Ex Parte BoulisDownload PDFBoard of Patent Appeals and InterferencesOct 7, 200910854726 (B.P.A.I. Oct. 7, 2009) 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. 10/854,726 05/27/2004 Nicholas M. Boulis 12637/39 8744 23838 7590 10/08/2009 KENYON & KENYON LLP 1500 K STREET N.W. SUITE 700 WASHINGTON, DC 20005 EXAMINER SWARTZ, RODNEY P ART UNIT PAPER NUMBER 1645 MAIL DATE DELIVERY MODE 10/08/2009 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 NICHOLAS M. BOULIS ____________ Appeal 2009-003388 Application 10/854,726 Technology Center 1600 ____________ Decided: October 8, 2009 ____________ Before DONALD E. ADAMS, RICHARD M. LEBOVITZ, and JEFFREY N. FREDMAN, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON APPEAL This appeal under 35 U.S.C. § 134 involves claims 1, 5-14 and 28-30. Pending “[c]laims 15-27 and 31-33 have been withdrawn from consideration” (App. Br. 2). We have jurisdiction under 35 U.S.C. § 6(b). STATEMENT OF THE CASE The claims are directed to a method of producing in a cell in vivo in a mammalian body a clostridial neurotoxin light chain peptide (claims 1 and Appeal 2009-003388 Application 10/854,726 2 5-14) and a method of producing a clostridial neurotoxin light chain peptide in cells transplanted into a target site of a body (claims 28-30). Claims 1 and 28 are illustrative: 1. A method of producing in a cell in vivo in a mammalian body a clostridial neurotoxin light chain peptide, the method comprising: delivering into a cell in vivo in a mammalian body, a nucleic acid construct comprising (a) a nucleic acid encoding a clostridial neurotoxin light chain peptide and (b) a regulatory sequence operably linked to the nucleic acid to allow expression of the nucleic acid, wherein the expression of the nucleic acid produces the clostridial neurotoxin light chain peptide in the cell in vivo. 28. A method of producing a clostridial neurotoxin light chain peptide in cells transplanted into a target site of a body, the method comprising: transfecting cells in vitro with a nucleic acid construct comprising (a) a nucleic acid encoding a clostridial neurotoxin light chain peptide and (b) a regulatory sequence operably linked to the nucleic acid to allow expression of the nucleic acid in the transfected cells, selecting the transfected cells that express the nucleic acid and thereby produce the clostridial neurotoxin light chain peptide; and transplanting into a target site of a body the selected transfected cells that produce a clostridial neurotoxin light chain peptide. The Examiner relies on the following evidence: Zdanovsky US 6,214,602 B1 Apr. 10, 2001 Nicholas M. Boulis, M.D., et al., Neuronal survival following remote adenovirus gene delivery, 96 J. Neurosurg (Spine 2) 212-219 (2002). Appellant relies on the following evidence: Introducing Cloned Genes into Cultured Mammalian Cells in Molecular Cloning: A Laboratory Manual Ch. 16, pp. 16.1-16.2 (Cold Spring Harbor Laboratory Press (2001). Appeal 2009-003388 Application 10/854,726 3 The rejections presented by the Examiner are as follows: 1. Claims 1 and 5-14 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Zdanovsky. 2. Claims 28-30 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Zdanovsky and Boulis. We affirm the rejection over Zdanovsky and reverse the rejection over the combination of Zdanovsky and Boulis. PRINCIPLES OF LAW In proceedings before the Patent and Trademark Office, the Examiner bears the burden of establishing a prima facie case of obviousness based upon the prior art. In re Fritch, 972 F.2d 1260, 1265 (Fed. Cir. 1992). On appeal to this Board, Appellants must show that the Examiner has not sustained the required burden. See Ex parte Yamaguchi, 88 USPQ2d 1606, 1608 and 1614 (BPAI 2008) (precedential); Ex parte Fu, 89 USPQ2d 1115, 1118 and 1123 (BPAI 2008) (precedential). “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’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). It is proper to “take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. at 418. See also id. at 421 (“A person of ordinary skill is also a person of ordinary creativity, not an automaton.”). 35 U.S.C § 103(a) “forbids issuance of a patent when ‘the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the Appeal 2009-003388 Application 10/854,726 4 invention was made to a person having ordinary skill in the art to which said subject matter pertains.’” KSR, 550 U.S. at 405 (quoting 35 U.S.C. § 103(a)). Argument by counsel cannot take the place of evidence. In re Cole, 326 F.2d 769, 773 (CCPA 1964); In re Geisler, 116 F.3d 1465, 1471 (Fed. Cir. 1997). Zdanovsky: ISSUE Has Appellant established error in the Examiner’s prima facie case of obviousness? FINDINGS OF FACT FF 1. There is no dispute that “Zdanovsky teaches the nucleic acid constructs of the claims” (Ans. 3). FF 2. There is no dispute that Zdanovsky teaches microinjection (id.). FF 3. The Examiner finds that Zdanovsky teaches that nucleic acid constructs within the scope of Appellant’s claims “can be transferred via vectors into host cells” including eukaryotic cells (id.). FF 4. Zdanovsky teaches that “[t]he term ‘transfection’ as used herein refers to