Free Brief - District Court of Colorado - Colorado

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IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLORADO

Civil Action No. 1:03-cv-02372-PSF-PAC JACK BARRECA Plaintiff, v. SOUTH BEACH BEVERAGE CO., INC.; LOTTE U.S.A; and 7-ELEVEN, INC. Defendants. ________________________________________________________________________ PLAINTIFF'S BRIEF IN RESPONSE TO COURT ORDER ON PLAINTIFF'S MOTION FOR SUMMARY JUDGMENT ON VALIDITY OF THE '839 PATENT [DOCKET ENTRY 142] ________________________________________________________________________ Plaintiff responds to the Court's September 30, 2005 Order requesting a 10-page brief on enablement issues regarding the `839 patent claims. I. Introduction The Court requested that each party address whether plaintiff's '839 patent meets the enabling requirements of § 112. The Court stated that "Thus while the claims of the '839 patent claim an invention that contains active ingredients only in the outer gum shell, the description of the invention that appears in the specifications would apparently lead one skilled in the art to make a gum product similar to that claimed in the '540 patent where the active ingredients are contained in the interior of the gum in the liquid fill center, and not what is claimed in the '839 patent, where the active ingredient is found in the gum substance itself. Such a description does not appear to the Court to meet the enabling requirement of § 112...."

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As explained below, the Court is mistaken as to the factual and legal aspects of how the enablement requirement under 35 USC section 112, 1st paragraph is properly applied in this case. 1 In the `540 litigation (involving the identical patent specification as in the `839 patent litigation) 2 , the issue of invalidity for alleged violation of the enablement requirement under 35 USC section 112 was never mentioned by Defendants. Because the `839 claims are fully enabled by the patent specification (by explicit language in the specification and by "incorporation by reference" to numerous prior art patents), there is an absence of any evidence, let alone the requisite clear and convincing evidence, that the `839 claims are invalid for failure to satisfy the enablement requirement under section 112. Because there has been no showing of clear and convincing evidence of invalidity of any claim of the `839 patent, Plaintiff respectfully requests that the Court reconsider its earlier findings and rule as a matter of law that the `839 claims retain their statutory presumption of validity.

Plaintiff respectfully notes that the present brief is solely directed to "enablement", rather than "written description" issues under 35 USC 112, since the Court specifically requested briefing on "enablement." Plaintiff requests the opportunity to further address any outstanding written description concerns, if any, that the Court may later raise. 2 The Court's recent Order states: "To the Court, it appears as the drafter of the '839 patent merely `cut and pasted' the verbiage from the '540 patent into the '839 patent." The reason the `540 and `839 specifications are identical is that this is required. See 35 USC section 120. (The `839 patent is a straight "continuation" of the `540 patent.) The specification, however, is able to support a multitude of various claimed embodiments, not just those encompassed by the originally issued `540 claims. (See e.g., the distinct claims of U.S. Patent No. 6,869,614). 2

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II.

Applicable Law A. Enablement

The enablement requirement is set forth in the first paragraph of section 112 of title 35, and provides in pertinent part that the specification shall describe "the manner and process of making and using [the invention], in such clear and 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 invention]." 35 U.S.C. § 112, 1 (2000). The enablement requirement is satisfied when one skilled in the art, after reading the specification, could practice the claimed invention without undue experimentation. Adang v. Fischhoff, 286 F.3d 1346, 1355 (Fed. Cir. 2002) It is imperative when attempting to prove lack of enablement to show that one of ordinary skill in the art would be unable to make the claimed invention without undue experimentation. Johns Hopkins Univ. v. CellPro, Inc., 152 F.3d 1342 (Fed. Cir. 1998). Because a patent specification must enable the full scope of a claimed invention, In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993), an enablement inquiry typically begins with a construction of the claims, see MPEP § 2164.08. Because a patent is presumed to be valid, 35 U.S.C. § 282 (2000), the evidentiary burden to show facts supporting a conclusion of invalidity is one of clear and convincing evidence, WMS Gaming Inc. v. Int'l Game Techs., 184 F.3d 1339, 1355 (Fed. Cir. 1999). Although the legal criteria of enablement and written description are related and are often met by the same disclosure, they serve discrete legal requirements. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563 (Fed. Cir. 1991). The predictability or unpredictability of the

