Trademark Trial and Appeal Board Electronic Filing System. http://estta.uspto.gov
`ESTTA313098
`ESTTA Tracking number:
`10/22/2009
`
`Filing date:
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD
`92048656
`Plaintiff
`ICU Medical, Inc.
`Kimberly Van Voorhis, Erika Yawger
`Morrison & Foerster LLP
`755 Page Mill Rd.
`Palo Alto, CA 94304
`UNITED STATES
`kvanvoorhis@mofo.com, eyawger@mofo.com
`Other Motions/Papers
`Erika L. Yawger
`eyawger@mofo.com, kvanvoorhis@mofo.com
`/ELY/
`10/22/2009
`2009-10-22 Neutral Displacement.pdf ( 30 pages )(1472846 bytes )
`
`Proceeding
`Party
`
`Correspondence
`Address
`
`Submission
`Filer's Name
`Filer's e-mail
`Signature
`Date
`Attachments
`
`

`
`TRADEMARK
`Docket No. 63145-6002.501
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD
`
`ICU MEDICAL, INC.,
`
`Cancellation No. 92048656
`
`V.
`
`Petitioner,
`
`Mark: NEUTRAL DISPLACEMENT
`Reg. No. 3337575
`
`RYMED TECHNOLOGIES, INC.,
`
`
`
`Respondent.
`
`United States Patent and Trademark Office
`
`Trademark Trial and Appeal Board
`P.O. Box 1451
`
`Alexandria, VA 22313 -1451
`
`Dated: October 22, 2009
`
`NOTIFICATION OF ORDER AND JUDGMENT IN RELATED CIVIL LITIGATION
`
`Petitioner ICU Medical, Inc. (“ICU” or “Petitioner”) hereby notifies the Board of recent
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`activities in the matter, Rymed Technologies, Inc. v. ICU Medical, Inc., Case No. SA CV-O7-
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`1199 MRP (VBKX), pending in the United States District Court for the Central District of
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`California.
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`On April 22, 2009, the Court issued an order, attached hereto as Exhibit A, granting
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`lICU’s motion for partial summary judgment on the trademark claims and holding that the
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`“NEUTRAL DISPLACEMENT” mark at issue in this cancellation proceeding is generic and not
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`entitled to any trademark protection.
`
`pa-1366393
`Cancellation No. 92048656
`Docket No. 63145-6002.501
`
`

`
`On October 8, 2009, the Court issued an order granting ICU’s counterclaims 1 through 4
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`for invalidity and cancellation of the “neutral” and “neutral displacement” trademarks, and
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`dismissing as moot counterclaim 5 for non-infringement. The Court further ordered that
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`pursuant to 15 U.S.C. § 1119, the Director of the Patent and Trademark Office shall cancel U.S.
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`Registration No. 3,337,575 for the term “neutral displacement.” Attached hereto as Exhibit B is
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`a true and correct copy of the October 8, 2009 Order.
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`On October 8, 2009, the Court also entered final judgment in ICU’s favor. Attached
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`hereto as Exhibit C is a true and correct copy of the Court’s October 8, 2009 Judgment.
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`RyMed has not appealed the District Court’s decision, and the time for appeal will expire
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`on November 9, 2009. Petitioner will notify the Board when the judgment in the civil action is
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`deemed final pursuant to § 510.02(b).
`
`MORRISON & FOERSTER LLP
`
` Eri a L. Yawger
`
`Morrison & Foerster, LLP
`755 Page Mill Road
`Palo Alto, California 94304-1018
`Telephone: (650) 813-5600
`Facsimile: (650)494-0792
`
`Attorneys for Petitioner
`ICU MEDICAL, INC.
`
`pa-1366393
`Cancellation No. 92048656
`
`Docket No. 63145-6002.501
`
`

`
`Exhibit A
`
`

`
`Cas 8:07—cv—01199-MRP-VBK Document182
`
`Filed 04/22/2009
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`Page 1 of 20
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`UNITED STATES DISTRICT COURT
`
`CENTRAL DISTRICT OF CALIFORNIA
`
`RyMed Technologies, Inc.,
`
`Case No. 8:07-CV-1199 MRP (VBKX)
`
`v.
