Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claims 17-31 are pending and examined herein on the merits.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained through the invention is not identically disclosed or described as set forth in section 102, if 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 invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 17-31 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Dong et al (2006 Plant Cell Rep 25:457-465) in view of Brucker et al (2005 Planta 220:864-874) and in view of Parekh-Omedo et al (2002 Chemistry and Biology 9:1073-1084).
The claims are drawn to a method comprising contacting a plant protoplast with a synthetic single-stranded nucleobase having a length of between 10-60 nucleotides wherein the nucleobase is DNA and has a modification including mismatches and locked nucleic acids and is conjugated to a protein, wherein the modification is chemical to protect against degradation, wherein the locked nucleic acids comprise one or more propyne substitutions, a phosphorothioate linkage or O-methyl analog wherein the contacting is done within a medium comprising Polyethylene glycol known as PEG.
Dong et al teach oligonucleotide-directed gene repair wherein within the methods and process compositions comprising single-stranded repair oligonucleotides wherein the single-stranded nucleobase is 41 bases and has a chemically modified base wherein the 3’ end has an inverted cytosine, targeting the GFP in the plant genome (see first paragraph under Materials and Methods) wherein it contains a mismatch (see Figure 1). It is further noted, that the introduction describes that the prior art teaches oligonucleotide-directed gene conversion of a tobacco ALS gene as in the instant specification.
Dong et al does not teach using PEG-mediated transformation, or the specified locked nucleic acids of the dependent claims.
Brucker et al teach using site-directed mutagenesis using PEG-mediated transformation to alter an endogenous gene, namely the CpHO1 gene in Physcomitrella patens (See Page 2, 2nd column for example).
Parekh-Olmedo et al teach the process of using locked nucleic acids in conjunction with oligonucleotides for targeted nucleotide exchange including vectors 25-74 bases in length with phosphorothioate linkages and O-methyl analogs (see introduction for example in 2nd column of page 1 as well as page 3, Figure 3 showing the positions described in the instant claims.) Parekh-Olmedo et al further explicitly state the advantages of using locked nucleic acids in such DNA repair in that they have low levels of cellular toxicity and elevated levels of intracellular stability (see 1st paragraph under discussion).
Given the state of the art, the breadth of the claims and a review of the teachings of Dong et al, Brucker et al and Parekh-Olmedo et al it would have been obvious for one of ordinary skill in the art to practice the method taught by Dong et al, using the locked nucleic acids and approach taught by Parekh-Olmedo et al as a choice in design available to one of ordinary skill in the art using PEG-mediated transformation as taught by Brucker et al. At the time of filing, it would have been obvious in conducting DNA repair with single stranded nucleic acids to protect them from DNA degradation using the modified bases as taught by Parekh-Olmedo as taught by Parekh-Olmedo et al.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 17-20, and 22-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11008579. Although the claims at issue are not identical, they are not patentably distinct from each other because the methods of the patented claims comprise the instantly claimed methods and materials, specifically contacting plant protoplasts with the recited nucleobases in polyethylene glycol.
Claims 17-20, and 22-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11008579. Although the claims at issue are not identical, they are not patentably distinct from each other because the methods of the patented claims comprise the instantly claimed methods and materials, specifically contacting plant protoplasts with the recited nucleobases in polyethylene glycol.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRENT T PAGE whose telephone number is (571)272-5914. The examiner can normally be reached M-F 7-4 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad Abraham can be reached at 5712707058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BRENT T PAGE/Primary Examiner, Art Unit 1663