses two LED light sources positioned on opposite sides of the optical system. Ground 5 further differs from Grounds 3 and 4 in that the Patent Owner argued during reexamination that Olympus does not disclose an optical window and a gap between the window and the optical system and further argued that the Olympus capsule relied on mobility to enable the optical system to focus on the tissue to be imaged (petitioner disagrees with these arguments for the reasons discussed infra p ). None of these arguments apply to the Iddan or Boston Scientific capsules. Ground 5 further differs from Grounds 3 and 4 in that Olympus is 102(b) prior art, whereas the primary references in Grounds 3 and 4 are 102(a) and 102(e) prior art. 18

26 B. Non-Redundancy with Reexamination The Olympus reference was included in the inter partes reexamination proceeding as a primary reference in a proposed combination with Toshiba, Addair and Kanno. Ex (Order Granting Reexamination) p. 3. In this petition, petitioner relies on Olympus as a primary reference in combination with different secondary references (Katsunori and Danna). The difference in secondary references is significant. During reexamination the examiner declined to adopt the proposed invalidity ground because the secondary references were silent upon the white LED recited in claim 1. Ex at 4-6. Katsunori, however, expressly discloses the white LED as recited in claim 1. Ground 5 is further not redundant of the proposed but not adopted reexamination ground in which Olympus was the primary reference because it includes different evidence in the form of the declaration of Robert J. Wood Sr. ( Wood ), an engineer with more than 30 years of experience designing medical imaging devices. Ex As a result of this different evidence, the arguments for incorporating white light and CMOS imaging cameras in Olympus capsule are different than the arguments proffered in the reexamination proceeding. See,Mitsubishi Plastics Inc. v. Celgard, IPR , paper 27 at 4 (Nov. 21, 2014) (finding that expert testimony that differ[ed] in a small but material 19

27 respect justified different decisions on institution, even though, unlike here, the prior art relied upon was the same). The Olympus reference is the only prior art reference that was included in a proposed ground of rejection during reexamination, that is also included in a proposed ground of rejection in this IPR petition. Grounds 1 and 2 differ from all of the proposed (but not adopted) reexamination grounds in that the primary references are traditional endoscopes rather than capsule endoscopes. Grounds 3 and 4 differ from the proposed (but not adopted) reexamination grounds for the same reasons that Ground 5 differs from the proposed reexamination grounds the inclusion of a reference expressly disclosing white LED and the incorporation of different evidence in the form of the Wood Declaration. In addition, the other prior art capsule endoscope references relied on as primary references in the reexamination (German Patent No. 3,440,177 ( the German 177 patent ) and Japanese Patent Application ( Toshiba )) differ substantially in scope from those relied on in Grounds 3 and 4. For example, as admitted in the reexamination proceedings, Ex at p. 26, the German 177 patent does not include a dome shaped optical window. Similarly, while Toshiba discloses a dome shaped optical window, it discloses a single illumination source that is not identified as an LED. Moreover, as the patentee argued during 20

28 reexamination, this single light source may be blocked by, or may enter, the imager lens 3 resulting in a non-working system. Ex at 17. XIII. CLAIM-BY-CLAIM EXPLANATION OF GROUNDS FOR UNPATENTABILITY A. Technological Background Applicable to all Grounds The concept of a swallowable wireless imaging endoscope is not new and was not new at the time of the purported invention of the 634 patent. Ex (Wood Decl.) 14, 50. Indeed, the idea of an imaging capsule was described in patent applications dating back a decade or more before the 634 patent was filed. Figures showing a few such early exemplars of capsule endoscopes are reproduced below. Exs. 1028, 1034, 1004, 1032, and