`
`Plaintiff,
`
`ORDER GRANTING ICU MEDICAL,
`INC.’S MOTION FOR PARTIAL
`SUMMARY JUDGMENT
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`ICU Medical, Inc.,
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`
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`Defendant.
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`I. Background
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`A. Procedural History
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`ICU Medical, Inc. (“ICU”) brought suit against Rymed Technologies, Inc.
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`(“Rymed”) for patent infringement in the District of Delaware on July 27, 2007.
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`Rymed then filed this suit in the Central District of California on October 10, 2007
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`for declaratory judgment of non—infringement and patent invalidity, together with
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`state and federal trademark and related claims.‘ The patent claims were transferred
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`1 Rymed’s claims include federal claims under the Lanham Act: trademark
`infringement (15 U.S.C. § 1114), false designation of origin, and unfair
`competition (§ 1l25(a)); claims under California law: unfair competition (Cal.
`Bus. & Prof. Code §§ 17200, 17500); common law passing off and unfair
`competition; intentional interference with contract; and intentional interference
`
`-1-
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`

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`Cas 8:07-cv—O1199-MRP-VBK Document182
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`Filed 04/22/2009
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`Page 2 of 20
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`p_A
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`to the District of Delaware May 21, 2008. ICU filed in this Court a Motion for
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`Partial Summary Judgment of the “Neutral” False Advertising and Trademark
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`Claims?
`
`B. Needleless connectors
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`Since the early 1990s, intravenous catheters have almost exclusively
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`employed needleless connectors because they obviate many problems associated
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`with accidental needle stick injuries. When the original needleless intravenous
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`(I.V.) connectors were disconnected, they caused a “negative fluid displacement,”
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`or reflux of the patient’s blood within the catheter fluid pathway. If this blood
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`remained into the catheter, it would likely clot and block fluid flow, resulting in an
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`inability to draw blood or infuse medication to the patient, and the risk of catheter-
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`related bloodstream infection.
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`In the late 1990s, “positive fluid displacement” I.V. connectors were
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`developed, which were designed to push fluid out of the catheter upon
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`disconnection. However, upon connection, they caused negative fluid
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`displacement, drew patient blood into the catheter, and were likely to cause the
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`resulting issues associated with blood reflux.
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`In 2004, Rymed sought to alleviate the problems associated with negative
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`fluid flow with the InVision-Plus needleless connector, which was characterized b
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`Rymed as the first needleless connector with “zero fluid displacement.” Decl. of
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`Dana Wm. Ryan in Opp. to ICU Medical’s Mot. for Partial Summ. J. (“Ryan
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`Decl.”) at 5-6.
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`
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`with prospective business and economic advantages. Counts 1-9, Rymed’s First
`Am. Compl. for Injunctive Relief at 14-23.
`2 These claims include Counts 1, 2, 4, and 5 in their entirety, Counts 3, 6, and 7,
`with respect to the “Neutral” mark, but not Counts 8 and 9. Id.
`
`-2-
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`

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`Cas 8:07-cv—01199—MRP-VBK Document182
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`Filed 04/22/2009
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`Page 3 of 20
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`C. R3@ed’s trademark registrations
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`Rymed holds Trademark Registration No. 3,168,566 on the Principal
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`Register for the term “Neutral” in connection with “medical apparatus for use in
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`performing intravenous procedures, namely, tubing connectors and valves for use
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`in the collection and distribution of blood and intravenous fluids” in Class 10
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`(medical apparatus). Rymed filed for this trademark protection in the U.S. Patent
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`and Trademark Office (“U.S.P.T.O.”) on December 22, 2005, representing its first
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`use and first use in commerce as December 1, 2005. ICU filed a petition for
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`cancellation of Ryrned’s “Neutral” registered mark in the U.S.P.T.O. on November
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`6, 2007. The proceedings were stayed on April 2, 2008 by the Trademark Trial
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`and Appeal Board, pending the outcome of this case.
