Ex Parte Kuehne et alDownload PDFPatent Trials and Appeals BoardMay 10, 201913804557 - (D) (P.T.A.B. May. 10, 2019) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 13/804,557 03/14/2013 22045 7590 05/14/2019 Brooks Kushman 1000 Town Center 22nd Floor SOUTHFIELD, MI 48075 FIRST NAMED INVENTOR Kelley Kuehne UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www .uspto.gov ATTORNEY DOCKET NO. CONFIRMATION NO. CEMP0127PUSP 3326 EXAMINER JOYNER, KEVIN ART UNIT PAPER NUMBER 1799 NOTIFICATION DATE DELIVERY MODE 05/14/2019 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): docketing@brookskushman.com kdilucia@brookskushman.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte KELLEY KUEHNE, JOHN T. BAUER, CURT CARPENTER, and JESSICA LEGINSKI Appeal2018-007132 Application 13/804,557 Technology Center 1700 Before JEFFREY T. SMITH, MERRELL C. CASHION, JR., and JANEE. INGLESE, Administrative Patent Judges. SMITH, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE This is an appeal under 35 U.S.C. § 134(a) from a final rejection of claims 1-6, 8-15, and 21. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. Appeal2018-007132 Application 13/804,557 The invention of claims 1---6, 8-15, and 21 are generally directed to a pre- filled and pre-sterilized syringe assembly and a packaged kit comprising a sterilization sensitive material formed within a chamber and a barrier that keeps the sterilization sensitive material unchanged after a sterilization procedure. Spec. ,r,r 14, and 16-17. Claim 1 is illustrative of the subject matter on appeal and is reproduced below: 1. A pre-filled and pre-sterilized syringe assembly, compnsmg: a plunger including a stopper; a barrel having an open first end and an opposite second end, wherein the open first end is configured to receive the plunger; a tip cap removably attached to the second end; wherein a chamber is formed within the barrel between the stopper and the tip cap, the chamber contains a sterilization sensitive material, and wherein a portion of the tip cap that comes into contact with the sterilization sensitive material is constructed of butyl rubber, and wherein the barrel is formed of a plastic material having a barrier property that cooperates with the tip cap to create a barrier between the sterilization sensitive material and gases produced for sterilization purposes such that after an EtO sterilization procedure, the sterilization sensitive material disposed within the barrel remains unchanged after being subjected to the sterilization procedure. Appellant1 requests review of the following prior art rejections from the Examiner's Final Office Action: I. Claims 1---6 under pre-AIA 35 U.S.C. § 103(a) as unpatentable over 1 Centurion Medical Products Corporation is the Appellant and the real party in interest. App. Br. 1 2 Appeal2018-007132 Application 13/804,557 Hioki et al. (US 2011/0276005 Al, published Nov. 10, 2011) in view ofNanba et al. (US 2009/0281504, published Nov. 12, 2009). Final Act. 2; Ans. 3; App. Br. 4 and 7. II. Claims 8-15 under pre-AIA 35 U.S.C. § I03(a) as unpatentable over Hioki in view of Wirt et al. (US 6,458,095 Bl; published Oct. 1, 2002) and Nanba. Final Act. 4; Ans. 5; App. Br. 7. III. Claim 21 under pre-AIA 35 U.S.C. § I03(a) as unpatentable over Hioki in view of N anba and further in view of Vetter et al. (US 5,803,918; issued Sept. 8, 1998). Final Act. 7; Ans. 8; App. Br. 8. OPINION The Prior Art Rejections2 Appellant presents substantive arguments addressing independent claim 1. App. Br. 4--7. Appellant does not present separate arguments that address sufficiently the dependent claims 2---6. App. Br. 7. Appellant also contends separately rejected claims 8-15 and 21 are patentable for the reasons presented when discussing claim 1. App. Br. 7-8. We select independent claim 1 as representative of the rejected claims and limit our discussion thereto. After review of the respective positions, Appellant provides in the Appeal Brief and Reply Brief and the Examiner provides in the Final Action and the Answer, we affirm the Examiner's prior art rejections of claims 1---6, 8-15, and 21 2 Appellant relies on the same arguments in addressing independent claims 1 and 8 and all dependent claims. See generally App. Br. We limit our discussion to independent claim 1. 3 Appeal2018-007132 Application 13/804,557 under 35 U.S.C. § 103(a) for essentially the reasons the Examiner presents. We add the following for emphasis. Independent claim 1 is directed to a pre-filled and pre-sterilized syringe assembly comprising a barrier and a sterilization sensitive material that remains unchanged after being subjected to the sterilization procedure. We refer to the Examiner's Final Action for a statement of the rejection of independent claim 1. Final Act. 2--4. Briefly, the Examiner finds Hioki discloses a syringe assembly comprising a plunger including a stopper, a barrel configured to receive the plunger, a tip cap removably attached to the second end of the barrel. Final Act. 2-3; Hioki, ,r,r 53-62, and Figure 1. The Examiner finds Hioki does not disclose that the syringe is pre-sterilized. Final Act. 3. The Examiner finds Nanba discloses a syringe assembly comprising a sterilization sensitive material located within a chamber in the barrel, where the syringe is pre-filled then pre-sterilized prior to storage and use. Final Act. 3. The Examiner determines that it would have been obvious to one having ordinary skill in the