Trademark Trial and Appeal Board Electronic Filing System. http://estta.uspto.gov
`ESTTA359015
`ESTTA Tracking number:
`07/20/2010
`
`Filing date:
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD
`Notice of Opposition
`
`Notice is hereby given that the following party opposes registration of the indicated application.
`Opposer Information
`
`Name
`Granted to Date
`of previous
`extension
`Address
`
`ICU MEDICAL, INC.
`07/21/2010
`
`951 Calle Amanecer
`San Clemente, CA 92673
`UNITED STATES
`
`Attorney
`information
`
`Steven J. Nataupsky
`Knobbe, Martens, Olson & Bear, LLP
`2040 Main Street 14th Floor
`Irvine, CA 92614
`UNITED STATES
`efiling@kmob.com Phone:9497600404
`Applicant Information
`
`Application No
`Opposition Filing
`Date
`Applicant
`
`77691752
`07/20/2010
`
`Publication date
`Opposition
`Period Ends
`
`03/23/2010
`07/21/2010
`
`RyMed Technologies, Inc.
`137 Third Avenue North
`Franklin, TN 37064
`UNITED STATES
`Goods/Services Affected by Opposition
`
`Class 010.
`All goods and services in the class are opposed, namely: Medical devices, namely, intravenous
`connectors
`
`Grounds for Opposition
`
`The mark is merely descriptive
`
`Trademark Act section 2(e)(1)
`
`Related
`Proceedings
`
`Oppositions filed against applications for the marks ABSOLUTE NEUTRAL
`(77/691774), NEUTRAL BENEFIT (77/691816), NEUTRAL CHOICE
`(77/691837), NEUTRAL STANDARD (77/691760), NEUTRAL EDGE
`(77/691746) and NEUTRAL ADVANTAGE (77/691731)
`
`Attachments
`
`ICUMM 428M.pdf ( 31 pages )(2716285 bytes )
`
`Certificate of Service
`
`

`
`The undersigned hereby certifies that a copy of this paper has been served upon all parties, at their address
`record by First Class Mail on this date.
`
`Signature
`Name
`Date
`
`/gregory phillips/
`Gregory B. Phillips
`07/20/2010
`
`

`
`ICUMM.428M
`
`TRADEMARK
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD
`
`ICU Medical, Inc.,
`a Delaware corporation,
`
`Opposer,
`
`V-
`
`RyMed Technologies, Inc.,
`a Delaware corporation,
`
`Application No. 77/691 ,752
`
`Opposition No.
`
`I hereby certify that this correspondence and all marked
`attachments are being transmitted by electronic mail to
`the United States Patent and Trademark Office at
`http://www.uspto.gov on
`
`
`50. .20 2010
`(Date)
`
`
`
`Applicant.
`
`S CVCH J. Nataupsky
`
`NOTICE OF OPPOSITION
`
`Commissioner for Trademarks
`
`P.O. Box 1451
`
`Alexandria, VA 22313 -1451
`
`Dear Sir or Madam:
`
`ICU Medical, Inc., a Delaware corporation,
`
`located and doing business at 951 Calle
`
`Amanecer, San Clemente, California 92673 (“Opposer”), believes that it will be damaged by the
`
`registration of the mark shown in Application Serial No. 77/691,752 (“Application”), and hereby
`
`opposes the same.
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`A description of the Application is as follows:
`
`Mark:
`
`NEUTRAL INTEGRITY
`
`Serial No.:
`
`77/691,752
`
`Filing Date
`
`March 16, 2009
`
`Publication Date:
`
`March 23, 2010
`
`-1-
`
`

`
`Goods:
`
`Owner:
`
`Medical devices, namely, intravenous connectors in
`International Class 10
`
`RyMed Technologies, Inc. (“Applicant”)
`
`As grounds for opposition, it is alleged that:
`
`1.
`
`Opposer and Applicant are competitors in connection with the sale of medical
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`devices.
`
`2.
`
`Since at least as early as 1987, Opposer has been involved in the manufacture and
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`sale of medical devices, including intravenous connectors, which goods are identical to the goods
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`set forth in the Application.
`
`3.
`
`Opposer manufactures and sells a variety of intravenous connectors,
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`including
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`neutral intravenous connectors. An intravenous connector that is neutral means that there is no, or
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`Virtually no, reflux of blood into the catheter lumen either when medical personnel connect or
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`disconnect an intravenous fluid administration device.
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`4.
`
`On April 22, 2009, in a dispute between Applicant and Opposer, the United States
`
`District Court, Central District of California,
`
`found that
`
`the terms “neutral” and “neutral
`
`displacement” are generic when used in connection with intravenous connectors. A copy of the
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`Court’s decision is attached as Exhibit A.
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`5.
`
`Consistent with the April 22, 2009 decision, on October 8, 2009, the Court issued an
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`Order cancelling Applicant’s registrations for the purported marks NEUTRAL and NEUTRAL
`
`DISPLACEMENT. A copy of the Order is attached as Exhibit B.
`
`7
`The term “integrity” is defined as “an unimpaired condition.’ A printout of the
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`6.
`
`Merriam-Webster online dictionary definition for the term “integrity” is attached as Exhibit C.
`
`Applicant’s mark uses the term “integrity” to immediately convey to consumers the desired
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`

