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 .
Claim Status
Claims 1-2, 4-7, 9-20 are pending.
Claims 10-20 are withdrawn and not being examined as being part of non-elected inventions.
Claims 3 and 8 are cancelled by the Applicant.
Claims 1-2, 4-7 and 9 are currently being examined.
All previous objections and rejections not set forth below have been withdrawn in view of applicant’s amendments to the claims. Due to applicant’s amendments, the rejection is modified from the rejection set forth in the Office action dated 04/23/2025. However, claim amendments and Applicant’s reply to the Request for Information Under 37 CFR 1.105 necessitated new grounds of rejections, as discussed below.
Claim Rejections - 35 USC § 102
Response to Applicants’ arguments: Amendments made to the claims filed in Applicant’s
response submitted on 10/30/2025 overcame the rejections of record under 35 USC § 102.
Claim Rejections - 35 USC § 101
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.
Claims 1-2, 4-6 and 9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural phenomenon and a product of nature without significantly more. The claims directly or indirectly recite “a spinach plant that is resistant to downy mildew caused by Peronospora farinose” and a naturally occurring “resistance gene” “originates from a wild spinach species Spinacia tetrandra” (Applicant’s response dated 10/30/2025, page 2, last para, line 3-4). Instant description asserts that “the resistance gene (L3) is obtained by gene mapping in S. oleracea” (Spec, page 3, line 15-16).
The Applicant does not reply to the query, “ii) Please describe- how the mutations are created/obtained, and the breeding methodology and history regarding the development of the parent plant(s) if the gene is identified and/or isolated from a Peronospora farinosa resistant plant” to the previous Request for Information Under 37 CFR 1.105 (page 18 of Office action dated 4/23/2025).
The applicant does not describe how the resistant gene in Spinacia tetrandra got transferred to S. oleracea (spec, page 3, line 15-16). The Examiner interprets that the resistance trait in the S. oleracea plants occurred naturally as these two species are sexually compatible1; absent evidence to the contrary. It is well known in the art that different alleles of a specific gene conferring specific trait(s) arise primarily from spontaneous mutations creating new genetic variations that natural selection can then act upon. Silent mutations in the DNA sequence would not change the polypeptide sequence of the resistant protein while selective missense mutations will change the amino acid sequence while retaining the resistance trait under selection pressure.
The naturally occurring DNA segment encoding the resistance gene and/or the protein therein are present in spinach plants conferring resistant to Peronospora farinose which can have naturally occurring “one or more mutations” (as alleles) while retaining the resistance and without adding any other traits/benefits, which do not add “significantly more” to overcome the judicial exception.
Specific sequences in claims 1-2 do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The marker(s) associated with the resistance gene and any specific sequence(s) therein are also naturally occurring without any active step(s) by the Applicant being involved.
Regarding claim 4, naturally occurring wild spinach plants would have the resistance gene in either heterozygous or homozygous condition with one or more mutation(s) present in different naturally occurring alleles.
Regarding claims 5-6, it is the inherent property of the naturally occurring resistance gene to confer resistance to Peronospora farinosa races Pfs3 to Pfs 17 and that is irrespective of where it is obtained from.
Regarding claim 9, producing seed is also a naturally occurring inherent property of a naturally occurring plant.
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.
Written Description
Claims 1-2, 4-7 and 9 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 claims contain 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 1 and all its dependent claims 2, 4-7 and 9 are drawn to a spinach plant and seed thereof, resistant to downy mildew caused by Peronospora farinosa, wherein the spinach plant contains a resistance gene comprising one or more mutations, wherein the said resistance gene comprise 90% sequence identity with SEQ ID NO: 1 encoding a protein having at least 85% identity with SEQ ID NO: 2. The resistance gene is also associated with markers comprising SEQ ID NO: 3 and SEQ ID NO: 4, and the gene itself comprises SEQ ID NO: 13.
The Applicant describes a spinach plant resistant to downy mildew caused by Peronospora farinosa races Pfs 3-17 (Spec, page 11, table 3). Instant description teaches identifying the L3 resistance gene associated with markers SEQ ID NOs: 3-4 (Spec, page 3, line 17-18). The markers comprising SEQ ID NOs: 3-4 are linked to or associated with chromosome 1 of the spinach genome.
