DETAILED ACTION
Applicant's election with traverse of Group II (claims 1 and 5-12) and the species of SEQ ID NO:1 in the reply filed on 20 July 2026 is acknowledged..
The traversal is on the ground(s) that the claims satisfy the unity of invention requirement as groups I-II have the common technical feature of enhancing the tillering capacity and/or regeneration capacity of gramineous forage grasses via downregulation of miR528, a feature not disclosed in Li; the inventors have identified a previously unrecognized relationship between miR528 and the tillering (response pg 5). This is not found persuasive because the claimed method step, down-regulation of the expression and/or function of miR528 in gramineous forage grasses, is taught by Li et al, who transformed a construct expressing SEQ ID NO:7 into maize to produce plants with down regulation of their SEQ ID NO:15 (pg 76, line 28, to pg 78, line 10), which is miR528 (pg 22, lines 18-21); maize is a forage grass (pg 88, lines 21-28). That Li did not recognize an inherent relationship plays no role in showing that the technical feature linking the Groups is not special.
Applicant urges that unity of invention, not novelty, is the issue at hand, and they should be given the opportunity to argue the merits during prosecution (response pg 4). This is not found persuasive because novelty was not evaluated in the restriction requirement. A restriction does not prevent Applicant from arguing the merits of novelty in response to a rejection under 35 USC 102.
Applicant urges that the inventions of Group I and II are related because they are both methods of downregulating miR528 in gramineous forage grasses (response pg 4-5). This is not found persuasive because as discussed above, that technical feature is not special.
Applicant urges that searches for Groups I-II can be carried out using similar keywords and searches designed for Groups I-II would likely produce overlapping results, and thus search and consideration of Groups I-II would not impose a serious burden (response pg 5). This is not found persuasive because this is a 371, for which restriction is based on unity of invention practice. Search burden is not a consideration under unity of invention practice; Section 803 refers to US practice restriction.
The requirement is still deemed proper and is therefore made FINAL. Claims 2-4 drawn to invention I and claims 8 and 12 drawn to species SEQ ID NO:3 are withdrawn from consideration as being to nonelected inventions. Claims belonging to both groups, i.e., claims 1 and 9-10, are examined to the extent they read on the elected invention.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 1, 5 and 10 are objected to because of the following informalities:
In claim 1, line 1, “which” should be replaced with --said method--, as currently the phrase starting with “which” modifies “grasses”.
In claim 5, the comma after “mimic” in line 3, and the comma after “miR528” in line 4 should be deleted.
In claim 10, line 2, --said method-- should be inserted after the comma.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
Claims 1, 5-7, and 9-10 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 enhancing the tillering capacity and/or regeneration capacity of Panicum virgatum by down-regulating the function of miR528, does not reasonably provide enablement for enhancing the tillering capacity and/or regeneration capacity of the full scope of gramineous forage grasses by down-regulating the function of miR528. 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 the invention commensurate in scope with these claims.
The claims are broadly drawn to a method of enhancing the tillering capacity and/or regeneration capacity of a gramineous forage grass comprising downregulating the function of miR528 by expressing in a gramineous forage grass an artificial target mimic sequence and/or a short tandem target mimic, that interacts with miR528.
The instant specification provides a working example of transforming P. virgatum with a short tandem target mimic (STTM) construct comprising SEQ ID NO:1 to produce plants (example 5), resulting in plants with an increased number of tillers (example 6) and increased growth (“regeneration”) after mowing (example 7). The specification does not provide a working example in which a STTM construct was transformed into any other gramineous forage grass.
The instant specification teaches that expression of a STTM construct in gramineous forage grasses downregulates the function of miR528 (pg 2, paragraph 7) and that such downregulation results in increased tillering and regeneration (pg 3, paragraph 2).
If downregulation of miR528 results in increased tillering and regeneration, then overexpression should not do so. However, overexpression of miR528 in the gramineous forage grass creep bent grass resulted in increased tillering (Yuan et al, 2015, Plant Physiol. 169:576-593; see pg 578, right column, paragraph 1).
miR528 has a diverse range of roles in monocots and it affects different processes in different monocot species (Chen et al, 2019, Molecular Plant 12:1044–1046; see pg 1044, the paragraph spanning the columns, right column, paragraphs 2 and 4).
Thus, without evidence that downregulating the function of miR528 in the full scope of gramineous forage grasses, including the ones specifically claimed in instant claim 9, one of skill in the art would not expect that downregulating the function of miR528 in the full scope of gramineous forage grasses would enhancing the tillering capacity and/or regeneration capacity in in the full scope of gramineous forage grasses.
Given the claim breath, unpredictability, lack of working examples in the full scope of gramineous forage grasses, and nature of the invention as discussed above, the instant invention is not enabled throughout the full scope of the claims.
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 the second paragraph of 35 U.S.C. 112:
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 1, 5-7, and 9-10 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 that the inventor or a joint inventor, or for pre-AIA the applicant, regards as the invention. Dependent claims are included in all rejections.
