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 .
Status of the Claims
The amendments filed 16April2025 are acknowledged and have been fully considered. Claims 1-30 are canceled. Claims 31-50 are newly presented, pending, and 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 provisionals 63423768 and 63423765 filed 08November2022 as well as 63461174, 63461170, and 63497670 filed 21April2023] and under 35 U.S.C. 121 [divisional of 18504917 filed 08November2023] is acknowledged. Claims 31-50 have an effective filing date of 08November2022.
Applicant asserts that this is a divisional application of 18504917 (now US Pat. No. 12,365,908) for which a restriction requirement was mailed 16January2024 setting forth certain groups and/or species for election. The present claims have consonance with Group IV therein (see claim 22) and, therefore, the Office agrees that this is a proper divisional application (i.e., not merely a continuation application).
Claim Objections
Claims 40 and 41 are objected to because of the following informalities: it seems as though a reference to “or both” at the last line of the claim is missing (e.g., perhaps the last lines should be amended to something like “… the first diploid parent MiMe maize plant, of the second diploid parent MiMe maize plant, or both.”. Appropriate correction is required.
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 31-37, 40-46, 49-50 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.
The rejected claims refer to a maize “REC8 locus” or “REC8 protein”; a “SPO11-1 locus” or “SPO11-1 protein”; and/or a “OSD1-2 locus” or “OSD1-2 protein”. These terms are not given a limiting definition within the specification and do not have a well-known meaning within the art. Because it is unclear what is meant by these terms, the metes and bounds of the claimed subject matter is unclear. Specifically, for example, it is not clear from the record whether “REC8” in this context is the same as “AFD1” (which are sometimes considered synonymous names for the same molecule1), it is not clear from the record whether “SPO11-1” encompasses only one or both of what are called “A” and “B” maize SPO11-1 alleles in the art2, and the designation “OSD1-2” (as well as “OSD1-1” and “OSD1-3”) are used to denote mutant alleles in the art (not necessarily used to denote a distinct gene copy/duplication)3.
Please note that none of claims 38-39 and 47-48 are rejected here because those claims provide explicit clarity via reference to a particular amino acid sequence (there is little, if any, room for confusion as to what maize “REC8”, maize “SPO11-1”, and maize “OSD1-2” mean per the language of claims 38-39 and 47-48 because an amino acid sequence is provided for reference). It is recommended that these rejected claims be amended to also refer to a specific nucleotide or amino acid sequence and, in that way, explicitly define what is meant by a maize “REC8 locus” or “REC8 protein”; a “SPO11-1 locus” or “SPO11-1 protein”; and/or a “OSD1-2 locus” or “OSD1-2 protein”.
Claims 32-33 (therefore, also claim 34 which refers thereto), 43-44 (therefore, also claim 45 which refers thereto) 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.
These claims are indefinite for at least four reasons. (1) claims 32 and 43 say that the REC8/SPO11-1/OSD1-2 locus “is identified by aligning a [REC8/SPO11-1/OSD1-2] protein reference sequence from a monocot plant species to a translated nucleotide sequence database”. (1a) It is not clear whether this is an active method step or not and, assuming it is an active method step, (1b) its relationship to the steps of claims 31 and 42 is unclear (e.g., is the “identifying” step practiced before or after the steps of claims 31 or 42? If not, how can a person with ordinary skill in the art have the requisite possession to practice claims 31 and 42 if they do not even know what the REC8, SPO11-1, and/or OSD1-2 loci sequence is yet?) Further, . (2) it is not clear what constitutes a “reference sequence” and how a person with ordinary skill in the art can differentiate a non-reference sequence from a “reference sequence” sufficient to fall within the metes and bounds of these claims. To illustrate the problem, the following questions are relevant: is a “reference sequence” only one of the sequences within NCBI’s RefSeq database or are sequences within EBI’s Ensembl database also included? Those databases are updated occasionally, so do future monocot sequences also count as “reference sequence” here or can the “reference sequence” only be that which was in a database before the effective filing date of this application? (3) Claims 32-33 and 43-44 recite “aligns to” or “aligns with” the reference sequence, but it is not clear what “aligns to” or “aligns with” means (e.g., are specific pairwise alignment parameters needed? Does hybridization experiments count and, if yes, what conditions? Is the “aligns to” or “aligns with” across the full length of the reference sequence?). These phrases do not have a limiting definition within the specification and do not have a well-recognized meaning in the art. Given the use of “with at least 50% identity to” in claims 33 and 44, and using claim differentiation principles, it is believed that “aligns to” and “aligns with” is not a synonym for having a particular “percent identity” to the reference sequence (or else “identity to” would not be used by Applicant to modify the “aligns with” phrase). In general, a sequence “aligns to” or “aligns with” another sequence if it has any two or more consecutive nucleotides/amino acids in common—that cannot be what Applicant means here because it is also known that sharing only two consecutive nucleotides/amino acids would not be sufficient to “identify” a REC8/SPO11-1/OSD1-2 locus (i.e., applying the general meaning of “aligns to” or “aligns with” to these claims would undermine the stated purpose of the (supposed) “identified by” method step and, therefore, is not an interpretation that should be made (see MPEP § 2111.01(I))). Finally, (4), these claims are focused on “identifying a maize nucleotide sequence” (which is assumed to be within the queried database) but it is not clear what makes a particular sequence “a maize” sequence as opposed to just a “monocot sequence”. Part of the issue is that “reference sequences” are usually generated by combining sequence data sets and are not always the same as a “wild type” sequence or one that originated from a particular sample (i.e., many reference sequences are synthetic and do not actually occur within a particular organism). Does “maize nucleotide sequence” in these claims mean that the “reference sequence” has to be one that actually exists in a plant? Part of the issue with using “maize sequence” is that “maize” denotes origin and not structure: what happens if the “monocot reference sequence” (let’s say a rice sequence) has 100% sequence identity to another sequence—what would make that other sequence a “maize sequence” as opposed to just being a ”rice sequence” (i.e., what happens if the origin of the sequence is different, say rice versus maize, but the structure is the same—do we label either of those a “maize sequence” and what test does one use for making that determination?).
