# Petition for Writ of Certiorari — Neutrino Development Corp. v. Sonosite, Inc. (No. 06-1405) > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40386016_2465%3A1 ## Record - **Collection:** Supreme Court brief - **Document type:** Petition for Writ of Certiorari - **Published:** January 1, 2007 ## Text S. @ Serce5” 06140 5APR 1 9 2007 OFFICE OF THE CLERK No. 06- IN THE Supreme Court of the United States NEUTRINO DEVELOPMENT CORPORATION, Petitioner, v, SONOSITE, INC., Respondent. On PETITION FOR A WriT OF CERTIORARI TO THE UnitTep STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT PETITION FOR A WRIT OF CERTIORARI Scotr D. MARRS BEIRNE, MAYNARD & Parsons, L.L.P. 1300 Post Oak Boulevard Suite 2500 Houston, Texas 77056 (713) 623-0887 Counsel for Petitioner — wor 208200 ce COUNSEL PRESS (800) 274-3321 + (800) 359-6859 i QUESTIONS PRESENTED When is a patent drawing alone adequate disclosure to support a claim limitation so as to satisfy the written description requirement of 35 U.S.C. § 112? When is a patent drawing alone adequate disclosure to support later amendments to the specification and claims so as to avoid the “new matter” prohibition of 35 U.S.C. § 132? ii PARTIES TO THE PROCEEDING Petitioner is Neutrino Development Corporation, a Texas ~ corporation. Respondent is SonoSite, Inc., a Washington corporation. Counterclaim Defendant, Richard Redano, was not a party to the appeal to the United States Court of Appeals for the Federal Circuit and is not a party to this Petition. STATEMENT PURSUANT TO RULE 29.6 Petitioner, Neutrino Development Corporation, has no parent corporations and no publicly held company owns more that 10% of its stock. ii TABLE OF CONTENTS Page QUESTIONS PRESENTED ......ccccccceseeee i PARTIES TO THE PROCEEDING AND RULE 29.6 CORPORATE DISCLOSURE STATEMENT ... ii py i 8 ge ee Spr ena rere rere ili TABLE OF CITED AUTHORITIES ............ Vv TABLE OF APPENDICES .................4-. Vili I. PETITION FOR A WRIT OF CERTIORARI .. ] Il. OPINIONS AND ORDERS BELOW ........ | ey PE vas Keats Par aineerces ti 2 BV. STATUTES INVOLVED occ cccucscercces 2 V. STATEMENT OF THE CASE .............. 3 ee 8 Oe eer Te ower er ree 3 I TOO on 6 Go Fira ee ee ee: 5 VI. REASONS FOR GRANTING THE PUTRI i enc od ek beh eceeees 7 A. Binding Federal Circuit Law Is in Conflict with Other Binding Federal Circuit Law ... 7 iv Contents Page ie Li Lg ee ere 8 2. Neutrino’s Reliance upon Koito ...... 10 3. The Only Solution Is a Granting of the i eRe CRE PORT Per O re Cre ee 11 B. This Court Should Settle the Issue of Whether, and to What Extent, Patent Drawings May Be Relied Upon .......... 13 ahs GRE, kc aren Ss ek ee ache ei 15 TABLE OF CITED AUTHORITIES Page Federal Cases Hockerson-Halberstadt, Inc. v. Avia Group International, Inc., 222 FidG O91 (POG. Car, 20D) nc cc ccececwss 8-9, 11 Koito Manufacturing Co. v. Turn-Key-Tech, LLC, 301 F.3d 1142 (Ped. Cir. 2006) ........... 9, 10, 11 Markman vy. Westview Instruments, Inc., ee ee POU 65 bs iva cei eee hen eaves 12 Markman vy. Westview Instruments, Inc., ee en PF AWG als BPO) na ko es eseectasns 12 Neutrino Development Corp. v. SonoSite, Inc., 337 F. Supp. 2d 942 (S.D. Tex. 2004) ......... 1,3 Neutrino Development Corp. v. SonoSite, Inc., 410 F. Supp. 2d 529 (S.D. Tex. 2006 .......... ] Neutrino Development Corp. v. SonoSite, Inc., 423 F. Supp. 2d 673 (S.D. Tex. 2006 ......... 1, 6,9 Neutrino Development Corp. v. SonoSite, Inc., No. H-01-2484, 2007 WL 1040697 Ce Sc I BEE ov 0 eel Ci canes eens 2 Neutrino Development Corp. v. SonoSite, Inc., No. H-01-2484, 2007 WL 998636 Cs Ss Ns is AED a oc ic cveweecivvcets 2 vi Cited Authorities Page Vas-Cath Inc. v. Mahurkar, 955 F.2e 1550 LPO, Ce, FSR ccc evenidvass 8 Wisniewski v. United States, BaP es POT OE 4 shad reeds Shae SD Fy Oa Fe Statutes _ Be A ease bedi eee ees 2 an 5 BA. BAT eee ere veruneee: 8 Pe OG Oe 8 iiss Ce eae ERS 3 Be Ars BBS oe RCN Coa een ee eee eee 3,8 Be Ns EE i Ske CE Ria wd ee Rewer 3 Pe Ge NE, hu ee eee ee ences kaye Fe Aer BEE he cau hoor nine al Oebiee ken 14 Fe Re kek eens be ee oe es ee Rule Pe a PU Wy UL ED eek ease baae ers 12 vii Cited Authorities Page Law Review Articles Thomas W. Adams, The 1988 Revision of 28 U.S.C. § 1391(c): Corporate Venue Is Now Equivalent to In Personam Jurisdiction Effects on Civil Actions for Patent Infringement, 39 Clev. St. 1 TG SST See eh sh ietiveccereessia 7 vill TABLE OF APPENDICES Appendix A — Judgment Of The United States Court Of Appeals For The Federal Circuit Dated And epeee RPOMITIOE Gy QUO oe cece cc iecce pees Appendix B — Memorandum And Order Of The United States District Court For The Southern District Of Texas, Houston Division Dated March et Oe hehe pases ae eed ERK Appendix C — Memorandum And Order Of The United States District Court For The Southern District Of Texas, Houston Division Dated September 30, 2004 (Re: Plaintiff's Motion For Summary Judgment On Infringement) ......... Appendix D — Memorandum And Order Of The United States District Court For The Southern District Of Texas, Houston Division Dated September 30, 2004 (Re: Defendant’s Post- Markman Motion For Summary Judgment) ..... Appendix E — Opinion Of The United States District Court For The Southern District Of Texas, Houston Division Dated January 23, 2006 ..... Appendix F — Memorandum And Order Of The United States District Court For The Southern District Of Texas, Houston Division Filed March ea US ese ce eueweewses ix Appendices Page Appendix G — Order Of The United States District Court For The Southern District Of Texas, Houston Division Awarding Costs Dated March PES oie C6h 4 6 ob Redan a oe eke eae 105a Appendix H — Order Of The United States Court Of Appeals For The Federal Circuit Denying Petition For Rehearing Dated And Filed January SOG MT tbo KUE LOREEN Kabat Reateebe eee 114a Appendix I — Order Of The United States District Court For The Southern District Of Texas, Houston Division Dated August 20, 2003 ...... 116a Appendix J — Relevant Statutes ............... 133a 1 I, PETITION FOR A WRIT OF CERTIORARI Petitioner respectfully petitions for a writ of certiorari to review the judgments of the Court of Appeals for the Federal Circuit and of the United States District Court for the Southern District of Texas. II. OPINIONS AND ORDERS BELOW The United States Court of Appeals for the Federal Circuit did not render a written opinion, but instead, on December 8, 2006, it affirmed the judgment of the lower court through a judgment of affirmance pursuant to Rule 36 of the Federal Circuit Rules. This order, which is included within Petitioner’s Appendix at la, may be found at 2006 WL 3780734. Similarly, the Federal Circuit, in denying the request for « panel rehearing or rehearing en banc, did not issue a written opinion, but delivered an order on January 19, 2007, which is included within Petitioner’s Appendix at 114a. The opinion of the United States District Court for the Southern District of Texas, Neutrino Development Corp. v. SonoSite, Inc., 423 F. Supp. 2d 673 (S.D. Tex. 2006) (3a), is published, and it was issued on March 21, 2006. Other published opinions of the United States District Court for the Southern District of Texas are as follows: Neutrino Development Corp. v. SonoSite, Inc., 410 F. Supp. 2d 529 (S.D. Tex. 2006) (46a); Neutrino Development Corp. v. SonoSite, Inc., 337 F. Supp. 2d 942 (S.D. Tex. 2004) (30a); Neutrino Development Corp. v. SonoSite, Inc., 337 F. Supp. 2d 937 (S.D. Tex. 2004) (18a). Other judgments and orders from the United States District Court for the Southern District of Texas are as a “ follows: Neutrino Development Corp. v. SonoSite, Inc., No. H-01-2484, 2007 WL 998636 (S.D. Tex. Mar. 30, 2007) (105a) (awarding costs); Neutrino Development Corp. v. SonoSite, Inc., No. H-01-2484, 2007 WL 1040697 (S.D. Tex. Mar. 30, 2007) (89a) (denying attorneys’ fees). Il. JURISDICTION The United States District Court for the Southern District of Texas entered judgment on March 21, 2006, and the United States Court of Appeals for the Federal Circuit entered judgment on December 8, 2006. The Federal Circuit entered the order denying the request for panel rehearing and rehearing en banc on January 19, 2007. This Court has jurisdiction pursuani to 28 U.S.C. § 1254(1). IV. STATUTES INVOLVED 35 U.S.C. § 112, | 1, provides as follows: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. . The full text of § 112 is included within the Appendix at 1 33a. 3 35 U.S.C. § 132(a) provides, in pertinent part, that “[njo amendment shall introduce new matter into the disclosure of the invention.” The full text of § 132 is included within the Appendix at 135a. V. STATEMENT OF THE CASE This is a patent infringement case, and the United States District Court for the Southern District of Texas, which was the court of first instance, had jurisdiction pursuant to 28 U.S.C. §§ 1331 and 1338(a) because this case arose under the patent laws of the United States (35 U.S.C. § 100). A. Material Facts Richard T. Redano, an independent inventor of numerous patents, and a registered patent attorney, is the inventor of United States Patent No. 6,221,021, titled, “Method and Apparatus for Penile Hemodynamic Stimulation, Monitoring, and Drug Delivery Acceleration” (“the ‘021 patent”). Neutrino Development Corporation (“Neutrino”), a technology marketing and licensing corporation, is the assignee of the ‘021 patent. SonoSite, Inc. (“SonoSite”), is a manufacturer and provider of diagnostic medical ultrasound devices and services. Specifically, SonoSite manufactures the following products, all of which have been accused of infringing the ‘021 patent: (1) SonoSite 180; (2) SonoHeart; (3) SonoSite 180 Plus; and (4) SonoHeart Plus. These products are portable, hand-held devices, capable of measuring certain hemodynamic parameters—such as blood flow—through the use of ultrasound. Neutrino Dev. Corp., 337 F. Supp. 2d at 938. 4 The ‘021 patent claims priority from, and is a continuation-in-part of, an application filed on September 9, 1997, which is now United States Patent No. 5,947,901 (“the ‘901 patent”). The ‘021 patent discloses apparatus and method embodiments wherein an ultrasound device may be used in a therapeutic mode and/or a diagnostic mode. (U.S. Patent No. 6,221,021 Bl, col. 1, lines 15-17.) Ina therapeutic mode, the device is used to correct erectile dysfunction by stimulating the flow of blood in a penis (U.S. Patent No. 6,221,021 Bl, col. 1, lines 1-22), whereas in a diagnostic mode, the device measures certain hemodynamic parameters, such as blood flow. (U.S. Patent No. 6,221,021 Bl, col. 7, lines 25-27.) The claims in the ‘021 patent are directed only to the diagnostic embodiment of the disclosed apparatus. On May 10, 2000, an amendment was filed in response to the initial office action. The amendment at issue appears at col. 6, line T8=20, and it reads as follows: “As shown in FIG. 2, the ultrasonography generator unit 30 is sized to be grasped or held in a user’s hand.” (U.S. Patent No. 6,221,021 B1, col. 6, lines 18-20; Amendment and Resp. to First Office Action at 5, lines 25-26; Petitioner’s App. at 8a n.1.) In that same amendment, new claims were added, which included element “(a).”” Element “(a)” contains the following language: “a portable body sized to be hand held.” (Amendment and Resp. to First Office Action at 5-6.) The Examiner entered the amendment and the new claims without objection. (Amendment and Resp. to First Office Action at 5-6.) Throughout the stages of this case, Neutrino has argued that element “(a)” finds support in Fig. 2, which is the drawing at issue, of the original ‘021 patent application. The 5 claim element in question is element “32” in the drawing. The following illustration is Fig. 2, as it appears in the original application: he FIG. 2 B. Proceedings Below On July 24, 2001, Neutrino filed an action for patent infringement against SonoSite, alleging that SonoSite’s hand- held diagnostic medical ultrasound devices infringe the ‘021 patent. After holding a Markman hearing on February 20, 2002, the district court, on August 21, 2003, construed the meaning of certain words and phrases. Only one of the phrases— “a portable body sized to be hand held”— is relevant to this petition. That phrase appears in each of the independent claims at issue in the ‘021 patent as element “(a).” The district court construed the phrase as follows: “‘A portable body sized to be hand held’—A body that is sized such that it can be 6 held by hand and, so held, moved from one location to another.” (132a.) On March 21, 2006, the district court granted SonoSite’s motion for summary judgment of patent invalidity, holding that claims 8, 20, and 25, and all claims dependent thereon, of the ‘021 patent were invalid for failure to comply with 35 U.S.C. §§ 112,49 1, and 132(a). (3a.) On the same day, the district court entered its Final Judgment, in which it did the foilowing: (1) invalidated claims 8, 20, and 25, and all claims depending thereon; (2) reversed its summary judgment finding of literal infringement of these claims; and (3) dismissed with prejudice Neutrino’s claims of infringement. Neutrino Dev. Corp., 423 F. Supp. 2d at 680. The district court found claims 8, 20, and 25, and all claims depending thereon, invalid because of “new matter” that it determined was found in element “(a)” of each claim (“a portable body sized to be hand held”). Neutrino appealed to the United States Court of Appeals for the Federal Circuit. In the briefs that it filed in the Federal Circuit, Neutrino argued, inter alia, that the district court erred in holding that the claims were invalid because the district court disregarded binding precedent that provides that patent drawings alone may be relied upon, in certain Situations, to support claim limitations. After oral argument, the Federal Circuit affirmed the judgment of the district court without rendering a written opinion. Neutrino petitioned the Federal Circuit for a rehearing and for a rehearing en banc, but the Federal Circuit denied the petition. 