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 .
DETAILED ACTION
Claims 46-54 and 56-66 are pending.
Claims 50, 52 and 60-65 are withdrawn.
Claims 46-49, 51, 53-54, 56-59 and 66 are rejected.
Priority
This application is a 371 of PCT/IB2020/060941, filed 11/19/2020, and claims foreign priority to GB 2007924.0, 05/27/2020.
Claims 46-49, 51, 53-54, 56-59 and 66 have the effective filing date of 27 May 2020.
Oath or Declaration
It was noted in the Non-Final Office Action mailed on 08 September 2025 that an oath or declaration has not been filed with this application.
MPEP 602.01 (a)(I) states, in part: “The inventor, or each individual who is a joint inventor of a claimed invention, in an application for patent (other than a provisional application) must execute an oath or declaration directed to the application, except as provided for in 37 CFR 1.64.
An oath or declaration must: (1) identify the inventor or joint inventor executing the oath or declaration by their legal name; (2) identify the application to which it is directed; (3) include a statement the person executing the oath or declaration believes the named inventor or joint inventors to be the original inventor or an original joint inventor of a claimed invention in the application for which the oath or declaration is being submitted; and (4) state that the application was made or authorized to be made by the person executing the oath or declaration. Items (3) and (4) above are requirements of 35 U.S.C. 115(a) and (b).”
Submission of such an oath or declaration must be filed in order for examination of the application can proceed. Forms PTO/AIA /01 through PTO/AIA /11 may be used when submitting the inventor’s oath or declaration in an application filed on or after September 16, 2012 (MPEP 602.01 (a)(IV)).
Claim Rejections - 35 U.S.C. § 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.
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 46-49, 51, 53-54, 56-59 and 66 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 pre-AIA the applicant regards as the invention.
Claims 46-49, 51, 53-54, 56-59 and 66 are indefinite because the metes and bounds of the claimed subject matter are not clear.
Claim 46 recites: wherein the modified strain of Chlorella vulgaris comprises a nucleic acid sequence having one or more mutations in magnesium chelatase subunit I, wherein the nucleic acid sequence is as set forth in SEQ ID NO: 1.
Claim 66 recites: The modified strain of Chlorella vulgaris of claim 46, comprising a nucleic acid sequence having one or more mutations in O-methyltransferase as set forth in SEQ ID NO: 2, magnesium-protoporphyrin O-methyltransferase as set forth in SEQ ID NO: 3, 15-cis-phytoene desaturase as set forth in SEQ ID NOs: 4 and 5, or zeta-carotene desaturase as set forth in SEQ ID NOs: 6 and 7.
However, the sequences filed with the instant application represented by SEQ ID NOs.: 1-7 are amino acid sequences, not nucleic acid sequences. Therefore, it is not clear whether the claimed subject matter is directed to the nucleic acid sequences of the proteins cited in claims 46 and 66 or to their amino acid sequences.
Claims 47-49, 51, 53-54, 56-59 and 66 are dependent on claim 46 and are rejected for the same reason.
Claim Rejections - 35 U.S.C. § 103
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 of this title, 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. §102(b)(2)(C) for any potential 35 U.S.C. §102(a)(2) prior art against the later invention.
Claims 46-48, 56 and 58-59 are rejected under 35 U.S.C. §103 as being unpatentable over Brooks et al. (US 2016/0324167 A1) in view of Sanz Molinero (WO 2011/114313 A1) as evidenced by ABSS sequence search (SEQ ID NO.: 1, Downloaded on 19 February 2026, pp. 1-3).
Brooks et al. teaches that algal powders made with algae grown photosynthetically have a deep green color (from the chlorophyll) and a strong, unpleasant taste (pg. 1, para. [0005]). Microalgae of reduced (or lacking in) green pigmentation can be advantageous as a food ingredient. One advantage of microalgae of reduced (or is lacking in) green pigmentation is that the microalgae have a reduced chlorophyll flavor (pg. 18, para. [0199]). The described invention provides algal biomass suitable for human consumption (pg. 16, para. [0185]). Chlorella vulgaris strain(s) which produce(s) a lower content of chlorophyll (including, the amount cited in the claim) will be considered to be (a) modified strain(s), per claim 46.
Brooks et al. does not show: the modified strain of Chlorella vulgaris comprises an amino acid sequence having one or more mutations in magnesium chelatase subunit I, wherein the amino acid sequence is as set forth in SEQ ID NO.: 1 [Claim 46].
