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 .
Election/Restrictions
Applicant’s election without traverse of Group III, consisting of claims 7-10, in the reply filed on 13 May 2026 is acknowledged. Applicant has elected the species (e) of the OsCPRO1 protein as SEQ ID NO.3.
Claim Status
Claims 7-10 are under examination on the merits.
Claims 1-6 are withdrawn as non-elected subject matter.
Priority
Claims 7-10 claim priority to Chinese Patent Application 202210675450.5 and receive the effective filing date of 15 June 2022.
Claim Objections
Claims 7 & 8 are objected to because of the following informalities:
Claim 7; grammatical/translation error; on line 2 the claim recites a promoter for expression ‘in egg cells of the gene’. Genes do not possess egg cells. This appears to be a grammatical error or transposition, in which Applicant intended to refer to a gene or genes present in an egg cell.
Claim 8; grammatical/translation error; on line 3 the claim recites ‘the import’ from the method of claim 7. This again appears to potentially be a grammatical error due to incorrect translation, in which Applicant intended to refer to ‘the method’ referenced in claim 7.
Appropriate correction is required.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code [p.28, ¶2; p.21-22, ¶107]. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Rejections - 35 USC § 112
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.
Claims 7-10 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 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 7 recites “a gene according to claim 1” [lines 1-2]. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 has been withdrawn from examination based on Applicant’s elected inventive group. Referencing the withdrawn claim, it does not introduce ‘a gene’. Rather, the claim references a protein. Applicant has indicated election of the protein species OsCPRO1 and its corresponding polypeptide of SEQ ID NO.3. Claim 1 goes on to recite ‘orthologous genes’ of OsCPRO1 protein with as little as 90% sequence similarity, including related orthologs in 131 different plant species. This encompasses a wide variety of encoding nucleotide sequences differing from that which encodes the specific OsCPRO1 protein (i.e. SEQ ID NO.3).
As such, it is unclear which gene or sequence is used in the claimed method.
Applicant is advised to clearly specify the SEQ ID NO. designations corresponding to the gene encoding OsCPRO1 and the protein sequence of OsCPRO1 in the claim.
Independent claim 7 recites the limitations of both “the promoter” and “the plant” [line 3]. There is insufficient antecedent basis for this limitation in the claim. There is no introduction of ‘a promoter’ in claim 7. Although Applicant recites ‘plant haploids’ and ‘a positive transgene plant’ there is no introduction of ‘a plant’. Lacking a specifically introduced object, it is unclear which previously referenced ‘plants’ is intended.
Dependent claim 8 recites the limitation of “the nucleotide sequence shown in SEQ ID NO:7” [lines 2-3]. There is insufficient antecedent basis for this limitation in the claim. There is no introduction of ‘a nucleotide sequence’ in claim 7, which only references ‘a gene’.
Dependent claim 9 recites the limitation of “transgenic positive material” [line 2]. There is insufficient antecedent basis for this limitation in the claim. There is no introduction of ‘a transgenic positive material’ in claim 7, which only references ‘a positive transgene plant’.
Dependent claim 10 recites the limitation of “haploid inductive material” [line 1]. There is insufficient antecedent basis for this limitation in the claim. There is no introduction of ‘a haploid inductive material’ in claim 9, only ‘haploid material’.
Claim 7 is drawn to a method of generating plant haploids using the gene encoding OsCPRO1. Claims recite limitation to steps ‘of including the gene to obtain’ a transgenic plant.
The claims do not detail the step or method intended by ‘of including the gene to obtain’ and it is unclear to the reader what is meant by a process ‘of including…to obtain’. It is unclear if this is merely unusual grammar, or reflective of intended scope.
Turning to the specification, it describes identification of natural forms (i.e. included) of OsCPRO1 expressed and inducing spontaneous doubling [p.3, ¶.4—p.4, ¶.2], as well as transgenic approaches to manipulating the OsCPRO1 gene [p.14, ¶.2]. Reference is made to ‘including combining haploid induction material with the MiMe system to obtain apomictic material [p.6, ¶.8]. Reference is made to processes of using a vector including (i.e. requiring) three parts to obtain transgenic plants [p.27, ¶.3].
Because the scope of the claims varies based on interpretation of what is meant by a process ‘of including…to obtain’, one reading the instant application would not have a clear understanding of the metes and bounds of the claims. Absent further definition, one cannot ascertain with which particular method(s) one may be infringing Applicant’s claim. As such, claim 7 and its dependent claims 8-10 are rejected.
