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 .
Claim Status
Claims 1-2 and 5-16 are pending.
Claims 12-13 and 15-16 are withdrawn from consideration.
Claims 1-2, 5-11 and 14 are examined on the merits.
Response to Arguments - Specification
Applicant's amendments filed 25 June 2026 have overcome the objections of record.
Response to Arguments - Indefiniteness
Applicant's amendments to the claims and arguments filed 25 June 2026 have been fully considered and have overcome the rejections of record. On page 7 of the response filed 25 June 2026, Applicant makes claim that the definitions of “plant,” “plant part,” “inflorescence,” and “interspecific hybrid” should be interpreted based on the definitions provided that precede the recitations of “preferably” in the claims.
Response to Arguments - Failure to Further Limit
Applicant's amendments filed 25 June 2026 have overcome the rejections of record.
Response to Arguments - Lack of Written Description
Applicant's arguments filed 25 June 2026 have been fully considered but they are not persuasive.
Applicant urges that the claims have been amended to require that the 3’ to 5’ exonuclease activity of Mre11 be inhibited.
This argument is not persuasive. First, claim 14 has not been amended to be limited as such. Regarding, the other claims that have been amended to required that the 3’ to 5’ exonuclease activity of Mre11 be inhibited. This scope of the claims is still not adequately described. Only treating with Mirin has been exemplified and while Mirin is known to have the claimed function, knowledge in the art suggests that Mirin has additional functions. This leads to the question of whether the inhibition of 3’ to 5’ exonuclease activity of Mre11 is what actually leads to the improved fertility of interspecific hybrids. As such, the claims remain rejected.
Claim Rejections - 35 USC § 112
Lack of Written Description
The following is a quotation 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.
Claims 1, 5-11, and 14 remain 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are broadly drawn to methods of improving viability of plant pollen by treating at least part of the plant with an inhibitor of the MRN-ATM pathway. There are no structural limitations on the means of inhibiting the MRN-ATM pathway nor are there any limitations as to which component(s) of the MRN-ATM pathway are targeted (in the case of claim 14). Claims 1, 5-11 do require that Mre11 is inhibited with a compound that blocks the 3’ to 5’ exonuclease activity of Mre11, but fails to provide any structural limits on the possible compounds used.
The instant disclosure describes improving pollen viability of the F1 interspecific hybrid produced from a cross of Brassica rapa and Brassica oleracea. This improvement is achieved by treating immature flowers with Mirin (an inhibitor of the MRN-ATM pathway) which results in the anthers opening. Typically, this cross is infertile as its anthers do not open without the Mirin treatment (Figure legends and Examples). Dupre et al 2008 (Nature Chemical Biology 4:2, p. 119-125) prevents MRN-dependent activation of ATM, inhibits Mre11 activity, and abolishes the g2/M checkpoint and HDR. While this mechanism of action for Mirin was conducted in animal cells, a person of skill in the art would expect the mechanism of action to be similar in plants as cellular machinery of DNA repair and cell cycle regulation tends to be highly conserved across eukaryotes.
These descriptions are insufficient, because only a single inhibitor that has been identified as having multiple cellular targets was described as improving pollen viability. It was not described in the instant disclosure nor in the prior art what specific inhibition in a complex pathway leads to the improved fertility. The understanding of this discovery is further complicated by the teachings of Puizina et al 2004 (The Plant Cell 16: p. 1968-1978) who found that Arabidopsis mutants lacking Mre11 are infertile due to what is speculated to be genome fragmentation.
Given the broad scope of the claimed genus, the lack of working examples and the failure to describe the structures required to confer the claimed function, one of skill in the art would not have recognized that Applicant was in possession of the claimed genus at the time of filing.
Response to Arguments - Scope of Enablement
Applicant's arguments filed 25 June 2026 have been fully considered but they are not persuasive.
Applicant urges narrowing the claims to interspecific hybrids of angiosperms or gymnosperms overcomes the scope of enablement rejection of record.
This argument is not persuasive, because there is no evidence in the instant disclosure or the state of the art that inhibition of MRN-ATM can lead to increased fertility of plant already having normal levels of fertility. If the claims are amended to require that the interspecific hybrid is infertile or of low fertility in the absence of treatment, the scope of enablement rejection will be overcome. Some interspecific hybrids have normal levels of fertility, such as some hybrids of wheat species. Note that the written description rejection may still apply though.
Scope of Enablement
Claims 1-2, 5-11, and 14 remain rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for using the method to improve viability of pollen in infertile interspecific hybrids, does not reasonably provide enablement for any plant of normal fertility. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The claimed invention is not supported by an enabling disclosure taking into account the Wands factors. In re Wands, 858/F.2d 731, 8 USPQ2d 1400 (Fed. Cir. 1988). In re Wands lists a number of factors for determining whether or not undue experimentation would be required by one skilled in the art to make and/or use the invention. These factors are: the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples of the invention, the nature of the invention, the state of the prior art, the relative skill of those in the art, the predictability or unpredictability of the art, and the breadth of the claim.
The claims are broadly drawn to methods of improving pollen viability of any plant including plants of normal fertility or infertile plants.
Applicants teach improving pollen viability of the F1 interspecific hybrid produced from a cross of Brassica rapa and Brassica oleracea. This improvement is achieved by treating immature flowers with Mirin (an inhibitor of the MRN-ATM pathway) which results in the anthers opening. Typically, this cross is infertile as its anthers do not open without the Mirin treatment (Figure legends and Examples).
Applicants do not teach how to use the claimed methods to increase pollen viability of any plant of normal fertility.
The state-of-the-art is such that one of skill in the art cannot predict whether any improvement in fertility can be achieved in plants with normal fertility. The art regarding the effect of Mirin or any other inhibitor of the MRN-ATM pathway on flowering is sparse. The original discovery of the effects of Mirin on the MRN-ATM pathway was conducted in animal cells. Dupre et al 2008 (Nature Chemical Biology 4:2, p. 119-125) prevents MRN-dependent activation of ATM, inhibits Mre11 activity, and abolishes the g2/M checkpoint and HDR. Puizina et al 2004 (The Plant Cell 16: p. 1968-1978) teach that Arabidopsis mutants lacking Mre11 are infertile due to what is speculated to be genome fragmentation. Given that lack of Mre11 activity leads to infertility, yet treatment of typically infertile with an inhibitor of Mre11 leads to improved fertility, a person of skill in the art would find recognize attempts to improve pollen viability by inhibiting the MRN-ATM pathway as highly unpredictable.
Given the lack of guidance in the instant specification, undue trial and error experimentation would have been required for one of ordinary skill in the art to use the claimed methods within the broad scope of the claims.
Conclusion
No claims are allowed. THIS ACTION IS MADE FINAL. 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 extension fee 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 MATTHEW R KEOGH whose telephone number is (571)272-2960. The examiner can normally be reached M-Th 7-4:30, half day on Fridays.
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/MATTHEW R KEOGH/Primary Examiner, Art Unit 1663
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