7 VI. REASONS FOR GRANTING THE PETITION This Court should grant Neutrino’s Petition for a Writ of Certiorari for the following reasons: (1) the law in the Federal Circuit relating to the reliance upon patent drawings alone is in conflict, and in need of clarification; and (2) this Court has never addressed whether, and to what extent, patent drawings alone may be relied upon to support claim limitations, and such an important question should be settled by this Court. See Sup. Ct. R. 10 (providing reasons considered by the Court when determining whether to grant a petition for a writ of certiorari). A. Binding Federal Circuit Law Is in Conflict with Other Binding Federal Circuit Law Ordinarily, conflicts in the law regarding the same matter occur between different courts located in different jurisdictions, and on numerous occasions, this Court has granted writs of certiorari to resolve such conflicts when the conflicts concerned the same important matters. See Thomas W. Adams, The 1988 Revision of 28 U.S.C. § 1391(c): Corporate Venue Is Now Equivalent to In Personam Jurisdiction Effects on Civil Actions for Patent Infringement, 39 Clev. St. L. Rev. 357, 369 (1991) (“Historically, many of the Supreme Court’s grants of certiorari have been necessitated by conflicts between the Circuit Courts of Appeal.”). It is rather unusual for there to exist an actual conflict in the law of the same circuit, and this is because conflicting decisions are overruled by the same circuit that rendered them, thereby removing the conflict. See Wisniewski v. United States, 353 U.S. 901, 902 (1957) (stating that “(ijt is primarily the task of a Court of Appeals to reconcile 8 its internal difficulties”). Thus, there is normally little need for this Court to become involved. However, since the advent of the United States Court of Appeals for the Federal Circuit, the Federal Circuit is the only appellate court, other than this Court, that can hear patent-related appeals, where the patent issue is raised in the complaint, as in the case at bar. See 28 U.S.C. § 1295(a)(1) (2006) (providing that “(t]he United States Court of Appeals for the Federal Circuit shall have exclusive jurisdiction .. . of an appeal from a final decision of a district court of the United States . . . if the jurisdiction of that court was based, in whole or in part, on [28 U.S.C. § 1338]”). Consequently, if one Federal Circuit decision conflicts with another Federal Circuit decision concerning the same matter, and both decisions still stand, such a conflict will rarely be addressed because it is assumed that the Federal Circuit will resolve conflicts within its own court. See Wisniewski, 353 U.S. at 902. Moreover, it is simply counterintuitive to think that the same court could be in conflict with itself. Nevertheless, with regard to the issue presented in this petition, the Federal Circuit has created a conflict between two prior decisions, both of which still stand. 1. The Conflict at Issue The conflict at issue relates to whether, and to what extent, patent drawings alone may be relied upon to support claim limitations. The Federal Circuit has decided two seminal cases related to this matter': (1) Hockerson- ' There are other Federal Circuit cases that have addressed this issue as well. See, e.g., Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1566-67 (Fed. Cir. 1991) (“[T]he possibility that the ‘081 drawings may provide an adequate § 112 ‘written description’ of the subject matter of ... the claims ... should have been considered.”’). 9 Halberstadt, Inc. v. Avia Group International, Inc., 222 F.3d 951 (Fed. Cir. 2000); and (2) Koito Manufacturing Co. v. Turn-Key-Tech, LLC, 381 F.3d 1142 (Fed. Cir. 2004). Both decisions still stand, with one, Hockerson-Halberstadt, holding that support for precise proportions made in claims _ cannot be found in drawings, and the other, Koito, determining that drawings can support claim limitations when those limitations disclose relative dimensions. Until recently, these two decisions were not in conflict. However, after the district court issued its opinion in which it announced that situations regarding “precise” proportions recited in the claims were the same, under Federal Circuit law, as situations regarding “relative size,”’ it created a conflict between its decision and those of the Federal Circuit, and the Federal Circuit was presented with an opportunity to correct this misinterpretation of its own decisions. Yet the Federal Circuit did not to do so, despite Neutrino having apprised it of the inconsistency on two separate occasions.’ Instead of addressing, and resolving, this important issue, the Federal Circuit affirmed the district court’s judgment without even rendering a written opinion, thus creating the conflict at issue. Accordingly, what was once lucid Federal Circuit law is now conflicted. As such, a patentee confronted ? Neutrino Dev. Corp., 423 F. Supp. 2d at 678 (stating that “the Court does not believe that the Federal Circuit in Hockerson- Halberstadt intended for ‘precise proportions’ to carry a meaning distinct from ‘relative size’”). > In its Brief and in its Petition for Rehearing and Suggestion for Rehearing En Banc, Neutrino notified the Federal Circuit that the district court had misconstrued binding Federal Circuit law. (Br. of Pl.-Appellant at 20-21; Pet. for Reh’g & Suggestion for Reh’g En Banc at 1-9.) 10 with the issue at hand is faced with the precarious and unenviable task of attempting to determine whether the pane! of judges deciding the case will follow one decision. or the other. This creates uncertainty in the law, which directly affects all patent holders and potential patent holders, and, on a grander scale, American business as a whole, for if such a conflict is not resolved, a myriad of patents could be invalidated. 2. Neutrino’s Reliance upon Koito Neutrino relied upon Koito, and it was never determined by either the district court or the Federal Circuit that the ‘021 patent did not fit within the reasoning of that decision. Rather, the district court misconstrued Federal Circuit precedent, and the Federal Circuit exacerbated this problem by affirming the judgment, thereby unnecessarily creating a conflict. Neutrino’s reliance upon Koito was founded upon the fact that the Federal Circuit in that case decided that drawings alone could be relied upon to support claim limitations, when those limitations relate to relative dimensions. Koito Mfg. Co., 381 F.3d at 1155. In the present case, Figure 1 of the ‘268 patent clearly shows that flow channel 6 is ‘significantly thicker and wider’ than the adjacent mold cavity 2. Figure | thus demonstrates that the inventor was ‘in possession’ of the patent claims, including the claim limitation speaking to the relative dimensions of the flow channel, and thus that 1] the written description requirement was satisfied.” (emphasis added)). The drawing that follows is Figure 1 from Koito: The claim limitation at issue in this case—”a portable body sized to be hand held”—is nothing more than a limitation relating to relative size.* It does not speak to any precise proportions, and because of this, Hockerson- Halberstadt, and its prohibition against reliance upon drawings to support precise proportions, is inapplicable. 3. The Only Solution-Is a Granting of the Writ Rarely does this Court hear cases involving only an intracircuit conflict created by different panels of judges deciding the same matter in different, and conflicting, ways. In denying petitions based on intracircuit conflicts, this Court * This is obvious because no specific measurements, relating to the portable body, were provided, which precludes reaching a determination that any precise proportions are involved. Moreover, the portable body, as it is described in the limitation, must relate to something. That something is the hand of a human such as a hand grasping a pistol grip 10 in Fig. 2. Furthermore, there exists an abundance of evidence, offered by Neutrino’s experts, supporting the fact that the disclosure in the drawing (Fig. 2) reasonably conveys to one skilled in the art that the claim limitation at issue finds support in the drawing. 12 has explained that such conflicts should be resolved by the court of appeals in which the conflict arose. See Wisniewski, 353 U.S. at 902. This is accomplished through en banc review. See Fed. R. App. P. 35(a)(1) (explaining that “[a]n en banc hearing or rehearing is not favored and ordinarily will not be ordered unless ... en banc consideration is necessary to secure Or maintain uniformity of the court’s decisions”). As discussed in Part VI.B., below, there is another reason for granting the writ aside from the intracircuit conflict issue. Nevertheless, even if the intracircuit conflict was the only argued basis for granting the writ, the Court should still grant it because the reasoning behind the Court's denial of petitions for writ based upon intracircuit conflicts is inapposite to the present scenario. This is because the foundation upon which that reasoning has been based is, in the instant case, on less than solid ground due to the Federal Circuit’s denial of Neutrino’s Petition for Rehearing and Suggestion for Rehearing En Banc. It is also worth mentioning that this Court granted certiorari to hear the case of Markman vy. Westview Instruments, Inc., 52 F.3d 967 (Fed. Cir. 1995), despite the fact that that case had already been decided by the Federal Circuit while sitting en banc. See Markman v. Westview Instruments, Inc., 517 U.S. 370 (1996). Prior to the Federal Circuit’s en banc decision, there was an apparent conflict between different Federal Circuit decisions relating to the same matter (claim construction). See Markman, 52 F.3d at 976 (“The opinions of this court have contained some inconsistent statements as to whether and to what extent claim construction is a legal or factual issue, or a mixed issue.”’). Although this conflict was resolved through the en banc rehearing of the case, this Court still granted certiorari. This is further support for the argument that the Court should grant 4 13 certiorari in the instant action because the conflict at issue was not resolved by the Federal Circuit. Neutrino diligently pursued every option available to it in attempting to convince the Federal Circuit that a conflict existed between binding Federal Circuit precedent, and this diligence is evidenced by the arguments presented by Neutrino in its petition for rehearing. Yet the Federal Circuit refused to address the conflict, thereby failing to adhere to the doctrine of stare decisis. To put it another way, the system failed, and it is desperately in need of repair by this Court because the conflict will not be resolved by the Federal Circuit. Therefore, the newly created conflict regarding whether patent drawings may be relied upon to support claim limitations should be resolved by this Court, especially after considering that the Federal Circuit was presented with an opportunity to resolve it, but refused to do so. B. This Court Should Settle the Issue of Whether, and to What Extent, Patent Drawings May Be Relied Upon The United States Supreme Court has never directly addressed the issue presented, and it is imperative that the Court now resolve whether, and in what instances, patent drawings alone may be relied upon to support claim limitations. This issue directly affects two of the most fundamental federal statutes relating to the law of patents: (1) 35 U.S.C. § 112; and (2) 35 U.S.C. § 132. One of these statutes, § 112, requires a written description of the invention to be patented, and without such a written description, no . patent will issue. The other, § 132, prohibits new matter from 14 being added by amendment into the disclosure of the invention. If either of these statutes are ignored or construed too liberally—either by a patentee, the United States Patent and Trademark Office, or a court—then an overabundance of patents will issue, many of which will likely be declared invalid, with the end result being a complete waste of judicial resources. On the opposite end of the spectrum, if the statutes are applied in an aggressively rigid fashion, there will be a dearth of patents because many inventions deserving of a patent will go unpatented, and many deservingly valid patents will be invalidated. As the issue now stands, based upon the Federal Circuit’s affirmance of the district court’s published opinion, a patentee is likely° precluded—regardless of the circumstances—from ever relying upon drawings alone to find support for claim limitations. This places patent law in the latter situation described above. Such a result is inimical to the patent system, not to mention that it practically renders meaningless a federal statute—35 U.S.C. § 113, which requires drawings. See 35 U.S.C. § 113 (2001) The applicant shall furnish a drawing where necessary for the understanding of the subject matter sought to be patented.... Drawings submitted after the filing date of the application may not be used (1) to overcome any insufficiency of the specification due to lack of an enabling disclosure or otherwise inadequate disclosure therein, or (ii) to supplement the original * The word “likely” is employed because the law relating to this issue is altogether ambiguous due to the conflict discussed in Part VI.A. of this petition. 15 disclosure thereof for the purpose of interpretation of the scope of any claim. (Emphasis added). Whether a patentee may rely upon patent drawings to support claim limitations affects the very corpus of patent law, and such an important issue should be decided by this Court to bring clarity and consistency to the law. For as it currently exists, it is entirely unclear whether a patentee may rely upon patent drawings to support claim limitations. VII. CONCLUSION For the foregoing reasons, the petition for a writ of certiorari should be granted. Respectfully submitted, Scott D. Marrs BEIRNE, MayNARD & Parsons, L.L.P. 1300 Post Oak Boulevard Suite 2500 Houston, Texas 77056 (713) 623-0887 Counsel for Petitioner APPENDIX la APPENDIX A — JUDGMENT OF THE UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT DATED AND FILED DECEMBER 8, 2006 UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT No. 2006-1316 NEUTRINO DEVELOPMENT CORPORATION, Plaintiff/Counterclaim Defendant- Appellant, and RICHARD T. REDANO, Counterclaim Defendant, v. SONOSITE, INC., Defendant/Counterclaimant- Appellee. JUDGMENT ON APPEAL from the UNITED STATES DISTRICTCOURT. SOUTHERN DISTRICT OF TEXAS In CASE NO(S). 01-CV-2484 This CAUSE having been heard and considered, it is ORDERED and ADJUDGED: 2a Appendix A Per Curiam: (MAYER and PROST, Circuit Judges, WHYTE, District Judge*): AFFIRMED. See Fed. Cir. R. 36. ENTERED BY ORDER OF THE COURT s/ Jan Horbaly Jan Horbaly, Clerk DATED DEC -8 2006 * Honorable Ronald M. Whyte, United States District Court for the Northern District of California, sitting by designation. 3a APPENDIX B — MEMORANDUM AND ORDER OF THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF TEXAS, HOUSTON DIVISION DATED MARCH 21, 2006 UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF ‘TEXAS HOUSTON DIVISION CIVIL ACTION NO. H-01-2484 NEUTRINO DEVELOPMENT CORPORATION, Plaintiff, ¥. SONOSITE, INC., Defendant. MEMORANDUM AND ORDER Pending before the Court is Defendant’s Motion for Summary Judgment of Invalidity Based on New Matter (Dkt.