Applicant is advised to amend the wording/grammar of the claim language to resolve what appears to potentially be an error in document translation leading to indefinite meaning.
Claim 7 is drawn to a method of generating plant haploids using the gene encoding OsCPRO1. Claims recite limitation to plants, ‘preferably, the plant including a monocot and a dicotyledon; preferred of all... [selected from list of spp.]’.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claim 7 recites the broad recitation of ‘preferred of all’ followed by a list of species including Angiosperms, Gymnosperms (i.e. Taxus sp.) and non-flowering vascular plants (i.e. Selaginella sp.), and the claim also recites ‘preferably…a monocot and a [dicot]’ which is the narrower statement of the range/limitation. The claims is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Because of this, claim 7 and its dependent claims 8-10 are rejected.
Claim 8 is drawn to use of promoters for egg-specific expression of OsCPRO1. Claims recite limitation to promoters as, ‘a promoter of AtDD45 egg specific expression; preferably...SEQ ID NO:7’.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 8 recites the broad recitation of ‘a promoter of AtDD45 egg specific expression’, and the claim also recites ‘preferably…SEQ ID NO:7’ which is the narrower statement of the range/limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Because of this, claim 8 is rejected.
Claim 9 is drawn to a method of using transgenic plants to obtain haploids. Claims recite limitation to steps ‘of taking transgenic positive material…to obtain’ haploid material.
The claim does not detail the step or method intended by ‘of taking [transgenic plants] …to obtain’ and it is unclear to the reader what is meant by a process ‘of taking…to obtain’. It is unclear if this is merely unusual grammar, or reflective of intended scope.
Turning to the specification for clarification, none is provided as to what the scope of such a limitation is, nor what the ‘taking’ of a plant describes with reference to obtaining or generating haploid material.
Because the scope of the claims varies based on interpretation of what is meant by a process ‘of taking…to obtain’, one reading the instant application would not have a clear understanding of the metes and bounds of the claims. Absent further definition, one would not be able to ascertain under what conditions any particular method may be infringing Applicant’s claim. As such, claim 9 and its dependent claim 10 are rejected.
Applicant is advised to amend the wording/grammar of the claim language to resolve what appears to potentially be an error in document translation leading to indefinite meaning.
Claim 10 is drawn to a method of using haploid material to obtain apomictic material. The claim recites limitation to steps ‘combining haploid inductive material…with a MiMe system’ to obtain ‘apomixis material’.
The claim does not detail the step or method intended by ‘combining’ and it is unclear to the reader what is meant by a MiMe system, as this appears to be an abbreviation. Neither of these are defined by the claim language.
Turning to the specification for clarification, none is provided regarded what is meant by combining with a MiMe system, nor what the term MiMe means. Reference is once again made to ‘including combining haploid induction material with the MiMe system to obtain apomictic material [p.6, ¶.8]. Reference is made to the MiMe system as potentially referring to a triple mutant comprising (osd1 / rec8 / spo11-1) described in the external reference of Khanday [p.3, ¶.1].
Referring to the external reference to understand what MiMe is an abbreviation for, as none of the genes indicated appear to correspond to the abbreviated term per se, Khanday indicates MiMe means ‘to substitute mitosis for meiosis’ [Abstract].
Khanday indicates MiMe simply indicates production of unreduced gametes during sexual reproduction, broadly, and does not absolutely require the triple (osd1 / rec8 / spo11-1) mutant stated by Applicant in their written description [Figure 3]. While the Khanday reference uses the specific triple mutant example to demonstrate MiMe, they describe, “a genetic approach called MiMe, which eliminates recombination and substitutes mitosis for meiosis” [p.94, col.1, ¶.2]. Further review of research literature indicates researchers use alternate versions of MiMe systems, including those having different, or fewer gene combinations to achieve the same outcome [see p.1, col.1, ¶.2—p.2, col.1, ¶.2 in Geng, The Plant Cell, 2026, 38, 1–9; Published 18 May 2026].
Broadest reasonable interpretation of this definition is that MiMe, the substitution of mitosis for meiosis, is any controllable process leading to unreduced gametes for production of apomictic or tetraploid progeny. The triple mutant system produced via gene editing and referenced described in Khanday in rice, is simply one potential way of manipulating a plant to controllably to induce the altered MiMe process.
Thus, the use of this term by Applicant appears potentially different (i.e. more specific/narrow based on the reported triple mutant) than the term MiMe as can be used generally (i.e. any method that converts meiosis into mitosis).
