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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07April2026 has been entered.
Election/Restrictions
[Copied from the Final Action Dated 07January2026, Nonfinal Action Dated 08July2025 → ] Applicant's election with traverse of Group I and election without traverse of RPL3B-3, (wild type) SEQ ID NO: 78 and its associated SEQ ID NO: 77, as well as (mutant) amino acid sequence SEQ ID NO: 152 (corresponding to SEQ ID NO: 151), as well as SEQ ID NOs: 110 and 141 in the reply filed on 06May2025 is acknowledged. The traversal as to Group I is on the ground(s) that the subject matter of Groups I and II are so similar that it would not amount to an undue burden if the two were examined together (Remarks at the paragraph bridging pages 2 and 3). This is not found persuasive because, as evidenced of record, there are at least disparate anticipation considerations for Groups I and II in so far as “editing system” at Group II is considered a nuclease system such as CRISPR/Cas. To that end, what constitutes an “editing system” for the purposes of Group II is not relevant to present Group I and would need to be analyzed under 35 U.S.C. § 112(a) and (b).
The requirement is still deemed proper and is therefore made FINAL.
Claims 42, 45, 50, 51, 53, 75, 81, 83, 89, 91, and 94 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group of invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 06May2025.
Status of the Claims
The claims filed 07April2026 are acknowledged and have been fully considered. Claims 3-4, 6-8, 10-16, 18-19, 21-22, 24-25, 27-31, 33-41, 43-44, 46-49, 52, 54-74, 76-80, 82, 84-88, 90, 92-93, and 95-115 were previously canceled. Claim 2 is also now canceled. Claims 1, 5, 9, 17, 20, 23, 26, 32, 42, 45, 50, 51, 53, 75, 81, 83, 89, 91, and 94 remain pending. Claims 1, 5, 23 are currently amended and claims 9, 17, 20, 26, 32, 42, 45, 50, 51, 53, 75, 89 were previously presented. Claims 81, 83, 91, and 94 are original. Following the restriction requirement mailed 07March2025 and Applicant’s election dated 06May2023, claims 42, 45, 50, 51, 53, 75, 81, 83, 89, 91, and 94 remain withdrawn as being directed toward a non-elected group and/or species (rejoinder currently being inappropriate).
Claims 1, 5, 9, 17, 20, 23, 26, and 32 are examined on the merits herein.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) [US provisional 63328313 filed 07April2022] is acknowledged. Claims 1, 5, 9, 17, 20, 23, 26, and 32 maintain an effective filing date of 07April2022.
Claim Rejections - 35 USC § 101 & 112 - Utility
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.
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.
Claims 1, 5, 9, 17, 20, 23, 26, 32 REMAIN rejected under 35 U.S.C. 101 because the claimed invention is not supported by either a specific and substantial asserted utility or a well-established utility.
↓Materially Copied from the Final & Nonfinal, See Response to Applicant’s Remarks for New Content↓
These claims encompass any wheat plant/part having a complete knockout of RPL3 (note at claim 1, to which all claims refer, it is said “… wherein the at least one mutation results in no detectable RPL3 polypeptide ….”).
Further to the discussions of record regarding anticipation, it was previously shown that the expression of RPL3A and RPL3B is coordinated such that modulating the expression of one (e.g., decreasing RPL3A mRNA levels in tobacco) may cause modulated expression of the other (e.g., decreased RPL3A mRNA causing an overaccumulation of RPL3B mRNA in tobacco)1 and a corresponding change in plant phenotype2; it was also previously known that decreasing RPL3A and RPL3B causes deleterious plant phenotypes. Which makes sense, given the importance of RPL3 in ribosome machinery. For example, POPESCU & TUMER teach that, at least in tobacco plants/parts, suppressing RPL3B mRNA did not cause an increase in RPL3A mRNA accumulation (which is different from what they observed with RPL3A suppression) and noted that plants/parts which had reduced levels of total RPL3 mRNA (i.e., reduction of both RPL3A and RPL3B; therein referred to as “NT482” plants) exhibited “developmental delay, a decrease in the cell number and a significant increase in the epidermal cell size compared to [wild type] plants”.3 LEE et al. observed that rice plants/parts having its endogenous Plastid Ribosomal Protein L3 (PRPL3) gene sequence knocked out are “seedling lethal”.4
This specification only describes certain wheat RPL3 gene mutants (there is no description within the specification as to what functional/phenotypic effect those mutants have on any plant, let alone a wheat plant/part, including their functional/phenotypic effect when just one or all alleles of the gene comprise the mutant).
Given the teachings by the prior art, and without more information from Applicant, these claims appear to encompass plants/parts with such low RPL3 expression that the plant/part would reasonably be expected to have severe deformity (POPESCU & TUMER) and such low expression may even be lethal (LEE et al.).
