Ex Parte Collard et alDownload PDFPatent Trial and Appeal BoardDec 9, 201613256710 (P.T.A.B. Dec. 9, 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. 13/256,710 09/15/2011 Joseph Collard CURN00400 9439 92397 7590 OPKO Health, Inc. 4400 Biscayne Boulevard Miami, FL 33137 12/13/2016 EXAMINER MCGARRY, SEAN ART UNIT PAPER NUMBER 1674 NOTIFICATION DATE DELIVERY MODE 12/13/2016 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): patents @ opko .com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JOSEPH COLLARD, OLGA KHORHOVA SHERMAN, and CARLOS COITO Appeal 2015-002115 Application 13/256,710 Technology Center 1600 Before DONALD E. ADAMS, ERIC B. GRIMES, and JOHN E. SCHNEIDER, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON APPEAL1 This appeal under 35 U.S.C. § 134(a) involves claims 4, 5, and 7—16 (App. Br. I).2 Examiner entered a rejection under 35 U.S.C. § 112, first paragraph. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. STATEMENT OF THE CASE Appellants disclose that “[ejmbodiments of the invention comprise oligonucleotides modulating expression and/or function of DLK1 and 1 Appellants identify the real party in interest as “CURNA INC.” (App. Br. 1). 2 Pending claims 17—34 stand withdrawn from consideration (App. Br. 1). Appeal 2015-002115 Application 13/256,710 associated molecules” (Spec.312). Appellants’ claim 4 is representative and reproduced below: 4. A method of upregulating a function of and/or the expression of a Delta-like 1 homolog (DLK1) polynucleotide having SEQ ID NOS: 1 or 2 in human patient cells or tissues in vivo or in vitro comprising: contacting said cells or tissues with at least one antisense oligonucleotide of 12 to 30 nucleotides in length that specifically targets a region of a natural antisense oligonucleotide of the Delta-like 1 homolog (DLK 1) polynucleotide selected from SEQ ID NO: 3; thereby upregulating a function of and/or the expression of the Delta like 1 homolog (DLK1) polynucleotide in patient cells or tissues in vivo or in vitro. (App. Br. 15.) Claims 4, 5, and 7—16 stand rejected under the enablement provision of 35 U.S.C. § 112, first paragraph. ISSUE Does the evidence of record support Examiner’s conclusion that undue experimentation would be required to practice the claimed invention? FACTUAL FINDINGS (FF) FF 1. Appellants disclose that DNA-RNA and RNA-RNA hybridization are important to many aspects of nucleic acid function including DNA replication, transcription, and translation. Hybridization is also central to a variety of technologies that either detect a particular 3 Collard et al., US 2012/0010156 Al, published Jan. 12, 2012. All references to Appellants’ Specification refer to the Collard document. 2 Appeal 2015-002115 Application 13/256,710 nucleic acid or alter its expression. Antisense nucleotides, for example, disrupt gene expression by hybridizing to target RNA, thereby interfering with RNA splicing, transcription, translation, and replication. Antisense DNA has the added feature that DNA-RNA hybrids serve as a substrate for digestion by ribonuclease H, an activity that is present in most cell types. Antisense molecules can be delivered into cells, as is the case for oligodeoxynucleotides (ODNs), or they can be expressed from endogenous genes as RNA molecules. The FDA recently approved an antisense drug, VITRAVENE™ (for treatment of cytomegalovirus retinitis), reflecting that antisense has therapeutic utility. (Spec. 13.) FF 2. Appellants disclose that “[targeting the natural antisense sequence [of the DLK1 polynucleotide] preferably modulates the function of the target gene,” i.e. the DLK1 gene (Spec. 1125). FF 3. Appellants exemplify the modulation of DLK1 polynucleotides in HepG2 cells with antisense oligonucleotides, wherein “[r]eal time PCR results show that the levels of DLK1 mRNA in HepG2 cells are significantly increased 48 h after treatment” (Spec. ^fl[ 243—247). FF 4. Examiner finds that Appellants’ claimed invention is drawn to the treatment of a wide range of conditions via the upregulation of DLK1 function and/or expression” and fails to “recite any limitations that narrow the scope of conditions/diseases contemplated for the invention” (Ans. 3; see also Ans. 4—13 (listing “conditions [Examiner finds as] specifically included in the scope of [Appellants’] invention”). FF 5. Examiner finds that Appellants’ “[Specification as filed provides one example where an antisense targeting a DLK1 antisense transcript increases the level of a DLK1 mRNA,” but this “example does not show 3 Appeal 2015-002115 Application 13/256,710 whether there is any increased DLK1 activity or ‘function’ in the cell line used” (Ans. 3). FF 6. Examiner finds that Appellants’ “[Specification as filed fails to provide any guidance or examples that would show by correlation the treatment or prevention of any particular disease in any particular patient via the inhibition of a[]DLKl antisense transcript” (id.). ANALYSIS Examiner finds that Appellants’ Specification fails to describe Appellants’ claimed invention “in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention,” because “[t]he specification as filed fails to provide any guidance or examples that would show by correlation the treatment or prevention of any particular disease in any particular patient via the inhibition of a[]DLKl antisense transcript” (Ans. 2—3; see generally Ans. 2—17 ; see FF 4—6). We are not persuaded. Notwithstanding Examiner’s assertions to the contrary, Appellants’ claimed invention does not require the treatment of a disease (see Appellants’ claim 4; cf. Ans. 2—17; see (Reply Br. 6; see also id. at 9 (“There are no express limitations [in Appellants’ claims] related to the plethora of diseases and conditions the Examiner appears to require Applicant’s [sic] to enable”)). In sum, Examiner failed to provide an evidentiary basis on this record to support a conclusion that Appellants’ Specification fails to provide an enabling description of Appellants’ claimed invention. 4 Appeal 2015-002115 Application 13/256,710 CONCLUSION OF LAW The evidence of record fails to support Examiner’s conclusion that undue experimentation would be required to practice the claimed invention. The rejection of claims 4, 5, and 7—16 under the enablement provision of 35 U.S.C. § 112, first paragraph is reversed. REVERSED 5 Copy with citationCopy as parenthetical citation