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science is relevant to deciding how much experimental support is required to adequately describe the scope of an invention. In re Storrs, 245 F.2d 474, 478 (CCPA 1957). The specification itself need not necessarily describe how to make and use every possible variant of the claimed invention, for the artisan's knowledge of the prior art and routine experimentation can often fill gaps, interpolate between embodiments, and perhaps even extrapolate beyond the disclosed embodiments, depending upon the predictability of the art. See Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1366 (Fed. Cir. 1997) ("[A] specification need not disclose what is well known in the art.") A claim will not be invalidated on section 112 grounds simply because the embodiments of the specification do not contain examples explicitly covering the full scope of the claim language. See Union Oil Co. v. Atl. Richfield Co., 208 F.3d 989, 997 (Fed. Cir. 2000). That is because the patent specification is written for a person of skill in the art, and such a person comes to the patent with the knowledge of what has come before. In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995). Invalidity of a patent for lack of enablement is a conclusion of law and such conclusion must be supported by facts proved by clear and convincing evidence. National Recovery Technologies, Inc. v. Magnetic Separation Systems, Inc., 166 F.3d 1190, 1195 (Fed. Cir. 1999). In view of this high burden of proof, and only where no genuine issues of material fact exist, may a court determine that a specification fails to satisfy the requirements of § 112. Id.

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B.

Incorporation by Reference

The general incorporation of a U.S. patent by reference in a patent specification is sufficient to indicate what is likely to be known by persons of ordinary skill in the art. In re Howarth, 654 F.2d 103 (CCPA 1981). In re Hawkins, 486 F.2d 569, 573 (CCPA 1973) (The practice of incorporation by reference has "longstanding basis in the law"). "As the expression itself implies, the purpose of `incorporation by reference' is to make one document become a part of another document by referring to the former in the latter in such a manner that it is apparent that the cited document is part of the referencing document as if it were fully set out therein." In re Lund, 376 F.2d 982, 989 (CCPA 1967) (emphasis added); In re Heritage, 182 F.2d 639, 643 (CCPA 1950) ("There can be no question but that in a patent application, the disclosure thereof may be supplemented by reference to . . . any . . . disclosure which is available to the public."); see also MPEP 608.01(p). III. Argument The specification of the '839 patent describes in ample detail how to make and use the claimed invention, including the particular embodiments illustrated in Figure 1, which states: "GUM-BASED OUTER SHELL CONSISTING OF ALL OR SOME INGREDIENTS LISTED IN TABLES I AND II." With the extensive citation to and incorporation by reference of prior art in the area of center-fill gum manufacturing, there can be little question that the specification is enabling because it teaches those skilled in the art how to make and use the full scope of the claimed invention without "undue experimentation." See, In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993). There is no

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evidence whatsoever (and Defendants, after years of patent litigation, have never argued to the contrary) that any "undue experimentation" by a person having ordinary skill in the art would be required to make the invention encompassed by the `839 claims. Indeed, Defendants have argued just the opposite ­ providing expert reports that state that nothing in Plaintiff's issued patents is even "inventive." (See Exhibit A to Plaintiff's Motions to Exclude Expert Testimony of Douglas Fritz in the `839 and `540 cases). A. Incorporation By Reference In The `839 Patent