# 279). The Court, after reviewing the motion, the responses of the parties and the relevant law, is of the opinion that the motion should be GRANTED. Factual and Procedural Background This is an action for patent infringement brought by Neutrino Development Corporation (“Neutrino”) against Sonosite, Inc. (“Sonosite”). Neutrino is the owner of United 4a Appendix B States Patent No. 6,221,021 (“the ‘021 patent’). Neutrino alleges that four devices manufactured and marketed by Sonosite, the Sonosite 180, SonoHeart, Sonosite 180 PLUS, and the SonoHeart PLUS, infringe on the ‘021 patent. The ‘021 patent application was filed on May 30, 1999, and claimed priority to an earlier patent application, Application Serial No. 08/926, 209, filed on September 9, 1997, which was issued as U.S. Patent No. 5,947,901 (‘‘the ‘901 patent application” and the “ ‘901 patent,” respectively). The ‘021 patent application, entitled “Method and Apparatus for Penile Hemodynamic Stimulation, Monitoring, and Drug Delivery Acceleration,” described a device for “stimulating and/or monitoring hemodynamic activity, such as blood flow, in a penis.” U.S. Patent No. 6,221,021] at col. 1, ll. 15-16. On February 4, 2000, the U.S. Patent & Trade Office (“PTO”) rejected all of the claims in the original ‘021 Patent Application. In May 2000, Redano amended the pending ‘021 patent application. Part of that amendment became the claims of the ‘021 patent, which was issued on April 24, 2001. Defendant Sonosite began as a division of ATL Ultrasound, Inc., and was spun off as a public company in April 1998. Sonosite unveiled its first public product in the realm of hand-carried ultrasound devices, the Sonasite 180, on May 17, 1999. Sonosite began selling the device in June 1999. In January 2000, Sonosite launched its second product, the SonoHeart. In April 2001, Sonosite launched a new generation of these two devices with its introduction of the SonoSite 180 PLUS and the SonoHeart PLUS. Sa Appendix B On July 24, 2001, Neutrino filed this action, alleging that Sonosite had illegally used Redano’s invention and infringed the ‘021 patent. Sonosite answered the complaint on August 14, 2001, asserting that the ‘021 patent claims are not infringed and are invalid, and counterclaimed for declaratory judgment of non-infringement and invalidity. On February 20, 2002, after extensive briefing, the Court held a one-day Markman hearing on claim construction. On October 9, 2002, the Court stayed all proceedings pending the Court’s Markman and summary judgment rulings. The Court issued its claim construction on August 21, 2003. Subsequently, the Court granted Neutrino’s Motion for Summary Judgment on Infringement (Dkt. # 136) finding that Sonosite’s devices literally infringed the ‘021 patent and that the reverse doctrine of equivalents was not applicable (Dkt.# 162). Summary Judgment Standard Summary judgment is proper if “the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is-no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law.” Fed. R. Civ. P. 56(c); see also Christopher Village, LP v. Retsinas, 190 F.3d 310, 314 (Sth Cir.1999). “For any matter on which the non-movant would bear the burden of proof at trial... , the movant may merely point to the absence of evidence and thereby shift to the non-movant the burden of demonstrating by competent summary judgment proof that there is an issue of material fact warranting trial.” Transamerica Ins. Co. v. 6a Appendix B Avenell, 66 F.3d 715, 718-19 (Sth Cir.1995); see also Celotex Corp. v. Catrett, 477 U.S. 317, 323-25, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). To prevent summary judgment, the non- movant must “respond by setting forth specific facts” that indicate a genuine issue of material fact. Rushing v. Kansas City S. Ry. Co., 185 F.3d 496, 505 (Sth Cir.1999). When considering a motion for summary judgment, the Court must view the evidence in the light most favorable to the non-movant and draw all reasonable inferences in favor of the non-movant. See Samuel v. Holmes, 138 F.3d 173, 176 (Sth Cir.1998); Texas v. Thompson, 70 F.3d 390, 392 (Sth Cir. 1995). “The court may not undertake to evaluate the credibility of the witnesses, weigh the evidence, or resolve factual disputes; so long as the evidence in the record is such that a reasonable jury drawing all inferences in favor of the nonmoving party could arrive at a verdict in that party’s favor, the court must deny the motion.” /nt’l Shortstop, Inc. v. Rally’s, Inc., 939 F.2d 1257, 1263 (Sth Cir.1991). However, the non-movant cannot avoid summary judgment by presenting only “conclusory allegations,” or “unsubstantiated assertions,” such as the bare allegations of a complaint, but must present sufficient evidence, such as sworn testimony in a deposition or affidavit, to create a genuine issue of material fact as to the claim asserted. Little v. Liquid Air Corp., 37 F.3d 1069, 1075 (Sth Cir. 1994) (en banc). Patent cases are as amenable to summary judgment as any other case when no genuine issue of material fact exists and the movant is entitled to judgment as a matter of law. See Warner- Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 17, 39, 117 S.Ct. 1040, 137 L.Ed.2d 146 (1997); Johnston v. IVAC Corp., 885 F.2d 1574, 1576-77 (Fed.Cir.1989); SRI Int’l v. Matsushita Elec. Corp. of Am., 775 F.2d 1107, 1116 (Fed.Cir.1985). Ta Appendix B However, a court should apply a somewhat more exacting scrutiny to a motion for summary judgment based on invalidity because there is a statutory presumption that an issued patent is valid. This presumption “is based in part on the expertise of patent examiners presumed to have done their jobs.” Brooktree Corp. v. Adv. Micro Devices, Inc., 977 F.2d 1555, 1574 (Fed.Cir.1992). The Federal Circuit has held that “ ‘the fact that the Patent Office allows ... an amendment without objection thereto as new matter (within the meaning of Title 35 U.S.C. § 132) is entitled to an especially weighty presumption of correctness.’ ” Jd. (quoting In re Smythe, 480 F.2d 1376, 1385 n. 5 (Cust. & Pat.App.1973)). The Court has taken this strong ‘presumption into due consideration. Analysis The new matter prohibition of 35 U.S.C. § 132 “serves to ensure that the patent applicant was in full possession of the claimed subject matter on the application filing date.” TurboCare Division of Demag Delaval Turbomachinery Corp. v. General Elec. Co., 264 F.3d 1111, 1118 (Fed.Cir. 2001). The relevant portion of § 132(a) reads, “[nJo amendment shall introduce new matter into the disclosure of the invention.”” When an applicant amends the specification and/or claims after the original filing date, as Richard Redano did in this case, “the new claims or other added material must find support in the original specification.” /d. (citing Schering Corp. v. Amgen Inc., 222 F.3d 1347, 1352 (Fed.Cir.2000)). The relevant inquiry is whether one of ordinary skill in the art would have determined from the original application that the applicant was in possession of the amended subject matter at the time of the original application filing date. Ralston Purina Co. v. Far-Mar-Co, Inc., 772 F.2d 1570, 1575 (Fed.Cir.1985). In simpler terms, an amendment 8a Appendix B may only clarify, not change, the written description in the original patent application. Sonosite contends that the claims of the ‘021 patent that are the subject of this lawsuit ' are invalid because the hand- held size of the ultrasonography generator was “new matter” under § 132 introduced through amendments to the specifications and claims of the ‘021 patent application. Sonosite contends that the amendments specifying that the ultrasonography generator is sized to be hand-held found support neither explicitly nor inherently in the original patent application. Neutrino argues in response that (1) the diagrams in the original patent application indicate by proportion that the ultrasonography generator would be sized small enough to be hand-held, and (2) a genuine issue of material fact exists as to whether a person of ordinary skill in the art would have readily understood U.S. Pat. No. 5,578,060 (“Pohl patent”), incorporated by reference into the ‘021 patent application, to describe a hand-held ultrasonography generator. The Court will consider each of these arguments below. Neutrino contends that the hand-held size of the ultrasonography generator was disclosed inherently in the original application. The Federal Circuit has held that “[{iJn order for a disclosure to be inherent, ‘the missing descriptive matter must necessarily be present in the [original] application’s specification such that one skilled in the art would recognize such a disclosure.” TurboCare , 264 F.3d at 1119 (quoting Tronzo v. Biomet, Inc., 156 F.3d 1154, 1159 (Fed.Cir.1998)). Neutrino 1. Neutrino has asserted that Sonosite is infringing claims 8-14 and 20-27. See Dkt. # 75, p. 4. Of those, claims 8, 11-13, 20, 21, 23-27 include (directly or by reference) the amended language indicating that the ultrasonography generator is sized to be hand-held. 9a Appendix B argues that the proportions implied by the diagrams in the original application and in the Pohl patent necessarily lead one of ordinary skill in the art to conclude that the ultrasonography generator was intended to be small enough to be hand-held. In response, Sonosite argues that the possibility that the ultrasonography generator depicted in the diagrams and disclosed in the Pohl patent could be sized to be hand-held is not sufficient to qualify as inherent disclosure. Based on the analysis adopted by the Federal Circuit, the Court agrees with Sonosite that one of ordinary skill in the art must conclude that the diagrams and/or the Pohl patent necessarily disclose a hand- held ultrasonography generator. TurboCare, 264 F.3d at 1119. The conclusion that the diagrams or Pohl patent might disclose a hand-held ultrasonography generator is insufficient to stand as inherent support for an application amendment. To survive this motion for summary judgment, the diagrams must unequivocally depict an ultrasonography generator sized to be hand-held and/or the Pohl patent must explicitly disclose an ultrasonography generator that is sized to be hand-held. In the following paragraphs, the Court will review the specification diagrams and the Pohl patent to determine whether any reasonable jury could determine that a person of ordinary skill in the art of designing, testing, and building medical ultrasound devices could conclude that the diagrams and/or patent incorporated by reference necessarily disclose a hand-held ultrasonography generator. 1. Patent Application Diagrams Sonosite argues that the dravings in the original ‘021 patent application do not disclose the size of the ultrasonography generator because (1) patent drawings cannot be relied upon to show particular sizes where the specification 10a Appendix B is silent on the issue of size, and (2) the proportions loosely depicted in the drawings, if taken literally, would produce an untenable result. Neutrino objects to the applicability of the cases cited by Sonosite for the proposition that drawings cannot establish sizes on the grounds that these cases do not preclude reliance on drawings to show general proportions as opposed to specific dimensions. Neutrino contends that the original specification explicitly discloses a hand-held transducer housing (a fact that Sonosite does not dispute) and the drawings show the proportionate size of each component of the claimed invention in relation to the transducer housing. In Figure 2, reproduced below, the ultrasound generator and the ultrasonography generator are smaller than the hand-held transducer housing.’ Om) Q” 2. Unit 32 of Figure 2 depicts the ultrasonography generator. The component comprised of units 10, 18, and 24 represents the hand-held transducer housing. lla Appendix B Neutrino contends that one of ordinary skill in the art would understand from this drawing that the ultrasonography generator is proportionately smaller than the hand-held transducer housing and, therefore, is itself sized to be hand- held. However, Figure 2 contains neither a scale nor dimensions and under well-established Federal Circuit precedent, “patent drawings do not define the precise proportions of the elements and may not be relied upon to show particular sizes if the specification is completely silent on the issue.” Hockerson-Halberstadt, Inc. v. Avia Grp. Int'l, 222 F.3d 951, 956 (Fed.Cir.2000). Neutrino argues that Hockerson-Halberstadt and other similar cases do not apply to depictions of general proportions and “relative size.’’? Neutrino also argues that the ‘021 patent application specification was not “completely silent” on the issue of relative size because it incorporated the Pohl patent by reference. The Court rejects the latter argument on the grounds that the requirement that the specification not be “completely silent” on the issue of size in order to imply size in a drawing necessitates an explicit disclosure in the specification, not an implicit disclosure such as another patent incorporated by reference. To that end, the Pohl patent also lacks any explicit reference to the size of the ultrasonography generator. The implication of size within another patent incorporated by reference is insufficient to support contentions about the relative size of components depicted in an unspecific drawing. No reasonable jury could determine that a person of ordinary skill in the art would have readily recognized the size (specific or relative) of the ultrasonography generator from the drawings in the ‘021 patent. 3. Dkt. # 292, p. 9. 12a Appendix B Furthermore, the Court does not believe that the Federal Circuit in Hockerson-Halberstadt intended for “precise proportions” to carry a meaning distinct from “relative size.” The issue on appeal in Hockerson-Halberstadt was “whether the district court correctly construed the term ‘central longitudinal groove to require that the width of the groove’ must be less than the combined width of the fins.” Hockerson- Halberstadt, 222 F.3d at 954. The defendant in Hockerson- Halberstadt made the argument that statements submitted by the inventor during the prosecution about the width of the groove conflicted with the drawings in the specification of the original patent application and, therefore, the conflicting prosecution history should not be used to construe the claims. The Federal Circuit rejected the defendant’s argument on the grounds that the patent “is devoid of any indication that the proportions of the groove and fins are drawn to scale.” Id. at 956 (emphasis added). The Federal Circuit determined that the drawings could not be relied upon to establish the size of the groove relative to the fins. Ultimately, the Federal Circuit held that “a reasonable competitor, being aware that figures in a patent are not drawn to scale unless otherwise indicated, would” have accepted the specific statements about size in the prosecution history.’ 