DETAILED ACTION
Notice of 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 the species cucurbitaxanthin A in the reply filed on 20 February 2026 is acknowledged. The requirement is deemed proper and therefore made Final.
Status of Application
Claims 1-12 are pending and subject to examination on the merits.
Priority
The instant application is a 371 of PCT/JP2021/041098 filed 09 November 2021 which claims benefit of foreign priority document JP 2020-188462 filed 12 November 2020 is acknowledged. Said document has been received.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 11 May 2023 and 23 December 2025 have been considered by the examiner. See initialed and signed PTO/SB/08’s.
Claim Objections
Claim 1 is objected to because of the following informalities: the term “gene” after “crtY” and “crtZ” appears to inadvertently be missing.
Appropriate correction is required.
Claim Interpretation
The claims recite a promoter that is “unique to carotenoid biosynthesis”; this will be interpreted as defined in the specification (paragraph 0069, PG-Pub) as a promoter that is a naturally occurring promoter for carotenoid biosynthesis genes.
In addition, “upstream genes” (and “downstream genes”) for carotenoid biosynthesis will be interpreted as defined in the specification at paragraph 0062 (PG-Pub), crtE, crtB, crtI, crtY, and crtZ are classified into “upstream genes”, and the ZEP gene and the CCS gene are classified into “downstream genes”.
Finally, “promoter intensity” will also be interpreted as defined in the specification at paragraph 0064 (PG-Pub), e.g. promoter intensity refers to the frequency of transfer initiation and is measured by several well known techniques.
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.
Claim 7 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
The claim suffers from two separate indefinite issues.
First, in part (a), the claim recites: a polypeptide comprising a base sequence encoding the amino acid sequence set forth in SEQ ID NO: 4.
However, this does not make any sense scientifically given that the claim is claiming a polypeptide and not a polynucleotide. While polypeptides are encoded by polynucleotides, said polypeptides do not possess nucleotide base sequences, rather they possess amino acid sequences.
This part of the rejection can be overcome by amending the claim to something like: (a) a polypeptide comprising the amino acid sequence set forth in SEQ ID NO: 4;.
Second, part (b) of the claim recites “a polypeptide that has a sequence identity of 90% or more other than the 12th sequence with respect to the amino acid sequence set forth in SEQ ID NO: 4 and specifically binds to S protein.”
The claim is deemed indefinite because it is unclear what is the exception referring to because the “the 12th sequence” when referring to SEQ ID NO: 4 is unclear because said sequence is comprised of amino acids and not sequences.
The specification also recites this ambiguity many times over. However, there is one occurrence in paragraph 0086 (PG-Pub) which seems to suggest it is the 12th amino acid, that is substituted His12Phe and that it the rest of SEQ ID NO: 4 which must have at least 90% sequence identity thereto. It is noted, however, that SEQ ID NO: 4 already possesses the His12Phe substitution.
The rejection can be overcome by reciting something like:
(b) a polypeptide having at least 90% sequence identity to SEQ ID NO: 4, and wherein amino acid 12 is Phe.
Claims 8 and 9 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 8 and 9 recite the limitation "wherein the linker gene is interposed and linked between the ZEP gene and the S-tag gene….." in reference to claim 1. There is insufficient antecedent basis for this limitation in the claim because claim 1 does not recite a linker with an S-tag gene. Rather, claims 6 and 7 do.
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.
Claims 1-12 are rejected under 35 U.S.C. 112(a) 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 at the time the application was filed, had possession of the claimed invention.
The MPEP in section 2163(I) states that the purpose of the written description requirement is to ensure that the inventor had possession, at the time the invention was made/filed, of the specific subject matter claimed:
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonable conclude the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. However, a showing of possession alone does not cure the lack of a written description. Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 969-70, 63 USPQ2d 1609, 1617 (Fed. Cir. 2002). For example, it is now well accepted that a satisfactory description may be found in originally-filed claims or any other portion of the originally-filed specification. See In re Koller, 613 F.2d 819, 204 USPQ 702 (CCPA 1980); In re Gardner, 475 F.2d 1389, 177 USPQ 396 (CCPA 1973); In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). However, that does not mean that all originally-filed claims have adequate written support. The specification must still be examined to assess whether an originally-filed claim has adequate support in the written disclosure and/or the drawings.