The invention claims a large genus comprising any gene and any mutant allele in chromosome 1, which would be invariably “associated with” or linked to SEQ ID NO: 3 and/or SEQ ID NO: 4 while conferring resistance to Peronospora farinosa. The applicant describes only one gene, L3. The Applicant does not describe a representative number of species encompassed by the large genus claimed.
Instant specification describes that “the majority of disease resistance genes in plants encode nucleotide-binding site leucine-rich repeat proteins, also known as NBS-LRR proteins. These proteins are characterized by nucleotide-binding site (NBS) and leucine-rich repeat (LRR) domains as well as variable amino- and carboxyl-terminal domains and are involved in the detection of diverse pathogens, including bacteria, viruses, fungi, nematodes, insects and oomycetes” (Spec, page 4, line 13-17).
However, the Applicant does not describe the structure-function relationship between the nucleotide sequence of the resistance gene and/or the protein structure encoded by that gene with the resistant trait against downy mildew caused by Peronospora farinosa races. There are many NBS-LRR proteins comprising various R genes resulting in resistance to a diverse array of pathogens, as described by the Applicant (spec, page 4, line 25-28). NBS-LRR genes are known to be involved in the basal defense mechanism in plants by elevating salicylic acid (SA) level in plants (Dubey et al., Role of NBS-LRR Proteins in Plant Defense. 2018, In: Singh, A., Singh, I. (eds) Molecular Aspects of Plant-Pathogen Interaction. Springer, Singapore; page 118, para 2). NBS-LRR genes have been grouped into two classes, namely, TIR-NBS-LRR (TNL) and the non-TIR-NBS-LRR (nTNL) (Dubey et al.; page 116, para 2, line 1-2) while the functionality including resistance to any specific pathogen by NBS-LRR proteins is dependent on various other domains like LRR domain, TIR domain, CC domain, RPW8 domain etc. (Dubey et al., page 119-122).
The written description of the invention would not have allowed a skilled artisan to mutate up to 90% of 4608 nucleotide long SEQ ID NO: 1 or 85% of 1535 amino acid long SEQ ID NO: 2 while retaining the resistance trait against Peronospora farinose. Moreover, SEQ ID NO: 1 and/or SEQ ID NO: 2 is/are not well-characterized sequence(s), as indicated by the BLAST search using SEQ ID NO: 2, as shown below.
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The highest sequence identity to SEQ ID NO: 2 is less than 90% and that too with just 67% sequence coverage. An ordinarily skilled artisan would not get any guidance even from the sequences with highest identity to SEQ ID NO: 2 on how to mutate the resistant protein while retaining the resistance trait against Peronospora farinose.
An invention described solely in terms of a method of making or its function may lack written descriptive support where there is no described or art-recognized correlation between the disclosed function and the structure(s) responsible for the function. See MPEP § 2163.
Therefore, given the claim breadth, the lack of written description in the specification
with regard to the structure-functional relationship of the claimed composition, Applicant
does not appear to have been in possession of the claimed genus at the time this application was
filed.
Scope of Enablement
Claims 1-2, 4-7 and 9 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 SEQ ID NO: 1 and SEQ ID NO:2, does not reasonably provide enablement for a spinach plant resistant to downy mildew caused by Peronospora farinosa containing a resistance gene comprising any other mutation(s) in the resistance gene while having at least 90% sequence identity to instant SEQ ID NO: 1 and/or 85% sequence identity to instant SEQ ID NO: 2. 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.
Claim 1 and all its dependent claims 2, 4-7 and 9 are drawn to a spinach plant and seed thereof, resistant to downy mildew caused by Peronospora farinosa, wherein the spinach plant contains a resistance gene comprising one or more mutations, wherein said resistance gene is having 90% sequence identity with SEQ ID NO: 1 encoding a protein having at least 85% with SEQ ID NO: 2. The resistance gene is also associated with markers of SEQ ID No: 3 and SEQ ID No: 4.
