Ex Parte Asai et al

Patent Trial and Appeal BoardMay 4, 2018

13997513 (P.T.A.B. May. 4, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 13/997,513 06/24/2013 127226 7590 05/08/2018 BIRCH, STEW ART, KOLASCH & BIRCH, LLP 8110 Gatehouse Road Suite 100 East Falls Church, VA 22042-1248 Takashi Asai 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. 0033- l 479PUS 1 6986 EXAMINER IMPINK, MOLLIE LLEWELLYN ART UNIT PAPER NUMBER 3788 NOTIFICATION DATE DELIVERY MODE 05/08/2018 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): mailroom@bskb.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte T AKASHI ASAI, T ADATOSHI UCHIDA, MASANOBU IWASA, and RYOUJI KOMATSU Appeal2017-008948 1 Application 13/997,513 2 Technology Center 3700 Before HUBERT C. LORIN, ANTON W. PETTING, and KENNETH G. SCHOPPER, Administrative Patent Judges. SCHOPPER, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. Â§ 134(a) from the Examiner's Final Rejection of claims 2-7, which constitute all the claims pending in this application. Claim 1 has been cancelled. We have jurisdiction under 3 5 U.S.C. Â§ 6(b). We REVERSE. 1 Our decision references the Appeal Brief ("Br.," filed May 31, 2016), the Examiner's Answer ("Ans.," mailed Aug. 30, 2016), and the Final Office Action ("Final Act.," mailed Nov. 27, 2015). 2 According to Appellants, the real party in interest is "NIPRO CORPORATION." Br. 1. Appeal2017-008948 Application 13/997,513 BACKGROUND According to Appellants, "[t]he present invention relates to a vial rubber stopper, and more particularly to a vial rubber stopper suitable for production and/or use of a freeze-dried medical agent." Spec. 1, 11. 6-7. CLAIMS Claims 2, 3, and 4 are the independent claims on appeal. Claim 2 is illustrative of the appealed claims and recites: 2. A vial rubber stopper comprising: a cap portion having a top surface with at least one opening, a bottom surface and a flange; at least one piercing portion recessed downwardly from the top surface of the cap portion to form a recess, said recess having a sidewall inwardly tapered from the top surface of the cap portion toward a central axis of the at least one piercing portion, the at least one piercing portion being configured to traverse said cap portion from the at least one opening to the bottom surface of the cap portion in an axial direction along a central axis of the cap portion; and a leg portion extending downward from the bottom surface of the cap portion and having a recess wider than the top surface of the at least one piercing portion, wherein the top surface of the cap portion is formed of rubber having a Type A rubber hardness from 58 to 90, wherein the at least one piercing portion, the bottom surface of the cap portion and the leg portion are formed of rubber having a Type A rubber hardness from 20 to 35, wherein the cap portion, the at least one piercing portion and the leg portion are unitarily formed as one piece, and wherein the flange of the cap portion is the entire portion, which extends out of an outer diameter of the leg portion, of the cap portion, and includes a first portion made of the rubber having the Type A rubber hardness from 58 to 90 and a second 2 Appeal2017-008948 Application 13/997,513 portion made of the rubber having the Type A rubber hardness from 20-35. Br., Claims App'x. 1. REJECTION The Examiner rejects claims 2-7 3 under 35 U.S.C. Â§ 103(a) as unpatentable over Percarpio4 in view of Tezuka, 5 Teclock, 6 and Durometer. 7 DISCUSSION Each of independent claims 2--4 require a cap portion, a leg portion, and a piercing portion, "wherein the cap portion, the at least one piercing portion and the leg portion are unitarily formed as one piece." See Br., Claims App. 1-2. We are persuaded of reversible error in the rejection of independent claims 2--4 because we agree that the Examiner's findings regarding this claim limitation are in error. Specifically, we agree with Appellants that the Examiner erred in finding that Percarpio teaches a cap portion including a piercing portion and leg portion that are unitarily formed as one piece. Although this limitation may be described as a product by process limitation, the limitation ultimately requires a structure in which the cap, piercing portion, and leg portion are a single piece. Thus, although the art 3 We note that the Examiner has withdrawn one alternative rejection regarding this combination of art with respect to claims 4 and 7, but the Examiner maintains the rejection regarding the alternative interpretation of the art beginning at page six of the Final Action. See Ans. 2. 4 Percarpio, US 4,465,200, iss. Aug. 14, 1984. 