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An applicant shows that the inventor was in possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. Amer. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997)"
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co. the court stated:
"A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials." Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus ...") Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398 (Fed. Circ. 1997).
The instant claims are drawn to a transformed host cell in which: a first promoter, and an upstream gene of a carotenoid biosynthesis gene including a crtY and crtZ operably linked to the first promoter, and a second promoter having higher promoter intensity than that of the first promoter, and a ZEP gene and a CCS gene operably linked to the second promoter, have been introduced into a host cell; and methods of producing a carotenoid composition (specifically the elected species of curcurbitaxanthin A) comprising culturing said transformants. Thus, the claims are drawn to a large genus of transformed host cells, that produce carotenoids (for claims 10-12), wherein the minimal carotenoid producing genes need only be lycopene cyclase (crtY) and β-carotene hydroxylase (crtZ) under the control of one promoter; and capsanthin-capsorubin synthase (CCS) and zeaxanthin epoxidase (ZEP) under the control of a different, stronger promoter, wherein said genes and promoters can be one plasmid/vector or on separate promoter/vectors; and methods of making carotenoids using said transformants. However, the specification only provides a single representative example of transformed host cells which are E. coli, which further comprise all of the required carotenoid synthesis genes of: geranylgeranyl pyrophosphate synthase (GGPP) (crtE), phytoene synthase (crtB), phytoene desaturase (crtI), lycopene cyclase (crtY), β-carotene hydroxylase (crtZ) , and isopentenyl diphosphate isomerase IPP (idi) under the control of a weak promoter (weaker as compared to the second promoter); and a second vector/plasmid under the control of a stronger promoter than the first, and comprising the genes capsanthin-capsorubin synthase (CCS) and zeaxanthin epoxidase (ZEP). No other transformed hosts are described. The prior art suggests synthesizing certain carotenoids in transformed host cells varies from host cell to host cell as to what is required for carotenoid production (See Ha et al. KR 101424123; carotenoid synthesis in rice; Kumigawa et al. The Plant Journal, 1998; carotenoid synthesis in plants; Kajiwara et al., Biochem J., 1997, carotenoid synthesis in E. coli – All cited on IDS’s). Furthermore, trying to produce the carotenoids, as listed in claim 12, is not straight forward as evidenced by Furubayashi et al. (Ag. And Food Chem., 2021 – cited on IDS). Thus, the description of genetically transformed E. coli in the specification is not representative of all host cells.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-5 and 10-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Furubayashi et al. (J. Ag. Food Chem., April 2021 – cited on IDS 05/11/2023).
It is noted, the foreign priority document does not have a certified English translation to establish support for the current claims, as such, Furubayashi et al. currently applies as prior art.
Furubayashi et al. teach:
Regarding claims 1-5 and 10-12: a genetically engineered E. coli for the production of capsanthin and derivatives thereof, wherein said E. coli has been transformed with two vectors/plasmids, one of which comprises the upstream genes for carotenoid biosynthesis crtE, crtB, crtI, crtY, and crtZ from Pantoea ananatis, in addition to isopentenyl diphosphate isomerase (IDI) gene from green alga (Haematococcus pluvialis). These were operably linked to a first promoter. The E. coli was also transformed with a second vector/plasmid comprising zeaxanthin epoxidase (ZEP) and capsanthin-capsorubin synthase (CCS) both from C. annuum, which were operably linked to a second distinct promoter (Ptac, PBad or PT7), having greater promoter intensity than the first promoter (Plac) – See Figures 3 and 4, and Materials and Methods.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUZANNE M NOAKES whose telephone number is (571)272-2924. The examiner can normally be reached M-F (7-4).
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/SUZANNE M NOAKES/Primary Examiner, Art Unit 1656 12 March 2026