Regarding claim 46, Sanz Molinero shows a method for enhancing yield-related traits in plants by modulating expression in a plant of a nucleic acid encoding a Mg-chelatase subunit Chi I (pg. 1, lines 6-8). Preferably, a "Mg-chelatase subunit Chi I" of the described invention (i.e. the POI (protein of interest) polypeptide) as defined herein refers to any polypeptide containing a magnesium chelatase ATPase subunit (I) (pg. 39, lines 15-19). An isolated polypeptide is selected from a group which includes SEQ ID NO.: 2 and SEQ ID NO.: 28 (pg. 44, lines 26-40). Figure 3 shows the amino acid sequence alignment of exemplary polypeptide SEQ ID NO.: 2 with other related Mg-chelatase subunit I polypeptides, and includes a Chlorella vulgaris sequence and a Chlorella sp. sequence as such related sequences (pg. 61, lines 18-19; and Figure 3, entry "C.vulgaris_26598" and "Chlorella_143829" [nexus to Brooks et al.- C. vulgaris]).
Sanz Molinero does not show that SEQ ID NO.: 28 contains one or more mutations in the amino acid sequence of instant SEQ ID NO.: 1.
ABSS sequence search shows that SEQ ID NO.: 28, as shown by Sanz Molinero, is 79.8% identical to instant SEQ ID NO.: 1 (pg. 3). That is, SEQ ID NO.: 28 comprises more than one mutation in the amino acid sequence of SEQ ID NO.: 1.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have modified the modified strain of Chlorella vulgaris having a chlorophyll content in a range of 0.001 to 0.5mg/g DCW, as shown by Brooks et al., by including in the strain a magnesium (Mg) chelatase subunit I protein having one or more mutations in the amino acid sequence of SEQ ID NO.: 1 [Claim 46], as shown by Sanz Molinero as evidenced by ABSS sequence search, with a reasonable expectation of success, because Sanz Molinero et al. shows that Chlorella vulgaris expresses a magnesium chelatase subunit I protein (MPEP 2143 (I)(G)).
One of ordinary skill in the art would have been motivated to have made that modification, because Sanz Molinero teaches that there is a need to identify genes which confer, when over-expressed or down-regulated, increased tolerance to various stresses and/or improved yield under optimal and/or suboptimal growth conditions (pg. 2, lines 5-7). Plants having modulated expression of Mg-chelatase subunit Chi I have enhanced yield-related traits (pg. 1, lines 8-11). Therefore, one of ordinary skill in the art of producing Chlorella vulgaris (for example, on an industrial scale for use in food products, as shown by Brooks et al.) would have been motivated to have modified the C. vulgaris strain to express a mutated Mg-chelatase subunit I enzyme so as to increase microalgal yields.
Regarding claims 46 and 48, Brooks et al. teaches compositions of microalgae-derived flour. In one aspect, a microalgal flour comprising a homogenate of microalgal biomass is provided (pg. 1, para. [0009]-[0010]). Microalgae from the genus Chlorella are generally useful in the described methods (pg. 16, para. [0191]). Species of Chlorella suitable for use in the described methods include C. vulgaris (pg. 17, para. [0192]). "Dry weight" and "dry cell weight" mean weight determined in the relative absence of water. Reference to microalgal biomass, for example, as comprising a specified percentage of a particular component by dry weight means that the percentage is calculated based on the weight of the biomass after substantially all water has been removed (pg. 14, para. [0143]). In various embodiments, the biomass is derived from a single strain of microalgae (pg. 2, para. [0012]). In one embodiment, the chlorophyll content of the microalgal biomass is less than 200 ppm. In one embodiment, the chlorophyll content of the microalgal biomass is less than 2 ppm (pg. 8, para. [0069] [0.001 to 0.5mg/g = 1ppm to 500ppm]).
Claim 48 recites product-by-process claim language. MPEP 2113 states: “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior art product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Regarding claim 47, preferred microalgae for use in the described methods can grow heterotrophically (pg. 16, para. [0190]). In some cases, the cells are from a heterotrophic culture (pg. 3, cont. para. [0017]).
Regarding claim 56, in some cases, the biomass is derived from an algae that is a color mutant with reduced color pigmentation compared to the strain from which it was derived (pg. 2, para. [0012]). The described invention provides a method of providing a microalgal strain suitable for food production, comprising (a) mutagenizing a microalgal strain, (b) identifying a mutagenized colony having reduced coloration relative to the original strain when grown under the same conditions; and (c) culturing the mutagenized strain (pg. 7, para. [0061]).