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`At the same time as the application for “Neutral,” Rymed filed an
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`application for the term “Neutral Displacement” in connection with the same good
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`and in the same class as the “Neutral” term, but the first use and first use in
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`commerce of the mark were represented to be January 1, 2004.3 The examining
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`attorney at the U.S.P.T.O. refused the application for registration, on the grounds
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`that the term was “merely descriptive of the identified goods” and that Rymed was
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`“not the only user of this term [“Neutral Displacement”] to describe medical
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`valves,” citing ICU’s MicroClave marketing material. Rymed amended its
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`application to apply for registration on the Supplemental Register, rather than the
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`Principal Register. Rymed received Trademark Registration No. 3,337,575 on the
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`Supplemental Register on November 13, 2007.
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`The central dispute in this summary judgment centers around whether
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`“neutral” and “neutral displacement” are generic terms to describe features of
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`needleless connectors or are protectable as trademarks.
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`3 Rymed, in this suit, asserts that the first sale for clinical use of the “InVision—
`P1us® Neutral® Intraluminal Protection System” was in April 2004, which was
`after its application for U.S. Patent No. 6,994,315.
`
`-3-
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`Cas 8:07-CV-01199-MRP—VBK Document 182
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`Filed 04/22/2009
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`Page 4 of 20
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`II. Analysis
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`A. Legal Standard for Summary Judgment
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`Summary judgment is appropriate “if the pleadings, the discovery and
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`disclosure materials on file, and any affidavits show that there is no genuine issue
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`as to any material fact and that the movant is entitled to judgment as a matter of
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`law.” Fed. R. Civ. P. 56(c). In this inquiry, “[t]he evidence of the non-movant is
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`to be believed, and all justifiable inferences are to be drawn in his favor.”
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`Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255 (1986). However, for the non-
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`moving party to prevail, there must be evidence sufficient to allow a reasonable
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`jury to return a verdict in favor of the non—moving party. Id. at 248.
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`Summary judgment also “necessarily implicates the substantive evidentiary
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`standard of proof that would apply at trial on the merits.” See Anderson, 477 U.S.
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`at 252-255 (“Whether a jury could reasonably find for either party .
`.
`. cannot be
`defined except by the criteria governing what evidence would enable the jury to
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`find for either the plaintiff or the defendant .
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`.
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`. .”). The burden of the moving
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`party is “to show initially the absence of a genuine issue concerning any material
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`fact.” Celotex Corp. v. Catrett, 477 U.S. 316, 325 (U.S. 1986). The non—moving
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`party must then “go beyond the pleadings” and designate “specific facts showing
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`that there is a genuine issue for trial.” Id. at 324.
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`B. Trademark validity
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`1. Legal standard
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`The purpose of a trademark is to identify and distinguish the goods or
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`services of one party from those of another party. 15 U.S.C. § 1127. The Lanham
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`Act makes “actionable the deceptive and misleading use of marks” and “protect[s]
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`persons
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`against unfair competition.” Id. A trademark is defined as including
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`“any word, name, symbol, or device, or any combination thereof” used by a person
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`“to identify and distinguish his or her goods, including a unique product, from
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`-4-
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`Filed 04/22/2009
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`Page 5 of 20
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`those manufactured or sold by others and to indicate the source of the goods, even
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`if that source is unknown.” Id.
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`Cases generally identify four categories of marks, in ascending levels of
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`strength, they are (1) generic, (2) descriptive, (3) suggestive, and (4) arbitrary or
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`fanciful, although “the lines of demarcation are not always clear.” Surgicenters of
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`Am. v. Med. Dental Surgeries, 601 F.2d 1011, 1014 (9th Cir. 1979). A “‘generic’
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`term is one that refers, or has come to be understood as referring, to the genus of
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`which the particular product or service is a species” and “cannot become a
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`trademark under any circumstances.” Id. (citing Abercrombie & Fitch Co. v.