4. The Court notes that Hockerson-Halberstadt was about claim construction, not the issue of “new matter.” As in the present case, the district court in Hockerson-Halberstadt would not have evaluated the propriety of the amended language under § 132 while issuing the claim construction. The process of claim construction assumes the validity of the issued patent. The defendant in Hockersen- Halberstadt made the argument that a particular claim should be interpreted in light of the apparent proportions in the specification drawings. Because specific language in the prosecution history (Cont'd) 13a Appendix B The Court finds that it was precisely the sort of argument that Neutrino attempts to advance here that the Federal Circuit sought to preclude in Hockerson-Halberstadt. Put simply, the Federal Circuit prohibits reliance upon unspecific drawings to support claim limitations.° Therefore, the Court finds that no reasonable juror could conclude that a person of ordinary skill in the art would have relied upon the relative sizes depicted in the specification drawings of the original ‘021 patent application to determine the size of the ultrasonography generator. 2. The Pohl Patent Sonosite contends that the Pohl patent does not disclose an ultrasonography generator sized to be hand-held on the grounds that (1) the Pohl patent does not disclose an ultrasonography generator at all, and (2) even if unit 14 depicted in Figure | of the Pohl patent can be treated as an (Cont’d) explained the relative size of the groove, the court’s analysis pittea the prosecution disclaimer against the drawings. However, had there been no statements about relative size in the prosecution history, the plaintiff still would not have been able to rely on the specification drawings to establish relative size. The outcome in this alternative scenario would have been a claim construction without any specification about size. 5. Because the drawings in the original patent application cannot support the amendment pertaining to the hand-held size of the ultrasonography generator, it is not necessary to explore whether the proportions offered by Neutrino are so factually untenable as to warrant summary judgment. The Court does, however, note that the relative sizes depicted in Figure 2, if taken literally, would suggest an ultrasonography generator not merely hand-held, but small enough to fit in the palm of one’s hand. l4a Appendix B equivalent of the ultrasonography generator in the ‘021 patent, the device disclosed in the Pohl patent is not necessarily sized to be hand-held. The Court will address the latter argument first because it is dispositive. The component identified in the Pohl patent as analogous to the ultrasonography generator in the ‘021 patent is depicted as unit 14 in Figure 1 of the Pohl patent. The Pohl patent states that Figure | depicts “a relatively large physical therapy ~ apparatus.”® However, the description also states that the preferred embodiment depicted in Figure | could “be much smaller so as to be portable without departing from the spirit and scope of the present invention.”’ If a device sized small enough to be portable falls within the scope of the Pohl patent, it follows that unit 14, which is a component of the device, can potentially be sized small enough to be portable without broadening the scope of the patent. As an initial matter, Sonosite argues that being sized to be “portable” is not equivalent to being sized to be hand-held. Sonosite contends that portable could mean “capable of being moved from place to place” on a cart.* However, even if the Court accepts that a person of ordinary skill in the art would understand that unit 14 is equivalent to the ultrasonography generator in the ‘021 patent and that “portable” can include a size small enough to be hand-held, the Pohl patent still fails to disclose a hand-held ultrasonography generator sufficient to inherently support that limitation as an amendment to the original ‘021 patent application. The Federal Circuit has specified that 6. Dkt. # 279, Exhibit 1] (Poh) patent). 7. Id. 8. Dkt. # 279, p. 12. , 15a Appendix B “(t]he missing descriptive matter must necessarily be present in the [original] application’s specification such that one skilled in the art would recognize such a disclosure.” TurboCare, 264 F.3d at 1119 (emphasis added). The possibility that a variant of the device depicted in Figure | could be sized “much smailer” so as to be “portable” cannot support the conclusion that unit 14 in Figure 1 is necessarily hand-held. The Federal Circuit has been instructive on this point: It is true that the specification “does not have to provide in haec verba support for the claimed subject matter at issue.” Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1323 (Fed.Cir.2000) (citing Fujikawa v. Wattanasin, 93 F.3d 1559, 1570 (Fed.Cir.1996)). Nonetheless, the disclosure must clearly convey to one skilled in the art that the inventor was in possession of the invention. “Put another way, one skilled in the art, reading the ... disclosure, must immediately discern the limitation at issue in the claims.” /d. (citing Waldemar Link, GmbH & Co. v. Osteonics Corp., 32 F.3d 556, 558 (Fed.Cir.1994)) (emphasis added). Immediacy is important because it guarantees that the insight belongs to the author of the specification and appears at once to the intelligent and educated reader. It is a different matter, however, if the language of the specification triggers an insight that belongs to the reader, who, having thought about the extent of what was actually disclosed by the specification, concludes, “This also could be done l6a Appendix B another way.” In that circumstance, the reader is conceiving of an “obvious variant” of what is actually described, and that is not enough to satisfy the written description requirement. See Lockwood, 107 F.3d at 1572. The Court finds that sizing unit 14 to be hand-held (as opposed to more generally “portable’) qualifies as “an obvious variant” of the explicit disclosures in the specifications of the Pohl patent. An “obvious variant” of a patent incorporated by reference cannot provide support for an application amendment. To allow so many possible permutations of a given device to fall under the umbrella of inherent support would undermine the purpose of the written description requirement. Therefore, the Court finds that no reasonable juror could conclude that the Pohl patent provides support for the amendments made to the ‘021 patent application. 17a Appendix B Conclusion The Court finds that the claims covering the improperly amended subject matter outlined above are invalid for new matter. Therefore, Defendant’s Motion for Summary Judgment of Invalidity Based on New Matter (Dkt # 279) is GRANTED. Accordingly, all remaining motions are denied as moot. Furthermore, the finding that independent claims 8, 20, and 25 are invalid for new matter compels the Court to reverse claim construction (b) in its Markman Order (Dkt.# 125) and consequently to reverse the finding of literal infringement in the Court’s Order of September 29, 2004 (Dkt.# 162). Because Plaintiff's claims of infringement under 35 U.S.C. § 271(a) and (b) rely upon the inclusion of the invalid claims, the Court is also of the opinion that Plaintiff’s claims for direct infringement and inducing infringement should be DISMISSED with prejudice. It is so ORDERED. A final judgment shall be issued separately. Signed this 21st day of March, 2006. s/ John D. Rainey JOHN D. RAINEY UNITED STATES DISTRICT JUDGE 18a APPENDIX C — MEMORANDUM AND ORDER OF THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF TEXAS, HOUSTON DIVISION DATED SEPTEMBER 30, 2004 (Re: Plaintiff's Motion for Summary Judgment on Infringement) UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF TEXAS HOUSTON DIVISION No. CIV.A.H-01-2484 NEUTRINO DEVELOPMENT CORPORATION, Plaintiff, v. SONOSITE, INC., Defendant. Sept. 30, 2004. MEMORANDUM AND ORDER RAINEY, District Judge. Pending before the Court is Plaintiff's Motion for Summary Judgment on Infringement (Dkt.# 136). The Court, after reviewing the motion, the responses of the parties and the relevant law, is of the opinion that the motion should be GRANTED. 19a Appendix C Factual and Procedural Background This is an action for patent infringement brought by Neutrino Development Corporation (“Neutrino”) against Sonosite, Inc. (“Sonosite”). Neutrino is the owner of United States Patent No. 6,221,021 (“the ‘021 patent”). Neutrino alleges that four devices manufactured and marketed by Sonosite, the Sonosite 180, SonoHeart, Sonosite 180 PLUS, and the SonoHeart PLUS, infringe on the ‘021 patent. Richard T. Redano applied for a patent on the device in question on September 9, 1997. (Application Serial No. 08/ 926, 209).' The ‘021 patent, entitled “Method and Apparatus for Penile Hemodynamic Stimulation, Monitoring, and Drug Delivery Acceleration,” resulted from that application. It describes a device for “stimulating and/or monitoring hemodynamic activity, such as blood flow, in a penis.” U.S. Patent No. 6,221,021 at col. 1, ll. 15-16. Defendant Sonosite began as a division of ATL Ultrasound, Inc., and was spun off as a public company in April 1998. Sonosite unveiled its first public product in the realm of hand-carried ultrasound devices, the Sonosite 180, on May 17, 1999. Sonosite began selling the device in June 1999. In January 2000, Sonosite launched its second product, the SonoHeart. In April 2001, Sonosite launched a new generation of these two devices with its introduction of the SonoSite 180 PLUS and the SonoHeart PLUS. 1. On May 20, 1999, Redano field a continuation in patent application, serial No. 09/315,867 which eventually issued as the ‘021 patent. In May 2000, Redano amended the pending ‘021 Patent Application to broaden its disclosure and expand the claims. The ‘021 patent was issued on April 24, 2001. 20a Appendix C On July 24, 2001, Neutrino filed this action, alleging that Sonosite had illegally used Redano’s invention and infringed the ‘021 patent. Sonosite answered the complaint on August 14, 2001, asserting that the ‘021 patent claims are not infringed and are invalid, and counterclaimed for declaratory judgment of non-infringement and invalidity. On February 20, 2002, after extensive briefing, the Court held a one-day Markman hearing on claim construction. On October 9, 2002, the Court stayed all proceedings pending the Court’s Markman and summary judgment rulings. The Court issued its claim construction on August 21, 2003. This motion for summary judgment was filed as a result of the Court’s claim construction. Summary Judgment Standard Summary judgment is proper if “the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law.” Fed. R. Civ. P. 56(c); see also Christopher Village, LP v. Retsinas, 190 F.3d 310, 314 (Sth Cir.1999). “For any matter on which the non-movant would bear the burden of proof at trial... , the movant may merely point to the absence of evidence and thereby shift to the non-movant the burden of demonstrating by competent summary judgment proof that there is an issue of material fact warranting trial.” Transamerica Ins. Co. v. Avenell, 66 F.3d 715, 718-19 (Sth Cir. 1995); see also Celotex Corp. v. Catrett, 477 U.S. 317, 323-25, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). To prevent summary judgment, the non- 2la Appendix C movant must “respond by setting forth specific facts” that indicate a genuine issue of material fact. Rushing v. Kansas City S. Ry. Co., 185 F.3d 496, 505 (Sth Cir.1999). When considering a motion for summary judgment, the Court must view. the evidence in the light most favorable to the non-movant and draw all reasonable inferences in favor of the non-movant. See Samuel v. Holmes, 138 F.3d 173, 176 (Sth Cir.1998); Texas v. Thompson, 70 F.3d 390, 392 (Sth Cir. 1995). “The court may not undertake to evaluate the credibility of the witnesses, weigh the evidence, or resolve factual disputes; so long as the evidence in the record is such that a reasonable jury drawing all inferences in favor of the nonmoving party could arrive at a verdict in that party’s favor, the court must deny the motion.” Int’! Shortstop, Inc. v. Rally’s, Inc., 939 F.2d 1257, 1263 (Sth Cir.1991). However, the non-movant cannot avoid summary judgment by presenting only “conclusory allegations,” or “unsubstantiated assertions,” such as the bars allegations of a complaint, but must present sufficient evidence, such as sworn testimony in a deposition or affidavit, to create a genuine issue of material fact as to the claim asserted. Little v. Liquid Air Corp., 37 F.3d 1069, 1075 (Sth Cir. 1994) (en banc). Patent cases are amenable to summary judgment as any other case when no genuine issue of material fact exists and the movant is entitled to judgment as a matter of law. See Warner-Jenkinson Co. v. Hilton Davis Chem. Co., 520 US. 17, 39, 117 S.Ct. 1040, 137 L.Ed.2d 146 (1997); Johnston v. IVAC Corp., 885 F.2d 1574, 1576-77 (Fed.Cir.1989); SRI Int’l v. Matsushita Elec. Corp. of Am., 775 F.2d 1107, 1116 (Fed.Cir. 1985). 22a Appendix C Analysis Plaintiff Neutrino argues that Defendant’s Sonosite 180, SonoHeart, Sonosite 180 PLUS and SonoHeart PLUS read on every claim in the ‘021 patent, thereby establishing literal infringement. In response, Sonosite argues that the patent is not infringed under the “reverse doctrine of equivalents.” Sonosite’s argument centers on the idea that the accused devices are substantially different from the devices described in the original patent application. Sonosite supports this argument by asserting that the valid scope of the invention must be determined in accordance with the principles of 35 U.S.C. § 112 before the doctrine of equivalents can be applied. As stated by the Federal Circuit in SR/ International, and clarified by that court in 7Jexas Instruments, Inc. v. U.S. Int’l Trade Comm'n, 846 F.2d 1369, 1372 (Fed.Cir. 1988), before the reverse doctrine of equivalents can be applied, there must be a finding of literal infringement. Sonosite has offered no evidence to suggest that the devices in question do not infringe the patent. Rather, Sonosite argues that a fact issue exists as to whether the accused devices are so far changed from the invention at suit that the reverse doctrine of equivalents applies. See Sonosite’s Response to the Motion for Summary Judgment on Infringement, page 14. Thus it appears to the Court that Sonosite is conceding the issue of infringement by its argument in favor of the application of the reverse doctrine of equivalents. However, Neutrino still bears the burden of proving that the accused devices infringe on the patents. 