Ex Parte Muro-Galindo et alDownload PDFPatent Trial and Appeal BoardDec 29, 201612600947 (P.T.A.B. Dec. 29, 2016) Copy Citation 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. 12/600,947 11/19/2009 Silvia Muro-Galindo UPN-T4312AUSA 3505 270 7590 01/03/2017 HOWS ON fr HOWS ON T T P EXAMINER 350 Sentry Parkway SCHULTZ, JAMES Building 620, Suite 210 Blue Bell, PA 19422 ART UNIT PAPER NUMBER 1633 NOTIFICATION DATE DELIVERY MODE 01/03/2017 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): docketing@howsoniplaw.com ckodroff@howsoniplaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte SILVIA MURO-GALINDO and VLADIMIR R. MUZYKANTOV1 Appeal 2014-009890 Application 12/600,947 Technology Center 1600 Before ERIC B. GRIMES, FRANCISCO C. PRATS, and KRISTI L. R. SAWERT, Administrative Patent Judges. PRATS, Administrative Patent Judge. DECISION ON APPEAL This appeal under 35 U.S.C. § 134(a) involves claims to compositions useful for targeted drug delivery. The Examiner rejected the claims as anticipated. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. 1 Appellants identify the real party in interest as The Trustees of the University of Pennsylvania. App. Br. 4. Appeal 2014-009890 Application 12/600,947 STATEMENT OF THE CASE The sole rejection before us for review is the Examiner’s rejection of claims 1, 2, 4, 7, 8, 11, 16, 27, and 71—74 under 35 U.S.C. § 102(b) as anticipated by Cubicciotti.2 Ans. 2—3. Claims 1, 71, 72, and 74, the independent claims on appeal, illustrate the appealed subject matter and read as follows (App. Br. 23, 25, 26): 1. A composition comprising a DNA dendrimer, a cargo which is a biologically active agent whose action is required in the cytosol or other intracellular compartment which the cargo cannot access by itself, and a targeting moiety which is a polypeptide which binds to a cell surface molecule, wherein said composition provides cytosolic delivery of the cargo without the need for other means to permeate or disrupt the cell membrane. 71. A composition comprising a DNA dendrimer, a polypeptide which binds to a cell surface molecule, a biologically active agent, and polyethylene glycol (PEG). 72. A pharmaceutical composition comprising a DNA dendrimer, a polypeptide which binds to a cell surface molecule, a biologically active agent and a pharmaceutically acceptable carrier. 74. A composition consisting essentially of a DNA dendrimer, a cargo which is a biologically active agent, and a targeting moiety which is a polypeptide which binds to a cell surface molecule, wherein said composition provides intracellular delivery of the cargo. 2 US 2005/0089890 A1 (published Apr. 28, 2005). 2 Appeal 2014-009890 Application 12/600,947 ANTICIPATION The Examiner’s Rejection After initially summarizing the claimed subject matter (Ans. 2), the Examiner states as follows: Cubicciotti teaches DNA dendrimers (see paragraph [0265] or example 7, for example) that can be targeted using antibodies or fab subunits directed to at least selectins (throughout, see paragraph [0454] for example) to deliver drugs and/or toxins (throughout). Cubicciotti teaches using PEG linkers as well (at least paragraph [0143]). The invention is anticipated therefore. Id. at 3. Analysis As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992): [T]he examiner bears the initial burden ... of presenting a prima facie case of unpatentability. . . . After evidence or argument is submitted by the applicant in response, patentability is determined on the totality of the record, by a preponderance of evidence with due consideration to persuasiveness of argument. Appellants persuade us that a preponderance of the evidence does not support the Examiner’s finding that Cubicciotti anticipates the compositions recited in the rejected claims. In particular, Appellants persuade us (App. Br. 12—18) that the Examiner has not explained sufficiently how or why Cubicciotti describes a composition having each of the claim-required components arranged as in the claim. When determining whether a patent or printed publication anticipates claimed subject matter, “it is not enough that the prior art reference . . . includes multiple, distinct teachings that [an ordinary] artisan might 3 Appeal 2014-009890 Application 12/600,947 somehow combine to achieve the claimed invention.” Net Money