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`Hunting World, Inc., 537 F.2d 4, 9-10 (2nd Cir. 1976)). “A merely ‘descriptive’
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`term specifically describes a characteristic or ingredient of an article or service”
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`and can become a valid trademark by “acquiring a secondary meaning, i.e.,
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`becoming ‘distinctive of the applicant's goods.”’ Id. “A ‘suggestive’ term
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`suggests rather than describes an ingredient, quality, or characteristic of the goods
`and requires imagination, thought, and perception to determine the nature of the
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`goods” and therefore does not require proof of secondary meaning to be registered
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`as a trademark. Id. at 1014-15. “An ‘arbitrary or fanciful’ term is usually applied
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`to words invented solely for their use as trademarks” and may be registered as a
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`trademark without proof of secondary meaning, i.e., “without the need of debating
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`whether the term is ‘merely descriptive”’ and also “with ease of establishing
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`infringement.” Id. at 1015.
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`In a trademark infringement action, the plaintiff bears the ultimate burden
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`of persuasion, that is, proof of infringement. Tie Tech, Inc. v. Kinedyne Corp., 296
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`F.3d 778, 783 (9th Cir. 2002). The validity of the trademark is of course “a
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`threshold issue,” as there can be no infringement of an invalid mark. Id.
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`Federal registration is primafacie evidence of the validity of the mark. 15
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`U.S.C. § l057(b) (“A certificate of registration of a mark upon the principal
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`register provided by this chapter shall be prima facie evidence of the validity of the
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`-5-
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`Filed 04/22/2009
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`Page 6 of 20
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`registered mark and of the registration of the mark, of the registrant’s ownership of
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`the mark, and of the registrant’s exclusive right to use the registered mark”). Thus,
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`for registered marks, a defendant may rebut the presumption of validity, “by a
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`showing by a preponderance of the evidence that the term was or has become
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`generic.” Anti-Monopoly, Inc. v. General Mills Fun Group, Inc., 684 F.2d 1316,
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`1319 (9th Cir. 1982). When a mark is not registered, there is no presumption of
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`validity, and “the plaintiff is left with the task of satisfying its burden of proof of
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`establishing a valid mark absent application of the presumption.” Yellow Cab Co.
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`v. Yellow Cab ofElk Grove, Inc., 419 F.3d. 925, 928 (9th Cir. 2005).
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`If a plaintiff meets its burden of proving that he has a valid mark, he must
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`also prove that “the defendant’s use of the same or similar mark would create a
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`likelihood of consumer confiision” to maintain an action for trademark
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`infringement under 15 U.S.C. § 1114, false designation of origin under 15 U.S.C. §
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`l125(a), and unfair competition under California law. Murray v. Cable Nat ’l
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`Broadcasting C0., 86 F.3d 858, 860 (9th Cir. 1996).
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`Summary judgment is proper when there is no trademark protection.
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`Filipino Yellow Pages, Inc. v. Asian Journal Publ ’ns, Inc., 198 F.3d H43, 1147
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`(9th Cir. 1999) (affirming summary judgment of finding “Filipino Yellow Pages” a
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`generic term and dismissing trademark infringement, false designation of origin,
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`unfair competition and other claims).
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`In actions involving registered marks,
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`courts may determine the right to registration, and cancel registrations, in whole or
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`in part. 15 U.S.C. § 1119. See also Informix Software, Inc. v. Oracle Corp., 927
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`F. Supp. 1283 (N.D. Cal. 1996) (discussing concurrent jurisdiction of a federal
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`court and the Trademark Trial and Appeal Board over cancellation of trademarks).
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`2. Rymed’s marks
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`ICU asserts that Rymed’s marks “Neutral” and “Neutral Displacement” are
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`generic terms, or at most, merely descriptive marks without secondary meaning.
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`Mem. of P. & A.’s in Support of Mot. for Partial Summ. J. of “Neutral” False
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`-5-
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`Page 7 of 20
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`y_.A
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`Advertising and Trademark Claims (“ICU’s P. & A.’s”) at 17. ICU must present
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`facts to show by a preponderance of the evidence that Rymed’s marks are generic
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`to overcome the presumption of validity of the registered mark.