29 Not only was the concept known, but the essential components of a capsule endoscope were recognized almost universally well before the 634 patent was filed. As the above prior art figures reflect, it has long been recognized that a capsule endoscope must include: a light source, a camera, a lens, a window through which to capture an image, and a transmitter. Ex The 634 patent claims a capsule comprising these basic components. The patentees configuration of these essential components within the disclosed capsule of the 634 patent does not render claim 1 non-obvious. The 634 patent requires that the optical window be a dome type. The domed shape of the capsule which dictates the shape of the optical window is a characteristic shared by most of the above cited prior art capsules, driven by the need for the capsule to be swallowable. Ex , 43. The 634 patent further requires that the lens be spaced from the camera by a gap, a feature necessary in order to ensure that tissue pressed against the surface of the capsule remains in focus. Id Again, this feature is common to most of the above prior art patent figures. Moreover, the technique of spacing the lens from the tissue to capture images was a common endoscopic technique. Id. Finally, the 634 patent requires that two LEDs illuminate the tissue through the optical window and not through the lens. As Robert Wood, an engineer with more than 30 years of experience designing and developing medical imaging devices explains, in 22

30 an endoscopic capsule it is necessary (and obvious) to place multiple light sources behind the wall of the capsule to ensure full illumination of the target. Id Again, this is a feature common most of the above exemplary prior art capsules. Moreover, it would have been obvious not to illuminate through the lens because otherwise the light source would distort the image generated. Id. 47. Accordingly, there is nothing non-obvious about the layout of the optical system in the claimed capsule. Nor is there anything novel about the specific types of components recited in claim 1 of the 634 patent. For the light source, the 634 patent requires a specific type of light white light generated by a blue LED refracted through a crystal. Specifying the use of a particular type of LED light, however, does not lend novelty to the claims. As Wood explains, LED lights are the only possible lighting choice for a self-contained capsule. See Ex (explaining that the energy constraints of a capsule endoscope and the requirement that the light source not generate too much heat limit the choices of a light source). Moreover, it has long been known that true white light is necessary to produce color images, which are required for accurate medical diagnoses. Id Prior to 1993, it was not possible to generate white light from an LED because existing LED sources could not generate the required blue wavelengths. Ex In 1993, the blue LED was invented, making it possible to generate 23

31 white light. Id. There are two ways to generate white light from a blue LED source, RGB generated white light and blue/crystal generated white light. Id. 27. Of these two, blue/crystal white light was strongly preferred for medical imaging applications. Id In 1996 Nichia produced a phosphor-based white light from a blue LED ( blue/crystal white light ). Id. 32. This blue/crystal white light became commercially available in the US around Id. As soon as blue/crystal white light became available, designers of medical devices immediately recognized its potential for use in endoscopes and other medical imaging devices. Id. 33; see also, Ex Parte Cree, Appeal , 2014 Pat. App. LEXIS 7615, **35-59, *60 (P.T.A.B. Nov. 21, 2014)(discussing the evolution of white LED lights while noting that in view of blue LEDs available from Dr. Nakamura--the entire industry was adopting the known downconversion process via phosphors to create white light. ). The choice to include blue/crystal white LED light was thus not just obvious, but a practical necessity. See generally, Ex For the camera component, the 634 patent specifies the use of a CMOS or CCD camera. During reexamination the patentee tried to distinguish the claimed invention from prior art disclosing CCD cameras by amending its claims to recite just a CMOS camera. Ex No reexamination certificate has issued. Even 24

32 assuming the claims are limited to just a CMOS camera here, specifying this type of camera does not render the 634 patent non-obvious. The principal difference between CMOS and CCD cameras is that CMOS cameras are contained on a single chip whereas CCD cameras are contained on multiple chips (a chipset ). Ex High quality CMOS cameras became commercially available on a widespread scale around Id ; Ex When they became available, designers of medical instruments quickly recognized that they could be used in medical imaging products and routinely incorporated them where previously CCD cameras would have been used. Id 40. The choice to include a CMOS camera in place of a CCD camera in any medical imaging application was obvious because CMOS cameras are smaller, cheaper, and require less power. Id. 37. In sum, the capsule claimed in the 634 patent was nothing more than a combination of known elements that yielded predictable results. See KSR Intl. Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007) ( The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results. ). In view of the specific combinations of prior art recited below, a capsule having the components recited in the 634 patent arranged in the configuration recited in the 634 patent would have been obvious to the person of ordinary skill in the art at the time of the alleged invention of the 634 patent. 25