Therefore, while a severely deformed or dead plant/part may be said to have an increased resistance to a particular pathogen and lower accumulation of DON (as compared to a wild type plant/part); the Office fails to see how such plants/parts are useful from a practical perspective (severely deformed or dead plants/parts lose their commercial utility as a food crop, for example).
For context, MPEP § 2103 (I)(A) explains that: “the claimed invention as a whole must be useful. The purpose of [the Utility] requirement is to limit patent protection to inventions that possess a certain level of ‘real world’ value, as opposed to subject matter that represents nothing more than an idea or concept, or is simply a starting point for future investigation or research” (internal citations omitted). See also MPEP §§ 2164.01(c) and 2107.01-.03, e.g., 2107.02(III)(A) (“… a specification which contains a disclosure of utility which corresponds in scope to the subject matter sought to be patented must be taken as sufficient to satisfy the utility requirement of § 101 for the entire claimed subject matter unless there is a reason for one skilled in the art to question the objective truth of the statement of utility or its scope.”).
Claims 1, 5, 9, 17, 20, 23, 26, 32 REMAIN rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. Specifically, because the claimed invention is not supported by either a specific and substantial asserted utility or a well-established utility for the reasons set forth above, one skilled in the art clearly would not know how to use the claimed invention.
Response to Applicant’s Remarks Dated 07April2026:
As an initial matter, the declaration by (co-inventor) Dr. Miller is acknowledged. The substantive and relevant content therein is the following three paragraphs:
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The referenced section of the specification is shown below (from page 100, the elected species is boxed for ease of review):
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(1) At page 8 of the Remarks dated 07April2026, Applicant repeats the argument which was addressed as (2) within the Final Action (namely, that POPESCU & TUMER and LEE et al. regard non-wheat plants and that deleterious effects in non-wheat plants is not informative of these claimed wheat plants).
This argument remains unpersuasive. This specification does not describe any in planta data/results (Examples 2-6 of the specification are prophetic) and the Miller Declaration does not remedy that deficiency. As is shown above, the declaration does not provide any data or results to supplement the specification. As confirmed by ¶4 of the Miller Declaration and as stated within the rejection itself, RPL3 genes encode proteins that are subunits of the 60s ribosome. Given the importance of RPL3 in ribosome machinery and the fact that such machinery is not plant-type-specific (quite the opposite as Applicant no doubt knows: 60s ribosomes are ubiquitous among eukaryotes), it is unreasonable to suggest (without evidence) that the negative effects in tobacco or rice would not inform the expectations by a skilled artisan working with wheat.
(2) Applicant also points toward the Miller Declaration (Remarks at the bridge of pages 8-9) as supposedly showing that the wheat plants/parts “as claimed [have] practical utility.”
This is not persuasive because the declaration is missing material information. First, and as noted above, the declaration does not provide any data or results to supplement the specification. Further, and critically, the declaration fails to provide information that is material to this rejection: the declaration does not explain whether the edited wheat plants had a knock-out of RPL3 expression or function or whether the edited wheat plants simply had a down-regulation of RPL3 expression or function. This is material information because, as evidenced by at least LEE et al., knock-outs have been shown to be seedling lethal. Furthermore, the declaration does not explain whether the edited wheat plants actually had any of the Fusarium phenotypes recited in claims 23 and 26. To ensure a clear record, please note that these claims continue to encompass a complete knock-out of either or both of RPL3A and RPL3B (see claim 1).
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 5, 9, 17, 20, 23, 26, 32 REMAIN rejected under 35 U.S.C. 103 as being unpatentable over HARRIS et al. (US PAT. NO. 6855872 issued 15February2005) and DI et al. (“Expression of a truncated form of yeast ribosomal protein L3 in transgenic wheat improves resistance to Fusarium head blight.” 2010 Plant Science 178:374-380; of record IDS 17August2023) and BRAUER et al. (“Expression of a truncated form of yeast ribosomal protein L3 in transgenic wheat improves resistance to Fusarium head blight” 2020 MPMI 33(3):553-560) and LEE et al. (“Impaired Plastid Ribosomal Protein L3 Causes Albino Seedling Lethal Phenotype in Rice” 2019 J. Plant Biol. 62:419-428; of record PTO-892 08July2025).