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`To determine whether a mark is generic, the Ninth Circuit has endorsed the
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`“‘who-are-you/what-are-you’ test.” Filipino Yellow Pages, 198 F.3d at 1147. “‘A
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`mark answers the buyer’s questions ‘Who are you?’ ‘Where do you come from?’
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`‘Who Vouches for you?’ But the [generic] name of the product answers the
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`question ‘What are you?”’ Filipino Yellow Pages, 198 F.3d (citing Official Airline
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`Guides, Inc. v. Goss, 6 F.3d 1385, 1391 (9th Cir. 1993) (quoting 1 J. McCarthy,
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`Trademarks and Unfair Competition § 12.01 (3d ed. 1992)). Under the “who-are-
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`you/what-are-you” test, “[i]f the primary significance of the trademark is to
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`describe the typp of product rather than the producer, the trademark [is] a generic
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`term and [cannot be] a valid trademark.” (Id. at 1147 quoting Anti-Monopoly, Inc.
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`v. General Mills Fun Group, 611 F.2d 296, 304 (9th Cir. 1979)). For a
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`determination of genericness, the crucial date is the date the alleged infringer
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`entered the market with the disputed mark or term. Yellow Cab, 419 F.3d at 928.
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`The test for genericness depends on the “primary significanceof the registered
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`mark to the relevant public.” 15 U.S.C. § 1064(3). Evidence to prove genericness
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`can be varied, and may include plaintiffs use, competitors’ use, dictionary
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`definitions, media usage, testimony of people in the trade, and consumer surveys.
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`2 J. McCarthy on Trademarks and Unfair Competition § 12: 13 (4th ed. 2009). See
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`also Filipino Yellow Pages, 198 F.3d at 1145.
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`Marks that are descriptive can be protected as valid trademarks with a
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`showing of secondary meaning. Filipino Yellow Pages, 198 F.3d at 1151 (citing
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`Surgicenters ofAm., 601 F.2d at 1014). Secondary meaning has “attached” to a
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`mark when “the consuming public connects the mark with the producer rather than
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`the product.” Surgicenters, 601 F.2d at 1018 (citing Carter- Wallace, Inc. v.
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`Procter & Gamble Co., 434 F.2d 794 (9th Cir. 1970)).
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`-7-
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`Courts may look to the use of a mark by the trademark_holder itself as well
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`as others to determine genericness. Colt Defense LLC v. Bushmaster Firearms,
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`Inc., 486 F.3d 701, 707 (1st Cir. 2007). “Generic use by the party seeking
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`trademark protection is relevant because ‘[a] kind of estoppel arises when the
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`proponent of [a] trademark use is proven to have itself used the term before the
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`public as a generic name .
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`.
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`. .’” Id. (citing McCarthy § 12:13) (alterations in
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`original). See also CG Roxane LLC v. Fiji Water Co. LLC, 569 F. Supp. 2d 1019,
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`1029 (N.D. Cal. 2008).
`
`a. R3@ed’s use of the terms
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`Rymed filed a patent application for a “Swabbable Needle—Free Injection
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`Port Valve System with Neutral Fluid Displacement,” now U.S. Patent No.
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`6,994,315 (“the Rymed patent”), on January 13, 2004, before its filing of the
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`trademark applications for marks “Neutral” and “Neutral Displacement.” Rymed
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`used the word “neutral” within the term “neutral fluid displacement” throughout
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`the specification and in prosecution arguments.
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`The application recites the word “neutral” within the term “neutral fluid
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`displacement in the title and written description generically five times, and in the
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`claims three times. See the Rymed patent: title, col. 2, lines 42-45 (“It is another
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`object of the invention to provide an injection port valve system which has a
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`neutralfluid displacement to minimize blood being refluxed or retrograded into a
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`vascular access device lumen. . .”), col. 3, lines 58-59 (“The system achieves a
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`neutralfluid displacement and an improved microbial ingress barrier.”), col. 8,
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`lines 39-43 (“This new design eliminates any interstitial cavity chamber or dead
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`space between these two interfaces thus assisting in achieving a ‘neutralfluid
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`displacement’ when the valve is moved from the decompressed state to the
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`compressed state.”), and col. 9, lines 6-ll (“assisting in eliminating the dead space
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`between the septum/boot valve and boot valve/spike tip interfaces to achieve
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`neutralfluid displacement during the compression and decompression cycle.’’)