Regarding claim 58, in some cases, the microalgal biomass comprises between 20-115 μg/g of total carotenoids, including 20-70 μg/g lutein (pg. 2, para. [0014]).
Regarding claim 59, in some cases, the biomass comprises at least 40% protein by dry weight (pg. 4, para. [0033]).
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Claims 49, 51 and 53-54 are rejected under 35 U.S.C. §103 as being unpatentable over Brooks et al. in view of Sanz Molinero as evidenced by ABSS sequence search, as applied to claims 46-48, 56 and 58-59 above, and further in view of Tran et al. (WO 2020/097370 A2; Intl. Pub. Date: 14 May 2020).
Brooks et al. in view of Sanz Molinero do not show: the modified strain of Chlorella vulgaris comprises a mutation at one or more positions in a nucleic acid sequence or an amino acid sequence, and wherein each mutation is one of: a substitution, an insertion, or a deletion relative to a native strain of Chlorella vulgaris [Claim 49]; the mutation is in any of a coding region or a non-coding region of the nucleic acid sequence, and wherein mutation in the coding region results in any of: a neutral gene expression, an altered gene expression and/or a modified amino acid sequence [Claim 51]; the one or more mutated genes is associated with a metabolic change in the chlorophyll biosynthesis pathway [species election] [Claim 53]; and the one or more mutated genes is associated with at least 90% reduced gene expression relative to the native strain of Chlorella vulgaris [Claim 54].
Tran et al. shows compositions and processes for producing such compositions from an algae that overproduces protoporphyrin IX (PPIX) (pg. 2, para. [0006]). In some embodiments, the preparation has a protoporphyrin IX content greater than chlorophyll content (pg. 3, para. [0008]). In some embodiments, the method further comprises steps which include culturing the algae strain under a dark condition, wherein the strain does not produce or is reduced in the production of chlorophyll (pg. 6, para. [0022] [nexus to Brooks et al.- a modified algal strain with low chlorophyl content]). In some embodiments, the green algae is selected from the group consisting of, minimally, Chlorella, including C. vulgaris (pg. 17, para. [0063] thru pg. 18, para. [0064] [nexus to Brooks et al.- a modified Chlorella vulgaris strain]).
In some embodiments, the algae cultured under dark conditions lack or are reduced in chlorophyll production by at least 10%, up to at least 80% compared to the algae cultured under dark [sic?] conditions (pg. 21, para. [0070]). In Example 3, a composition of the PPIX-enriched algae contained 0% chlorophyll (pg. 36, para. [0102]).
Regarding claim 49, Tran et al shows that, in some embodiments, an algae strain is mutagenized and then a new strain is selected (pg. 17, para. [0062] [nexus to Brooks et al.- mutagenizing the algal strain]). The terms "a deficiency in" or the "lack of", or "reduction of", one or more genes and/or enzymes include, for example, mutation or deletion of the gene sequence, a reduction in or lack in the expression from a gene (RNA and/or protein) and/or a lack of accumulation or stability of a gene product (RNA and/or protein) (pg. 9, para. [0037] thru pg. 10, cont. para. [0037]). In some embodiments, the algae strain is deficient for one or more enzymes in the chlorophyll biosynthesis pathway. Such deficiencies include, but are not limited to, gene deletions, mutations and other alterations that result in a lack of expression of the enzyme or a deficiency in the functionality of the enzyme (pg. 12, para. [0048]).
Regarding claim 51, Tran et al. shows that, in some embodiments, the algae strain is deficient in magnesium chelatase which is the first step in converting protoporphyrin IX to chlorophyll (pg. 12, para. [0048]). The algae strain is deficient for one or more of the magnesium chelatase subunits CHLD, CHLH and CHLI. These subunits are also referred to by the gene names, CHLD1 (alternatively written as CH1D1), corresponding to CHLD subunit, CHLH1 (alternatively written as CH1H1), corresponding to the CHLH subunit, and CHLI1 and CHLI2, corresponding to the CHLI subunit, encoded by two genes, CHLI1 and CHLI2 (alternatively written as CHll1 and CHII2) (pg. 12, para. [0048] thru pg. 13, para. [0049]).
Regarding claim 53, in some embodiments, the algae strain is deficient for one or more enzymes in the chlorophyll biosynthesis pathway (pg. 12, para. [0048] [species election]).