5 Tezuka et al., US 2007/0066941 Al, pub. Mar. 22, 2007. 6 TeclockÂ®, Durometer Rubber Hardness Tester ("Teclock") 7 ShoreÂ® Durometers: Durometer Selection Guide, Wayback Machine, pp. 1-3, (March 11, 2006). ("Durometer") 3 Appeal2017-008948 Application 13/997,513 need not teach that the parts are "unitarily formed" during manufacture, the art must teach that the parts are fixed together to form one piece in the completed device. This is consistent with the processes described in the Specification, in which, for example, the stopper is created in a two-step process resulting in a stopper comprising rubber with two hardness values that is inseparable without destroying the device. See, e.g., Spec. 7-8. Thus, one of ordinary skill in the art would understand the requirement that the cap portion is one piece in the context in which it is described in the Specification, i.e., the claim requires more than mere attachment of two parts but an attachment that is permanent such that the two parts may be considered a single piece. With respect to claim 2, for example, the Examiner finds that Percarpio teaches a closure assembly as claimed except that Percarpio does not disclose the claimed rubber hardness values. Final Act. 6-7 (citing Percarpio Fig. 1; col. 2, 11. 11, 45-60; col. 3, 11. 20-30). More specifically, the Examiner finds that Percarpio teaches a closure assembly including a cap 30 and stopper 18 "that are fixedly secured together to form a unitary piece." Final Act. 6 (citing Percarpio col. 2, 11. 45-60). Further, in response to Appellants' argument, the Examiner finds: In response to [A ]ppellant[ s]' [] argument that the cap portion and stopper portion of Percarpio are not unitarily formed as one piece, examiner respectfully disagrees. Appellant[ s] appear[] to be applying a more limited definition of "unitarily formed" than is used in the specification. When looking to the specification to understand the meaning of "unitarily formed" examiner notes that the rubber stopper is formed in a two part process, first the harder rubber is formed then the softer rubber is formed, page 7 of the instant application. With this in mind, since the two parts, 18 and 30 of the closure assembly are also formed in separate processes 4 Appeal2017-008948 Application 13/997,513 and are also fixedly joined such that they will not come apart, Col. 2: 40-60, the overall closure assembly of Percarpio is understood to be unitarily formed within the meaning used in the specification. Ans. 3. We disagree that Percarpio' s combination of cap and stopper may be considered "one piece" as required by the claim. Percarpio discloses: In describing stopper 18 in more detail, stopper 18 includes an upper flange portion 24 which has an abutment lower surface 54 thereon which extends beyond the opening of the open end 14 of tube 12. Also, stopper 18 includes a depending annular portion, as shown in FIG. 1 which provides an annular outer sealing surface 22 which cooperates with the internal surface 20 of tube 12 to provide sealing of tube 12 to contain the vacuum therein when the assembly is made for subsequent taking of blood samples. Cap 30 includes an annular depending portion with an internal tapered groove 65 which cooperates with the tapered outer surface 66 of the upper flange portion 24 of stopper 18. The tapered groove 65 tapers away from the axis 70 of the assembly and ends in an abutment surface 56 which cooperates with the overhanging bottom surface 54 of the tapered upper flange portion 24 of the stopper 18. These cooperating surfaces serve to maintain the cap assembly 30 fixed in place on stopper 18. In addition, the opposed top surface 34 of stopper 18 and surface 37 on cap 30 serve this purpose. Percarpio col. 2, 11. 40-60. Although Percarpio states that the cap is fixed in place on the stopper, Percarpio describes only a snap and/or friction fit between the cap and stopper, and Percarpio does describe what may be considered the type of permanent connection that one of ordinary skill would consider to result in cap, leg, and piercing portion that is "one piece" as required by the claims. Because the Examiner erred in finding that Percarpio discloses a "one piece" cap, leg, and piercing portion combination as claimed, and because 5 Appeal2017-008948 Application 13/997,513 the Examiner has not otherwise explained that a one piece assembly would have been obvious, we do not sustain the rejection of independent claims 2- 4. We also do no sustain the rejection of dependent claims 5-7 for the same reasons. CONCLUSION We REVERSE the rejection of claims 2-7. REVERSED 6