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`Cas
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`8:O7—cv-01199—MRP—VBK Document182
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`Filed 04/22/2009
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`Page 9 of 20
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`(emphases added). Three claims of the Rymed patent recite the limitation as well:
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`claim 16 (“said second connector forces said second resilient barrier and said tip
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`portion of said first resilient barrier over said spike with neutralfluid displacement
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`and such that said second connector and said first connector are in fluid
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`communication with each other”), claim 28 (“such that the valve is opened putting
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`the device is in fluid communication with the fluid pathway with neutralfluid
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`displacement during coupling,” and claim 29 (“such that the device is no longer in
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`fluid communication with the fluid pathway with neutralfluid displacement during
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`uncoupling.). The Rymed patent; col. 12, lines 61-66; col. 15, lines 20-23; and col.
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`15, line 27 to col. 16, line 2 (emphases added).
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`While prosecuting the Rymed patent, Rymed used the neutral displacement
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`feature to overcome a rejection under 35 U.S.C. § l02(b) over its own prior patent.
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`To distinguish the claims from the prior art, Rymed characterized neutral fluid
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`displacement as “arguably the most important improvement over this inventor’s
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`prior apparatus which provided ‘low reflux’ but not ‘neutral fluid disp1acement’.”
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`Reply to Office Action dated Aug. 26, 2005 in Serial No. 10/756,601, at 18.
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`Rymed continued, “It wasn’t until the presently disclosed and claimed invention
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`that it was possible to provide completely neutral displacement, i.e.[,] absolutely
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`no reflux, a significant improvement” and offered to provide customer testimonials
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`to demonstrate that “the neutral (zero) fluid displacement is being heralded
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`throughout the U.S. at hospitals and by nursing associations as a significant
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`achievement which eliminates the need for heparin flushes.” Id.
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`The patent examiner allowed the claims, but amended claim 17 (which
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`issued as claim 16) to also include the limitation of “with neutral fluid
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`displacement” to “overcome potential prior art rejections.” Examiner’s
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`Amendment dated Sept. 20, 2005 in Serial No. 10/756,601, at 2. Rymed did not
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`comment on the examiner’s amendments.
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`Cas 8:07-cv-01199-MRP-VBK Document 182
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`Filed 04/22/2009
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`Page 10 of 20
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`While trademarks may be used in patent applications, they “should be
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`identified by capitalizing each letter of the mark (in the case of word or letter
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`marks) or otherwise indicating the description of the mar ” such as following the
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`mark with [trade] or ®, and “be accompanied by the generic terminology.”
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`Manual of Patent Examining Procedure (“M.P.E.P.”) § 608.0l(v). In addition, the
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`M.P.E.P. counsels “[a]lthough the use of trademarks is permissible in patent
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`applications, the proprietary nature of the marks should be respected and every
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`effort made to prevent their use in any manner which might adversely affect their
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`validity as trademarks” and counsels against the use of trademarks in the titles of
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`patent applications. Id.
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`Rymed’s use of the term “neutral fluid displacement” in the Rymed patent
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`and prosecution history are inconsistent with its assertion that the marks “Neutral”
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`and “Neutral Displacement” are protectable as trademarks. There is no indication
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`that Rymed intends these terms to be trademarks in the Rymed patent as filed, and
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`there is no generic terminology other than “neutra ” to describe the type of fluid
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`displacement. In fact, it was not until Rymed had to rely on the neutral fluid
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`displacement feature for patentability that it even discussed the feature with words
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`other than neutral fluid displacement.
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`Rymed, in its online video presentation “Neutral Fluid Displacement and
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`Base of Use,” used the terms “neutral” and “neutral fluid displacement”
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`generically. Kohut Decl., Ex. 59. Before introducing its product, Rymed’s
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`presentation describes the field of needlefree connectors, stating, “it is widely
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`believed that there are three types of Needle-Free IV Connector Systems as it
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`pertains to blood reflux: Neutral, Positive and Neutral. Actually, there are only
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`two types: Negative or Neutral.” Id. Rymed described how its needlefree
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`connector works “on the principle of neutral fluid displacement” and refers to the
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`InVision Plus connector as having a “neutral feature” and “neutral technology.”