23a Appendix C Infringement The determination of patent infringement is a question of fact. Karlin Tech., Inc. v. Surgical Dynamics, Inc., 177 F.3d 968, 974 (Fed.Cir.1999). With that in mind, the court must approach a summary judgment motion on the issue of infringement cautiously. See SRI Int'l, 775 F.2d at 1116. “Summary judgment is appropriate when it is apparent that only one conclusion as to infringement could be reached by a reasonable jury.” TechSearch, L.L.C. v. Intel Corp., 286 F.3d 1360, 1369 (Fed.Cir.2002). Infringement analysis is a two-step process. Seal-Flex, Inc. v. Athletic Track & Court Constr., 172 F.3d 836, 842 (Fed.Cir.1999); Markman v. Westview Instruments, Inc., 52 F.3d 967, 976 (Fed.Cir. 1995), aff’d, 517 U.S. 370, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996). First, the claims in question must be construed as a matter of law; and second, the properly construed claims must be compared to the accused device or process. Markman, 52 F.3d at 976. In a previous order, the Court construed the claims as follows: 1. “A transducer mounting assembly moveably connected to said body such that the distance between said assembly and said body can be adjusted by a user using only one hand”—-An assembly sized to contain at least one ultrasound emitter or transducer, which is connected to the portable body such that a user of the apparatus can cause a change in the distance between the transducer mounting assembly and the portable body, using only one hand. 24a Appendix C 2. “A portable body sized to be hand held”—A body that is sized such that it can be held by hand and, so held, moved from one location to another. 3. “Ultrasound emitter”——At least one component, also known as a “transducer” or “emitter,” and capable of emitting ultrasound energy.’ Therefore, the Court proceeds to the second step in the infringement analysis: comparing the claim, as construed by the Court, with the accused device. Infringement means that the accused device or process contains, either literally or under the doctrine of equivalents, “every limitation of the properly construed claim.” Seal-Flex, 172 F.3d at 842. Literal infringement exists when the accused device embodies each claim limitation precisely. Kraft Foods, Inc. v. Int'l Trading Co., 203 F.3d 1362, 1370 (Fed.Cir.2000). If even one component of the claim is not found in the accused device exactly as recited in the claim, the claim does not “read on” the accused device and there can be no literal infringement. See Pennwalt Corp. v. Durand-Wayland, Inc., 833 F.2d 931 (Fed.Cir. 1987). Infringement under the doctrine of equivalents requires that the accused product contain each limitation of the claim or its equivalent. See Warner- Jenkinson, 520 U.S. at 40, 117 S.Ct. 1040. “A claim element is equivalently present in an accused device if only 2. The Court held that the following terms did not need to be interpreted because they were unambiguous: 1) “mounicd in,” “mounted on,” “housed within,” and “top surface;” 2) “portable body comprising a top surface;” 3) “connected to” and “coupled to;” 4) “generating an instruction;” and 5) “display.” 25a Appendix C ‘insubstantial differences’ distinguish the missing claim element from the corresponding aspects of the accused device.” Sage Prods., Inc. v. Devon Indus., 126 F.3d 1420, 1423 (Fed.Cir. 1997). “Whether a component in the accused subject matter performs substantially the same function as the claimed limitation in substantially the samc way to achieve substantially the same result may be relevant to this determination.” Ethicon Endo-Surgery, Inc. v. U.S. Surgical Corp., 149 F.3d 1309, 1315 (Fed.Cir.1998). Neutrino argues that the devices produced by Sonosite literally infringe on each of the patent claims. As support for this contention, Neutrino offers the testimony, in declaration form, of Richard Redano, the inventor of the ‘021 patent. In his declaration, Mr. Redano compares every element of the asserted claims of the ‘021 patent, as construed by the Court, to the Sonosite 180, Sonosite 180 PLUS, SonoHeart, and SonoHeart PLUS devices and concludes that every element is literally embodied in those devices. Mr. Redano’s declaration sets out in detail how each of the claims is infringed by the Sonosite devices. His declaration specifically references which portion of the Sonosite devices pertain to each claim. For example, with regard to the “portable body sized to be hand held” requirement, Mr. Redano, referencing pictures of the Sonosite devices produced in discovery, that “page P0216 and page P0240 the body is shown grasped in a user’s hand. The body is sized such that it can be held by hand. . .” See Declaration of Richard Redano, attached as Exhibit A to Neutrino’s Motion for Summary Judgment on Infringement, para. 15. 26a Appendix C Sonosite offers no evidence to contradict the testimony of Mr. Redano. Rather, Sonosite argues that the reverse doctrine of equivalents should apply in this case. The Reverse Doctrine of Equivalents The reverse doctrine of equivalents states that the doctrine may be used to restrict a claim and thus defeat a patentee’s action for infringement where a device is “so far changed in principle from a patented article that it performs the same or similar function in a substantially different way, but nevertheless falls within the literal words of the claim.” Graver Tank & Mfg. v. Linde Air Prods. Co., 339 U.S. 605, 608-09, 70 S.Ct. 854, 94 L.Ed. 1097 (1950). The Federal Circuit, sitting en banc, phrased the inquiry as a single question in SRI International vy. Matsushita Electric Corporation, stating that the reverse doctrine of equivalents...raises a fact question, determinable on inquiry into whether a product has been so far changed in principle that it performs the same or similar function in a substantially different way. 775 F.2d 1107, 1124 (Fed.Cir.1985) (en banc). The Federal Circuit went on to say that though this inquiry differs from the inquiry under the doctrine of equivalents because literal infringement is inherently present in a reverse doctrine of equivalents case, it is nonetheless directed to a fact issue. Jd. Therefore, when a patentee establishes literal infringement, “the accused infringer may 27a Appendix C undertake the burden of going forward to establish the fact of non-infringement under the doctrine of reverse equivalents. If the accused infringer makes a prima facie case, the patentee, who retains the burden of persuasion on infringement, must rebut that prima facie case.” Id. Sonosite’s argument centers on the idea that the accused devices are substantially different from the devices described in the original patent application. Sonosite supports this argument by asserting that the valid scope of the invention must be determined in accordance with the principles of 35 U.S.C. § 112 before the doctrine of equivalents can be applied. Sonosite furthers its contention by asserting that the enablement and the written description requirements of § 112 do not support a finding that the claimed invention enables or adequately describes a hand-held device. Rather, Sonosite asserts that a person skilled in the art of ultrasound would interpret the contents of the patent application, and the specifications contained therein, as describing a hand- held device that would connect to a standard ultrasound imaging system that is separate and distinct from the hand- held housing, and not an ultrasonography generator that would fit in a hand-held enclosure. The Court, however, has already construed the claims of the patent to include a “body that is sized such that it can be held by hand . . .” The claim construction also indicates that the ultrasonography generator would be “mounted in said body.” Additionally, the Federal Circuit made it clear in SRI International that the relevant test was whether the accused product was so far changed in principle that it performs the function of the claimed invention in a 28a Appendix C substantially different way, not whether the accused device is so far changed in principle that it performs the function of the patent application, prior to any amendments in a substantially different way. See SRI Int’l, 775 F.2d at 1124. At that point, the court in SRI International looked to the evidence presented regarding the ways the two products functioned to determine whether they were substantially different. /d. The Court has found no case where a court has discussed the enablement or written description arguments made by the Defendant when discussing the reverse doctrine of equivalents. Sonosite’s summary judgment evidence in support of its contention that the reverse doctrine of equivalents applies in this case does not address the patented device. Rather,” Sonosite attempts to create a fact issue on the doctrine of equivalents by comparing the accused devices to the language of the patent application prior to its amendment and prior to the issuance of the ‘021 patent. The Court finds, however, that this analysis is against the weight of the authority on this subject. Therefore, the Court declines to apply the reverse doctrine of equivalents in this case. Sonosite has not met its burden of establishing that the accused devices perform in a substantially different manner from the patented claim. 29a Appendix C Conclusion The Court finds that there is no evidence to support Sonosite’s contention that the reverse doctrine of equivalents should be applied in this case. Therefore, because Sonosite does not raise a fact issue on the question of infringement, and the Court declines to apply the doctrine based on the facts presented by Defendant, Plaintiff's Motion for Summary Judgment on Infringement (Dkt.# 136) is GRANTED. It is so ORDERED. 30a APPENDIX D— MEMORANDUM AND ORDER OF THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF TEXAS, HOUSTON DIVISION DATED SEPTEMBER 30, 2004 (Re: Defendant’s Post-Markman Motion for Summary Judgment) UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF TEXAS HOUSTON DIVISION No. CIV.A.H-01-2484 NEUTRINO DEVELOPMENT CORPORATION, Plaintiff, v. SONOSITE, INC., Defendant. Sept. 30, 2004. MEMORANDUM AND ORDER RAINEY, District Judge. Pending before the Court is Defendant’s Post-Markman Motion for Summary Judgment based on Invalidity (Dkt.# 131). The Court, after reviewing the motion, the responses of the parties and the relevant law, is of the opinion that the motion should be DENIED. 3la Appendix D Factual and Procedural Background This is an action for patent infringement brought by Neutrino Development Corporation (“Neutrino”) against Sonosite, Inc. (“Sonosite”). Neutrino is the owner of United States Patent No. 6,221,021 (“the ‘021 patent”). Neutrino alleges that four devices manufactured and marketed by Sonosite, the Sonosite 180, SonoHeart, Sonosite 180 PLUS, and the SonoHeart PLUS, infringe on the ‘021 patent. Richard T. Redano applied for a patent on the device in question on September 9, 1997. (Application Serial No. 08/ 926, 209).' The ‘021 patent, entitled “Method and Apparatus for Penile Hemodynamic Stimulation, Monitoring, and Drug Delivery Acceleration,” resulted from that application. It describes a device for “stimulating and/or monitoring hemodynamic activity, such as blood flow, in a penis.” U.S. Patent No. 6,221,021 at col. 1, ll. 15-16. Defendant Sonosite began as a division of ATL Ultrasound, Inc., and was spun off as a public company in April 1998. Sonosite unveiled its first public product in the realm of hand-carried ultrasound devices, the Sonosite 180, on May 17, 1999. Sonosite began selling the device in June 1999. In January 2000, Sonosite launched its second product, the SonoHeart. In April 2001, Sonosite launched a new generation of these two devices with its introduction of the SonoSite 180 PLUS ‘nid the SonoHeart PLUS. 1. On May 20, 1999, Redano field a continuation in patent application, serial No. 09/315,867 which eventually issued as the ‘021 patent. In May 2000, Redano amended the pending ‘021 Patent Application to broaden its disclosure and expand the claims. The ‘021 patent was issued on April 24, 2001. 32a Appendix D On July 24, 2001, Neutrino filed this action, alleging that Sonosite had illegally used Redano’s invention and infringed the ‘021 patent. Sonosite answered the complaint on August 14, 2001, asserting that the ‘021 patent claims are not infringed and are invalid, and counterclaimed for declaratory judgment of non-infringement and invalidity. On February 20, 2002, after extensive briefing, the Court held a one-day Markman hearing on claim construction. On October 9, 2002, the Court stayed all proceedings pending the Court’s Markman and summary judgment rulings. The Court issued its claim construction on August 21, 2003. This motion for summary judgment was filed as a result of the Court’s claim construction. Summary Judgment Standard Summary judgment is proper if “the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law.” Fed. R. Civ. P. 56(c); see also Christopher Village, LP v. Retsinas, 190 F.3d 310, 314 (Sth Cir.1999). “For any matter on which the non-movant would bear the burden of proof at trial... , the movant may merely point to the absence of evidence and thereby shift to the non-movant the burden of demonstrating by competent summary judgment proof that there is an issue of material fact warranting trial.” Transamerica Ins. Co. v. Avenell, 66 F.3d 715, 718-19 (Sth Cir.1995); see also Celotex Corp. v. Catrett, 477 U.S. 317, 323-25, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). To prevent summary judgment, the non- 33a Appendix D movant must “respond by setting forth specific facts” that indicate a genuine issue of material fact. Rushing v. Kansas City S. Ry. Co., 185 F.3d 496, 505 (Sth Cir.1999),. When considering a motion for summary judgment, the Court must view the evidence in the light most favorable to the non-movant and draw all reasonable inferences in favor of the non-movant. See Samuel v. Holmes, 138 F.3d 173, 176 (Sth Cir.1998); Texas v. Thompson, 70 F.3d 390, 392 (Sth Cir.1995). “The court may not undertake to evaluate the credibility of the witnesses, weigh the evidence, or resolve factual disputes; so long as the evidence in the record is such that a reasonable jury drawing all inferences in favor of the nonmoving party could arrive at a verdict in that party’s favor, the court must deny the motion.” /nt’l Shortstop, Inc. v. Rally’s, Inc., 939 F.2d 1257, 1263 (Sth Cir.1991). However, the non-movant cannot avoid summary judgment by presenting only “conclusory allegations,” or “unsubstantiated assertions,” such as the bare allegations of a complaint, but must present sufficient evidence, such as sworn testimony in a deposition or affidavit, to create a genuine issue of material fact as to the claim asserted. Little v. Liquid Air Corp., 37 F.3d 1069, 1075 (Sth Cir.1994) (en banc). Patent cases are amenable to summary judgment as any other case when no genuine issue of material fact exists and the movant is entitled to judgment as a matter of law. See Warner-Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 17, 39, 117 S.Ct. 1040, 137 L.Ed.2d 146 (1997); Johnston v. IVAC Corp., 885 F.2d 1574, 1576-77 (Fed.Cir.1989); SRI Int’l v. Matsushita Elec. Corp. of Am.; 775 F.2d 1107, 1116 (Fed.Cir. 1985). 