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
1. Claims 1-4 and 16-17 are pending and under examination on the merits.
Claims 5-14 and 18-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on March 23, 2026.
Claim 15 is cancelled.
Restrictions/Elections
2. The Office acknowledges receipt of Applicant’s restriction election filed March 23, 2026. Applicant elects Group I, claims 1-4 and 16-17, directed to a DNA construct comprising nucleotide sequences encoding for a combination of three protein for apocarotenoids compound biosynthesis, with traverse. Applicant further elects the species of SEQ ID NO:2, SEQ ID NO:4, SEQ ID NO:6, SEQ ID NO:7, and SEQ ID NO:24.
In traversing the requirement for restriction, Applicant argues primarily that the claims share unity of invention and comprise a special technical feature that renders the instant invention patentable over Diretto et al. (New Phytologist. 2019; 224(2):725-740 (Applicant’s IDS)), because the claims comprise nucleotide sequences encoding three proteins, UGT2, UGT709G1, and CCD2L and Diretto does not disclose a construct comprising UGT2, UGT709G1, and CCD2L (p. 07, first full paragraph).
This argument is not persuasive because the claims do not require the claimed DNA construct comprises sequences encoding UGT2, UGT709G1, and CCD2L. The claims require a DNA construct comprising sequences encoding a combination of three proteins comprising UGT2, UGT709G1, CCD2L, or functionally equivalent sequences thereof. Thus, the claims do not require the claimed construct to comprise UGT2, UGT709G1, and CCD2L. For example, claimed construct may encode two copies of UGT2 and one copy of UGT709G1; a single copy of UGT2, a single copy of UGT709G1, and a single copy of some protein functionally equivalent to UGT2 or UGT709G1; or even three copies of UGT2. Accordingly, the claims, as written, do not require a combination of UGT2, UGT709G1, and CCD2L. Thus, the claims are anticipated by and lack unity in view of the teachings of Diretto as stated below in the rejection of the claims under 35 U.S.C. 102 and as stated previously in the Office Action dated March 10, 2026 (p. 04).
The restriction requirement is deemed proper and is made FINAL.
Priority
3. This Application is a 371 of International Application No. PCT/EP2022/075670 filed September 15, 2022. The Office acknowledges receipt of foreign priority document EP21382833.8 filed on September 15, 2021.
Information Disclosure Statement
4. The Information Disclosure Statements (IDS) submitted on March 13, 2024 and May 07, 2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS have been considered by the Examiner. Signed copies are attached.
Specification
5. The disclosure is objected to because of the following:
P. 27 (lns. 10-13) and p. 29 (lns. 20-25) contain embedded hyperlinks and/or other forms of browser-executable code. 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.
Appropriate correction is required.
Abstract
6. The abstract of the disclosure is objected to because lns. 8-9 contain a typographical error; the word “the” is repeated in the phrase “the the food products”.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
7. Claims 1-4 and 16-17 are objected to because of the following:
Claim 1, ln. 2 contains a grammatical error; “apocarotenoids compounds biosynthesis” should be amended to “apocarotenoid compound biosynthesis” for proper subject-verb agreement.
Claim 1 is an incomplete sentence. The recitation in lns. 11-13 is grammatically incorrect, comprises an incorrectly conjugated verb (i.e., “being” in ln. 11), and/or is missing words that obscure the intended recitation. A close and careful review of the claim is requested. Appropriate correction is required.
Claim 1, ln. 14 contains a grammatical error. If the phrase “CCD2L” refers to a protein, it is recommended Applicant amend “the CCD2L” to “CCD2L”. If the phrase “CCD2L” refers to a gene sequence, it is recommended Applicant amend “the CCD2L” to “the CCD2L gene” because it is standard to italicize the names of genes in the biological arts to distinguish said genes from the protein products encoded therein.
Claim 1, lns. 12 and 15 contain multiple typographical/grammatical errors. The terms “fruit specific promoter” and “tuber specific promoter” should be amended to insert a hyphen between “fruit”/”tuber” and “specific”.
Claim 1 contains multiple typographical and grammatical errors. A close and careful review is suggested.
Regarding claim 3, it is suggested Applicant insert an oxford comma after “(SEQ ID NO:9)” to clarify the number of embodiments within the recited list.
Claim 4, ln. 3 contains a typographical error. It is recommended Applicant remove the “)” at the end of the claim.
Dependent claims are included. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
8. 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.