`
`
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`uncontaminated, no blood reflux feature, function and characteristic of a “neutral” intravenous
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`connector. The term “integrity” is thus merely descriptive.
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`7.
`
`The term “neutral
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`integrity” immediately describes a function,
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`feature or
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`characteristic of the goods marketed by Applicant.
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`8.
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`Applicant’s alleged mark NEUTRAL INTEGRITY is comprised of the generic
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`term “neutral” and the merely descriptive term “integrity.” Thus, the alleged mark NEUTRAL
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`INTEGRITY is merely descriptive of the goods set forth in the Application and is not entitled to
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`registration pursuant to section 2(e)(l) of the Lanham Act, 15 USC. § l052(e)(l).
`
`9.
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`Applicant’s alleged mark is integral to the accurate and efficient description of
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`Opposer’s products, and if a registration is granted to Applicant, it will impair Opposer’s right to
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`use the term “neutral integrity” descriptively. Opposer will therefore be damaged by the inability to
`
`use the term “neutral integrity” on goods that are similar to those listed in the Application.
`
`WHEREFORE, Opposer prays that Application Serial No. 77/691,752 be rejected and
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`stricken, that no registration be issued thereon to Applicant, and that this opposition be sustained
`
`in favor of Opposer.
`
`Respectfully submitted,
`
`KNOBBE, MARTENS, OLSON & BEAR, LLP
`
`Dated:
`
`July 20, 2010
`
`By:
`
`1 2
`
`Steven J. Na aupsky
`Christopher L. Ross
`Gregory B. Phillips
`2040 Main Street
`
`Fourteenth Floor
`
`Irvine, CA 92614
`
`(949) 760-0404
`
`

`
`CERTIFICATE OF SERVICE
`
`I hereby certify that I served a copy of the foregoing NOTICE OF OPPOSITION upon
`
`Applicant’s counsel of record by depositing a copy thereof in the United States Mail, first-class
`
`postage prepaid on July 20, 2010, addressed as follows:
`
`David P. Gordon, Esq.
`
`Gordon & Jacobson, P.C.
`
`60 Long Ridge Road, Suite 407
`
`Stamford, CT 06902-1842
`
`if
`
`-Gregory B. Phillips
`
`9376470
`
`

`
`
`
`EXHIBIT AEXHIBIT A
`
`

`
`Case :07-cv-O1199—MRP—VBK Document 182
`#2326
`
`Filed 04/22/09 Page 1 of 20 Page ID
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`UNITED STATES DISTRICT COURT
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`CENTRAL DISTRICT OF CALIFORNIA
`
`RyMed Technologies, Inc.,
`
`Case No. 8:07’-CV-l 199 MRP (VBKX)
`
`ORDER GRANTING ICU MEDICAL,
`INC.’S MOTION FOR PARTIAL
`SUMMARY JUDGMENT
`
`v.
`
`Plaintiff,
`
`ICU Medical, Inc.,
`
`Defendant.
`
`I. Background
`
`A. Procedural History
`
`ICU Medical, Inc. (“ICU”) brought suit against Rymed Technologies, Inc.
`(“Rymed”) for patent infringement in the District of Delaware on July 27, 2007.
`Rymed then filed this suit in the Central District of California on October 10, 2007
`for declaratory judgment of non-infringement and patent invalidity, together with
`state and federal trademark and related claims.’ The patent claims were transferred
`
`
`
`' Rymed’s claims include federal claims under the Lanham Act: trademark
`infringement (15 U.S.C. § 1 1 l4), false designation of origin, and unfair
`competition (§ l125(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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`Case :07-cv-01199-MRP-VBK Document 182
`#:2327
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`Filed 04/22/09 Page 2 of 20 Page ID
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`to the District of Delaware May 21, 2008. ICU filed in this Court a Motion for
`
`Partial Summary Judgment of the “Neutral” False Advertising and Trademark
`Claims?
`
`B. Needleless connectors
`
`Since the early 1990s, intravenous catheters have almost exclusively
`
`employed needleless connectors because they obviate many problems associated
`
`with accidental needle stick injuries. When the original needleless intravenous
`
`(I.V.) connectors were disconnected, they caused a “negative fluid displacement,”
`
`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
`inability to draw blood or infuse medication to the patient, and the risk of catheter-
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`related bloodstream infection.
`
`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.
`
`In 2004, Rymed sought to alleviate the problems associated with negative
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`fluid flow with the lnVision—Plus needleless connector, which was characterized b
`
`Rymed as the first needleless connector with “zero fluid displacement.” Decl. of
`
`Dana Wm. Ryan in Opp. to ICU Medical’s Mot. for Partial Summ. J. (“Ryan
`
`Decl.”) at 5-6.
`
`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-
`
`