↓Materially Copied from the Final, See Response to Applicant’s Remarks for New Content↓
The claims were amended 08December2025 to specify that the plant is a wheat plant and that “the mutation is an out-of-frame deletion and/or an out-of-frame insertion” (taken from claim 9). LEE et al. (formerly used in an anticipation rejection) is added to the list of cited reference here in view of the claim amendments. LEE et al., which regard rice plants, teach mutating (by base insertion and deletion) the endogenous Plastid Ribosomal Protein L3 (PRPL3) gene sequence of rice using CRISPR/Cas to obtain plants with PRPL3 knocked out. [relevant to claims 1, 5, 9, 23] To be clear, rice plants with PRPL3 knocked out are “seedling lethal”,5 meaning those mutant plants/parts have resultant “no detectable RPL3 polypeptide” as well as “reduced binding to a … mycotoxin” [relevant to claim 1 and the Utility rejection] such as DON as well as “increased resistance to FHB”, and/or a “decreased amount of F. graminearum” and/or an ‘increased tolerance to DON” [relevant to claim 23]. Absent evidence to the contrary, and based on the highly conserved nature of RPL3 sequences6, the rice RPL3 gene sequence of LEE et al. is presumed to have at least “80% sequence identity to … SEQ ID NO: 78” and/or “and least 80% sequence identity to … SEQ ID NO: 110 or 141” and/or encode an amino acid sequence with “at least 80% sequence identity to … SEQ ID NO: 77”. [relevant to claim 20]
↓Materially Copied from the Nonfinal, See Response to Applicant’s Remarks for New Content↓
HARRIS et al. is cited for teaching a wheat RPL3 amino acid sequence that has 100% sequence identity to this application’s SEQ ID NO: 77 (= SEQ ID NO: 16 of HARRIS et al.)7 and, therefore, making the RPL3 gene sequences that encode one such amino acid sequence obvious.8 For clarity of the record, please also note that SEQ ID NO: 78 of this application is an RPL3 genomic sequence and has at least 84% sequence identity to the RPL3 coding sequence SEQ ID NO: 13 of HARRIS et al.9
DI et al. is considered the primary reference and is cited for teaching transgenic (hexaploid) wheat plants and plant parts expressing both its endogenous RPL3 genes as well as a transgenic, mutant RPL3 sequence (referred to therein as “L3Δ”) which encodes a truncated RPL3 protein that only has the first 99 amino acids from the wild type wheat RPL3 protein (i.e., N’-1 … 99*).10 DI et al. teach that when wheat plants/parts express both its endogenous (wild type) RPL3 sequence as well as a truncated form of RPL3 (“L3Δ”), plants/seeds are protected from FHB and show reduced DON accumulation.11 For clarity of the record, this application’s (elected) mutant sequence SEQ ID NO: 151 encodes the amino acid sequence SEQ ID NO: 152 [see claim 32] and the sequence SEQ ID NO: 152 consists of the first 105 amino acids from the wild type wheat RPL3 protein (corresponding to amino acids 1-105 of SEQ ID NO: 16 from HARRIS et al.12). There is nothing of record to suggest that the 6 amino acid extension in SEQ ID NO: 152 (as compared to the “L3Δ” truncated RPL3 protein taught by DI et al.) has a material effect on the protein function. Therefore, the sequence SEQ ID NO: 152 (amino acids 1-105) of claim 32 is considered a range of amino acids that overlap with those of the “L3Δ” sequence taught by DI et al. (amino acids 1-99) and, absent evidence to the contrary (such as a showing of functional differences), the sequence SEQ ID NO: 152 is considered prima facie obvious in view of the “L3Δ” sequence taught by DI et al.13 DI et al. do not teach editing an endogenous RPL3 gene.
BRAUER et al. is cited for teaching the use of CRISPR/Cas gene editing of an endogenous gene in wheat (there, the DON-induced gene referred to as “TaNFXL1”) to introduce deletion mutations and increase the wheat plant’s/part’s resistance to F. graminearum.14 Therefore, while BRAUER et al. do not regard RPL3 sequences; they nonetheless demonstrate successful use of CRISPR/Cas to edit an endogenous gene (including by deletion mutations) in wheat and regarding F. framinearum/FHB resistance.
Without more information from Applicant, it is believed that a person with ordinary skill in the art at the time this application was filed (a “POSA”) would have been motivated to combine the prior art teachings and with a reasonable expectation of successfully arriving at the claimed subject matter. It is believed that a POSA would have been motivated to do so because it is/was desirable to obtain wheat plants/parts having increased resistance to F. graminearum (and FHB) and/or decreased accumulation of DON.15 Given the results by DI et al. when expressing both the endogenous RPL3 genes and a transgenic, truncated “L3Δ” RPL3 sequence within wheat plants/parts; a POSA would have viewed it as at least “obvious to try” to use a gene editing method like CRISPR/Cas to introduce mutations (e.g., deletion mutations) into at least one of the six RPL3 alleles (e.g., one of the three RPL3B alleles) to arrive at a truncated RPL3 protein similar in structure to DI et al.’s “L3Δ” (i.e., the sequence SEQ ID NO: 152 consisting of amino acids 1-105) and thereby obtain a wheat plant/part expressing both wild type endogenous RPL3 sequences as well as a mutant, truncated RPL3 sequence (which, per the results of DI et al., a POSA would reasonably expect to have increased protection from FHB and show reduced DON accumulation). MPEP § 2143(I)(E). To be clear, it is the Office’s position that the sequence particulars of claims 20 and 32 are taught (claim 20) or suggested (claim 32) by HARRIS et al. and DI et al., respectively.
