Ex Parte Ambati et al

Patent Trial and Appeal BoardDec 18, 2017

13543597 (P.T.A.B. Dec. 18, 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. 13/543,597 07/06/2012 Balamurali K. Ambati 846-U4404.PCT.US.CIP2 2336 20551 7590 12/20/2017 THORPE NORTH & WESTERN, LLP. P.O. Box 1219 SANDY, UT 84091-1219 EXAMINER BOSQUES, EDELMIRA ART UNIT PAPER NUMBER 3763 NOTIFICATION DATE DELIVERY MODE 12/20/2017 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): patentdocket @ tn w. com rich@tnw.com annette. fields @ tnw .com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte BALAMURALI K. AMBATI, BRUCE K. GALE, and SRINIVAS RAO CHENNAMANENI Appeal 2016-002492 Application 13/543,597 Technology Center 3700 Before: LISA M. GUIJT, PAUL J. KORNICZKY, and BRENT M. DOUGAL, Administrative Patent Judges. DOUGAL, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellants appeal under 35 U.S.C. § 134(a) from a Final Rejection of claims 1—8, 10, 11, 13—20, and 22. We have jurisdiction under 35 U.S.C. § 6(b). A hearing was held on December 5, 2017. We reverse. Appeal 2016-002492 Application 13/543,597 CLAIMED SUBJECT MATTER The claims are directed to an intraocular drug delivery device and associated method. Claim 1, reproduced below, is illustrative of the claimed subject matter: 1. An intraocular active agent delivery device, comprising: an active agent dispersed within a biodegradable active agent matrix, said active agent including dexamethasone and said delivery device being configured to fit within a lens capsule or ciliary sulcus of an eye without obstructing a line of sight of an intraocular lens within the lens capsule, wherein the delivery device is a homogeneous device formed of the active agent and the biodegradable active agent matrix. REFERENCES The prior art relied upon by the Examiner in rejecting the claims on appeal is: Sankaram Snyder Whitcup Parmar US 6,277,413 B1 US 2003/0149479 A1 US 2005/0244469 A1 US 2006/0051406 A1 Aug. 21,2001 Aug. 7, 2003 Nov. 3, 2005 Mar. 9, 2006 REJECTIONS Claims 1, 5, 6, 8, 10, 11, and 14—18 are rejected under 35 U.S.C. § 102(b) as being anticipated by Snyder. Claims 2—\ are rejected under 35 U.S.C. § 103(a) as being obvious over Snyder and Whitcup. Claim 7 is rejected under 35 U.S.C. § 103(a) as being obvious over Snyder and Sankaram. Claims 13, 19, and 20 are rejected under 35 U.S.C. § 103(a) as being obvious over Snyder. 2 Appeal 2016-002492 Application 13/543,597 Claim 22 is rejected under 35 U.S.C. § 103(a) as being obvious over Snyder and Parmar. OPINION Independent claim 1 is directed to “[a]n intraocular active agent delivery device.” Independent claim 14 is directed to “[a] method of treating an eye condition . . . using an intraocular active agent delivery device.” Both claims 1 and 14 include the limitation “wherein the delivery device is a homogeneous device formed of the active agent and the biodegradable active agent matrix” which the Examiner finds is taught by Snyder Figure 1. Final Act. 2, 4. In response to arguments by Appellants (see Appeal Br. 14— 18), the Examiner clarifies this finding stating “the examiner is considering the device to be ‘the layer over the implant’ [of Snyder], because this layer ... is the delivery device with an active agent dispersed within the biodegradable matrix,. . . and this layer is considered to be homogeneous.” Ans. 10. The Examiner points to layer 74 of Snyder Figure 12, shown below, as teaching the claimed homogeneous device. Id. Fig-12 Snyder Figure 12 illustrates a sustained release layer 74 as part of an implant. Snyder 124. Figure 12 also illustrates that the layer 74 is attached to a member 72. Id. at | 83. Snyder teaches that the implants “include at least one member, such as a filament. . . [to] support[] a pharmaceutical 3 Appeal 2016-002492 Application 13/543,597 agent.” Id. at 126; see also Reply Br. 7. Thus, the implant includes a member 72 which is a support structure, to which a layer 74 including a pharmaceutical agent is attached. Appellants argue that “[t]o construe [Snyder’s] layer as ‘a device’” is unreasonable, as it is, among other things, inconsistent with Snyder and Appellants’ Specification. Reply Br. 7—9. Appellants further argue that “to construe [Snyder’s] coating or layer to be a ‘device’ under the current claims, would entirely eviscerate the term ‘homogeneous.’ Following the Examiner’s logic would preclude any imaginable ‘device’ from being non- homogeneous. This would clearly render the express limitation ‘homogeneous’ meaningless.” Id. at 8. We agree that the Examiner’s claim construction is overly broad. To interpret the claim term “delivery device” as reading on only a portion of Snyder’s implant, and not the entire implant, is unreasonably broad and not supported by either the teachings of Snyder or Appellants’ Specification. Snyder consistently refers to “an implant” as the entire device for delivering intraocular therapeutics. See, e.g., Spec. 17 (“[t]he implant may be fabricated in any of a number of different ways [including] a plurality of layers”). In addition, Snyder teaches that the pharmaceutical agent is attached to an underlying structure, such as being a coating on an implant. See, e.g., id. ^fl[ 7—16. We find no indication that one of ordinary skill in the art would consider the Snyder’s layer 74 by itself to be a “delivery device.” As noted by Appellants, the Specification teaches embodiments covered by the claims, where the “device” is “the entire annular body [which] is made of an active agent matrix.” Reply Br. 8. We further note that the Specification uses the term “delivery device” to denote the entire 4 Appeal 2016-002492 Application 13/543,597 structure to be implanted in the eye to provide drug delivery. See e.g., Spec. 6 (under heading “Intraocular Drug Delivery Device”). For this reason we do not sustain the Examiner’s rejections which all depend upon an improper claim construction. DECISION The Examiner’s rejections of claims 1—8, 10, 11, 13—20, and 22 are reversed. REVERSED 5