Ex Parte Bendix et al

Patent Trial and Appeal BoardAug 8, 2017

13375294 (P.T.A.B. Aug. 8, 2017)

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. 13/375,294 02/16/2012 Klaus Bendix 8015.204-US 8984 23650 7590 NOVO NORDISK INC. INTELLECTUAL PROPERTY DEPARTMENT 800 Scudders Mill Road Plainsboro, NJ 08536 EXAMINER BOUCHELLE, LAURA A ART UNIT PAPER NUMBER 3763 NOTIFICATION DATE DELIVERY MODE 08/10/2017 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): nnipatent @ novonordisk. com KISW @novonordisk.com lklw @ novonordisk. com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte KLAUS BENDIX, MICHAEL BECH REISENHUS, and HENRIK LJUNGGREEN Appeal 2016-000640 Application 13/375,294 Technology Center 3700 Before LYNNE H. BROWNE, ERIC C. JESCHKE, and GORDON D. KINDER, Administrative Patent Judges. BROWNE, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellants appeal under 35 U.S.C. § 134 from the rejection of claim 1 under 35 U.S.C. § 103(a) as unpatentable over Kato (US 5,935,101, iss. Aug. 10, 1999) and Shih (US 7,364,569 B2, iss. Apr. 29, 2008).1 We have jurisdiction under 35 U.S.C. § 6(b). We reverse. 1 Claims 1—15 are pending and rejected; however, Appellants only contest the rejection of claim 1. See Final Act. 1. Appeal 2016-000640 Application 13/375,294 CLAIMED SUBJECT MATTER Claim 1 is reproduced below: 1. A drug delivery device comprising: - a container comprising a first end and a second end, - a front piston arranged between the first end and the second end, defining a first variable volume chamber therebetween, - a rear piston arranged between the front piston and the second end, defining a second variable volume chamber therebetween, the rear piston comprising a material having a first modulus of rigidity, - a piston rod adapted to move the rear piston with respect to the container, - a first substance arranged in the first variable volume chamber, - a second substance arranged in the second variable volume chamber, - passage between the container and the front and/or rear piston, adapted to allow the second substance to move from the second variable volume chamber to the first variable volume chamber, and - coupling structure adapted to non-releasably couple the front piston and the rear piston, the coupling means comprising a material having a second modulus of rigidity, - wherein the second modulus of rigidity is higher than the first modulus of rigidity. DISCUSSION Rejection I The Examiner finds that Kato discloses all of the limitations of claim 1 except for “the modulus of elasticity2 of the second piston and the 2 We note that the claims recite two different moduli of rigidity, not moduli of elasticity. A modulus of rigidity refers to “a modulus of elasticity equal to the ratio of the tangential force per unit area to the resulting angular deformation,” whereas a modulus of elasticity refers to the “ratio of the stress applied to a body or substance to the resulting strain within the elastic 2 Appeal 2016-000640 Application 13/375,294 coupling member.” Final Act. 3. The Examiner further finds that “Shih teaches a piston having a coupling member, the piston formed from an elastic material and the coupling member is formed from an extension of the rigid piston rod (col. 3, line 61 — col. 4, line 5).” Id. The Examiner reasons that “[t]his configuration allows the piston to be compliant so as to form a reliable seal against the inner surface of the container, while ensuring that the coupling member is rigid enough to maintain a secure connection.” Id. Based on these findings and reasoning, the Examiner concludes that it would have been obvious “to modify the device of [Kato] to form the coupling member from a portion of the rigid piston rod as taught by Shih to simplify the construction of the device and ensure that the piston maintains its desirable elasticity and the coupling member forms a secure attachment.” Id. Appellants contest the Examiner’s characterization of Shih. See Appeal Br. 10. Specifically, Appellants argue that “Shih fails to specifically disclose or suggest using a different modulus of rigidity as between a rear piston and the coupling structure as recited in claim 1 ” and “that Shih fails to specifically disclose that the piston rod (62) is rigid as stated in the Final Office Action.” Id. at 11. Responding to this argument, the Examiner observes that “[t]he piston shaft or plunger must be rigid enough to transmit the force applied by the user to the fluid within the syringe reservoir to force the fluid out of the needle at the distal end.” Ans. 3. Based on this observation, the Examiner concludes that: limit.” The Free Dictionary by Farlex, http://www.thefreedictionary.com. Accordingly, these terms are not interchangeable. 3 Appeal 2016-000640 Application 13/375,294 Since the piston shaft and the coupling structure of Shih are formed from a material that is not compressible, and the piston is formed from a material that is compressible, it is clear that the modulus of rigidity of the piston shaft and coupling structure is greater than the modulus of rigidity of the piston. Ans. 3. We understand the rejection to identify Shih’s engaging portion 64 as corresponding to the claimed coupling structure. Shih’s Specification does not address the material from which the engaging portion 64 is made. See generally Shih. Although, it is quite possible that Shih’s engaging portion 64 has a modulus of rigidity that is greater than the modulus of rigidity of its piston, the Examiner’s finding that this is so is speculative at best. Such speculation raises doubts as to whether or not the Examiner’s finding that Shih’s engaging portion 64 is not compressible is supported by Shih’s disclosure, thus, calling into question the underlying support for the Examiner’s finding. When such doubts exist, they must be resolved in favor of Appellants’ position. In re Warner, 379 F.2d 1011, 1017 (CCPA 1967) (“We may not resolve doubts in favor of the Patent Office determination when there are deficiencies in the record as to the necessary factual bases supporting its legal conclusion of obviousness.)” Moreover, the Examiner’s reasoning is based on that proposition that the modulus of rigidity of the material from which Shih’s piston shaft and engaging portion are made must inherently be greater than the modulus of rigidity of material from which Shih’s piston is made. See Ans. 3. However, the fact that a certain characteristic may be present in the prior art is not sufficient to establish the inherency of that characteristic. In re Rijckaert, 9 F.3d 1531, 1534 (Fed. Cir. 1993). In this case we see no reason why a piston shaft and coupling structure made from a material having the 4 Appeal 2016-000640 Application 13/375,294 same or a lesser modulus of rigidity as the material from which the piston is made would render Shih’s device inoperable. Thus, a coupling structure made from a material with a modulus of rigidity greater than the modulus of rigidity of the material from which the piston is made is not an inherent characteristic of Shih’s device. Accordingly, the Examiner’s reasoning lacks rational underpinning. For these reasons, we do not sustain the Examiner’s decision rejecting claim 1, and claims 2-4, 6, and 12—15 which fall therewith. Rejections II—IV Rejections II—IV rely upon the same unsupported finding and reasoning as Rejection I. Accordingly, we do not sustain the Examiner’s decisions rejecting claims 5 and 7—11 for the reasons discussed supra. DECISION The Examiner’s rejections of claims 1—15 are REVERSED. REVERSED 5