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 .
Second Action Non-Final
It is noted that this Office action is a Second Action Non-Final. The Office has reconsidered the allowable subject matter of 90% sequence identity with the nucleotide sequences of SEQ ID NOs: 78, 18, and 30, and is re-opening prosecution to make a new rejection over that limitation.
Status of Claims
The amendments received on 01/12/2026 have been entered. Claims 3, 5-6, and 9-17 are pending.
Claim 4 has been cancelled.
Claims 3, 5-6, and 9-15 have been amended.
Claims 3, 5-6, and 9-17 are examined in this Office action.
Objections/Rejections that are Withdrawn
All Objections/Rejections of claim 4 have been rendered moot by Applicant’s cancellation of the claim.
The Objections to the Specification have been withdrawn in light of Applicant’s amendments to the Specification.
The Objections to claims 9-10 and 12-15 have been withdrawn in light of Applicant’s amendment to the claims.
The 35 USC 112(b) Indefiniteness rejection of claims 15-17 has been withdrawn in light
of Applicant’s amendment to the claims. However, Applicant’s amendments have raised new grounds for a 35 USC 112(b) Indefiniteness rejection.
The 35 USC 102 rejection of claims 3 and 9-17 has been withdrawn in light of Applicant’s
amendment to the claims.
The text of those sections of Title 35, U.S. Code, not included in this action, can be found in a prior Office action.
Claim Objections
Claims 3, 10, 12, and 15 are newly objected to and claims 5-6 remain objected to because of the following informalities:
Claims 3 and 5-6 are objected to for the phrase “comprises SEQ ID NOS”. It is suggested to rewrite the phrase as ---comprises SEQ ID NO:---.
Claim 10 is objected to for containing a double comma in line 1 after [[1]].
Claim 12 is objected to for the recitation of “any of claims 9”. It is suggested to rewrite the phrase as ---claim 9---.
Claim 15 is objected to for the recitation of “the expression cassette or vector of claim 3”. There is a lack of antecedent basis for “or vector” since claim 3 does not recite “a vector”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
Indefiniteness
Claim 11 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. This is a new rejection necessitated by amendment.
The claim is directed to an RNA or protein of interest that confers a characteristic upon a plant. Two of the recited characteristics, “performance in an industrial process” and “reproductive capability”, render the claim indefinite. It is implied from the claim that a plant lacking the RNA or protein of interest would not have any “performance in an industrial process” or any “reproductive capability”. Does the plant only have “performance in an industrial process” or “reproductive capability” when it comprises the RNA or protein of interest? Thus, it is unclear what effect the RNA or protein of interest would have on “performance in an industrial process” and “reproductive capability”.
Claim Rejections - 35 USC § 112(a)
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.
Written Description
Claims 3, 5-6, and 9-17 are 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. All dependent claims are included in these rejections unless they include a limitation that overcomes the deficiencies of the parent claim.
Claim 3 recites “at least 90% identity with…SEQ ID NO: 78”; claim 5 recites “at least 90% identity with…SEQ ID NO: 18”; and claim 6 recites “at least 90% identity with…SEQ ID NO: 30”.
Applicant constructed 80 vectors comprising 80 different enhancer sequences (single enhancers SEQ ID NOs: 1-48 and dual enhancers SEQ ID NOs: 49-80). Dual enhancer SEQ ID NO: 78 comprises plant enhancer eZM18 (SEQ ID NO: 18) and viral enhancer eMMV (SEQ ID NO: 30). Of the other 31 dual enhancers tested by the Applicant, only dual enhancers SEQ ID NOs: 53, 56-58, and 68-70 were disclosed in a sequence search for dual enhancer SEQ ID NO: 78. Each of the disclosed dual enhancers SEQ ID NOs: 53, 56-58, and 68-70 had only 20.8-21.2% sequence identity with dual enhancer SEQ ID NO: 78. As such, Applicant has not reduced to practice a dual enhancer comprising less than 100% sequence identity to SEQ ID NO: 78, which in turn comprises less than 100% sequence identity to plant enhancer eZM18 (SEQ ID NO: 18) and/or less than 100% sequence identity to viral enhancer eMMV (SEQ ID NO: 30).