34a Appendix D Analysis Defendant challenges the validity of the ‘021 patent by asserting that the invention was on sale in the country more than one year prior to the date of the patent and thus the patent is invalid because it violates the on-sale bar of 35 U.S.C. § 102(b). Additionally, Defendant challenges the validity of the patent by asserting that the claims of the patent read on a prior art product, a Diasonics Ultrasound Model Inpact VFI, also known as the Compact System (“Compact System”), and is thus anticipated under 35 U.S.C. § 102(b). Under 35 U.S.C. § 282, a patent is presumed valid and an attack on its validity requires proof of facts by “clear and convincing evidence or its equivalent, by whatever form of words it may be expressed.” American Hoist & Derrick Co. v. Sowa & Sons, 725 F.2d 1350, 1360 (Fed.Cir.), cert. denied, 469 U.S. 821, 105 S.Ct. 95, 83 L.Ed.2d 41 (1984). The “clear and convincing” standard of proof of facts is an intermediate standard which lies somewhere between “beyond a reasonable doubt” and a “preponderance of the evidence.” Addington v. Texas, 441 U.S. 418, 425, 99 S.Ct. 1804, 60 L.Ed.2d 323 (1979). Although not susceptible to precise definition, “clear and convincing evidence” has been described as evidence which produces in the mind of the trier of fact “an abiding conviction that [the] truth of the factual contentions are ‘highly probable.’ ” Colorado v. New Mexico, 467 U.S. 310, 316, 104 S.Ct. 2433, 81 L.Ed.2d 247 (1984). 35a Appendix D - On-Sale Bar Under § 102(b), “[a] person shall be entitled to a patent unless . . . the invention was. . . on sale in this country, more than one year prior to the date of the application for the patent in the United States.” 35 U.S.C. § 102(b) (2000). A § 102(b) determination is a conclusion of law based on underlying findings of fact. Linear Tech. Corp. v. Micrel, Inc., 275 F.3d 1040, 1047 (Fed.Cir.2001). A two pronged test governs the application of the on-sale bar: “First, the product must be the subject of a commercial offer for sale ... Second, the invention must be ready for patenting.” Pfaff v. Wells Elecs., Inc. , 525 U.S. 55, 67, 119 S.Ct. 304, 142 L.Ed.2d 261 (1998). Sonosite’s motion for summary judgment focuses on the first prong of this test. Although the standard for determining what constitutes an Offer to sell sufficient to raise the on sale bar had been subject to come confusion, the Federal Circuit clarified the standard in Group One Limited v. Hallmark Cards, 254 F.3d 1041 (Fed.Cir.2001). In Group One, the Federal Circuit held that “[o]nly an offer which rises to the level of a commercial offer for sale, one which the other party could make into a binding contract by simple acceptance (assuming consideration), constitutes an offer for sale under § 102(b).” Id. at 1048 (concluding that the need for national uniformity in patent law requires the application of federal common law). To determine if the offer is sufficiently definite, one must examine the language of the proposal in accordance with the principles of general contract law. Jd. at 1048. Because this issue is governed by federal common law, an important relevant source of general contract law for determining 36a Appendix D whether a “communication or series of communications rises to the level of a commercial offer for sale” is the Uniform Commercial Code (“UCC”). Id. at 1047; see also Univ. of Colo. Found., Inc., v. Am. Cyanamid Co., 196 F.3d 1366, 1372 (Fed.Cir.1999). Notably, an offer for sale does not have to be accepted to implicate the on-sale bar. UMC Elecs. Co. v. United States, 816 F.2d 647, 653 (Fed.Cir. 1987) (overruled on other grounds by Pfaff, 525 U.S. 55, 119 S.Ct. 304, 142 L.Ed.2d 261 (1998)). Sonosite asserts that a device embodying each claim of the disputed patent was on sale prior to September 9, 1996, the critical date for determining whether the on-sale bar applies. Specifically, Sonosite asserts that Diasonics Ultrasound Inc. (“Diasonics”) advertised and sold its Impact VFI portable ultrasound imaging device, also known as the Compact System (“Compact System”) prior to the critical date. To support this contention, Sonosite relies on the declaration of David Sherman, an employee of Sonosite who was previously employed by Diasonics Ultrasound. Sherman’ s declaration states that he was “personally involved in the sales process for the Impact VFI portable ultrasound smaging device, also known and marketed as the Compact VFI and the Diasonics Compact System, which was sold by Diasonics and manufactured by Ausonics Pty. Ltd.” Declaration of David Sherman, attached to Sonosite's Motion for Summary Judgment, para. 12. Sherman goes on to state that “Diasonics first placed this device on sale in the United States prior to April 1996.” Mr. Sherman also states that he has reviewed the advertising literature (the Diasonics brochure)and asserts that it was “printed in April 1996 and that it was widely distributed to potential customers of the device.” /d. at para. 13. 37a Appendix D The Federal Circuit, however, has made it clear that “uncorroborated oral testimony, particularly that of interested persons recalling long past events, does not, of itself, provide the clear and convincing evidence required to invalidate a patent . . .” Woodland Trust v. Flowertree Nursery, 148 F.3d 1368, 1369 (Fed.Cir. 1998). As supporting documentation, Sonosite has provided a copy of a brochure created by Diasonics, which describes the Compact System. The only date information on the brochure is a notation on the last page which reads “Diasonics Ultrasound Pt. No. 925-00001-00 Rev C 4/96.” This is the only possible corroboration on the document that suggests that the device was on sale on or before April of 1996. This evidence is not enough, however, to trigger the on sale bar. See Lacks Indus., Inc. v. McKechnie Vehicle Components USA, Inc., 322 F.3d 1335 (requiring a formal offer under principles of contract law before the on-sale bar is implicated). At best, this date corroborates Mr. Sherman’s testimony that the brochure was printed in April of 1996. Thus, the Court finds that Sonosite does not provide sufficient evidence to corroborate Sherman’s testimony. Rather, Sonosite asks the Court to draw inferences from a date on a brochure and the testimony of an individual who does not provide a date certain for Diasonics’s sale of the Compact System, but rather testifies that it was on sale “before April 1996.” The Court finds that this information, without something more definite to show that the device was actually on sale, fails to meet the clear and convincing evidence standard necessary to trigger the on-sale bar. See Intel Corp. v. U.S. Int’l Trade Comm’n, 946 F.2d 821 38a Appendix D (Fed.Cir. 1991) (holding that the Court would have to “engage in extensive inference drawing to conclude” that the product in question had actually been sold prior to the critical date merely because protypes had been given to salesmen with instructions to sell them). Anticipation. Sonosite further argues that the Diasonics device anticipates every Claim of the ‘021 patent. Although the question of whether a device was on-sale before the critical date is a question of law determined by underlying factual issues, anticipation is a question of fact. Compare Paragon Podiatry Lab., Inc. v. KLM Labs., Inc., 984 F.2d 1182, 1186 (Fed.Cir.1993) (holding that the on sale bar was a question of law amenable to summary judgment where there were no underlying material facts in issue) with Advanced Display Sys. Inc. v. Kent State Univ., 212 F.3d 1272, 1281 (Fed.Cir.2000) (holding that anticipation is a question of fact (internal citation omitted)). To-make such a finding on summary judgment, the Court must determine that no facts material to the question are disputed; or that even if all material factual inferences are drawn in favor of the non- movant, there is no reasonable basis on which the non-movant can prevail. Cooper v. Ford Motor Co., 748 F.2d 677, 679 (Fed.Cir. 1984). Section 102(b) provides that “a person shall be entitled to a patent unless the invention was patented or described in a printed publication . . . more than onc year prior to the date of publication.” 35 U.S.C. § 102(b) (2000). Accordingly, invalidity by anticipation requires that the four corners of a 39a Appendix D single, prior art document describe every element of the claimed invention, either expressly or inherently, such that a person of ordinary skill in the art could produce the invention without undue experimentation. See Atlas Powder Co. v. Treco Inc., 190 F.3d 1342, 1347 (Fed.Cir.1999). Material not explicitly contained in the single, prior art document may still be considered for purposes of anticipation if that material is incorporated by reference into the document. See Ultradent Prods., Inc. v. Life-Like Cosmetics, Inc., 127 F.3d 1065, 1069 (Fed.Cir.1997) (holding that material incorporated by reference into a document may be considered in an anticipation determination). Additionally, extrinsic information may be considered to explain the disclosure of a reference. The role of extrinsic evidence is to educate the decision-maker to what the reference meant to persons of ordinary skill in the field of the invention, not to fill gaps in the reference. See Studiengesellschaft Kohle, m.b.H. v. Dart Indus., Inc., 726 F.2d 724, 727 (Fed.Cir.1984) (although additional references may serve to reveal what a reference would have meant to a person of ordinary skill, it is error to build “anticipation” on a combination of these references). If it is necessary to reach beyond the boundaries of a single reference to provide missing disclosure of the claimed invention, the proper ground is not § 102 anticipation, but § 103 obviousness. Scripps Clinic and Research Found. vy. Genentech, Inc., 927 F.2d 1565, 1577 (Fed.Cir.1991). Evaluating an anticipation claim requires a two step analysis. The first step of an anticipation analysis is claim construction. See Key Pharms. v. Hercon Labs. Corp., 161 F.3d 709, 714 (Fed.Cir.1998). The Court, after hearing evidence and testimony at a Markman hearing, issued its 40a Appendix D claim construction on August 20, 2003. In its order, the Court construed the ‘021 patent as follows: 1. “A transducer mounting assembly moveably connected to said body such that the distance between said assembly and said body can be adjusted by a user using only one hand”-An assembly sized to contain at least one ultrasound emitter or transducer, which is connected to the portable body such that a user of the apparatus can cause a change in the distance between the transducer mounting assembly and the portable body, using only one hand. 2. “A portable body sized to be hand held”-A body that is sized such that it can be held by hand and, so held, moved from one location to another.- 3. “Ultrasound emitter”-At least one component, also known as a “transducer” or “emitter,” and capable of emitting ultrasound energy.’ The second step of the analysis involves a comparison of the construed claim to the prior art. See Key Pharms., 161 F.3d at 714. To be anticipating, a prior art reference must disclose “each and every limitation of the claimed invention{,] . . . must be enabling[,] and [must] describe . . . {the]claimed invention sufficiently to have placed it in possession of a person of ordinary skill in the field of the 2. The Court held that the following terms did not need to be interpreted because they were unambiguous: |) “mounted in,” “mounted on,” “housed within,” and “top surface,” 2) “portable body comprising a top surface;” 3) “connected to” and “coupled to;” 4) “generating an instruction,” and 5) “display.” 4la Appendix D invention.” Helifix Ltd. v. Blok-Lok, Ltd., 208 F.3d 1339, 1346 (Fed.Cir.2000)(quoting Jn re Paulsen, 30 F.3d 1475, 1478- 79 (Fed.Cir.1994)). If there is a genuine issue of material fact relevant to any one of these factors, summary judgment is not proper. Id. Sonosite’s motion for summary judgment argues that the Diasonics device discloses each of the limitations of claims 8, 11, 12, 13, 20, 21, and 23-27 of the ‘021 patent as construed by the Court. To support this contention, Sonosite attached as exhibits the Diasonics brochure, the declaration of David Sherman, the declaration of Robert Isackson, and a transcript of the testimony of Jens Quistgaard from the Markman hearing. Sonosite also attached a “detailed claims chart” outlining the ways in which the Diasonics device anticipates each claim of the patented device. See Sonosite’s Motion for Summary Judgment, Exhibit 1. Neutrino objects to these supporting documents as being hearsay, uncorroborated, lacking in foundation, speculation, and wholly based on interested testimony. With regard to the declarations of Isackson, Sherman and Quistgaard and the testimony of Quistgaard from the Markman hearing, Neutrino also objects that they are providing expert opinions without having been designated as experts. First, with respect to the Diasonics brochure, Neutrino questions its authenticity as well as arguing that it contains hearsay and that it is uncorroborated. The Court ruled on this same issue in an order dated September 24, 2002. In that order, the Court held that the brochure was noi hearsay because it is a legally operative document. See Court’s Order on Plaintiff Neutrino’s Motion to Strike Inadmissible Exhibits (Dkt.