Regarding claim 54, in some embodiments, the algae strain is deficient for one or more of CHLD1, CHLH1, CHLI1, CHLI2 or portions thereof (including genetic modification in one or more of intron, exon, regulatory regions, or full gene sequences, such as a genetic modification to one or more of SEQ ID NOs: 45-69, 70-88, 89-113, or 130-150). For example, one of the red algae strain has genetic modification in CHLH locus. The modification deletes a single base pair in CHLH as compared to a green strain, causing a frameshift in the CHLH open reading frame and/or generate a stop codon such that the protein is translated into a truncated form (pg. 13, para. [0050]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have modified the modified strain of Chlorella vulgaris having a chlorophyll content in a range of 0.001 to 0.5mg/g dry cell weight, as shown by Brooks et al. in view of Sanz Molinero as evidenced by ABSS sequence search, as applied to claims 46-48, 56 and 58-59 above, by mutagenizing the strain in order to create one or more mutations in the nucleic acid and/or amino acid sequence of the strain, such as a substitution, an insertion or a deletion [Claim 49], as shown by Tran et al., with a reasonable expectation of success, because Brooks et al. shows that the described modified Chlorella strain can be mutagenized so as to produce a color mutant with reduced color/green pigmentation (Brooks et al., pg. 7, para. [0058] and [0061]), which is the type of mutant Chlorella strain shown by Tran et al. (MPEP 2143 (I)(G)). Tran et al. describes the algae generated by mutagenesis as red or red-like in color (i.e., not green) (pg. 6, para. [0018]).
It would have been further obvious to have: 1) created a mutation in the coding region of a nucleic acid sequence so as to produce altered gene expression and/or a modified amino acid sequence [Claim 51]; 2) mutated one or more genes in the chlorophyll biosynthesis pathway [Claim 53]; and 3) reduced gene expression by at least 90% as a result of the one or more mutated genes [Claim 54], as shown by Tran et al., with a reasonable expectation of success, because Tran et al. shows a mutagenesis process in which the resulting modified algal strain is deficient for one or more of the magnesium chelatase subunits, which are the chelatase enzymes shown by Sanz Molinero (MPEP 2143 (I)(G)).
This deficiency would mean (e.g., by the described introduced stop codon mutation) that a relevant Mg-chelatase subunit gene would be altered (specifically, reduced) in expression by at least 90%. Magnesium chelatase is a component of chlorophyll biosynthesis pathway as the first step in converting protoporphyrin IX to chlorophyll (Tran et al., pg. 12, para. [0048]). Tran et al. shows that any subunit (including subunit I) can be targeted for mutagenesis.
Tran et al. also shows that the algal strain can be mutagenized (or grown in the dark) so as to reduce the chlorophyll content by at least 10% up to at least 90%. Therefore, one of ordinary skill in the art would have utilized routine optimization in order to have produced a modified Chlorella vulgaris strain having a chlorophyll content specifically in the range of 0.001 and 0.5mg/g dry cell weight, as shown by Brooks et al. (MPEP 2144.05 (II)(III)).
One of ordinary skill in the art would have been motivated to have made those modifications, because Brooks et al. teaches that algal powders made with algae grown photosynthetically have a deep green color (from the chlorophyll) and a strong, unpleasant taste (pg. 1, para. [0005]). Microalgae of reduced (or lacking in) green pigmentation can be advantageous as a food ingredient. One advantage of microalgae of reduced (or is lacking in) green pigmentation is that the microalgae have a reduced chlorophyll flavor (Brooks et al., pg. 18, para. [0199]).
Tran et al. shows compositions and processes for producing such compositions that provide new sources for flavor, color, mouth feel, taste, odor, texture and nutrition for food products and food ingredients, as well as other uses such as animal feed (pg. 2, para. [0006]). In addition, Tran et al. teaches that to improve the sustainability of the food ecosystem it is imperative that products are developed that appeal to consumers who currently prefer meat (pg. 2, cont. para. [0004]). That is, algae with low chlorophyll content and/or a higher content of heme (PPIX is a heme-binding protein) produce plant-based food products which are more palatable than other algae-containing "meatless" food products.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Claim 57 is rejected under 35 U.S.C. §103 as being unpatentable over Brooks et al. in view of Sanz Molinero as evidenced by ABSS sequence search, as applied to claims 46-48, 56 and 58-59 above, and further in view of Shin et al. ((2016) J. Appl. Phycol. 28: 3193-3202).
