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 .
The amendments to the claims to do not follow the Revised Amendment Practice of 37 CFR 1.121. All additions should be indicated by underlining, and all deleted material should be struck through. See the Revised Amendment Practice of 37 CFR 1.121. Claim 13 (line 1) has an additional “wherein” that is not annotated.
In response to this Office action, Applicant is required to submit a properly marked up claim set.
Status of Claims
Claims 12-13 & 15-16 are under examination on the merits.
The objection to the specification is withdrawn in light of Applicant’s amendments.
The objections to the claims are withdrawn in light of Applicant’s amendments or cancelation of the claims.
The rejections of claims 1, 3-11 & 16 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn in light of Applicant’s amendments or cancelation of the claims.
The rejection of claim 10 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, is withdrawn in light of Applicant’s cancelation of the claim.
The rejection of claim 10 under 35 U.S.C. 102(a)(1) over Noivirt-Brik et al (US 2014/0068814 A1 is withdrawn in light of Applicant’s cancelation of the claim.
The rejection of claims 1, 3-8 & 10-16 under 35 U.S.C. 103 as being unpatentable over Coruzzi et al (US 8,624,084 B2) is withdrawn in light of Applicant’s amendments or cancelation of the claims.
Claim Objections
Claims 13, 15 & 16 are objected to because of the following informalities:
Claim 13 (line 5): “a mutation an ARF8” should read --a mutation in an ARF8--.
Claim 15 (line 5): “a mutation an ARF8” should read --a mutation in an ARF8--.
Claim 16 (line 9): “a mutation an ARF8” should read --a mutation in an ARF8--.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 12-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more.
Due to Applicant' s amendment of the claims, the rejection is modified from the rejection set forth in the Office action mailed 4/8/2025, as applied to claims 12-14 & 15. Applicant' s arguments filed 9/8/2025 have been fully considered but they are not persuasive.
The claims recite a seed obtained from propagating or plant obtained by breeding at least one plant comprising a cell comprising a mutation that results in the decrease in the expression and/or activity of ARF8. The claims do not require that the seed or plant obtained itself comprises a cell comprising a mutation that results in the decrease in the expression and/or activity of ARF8. Thus, the claims do not require additional limitations not found in any other seed or plant considered a natural phenomenon.
This judicial exception is not integrated into a practical application because the claims are drawn to the seeds or plants themselves. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because although the plant comprising a cell comprising a mutation that results in the decrease in the expression or activity of ARF8 may require significantly more than a naturally occurring plant, there is no requirement that a seed or plant obtained by propagating or breeding said plant also comprises a cell comprising the mutation. The product of claims 12-13 are claimed by the process by which they are obtained (from a plant comprising a mutation), but the patentability of a product does not depend on its method of production if the method of production does not confer markedly different characteristics. See MPEP 2113 (I). A seed or plant obtained by propagating or breeding a plant carrying a mutation will not necessarily inherit the mutation, and seeds or plants without the mutation will have no patentably distinct characteristics from the natural phenomenon plant.
Applicant urges that the claims are amended to recite the non-natural features of claim 1 (Remarks page 6, paragraph 1).
This argument is unpersuasive for claims 12-13, because the amended claims recite the non-natural features of a plant from which the seed or plant of claims 12-13 are obtained but do not require those same non-natural features in the seed or plant. Amended claim 15, which requires the progeny, descendant, part or propagule to comprise a gene with a mutation does require a feature that is markedly different from a natural phenomenon.
Claim Rejections - 35 USC § 112
Indefiniteness
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.
Claims 12-13 & 15-16 are 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.
Due to Applicant' s amendment of the claims, the rejection is modified from the rejection set forth in the Office action mailed 4/8/2025, as applied to claim 10. Applicant' s arguments filed 9/8/2025 have been fully considered but they are not persuasive.
Claim 15 (line 4) and Claim 16 (line 4) recite the limitation "said comparable plant cell". There is insufficient antecedent basis for this limitation in the claim.