Response to Applicant’s Remarks 07April2026:
(1) At page 10 of the Remarks dated 07April2026, Applicant repeats the argument which was addressed as (1) within the Final Action (namely, that none of the cited references independently or together teach or suggest (a) mutation of an endogenous RPL3 gene and (b) editing a wheat plant/part).
This argument remains unpersuasive. Regarding (a), given the technological advances in the field regarding CRISPR/Cas protocols (and their use in wheat as evidenced by at least BRAUER et al.), a POSA would have found the work of these cited references informative for the claimed editing of an endogenous RPL3 gene. Regarding (b), the argument regarding these claims requiring wheat plants (whereas HARRIS et al. and DI et al. relate to non-wheat plants) was addressed of record and again hereinabove with respect to Utility. Given the importance of RPL3 in ribosome machinery and the fact that such machinery is not plant-type-specific (quite the opposite as Applicant no doubt knows: 60s ribosomes are ubiquitous among eukaryotes), it is unreasonable to suggest (without evidence) that the negative effects in tobacco or rice would not inform the expectations by a skilled artisan working with wheat.
(2) Applicant asserts that a POSA would not have been motivated to modify the cited references and arrive at the claimed subject matter (second to the last paragraph on page 10 of the Remarks).
Absent supportive evidence, this argument is not persuasive in view of the last paragraph of the rejection (of record and hereinabove).
(3) At the paragraph bridging pages 10-11, Applicant argues that the wheat and rice RPL3 genes and proteins are structurally and functionally distinct (discussing LEE et al. for rice RPL3).
This is not persuasive because it overlooks the comprehensive knowledge within the art of wheat RPL3, evidenced by SEQ ID NO: 16 of HARRIS et al.
(4) Applicant asserts at page 11 that:
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This is not persuasive. First, Applicant should be cautious in advancing an argument of unpredictability because, as discussed with respect to Utility, this specification does not provide in planta evidence and this specification must rely upon the prior art to meet both of the Written Description and Enablement requirements. Addressed hereinabove, the Miller Declaration filed 07April2026 does not supplement the specification with additional data or experimental results. Second, as also discussed above with respect to Utility, these claims remain broad (continuing to encompass a complete knock-out of either or both of RPL3A and RPL3B). Third, Applicant’s argument overlooks at least DI et al. who teach partial RPL3 down-regulation (via transformation ) in wheat and resulting FHB and DON phenotypes.
Conclusion
As a courtesy to Applicant and in the interest of preserving both temporal and monetary resources, please note that the Office does not currently see a path toward patentability for the examined claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Rebecca STEPHENS whose telephone number is (571)272-0070. The examiner can normally be reached Monday through Friday 8:30-4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad ABRAHAM can be reached at (571) 270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA STEPHENS/Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663
1 POPESCU & TUMER “Silencing of ribosomal protein L3 genes in N. tabacum reveals coordinate expression and significant alterations in plant growth, development and ribosome biogenesis” 2004 The Plant J. 39:29-44 at page 34.
2 POPESCU & TUMER at pages 35-36.
3 POPESCU TUMER at the lower right column on page 40.
4 LEE et al. at the right column on page 422 to the left column on page 423, as well as figure 4 on page 423.
5 LEE et al. at the right column on page 422 to the left column on page 423, as well as figure 4 on page 423.
6 See FIG8A and 8B, as well as the description thereof, of HARRIS et al. (US Pat. No. US6855872 at column 4).
7 See Result 1 of the sequence search results file of record entitled “20250515_125153_us-18-296-392b-77.rai” as well as Result 2 therein for alignment to SEQ ID NO: 17 of HARRIS et al. See also FIGs 7 and 8 of HARRIS et al. as well as the descriptions thereof at column 4, lines 38-53.
8 MPEP § 2143 citing In re Kubin, 561 F.3d 1351 (Fed. Cir. 2009).
9 See Result 1 of the sequence search results file of record entitled “20250515_125107_us-18-296-392b-78.rni”.
10 DI et al. at the left column of page 379; see also figure 2 on page 377 showing sequence alignments to various RPL3 sequences.
11 DI et al. at the left column of page 379; see generally DI et al. at the Abstract, left column on page 375, right column on page 376-379.
12 See Result 3 of the sequence search results file of record entitled “20250515_125153_us-18-296-392b-152.rai”.
13 MPEP 2144.05(I).
14 BRAUER et al. at Abstract, left column on page 554, left column on page 555, left column on page 556.
15 As is discussed generally by at least HARRIS et al. and DI et al.
Prosecution Insights