33 B. Ground I - Claim 1 of the 634 Patent is Obvious Over Yoon in View of Katsunori and in Further View of the Gastric Camera Patent The availability of high quality CMOS cameras and the invention of white LED lights in the mid to late 1990 s, described supra pp , made it possible to make a self-contained miniature endoscopic device. Ex , 60. As discussed supra p , medical device designers immediately began incorporating these technologies into medical imaging devices. Id. 33, 40. These developments would have motivated the person of ordinary skill in the art to make a swallowable imaging capsule incorporating these technologies. Id 60. Further motivation would have been provided in reports, like that found in the journals Gastrointestinal Endoscopy and Gut, describing wireless transmission of images from inside a porcine stomach. Id.; Exs and Fig. 5 of Yoon (reproduced below) teaches the imaging (distal) portion of an endoscope camera. It includes a CMOS camera, a dome shaped window, and a focusing lens spaced back from the window (thus creating a gap between the window and the lens) and housed in a package with a small diameter. Ex. 1031, Fig. 5; Ex

34 The camera and lens are positioned behind the window to bring tissue that touches the top of the dome into clear focus. Id. A person of ordinary skill in the art would have immediately recognized that this sphere-shaped imaging portion was well suited for capsule endoscopy and that the bulk of the endoscope (e.g. Ex. 1031, element 162 in Fig. 6) is simply a delivery mechanism that would be unnecessary in a swallowable capsule. Ex Yoon also teaches that LEDs may be used to illuminate the target area. Ex. 1031, 7: While Yoon does not disclose the type of LEDs used or specify where they are to be positioned, a person of ordinary skill in the art would have understood that white LEDs would be necessary to generate a color image. Ex , 54. It would have been obvious to a person of ordinary skill in the art to position the LEDs around the camera and behind the window in order to 27

35 uniformly illuminate the target tissue from different angles, thus avoiding dark spots Id , 64. A person of ordinary skill in the art with knowledge of Yoon alone would have oriented the LEDs similarly and consistent with the LEDs disclosed in Katsunori. Ex Katsunori teaches the use of a plurality of blue/crystal white LED light sources. Ex (Katsunori) at [0004, 0025, and 0028]; Fig 5 (below). The LEDs in Katsunori are placed around the imager in order to provide even illumination from different angles at the point of focus. Ex Katsunori also points out that the blue LEDs disclosed offer the advantage of low heat generation and energy efficiency. Ex at [ ]. To the extent the use of a plurality of blue/crystal white LEDs positioned behind the window would 28

36 not have been obvious in view of Yoon alone, it would have been obvious in view of Katsunori. Ex Yoon and Katsunori thus would have taught the person of ordinary skill in the art to use a CMOS camera, to use blue/crystal white LEDs, to arrange the LEDs around the camera, and to space the camera lens and the LEDs back from a dome shaped optical window. Ex Put another way, Yoon and Katsunori teach the basic optical system of an endoscope suitable for encapsulation in a wireless device. Id. In order for the Yoon/Katsunori optical system to function as a capsule endoscope, it needs the ability to transmit wirelessly. The Gastric Camera patent discloses all of the basic components of the claimed endoscopic capsule, including the one element not taught by the combination of Yoon and Katsunori a transmitter. Ex. 1004, Fig. 1. The Gastric Camera teaches that wireless transmission will avoid the great pain patients experience from tethered endoscopes. Id. p. 1. It would have been obvious to the person of ordinary skill in the art to add a transmitter, like the one disclosed in the Gastric Camera patent, in order to allow wireless image transmission. Ex Claim 1 is thus invalid as obvious over Yoon in view of Katsunori and in further view of the Gastric Camera patent. Provided below is a claim chart showing where each of the elements of these claims can be found in the prior art. 29