The `839 patent provides enabling support for the claims invention by incorporating by reference well recognized principals, practices and techniques employed in the gum industry. "Incorporated by reference in its entirety are the following U.S. patents directed generally to chewing gum compositions, methods and apparatus for making chewing gum, and in particular, methods for enabling one of skill in the art to produce soft-centered chewing gums as contemplated by the present invention. The novelty of the present invention, however, should be understood as being distinguished from such prior art references and such incorporation by reference is only provided for enabling support of the numerous ways in which the particular novel product can be manufactured. The U.S. patents incorporated by reference are as follows: U.S. Pat. Nos. 5,922,347; 5,916,606; 5,912,030; 5,900,230; 5,885,630; 5,866,179; 5,858,423; 5,846,557; 5,834,002; 5,827,526; 5,824,291; 5,736,175; 4,156,740; 5,498,429; 4,466,983; 4,157,402; 5,569,477; 5,125,819; 5,248,508; 4,975,288; 4,792,453; 4,980,178; 4,683,138; 5,087,460; 4,292,329; 4,642,235; 4,316,915; 4,513,012; 4,250,196; 5,431,929; and 4,647,450." (Col. 2, lines 30-48)(emphasis added)

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As an example of how the prior art patents incorporated by reference provides more than sufficient enabling support to make the claimed invention, one need only look to U.S. Patent No. 4,980,178 to Cherukuri et al. 3 and Ogawa et.al. 4 B. The Court Misreads The `839 Claims

The Court incorrectly states in its recent Order that "the claims of the '839 patent claim an invention that contains active ingredients only in the outer gum shell...." Viewed correctly, all of the claims of the `839 patent have the same language (indicated in bold) as in claim 1:

1.

A chewing gum consisting essentially of a first substance comprised of gum configured so as to have at least one cavity capable of retaining a liquid or semi-liquid substance as a second substance, wherein at least said first substance has active ingredients consisting essentially of guarana, ginseng and at least one metabolic enhancer that increases a user's metabolism in order to achieve a higher caloric burn rate, said active ingredients together present in an amount of up to 5 grams.

Unlike the `540 claims, which required active ingredients to be present in the center-fill of the gum, the `839 patent claims expressly provide that the active ingredients are "at least" in the gum-based portion of the gum. Therefore, embodiments where active ingredients are in the gum base solely and where such ingredients are also in the centerfill material (the "second substance") are both encompassed by the `839 claims.

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U.S. Pat. No. 4,980,178, "One stability problem with center-filled chewing gum compositions is that ... the liquid center tends to be absorbed by, or migrates into, the solid outer shell...." 4 U.S. Pat. No. 4,157,402, assigned to Lotte Co., Ltd., discloses a center-filled chewing gum which contains "an aqueous liquid center containing an emulsifier ... thereby reducing separation and migration of the center." 7

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C.

The `839 Patent Specification Supports Active Ingredients Being In Both The Gum Base And The Center-Fill Material

The patent specification expressly provides support for the `839 claims having active ingredients in the gum base and/or the center-fill. FIG. 1 represents one embodiment of the invention depicting a "GUM-BASED OUTER SHELL CONSISTING OF ALL OR SOME INGREDIENTS LISTED IN TABLES I OR TABLE II." It also depicts: "LIQUID OR SYRUP CENTER CONSISTING OF ALL OR SOME INGREDIENTS LISTED IN TABLES I AND II." (See Exhibit A). "It is within the scope of the present invention to incorporate various known diet control substances in either the gum material itself and/or in the liquid interior material encompassed by the gum material." (Col. 3, lines 47-52) (emphasis added) ".....the gum itself can be of a traditional gum composition and/or may incorporate various other desirable metabolic increasing components to supplement and/or coact with components contained in the liquid center of the gum." (Col. 3, lines1923) (emphasis added) D. The Court's Prior Markman Order Regarding The `540 Patent Claims Acknowledges Enabling Support For The `839 Claims

The Court previously noted the following in its Order dated June 16, 2004: "It is true, as plaintiff points out, that there is a sentence in the summary of the invention which states that "[I]t is within the scope of the present invention to incorporate various known diet control substances in either the gum material itself and/or in the liquid interior material encompassed by the gum material." (Col. 3, ln. 47-50)." ..."While active ingredients may appear in the outside gum, they must be found in the center cavity." (Order, p. 24) (emphasis added)

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E.

