Ex Parte Burr et alDownload PDFPatent Trial and Appeal BoardJun 22, 201810298177 (P.T.A.B. Jun. 22, 2018) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 10/298,177 11/14/2002 1095 7590 06/26/2018 NOVARTIS PHARMACEUTICAL CORPORATION INTELLECTUAL PROPERTY DEPARTMENT ONE HEAL TH PLAZA 433/2 EAST HANOVER, NJ 07936-1080 John D. Burr 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. P AT053292-US-CNT 2311 EXAMINER MENDOZA, MICHAEL G ART UNIT PAPER NUMBER 3731 NOTIFICATION DATE DELIVERY MODE 06/26/2018 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): phip.patents@novartis.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JOHN D. BURR, JEFF R. WOOD, ADRIANE. SMITH, JOHN A. HOW ARD, and FABRIZIO NICCOLAI Appeal2016-004124 Application 10/298, 177 Technology Center 3700 Before BIBHU R. MOHANTY, MEREDITH C. PETRA VICK, and JAMES A. TARTAL, Administrative Patent Judges. MOHANTY, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE The Appellants seek our review under 35 U.S.C. § 134 of the final rejection of claims 1, 3, 5-8, 14-22, 28, 30, 31, 33-35 and 37-50 which are all the claims pending in the application. We have jurisdiction under 35 U.S.C. § 6(b). SUMMARY OF THE DECISION We REVERSE. Appeal2016-004124 Application 10/298, 177 THE INVENTION The Appellants' claimed invention is directed to an aerosolization apparatus (Spec. 3). Claim 1, reproduced below, is representative of the subject matter on appeal. 1. An aerosolization apparatus comprising: a body having an inlet; an endpiece having an outlet, the endpiece being connectable to the body to define a chamber, wherein the chamber is sized to receive a capsule containing a pharmaceutical formulation in a manner which allows the capsule to move within the chamber and wherein the inlet is shaped to provide a swirling air flow in the chamber; a connection mechanism comprising engageable threads to provide selective connection of the endpiece to the body, wherein a rotational force between the endpiece and the body is needed to connect and to disconnect the endpiece from the body, the rotational force being applied about an axis passing through the chamber, wherein the endpiece may be disconnected from the body to allow for insertion or removal of the capsule, and wherein the threads extend for less than two complete turns around the body; a cap insertable over the endpiece and which covers at least a portion of the inlet when the endpiece is connected to the body, wherein the cap is connectable to the body by a press fit arrangement; and a puncturing mechanism capable of providing an opening in the capsule; whereby when a user inhales, air enters into the chamber through the inlet so that the pharmaceutical formulation is aerosolized within the chamber and the aerosolized pharmaceutical formulation is delivered to the user through the outlet. THE REJECTION The Examiner relies upon the following as evidence in support of the rejections: Cocozza Valentini Ohki us 3,906,950 us 4,995,385 us 5,901,703 2 Sept. 23, 1975 Feb.26, 1991 May 11, 1999 Appeal2016-004124 Application 10/298, 177 Horlin Edwards us 6,4 70,884 us 6,766,799 The following rejection is before us for review: Oct. 29, 2002 July 27, 2004 Claims 1, 3, 5-8, 14-22, 28, 30, 31, 33, 34, 35, and 37-49 1 are rejected under 35 U.S.C. § 103(a) as unpatentable over Edwards, Ohki, Valentini, Cocozza, and Horlin. FINDINGS OF FACT We have determined that the findings of fact in the Analysis section below are supported at least by a preponderance of the evidence2. ANALYSIS The Appellants argue that the rejection of claim 1 is improper because the combination of references would not have been obvious (App. Br. 6-10, Reply Br. 4-8). The Appellants argue that the cited combination of references uses impermissible hindsight reasoning (App. Br. 9, Reply Br. 7). In contrast, the Examiner has determined that the rejection of record is proper (Final Rej. 3-6, Ans. 2-4). We agree with the Appellants. In combination with the other elements, the claim requires that the connection mechanism threads "extend 1 The Final Rejection mailed November 19, 2014 does not indicate that claim 50 either is pending or rejected on the PTOL-326 form and at page 3. The Answer at page 2 also does not list claim 50 as rejected. 2 See Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1427 (Fed. Cir. 1988) (explaining the general evidentiary standard for proceedings before the Patent Office). 3 Appeal2016-004124 Application 10/298, 177 for less than two complete turns around the body" and further requires a "press fit arrangement" for the cap. In order to meet all the limitations of claim 1, the rejection of record requires the combination of five references in Edwards, Ohki, Valentini, Cocozza, and Horlin. Edwards does disclose an aerosolization device having a body inlet (130) and endpiece (120). Edwards at column 7, lines 65 and 66, does disclose a "friction fit" between members as well. Ohki does disclose a rotatable connection about an axis (Figure 2). Valentini does disclose swirling air flow in a chamber surround a capsule (Figure 1 ). Cocozza does show threads (39) that extend less than two turns. Horlin does disclose a cap (2) that covers at least a part of the inlet. However, in KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398 (2007) the Supreme Court at 418 noted that in an obviousness analysis that "[R ]ejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness". Here the cited combination of these five references simply lacks articulated reasoning with rational underpinnings without impermissible hindsight. For instance, the rejection requires using the cap of Horlin which is modified to include the specific friction fit of Edwards, as well as further being modified to have the connection mechanism extend for less than two thread turns as taught by Cocozza, as well as using the rotatable connection taught by Ohki, in combination with all other modifications. Here, we determine that this cited combination simply would not have been obvious without impermissible hindsight. 4 Appeal2016-004124 Application 10/298, 177 For these reasons the rejection of claim 1 and its dependent claims is sustained. The same rejection using these five references has been applied to the remaining claims and the rejection of these claims is not sustained as well. CONCLUSIONS OF LAW We conclude that Appellants have shown that the Examiner erred in rejecting claims 1, 3, 5-8, 14-22, 28, 30, 31, 33, 34, 35, and 37-49 are rejected under 35 U.S.C. § 103(a) as unpatentable over Edwards, Ohki, Valentini, Cocozza, and Horlin. DECISION The Examiner's rejection of claims 1, 3, 5-8, 14-22, 28, 30, 31, 33, 34, 35, and 37-49 is reversed. REVERSED 5 Copy with citationCopy as parenthetical citation