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`Id. Similarly, in marketing material for the “InVision-Plus® Neutral” I.V.
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`-10-
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`

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`Cas 8:07-cv-O1199—MRP-VBK Document 182
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`Filed 04/22/2009
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`Page 11 of 20
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`Connector System,” Rymed characterizes the system as “the original and patented
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`neutral fluid displacement connector system.” Kohut Decl. Ex. 7 1. Additionally,
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`Rymed’s CEO Dana Ryan discussed the “‘clinical advantages’ of ‘Neutral Fluid
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`Displacement”’ and described the “‘Neutral’ displacement feature” in an email to a
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`physician. Supp. Decl. of Laura L. Kohut in Supp. of Reply Mot. by ICU Medical
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`for Partial Summ. J. of “Neutral” False Advertising and Trademark Claims at Ex.
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`13.
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`In February 2009, well after this case was underway, Rymed sought to
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`clarify the use of the term “neutral” to its own sales force, by stating “The
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`Neutral® is Rymed’s product.
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`How do you define ‘neutral?’ The Neutral is
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`what our product is called. It is not defined as anything and doesn’t mean anything
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`other than our product name. Zero displacement is a feature of The Neutral® and
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`the MicroClave® does not offer that. Clear?” Id. at Ex. 14. Evidence that
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`Rymed’s sales force did not understand that the term “neutral” was part of the
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`trademarked name of the products they sold further supports a finding of
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`genericness.
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`None of these uses or explanations, other than in the product name
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`“InVision-Plus® NeutralTM I.V. Connector System,” are consistent with anything
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`other than genericness.
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`b. Others’ use of the terms
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`ICU has provided evidence of others’ use of the words “neutral” and
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`“neutral displacement” in publications as evidence of the generic nature of these
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`An analysis of needlefree valves was published by the ECRI Institute, a
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`nonprofit organization that does evidence-based research in the medical field. In
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`its 2008 evaluation entitled “Needleless Connectors,” ECRI used the term “neutral
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`fluid displacement” generically. Decl. of Alison D. Burcar in Supp. of Mot. by
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`ICU Medical for Partial Summ. J. of “Neutral” False Advertising and Trademark
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`-11-
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`

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`Cas 8:07-CV-01199-MRP-VBK Document 182
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`Filed 04/22/2009
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`Page 12 of 20
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`Claims (“Burcar Decl.”), Ex. 4 (“Because both positive- and negative—reflux
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`devices have presented some concern in clinical practice, neutral fluid
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`displacement devices were introduced,” “Instructions with neutral fluid
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`displacement devices generally allow clamping [upon connection and
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`disconnection],” describing “neutral reflux” as a modification to IV-access
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`technology to eliminate infections). In addition, the ECRI Institute tested the
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`amount of displacement in needlefree connectors and classified them as “Negative
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`Displacement,” “Neutral Displacement,” and “Positive Displacement.” ICU’s P.
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`A.’s at 5. The Vygon Bionector, ICU MicroClave and Rymed Invision Plus were
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`each classified as “Neutral Displacement.” Id.
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`ICU has provided examples of generic use of the terms at issue in the
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`medical literature as well. A 2006 medical journal article entitled “Technology of
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`Flushing Vascular Access Devices” defines the term “neutral displacement
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`needleless system,” defining it as “not allow[ing] fluid to move in either direction
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`when tubing or a syringe is disconnected,” and classified types of needleless
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`injection systems as “Negative-displacement Devices,” “Positive-displacement
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`Devices,” and “Neutral-displacement Devices.” Burcar Decl., Ex. 9. Similarly, a
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`2006 article entitled “Heparin Locking for Central Venous Catheters” describes
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`prevention of intraluminal blood by catheter disconnection with “a positive or a
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`neutral needleless system,” which it also describes as eliminating the need for
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`flushing techniques. Id. at Ex. 15. The Association for Vascular Access described
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`locking catheters with a “positive or neutral displacement device.” Id. at Ex. 13.
