10770588 (B.P.A.I. Jan. 26, 2010)

Ex Parte Herweijer et al

Board of Patent Appeals and InterferencesJan 26, 2010

10770588 (B.P.A.I. Jan. 26, 2010)

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. 10/770,588 02/03/2004 Hans Herweijer 25761 US1 2243 83890 7590 01/26/2010 ROCHE MADISON INC. 465 Science Drive Suite C MADISON, WI 53711 EXAMINER CHONG, KIMBERLY ART UNIT PAPER NUMBER 1635 MAIL DATE DELIVERY MODE 01/26/2010 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte HANS HERWEIJER, JULIA HEGGE, JON A. WOLFF, and DAVID L. LEWIS __________ Appeal 2009-011012 Application 10/770,588 Technology Center 1600 __________ Decided: January 26, 2010 __________ Before DONALD E. ADAMS, ERIC GRIMES, and FRANCISCO C. PRATS, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a process for delivering a polynucleotide to a heart muscle cell in vivo. The Examiner has rejected the claims as anticipated. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. Appeal 2009-011012 Application 10/770,588 2 STATEMENT OF THE CASE The Specification discloses “an in vivo process for the delivery of polynucleotides to cardiac muscle cells in a mammal comprising: injecting the polynucleotides in a solution into a vessel, wherein the volume and rate of the injection results in increasing permeability of the vessel to provide for delivery of the polynucleotide to cardiac cells outside the vessel” (Spec. 5). Claims 1-15 and 17 are on appeal. Claim 1 is representative and reads as follows: 1. A process for delivering a polynucleotide to a muscle cell in a mammalian heart in a mammal in vivo to inhibit gene expression, comprising: a) making a polynucleotide containing a sequence that is substantially complementary to a nucleic acid sequence in the mammal heart cell, b) accessing a[] blood vessel in vivo; and, c) inserting a single injector into the blood vessel near or in the heart; and, d) injecting a solution containing the polynucleotide into the blood vessel lumen and increasing hydrostatic pressure in the lumen thereby delivering the polynucleotide to the heart muscle cell outside of the blood vessel via the pressure, wherein invasiveness is limited to inserting the single injector into the blood vessel, and injecting the solution. ANTICIPATION Issue The Examiner has rejected claims 1-15 and 17 under 35 U.S.C. § 102(b) as anticipated by Mann,1 with evidence provided by Von Der 1 Mann et al., US 5,922,687, Jul. 13, 1999 Appeal 2009-011012 Application 10/770,588 3 Leyen.2 The Examiner finds that Mann discloses the “injection of a polynucleotide via injection into a vessel using a catheter” and the “injection of polynucleotides into cells using increased pressure” (Ans. 4). The Examiner cites Von Der Leyen as disclosing that “increased pressure in a vessel increased the permeability of the vessel which led to increased transfer of DNA across the cell membrane and increased transduction efficiency” (id.). Appellants contend that the Examiner erred in finding that Mann discloses delivery of a polynucleotide to heart muscle cells via injection with a single injector or with invasiveness limited to a single injector (Appeal Br. 8-10). The issue with respect to this rejection is: Does the evidence of record support the Examiner’s finding that Mann discloses delivering a polynucleotide to a heart muscle cell by injecting a polynucleotide solution into a heart blood vessel lumen via a single injector, without additional invasiveness? Findings of Fact 1. Mann discloses that nucleic acid is delivered to cells in a tissue by placing the nucleic acid in an extracellular environment of the cells, and establishing an incubation pressure around the cells and the extracellular environment. Surprisingly, the establishment of the incubation pressure facilitates the uptake of the nucleic acid by the cells, and enhances localization to the cell nuclei. 2 Heiko E. Von Der Leyen et al., “A Pressure-Mediated Nonviral Method for Efficient Arterial Gene and Oligonucleotide Transfer,” 10 Human Gene Therapy 2355-2364 (1999). Appeal 2009-011012 Application 10/770,588 4 (Mann, col. 2, ll. 19-26) 2. Mann discloses that, in a blood vessel, a sealed enclosure is preferably defined between occlusions formed by inflatable balloons or tie wraps. A nucleic acid solution is delivered to the enclosure through a catheter having a delivery outlet between the occlusions. More generally, an enclosure is defined within an organ by establishing occlusions within organ conduits (e.g. blood vessels), such that a space within the organ can be pressurized. (Id. at col. 2, ll. 42-26.) 3. Figures 4A and 4B of Mann are shown below: Figure 4A shows “a two-balloon catheter adapted to deliver a nucleic acid solution into a blood vessel” and Figure 4B shows “the catheter of FIG. 4-A with the balloons in an inflated state” (id. at col. 4, ll. 47-51). 4. Mann discloses that “[b]alloons 332A and 332B occlude vessel 324 and create a sealed enclosure 334 within vessel 324. … Solution 340 is delivered under pressure, such that enclosure 334 becomes pressurized.” (Id. at col. 7, ll. 47-52.) 