The Applicant does not describe any mutant allele of the resistant gene L3. A mutated gene comprising 90% sequence identity with 4608 nucleotide long SEQ ID NO: 1 would allow mutating up to 460 nucleotides, which can mutate up to 460 amino acid residues based on the position of the mutated nucleotide in the codons. Similarly, mutated protein(s) comprising 85% sequence identity with a 1535 amino acid long polypeptide sequence consisting of SEQ ID NO: 2 would allow mutating up to 230 amino acid residues. It would not be possible for a person with skill in the art to predict the function of any novel protein based on the instant description or the current status of the art, as described above, comprising mutation(s) up to 460 nucleotide in the gene and/or up to 230 amino acid residues in the polypeptide encoded by the gene. It would not be possible for a person with skill in the art to predict retention of the existing resistance trait (as present in the native resistance gene) or loss-of-function of resistance against Peronospora farinosa for a previously resistant protein while mutating up to 460 nucleotide in the gene and/or up to 230 amino acid residues in the polypeptide encoded by the gene.
Undue trial and error experimentations would be needed to identify if any specific mutant allele increase, retains, or lose resistance trait against Peronospora farinose.
Based on breadth of the claims, lack of any working example, lack of guidance in the instant description or in prior art, the specification at the time of the application filed would not have taught one skilled in the art how to make and use the full scope of the claimed invention without performing undue experiments.
Response to Applicants’ arguments for USC 112 (a): Amendments made to the claims filed in Applicant’s response submitted on 10/30/2025 is fully considered but not found persuasive.
The Applicant argued that, “amended claim 1 specifically recites the sequences for the resistance gene, thus a structure-function relationship is present.” (response, page 5, para 5, line 2-5). The Examiner agrees that amended claim 1 provides a structure (i.e., the sequence) of the resistance gene. However, the applicant failed to establish adequate structure-function relationship. A skilled artisan would not be able to predict any function of a novel polynucleotide or a novel polypeptide simply by analyzing its sequence. It is well known in the art that even a single nucleotide/amino acid change can drastically alter any specific function of a gene/protein.
Claim Rejections - 35 USC § 112(b)
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 1-2, 4-7 and 9 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 1 recites “resistance gene is associated with markers of SEQ ID NO: 3 and SEQ ID NO: 4”. The term “associated with” is not defined in the view of the relationship between the resistance gene and SEQ ID NOs: 3-4. Any polynucleotide sequence can be “associated with” a gene in many ways (e.g., by using the polynucleotide sequence of SEQ ID NOs: 3-4 to detect the resistance gene via southern hybridization using SEQ ID NOs: 3-4 as probes/markers). It is suggested to replace “associated with” with “linked to”.
Claims 2-9 inherit the indefiniteness because of its dependency on claim 1.
Response to Applicants’ arguments for USC 112 (b): Amendments made to the claims filed in Applicant’s response submitted on 10/30/2025 is fully considered and not found fully persuasive.
Although most of the previous rejects under USC 112(b) are withdrawn while one of the rejections is maintained with some modification to make the argument for the rejection clearer, as discussed above. Moreover, the amendment to claim 1 by adding the language similar to (currently cancelled) claim 8, raises a new 112(b) rejection. The rejection is modified from the previous 112(b) rejection against claim 8.
Conclusion
No claim is allowed. However, all claims examined are free of prior art.
Applicant's amendment including the information provided in response to specific questionnaires under 37 CFR § 1.105, necessitated the new ground(s) of rejection presented in this Office action.
Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAY CHATTERJEE whose telephone number is (703)756-1329. The examiner can normally be reached (Mon - Fri) 8.30 am to 5.30 pm..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bratislav Stankovic can be reached at (571) 270-0305. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jay Chatterjee
Patent Examiner
Art Unit 1662
/Jay Chatterjee/Examiner, Art Unit 1662
/BRATISLAV STANKOVIC/Supervisory Patent Examiner, Art Units 1661 & 1662
1 Zdravkovi´c-Kora et al. (Somatic Embryogenesis in Spinach—A Review. 2023, Horticulturae, 9:1048) provides the evidence that Spinacia oleracea and S. tetrandra are sexually compatible (page 2, para 2, line 3-4).