DETAILED ACTION
The Amendment filed January 26, 2026 has been entered.
Claims 5, 8, 11, 22, 24 and 25 are currently amended.
Claims 1-26 are pending.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
All previous objections and rejections not set forth below have been withdrawn.
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 .
Withdrawn Claim Rejections
The rejection of claims 1-26 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in light of the amendment of the specification.
The rejection of claim 11, and claims 12-13 dependent thereon, under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in light of the amendment of claim 11.
The rejection of claim 12, and claim 13 dependent thereon, under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in light of the amendment of claim 11.
The rejection of claim 13 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in light of the amendment of claim 11.
The rejection of claims 6, 7, 9 and 10 under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Barham et al. (U.S. Patent No. 6,294,715, issued Sep. 25, 2001) is withdrawn in light of the claim amendments.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 25 remains rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 25 as currently amended is drawn to a broccoli plant produced by the method of claim 24, wherein the broccoli plant contains the desired trait and otherwise all of the physiological and morphological characteristics if broccoli BG-3.
Claim 24 as currently amended is drawn to a method of editing the genome of broccoli plant BG-3, said method consisting of editing the genome of the plant, or plant part thereof, of claim 2, wherein said method is selected from the group comprising zinc finger nucleases, transcription activator-like effector nucleases (TALENs), engineered homing endonucleases/meganucleases, and the clustered regularly interspaced short palindromic repeat (CRISPR)-associated protein9 (Cas9) system.
Claim 25 encompasses a broad genus of plants that have been subjected to a wide variety of nucleases that edit their genome in an unspecified manner. While the specification at page 19 generally describes the use of CRISPR/Cas9 technology for genome editing, the specification does not describe any broccoli plant that has been edited using this or other genome editing techniques. Further, the specification does not describe targets in the genome of the broccoli plant BG-3 that can be edited such that the resultant plants have a specific phenotype.
At the time of filing it was understood that genome editing techniques, in addition to making targeted genetic alterations, can also alter the genome in unexpected ways.
See, for example, Lozano-Juste et al. (Plant genome engineering in full bloom. Trends Plant Sci. 2014 May;19(5):284-7; Epub 2014 Mar 24, page 285 column 2 in particular), who teach that all genome editing technologies have limitations that include the occurrence of off-target effects, which effects vary by orders of magnitude between different target sequences and organisms. Lozano-Juste et al. also teach that a variety of techniques have been developed that may help reduce these off-target effects, but that the effectiveness of these techniques needs to be evaluated empirically.
Given the breadth of the claim which encompasses a large genus of plants that have been subjected to a wide variety of nucleases that edit their genome in an unspecified manner, given that genome editing techniques, in addition to making targeted genetic alterations, can also alter the genome in unexpected ways, given the extremely limited disclosure of only general methods that are known in the art to be useful for plant genome editing combined with the failure to disclose any broccoli plant that has been edited using these techniques, or targets in the genome of the broccoli plant BG-3 that can be edited such that the resultant plants have a specific phenotype, one skilled in the art would not recognize that the applicant was in possession of the claimed invention as a whole at the time of filing.
Response to Arguments
Applicant's arguments filed January 26, 2026 have been fully considered but they are not persuasive.
Applicant maintains that the amendment of claim 25 overcomes the rejection.
Applicant's arguments are not persuasive.
Applicant's arguments are not persuasive because a broccoli plant produced by the method of claim 24 that contains the desired trait and otherwise all of the physiological and morphological characteristics of broccoli BG-3 has no antecedent basis for “the desired trait”, and because the specification does not describe any broccoli plant that has been edited using the recited techniques to contain a particular trait, or the targets in the genome of the broccoli plant BG-3 that can be edited such that the resultant plants contain a particular trait.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 22 remains rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 22 is indefinite because it is unclear whether the method is intended to be limited to crossing, recurrent selection, mutation breeding, wherein said mutation breeding selects for a mutation that is spontaneous or artificially induced, backcrossing, pedigree breeding, marker enhanced selection, haploid/double haploid production, or transformation, because “comprising” recited before the list of alternatives is open claim language, and thus nonlimiting.
Response to Arguments
Applicant's arguments filed January 26, 2026 have been fully considered but they are not persuasive.
Applicant maintains that the amendment of claim 22 overcomes the rejection.
Applicant's arguments are not persuasive.
Applicant's arguments are not persuasive because the amendment of claim 22 does not address the recitation of “comprising” before the list of alternatives, i.e. crossing, recurrent selection, mutation breeding, wherein said mutation breeding selects for a mutation that is spontaneous or artificially induced, backcrossing, pedigree breeding, marker enhanced selection, haploid/double haploid production, or transformation. In order to overcome the rejection, the following claim amendments are suggested:
22. (CURRENTLY AMENDED) A method for developing a broccoli plant in a plant breeding program, said method comprising applying plant breeding techniques to the plant, or plant part thereof, of claim 2, wherein the plant breeding techniques are selected from the group consisting of crossing, recurrent selection, mutation breedingthat selects for a mutation that is spontaneous or artificially induced, backcrossing, pedigree breeding, marker enhanced selection, haploid/double haploid production, or transformation, wherein application of said techniques results in development of a broccoli plant.
Claim 24, and claim 25 dependent thereon, remain rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 24 is indefinite because it is unclear whether the method is intended to be limited to zinc finger nucleases, transcription activator-like effector nucleases (TALENs), engineered homing endonucleases/meganucleases, and the clustered regularly interspaced short palindromic repeat (CRISPR)-associated protein9 (Cas9) system, because “comprising” recited before the list of alternatives is open claim language, and thus nonlimiting. Claim 24 is also indefinite because zinc finger nucleases, transcription activator-like effector nucleases (TALENs), engineered homing endonucleases/meganucleases, and the clustered regularly interspaced short palindromic repeat (CRISPR)-associated protein9 (Cas9) system are compositions (proteins), not methods.
Response to Arguments
Applicant's arguments filed January 26, 2026 have been fully considered but they are not persuasive.
Applicant maintains that the amendment of claim 24 overcomes the rejection.
Applicant's arguments are not persuasive.
Applicant's arguments are not persuasive because the amendment of claim 24 does not address the recitation of “comprising” before the list of alternatives, i.e. zinc finger nucleases, transcription activator-like effector nucleases (TALENs), engineered homing endonucleases/meganucleases, and the clustered regularly interspaced short palindromic repeat (CRISPR)-associated protein9 (Cas9) system. Applicant's arguments are also not persuasive because the amendment of claim 24 does not address the issue of zinc finger nucleases, transcription activator-like effector nucleases (TALENs), engineered homing endonucleases/meganucleases, and the clustered regularly interspaced short palindromic repeat (CRISPR)-associated protein9 (Cas9) system being compositions (proteins), and not methods. In order to overcome the rejection, the following claim amendments are suggested:
24. (CURRENTLY AMENDED) A method of editing the genome of broccoli plant BG-3, said method comprising editing the genome of the plant, or plant part thereof, of claim 2, wherein said method [[is]] uses a nuclease selected from the group consisting of nucleases.
Claim 25 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 25 as currently amended is indefinite because there is insufficient antecedent basis for “the desired trait”, in claim 25, or in claim 24 from which claim 25 depends.
Allowable Subject Matter
Claims 1-21, 23 and 26 allowed.
Conclusion
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.
Remarks
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CYNTHIA E COLLINS whose telephone number is (571)272-0794. The examiner can normally be reached M-F 8:30 am - 5:00 pm.
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/CYNTHIA E COLLINS/Primary Examiner, Art Unit 1662
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