37 U.S. Patent No. 7,009, A swallowable capsule for in-vivo imaging of the gastrointestinal tract, said capsule comprising: a housing, said housing including at least a dome type optical viewing window portion disposed along a longitudinal axis of said capsule, said dome type optical viewing window portion being part of the external surface of said housing, said housing enclosing at least: at least one CMOS or CCD imaging camera; at least two white LED illuminating sources for illuminating said gastrointestinal tract site only through said optical viewing window; an optical system comprising at least one lens for collecting light from said gastrointestinal tract site through said optical viewing window onto said CMOS or CCD imaging camera for imaging said gastrointestinal tract site onto said CMOS or CCD imaging camera, said optical system being separated from said dome type optical viewing window portion, which is not part of said optical system, by a gap, the at least two white LED illuminating sources positioned in the Prior Art Disclosures Relied Upon JP (Gastric Camera) at p. 1 ( The unit is housed in a small capsule in size which may be inserted via the human mouth, passes through the digestive system including the esophagus, stomach and intestines without being digested, and excreted from the anus. ) U.S. Patent 6,277,064 ( Yoon ) Fig. 5. Gastric Camera at p. 1. Yoon Fig. 5. Gastric Camera at p. 1. Yoon at 4:60-62; 6: Gastric Camera at p. 1; Fig. 1 (element 2). Gastric Camera at p. 1; Fig. 1 (element 3). Katsunori at [ ]. Yoon at 7: Yoon at 4:54-67; 6:56-61; 7:22-24; Figs. 1B and 4-6. Gastric Camera at p. 1; Fig. 1 (element 1). Yoon Fig. 5. Gastric Camera at p. 1. Gastric Camera Fig

38 U.S. Patent No. 7,009,634 vicinity of said optical system and not on the longitudinal axis of said optical system so that the at least two white LED illuminating sources illuminate said gastrointestinal tract site directly through said optical viewing window and not through said optical system, and said CMOS or CCD imaging camera imaging said gastrointestinal tract site via said optical viewing window and via said optical system; and a transmitter for transmitting the signal of the CMOS or CCD imaging camera to a receiving system. Prior Art Disclosures Relied Upon Katsunori at [ ]. Yoon at 4:54-67; 6:56-61; 7:22-24; Fig. 1B; Fig. 5. Gastric Camera at p. 1; Fig. 1 (element 5). C. Ground II - Claim 1 of the 634 Patent is Obvious over Welch Allyn in View of the Gastric Camera Patent As discussed in connection with Ground I, the development of CMOS cameras and white LED lights, and reports of wireless transmission of medical images would have motivated the person of ordinary skill in the art to make a swallowable imaging capsule. See supra p. 26; Ex , 72. A person of ordinary skill in the art would have recognized that Welch Allyn provides an excellent starting point for making an endoscopic capsule. Ex As illustrated in the below figure, Welch Allyn teaches the use of a plurality of blue/crystal white LEDs, surrounding a lens that focuses an image on a CMOS camera. Id. 74; Ex. 1030, Fig. 8, 5:2-5, 8:59-9:20. 31

39 The blue/crystal white light LEDs in Welch Allyn are described as a significant advantage over fiber optics. Welch Allyn explains: white-light emitting LEDs provide[] a compact, low power and efficient light source, deleting the need for optical fiber bundles or other external illumination source, and greatly simplifying the manufacture and maintenance of an instrument having the described system. Ex at 6: The CMOS imager is also taught to provide an advantage over other imagers in that it requires low power in comparison to other solid state imaging elements. Id. at 9: Welch Allyn also teaches that a circular plate of plastic or of an optical grade material (not shown) can be added to the exterior of the distal face of the housing so as to uniformly distribute the light to the target. Ex at 9: The addition of an optical grade material would create an optical window and would space the lens (and the LEDs) from exterior wall of the capsule, creating a gap between the lens and the optical window. Ex Welch Allyn thus 32