Brooks et al. in view of Sanz Molinero do not show the reduced chlorophyll content is associated with at least one of: chlorophyll a (a-chlorophyll) and/or chlorophyll b (b-chlorophyll) [Claim 57].
Shin et al. shows random mutants with reduced chlorophyll antenna size generated by ethyl methanesulfonate (EMS)-mediated mutagenesis of Chlorella vulgaris (pg. 3193, column 1, Abstract [nexus to Brooks et al. and Tran et al.- C. vulgaris strains with reduced chlorophyll content]). The cells underwent an exposure to a chemical mutagen, ethyl methanesulfonate (EMS), in order to induce random point mutations, and mutants representing light green color were isolated, including isolated strain E5 (pg. 3194, column 2, para. 1 [nexus to Brooks et al. and Tran et al.- mutations introduced into the strain]).
Regarding claim 57, the antenna size mutant, designated E5, exhibited 56.5 and 75.8% decreases in chlorophyll a and b contents, respectively, with significant reductions in the expression levels of peripheral light-harvesting antenna proteins in photosystem II (pg. 3193, column 1, Abstract).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have modified the modified strain of Chlorella vulgaris having a chlorophyll content in a range of 0.001 to 0.5 mg/g dry cell weight, as shown by Brooks et al. in view of Sanz Molinero as evidenced by ABSS sequence search, as applied to claims 46-48, 56 and 58-59 above, by: demonstrating that the reduced chlorophyll is associated with at least one of: chlorophyll a ( a-chlorophyll) and/or chlorophyll b (b-chlorophyll) [Claim 57], as shown by Shin et al., with a reasonable expectation of success, because Shin et al. shows a mutagenized Chlorella vulgaris strain with reduced chlorophyll content, which is the modified strain of Chlorella vulgaris, shown by Brooks et al. and Tran et al. (MPEP 2143 (l)(G)).
That is, Shin et al. teaches that the major light-harvesting antenna proteins bind to both chlorophyll a (Chl a) and chlorophyll b (Chl b), while the photosystem core proteins mainly bind to Chl a (pg. 3197, column 1 , para. 1). Therefore, one of ordinary skill in the art of producing an algal composition would understand that chlorophyll a and chlorophyll b are the major chlorophylls found in algae, and, therefore, it would have been obvious to have expected that the reduced chlorophyll amounts, shown by Brooks et al. and Tran et al., would have included reduced amounts of chlorophyll a and/or chlorophyll b (MPEP 2143 (l)(G) and MPEP 2144 (I)).
One of ordinary skill in the art would have been motivated to have made that modification, because Shin et al. shows that the described findings suggest that the engineered reduction in chlorophyll light harvesting antenna size and chlorophyll content increases the culture density in photosynthetic microalgae (pg. 3200, column 2, para. 1). The results suggest that a reduction of antenna size through genetic approach of microalgae could be applied to improve the economics of mass cultivation of microalgae for biofuel production (Shin et al., pg. 3201, column 1, para. 1) or food production, as shown by Brooks et al.
Therefore, the invention as a whole would have been prima facie obvious to person of ordinary skill before the effective filing date of the claimed invention.
Claim 66 is rejected under 35 U.S.C. §103 as being unpatentable over Brooks et al. in view of Sanz Molinero as evidenced by ABSS sequence search, as applied to claims 46-48, 56 and 58-59 above, and further in view of Li et al. (Mol. Biol. Rep. 2013, 40:3351-3361) as evidenced by NCBI sequence search (SEQ ID NO.: 4. Downloaded on 19 February 2026, pp. 1-4).
Brooks et al. in view of Sanz Molinero do not show an amino acid sequence having one or more mutations in 15-cis-phytoene desaturase as set forth in SEQ ID NO: 4 [Claim 66].
Li et al. teaches that phytoene desaturase is the key enzyme involved in the biosynthesis pathway of lutein. Phylogenetic analysis revealed that the phytoene desaturases are derived from the algal family (pg. 3351, column 1, Abstract [nexus to Brooks et al.- the microalgal biomass produces lutein]). Phytoene desaturase (pds), as one of the most commonly reported rate-limiting enzymes in carotenoid biosynthesis, is highly conserved. The aim of the described study was to identify the pds gene and address its characteristics from Chlorella protothecoides CS-41 (pg. 3352, column 1, para. 1). The pds nucleotide sequence was deposited in GenBank with accession number of GU269620 (pg. 3355, column 2, para. 1).
