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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/04/2026 has been entered.
Claim Status
Claims 1-2, 4-7 and 9-20 are pending.
Claims 10-20 are withdrawn and not being examined as being part of non-elected inventions.
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All previous objections and rejections not set forth below have been withdrawn in view of applicant’s amendments to the claims.
Claim Rejections - 35 USC § 101
Claims 1-2, 4-6 and 9 remained rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., 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). It implies that no active step was undertaken by the Applicant to create and/or transfer the resistance trait which is present in S. oleracea.
It is noted that 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 claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception, as discussed below. 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 compatible (Zdravkovic-Korac et al.; page 2, para 2, line 3-4); absent evidence to the contrary.
Even just one plant arising from a cross between Spinacia tetrandra and S. oleracea would be sufficient to transfer the resistance trait against downy mildew caused by Peronospora farinose to the target spinach plant (to S. oleracea). 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 such S. oleracea 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, are not markedly different to the S. oleracea plant recited in the claims 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 phenomenon and an inherent property of a naturally occurring plant.
Response to Applicant’s arguments
Amendments made to the claims filed in Applicant’s response submitted on 05/04/2026 is fully considered but not found persuasive.
Regarding 35 U.S.C. 101 rejections, the Applicant argues that although “S. oleracea and S. tetrandra are sexually compatible, they are only partially compatible: they can form interspecific hybrids, not S. oleracea as now claimed, and these hybrids show strongly reduced pollen fertility (limited but present sexual compatibility) and thus poor reproductive success. Therefore, using a S. tetandra as a parent in simple crossings will not provide the plant of present invention as natural product.” (response, p. 6, para 5, line 3-8).
The Examiner disagrees. As per the cited reference (Zdravkovi´c-Kora et al.) and as admitted by the Applicant, “S. oleracea and S. tetrandra are sexually compatible” and can produce at least one viable offspring with some/many viable pollens (albeit with reduced pollen viability compared to either of the parents) which would be sufficient to breed with naturally occurring S. oleracea plants around it and giving rise to subsequent generations of S. oleracea plants with the specific resistance against Peronospora farinose.
Moreover, a plant with less viable pollens or even no viable pollen at all can breed with sexually compatible plants (with viable pollens) as a female parent producing viable seeds. That phenomenon is more pronounced in dioecious plant species (that have distinct, separate male and female individuals in the species) like spinach (Zdravkovic-Korac et al.; p.2, para 4, line 2-3). Besides, the existence and use of male-sterile lines is well known and widely used in hybrid seed production. Also, natural pollination and breeding between S. oleracea and S. tetrandra would not affect inheritance of the resistance trait against Peronospora farinose as the resistance allele is a nuclear gene.
Evidence in the art also suggests that crossing between S. oleracea and S. tetrandra produces viable seeds and “a Spinacia oleracea spinach plant comprising in its genome an introgressed locus from Spinacia tetrandra that confers broad-spectrum resistance to Peronospora farinas” (US 2020/0170208 A1, p.1, para 0005, line 17-21; claim 1).
Preponderance of evidence indicate that the S. oleracea plants resistant to downy mildew caused by Peronospora farinose due to the resistance allele originated in and obtained from S. tetrandra can be naturally occurring without any human intervention.
Conclusion
No claim is allowed.
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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Jay Chatterjee
Patent Examiner
Art Unit 1662
/Jay Chatterjee/Examiner, Art Unit 1662
/BRATISLAV STANKOVIC/Supervisory Patent Examiner, Art Units 1616 & 1662
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