5. Figures 5A and 5B of Mann are shown below: Appeal 2009-011012 Application 10/770,588 5 Figure 5A shows “the use of system 11 for delivery to blood conduits (vessels and/or atria and ventricles) of an organ 124 such as a heart” (id. at col. 7, ll. 63-65). Figure 5B shows “the use of balloon-catheters for sealing an inlet and an outlet of an organ (e.g. a gastrointestinal organ)” (id. at col. 8, ll. 11-22). 6. Von Der Leyen discloses transfection experiments in isolated carotid arteries (Von Der Leyen, 2356). Principles of Law “Under 35 U.S.C. § 102, every limitation of a claim must identically appear in a single prior art reference for it to anticipate the claim.” Gechter v. Davidson, 116 F.3d 1454, 1457 (Fed. Cir. 1997). Appeal 2009-011012 Application 10/770,588 6 An anticipatory reference under 35 U.S.C. § 102 “must clearly and unequivocally disclose the claimed compound or direct those skilled in the art to the compound without any need for picking, choosing, and combining various disclosures not directly related to each other by the teachings of the cited reference.” In re Arkley, 455 F.2d 586, 587 (CCPA 1972) Analysis Claim 1 is directed to a process for delivering a polynucleotide to a heart muscle cell comprising, among other things, inserting a single injector into a blood vessel near or in the heart in vivo and injecting a polynucleotide solution into the blood vessel lumen with increasing hydrostatic pressure, to deliver the polynucleotide to a heart muscle cell outside of the blood vessel. Claim 1 also requires that the invasiveness is limited to inserting a single injector into the blood vessel. Appellants contend that the Examiner erred in finding that Mann discloses injecting a polynucleotide solution into a heart blood vessel lumen via a single injector, or with invasiveness limited to a single injector (Appeal Br. 8-10). The Examiner responds to this argument by pointing out that the claims use the transition term “comprising” and therefore “are not limited to only accessing one blood vessel for delivery of the polynucleotide into the blood vessel” (Ans. 5). We do not agree with the Examiner’s claim interpretation. Claim 1 specifies both “inserting a single injector into the blood vessel near or in the heart” and that “invasiveness is limited to inserting the single injector.” Thus, although the claim is open to additional, unrecited steps, it expressly Appeal 2009-011012 Application 10/770,588 7 limits invasiveness to insertion of a single injector. Claim 1 therefore does not read on a process that includes separately obstructing two blood vessels or other inlet/outlets, as in Mann’s Figures 5A and 5B, because such processes include invasive steps beyond inserting a single injector. The Examiner also reasons that Mann discloses a single catheter with two balloon obstructions for the transfection of blood vessels (Ans. 8). The Examiner has not adequately explained how Mann’s single- catheter embodiment meets all the limitations of claim 1. Although Figures 4A and 4B show the use of a single injector to pressurize a blood vessel, Mann does not disclose that the blood vessel is in the heart or that nucleic acids would pass through the cells of the blood vessel into a heart muscle cell. Thus, to read Mann as disclosing that the catheter of its Figures 4A-4B are placed in a heart and at sufficient pressure to allow for polynucleotides to pass through the vessel to heart muscle cells requires the type of “picking, choosing, and combining various disclosures not directly related to each other” that is prohibited in establishing anticipation. In re Arkley, 455 F.2d at 587. The Examiner relies on Von Der Leyen as providing evidence that pressurizing a blood vessel would result in the transfection of cells beyond the blood vessel (Ans. 4). However, Von Der Leyen discloses the transfection of isolated blood vessels. Von Der Leyen discloses “oligonucleotide and plasmid DNA transfer into normal as well as injured nonatherosclerotic or atherosclerotic arteries” (Von Der Leyen 2356); i.e., into cells of the arteries themselves. The Examiner has not adequately Appeal 2009-011012 Application 10/770,588 8 explained how Von Der Leyen provides evidence that Mann’s single- catheter method would result in transfection of heart muscle cells. Thus, the Examiner has not adequately shown that Mann discloses the invention of claim 1. Claim 11, the other independent claim on appeal, also requires inserting a single injector and limits invasiveness to inserting a single injector. Claims 2-10, 12-15 and 17 depend from claim 1 or claim 11. The rejection of claims 2-15 and 17 also fails for the reasons discussed above. Conclusion of Law The evidence of record does not support the Examiner’s finding that Mann discloses delivering a polynucleotide to a heart muscle cell by injecting a polynucleotide solution into a heart blood vessel lumen via a single injector, without additional invasiveness. SUMMARY We reverse the rejection of claims 1-15 and 17 under 35 U.S.C. § 102(b) as anticipated by Mann. REVERSED lp Appeal 2009-011012 Application 10/770,588 9 ROCHE MADISON INC. 465 SCIENCE DRIVE SUITE C MADISON WI 53711