# 122) 42a Appendix D (citing Stuart v. UNUM Life Ins. Co. of Am., 217 F.3d 1145, 1154 (9th Cir.2000)). The Court also held that the document “need only be authenticated to be admissible.” /d. citing Kepner-Tregoe, Inc. v. Leadership Software, Inc., 12 F.3d 527, 540 (Sth Cir.1994). In the Court’s opinion, the declaration of David Sherman authenticates the brochure when he states that he has reviewed the advertising literature (the Diasonics brochure) and can “confirm that it accurately depicts the Diasonics Impact VFI device,” and “that it was printed in April 1996. . .”” See Declaration of David Sherman, attached to Sonosite’s Post-Markman Motion for Summary Judgment based on Invalidity, para. 12. Second, with regard to the “claims chart,” Neutrino objects that the chart is uncorroborated and wholly based on interested testimony. The Court notes, however, that Neutrino provides a chart of its own to detail how and why the claims are not anticipated by the Diasonics device. Although Neutrino’s chart is different from Sonosite’s in that Nevtrino’s chart contains references to both interested and purportedly uninterested testimony, this is a credibility determination to be made by the finder of fact, not the Court. Finally, with respect to the declarations of Isackson, Sherman and Quistgaard, and the Quistgaard testimony, Neutrino objects that these statements offer expert opinions although the individuals giving them have not been designated as experts. The Court finds these to be substantially similar to the declarations of Douglas Beall and Richard Redano, which are attached to Neutrino’s response to the Motion for Summary Judgment and are used by Neutrino to support its contention that the patent is not invalid. Although the Court notes that neither side has designated experts, the Court also notes that neither side is preciuded from submitting the opinions of lay witnesses, so —_, -_ 43a Appendix D long as those opinions are limited to “those opinions which are (a) rationally based on the perception of the witness; (b) helpful to a clear understanding of the witness’ testimony or the determination of a fact in issue, and (c) not based on scientific, technical, or other specialized knowledge within the scope of Rule 702.” Fed.R.Evid. 701. To the extent that any of the declarations or transcript testimony rises to the level of expert testimony, the Court will disregard those portions of the declarations or transcript testimony. The majority of the declarations’ contents, however, are admissible as perceptions of the witnesses or as being helpful to a clear understanding of the witnesses’ testimony and the determination of a fact in issue. Therefore, the Court wiil allow the- declarations to be used as summary judgment evidence. Having reviewed all of the documentation discussed above, the Court believes that a fact issue exists on the issue of anticipation. The Court cannot reconcile the testimony of Dr. Quistgaard with that of Dr. Beall. Dr. Quistgaard’s testimony, coupled with that of Mr. Sherman, is that the Diasonics device anticipates each claim of the ‘021 patent. Dr. Beall, on the other hand, asserts that the Diasoncs device does not anticipate any of the claims of the ‘021 patent. For example, with regard to the claim that the device contain “a body that is sized such that it can be held by hand, and so held, moved from one location to another,” Dr. Quistgaard testified that the Diasonics device was capable of being picked up by someone such as himself and moved from one location to another. See Testimony of Jens Quistgaard, attached as Exhibit R to the Declaration of Robert Isackson, page 14, lines 8-10. Thus, Dr. Quistgaard believes that the 44a Appendix D claims relating to the device being hand-held are anticipated by the Diasonics device. Dr. Beall’s declaration states, however, that from his review of the Diasonics literature and his observations of the device, the Diasonics device would be too large and too heavy for someone such as himself to hold the body of the device by hand and move it from one location to another. See Declaration of Douglas Beall attached to Plaintiff ’s Response to the Motion for Summary Judgment, page 4, paragraph 9 & 10. Thus, Dr. Beall believes that the Diasonics device does not anticipate the hand-held portions of the ‘021 patent. The portability of the device is an issue that occurs in independent claim numbers 8, 20, and 25. The parties’ witnesses have equally competing views on issues relating to the transducers, the ability of an operator of the Diasonics device to change the distance between the transducer mounting assembly and the portable body using only one hand, and whether the Diasonics device actually contains “at least two ultrasound emitters” as required by the ‘021 patent. Thus, the Court is faced with conflicting testimony regarding virtually every aspect of the ‘021 patent. Whether the Diasonics device anticipates each of the claims in the pateni, based on the observations of the parties’ competing witnesses, is a question for the trier of fact, rather than the Cowrt. 6 decide. Therefore, the Court finds that summary judgment is inappropriate. ites 45a Appendix D Conclusion The Court finds that there are fact issues surrounding the on-sale bar and the issue of anticipation. Therefore, Defendant’s Post-Markman Motion for Summary Judgment based on Invalidity (Dkt. # 131) is DENIED. It is so ORDERED. 46a APPENDIX E — OPINION OF THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF TEXAS, HOUSTON DIVISION DATED JANUARY 23, 2006 UNITED STATES DISTRICT COURT S.D. TEXAS HOUSTON DIVISION No. CIV.A. H-01-2484. Jan, 23, 2006. NEUTRINO DEVELOPMENT CORPORATION, Plaintiff, V. SONOSITE, INC., Defendant. MEMORANDUM AND ORDER RAINEY, District Judge. Pending before the Court are Neutrino Development Corporation’s (“Neutrino”) Motion to Exclude Testimony of Defendant SonoSite’s Expert Witness Joan Baker (Dkt. # 258), Neutrino’s Motion to Exclude Testimony of Defendant SonoSite’s Expert Witness Donald W. Baker (Dkt.# 259), Neutrino’s Motion to Exclude Testimony of Defendant SonoSite’s Expert Witness Dr. Don L.. 47a Appendix E Berardinucci (Dkt.# 260), Neutrino’s Motion to Exclude Testimony of Defendant SonoSite’s Expert Witness Cameron Weiffenbach (Dkt.# 261), Neutrino’s Motion to Exclude Testimony of Defendant SonoSite’s Expert Witness Jens U. Quistgaard (Dkt.# 262), Neutrino’s Motion to Exclude Testimony of Defendant SonoSile’s Expert Witness Jens U. Quistgaard on Lack of Infringement by SonoSite’s Products (Dkt.# 266), Neutrino’s Motion to Exclude Testimony of Defendant SonoSite’s Expert Witness Lauren S. Pflugrath (Dkt.# 267), and Neutrino’s Motion to Exclude, or In Limine, the Testimony of Stephen M. Graham (Dkt. # 343). The Court, having reviewed the motions, the responses of the parties, and the applicable law, is of the opinion that Plaintiff's motions (Dkt.4#258, 267, and 343) should be DENIED, Plaintiff’s motion (Dkt.# 260) should be GRANTED, and Plaintiff's motions (Dkt.#259, 261, 262, and 266) should be GRANTED in part and DENIED in part. Factual and Procedural Background This is an action for patent infringement brought by Neutrino Development Corporation (“Neutrino”) against Sonosite, Inc. (“Sonosite”). Neutrino is the owner of United States Patent No. 6,221,021 (“the ‘021 patent”). Neutrino alleges that four devices manufactured and marketed by Sonosite, the Sonosite 180, SonoHeart, Sonosite 180 PLUS, and the SonoHeart PLUS, infringe on the ‘021 patent. Richard T. Redano applied for a patent on the device in qucstion on September 9, 1997. (Application Serial No. 08/ 926, 209). The ‘021 patent, entitled “Method and Apparatus for Penile Hemodynamic Stimulation, Monitoring, and Drug 48a Appendix E Delivery Acceleration,” resulted from that application. It describes a device for “stimulating and/or monitoring hemodynamic activity, such as blood flow, in a penis.” U.S. Patent No. 6,221,021] at col. 1, ll. 15-16. Defendant Sonosite began as a division of ATL Ultrasound, Inc., and was spun off as a public company in April 1998. Sonosite unveiled its first public product in the realm of hand-carried ultrasound devices, the Sonosite 180, on May 17, 1999. Sonosite began selling the device in June 1999. In January 2000, Sonosite launched its second product, the SonoHeart. In April 2001, Sonosite launched a new generation of these two devices with its introduction of the SonoSite 180 PLUS and the SonoHeart PLUS. On July 24, 2001, Neutrino filed this action, alleging that Sonosite had illegally used Redano’s invention and infringed the ‘021 patent. Sonosite answered the complaint on August 14, 2001, asserting that the ‘021 patent claims are not infringed and are invalid, and counterclaimed for declaratory judgment of non-infringement and invalidity. On February 20, 2002, after extensive briefing, the Court held a one-day Markman hearing on claim construction. On October 9, 2002, the Court stayed all proceedings pending the Court’s Markman and summary judgment rulings. The Court issued its claim construction on August 21, 2003. Subsequently, the Court granted Neutrino’s Motion for Summary Judgment on Infringement (Dkt.# 136) finding that Sonosite’s devices literally infringed the ‘021 patent and the reverse doctrine of equivalents was not applicable (Dkt.# 162). Consequently, Sonosite’s case for trial focuses on the 49a Appendix E invalidity of the ‘021 patent, which requires expert testimony about the ‘021 patent and certain prior art. Neutrino has objected to the testimony of the above-named seven Sonosite experts. Expert Testimony Standard Federal Rule of Evidence 702 provides: If scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training, or education, may testify thereto in the form of an opinion or otherwise, if (1) the testimony is based upon sufficient facts or data, (2) the testimony is the product of reliable principles and methods, and (3) the witness has applied the principles and methods reliably to the facts of the case. This “imposes 4 special obligation upon a trial judge to ‘ensure that any and all scientific testimony’ .. . is not only relevant, but reliable.” Kumho Tire Co., Ltd. v. Carmichael, 526 U.S. 137, 147, 119 S.Ct. 1167, 143 L.Ed.2d 238 (1999) (quoting Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 589, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993)). The expert testimony must be relevant, not simply in the sense that all testimony must be relevant under Federal Rule of Evidence 402, but also in the sense that the expert’s proposed opinion is based on a valid scientific inquiry. Daubert, 509 U.S. at 592, 113 S.Ct. 2786. cemented 50a Appendix E The Supreme Court has provided five non-exclusive factors to consider when assessing whether the methodology upon which an expert rests his opinion is scientifically reliable. These factors are (1) whether the expert's theory can be or has been tested, (2) whether the theory has been subject to peer review and publication, (3) the known or potential rate of error of a technique or theory when applied, (4) the existence and maintenance of standards and controls, and (5) the degree to which the technique or theory has been generally accepted in the scientific community. Daubert, 509 U.S. at 593-94, 113 S.Ct. 2786; Burleson v. Texas Dept. of Criminal Justice, 393 F.3d 577 (Sth Cir.2004). The test for determining reliability is flexible and can adapt to the particular circumstances underlying the testimony at issue. Kumho Tire, 526 U.S. at 150-51, 119 S.Ct. 1167. The party seeking to have the district court admit expert testimony must demonstrate by a preponderance of the evidence that the expert’s findings and conclusions are reliable, but need not show that the expert’s findings and conclusions are correct. Moore v. Ashland Chem., Inc., 151 F.3d 269, 276 (Sth Cir.1998), Discussion I. Joan Baker Ms. Baker’s testimony pertains to whether certain amendments made to the ‘021 patent specification constituted a “new matter” and were therefore improperly included under the patent.' For such an amendment to be properly included 1. See Sonosite’s Exhibit 12. Amendments made via letter of May 4, 2000 and letter of November 14, 2000. Sla Appendix E it must be inherently supported in the original patent application. 35 U.S.C. § 132. That is, a person of ordinary skill in the art could have looked at the patent application as of the filing date and determined that the claimed invention included the later-claimed subject matter. TurboCare Div. of Demag Delaval Turbomach. Corp. v. Gen. Elec. Co., 264 F.3d 1111, 1118-19 (Fed.Cir.2001). Neutrino objects to Ms. Baker’s testimony on three grounds: (1) Ms. Baker is not qualified to give expert opinions on the “ordinary level of skill in the art” for the ‘021 patent; (2) Ms. Baker has failed to determine what “one of ordinary skill in the art” would recognize from the initial disclosures of the ‘021 patent; and (3) Ms. Baker’s opinions are conclusory and are not supported by any of the reliability factors recognized under Daubert.* Sonosite opposes Neutrino’s contention that Ms. Baker’s qualifications are wanting on the grounds that she is a “pioneer” in the field of medical ultrasound and has extensive experience with the use and operation of diagnostic medical ultrasound devices.’ The Court acknowledges that Ms. Baker’s resume and professional experience support Sonosite’s characterization of her qualifications. However, Ms. Baker’s qualifications must allow her to offer opinions from the perspective of “one of ordinary skill in the art.” The appropriate level of ordinary skill in the art is a complex factual inquiry within an abstract legal standard. Ryko Mfg. Co. v. Nu-Star, Inc., 950 F.2d 714, 718 (Fed.Cir.1991). Although the finder of fact will ultimately decide the level — oe ee 2. Dkt. # 258, p. 2. 3. Dkt. # 300, at 1-4. 52a Appendix E of ordinary skill in the art, the Court must determine the relevant art area as a matter of law in order to determine whether particular experts are qualified under Daubert. Courts have long acknowledged the difficulty of this task. Judge Learned Hand, writing for the Second Circuit Court of Appeals before the regional appellate courts were rescued from such matters in 1982, quipped that, “[w]hen all is said, we are called upon imaginatively to project this act of discovery against an hypostatized average practitioner, acquainted with all that has been published and all that has been publicly sold. If there be an issue more troublesome, or more apt for litigation than this, we are not aware of it.” Harries v. Air King Products Co., 183 F.2d 158, 162 (2d Cir.1950). The “new matter” defense at bar requires the hypothetical person of ordinary skill in the art to be able to construe the ‘O21 patent application and thereby understand what comprises the claimed invention. The specific issue at bar is whether the hand-held nature of the ultrasonography generator claimed in the amendment was inherent in the original patent application. The Court finds that the relevant art area for making this determination is the “designing, testing and building” of medical ultrasound devices.* The law does not require an expert opining from the perspective of “one of ordinary skill in the art” to have the same qualifications as the inventor or even be an inventor herself. See Orthopedic Equip. Co. v. All Orthopedic Appliances, 707 F.2d 1376, 1382 (Fed.Cir.1983). But it does require that she is sufficiently qualified to construe the patent and understand 4. Sonosite’s Exhibit 10. This formulation of the relevant art area clarifies the Court's broader formulation in Dkt. # 325, p. 6. 