`
`Case :07-cv—O1199-MRP-VBK Document 182
`#:2328
`
`Filed 04/22/09 Page 3 of 20 Page ID
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`C. R_\{Jged’s trademark registrations
`
`Rymed holds Trademark Registration No. 3,168,566 on the Principal
`Register for the term “Neutral” in connection with “medical apparatus for use in
`
`performing intravenous procedures, namely, tubing connectors and valves for use
`
`in the collection and distribution of blood and intravenous fluids” in Class 10
`
`(medical apparatus). Rymed filed for this trademark protection in the U.S. Patent
`
`and Trademark Off1ce(“U.S.P.T.O.”) on December 22, 2005, representing its first
`use and first use in commerce as December 1, 2005. ICU filed a petition for
`cancellation of Rymed’s “Neutral” registered mark in the U.S.P.T.O. on November
`
`6, 2007. The proceedings were stayed on April 2, 2008 by the Trademark Trial
`
`and Appeal Board, pending the outcome of this case.
`
`At the same time as the application for “Neutral,” Rymed filed an
`
`application for the term “Neutral Displacement” in connection with the same good
`and in the same class as the “Neutral” term, but the first use and first use in
`
`commerce of the mark were represented to be January 1, 2004.3 The examining
`attorney at the U.S.P.T.O. refused the application for registration, on the grounds
`that the term was “merely descriptive of the identified goods” and that Rymed was
`“not the only user of this term [“Neutral Displacement”] to describe medical
`
`valves,” citing lCU’s MicroClave marketing material. Rymed amended its
`
`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
`
`Supplemental Register on November l3, 2007.
`
`The central dispute in this summary judgment centers around whether
`
`“neutral” and “neutral displacement” are generic terms to describe features of
`
`
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`needleless connectors or are protectable as trademarks.
`
`
`
`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-
`
`

`
`Case :07-cv-01199—MRP-VBK Document 182
`#2329
`
`Filed 04/22/09 Page 4 of 20 Page ID
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`II. Analysis
`
`A. L_egal Stangfifor Summary Judgment
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`Summary judgment is appropriate “if the pleadings, the discovery and
`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(0). 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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`l 2
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`3
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`4
`5
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`6
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`7
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`8
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`9 Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255 (1986). However, for the non-
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`10 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.
`
`Summary judgment also “necessarily implicates the substantive evidentiary
`standard of proof that would apply at trial on the merits.” See Anderson, 477 U.S.
`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
`find for either the plaintiff or the defendant .
`.
`. .”). The burden of the moving
`party is “to show initially the absence of a genuine issue concerning any material
`fact.” Celotex Corp. v. Catrett, 477 U.S. 316, 325 (U.S. 1986). The non—moving
`party must then “go beyond the pleadings” and designate “specific facts showing
`that there is a genuine issue for trial.” Id. at 324.
`
`B. Trademark validity
`
`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. § 1 127. The Lanham
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`25 Act makes “actionable the deceptive and misleading use of marks” and “protect[s]
`26
`persons
`against unfair competition.” Id. A trademark is defined as including
`27
`“any word, name, symbol, or device, or any combination thereof’ used by a person
`28
`“to identify and distinguish his or her goods, including a unique product, from
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`-4-
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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 isunknown.” 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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`6 Am. v. Med. Dental Surgeries, 601 F.2d 1011, lOl4 (9th Cir. 1979). A “‘generic’
`
`7
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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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`8 which the particular product or service is a species” and “cannot become a
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`9
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`trademark under any circumstances.” Id. (citing Abercrombie & Fitch Co. v.
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`10 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
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`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 l0l4-15. “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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`20 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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`24 F.3d 778, 783 (9th Cir. 2002). The validity of the trademark is of course “a
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`25
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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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`27 9 U.S.C. § l057(b) (“A certificate of registration of a mark upon the principal
`28
`register provided by this chapter shall be prima facie evidence of the validity of the
`
`-5-
`
`