Claim 15 requires a gene with a mutation that results in the decrease in the expression and/or activity of ARF8 (lines 3-4). Claim 15 also recites “said mutation is a mutation [in] an ARF8 regulatory sequence or in the ARF8 coding sequence” (line 5). The “said mutation” in line 5 could most reasonably be interpreted as the “said mutation” in an ARF8 regulatory sequence or in the ARF8 coding sequence of claim 12, lines 3-4. However, the said mutation in line 5 could instead refer to the “a mutation” in claim 15 lines 3-4, and it is unclear if the mutation in an ARF8 regulatory sequence or coding sequence is the same mutation or a different mutation than the mutation in a gene in claim 15 lines 3-4. Because there is more than one distinct interpretation, claim 15 is indefinite. In addition, if these two mutations are not the same mutation, there is more than one possible mutation that the “said” mutation in claim 15, line 5, could refer to, and there is insufficient antecedent basis for this limitation in the claim.
Claims 12 (lines 3-4), 13 (line 5), 15 (line 5), and 16 (lines 9-10) recite “said mutation is a mutation [in] an ARF8 regulatory sequence or in the ARF8 coding sequence.” The instant specification, however, defines a mutation as a variation in the nucleotide sequence encoding the target gene product (page 23, lines 9-10). A mutation in a regulatory sequence does not comprise a mutation according to the definition provided by the Applicant, so it is indefinite as to what mutations are encompassed by claims 12, 13, 15 & 16.
Claim 13 recites a plant according to claim 11 (line 2), but claim 11 has been canceled. Because claim 13 requires the limitations of a canceled claim, the subject matter that is encompassed is indefinite.
Applicant urges that the specification (page 23, lines 8-10) which states “As used herein, the term “mutation” encompasses a natural genetic variant or an engineered variant. In particular, the term “mutation” refers to a variation in the nucleotide sequence encoding the target gene product.” is not intended to be a definition of the term “mutation” and does not limit the nature of all mutations within the scope of the disclosure because the paragraph begins with “in an embodiment” (Remarks, page 6, paragraph 2).
This argument is unpersuasive, because the paragraph that starts “in an embodiment” is after the paragraph in which the term “mutation” is defined (page 23, line 11-16) and therefore it would not be an obvious interpretation that the definition of “mutation” is limited to a single embodiment. It would not be clear to one of skill in the art that the definition for the term “mutation” provided by Applicant is only applicable to one of all possible embodiments and so the meaning of the claims are indefinite.
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 (i.e., changing from AIA to pre-AIA ) 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.
Claims 12-13 & 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Goetz et al (2006) The Plant Cell. 18: 1873-1886 (published 7/7/2006, hereafter Goetz) taken with the evidence of Vivian-Smith et al (2001) Development. 128: 2321-2331 (published 6/15/2001, hereafter Vivian-Smith).
Due to Applicant' s amendment of the claims, the rejection is modified from the rejection set forth in the Office action mailed 4/8/2025, as applied to claims 1, 3-4 & 6-16. Applicant' s arguments filed 9/8/2025 have been fully considered but they are not persuasive.
Goetz discloses Arabidopsis plants carrying an AUXIN RESPONSE FACTOR 8 (ARF8) gene with a mutation in the translation initiation codon that leads to a cleaved-amplified polymorphic sequence marker (page 1874, left column, paragraph 2) as well as other known ARF8 mutations with different described phenotypes in Arabidopsis (page 1874, left column, paragraph 3-page 1875, left column, paragraph 1). Some of the mutations are located in the promoter and others in the coding sequence of the ARF8 gene (figure 2D). Goetz discloses that some of the disclosed mutations lead to lower expression of ARF8 mRNA compared to wildtype (table 1). Goetz describes some of the mutant lines as T-DNA insertion lines (page 1884, left column, paragraph 5). Goetz describes obtaining seed of lines of arf8 mutants (page 1883, left column, paragraph 4) as well as crosses between fwf double mutants and Col-4 plants (page 1883, left column, paragraph 2). The fwf mutant, also referred to as arf8-4 (page 1875, left column, paragraph 1), comprises a mutation in the translation initiation codon of the ARF8 gene and reads on a mutation in the ARF8 coding sequence (page 1874, left column, paragraph 2).