53a Appenaix E the design and components of the claimed invention as one with ordinary skill in the art of designing, testing, and building medical ultrasound devices. Ms. Baker’s report and curriculum vitae establish that her qualifications are in the relevant art area. Ms. Baker’s experience consulting on the design features of prototype medical ultrasound devices and considering the ergonomic aspects of medical ultrasound devices qualify her to opine about what design features would be inherently understood from the description of the ultrasonography generator in the original patent application.® The ability of a user to hold a component of the device in his hand is specifically an ergonomic issue. Whether such an ergonomic feature is inherently described in the original patent application is something about which Ms. Baker is qualified to testify under Daubert. Neutrino also challenges Ms. Baker’s testimony on the grounds that she has not properly resolved the skill level of one of “ordinary skill in the art.” Neutrino argues that, because Ms. Baker has failed to determine the level of ordinary skill in the art, her opinions are irrelevant because they are not offered from the legally requisite perspective. “In determining [the level of ordinary skill in the art], the [trier of fact] may consider various factors including ‘type of problems encountered in the art; prior art solutions to those problems; rapidity with which innovations are made; sophistication of the technology; and educational level of active workers in the field.’” Jn re GPAC Inc., 57 F.3d 1573, 4, Sonosite’s Exhibit 12, pp. 1-3. 54a Appendix E 1579 (Fed.Cir.1995) (quoting Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962-63 (Fed.Cir.1986)). Neutrino objects to Ms. Baker’s failure to establish the level of skill she applied to her analysis through the investigation of these factors. In order for Ms. Baker’s testimony to be relevant to the issue of “new matter,” Sonosite must establish that she has knowledge of the level of ordinary skill in the art and that she has applied that perspective to her testimony. Any disagreement between the parties about what constitutes the level of ordinary skill would present a fact issue to be resolved by the jury. However, Neutrino claims that Ms. Baker has failed to offer any factual basis - that could be evaluated by the jury.® The Court disagrees. In her deposition, Ms. Baker testified that she considered the level of ordinary skill in the art to be a person who “has been trained and passed one’s credentialing examinations . . .”’ This statement is sufficient to allow the jury to determine whether this is the appropriate level of ordinary skill in art. Neutrino’s disagreement with Ms. Baker’s formulation of the level of ordinary skill goes to the weight of her testimony, not to its admissibility. Finally, Neutrino objects to the reliability of Ms. Baker’s testimony on the grounds that (1) she failed to consider all the patents incorporated by reference in the ‘021 patent, (2) she did not understand the terms “ultrasound generator” and “ultrasonography generator,” (3) she only considered one embodiment of the Pohl patent, and (4) she incorrectly concludes that it would require 4 hands to operate the device 6. Dkt. # 258, pp. 4-6. 7. Sonosite’s Exhibit 15, at 59. 55a Appendix E described in the ‘021 patent. Neutrino’s allegation that Ms. Baker failed to consider all of the patents incorporated by reference in the ‘021 patent is based on her admission that she did not use United States Patent No. 5,565,466 disclosed to Gioco et al. (“the ‘466 patent”) in preparing her report.* Neutrino argues that this admitted omission renders her evaluation of the ‘021 patent incomplete and therefore unreliable under Daubert. Materials incorporated by reference in a patent are effectively part of the patent as though they were explicitly included in their entirety within the patent document. Adv. Display Sys., Inc. v. Kent State Univ., 212 F.3d 1272, 1282 (Fed.Cir.2000). Ambiguous terms within the patent can sometimes be interpreted in light of disclosures made in the materials incorporated by reference. The “new matter” issue relevant to Ms. Baker’s testimony focuses on the ambiguity of the term “ultrasonography generator” in the ‘021 patent. Proper evaluation of that term would require Ms. Baker to interpret it in light of disclosures made in the patents incorporated by reference in the ‘021 patent. Ms. Baker explains in her deposition testimony that she did not consider the ‘466 patent and did not include it with her report because its disclosures were irrelevant to opinions about the size of the ultrasonography generator in the ‘021 patent. The ‘466 patent discloses a method for enhancing sexual stimulation by introducing a vasodilator agent into circulation to improve blood flow to the genital region. The ‘466 patent does not involve or discuss medical ultrasound devices or disclose any information that could have informed Ms. Baker’s conclusions about the size of the ultrasonography generator described in the ‘021 patent. 8. Dkt. # 258, at 15. 56a Appendix E Therefore, the Court finds that Ms. Baker’s exclusion of the ‘466 patent from her report was appropriate under the circumstances and does not compromise the reliability of her cima Neutrino also argues that Ms. Baker admitted in her deposition testimony that she did not understand the terms “ultrasound generator” and “ultrasonography generator” and therefore her testimony about the meaning of these terms is uninformed and unreliable.’ Ms. Baker explained in her report that the “terms ‘Ultrasonography Generator’ and ‘Ultrasound Generator’ are not terms typically used in the field of ultrasound, and have no special meaning.”'® Similarly, Ms. Baker’s subsequent deposition testimony that she could not be sure what Mr. Redano meant by those terms in the ‘021 patent simply indicated that those terms did not have meaning in common usage independent of the ‘021 patent. Nothing in Ms. Baker’s report or deposition testimony indicates that her understanding of the those terms was deficient. Ms. Baker’s specific understanding of the meaning of those terms is a matter ripe for cross-examination. Neutrino also challenges Ms. Baker’s testimony on the grounds that her report only considered one embodiment of United States Patent No. 5,578,060 disclosed to Pohl et al. (“Pohl patent”). Neutrino has taken the position that the original ‘901 patent application inherently disclosed a portable, hand-held ultrasonography generator by 9. Id. at 16. 10. Sonosite’s Exhibit 12, p. 4. 57a Appendix E incorporating by reference the Pohl patent. Ms. Baker concluded in her report that the Poh! patent did not describe a hand-held device.'' Neutrino challenges the reliability of Ms. Baker’s conclusion on the grounds that she failed to evaluate the entirety of the Pohl patent. Sonosite argues that Neutrino’s challenge goes to the weight of Ms. Baker’s testimony, not to its admissibility. The Court agrees. The reliability inquiry under Daubert asks the Court to consider the methodology the expert employed to reach her conclusion, not the accuracy of the conclusion itself. Moore v. Ashland Chem., Inc., 151 F.3d 269, 276 (Sth Cir.1998). Ms. Baker’s report discusses several aspects of the Pohl patent and specifically considers Mr. Redano’s claims about the Pohl patent. Neutrino presents no evidence that Ms. Baker’s evaluation of the Pohl patent was deficient for purposes of determining whether or not that patent disclosed a hand-held component equivalent to the ultrasonography generator in the ‘901 and ‘021 patent applications. Sonosite Suggests, and the Court agrees, that the accuracy of Ms. Baker’s conclusions about the Pohl patent are a matter ripe for cross-examination and not appropriate grounds for exclusion. Finally, Neutrino challenges the reliability of Ms. Baker’s testimony on the grounds that her report improperly concludes that four hands would be required to operate the device disclosed in the ‘021 patent. Neutrino objects to Ms. Baker’s reliance on “the originally filed application from which the ‘021 Patent claims priority.”'? Neutrino contends 11. Jd. at 8-10. 12. Dkt. # 258, at 20. 58a Appendix E that the appropriate focus should have been the “invention,” which it defines as “the claims of the patent.’”'* However, the Federal Circuit has explained that “[t}he written description requirement and its corollary, the new matter prohibition of 35 U.S.C. § 132, both serve to ensure that the patent applicant was in full possession of the claimed subject matter on the application filing date.” TurboCare, 264 F.3d at 1118. New claims and any other added material must find Support in the original specification. Therefore, the Court finds that Ms. Baker properly focused her “new matter” analysis on the specification in the original patent application. As for Neutrino’s disagreement with Ms. Baker over the numbers of hands required to hold different components and turn different knobs, the Court finds that such a factual controversy is more appropriate for cross-examination. Therefore, the Court finds that Ms. Baker’s testimony is admissible under Daubert. II. Donald W. Baker Mr. Baker’s testimony pertains to whether the ‘021 patent would have enabled a person of ordinary skill in the art at the time the patent application was filed to make and use the claimed invention without undue experimentation. 35 U.S.C. § 112; Adang v. Fischhoff, 286 F.3d 1346, 1355 (Fed.Cir.2002); In re Wands, 858 F.2d 731, 737 (Fed.Cir. 1988). Neutrino objects to Mr. Baker’s testimony on five grounds: (1) Mr. Baker’s underlying expertise was out-dated at the time the ‘021 patent was filed; (2) Mr. Baker 13. Id. at 21. 59a Appendix E has demonstrated no knowledge of the level of ordinary skill in the art; (3) Mr. Baker’s “real world feasibility” testimony is irrelevant and unreliable; (4) Mr. Baker failed to exclusively focus on the claims of the ‘021 patent; and (5) Mr. Baker failed to properly consider the patents incorporated by reference in the ‘021 patent. Neutrino challenges Mr. Baker’s qualifications to testify from the perspective of one of ordinary skill in the art at the time the patent application was filed on the grounds that he had been retired from the field for 12 years at the time of the filing in 1997. Mr. Baker’s curriculum vitae confirms that he held his last professional position in the field in 1983. Furthermore, during his deposition, Mr. Baker conceded that “many advances” in medical ultrasound technology and in the miniaturization of electronic components used in commercial products had taken place in the 12-year period between his last professional position in the field and the date the ‘021 patent was filed.'* Sonosite contends that Mr. Baker remained current in the field through teaching, consulting, and reading professional journals and was thereby knowledgeable about the level of ordinary skill in the art in 1997. Sonosite further argues that Mr. Baker’s retirement from the field is not sufficient to disqualify him as an expert. The Court agrees that the simple fact that Mr. Baker was retired in 1997 does not, in and of itself, disqualify his testimony; however, the relevant inquiry under the enablement defense requires Mr. Baker’s knowledge to be contemporary to the patent application filing. Mr. Baker testifies in his supplemental declaration that he kept abreast 14. Dkt. # 259, Exhibit B, p. 71. 60a Appendix E of developments in the field through consulting, teaching and various other activities from the time of his retirement through the time of the filing date of the ‘021 patent application.'> Mr. Baker also explicitly qualifies his explanation of the level of skill in the art in terms of his knowledge of the field in 1997. Thus, the Court finds that Mr. Baker’s knowledge of the field was not out-dated in 1997. Any objections that Neutrino maintains about Mr. Baker’s specific consideration of issues relevant to the field in 1997 are appropriate material for cross-examination. Neutrino also objects generally to the sufficiency of Mr. Baker’s knowledge of the level of ordinary skill in the art in 1997. Neutrino’s assertion that Mr. Baker “has no idea how to legally determine the level [of ordinary skil! in the art]. . .” (emphasis added) misapprehends the proper inquiry into the level of ordinary skill in the art. The relevant analysis is factual. Ryko Mfg., 950 F.2d at 718. Mr. Baker’s factual conclusions about the level of ordinary skill in the art are under the purview of the jury so long as the Court determines that his testimony is reliable. Neutrino contends that the absence of analysis underlying Mr. Baker’s factual conclusions about the level of ordinary skill fails the reliability analysis set forth under Daubert. However, Mr. Baker’s conclusivns about the level of ordinary skill in the art are nonscientific expert opinions based on specialized knowledge. See MCCORMICK ON EVIDENCE § 13. Where scientific knowledge is not at issue, the Court need not use the Daubert factors to determine reliability, but may gauge reliability from a more flexible analysis. Kumho Tire, 526 15. Sonosite’s Exhibit 31. 6la Appendix E U.S. at 149, 119 S.Ct. 1167. Mr. Baker’s opinions as to the level of ordinary skill in the art are necessarily based on his own experience. In his supplemental declaration, Mr. Baker sets forth the education and experience necessary to be one of ordinary skill in the art and explains that he derived these standards fromm his own experience working and teaching in the field.'© The Court is satisfied that Mr. Baker has ample experience in the field to reliably opine about the level of ordinary skill in the art. Neutrino also argues that Mr. Baker’s “real-world feasibility” testimony is not relevant because it “is not a correct focus in an enablement analysis.”'’ The Federal Circuit Court of Appeals has articulated the test for enablement as follows: A decision on the issue of enablement requires determination of whether a person skilled in the pertinent art, using the knowledge available to such a person and the disclosure in the patent document, could make and use the invention without undue experimentation. Northern Telecom, Inc. v. Datapoint Corp., 908 F.2d 931, 941 (Fed.Cir. 1990). Neutrino contends that testimony by Mr. Baker about the “feasibility” of designing the patented invention subjects the patent to a more rigorous analysis than that demanded by the “make and use ... without undue experimentation” requirement of § 112. Specifically, 16.. Id. 17. Dkt. # 258, p. 13. 62a Appendix E Neutrino offers portions of Mr. Baker’s deposition testimony that suggest Mr. Baker equated [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40386016_2465%3A1. Public record. Not legal advice.