DETAILED ACTION
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 .
Status
1. Claims 1-13 as filed on 2 January 2023 were examined and rejected in an Office action posted 11 June 2025. Applicant responded on 5 December 2025 cancelling all claims and adding claims 14-18. These pending claims are examined herein.
Applicant filed a terminal disclaimer – however it was NOT entered (16 December).
Applicant is reminded that upon the cancellation of claims, the inventorship should be amended in compliance with 37 CFR 1.48(b) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
Examiner’s Notes
2. Citations to Applicant’s specification are abbreviated herein “Spec.”
Applicant provides an explicit definition of “GRON” in paragraph 0010.
The prior Office action contains a “Summary of Applicant’s Description” on page 3 is incorporated by reference here.
Withdrawal of Objections and Rejections
Any rejection or objection applying to a cancelled claim is rendered moot in view of the claim’s cancellation. All previously pending claims were cancelled.
35 USC § 103-based Claim Rejections
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:
§ 103. Conditions for patentability; non-obvious subject matter
A patent for a claimed invention may not be obtained, . . . . 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 14-18 are rejected under 35 U.S.C. 103 as being unpatentable over Gocal et al., US Patent Publication No. 2009/0307802 A1 in view of over Cigan et al., WO2015/026885 A 1, published 26 February 2015.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) are summarized as follows:a. Determining the scope and contents of the prior art.b. Ascertaining the differences between the prior art and the claims at issue.c. Resolving the level of ordinary skill in the pertinent art.d. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Instant claim 14 is drawn to introducing a GRON into a flax cell after removing the plant cell wall to generate protoplasts. The claim also requires hybridization but that is part of the normal operation of the CRISP technique which, as seen above, is an embodiment of a GRON. The CRISPR machinery is allowed to work and the target is producing T178I and/or the P182A changes to the flax EPSPS gene represented by SEQ ID NO:12. The claim then requires identifying altered cells without herbicide selection. Then regenerating a plant. It requires non-transgenic plants.
Gocal et al. teaches creating a non-transgenic plant by targeting a mutation in the EPSPS gene to increase herbicide resistance/ tolerance where one of the plants is flax. Gocal et al., claims 1 & 9. Gocal et al. does not teach using CRISPR or TALENs.
Cigan et al. discloses using CRISPR to modify a plant's DNA using a DNA template where the DNA template falls within Applicant's definition of a GRON.
Cigan et al. also teaches targeting an EPSPS gene to increase herbicide tolerance. Cigan et al., p. 49. Cigan et al. also teaches using sequencing, not herbicide selection, to detect successful changes. Cigan et al., p. 10, l. 19.
Given that Gocal et al. teaches modifying a flax EPSPS gene and Cigan et al. teaches using CRISPR to accomplish this, and ordinary artisan would have been motivated to follow the combined teachings to modify a flax plant's EPSPS gene using CRISPR. Therefore claim 14 is obvious.
The claim limitations “nucleic acid sequence that hybridizes at a target DNA sequence within an EPSPS gene in the flax cell genome and comprises one or more mismatched base-pair(s) relative to the target DNA sequence that encodes the targeted mutation(s), wherein the” and “under conditions that increase one or more cellular DNA repair processes” are Routine in CRISPR as taught by Cigan et al.
Cigan et al. teaches heterozygous and homozygous plants (p. 67, ll. 10-13) and thus claims 15-16 are obvious. They are design choices from a very limited number of options.
Obtaining seeds and growing plants are obvious steps, see, e.g., Cigan et al., p. 81, ll. 20-24; and thus claims 17-18 are obvious.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
11. Claims 14-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11,542,515 B2 (the ‘515 Patent). Although the claims at issue are not identical, they are not patentably distinct from each other because of the reasons as follows.
The claims of the ‘515 Patent application also claim using chemically modified GRONs and using, e.g. CRISPR, to modify a plant’s genomic DNA, focusing on flax.
For example, its claim 1 introduces a GRON into a flax cell, modifies the DNA of an EPSPS gene, identifies successful changes with next generation sequencing; then regenerates a plant.
Instant claim 14 also introduces a GRON into a cell but explicitly removes the plant cell wall to go to protoplasts then introduces the GRON. It requires hybridization but that is part of the CRISP technique which is an embodiment of a GRON.
The claim also requires the T178I and/or the P182A changes to the flax EPSPS gene represented by SEQ ID NO:12.
The claim then requires identifying altered cells without herbicide selection. It requires non-transgenic plants.
The non-herbicide selection of the ‘515 requires next generation sequencing which is a species of any non-herbicide selection.
This is a species of the claimed genus in the 515 Patent’s claim1 but it is a species explicitly taught by the disclosure. See the teachings at the bottom of column 60 of the ‘515 Patent.
Claims 14-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 18/927,705 (the ‘705 application). Although the conflicting claims are not identical, they are not patentably distinct from each other. This is a provisional double patenting rejection since the conflicting claims have not yet been patented.
Claim 1 of the ‘705 application uses CRISPR to modify a plant’s genomic DNA. CRISPR is a species of the claimed genus of GRONs. The ‘705’s claim 3 lists flax.
In the middle of page 31’s right column, the ‘705’s patent publication (025/0066805 A1) teaches the specific amino acid changes required by the claims.
Homozygosity versus heterozygosity are obvious in view of routine genetics. Collecting seeds and growing plants from the seeds are also obvious.
At this stage of the prosecution of the ‘705 application, the claims lack distinguishing limitations.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUSSELL T BOGGS whose telephone number is (571)272-2805. The examiner can normally be reached Monday - Friday, 0800 to 1830 Mtn.
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/RUSSELL T BOGGS/ Examiner, Art Unit 1663