9. Claims 1-4 and 16-17 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.
Regarding claim 1, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. Descriptions of examples and preferences is properly set forth in the specification rather than in a single claim. See MPEP 2173.05(c) and MPEP 2173.05(d).
The scope of claim 1 is indefinite because it is unclear if the claim encompasses functionally equivalent sequences of UGT2 and UGT709G1 or only functional equivalents of CCD2L, because the claim recites only one functional equivalent in the singular.
The metes and bounds of claim 3 are indefinite because it is unclear if the embodiments in the parentheses represent claim limitations or merely exemplary embodiments. The presence of multiple reasonable interpretations renders the claim indefinite. It is recommended Applicant amend the claim to remove the parentheses and/or clarify the relationship between the recited promoters and SEQ ID NOs as appropriate to clarify the intended recitation.
The metes and bounds of claim 16 are indefinite because it is unclear how a protein could belong to a genus. However, proteins may originate from and/or be native to a genus. A genus cannot claim ownership or a protein or any other matter. Furthermore, it is unclear how ownership is to be established. For example, would a protein transformed into Arabidopsis then belong to Arabidopsis?
The metes and bounds of claim 17 are indefinite because it is unclear how a protein could belong to a species. However, proteins may originate from and/or be native to a species. A species cannot claim ownership or a protein or any other matter. For example, would a protein transformed into A. thaliana then belong to A. thaliana?
Appropriate correction is required.
Claim Rejections - 35 USC § 103
10. 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.
11. Claim(s) 1-4 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Diretto et al. (New Phytologist. 2019; 224(2):725-740 (Applicant’s IDS; U)) in view of Houhou et al. (bioRxiv, Feb 2021 (V)), further in view of Chung et al. (J Plant Biotechnol 2020; 47(2): 172-178 (W)), further in view of Moraga et al. (Planta. 2004; 219(6):955-66 (X); see STIC search results attached at end of reference), and further in view of Ahrazem et al. (New Phytol. 2016; 209(2):650-63 (Y); see STIC search results attached at end of reference).
Regarding claim 1, Diretto teaches a chromoplast-controlled biosynthetic pathway for apocarotenoid compounds wherein the pathway comprises Crocus sativus UGT2, UGT709G1, and CCD2L (p. 725, “Summary”; p. 726, left column, second full paragraph; p. 727, Figure 1); DNA constructs comprising nucleotide sequences encoding a combination of proteins for the biosynthesis of apocarotenoid compounds, wherein the proteins are selected from C. sativus UGT709G1 and CCD2L, wherein the amino acid sequence for UGT709G1 is identical to SEQ ID NO:6 (Supporting Information Fig. S1), wherein each nucleotide sequence is operably linked to a constitutive promoter, and wherein the sequence encoding CCD2L is operably linked to a constitutive promoter (p. 729, “Transient expression of CsCCD2L and UGT709G1 in Nicotiana leaves”); and that saffron is a very expensive spice (p. 725, second full paragraph).
Diretto does not teach fruit- or tuber-specific promoters and is silent to the sequence of CCD2L and UGT2. However, Diretto teaches C. sativus CCD2L and UGT2 (p. 727, Figure 1).
Houhou suggests modifying fruit to produce apocarotenoids for dietary and nutrition purposes (Abstract).
Chung teaches the use of fruit specific promoters for genetic-based improvement of fruit quality (Abstract; pp. 172-173, first paragraph of the introduction).
Moraga teaches a C. sativus UGT2 that is identical to SEQ ID NO:4 and functions in the catalysis of apocarotenoids and that saffron is considered the world’s most expensive spice (Abstract; see STIC search results).
Ahzarem teaches a plastid- and chromoplast-localized C. sativus CCD2L that is identical to SEQ ID NO:2 and catalyzes the biosynthesis of apocarotenoids (Abstract; see STIC search results).
The combination of Diretto, Houhou, Chung, Moraga, and Ahzarem teaches DNA constructs comprising nucleotide sequences encoding a combination of proteins for the biosynthesis of apocarotenoid compounds, wherein the proteins are selected from UGT2, UGT709G1, and CCD2L, wherein the amino acid sequence for UGT2 is SEQ ID NO:4, the amino acid sequence for UGT709G1 is SEQ ID NO:6, and the amino acid sequence for CCD2L is SEQ ID NO:2, wherein each nucleotide sequence is operably linked to a constitutive or fruit-specific promoter.