IN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008). Instead, as Appellants contend, the reference “must clearly and unequivocally disclose the claimed [invention] or direct those skilled in the art to the [invention] without any need for picking, choosing, and combining various disclosures not directly related to each other by the teachings of the cited reference.” Id. (quoting In reArkley, 455 F.2d 586, 587 (CCPA 1972)). The Federal Circuit also explained in Net Money IN, however, that the inquiry is “not constrained to proceed example-by-example when reviewing an allegedly anticipating prior art reference. Rather, the [reviewer] must, while looking at the reference as a whole, conclude whether or not that reference discloses all elements of the claimed invention arranged as in the claim.” Net MoneyIN, 545 F.3d at 1369 n. 5 (emphasis added). To that end, the Examiner contends that, “[w]hat appears to be labeled [by Appellants] as ‘picking and choosing’ is actually nothing more than a logical reading of Cub[]icciotti as interpreted by one of ordinary skill in the art.” Ans. 4. We are not persuaded, however, that the Examiner has explained adequately how a logical reading of Cubicciotti provides a description of the claimed subject matter arranged as in the claims. Each of independent claims 1, 71, 72, and 74 recites a composition that contains, at a minimum, three ingredients: (1) a DNA dendrimer, (2) a biologically active agent, and (3) a polypeptide targeting moiety which binds to a cell surface molecule. App. Br. 23, 25, 26. The Examiner initially directs us to Cubicciotti’s Example 7. Ans. 3. Example 7 of Cubicciotti describes a composition composed of a first polynucleotide that binds to prostate-specific antigen (PSA), a second 4 Appeal 2014-009890 Application 12/600,947 defined polynucleotide segment that binds to a DNA dendrimer, with the complexed combination of those polynucleotides being bound to a detectable dye, such as phycoerythrin. Cubicciotti || 721—22. The complex may be used in assays for detecting PSA. See id. at 1721. Appellants contend that Cubicciotti’s Example 7 does not contain a polypeptide that binds to a cell surface molecule, as required in each of Appellants’ independent claims. App. Br. 17—18. The Examiner does not dispute Appellants’ characterization of Example 7. The Examiner contends instead: [T]he teachings of Cubicciotti are not limited solely to examples 7 and 8. Rather, these examples, and particularly the DNA dendrimers therein, are merely exemplary of the multivalent heteropolymeric structures contemplated throughout the Cubicciotti disclosure. Cubicciotti teaches throughout the use of [a] variety of targeting agents, including polypeptide targeting agents such as that pointed to in previous actions at paragraph [0856]. Ans. 6. Paragraph 856 of Cubicciotti relates to Example 24. Example 24 discloses a “prodrug complex comprising [the antifungal drug] amphotericin B specifically bound to a synthetic receptor comprising amino acids, nucleotides, sugars and/or other small organic monomers.” Cubicciotti 1 855. Cubicciotti explains that its prodrug complex “provides a means for increasing selectivity for fungi by specifically partitioning drug from synthetic receptors to ergosterol-containing membranes, thereby reducing toxic effects on mammalian cells.” Id. at | 854. Paragraph 856 further explains that, in the embodiment taught in Example 24, “[s]ynthetic receptors useful in this formulation are identified through iterative screening 5 Appeal 2014-009890 Application 12/600,947 and selection for specific binding attributes and physicochemical properties, preferably from a diverse pool of molecular candidates and more preferably from a combinatorial shape library.” Cubicciotti | 856. We are not persuaded that Cubicciotti’s disclosure of two separate working examples, Examples 7 and 24, whose individual components might be selectively combined to yield a composition having the ingredients required in Appellants’ claims, constitutes a description of the claimed composition, within the meaning of § 102. See Net Money IN, 545 F.3d at 1371 (“[I]t is not enough that the prior art reference . . . includes multiple, distinct teachings that [an ordinary] artisan might somehow combine to achieve the claimed invention.”). We have carefully reviewed each of the