Goetz discloses plants that are homozygous for each mutation as well as F1 plants resulting from crosses between lines with different mutations (page 1875, left column, paragraph 3). Goetz discloses growing Arabidopsis from seeds, emasculating the flowers, and phenotyping at silique formation (page 1883, left column, paragraph 1). One feature described for arf8-1, arf8-4, and arf8-6 mutants is reduced seed set in proximal silique regions (page 1875, left column, paragraph 4), which is notably distinct from no seed set. arf8-5 plants did not show this reduced seed set phenotype at all.
Vivian-Smith provides evidence that the fwf/arf8 mutant disclosed in Goetz was generated by ethylmethane sulfonate mutagenesis (page 2322, right column, paragraph 1).
The seeds of the arf8 mutant lines of Goetz, especially arf8-1 and arf8-6, anticipate a seed obtained from propagating a plant composed of cells comprising a mutation that results in the decrease in expression and/or activity of ARF8 wherein the mutation is a mutation in a regulatory sequence or the coding sequence (claim 12). The F1 plants of crosses between mutants anticipate a plant obtained by breeding two plants wherein at least one is a plant composed of cells comprising a mutation that results in the decrease in expression and/or activity of ARF8 wherein the mutation is a mutation in a regulatory sequence or the coding sequence (claim 13). The generated seeds also anticipate a progeny, descendant, part or propagule of the seed of such a plant, wherein the progeny also comprise a gene with a mutation in an ARF8 regulatory sequence or coding sequence that results in the decrease in the expression and/or activity of ARF8 (claim 15).
Applicant urges that Goetz shows that ARF8 mutants give rise to seedless fruit in Arabidopsis thaliana and that GUS activity under an ARF8 promoter declines in developing seed. Applicant urges that Goetz proposes a role for ARF8 in restricting signal transduction in ovules and growth in pistils until fruit initiation cue. Applicant claims that Goetz could not breed their seedless plants and that breeding a plant with a mutation in arf8, a seed obtained from propagating the plant, progeny, part, etc. of such a seed, and a method comprising planting a seed with the arf8 mutation would be impossible given the disclosure of Goetz. Applicant urges that Vivian-Smith shows that arf8 (fwf) functions in the carpel wall and modulates silique growth and Applicant claims that the fwf mutant of Vivian-Smith is seedless. Applicant urges that those in the field who understand biology and agriculture would appreciate that such mutants are useless to improve seed size or yield because they do not have seed. (Remarks page 7, paragraph 5-page 9, paragraph 1).
This argument is unpersuasive, because Goetz explicitly discloses seed of multiple arf8 mutants in Arabidopsis, as summarized in the rejection above. Goetz discloses cross breeding arf8 mutants both to map the fwf trait and to test whether different mutant lines were allelic. The existence of F1 plants of these crosses very clearly demonstrates that Goetz could breed the arf8 mutant plants, and it is unclear where Applicant believes Goetz claims to not be able to breed their “seedless” plants. The F1 plants of Goetz are a descendant of the seed of claim 12 and would in fact produce cells. None of what is described in the instant claims are impossible in light of Goetz; Goetz anticipates the limitations of the claims.
Applicant appears to have conflated the existence of parthenocarpic fruits on mutant plants with the total absence of seed from such plants, but these are not the same concept. Those with skill in the art would know that parthenocarpy allows for fruits to develop without seeds, but parthenocarpy does not mean a plant cannot produce seeds. Goetz describes a method of emasculating flowers (to prevent fertilization and thus prevent seed set) in order to observe the parthenocarpic phenotype and discloses that seed set is reduced in proximal silique regions (page 1875, left column, paragraph 2), which demonstrates that seedless fruits are not fully penetrant in un-altered arf8 mutants and seeds are normally obtainable from the mutants.
The location of the expression of arf8 does not change the existence of seeds, progeny, and crossbreeding offspring of the arf8 mutants of Goetz.
Motivation to grow arf8 mutants, such as evidence that arf8 plays a role in seed size, is irrelevant to this 102 rejection over claims 12-13 & 15 because Goetz discloses seeds, plants, and progeny that anticipate all limitations of the inventions of the claims.