As evidenced in the prior art, it is unpredictable how variations in an enhancer sequence effect enhancer functionality. For example, JORES (Jores et al., 2024, The Plant Cell, Vol. 36, pages 2570-2586) describes enhancers as playing a pivotal role in orchestrating the precise gene expression programs required for plants to develop and thrive in concert with their ever-changing abiotic and biotic environments. They integrate spatiotemporal, developmental, and environmental cues by binding to transcription factors to enhance the transcription of their target genes (Introduction). Plant enhancers function independently of orientation, are active over a wide range of distances, and occur upstream or downstream of their target promoter (page 2571, left column, first full paragraph).
JORES used saturation mutagenesis to characterize the functional underpinnings of 3 light-responsive plant enhancers: AB80 from pea (Pisum sativum), Cab-1 from wheat (Triticum aestivum), and rbcS-E9 from pea. JORES identified several mutation-sensitive regions within each enhancer that are crucial for condition-specific activity (page 2571, left column, last paragraph).
JORES determined the activity of over 99% of all possible single-nucleotide variants. While most mutations had little to no effect, some of the variants resulted in an up to 4-fold increase or to a decrease to as low as 1/20 in enhancer strength relative to the wild-type sequence (page 2573, left column, fourth paragraph).
In summary, JORES found that the activity of the full-length enhancers is the result of cooperative interactions between their constituent mutation-sensitive regions. This interpretation is supported by the observation that the enhancer strength of the combinations of mutation-sensitive regions depends on their spacing and order. Because JORES analyzed only 3 plant enhancers, it remains to be tested how generalizable the findings are (page 2578, right column, first full paragraph).
A Written Description rejection is based on what the Applicant was in possession of at the time of filing. Applicant has reduced to practice a dual enhancer comprising 100% sequence identity to SEQ ID NO: 78, which in turn comprises a plant enhancer with 100% sequence identity to plant enhancer eZM18 (SEQ ID NO: 18) and a viral enhancer with 100% sequence identity to viral enhancer eMMV (SEQ ID NO: 30). Given that there have not been an adequate number of species reduced to practice to be representative of the broad genera of claimed enhancers, and there is no description of structures that are correlated with the required function, there is not an adequate written description to support the breadth of the claims.
Scope of Enablement
Claims 3, 5-6, and 9-17 are 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 a dual enhancer comprising 100% sequence identity to SEQ ID NO: 78, which in turn comprises a plant enhancer with 100% sequence identity to plant enhancer eZM18 (SEQ ID NO: 18) and a viral enhancer with 100% sequence identity to viral enhancer eMMV (SEQ ID NO: 30), does not reasonably provide enablement for a dual enhancer comprising less than 100% sequence identity to SEQ ID NO: 78, which in turn comprises less than 100% sequence identity to plant enhancer eZM18 (SEQ ID NO: 18) and/or less than 100% sequence identity to viral enhancer eMMV (SEQ ID NO: 30). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims. All dependent claims are included in these rejections unless they include a limitation that overcomes the deficiencies of the parent claim.
The instant Specification does not describe a dual enhancer comprising less than 100% sequence identity to SEQ ID NO: 78, which in turn comprises less than 100% sequence identity to plant enhancer eZM18 (SEQ ID NO: 18) and/or less than 100% sequence identity to viral enhancer eMMV (SEQ ID NO: 30). In the instant case, the Specification does not provide sufficient guidance with respect to how to alter SEQ ID NOs: 78, 18, and 30 and still retain enhancer functionality. As outlined in the Written Description rejection above, plant enhancers comprise mutation-sensitive regions that are crucial for condition-specific activity, and the enhancer strength of the combinations of mutation-sensitive regions depends on their spacing and order. Absent such guidance, one skilled in the art would have to make each of the variations of enhancers SEQ ID NOs: 78, 18, and 30, and then test the ability of each enhancer variant to maintain enhancer functionality, in order to determine whether and how an enhancer variant can be used as a functional enhancer. Such a trial-and-error approach to practicing the claimed invention would constitute undue experimentation.
Summary
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA MEADOWS whose telephone number is (703)756-1430. The examiner can normally be reached Monday - Friday 9:00 am - 5:00 pm.
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CHRISTINA MEADOWS
Examiner
Art Unit 1663
/CHRISTINA L MEADOWS/Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663
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