40 teaches all of the elements of claim 1 of the 634 patent except the dome shape of the optical window and the use of a transmitter. Id. The imaging unit described in Welch Allyn is extremely compact. Ex at 10: Welch Allyn states that the entire imaging assembly previously requiring several components can be situated in a space envelope which is orders of magnitude smaller than any previously contemplated. Id. at 6:2-9. (emphasis added). Because of its extremely small size, the Welch Allyn imaging unit lends itself naturally to encapsulation in a capsule endoscope. Ex This is particularly true given the teaching in Welch Allyn that the entire imaging system, including the processing circuitry can be detachably mounted and removed from the instrument of use. Ex at 10: Given its small size and detachability, it would have been obvious to a person of ordinary skill in the art to place the Welch Allyn imaging system in a capsule endoscope. Ex The Gastric Camera Patent teaches all of essential components of a swallowable capsule. Ex p. 1; Ex It discloses a unit (shown in Figure 1 of the patent) with an imager and a transmitter that can be housed in a small capsule in size which may be inserted via the human mouth thus avoiding the great pain associated with traditional endoscopic methods. Ex p. 1. It would have been obvious to a person of ordinary skill in the art to house the extremely small imaging unit disclosed in Welch Allyn in a capsule with a 33

41 transmitter as taught by the Gastric Camera Patent. The shape of the capsule, which is obvious, dictates that the optical grade material that Welch Allyn teaches can be added to the distal face of the housing, be dome shaped when the imaging unit of Welch Allyn is encapsulated. Ex The resulting encapsulation of the Welch Allyn imaging unit would thus produce a capsule that includes all of the elements of claim 1 of the 634 patent. Id. Claim 1 is thus invalid as obvious over Welch Allyn in view of the Gastric Camera Patent. Ex Provided below is a claim chart showing where each of the elements of these claims can be found in each reference. U.S. Patent No. 7,009, A swallowable capsule for in-vivo imaging of the gastrointestinal tract, said capsule comprising: Prior Art Disclosures Relied Upon JP (Gastric Camera) at p. 1 ( The unit is housed in a small capsule in size which may be inserted via the human mouth, passes through the digestive system including the esophagus, stomach and intestines without being digested, and excreted from the anus. ) a housing, said housing including at least Gastric Camera at p. 1 a dome type optical viewing window portion disposed along a longitudinal axis of said capsule, said dome type optical viewing window EP A1 ( Welch Allyn ) at portion being part of the external surface 9: of said housing, Gastric Camera at p. 1 said housing enclosing at least: at least one CMOS or CCD imaging camera; Welch Allyn at 5:2-5, 9: Gastric Camera at p. 1; Fig. 1 34

42 U.S. Patent No. 7,009,634 Prior Art Disclosures Relied Upon (element 2). at least two white LED illuminating sources for illuminating said gastrointestinal tract site only through said optical viewing window; Welch Allyn at 8:58 9:15. an optical system comprising at least one lens for collecting light from said gastrointestinal tract site through said optical viewing window onto said CMOS or CCD imaging camera for imaging said gastrointestinal tract site onto said CMOS or CCD imaging camera, said optical system being separated from said dome type optical viewing window portion, which is not part of said optical system, by a gap, the at least two white LED illuminating sources positioned in the vicinity of said optical system and not on the longitudinal axis of said optical system so that the at least two white LED illuminating sources illuminate said gastrointestinal tract site directly through said optical viewing window and not through said optical system, and said CMOS or CCD imaging camera imaging said gastrointestinal tract site via said optical viewing window and via said optical system; and a transmitter for transmitting the signal of the CMOS or CCD imaging camera to a receiving system. Welch Allyn at 5:2-5, 8:58 9:15, 9:28-32; Fig. 7(b); Fig. 8. Gastric Camera at p. 1; Fig. 1 (element 3). 35 Gastric Camera at p. 1; Fig. 1 (element 1). Gastric Camera at p. 1 Welch Allyn at 5:2-5, 8:58 9:15, 9:28-32; Fig. 7(b); Fig. 8. Gastric Camera at p. 1 Gastric Camera at p. 1; Fig. 1 (element 5).