Claims 1 and 10 lack antecedent basis for the limitation “the … function of miR528” because miR528 has multiple functions.
Claims 1 and 6 are indefinite in their recitation of “in gramineous forage grasses”. It is unclear if it is intended that the method be practiced in all gramineous forage grasses, in merely two species of forage grass, or in merely two forage plants, even of the same species. It is also unclear if the method were practiced in a single gramineous forage grass, it would be encompassed by the claims. For purposes of examination, it was assumed that practicing the methods in a single plant is encompassed. Such treatment does not relieve Applicant of the responsibility to respond to this rejection.
It is unclear in claim 9 if the method is practiced in all the grass species and genera listed at the same time, or if practicing it in only one species is encompassed. For purposes of examination, it was assumed that practicing the methods in a single plant species is encompassed. Such treatment does not relieve Applicant of the responsibility to respond to this rejection.
Claim Rejections - 35 USC § 102
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.
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.
Claims 1, 5, 7, and 10-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li et al (US 2020/0283786).
Li et al teach their SEQ ID NOs:7 and 8, which comprise the instant SEQ ID NO:1:
US-16-758-559-7
Sequence 7, US/16758559
Publication No. US20200283786A1
GENERAL INFORMATION
APPLICANT: Marks & Clerk LLP
APPLICANT: Williams, Andrea
TITLE OF INVENTION: Lodging Resistance in Plants
FILE REFERENCE: PC928630WO
CURRENT APPLICATION NUMBER: US/16/758,559
CURRENT FILING DATE: 2020-04-23
PRIOR APPLICATION NUMBER: CN201711001759.1
PRIOR FILING DATE: 2017-10-24
PRIOR APPLICATION NUMBER: CN201711001789.2
PRIOR FILING DATE: 2017-10-24
NUMBER OF SEQ ID NOS: 79
SEQ ID NO 7
LENGTH: 524
TYPE: DNA
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: RNA inhibitor
Query Match 100.0%; Score 24; Length 524;
Best Local Similarity 100.0%;
Matches 24; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 CTCCTCTGCATCTAGCCCCTTCCA 24
||||||||||||||||||||||||
Db 218 CTCCTCTGCATCTAGCCCCTTCCA 241
US-16-758-559-8
Sequence 8, US/16758559
Publication No. US20200283786A1
GENERAL INFORMATION
APPLICANT: Marks & Clerk LLP
APPLICANT: Williams, Andrea
TITLE OF INVENTION: Lodging Resistance in Plants
FILE REFERENCE: PC928630WO
CURRENT APPLICATION NUMBER: US/16/758,559
CURRENT FILING DATE: 2020-04-23
PRIOR APPLICATION NUMBER: CN201711001759.1
PRIOR FILING DATE: 2017-10-24
PRIOR APPLICATION NUMBER: CN201711001789.2
PRIOR FILING DATE: 2017-10-24
NUMBER OF SEQ ID NOS: 79
SEQ ID NO 8
LENGTH: 524
TYPE: DNA
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: RNA inhibitor
Query Match 100.0%; Score 24; Length 524;
Best Local Similarity 70.8%;
Matches 17; Conservative 7; Mismatches 0; Indels 0; Gaps 0;
Qy 1 CTCCTCTGCATCTAGCCCCTTCCA 24
|:||:|:|||:|:||||||::|||
Db 218 CUCCUCUGCAUCUAGCCCCUUCCA 241
Li et al teach a method comprising down-regulating the function of miR528 by expressing in maize a construct (pCUB-MIM) comprising a target mimic comprising their SEQ ID NO:7 (¶388-390, 392) to produce plants, which they call TM-3 and TM-7, in which the expression, and thereby the function, of miR528 (their SEQ ID NO:15) is reduced (¶397). The resulting plants would have enhanced tillering capacity and/or regeneration capacity because the instantly claimed method steps are practiced. Maize is a forage grass.
Claim Rejections - 35 USC § 103
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:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, 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 1, 5-7, and 10-11 are rejected under 35 U.S.C. 103(a) as being unpatentable over Li et al (US 2020/0283786).
The claims are drawn to a method comprising down-regulating the function of miR528 by transforming a gramineous forage grass with a vector constitutively expressing an artificial target mimic sequence comprising SEQ ID NO:1.
The teachings of Li et al are discussed above. Li et al do not teach what kind of promoter was used in their construct.
The broad teachings of Li et al cure this deficiency. Li et al suggests expressing a constructs comprising their SEQ ID NO:7 or 8 from a constitutive promoter (¶45) and provide the CaMV35S promoter as an example of one (¶181).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify Li et al’s method of down-regulating the function of miR528 to express the target mimic comprising their SEQ ID NO:7 from a constitutive promoter. One of ordinary skill in the art would have been motivated to do so because Li et al suggests doing so (¶45).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anne R. Kubelik, Ph.D., whose telephone number is (571) 272-0801. The examiner can normally be reached Monday through Friday, 9:00 am - 5:00 pm Eastern.
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/Anne Kubelik/Primary Examiner, Art Unit 1663