Please clarify or cancel these claims. For the sake of transparency, the Office cannot identify a claim amendment (supported by the specification) that would overcome these issues and result in claims that are distinct from (i.e., not redundant to) the other pending claims. Claims 32-33 and 43-44 seem to add unnecessary indefiniteness to method claims 31 and 42, respectively.
Claim 42 (therefore, claims 43-50 which refer thereto) is/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.
Claim 42 refers to “the first diploid parent” and “the second diploid parent” which lack antecedent basis.
Claims 34 and 45 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.
These claims recite “the monocot plant species” (6th line from the bottom), which lacks antecedent basis. See also the rejection immediately below for “Failure to Further Limit”.
Claim Rejections - 35 USC § 112 – Failure to Further Limit
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 34 and 45 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 32 and 43, to which claims 34 and 45 refer (respectively), already require that the plant is a maize plant, but claims 34 and 45 say that the plant may be the monocot species “Zea mays, Oryza sative, Aegilops tauschii, Brachypodium distachyon, Hordeum vulgare, Musa acuminata, Sorghum bicolor, or Triticum aestivum” which is clearly broader than just maize/Zea mays.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 112 – Written Description
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.
Claim 42 (and, therefore, claims 43-50 which refer thereto) is/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.
Claim 42 generally regards crossing a diploid (2n) parent MiMe maize plant with a tetraploid (4n) parent MiMe maize plant. The claim also then says that the resulting polyploid maize seed is tetraploid (4n). It is material that the method of claim 42 does not recite any additional steps which impact ploidy.
Based on the specification and prior art, because knocking out the function of REC8, SPO11-1, and OSD1-2 in maize causes unreduced gametes, crossing a diploid (2n) MiMe maize plant with a tetraploid (4n) MiMe maize plant (absent additional steps) is expected to produce hexaploid (6n) seed.
Absent evidence to the contrary or clarification of the claims, a skilled artisan would not reasonably recognize Applicant as being in possession of obtaining tetraploid (4n) seed by crossing a diploid (2n) parent MiMe maize plant with a tetraploid (4n) parent MiMe maize plant. Is current claim 42 missing a method step?
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 31-50 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 8, 32, 35, 37, 38, 39, 40, of copending Application No. 18595300 (Attny. Dkt. No. 19707-20001.01 published as US20240409950). Application 18595300 is also docketed to this Examiner (outstanding nonfinal action mailed 18March2026 includes an ODP rejection over this application, amongst others).
Although the claims at issue are not identical, they are not patentably distinct from each other. Claims 31-37, 42-26 are species taught by the referenced genus claims of 18595300 and claims 38-42, 47-50 recite inherent or obvious modifications of the referenced genus claims of 18595300. For example, method claim 1 of 18595300 is copied below (REC8, SPO11-1, and OSD1 mutations are listed as amongst the optional “MiMe” gene combinations and maize is recited near the bottom of the claim):
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This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/REBECCA STEPHENS/Examiner, Art Unit 1663
/MATTHEW R KEOGH/Primary Examiner, Art Unit 1663
1 See HAMANT et al. “A REC8-dependent plant shugoshin is required for maintenance of centromeric cohesion during meiosis and has no mitotic functions” 2005 Current Biology 15:948-954 and GOLUBOVSKAYA et al. “Alleles of afd1 dissect REC8 functions during meiotic prophase I” 2006 J. of Cell Science 119:3306-3315 doi:10.1242/jcs.03054.
2 See Supplemental FIG. 4 of KU et al. “Dynamic localization of SPO11-1 and conformational changes of meiotic axial elements during recombination initiation of maize meiosis” 2020 PLoS Genetics 16(4): e1007881, article is 30 total pages (31 page document including Supplemental FIG. 4).
3 See D’ERFURTH et al. “Turning meiosis into mitosis” 2009 PLoS Biology 7(6): e1000124; of record IDS 20May2025.
Prosecution Insights