Because the scope of the claim varies based on interpretation of what constitutes a MiMe system, and the intended usage is not specifically defined by Applicant, one reading the instant application would not have a clear understanding of the metes and bounds of the claims. It is unclear if claims are limited to the specific triple mutant known in rice and briefly mentioned by reference in the specification [Specification, p.3, ¶.1] or meant to encompass any system which controllably produces unreduced gametes [see Khanday, Figure 3; Geng, Abstract].
Absent further definition, one would not be able to ascertain under what conditions any particular method employing unreduced gametes may be infringing Applicant’s claim. As such, claim 10 is rejected.
The claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
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.
Claims 7-10 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 sequences of 100% identity to SEQ ID NO.3 in rice, does not reasonably provide enablement for those of <100% identity in any and all plant species. 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 use the invention commensurate in scope with these claims.
Claim 7, from which all other claims depend, encompasses a method of inducing plant haploids via transgenic expression of OsCPRO1 in any and all plant species (i.e. inducing plant haploids).
Turning to the specification for support to such broad claim, we find Applicant only describes the genetic manipulation and transfer of OsCPRO1 in two flowering plants, rice and Arabidopsis [Specification, p.30-32, Example 3].
Because of this, claim 7 and its dependents are rejected as not having been fully enabled, as generating apomictic doubled-haploid progeny in a reasonably representative sample of any and all plants is not described by Applicant. Additionally, the research literature indicates that synthetic apomictic systems have had little success in crops other than rice, maize, or Sorghum and the model Arabidopsis, despite efforts to apply the method in other economically important crops, including dicot vegetable species [p.14, col.1, ¶.1 & ¶.3-4 in Xiong, Current Opinion in Biotechnology 2023, 79; Published 9 Jan 2023 & p.1, col.1, ¶.3—col.2, ¶.1, p.2, col.1, ¶.3, p.28, col.2, ¶.4 & col.2, ¶.7-col.3, ¶.1 in Lewis, Nature Vol.645, p.26-28; Published 4 Sep 2025].
Therefore, without guidance from the specification as to the methods of making such plants across a diverse and variable range of species, this would require undue experimentation to make and use such apomictic plants via transgenic approaches, if it is even possible to do so.
Claim 7, from which all other claims depend, encompasses a gene which appears to encode OsCPRO1 (SEQ ID NO.3) protein conferring haploid induction activity.
While claim 7, as currently written, is indefinite as to which specific gene is being referenced in the claimed method, for the purposes of compact prosecution the claim is currently being interpreted to refer to the corresponding sequences of OsCPRO1 referenced in the withdrawn claim 1. Applicants state such genes are derived from orthologs of the nucleotide encoding SEQ ID NO.3 (i.e. SEQ ID NO.1) with as little as 90% identity.
A review of sequence search information reveals that there appear to be no reports of nucleotides of less than 100% identity to the OsCPRO1 encoding sequence of SEQ ID NO.1 and reported as conferring haploid induction ability as reported by Applicant. Thus, prior art does not provide structural description of genes encoding proteins conferring haploid induction activity with less than 100% identity to SEQ ID NO.1.
Genes with 90% identity to the 6,654 bp long SEQ ID NO.1 encompass polynucleotides with approximately 665 random base pair substitutions. Describing a genus of polynucleotides with all such possible substitution variations relative to the 6,654 bp long nucleotide of SEQ ID NO.1 would require describing many sequences for manipulation via molecular methods; a representative number of this potentially large array of sequences which were not described by the Applicant at the time of filing.
Applicant is claiming a broad range of nucleic acids as a result of requiring only 90% identity to encoding SEQ ID NO.1, or related orthologs from plant species other than rice or Arabidopsis. Without further guidance in the written description, such structural modification would amount to making random mutational changes in the CsPRO1 protein. Making random changes in proteins is unpredictable, and therefore one would not be enabled to isolate or derive such alleles of CsPRO1 conferring haploid induction ability with less than 100% identity to SEQ ID NO.1 with any reasonable certainty that it would function properly.
Because of this, claim 7 and its dependents are rejected as not having been fully enabled, as such variable proteins conferring haploid induction activity are not described in the specification, nor taught by the existing art. Even with previous studies directed to use of such two-component systems using a haploid induction gene such as baby-boom (BBM), which is functionally similar to CsPRO1, and a MiMe system (i.e. conversion of mitosis to meiosis) in rice and Arabidopsis, no variants of CsPRO1, with ability to confer the required apomictic characteristic(s) of such a two-component system, have been described with less than 100% identity to encoding SEQ ID NO.1.
