11840119 (P.T.A.B. Dec. 17, 2018)

Ex Parte Ludwig et al

Patent Trial and Appeal BoardDec 17, 2018

11840119 (P.T.A.B. Dec. 17, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 11/840,119 08/16/2007 45159 7590 12/19/2018 SQUIRE PB (Abbott) 275 BATTERY STREET, SUITE 2600 SAN FRANCISCO, CA 94111-3356 FIRST NAMED INVENTOR Florian Niklas Ludwig 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. 085847.00034 9734 EXAMINER WHEELER, THURMAN MICHAEL ART UNIT PAPER NUMBER 1619 NOTIFICATION DATE DELIVERY MODE 12/19/2018 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): sfripdocket@squirepb.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte FLORIAN NIKLAS LUDWIG, SYED F AIY AZ AHMED HOSSAINY, KATSUYUKI MURASE, LI ZHAO, and IRINA AST AFIEV A 1 Appeal2017-010916 Application 11/840, 119 Technology Center 1600 Before JEFFREYN. FREDMAN, RYAN H. FLAX, and DAVID COTTA, Administrative Patent Judges. FLAX, Administrative Patent Judge. DECISION ON APPEAL This is a decision on appeal under 35 U.S.C. Â§ 134(a) involving claims directed to a formulation of nanoparticles. Claims 27-30 and 33-36 are on appeal as rejected under 35 U.S.C. Â§ 103(a). We have jurisdiction under 35 U.S.C. Â§ 6(b ). We reverse. 1 Appellants identify the Real Party in Interest as "Abbott Cardiovascular Systems Inc." Br. 2. Appeal2017-010916 Application 11/840, 119 STATEMENT OF THE CASE Claim 27 is representative and is reproduced below: 27. A formulation comprising: a first population of nanoparticles having a maximum linear dimension of less than 500 nm and a density between 1.0 g/cm3 and 1.2 g/cm3; and a second population of nanoparticles having a maximum linear dimension of less than 500 nm and a density between 1.3 g/cm3 and 3.0 g/cm3, or having a maximum linear dimension of less than 500 nm and a density between 0.01 g/cm3 and 0.9 g/cm3, wherein the second population of nanoparticles is modified to operatively couple to the surface of the first population of nanoparticles, and wherein the second population of nanoparticles is coupled to the first population of nanoparticles thereby forming supra- assemblies having a density higher than or lower than that of blood. Br. 16 (Claims Appendix). The following rejections are appealed: Claims 27-30, 33, and 35 stand rejected under 35 U.S.C. Â§ I03(a) over Schneider,2 Micklus, 3 Chang, 4 and Decuzzi. 5 Non-Final Action 3. 2 US 6,258,378 Bl (issued July 10, 2001) ("Schneider"). 3 US 2002/0025313 Al (published Feb. 28, 2002) ("Micklus"). 4 US 6,376,643 Bl (issued Apr. 23, 2002) ("Chang"). 5 P. Decuzzi et al., A Theoretical Model for the Margination of Particles within Blood Vessels, 33(2) ANNALS OF BIOMED. ENG. 179-90 (2005) ("Decuzzi"). 2 Appeal2017-010916 Application 11/840, 119 Claim 34 stands rejected under 35 U.S.C. Â§ I03(a) over Schneider, Micklus, Chang, Decuzzi, Hasskamp, 6 and Hossainy. 7 Id. at 9--10. Claim 36 stands rejected under 35 U.S.C. Â§ I03(a) over Schneider, Micklus, Chang, Decuzzi, and Zhong. 8 Id. at 11. DISCUSSION "[T]he examiner bears the initial burden, on review of the prior art or on any other ground, of presenting aprimafacie case ofunpatentability. If that burden is met, the burden of coming forward with evidence or argument shifts to the applicant." In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992) ( emphasis added). "The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,416 (2007). However, "obviousness requires a suggestion of all limitations in a claim." CFMT, Inc. v. Yieldup Int 'l Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003) ( citing In re Royka, 490 F.2d 981,985 (CCPA 1974)). The Examiner determined that the combination of Schneider, Micklus, Chang, and Decuzzi taught and suggested the subject matter of independent claim 27. Non-Final Action 3-9; Answer 2-8. To summarize, the Examiner determined that Schneider taught a formulation of nanoparticles for drug delivery where a first type of nanoparticle (liposome with drug) is coupled to a second type of nanoparticle (gas-filled microsphere). Non-Final Action 3- 9; Answer 2-8. The Examiner determined that Micklus taught that such 6 WO 94/26299 Al (published Nov. 24, 1994) ("Hasskamp"). 7 US 2007/0148251 Al (published June 28, 2007) ("Hossainy"). 8 US 2005/0181015 Al (published Aug. 18, 2005) ("Zhong"). 3 Appeal2017-010916 Application 11/840, 119 liposomes could be of the claimed size and density (e.g., 100 nm diameter and 0.9 g/cm3 density) to satisfy the claimed second population of nanoparticles. Non-Final Action 3-9; Answer 2-8. The Examiner further determined that Schneider taught that its microspheres could be composed of polylactide and that, because Chang taught that polylactide can have a density of 1.0---1.5 g/cm3, Schneider's microspheres (which Schneider teaches can be as small as 0.7 Âµm or 700 nm, or potentially smaller, e.g., 10 Âµm or less) composed of polylactide would satisfy the claimed first population ofnanoparticles. Non-Final Action 3-9; Answer 2-8. Furthermore, the Examiner identified how Decuzzi emphasizes the importance of tailoring nanoparticle density, size, and, relatedly, buoyancy with respect to blood for drug-delivery purposes. Non-Final Action 3-9; Answer2-8. The Examiner presents a superficially attractive case for obviousness. However, Appellants argue that there is a distinction between the material polylactide, e.g., poly(D,L-lactide ), generally, and the microspheres of Schneider, which would not be merely polylactide, but would be gas-filled polylactide microballoons that would be burstable in use. See Br. 8-10. Based on Appellants' argument, we are persuaded that the Examiner has not established that the Schneider microspheres would necessarily ( or obviously) have the claimed density of the first population of nanoparticles, even were they composed of polylactide material having a density as indicated by Chang. The Examiner's determination does not account for the fact that Schneider's microspheres must be filled with gas and, therefore, would have a density that would be the result of a combination of materials 4 Appeal2017-010916 Application 11/840, 119 ( and therefore not only the density of polylactide alone) that is not described or explained by the cited prior art combination. For this reason, we conclude the Examiner has not established a prima facie case that claim 27 would have been obvious over the cited prior art combination. The same issues and conclusion are determinative for the dependent claims. SUMMARY The obviousness rejections are each reversed. REVERSED 5