Claims 12 & 15 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Coruzzi et al (US 8,624,084 B2 published 1/7/2014, hereafter Coruzzi).
Due to Applicant' s amendment of the claims, the rejection is modified from the rejection set forth in the Office action mailed 4/8/2025, as applied to claims 1, 3, 4, 6-8, 10-12 & 15-16. Applicant' s arguments filed 9/8/2025 have been fully considered but they are not persuasive.
Coruzzi discloses knockout arf8-3 and arf6-2 arf6-2 arf8-3/+ lines of Arabidopsis (column 56, lines 15-30) and screening for plants carrying two copies of the arf8-3 allele (column 57, lines 4-10). Coruzzi specifically discloses seeds of the segregating arf6-2 arf6-2 arf8-3/+ lines (column 56, line 67). Coruzzi discloses that the mutation is in ARF8 (column 55, lines 47-49), which reads on a mutation in a regulatory sequence or coding sequence. A knockout reads on decreased expression or activity.
Coruzzi discloses growing the Arabidopsis by planting seeds on mesh on MS basal medium and placing seedlings in a growth chamber (column 56, lines 31-53). Coruzzi discloses that arf8 mutants have less N-responsiveness of root architecture (column 63, lines 38-41).
Thus, Coruzzi anticipates seeds obtained from propagating a plant composed of cells comprising a mutation that results in the decrease in expression of ARF8 wherein said mutation is in an ARF coding region (instant claim 12) and the screened plants grown by Coruzzi from such seeds anticipate progeny or propagules of the seed (instant claim 15).
Applicant urges that the term mutation as defined in the specification and the amended claims exclude heterologous expression constructs of Coruzzi (Remarks page 10, paragraph 3).
This argument is unpersuasive with regards to the arf8-3 mutant disclosed by Coruzzi. The rejection over plants comprising heterologous expression constructs that do not comprise an arf8-3 mutation are withdrawn; however, Coruzzi does still disclose seed and progeny of arf8 mutants and anticipates claims 12 & 15 as presented above.
Claims 12, 15, & 16 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Lee et al (2019) BMC Plant Biology. 19. 46. (published 1/31/2019, hereafter Lee), taken with the evidence of Goetz.
This is a new rejection necessitated by amendment.
Lee discloses an arf8-2 T-DNA knockout line in Arabidopsis (CS24608) (page 7, right column, paragraph 4). Lee discloses growing Arabidopsis seedlings on filter paper on top of agar plants, which reads on plants grown from a seed (page 7, right column, paragraph 3), and measuring LBD16 and LBD18 expression in the arf8 mutant seedlings (figure S1, appended to provided copy of Lee).
The existence of seedlings anticipates the existence of seeds obtained from propagating the arf8-2 knockout plants, which are composed of cells comprising a mutation that results in the decrease of expression or activity of ARF8 and is located in the ARF8 coding sequence (claim 12) and the seeds of arf8-2 mutants inherently comprise parts composed of cells comprising an arf8 gene with a mutation (claim 15).
Goetz provides evidence that the arf8-2 mutation is in the ARF8 coding region (figure 2D).
Growing seedlings of arf8-2 mutants on filter paper on agar plates reads on planting a seed comprising a gene with mutation that results in the decrease in the expression or activity of ARF8 and cultivating a plant grown from said seed (claim 16). Although Lee is silent as to the size of the seeds of arf8-2 mutants, arf8-2 mutants of Arabidopsis line CS24608 inherently produce larger seeds compared to wild-type (as demonstrated by the instant specification, page 31, lines 17-18 & page 32, lines 10-22 & table 1). Thus, the method of growing seedlings of Arabidopsis arf8-2 mutants disclosed by Lee anticipates claim 16.
Conclusion
No claims are 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 Victoria L DeLeo whose telephone number is (703)756-5998. The examiner can normally be reached M-Th 7:30am-5pm EST; F 7:30am-12pm EST.
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/VICTORIA L DELEO/Examiner, Art Unit 1662
/Anne Kubelik/Primary Examiner, Art Unit 1662