13952240 - (D) (P.T.A.B. Apr. 15, 2020)

Sai Shankar

Patent Trials and Appeals BoardApr 15, 2020

13952240 - (D) (P.T.A.B. Apr. 15, 2020)

UNITED STATES PATENT AND TRADEMARK OFFICE 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 APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 13/952,240 07/26/2013 Sai Shankar 19077 (AP) 5457 51957 7590 04/15/2020 ALLERGAN, INC. 2525 DUPONT DRIVE, T2-7H IRVINE, CA 92612-1599 EXAMINER ZIMBOUSKI, ARIANA ART UNIT PAPER NUMBER 3781 NOTIFICATION DATE DELIVERY MODE 04/15/2020 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): blake.morgan@allergan.com pair_allergan@firsttofile.com patents_ip@allergan.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte SAI SHANKAR Appeal 2018-003217 Application 13/952,240 Technology Center 3700 Before JAMES P. CALVE, JEREMY M. PLENZLER, and SUSAN L.C. MITCHELL, Administrative Patent Judges. PLENZLER, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 1–20. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R. § 1.42(a). Appellant identifies the real party in interest as Allergan, Inc. Appeal Br. 3. Appeal 2018-003217 Application 13/952,240 2 CLAIMED SUBJECT MATTER2 The claims are directed to a cap system to maintain dispensing tip sterility. Claim 1, reproduced below, is illustrative of the claimed subject matter: 1. An apparatus for dispensing a sterile, non-preserved therapeutic liquid, comprising: a container configured to hold the sterile, non-preserved therapeutic liquid and having a dispensing tip configured to dispense a dose of the therapeutic liquid; a vented cap configured to fit over at least a portion of the container including the dispensing tip and having one or more vents that allow air to pass into and out of a cavity defined between the vented cap and the dispensing tip; a second cap configured to fit over at least a portion of the vented cap; and a tamper evident seal coupled to the second cap and one or both of the container and the vented cap. 2 Although independent claim 18 recites a “method,” claim 19 depends from claim 18 and recites “[t]he apparatus according to claim 18.” Appeal 2018-003217 Application 13/952,240 3 REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Molina US 5,451,374 Sept. 19, 1995 Kubo US 2005/0139611 A1 June 30, 2005 Arvizu US 2010/0084436 A1 Apr. 8, 2010 Manesis US 2010/0108712 A1 May 6, 2010 Pearcy US 2011/0127294 A1 June 2, 2011 Levy Sarraf US 2012/0279968 A1 Nov. 8, 2012 Stack US 2013/0020227 A1 Jan. 24, 2013 REJECTIONS3 Claim 20 is rejected under 35 U.S.C. § 102(b) as being anticipated by Kubo. Claims 1–3, 9, 10, 13, and 17 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Kubo and Molina. Claims 1, 4–6, 18, and 19 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Kubo and Arvizu. Claims 7 and 8 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Kubo, Molina, and Levy Sarraf. Claim 11 is rejected under 35 U.S.C. § 103(a) as being unpatentable over Kubo, Molina, and Pearcy. Claim 12 is rejected under 35 U.S.C. § 103(a) as being unpatentable over Kubo, Molina, and Manesis. Claim 14 is rejected under 35 U.S.C. § 103(a) over Kubo, Molina, and Stack. 3 The rejection under 35 U.S.C. § 112, first paragraph, was withdrawn by the Examiner in the Answer. Ans. 2. Appeal 2018-003217 Application 13/952,240 4 Claims 15 and 16 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Kubo, Molina, Stack, and Manesis. OPINION Each of the Examiner’s rejections relies on findings that Kubo teaches “a dispensing tip 83 configured to dispense a dose of the therapeutic liquid” and “a vented cap 2 configured to fit over at least a portion of the container including the dispensing tip.” Non-Final Act. 6, 8, 10. Appellant disputes these findings, contending that “[t]he feature designated as 2 in Kubo, which the Examiner refers to as the ‘vented cap,’ is referred to in Kubo as a ‘nozzle member’ . . . and does not fit over a dispensing tip” as required by all claims. Appeal Br. 18; Appeal Br. 32 (claim 1), 34 (claim 18), 35 (claim 20). Appellant also argues that “[f]eature 2 does not function as a cap as it has a nozzle hole 231 at its top for dispensing liquid from the container and would leak liquid.” Id. at 19. Appellant contends that “[r]eference number 83 cannot be considered a ‘dispensing tip’ as it does not ‘dispense a dose of therapeutic liquid,’” and, instead, “is merely an opening or channel in which liquid can pass through to the nozzle hole 23.” Id. Appellant has the better position for both limitations at issue. Figures 4 and 5 from Kubo are reproduced below. Appeal 2018-003217 Application 13/952,240 5 Figure 4 is an exploded perspective view of a liquid drug container with our annotations included, and Figure 5 is a sectional view of that container. Kubo ¶¶ 33–34. The region circled in red is Kubo’s projection 83 (id. ¶ 66), which, as noted above, the Examiner considers the recited “dispensing tip.” The region circled in blue is Kubo’s nozzle 23, which is part of nozzle member 2. Id. ¶ 62. Although Kubo explains that “[t]he nozzle member 2 is a cap-shaped member,” a separate “cap 6 . . . comes into close contact with the tip of the nozzle 23 to air-tightly seal the nozzle hole 231.” Kubo ¶¶ 54, 61. Thus, Kubo evidences an understanding in the art that a “cap” seals or closes an opening such as nozzle hole 231 of nozzle 23. A “filter-mounting member 8 is provided with a small cylindrical projection 83” including “a nozzle- communicating hole 84 passing through a central part of the cylindrical Appeal 2018-003217 Application 13/952,240 6 projection 83.” Id. ¶ 66. That is, projection 83 with hole 84 is simply used to provide a flow path from container body 1 through nozzle 23 to nozzle hole 231. As is clear from the drawings, nozzle 23 is not a “cap” for cylindrical projection 83 and nozzle-communicating hole 84 because it provides an unobstructed flow path at hole 84 through to nozzle hole 231. Nozzle 23 does not seal or cover hole 84 of cylinder projection 83, which the Examiner considers to be the dispensing tip. An ordinary meaning of “cap” includes “a fitting for closing the end of the tube” and “something that serves as a cover or protection especially for a tip, knob, or end.” See Merriam-Webster.com at “http://www.merriam- webster.com/dictionary/cap” (accessed Apr. 12, 2020). This meaning comports with the teachings of Kubo, as discussed above, that element 6 is a “cap” because it forms an air-tight seal on nozzle hole 231 of nozzle 23. It also is consistent with Appellant’s Specification, which describes the claimed cap as fitting over the dispensing tip 130, 230 and forming a seal therewith to provide a desired degree of sealing. Spec. 1:15–16, 3:3–6, 6:7– 11. Kubo’s nozzle 23 cannot be considered as a “cap” of cylinder projection 83 because nozzle 23 includes nozzle hole 231 that allows liquid from container 1 to flow through projection 83 and its hole 84. See Kubo ¶ 68. Thus, Kubo’s nozzle 23 does not cover or seal projection 83 and its dispensing hole 84. Furthermore, nozzle 23 with nozzle hole 231 in Kubo corresponds to the recited “dispensing tip” that is “configured to dispense a dose of the therapeutic liquid.” Cylindrical projection 83 is not such a “dispensing tip,” but, rather, a communication path to Kubo’s nozzle 23 and ultimately nozzle hole 231 that dispenses a dose of the therapeutic liquid. Appeal 2018-003217 Application 13/952,240 7 For at least these reasons, the Examiner has not established that Kubo teaches the “dispensing tip” and “vented cap” recited in the claims. Accordingly, we do not sustain the Examiner’s decision to reject claims 1– 20. CONCLUSION The Examiner’s rejections are reversed. DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 20 102(b) Kubo 20 1–3, 9, 10, 13, 17 103(a) Kubo, Molina 1–3, 9, 10, 13, 17 1, 4–6, 18, 19 103(a) Kubo, Arvizu 1, 4–6, 18, 19 7, 8 103(a) Kubo, Molina, Levy Sarraf 7, 8 11 103(a) Kubo, Molina, Pearcy 11 12 103(a) Kubo, Molina, Manesis 12 14 103(a) Kubo, Molina, Stack 14 15, 16 103(a) Kubo, Molina, Stack, Manesis 15, 16 Overall Outcome 1–20 REVERSED