art to pre-fill and pre-sterilize the syringe assembly of Hioki prior to storage and use in order to create and ensure a sterile assembly that will be contaminant free during application as exemplified by Nanba. Final Act. 3. Appellant argues that Hioki does not disclose or suggest the barrel contains a sterilization sensitive material. App. Br. 5. Specifically, Appellant argues "Hioki is silent on prefilling a barrel of a syringe, pre-sterilization, with a sterilization sensitive material (the very problem that the present application is seeking to solve)" ( emphasis original). Id. Appellant additionally argues that Hioki does not disclose sealing a sterilization sensitive drug within a barrel where a barrier is created such that the sterilization material remains unchanged during an EtO sterilization procedure. App. Br. at 6. Appellant argues Nanba's disclosure of pre- 4 Appeal2018-007132 Application 13/804,557 filling the syringe and shrink wrapping teaches away from the present application which avoids applying a separate barrier packaging around the syringe. App. Br. 6-7. Appellant additionally argues Nanba does not disclose a sterilization sensitive material nor a barrel that operates as a barrier such that the sterilization sensitive materials remain unchanged during an EtO sterilization procedure as Nanba merely discloses shrink wrapping using steam. Id. We are unpersuaded of reversible error. The premise of Appellant's arguments is that Hioki and Nanba fail to describe prefilling a barrel of a syringe with a "sterilization sensitive material" and sealing against an EtO sterilization procedure. However, the claimed invention is directed to an apparatus-a syringe assembly-that must be distinguished from the prior art apparatus on the basis of structure. The patentability of an apparatus claim depends only on the claimed structure, not on the use or purpose of that structure, Catalina Marketing Int'!., Inc. v. Coolsavings.com Inc., 289 F.3d 801, 809 (Fed. Cir. 2002), or the function or result of that structure, In re Danly, 263 F.2d 844, 848 (CCPA 1959); In re Gardiner, 171 F .2d 313, 315-16 (CCP A 1948). Language in an apparatus claim directed to the function, operation, intent-of-use, and materials upon which these apparatus components work that does not structurally limit the apparatus components or patentably differentiate the claimed apparatus from an otherwise identical prior art apparatus will not support patentability. See, e.g., In re Rishoi, 197 F.2d 342, 344--45 (CCPA 1952); In re Otto, 312 F.2d 937,940 (CCPA 1963); In re Ludtke, 441 F.2d 660, 663-64 (CCPA 1971); In re Yanush, 477 F.2d 958,959 (CCP A 1973). Hioki discloses the same materials for the syringe, e.g., tip cap and stopper comprising butyl rubber and the barrel formed of cyclic olefin polymers, as required by the claimed invention. Hioki discloses these materials prevent 5 Appeal2018-007132 Application 13/804,557 contamination and leakage. Hioki ,r,r 56, 60, 71, and 93. Appellant has not adequately explained why Hioki' s device is patentably distinct from the claimed invention. Appellant has also failed to explain why Hioki' s barrier material would have been ineffective against EtO sterilization. Appellant additionally argues that "pre-filled" should be construed as filled before sterilization. 3 App. Br. 5. Appellant rationalizes that the definition is supported by "the syringe assembly may be formed of various materials and/or solutions that permit the syringe assembly to be sterilized." Id. As stated above, the claimed invention is directed to a syringe assembly. The pre-filling of the syringe with a sterilization sensitive material which is sealed against an EtO sterilization procedure does not change the structure of the syringe assembly. As noted by the Examiner, Hioki discloses a syringe that is suitable for storing a drug inside the chamber formed within the barrel between the stopper and the tip cap. Ans. 4; see Hioki ,r 53. Hioki discloses the same materials are utilized for forming the syringe, e.g., tip cap and stopper comprises butyl rubber and the barrel formed of cyclic olefin polymers as required by the claimed invention. Hioki discloses these materials prevent contamination and leakage. Hioki ,r,r 56, 60, 71, and 93. The Specification identifies that the "seal" is created within the barrel by the stopper and tip cap. Spec. ,r,r 24--25. Appellant has not adequately explained why Hioki' s device is materially different from the claimed invention nor how Hioki' s barrier would be ineffective against EtO sterilization. Consequently, after consideration of Appellant's arguments, we are unpersuaded of reversible error in the Examiner's determination of obviousness. 3 Appellant's Specification provides a description of several categories of materials that may be included within the syringe assembly including IV flush, drugs and vaccines. Spec. ,r 16. 6 Appeal2018-007132 Application 13/804,557 Accordingly, we sustain the Examiner's prior art rejections of claims 1---6, 8- 15, and 21 under 35 U.S.C. § 103(a) (Rejections I-III) for the reasons the Examiner presents and we provide above. ORDER The Examiner's prior art rejections of claims 1---6, 8-15, and 21 under 35 U.S.C. § 103(a) are affirmed. TIME PERIOD No time period for taking any subsequent action in connection with this appeal may be extended under 3 7 C.F .R. § 1.13 6( a )(1 )(iv). AFFIRMED 7 Copy with citationCopy as parenthetical citation