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`Case :O7—cv—O1199-MRP-VBK Document182
`#2331
`
`Filed 04/22/O9 Page6of20 Page ID
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`._.A
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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.
`
`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 confusion” 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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`1 l25(a), and unfair competition under California law. Murray v. Cable Nat ’l
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`Broadcasting Co., 86 F.3d 858, 860 (9th Cir. 1996).
`
`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 U43, U47
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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).
`
`In actions involving registered marks,
`
`courts may determine the right to registration, and cancel registrations, in whole or
`
`in part.
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`l5 U.S.C. § lll9. See also Informix Software, Inc. v. Oracle Corp, 927
`
`F. Supp. 1283 (N.D. Cal. 1996) (discussing concurrent jurisdiction of a federal
`
`court and the Trademark Trial and Appeal Board over cancellation of trademarks).
`
`2. Rmed’s marks
`
`ICU asserts that Rymed’s marks “Neutral” and “Neutral Displacement” are
`
`generic terms, or at most, merely descriptive marks without secondary meaning.
`Mem. of P. & A.’s in Support of Mot. for Partial Summ. J. of “Neutral” False
`
`-6-
`
`

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`Case :O7—cv-01199-MRP—VBK Document 182
`#:2332
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`Filed 04/22/09 Page 7 of 20 Page ID
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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 Oflicial 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 “wh0-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 type of product rather than the producer, the trademark [is] a generic
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`term and [cannot be] a valid trademark.” (Id. at 1 147 quoting Anti—Monopoly, Inc.
`
`v. General Mills Fun Group, 61 1 F.2d 296, 304 (9th Cir. 1979)). For a
`
`determination of genericness, the crucial date is the date the alleged infringer
`
`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 significance of the registered
`
`mark to the relevant public.” 15 U.S.C. § 1064(3). Evidence to prove genericness
`
`can be varied, and may include plaintiffs use, competitors’ use, dictionary
`
`definitions, media usage, testimony of people in the trade, and consumer surveys.
`
`2 J. McCarthy on Trademarks and Unfair Competition § 12:13 (4th ed. 2009). See
`
`also Filipino Yellow Pages, 198 F.3d at 1145.
`
`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
`
`Surgicenters ofAm., 601 F.2d at 1014). Secondary meaning has “attached” to a
`
`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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`Case :07-cv-01199-MRP-VBK Document 182
`#:2333
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`Filed 04/22/09 Page 8 of 20 Page ID
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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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`. .’” Ia’. (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).
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`a. Ry_med’s use of the terms
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`Rymed filed a patent application for a “Swabbab1e 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 6-11 (“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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`-3-
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`Case :O7—cv-O1199—MRP-VBK Document 182
`#12334
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`‘Filed 04/22/09 Page 9 of 20 Page ID
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`1
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`\D0O\}O\U1-Xi-UJl\)
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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
`portion of said first resilient barrier over said spike with neutralfluid displacement
`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
`the device is in fluid communication with the fluid pathway with neutralfluid
`displacement during coupling,” and claim 29 (“such that the device is no longer in
`fluid communication with the fluid pathway with neutralfluid displacement during
`uncoupling.). The Rymed patent; col. 12, lines 61-66; col. 15, lines 20-23; and col.
`15, line 27 to col. 16, line 2 (emphases added).
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`While prosecuting the Rymed patent, Rymed used the neutral displacement
`11
`feature to overcome a rejection under 35 U.S.C. § l02(b) over its own prior patent.
`12
`13 To distinguish the claims from the prior art, Rymed characterized neutral fluid
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`14
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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 displacement’.”
`15
`16 Reply to Office Action dated Aug. 26, 2005 in Serial No. 10/756,601, at 18.
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`17 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
`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
`achievement which eliminates the need for heparin flushes.” Id.
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`The patent examiner allowed the claims, but amended claim 17 (which
`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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`26 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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`27
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`28
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`Case
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`O7—cv-01199-MRP-VBK Document 182
`#:2335
`
`Filed 04/22/09 Page 10 of 20 Page ID
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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 mark” 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 “neutral” 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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`Ease 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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`
`Case
`
`O7—cv-01199-MRP—VBK Document 182
`#:2336
`
`Filed 04/22/09 Page 11 of 20 Page ID
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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. 71. Additionally,
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`Rymed’s CEO Dana Ryan discussed the “clinical advantages’ of ‘Neutral Fluid
`7!!
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`Displacement
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`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.
`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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`'
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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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`terms.
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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
`
`-11-
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`

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`Case
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`O7-cv-01199-MRP-VBK Document 182
`#:2337
`
`Filed 04/22/09 Page 12 of 20 Page ID
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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.” lCU’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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`)-\
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`-12-
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`Case
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`O7-cv-01199-MRP-VBK Document 182
`#:2338
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`Filed 04/22/09 Page ‘I3 of 20 Page ID
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`for Partial Summ. J. of “Neutral” False Advertising and Trademark Claims
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`(“Kohut Decl.”), Ex. 14, 9.
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`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
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`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