Li et al. does not explicitly show the amino acid sequence translated from the nucleotide sequence of deposited GU269620.
NCBI sequence search (SEQ ID NO.: 4) shows that the translated amino acid sequence of accession no. GU269620.1 (deposited as ADR82199.1) is 99% identical to SEQ ID NO.: 4 (pg. 4). That is, Li et al. shows that the amino acid sequence of ADR82199.1 has one mutation in the amino acid sequence represented by instant SEQ ID NO.: 4.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have modified the modified strain of Chlorella vulgaris having a chlorophyll content in a range of 0.001 to 0.5mg/g DCW, as shown by Brooks et al. in view of Sanz Molinero as evidenced by ABSS sequence search, as applied to claims 46-48, 56 and 58-59 above, by including in the strain an amino acid sequence of SEQ ID NO.: 4 having one or more mutations in the encoded phytoene desaturase enzyme [Claim 66], as shown by Li et al. as evidenced by NCBI sequence search, with a reasonable expectation of success, because Li et al. shows that Chlorella species express a phytoene desaturase protein, as the key enzyme in the lutein biosynthesis pathway. Brooks et al. shows the production of lutein resulting from the propagation of Chlorella sp. in bioreactors (see 103 rejection above) (MPEP 2143 (I)(G)).
One of ordinary skill in the art would have been motivated to have made that modification, because Li et al. teaches that lutein is not only an important natural food colorant and additive but also plays an important role in preventing some diseases, such as age-related macular degeneration. Chlorella protothecoides is a promising alternative resource of lutein for it can be cultivated heterotrophically and efficiently in a fermenter (Li et al., pg. 3358, column 2, para. 1 thru pg. 3359, column 1, line 1). Therefore, one of ordinary skill in the art would have been motivated to have included the phytoene desaturase enzyme in a modified Chlorella vulgaris strain, including a strain comprising one or more mutations to promote the increased production of lutein.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Response to Arguments
Applicant’s arguments, pp. 7-10, filed on 08 January 2026, with respect to the prior art references cited in the 35 U.S.C. §103 rejections, have been fully considered but they are either not persuasive or are moot because the arguments do not apply to the references as they are applied in the context of the current rejection, or as new grounds necessitated by Applicant’s amendment, in which claim 46 was amended, and new claim 66 was added.
1. Applicant remarks (pg. 7, last para. thru pg. 8) that the Examiner asserted it would have been obvious to one of ordinary skill in the art to modify Chlorella vulgaris as shown in Brooks et al. by mutagenizing the strain in order to create one or more mutations as shown by Tran et al. with regard to magnesium chelatase.
However, in response to Applicant, this argument is moot because Applicant's amendment to independent claim 46 prompted a rejection based on new references. With regard to former claim 55, the specific examination of SEQ ID NO.: 1 was not required (see 112(b) rejection cited in the Non-Final Office Action mailed 08 September 2025). Therefore, Applicant's amendment required further search of SEQ ID NO.: 1; and, as a result, new references are herein applied.
2. Applicant remarks (pg. 9) that claim 46 is now directed to the modified strain of Chlorella vulgaris comprises a nucleic acid sequence having one or more mutations in magnesium chelatase subunit I, wherein the nucleic acid sequence is as set forth in SEQ ID NO: 1. Those highlighted claim recitations are not taught or suggested by Brooks et al., either alone, or in combination with Tran et al.
In response to Applicant, new references have been applied to address this new limitation in claim 46.
3. Applicant remarks (pg. 9, last para. thru pg. 10), with regard to dependent claim 57, that all of the arguments hereinabove as to why Brooks et al. and Tran et al. do not teach or suggest the claimed subject matter are herein incorporated by reference in entirety. Since Brooks et al. and Tran et al. do not teach or suggest the claimed features of claim 46, that Shin et al. teach certain random mutants via chemical mutagenesis, does not cure the fatal deficiencies of the primary reference as to the rejected claims.
However, in response to Applicant, Shin et al. was cited to address the reduced content of chlorophyll-a and chlorophyll-b in Chlorella vulgaris after mutagenesis. The reference was not cited to remedy any purported deficiencies of Brooks et al. and Tran et al.- which are not used in combination to address amended claim 46.
Conclusion
Applicant's amendment 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 extension fee 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 date of this final action.
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/SMP/Examiner, Art Unit 1657
/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657