the introduction of foreign DNA into cells (eukaryotic or prokaryotic)” (Zdanovsky, col. 15, ll. 1-3). FF 5. Appellant’s Specification discloses “[a]n assortment of delivery devices can be employed to deliver the CNLC (clostridium neurotoxin light chain) nucleic acid construct to the desired cells of the target site. For example, the delivery device can include a hollow microneedle having an Appeal 2009-003388 Application 10/854,726 5 opening at its distal end through which the CNLC nucleic acid construct can be injected” (Spec. 21: 12-15). ANALYSIS Appellant contends that microinjection “has nothing to do with delivering nucleic acid constructs into a mammalian body in vivo” (App. Br. 4). In support of this assertion Appellant directs attention to “Molecular Cloning: A Laboratory Manual” which allegedly teaches that “transfection is a method that can be only used to ferry foreign nucleic acid constructs into cells in a dish” (id.). We disagree. Chapter 16 of the Molecular Cloning manual relied upon by Appellant is directed to the concept of “Introducing Cloned Genes into Cultured Mammalian Cells” (see Molecular Cloning: A Laboratory Manual, ch. 16, Title). This document does not restrict transfection to cultured cells. Further, contrary to Appellant’s contention, Zdanovsky teaches that the term “transfection” has a broader meaning and refers to “the introduction of foreign DNA into cells” (FF 4). Zdanovsky does not limit the term “transfection” to in vitro or ex vivo environments. Accordingly, we are not persuaded by Appellant’s contention that the term “transfection” is exclusively limited to the introduction of foreign DNA into cells that are not in an in vivo environment. Simply stated, Appellant has provided no evidence on this record that expressly teaches that the term “transfection” is limited to an in vitro or ex vivo environment. As the Examiner points out, “[t]he instant claims do not restrict the method of delivery . . . but permit any method which delivers into a cell in vivo[ ] a nucleic acid construct” (Ans. 5). Appellant’s Specification Appeal 2009-003388 Application 10/854,726 6 discloses “[a]n assortment of delivery devices can be employed to deliver the CNLC nucleic acid construct to the desired cells of the target site. For example, the delivery device can include a hollow microneedle having an opening at its distal end through which the CNLC nucleic acid construct can be injected” (FF 5). Appellant fails to identify any evidence on this record that microinjection can not be used to “transfect” nucleic acid into a cell in vivo. In addition, Appellant fails to direct our attention to any evidence on this record to support the contention that there was no “reasonable expectation of success that just because a clostridial neurotoxin which is expressed and harvested in vitro” exhibits a biological activity that this same construct would exhibit a biological effect when expressed in vivo (App. Br. 6-7). Unsupported argument by counsel cannot take the place of evidence. In re Cole, 326 F.2d at 773; In re Geisler, 116 F.3d at 1471. In sum, the weight of the evidence falls in favor of the Examiner. CONCLUSION OF LAW Appellant failed to establish error in the Examiner’s prima facie case of obviousness. The rejection of claim 1 under 35 U.S.C. § 103(a) as unpatentable over Zdanovsky is affirmed. Since they are not separately argued claims 5-14 fall together with claim 1. 37 C.F.R. § 41.37(c)(1)(vii). Zdanovsky and Boulis: ISSUE Has Appellant established error in the Examiner’s prima facie case of obviousness? Appeal 2009-003388 Application 10/854,726 7 FINDINGS OF FACT FF 6. The Examiner relies on Zdanovsky as discussed above (Ans. 4). FF 7. The Examiner relies on Boulis to “teach injecting a host vector into [the] central nervous system in order to deliver a gene to the central nervous [system] cells” (id.). FF 8. Boulis’s host vector is an adenoviral vector (Boulis, 214, col. 1, ll. 1- 17). ANALYSIS Claim 28 requires, inter alia, the transplantation of cells that are transfected in vitro into a target site of a body (claim 28). Claims 29 and 30 depend from claim 28. Appellant contends that “Zdanovsky does not even hint to transplanting transfected cells into a body” (App. Br. 3). The Examiner identifies no teaching in Zdanovsky that teaches the transplantation of transfected cells into a body. Boulis speaks of the injection of a viral vector, not transfected cells, and therefore fails to make up for the deficiency in Zdanovsky. Accordingly, we disagree with the Examiner’s conclusion that “it would be obvious to utilize the transplantation method of Boulis et al in order to deliver cells producing neurotoxin into a target site of a host body” (Ans. 4). CONCLUSION OF LAW Appellant established error in the Examiner’s prima facie case of obviousness. The rejection of claims 28-30 under 35 U.S.C. § 103(a) as unpatentable over the combination of Zdanovsky and Boulis is reversed. Appeal 2009-003388 Application 10/854,726 8 TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED-IN-PART lp KENYON & KENYON LLP 1500 K STREET N.W. 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