Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on 09/16/2025 is acknowledged. The traversal is on the ground(s) that there would be no search burden between the groups. This is not found persuasive because the additional groups each contain elements that require search that the elected group does not require a search of, therefore the restriction is proper.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1, 3-5, 7-10, 13, 17-21, 23, 46-48 and 50 are pending. Claims 19-20, 46-48 and 50 are withdrawn by the Examiner as being drawn to nonelected subject matter.
Claims 1, 3-5, 7-10, 17-18, 21 and 23 are examined herein on the merits.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, 7-10, 13, 18, 21 and 23 are rejected under 35 U.S.C. 102(a)(2) and 35 U.S.C. 102(a)(1) as being anticipated by Fillatti et al (US Patent 8609934).
The applied reference has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
The claims are drawn to a method of providing a sequence of interest to the genome of a plant cell comprising contacting the cell with a Rhizobiales cell (which includes Agrobacterium) capable of transforming the plant cell wherein the cell comprises at least one vector capable of forming two T-strands that are essentially complementary wherein the vector comprises a number of interchangeable options including a first right border sequence a second right border sequence, a sequence of interest wherein the first T-strand is initiated and synthesized in the sense orientation form 5’ to 3’ and the second T-strand is synthesized in the anti-sense orientation and the two strands are essentially complementary wherein the RB1 and RB2 comprise an Agrobacterium Ti Plasmid right border sequence and LB1 and LB2 comprise an Agrobacterium Ti plasmid left border sequence, wherein the sequence of interest could be any sequence at all given the list of options, but including a gene or target sequence for down regulation, wherein the sequence of interest comprises a homology arm wherein it comprises a left and right homology arm sequence (Wherein it is understood that sequences are complementary to one another) and wherein the homology arm sequence is at least 80% identical to a target gene, wherein the modification is achieved through homologous recombination (see 10th paragraph under background of invention) wherein the Rhizobiales cell is selected from a list including Agrobacterium and the plant cell is selected from a corn cell, soybean cell, canola cell, cotton cell, wheat cell or sugarcane cell.
Fillati et al teach methods of assembling transcription units for gene suppression comprising introducing into a cell a plasmid vector for Agrobacterium-mediated, tandem co-integration of two DNAs into the genome wherein the plasmid comprises a first T-DNA between right and left borders, a second T-DNA between right and left borders wherein the two produced strands form a double stranded RNA which inherently means they are complementary and wherein one strand is identical to the targeted gene for suppression (see claims 1, 7-8, 12, 14-17 and 19-20 as well as 10th paragraph under summary of Invention), wherein the right border is an Agrobacterium Ti plasmid right border and the left border is an Agrobacterium Ti plasmid left border (see Example 1) and wherein the sequence of interest is a gene wherein the Rhizobiales cell is Agrobacterium (see claims) and wherein the plant cell is corn, soybean or sugarcane (see 6th paragraph under Detailed Description of Invention). It is noted that the two strands that upon transcription form the double stranded RNA are considered homology arms both right and left.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 4-5 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Fillatti et al (US Patent 8609934) in view of Rommens et al (USPGPUB20060070137).
The claims are drawn to the above wherein additionally a site-specific enzyme including endonuclease, recombinase and transposase are the sequence of interest, wherein the sequence of interest is a vir gene from the Ti plasmid, , wherein the construct comprises a spacer and two segments.
Fillati et al teach methods of assembling transcription units for gene suppression comprising introducing into a cell a plasmid vector for Agrobacterium-mediated, tandem co-integration of two DNAs into the genome wherein the plasmid comprises a first T-DNA between right and left borders, a second T-DNA between right and left borders wherein the two produced strands form a double stranded RNA which inherently means they are complementary and wherein one strand is identical to the targeted gene for suppression (see claims 1, 7-8, 12, 14-17 and 19-20 as well as 10th paragraph under summary of Invention), wherein the right border is an Agrobacterium Ti plasmid right border and the left border is an Agrobacterium Ti plasmid left border (see Example 1) and wherein the sequence of interest is a gene wherein the Rhizobiales cell is Agrobacterium (see claims) and wherein the plant cell is corn, soybean or sugarcane (see 6th paragraph under Detailed Description of Invention). It is noted that the two strands that upon transcription form the double stranded RNA are considered homology arms both right and left.
Fillati et al based on the figures could be asserted to teach spacer sequences but does not explicitly name them as such and do not teach wherein the sequence of interest is a endonuclease, recombinase or transposase, or wherein it is a vir gene.
Rommens et al teach transfer cassettes for transforming plant cells that comprise many of the features of the instant invention, including SEQ ID NOs 21, 22 and 23, the vir gene as a sequence of interest (see claims 3, 26 and 27) a transposase as a sequence of interest (see claim 18) as well as the use of spacer sequences (see Figure 2).
Given the state of the art wherein each claimed vector element is known in the prior art, it would have been obvious for one of ordinary skill in the art to add the vector features taught by Rommens et al to the invention taught by Fillati et al, and one would have had a reasonable expectation of success given that these elements have all been successfully used in plant transformation by numerous research groups, represented herein by Fillati et al and Rommens 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 1, 3-5, 7-10, 17-18, 21 and 23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11732268. Although the claims at issue are not identical, they are not patentably distinct from each other because they claim very similar vector constructs with most if not all of the same components for right border sequences in particular as well as the homology arms, vir gene and SEQ ID NOS.
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.
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/BRENT T PAGE/Primary Examiner, Art Unit 1663