Therefore, without guidance from the specification as to which particular polynucleotide sequence variants of 90% identity to SEQ ID NO.1 reliably confer haploid induction ability, it would require undue experimentation to find these variant encoding sequences, if it is even possible to do so.
Claims 7-10 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 7, from which all other claims depend, encompasses a method of inducing plant haploids via transgenic expression of OsCPRO1 in any and all plant species (i.e. inducing plant haploids).
Turning to the specification for support to such broad claim, we find Applicant only describes the genetic manipulation and transfer of OsCPRO1 in two flowering plants, rice and Arabidopsis [Specification, p.30-32, Example 3].
Because of this, claim 7 and its dependents are rejected as not having been within possession of the inventor, as generating apomictic doubled-haploid progeny in a reasonably representative sample of any and all plants is not described by Applicant. Additionally, the research literature indicates that synthetic apomictic systems have had little success in crops other than rice, maize, or Sorghum and the model Arabidopsis, despite efforts to apply the method in other economically important crops, including dicot vegetable species [p.14, col.1, ¶.1 & ¶.3-4 in Xiong, Current Opinion in Biotechnology 2023, 79; Published 9 Jan 2023 & p.1, col.1, ¶.3—col.2, ¶.1, p.2, col.1, ¶.3, p.28, col.2, ¶.4 & col.2, ¶.7-col.3, ¶.1 in Lewis, Nature Vol.645, p.26-28; Published 4 Sep 2025].
For these reasons, the written description does not reasonably convey to one skilled in the relevant art that the inventor had possession of the claimed invention. Their disclosure does not support that they are or were able to generate functional analogs of OsCPRO1 able to induce haploids within plant species other than rice or Arabidopsis.
Claim 7, from which all other claims depend, encompasses a gene which appears to encode OsCPRO1 (SEQ ID NO.3) protein conferring haploid induction activity.
While claim 7, as currently written, is indefinite as to which specific gene is being referenced in the claimed method, for the purposes of compact prosecution the claim is currently being interpreted to refer to the corresponding sequences of OsCPRO1 referenced in the withdrawn claim 1. Applicants state such genes are derived from orthologs of the nucleotide encoding SEQ ID NO.3 (i.e. SEQ ID NO.1) with as little as 90% identity.
A review of sequence search information reveals that there appear to be no reports of nucleotides of less than 100% identity to the OsCPRO1 encoding sequence of SEQ ID NO.1 and reported as conferring haploid induction ability as reported by Applicant. Thus, prior art does not provide structural description of genes encoding proteins conferring haploid induction activity with less than 100% identity to SEQ ID NO.1.
Genes with 90% identity to the 6,654 bp long SEQ ID NO.1 encompass polynucleotides with approximately 665 random base pair substitutions. Describing a genus of polynucleotides with all such possible substitution variations relative to the 6,654 bp long nucleotide of SEQ ID NO.1 would require describing many sequences for manipulation via molecular methods; a representative number of this potentially large array of sequences which were not described by the Applicant at the time of filing.
Applicant is claiming a broad range of nucleic acids as a result of requiring only 90% identity to encoding SEQ ID NO.1, or related orthologs from plant species other than rice or Arabidopsis. Without further guidance in the written description, such structural modification would amount to making random mutational changes in the CsPRO1 protein. Making random changes in proteins is unpredictable, and therefore one would not reasonably be in possession of methods to isolate or derive such alleles of CsPRO1 conferring haploid induction ability with less than 100% identity to SEQ ID NO.1 with any certainty that such variants would function properly.
Because of this, claim 7 and its dependents are rejected as not having been fully enabled, as such variable proteins conferring haploid induction activity are not described in the specification, nor taught by the existing art. Even with previous studies directed to use of such two-component systems using a haploid induction gene such as baby-boom (BBM), which is functionally similar to CsPRO1, and a MiMe system (i.e. conversion of mitosis to meiosis) in rice and Arabidopsis, no variants of CsPRO1, with ability to confer the required apomictic characteristic(s) of such a two-component system, have been described with less than 100% identity to encoding SEQ ID NO.1
For these reasons, the written description does not reasonably convey to one skilled in the relevant art that the inventor had possession of the claimed invention. Their disclosure does not support that they are or were able to generate functional analogs of OsCPRO1 able to induce haploids with 90% identity to SEQ ID NO.1.
Conclusion
No claims are allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEITH R WILLIAMS whose telephone number is (571)272-3911. The examiner can normally be reached Mon - Fri, 9:30 - 5:30 EST.
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/KEITH R. WILLIAMS/Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663
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