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`Competitors of Rymed and ICU also use the word “neutral” in the field of
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`needlefree valves. For example, Vygon Corporation markets its Bionector device
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`as a “Capless, Self-Sealing, Needle-Free, Neutral Pressure I.V. Access Device”
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`and describes it in its 510(k) Summary as “a Male/Female Luer, neutral
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`displacement device.” Decl. of Laura L. Kohut in Supp. of Mot. by ICU Medical
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`Cas
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`8:07-cv-O1199—MRP—VBK Document 182
`
`Filed 04/22/2009
`
`Page 13 of 20
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`for Partial Summ. J. of “Neutral” False Advertising and Trademark Claims
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`(“Kohut Dec1.”), Ex. 14, 9.
`
`In addition, Rymed has provided evidence of generic use of the term
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`“Neutral” by those in the field. Laura Hayes, a product implementation nurse, in
`
`her deposition stated that she associates the brand name “Neutral” with the
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`InVision—Plus Neutral because “it’s part of [the] name,” but also stated that she
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`“tested the product and found it to be neutral,” and uses the term “neutra ”
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`“interchangeably with zero fluid displacement.” Declaration of Sarah M. Jalali in
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`Supp. of Rymed Technologies, Inc.’s Opp. to ICU Medical, Inc.’s Mot. for Partial
`
`Summ. J. (“Jalali Dec1.”) at Ex. 9. In response to a question regarding testing she
`
`and her colleagues performed to determine the fluid displacement of needleless
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`connectors, she stated “Yes, it was [neutral] —— I’m using these terms
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`interchangeably again, neutral, no reflux or zero displacement.” Id. Hayes’
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`testimony demonstrates that she uses the tenn “neutra ” generically to describe a
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`feature of needleless connectors. Similarly, Rymed provides evidence of the
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`understanding of the term “Neutral” to be functional in the deposition testimony of
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`Kenneth Knighten, a former ICU product specialist. Id. at Ex. 3. In response to a
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`question regarding whether ICU marketed the MicroClave connector in sales
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`materials as neutral or not, Knighten replied “No. Neutral is just part ofjust the
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`function.” Id. Rather than support Rymed’s position that such uses cause product
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`source confusion between ICU and Rymed, this evidence of “neutral” as a
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`characteristic supports the finding of “neutral” as a generic mark. Rymed has not
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`adequately rebutted this evidence.
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`3. Genericness of Rmed’s marks
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`When applying the "who-are-you/what-are-you" test for
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`genericness articulated in Filz'pz'no Yellow Pages, it is clear that “neutral,” “neutral
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`displacement,” and “neutral fluid displacement” answer the question “what—are-
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`you?” 198 F.3d at 1147. All of the evidence demonstrates that primary
`
`-13-
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`

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`Cas 8:07-cv-01199-MRP-VBK Document 182
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`Filed 04/22/2009
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`Page 14 of 20
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`I significance of the terms is to describe a feature of needleless connectors. Rymed
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`emphasizes the neutral fluid displacement feature as the point of improvement over
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`the prior art to receive a patent on its needlefree injection system, and marketed its
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`product as having “neutral technology” and a “neutral feature.” Rymed’s
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`competitors, other third parties, and evidently its own sales force also referred to
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`“neutral displacement” and “neutral” as features of needleless connectors, just as
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`the terms “positive” and “negative” identify fluid displacement features of
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`connectors. The primary purpose of the terms at issue with respect to needleless
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`connectors is to identify the type of fluid displacement the connector has, and not
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`the source of the product. In other words, “neutral displacement” and “neutral” do
`not answer the question “who-are-you?,” but rather, “what-are-you?”
`8
`
`Rymed, relying on Horizon Mills, states “In order to find ‘neutral’ generic,
`the Court has to find that a majority of the relevant buying public .
`.
`. do not View
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`‘neutral’ as a Rymed brand name and th