43 D. Ground III Claim 1 is Obvious Over Iddan in view of Welch Allyn, or in view of Katsunori and Danna3 As discussed supra p 21-22, the concept of capsule endoscopy is not new and predates the purported invention of the 634 patent by many years. Ex (Wood Decl.) 14, 50. It was not until the development of white LED light and CMOS cameras, however, that capsule endoscopy became practical. Id. 81. Once these technologies became available, a person of ordinary skill in the art would have been motivated to adapt prior art capsule endoscopes to incorporate the new technology. Id. The combination of Iddan, which discloses a capsule endoscope, and Welch Allyn, which discloses white LEDs and a CMOS camera meets every element of claim 1 of the 634 patent. Iddan discloses an in-vivo video capsule for imaging the gastrointestinal tract with an optical viewing window (40) disposed along a 3 The disclosure of Katsunori with respect to blue/crystal white LEDs is similar to that of Welch Allyn. The disclosure of Danna with respect to the use of a CMOS camera is similar to that of Welch Allyn. Katsunori and Danna are not redundant of Welch Allyn because patentee is likely to try to swear behind Welch Allyn, but cannot swear behind Katsunori and Danna. Welch Allyn is not redundant of Katsunori and Danna because it discloses both white LEDs and a CMOS camera. 36

44 longitudinal axis and an imaging unit (12) that is separated from the optical viewing window by a gap. See Ex. 1027, Fig. 4 (below). Iddan further discloses that the imaging unit includes a radio transmitter (27), light emitter (26), and a camera (25). See id., Fig. 2, below (showing the components of the imaging unit (12)). As Iddan provides only a general description of an imaging system, it would have been obvious to a person of ordinary skill in the art to turn to other sources 37

45 for the details of an imaging system. Ex More specifically, it would have been obvious to integrate Welch Allyn s compact diagnostic video imaging system as the imaging unit of Iddan. Id. The extremely small size of the imaging unit in Welch Allyn would makes it ideal for use as the imaging unit required Iddan. Id. 84. Iddan identifies a need for energy savings and teaches that the camera is one of the major sources of energy consumption. See e.g., Ex at 6:21-23 ( The imaging unit comprises three major power consumers, namely radio transmitter 27, illuminator (light emitter) 26, and camera assembly 25. ). Welch Allyn provides an energy efficient light source and camera. Ex While disclosing both CMOS and CCD cameras, Welch Allyn teaches that CMOS cameras offer the advantage of smaller size and lower power consumption. Ex at [0043]( The presently described CMOS imager 174 requires low power in comparison to other solid state imaging elements, such as CCD imagers[.] ). Welch Allyn also discloses the use of a plurality of white-light producing LEDs disposed circumferentially between the lens and the exterior of imaging assembly. Ex. 1030, Fig. 8. Welch Allyn thus meets the claimed configuration of two white LED illuminating sources positioned in the vicinity of said optical system and not on the longitudinal axis the camera. Ex at 8:51-53; see Ex. 1030, Fig. 8 (below). 38

46 Welch Allyn provides the major advantage of not only pure white light, but also the energy savings presented by LEDs. Ex ; see also A person of ordinary skill in the art would thus have been motivated by these advantages to combine Iddan and Welch Allyn to make an endoscopic capsule with all of the elements of claim 1 of the 634 patent. Id It would also have been obvious to a person of ordinary skill in the art to use an imaging unit like the one disclosed in Katsunori, where Iddan discloses generally an imaging unit. Ex Katsunori teaches an endoscope using a plurality of blue/crystal white LED light sources surrounding a CCD camera. Ex at [0004, 0025, and 0028]; Fig 5 (below); Ex