portions of Cubicciotti cited by the Examiner. See Ans. 4—8. Contrary to the court’s directive in Net Money IN, however, the Examiner’s analysis of Cubicciotti consistently requires the selective combination of distinctly disclosed elements from disparate embodiments described in the reference. See Net MoneyIN, 545 F.3d at 1371. For example, 1 534 of Cubicciotti, cited by the Examiner (Ans. 4), relates to a “[transducer” embodiment described by Cubicciotti, which may use dendrimers as a solid support, among numerous other alternatives, “as used in diagnostics, drug delivery and medical devices.” Cubicciotti | 534. That dendrimers, among numerous other alternatives, might be contemplated for use in Cubicciotti’s drug delivery transducer embodiments, and could be selectively combined with polypeptides that bind to cell surface molecules disclosed elsewhere in the reference, does not persuade us that Cubicciotti 6 Appeal 2014-009890 Application 12/600,947 describes the composition of Appellants’ claims, within the meaning of § 102. See Net MoneylN, 545 F.3dat 1371. The Examiner advances a similar rationale as to 1 598 of Cubicciotti: Paragraph [0598] describes multivalent heteropolymer structures that comprise at least two defined sequence segments, one of which recognizes a ligand or a drug, the second of which binds to itself or to a linker molecule, which is specifically contemplated as a dendrimer. Targeting moieties such as antibodies conjugated to the heteropolymer at [sic] compositions of Cubicciotti are taught throughout the disclosure, and directly embrace the compositions encompassed by the present claims. Ans. 4. As is evident, the Examiner’s analysis requires combining elements of the specific embodiments described at | 598 with distinct, unidentified disclosures of targeting moieties taught elsewhere in the reference. The Examiner does not explain, where, specifically, Cubicciotti discloses the particular targeting moieties encompassed by Appellants’ claims, or where, specifically, those claim-encompassed moieties are described as being in combination with the dendrimer conjugate disclosed in | 598. It may be true, as the Examiner contends, that Cubicciotti discloses that DNA dendrimers may be used as carriers for biologically active agents, and describes specific embodiments to that end. See Ans. 6—7 (citing Cubicciotti || 9, 13, 19, 482, 598). It may be true, as the Examiner contends also, that Cubicciotti elsewhere discloses embodiments of its compositions that include a polypeptide ligand and biologically active agent. See Ans. 6 (citing Cubicciotti || 629-631). It may also be true, as the Examiner contends, that Cubicciotti discloses multi-molecular drug delivery embodiments composed of receptor-targeted pro-drugs, and also discloses 7 Appeal 2014-009890 Application 12/600,947 that, in general, antibodies were known in the art to be used as drug targeting agents in hybrid molecules. See Ans. 6—7 (citing Cubicciotti || 7, 8, 43). Again, however, that dendrimers, among numerous other described alternatives, might be contemplated for use in Cubicciotti’s drug delivery embodiments, and that polypeptides that bind to cell surface molecules, among numerous other described alternatives, might also be contemplated for use in Cubicciotti’s drug delivery embodiments, does not persuade us that Cubicciotti describes a composition that contains those elements, within the meaning of § 102. To the contrary, having carefully reviewed Cubicciotti, we agree with Appellants that, as posited by the Examiner, arriving at the compositions recited in independent claims 1, 71, 72, and 74, from the cited disclosures in Cubicciotti requires selective combination of distinctly disclosed elements from disparate embodiments described in the reference. Accordingly, we also agree with Appellants that Cubicciotti does not describe the compositions recited in independent claims 1, 71, 72, and 74, within the meaning of § 102. We, therefore, reverse the Examiner’s rejection of independent claims 1, 71, 72, and 74, and their dependents, as anticipated by Cubicciotti. SUMMARY For the reasons discussed, we reverse the Examiner’s rejection of claims 1, 2, 4, 7, 8, 11, 16, 27, and 71—74 under 35 U.S.C. § 102(b) as anticipated by Cubicciotti. REVERSED 8 Copy with citationCopy as parenthetical citation