Defendants' Arguments That The `839 Patent Claims Are Invalid Based On Prior Art Teachings Demonstrates That The Present Invention Is Enabled

Defendants' technical expert, who contends that he is one of skill in the art, has stated that the claims of the `839 patent are rendered obvious by several prior art publications. In order to "invalidate" a prior art disclosure must also be enabling, such that one of ordinary skill in the art could practice the invention without undue experimentation. SmithKline Beecham v. Apotex Corp., 403 F.3d 1328, 1342. If the prior art is not enabling, it does not invalidate the patent. See, e.g. Rockwell Int'l Corp. v. U.S., 147 F.2d 1358 (Fed. Cir. 1998). Because each of Defendants' allegedly invalidating references must, as a matter of law, be "enabling" themselves, and because at least some of these references were incorporated by reference in the `839 specification, the Defendants' prior statements support, rather than contradict, the fact that the `839 patent claims are enabled. 5 Here, the Defendants have admitted that the claimed invention is not complex. Defendants previously acknowledged that "[t]he invention disclosed in the '839 is not a microchip, a pharmaceutical, or a complex machine." (Defendants' Response to Plaintiff's Motion to Exclude Expert Testimony of Douglas Fritz). Because the predictability of the admittedly non-complex area of gum making is high, the amount of enabling disclosure required is consequently low. See, e.g. In re Storrs, 245 F.2d 474, 478 (CCPA 1957). "The determination of what constitutes undue experimentation in a

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Mr. Fritz's expert report quotes from the Hager patent, US Patent No. 4,975,288, as follows: "Various other machines and methods are known in the prior art for making center-filled chewing gum, ..." 9

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given case requires the application of a standard of reasonableness, having due regard for the nature of the invention and the state of the art." Ansul Co. v. Uniroyal, Inc., 448 F.2d 872, 878-79, (2d Cir. 1971). Finally, the PTO allowed the `839 (and also the `540 and `614) claims without finding any enablement concerns. Issued claims reflect a reasoned and careful review by trained Patent examiners. See, Amgen Inc. v. Hoechst Marion Roussel Inc., 314 F.3d 1313, 1330 (Fed. Cir. 2003)("We must presume the examiner did his job..."). Here, Supervising Examiner Thurman Page was the examiner on the `540, `614 and `839 patents, 6 and has significant experience in examining patents in the chewing gum art. He would not have allowed claims (on three separate occasions) that violated the enablement requirement. IV. Conclusion For the foregoing reasons, Plaintiff respectfully requests that the Court find that there has been no evidence, let alone clear and convincing evidence, to alter the statutory presumption of validity of the `839 patent claims.

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He was also aware of the Defendants' invalidity defenses in the `540 patent litigation because Plaintiff provided him with such information pursuant to MPEP 2001.06(c). 10

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DATED: October 28, 2005 Respectfully submitted,

s/ Robert R. Brunelli____________ Robert R. Brunelli, Esq. ([email protected]) Joseph E. Kovarik, Esq. ([email protected]) Sheridan Ross P.C. 1560 Broadway, Suite 1200 Denver, Colorado 80202 (303) 863-9700

ATTORNEYS FOR PLAINTIFF JACK BARRECA

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CERTIFICATE OF SERVICE

I hereby certify that on October 28, 2005, I electronically filed the foregoing with the Clerk of Court using the CM/ECF system which will send notification of such filing to the following e-mail addresses: [email protected] [email protected] [email protected] [email protected] [email protected] [email protected]

s/ Brenda A. Carpenter Brenda A. Carpenter Assistant to Joseph E. Kovarik Attorney for Plaintiff SHERIDAN ROSS P.C. 1560 Broadway, Suite 1200 Denver, CO 80202-5141 Telephone: 303-863-9700 Facsimile: 303-863-0223 Email: [email protected] [email protected]

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