The level of ordinary skill in the plant biotechnology art is high as evidenced by Diretto, Houhou, Chung, Moraga, and Ahzarem. It would have been prima facie obvious to combine the teachings of Diretto with the teachings of Moraga and Ahzarem to produce DNA constructs comprising C. sativus sequences encoding UGT2, UGT709G1, and CCD2L. One of ordinary skill in the art would have been motivated to do so because saffron is a globally valuable spice, Diretto teaches that C. sativus UGT2, UGT709G1, and CCD2L function in the apocarotenoid metabolic pathway responsible for the production of various molecules (e.g., picrocrocin, crocin, crocetin) that comprise saffron, and Diretto demonstrates that DNA constructs comprising UGT709G1 and CCD2L alone are sufficient to promote synthesis of apocarotenoids. Given that the particular taste and aroma of saffron results from the characteristics of the apocarotenoids of which it is composed, one of ordinary skill in the art would be sufficiently motivated to modify the DNA constructs of Diretto to further comprise a DNA construct comprising UGT2 to produce more classes of saffron apocarotenoids than can be synthesized by UGT709G1 and CCD2L alone. Though Diretto is silent to the sequence of C. sativus UGT2, UGT709G1, and CCD2L, both of these sequences are present in the prior art and readily and easily available to one of ordinary skill in the art. Given the economic importance of saffron, one of ordinary skill in the art would have been sufficiently motivated to search the prior art for said sequences. Additionally, though Diretto does not teach fruit- or tuber-specific promoters, Houhou provides sufficient motivation for one of ordinary skill in the art to modify the teachings of Diretto to express CCD2L (or any of the recited proteins) within the fruit of a target plant and Chung teaches several fruit-specific promoters and the use of fruit-specific promoters to enrich fruit quality. Furthermore, the selection of promoters is a routine design choice parameter well within the means of one of ordinary skill in the art and Applicant has provided no evidence or assertion that expressing CCD2L under the control of fruit- or tuber-specific promoters would provide any surprising or unexpected results in comparison in to expressing CCD2L under the control of the constitutive promoter taught by Diretto. See MPEP 716 and MPEP 2183. Accordingly, one of ordinary skill in the art would have been motivated to produce the claimed invention with a reasonable expectation of success and without any surprising or unexpected results.
Regarding claim 2, the nucleotide sequences encoding a protein are inherent to said protein. Therefore, in addition to the teachings discussed above, the combination of Diretto, Houhou, Chung, Moraga, and Ahzarem also renders obvious SEQ ID NO:3, SEQ ID NO:5, and SEQ ID NO:1.
Regarding claim 3, in addition to the teachings discussed above, Diretto teaches a Cauliflower Mosaic Virus 35S promoter. As discussed above in the rejection of the claims under 35 U.S.C. 112(b), claim 3 is indefinite. For the purpose of compact prosecution, the recitations in parentheses are herein interpreted to comprise non-limiting exemplary embodiments. Thus, the teachings of Diretto render obvious this claim limitation.
Regarding claim 4, Diretto does not teach SEQ ID NO:24. However, Diretto teaches DNA constructs comprising UGT2, UGT709G1, and CCD2L. The selection and design of DNA constructs and expression vectors is a routine design choice parameter well within the skill of one of ordinary skill in the art and Applicant has provided no evidence or assertion that expressing UGT2, UGT709G1, and CCD2L from SEQ ID NO:24 would provide any surprising or unexpected results in comparison in to expressing the proteins from the DNA constructs taught by Diretto. See MPEP 716 and MPEP 2183. Accordingly, one of ordinary skill in the art would have been motivated to produce the claimed invention with a reasonable expectation of success and without any surprising or unexpected results.
Regarding claims 16-17, in addition to the teachings discussed above, Diretto teaches wherein the UGT2, UGT709G1, and CCD2L are native to C. sativus.
Accordingly, one of ordinary skill in the art would have been motivated to produce the claimed invention with a reasonable expectation of success and without any surprising or unexpected results.
Conclusion
12. No claim is allowed.
Examiner’s Contact Information
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEQUANTARIUS J SPEED whose telephone number is (703)756-4779. The examiner can normally be reached M-F; 9AM-5PM ET.
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/DEQUANTARIUS JAVON SPEED/Junior Examiner, Art Unit 1663
/Amjad Abraham/ SPE, Art Unit 1663
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