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 .
Priority
This application is a 371 of PCT/IB2019/060048, filed 11/21/2019, and claims foreign priority to UK 1818986.0, 11/21/2018.
Claims 39-42, 47-49, 51-57 and 62-67 have the effective filing date of 21 November 2018.
DETAILED ACTION
New grounds of rejection under 35 U.S.C. §112(a), 35 U.S.C. §112(b) and 35 U.S.C. §103 over Brooks et al. are necessitated by Applicants’ amendment on 20 January 2026; specifically, amended claims 39 and 42 and new claims 62-67. See MPEP 706.07(a).
Claims 39-42, 47-49, 51-58 and 62-67 are pending. Claim 58 is withdrawn.
Claims 39-42, 47-49, 51-57 and 62-67 are rejected.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 20 January 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the Examiner except for non-patent literature (NPL) citation #1 on the IDS received 20 January 2026 is not being considered because no copy was provided.
Claim Objections
Claims 39-42, 47-49, 51-57 and 62-65 are objected to because of the following informalities:
Claim 39 recites: "...wherein the microalgae comprises one or more modified wild-type strains of Chlorella vulgaris..., wherein the modified strain of Chlorella vulgaris has...", which should read, for the purpose of claim language consistency, "...wherein the microalgae comprises one or more modified wild-type strains of Chlorella vulgaris..., wherein the one or more modified wild-type strains of Chlorella vulgaris have..."
Claims 40-42, 47, 49, 51-53, 57, 62 and 66-67 recite the phrase "the modified strain of Chlorella vulgaris", which should read, for the purpose of claim language consistency, "the one or more modified wild-type strains of Chlorella vulgaris".
Claims 40-42, 47-49 and 51-57 show incorrect status identifiers. Claims 40-42, 47-49 and 51-57 show the status identifier "(Previously presented)", but should show the status identifier "(Currently amended)".
Appropriate correction is required.
Claim Rejections - 35 U.S.C. § 112
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. §112:
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 of carrying out his invention.
New claims 66 and 67 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 enablement requirement. The claim(s) contain(s) 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 66 and 67 fail to comply with the enablement requirement because they do not adequately describe the manner and process of making and using the invention.
Claim 66 recites: "..., wherein the modified strain of Chlorella vulgaris is one or more of YC06, YC03, YC 10, YC 18, YC24, YC 14 and YC20."
Claim 67 recites: "..., wherein the modified strain of Chlorella vulgaris is one or more of YC03, and YC20."
MPEP 2402 states, in part: "Every patent must contain a written description of the invention sufficient to enable a person skilled in the art to which the invention pertains to make and use the invention. Where the invention involves a biological material and words alone cannot sufficiently describe how to make and use the invention in a reproducible manner, access to the biological material may be necessary for the satisfaction of the statutory requirements for patentability under 35 U.S.C. §112. Courts have recognized the necessity and desirability of permitting an applicant for a patent to supplement the written disclosure in an application with a deposit of biological material which is essential to meet some requirement of the statute with respect to the claimed invention."
It is not clear that the practitioner would know what steps would be required in order to produce microalgal strains that are genetically identical to those cited in claims 66 and 67; i.e., YC06, YC03, YC10, YC18, YC24, YC14 and/or YC20, so as to reproducibly produce genetically-identical modified Chlorella vulgaris strains YC06, YC03, YC10, YC18, YC24, YC14 and YC20. In addition, it is not clear that these strains have been deposited so as to make these strains available to the public upon the granting of a patent. Figure 4 shows the abovementioned strains with what appears to be more specific strain designations.
The specification describes a general mutagenesis protocol (originally-filed specification, pg. 21, para. 1 thru pg. 23). However, there are no method steps described which would lead to the reproducible production of modified C. vulgaris strains YC06, YC03, YC10, YC18, YC24, YC14 and YC20.
MPEP 2404 states, in part: "...biological material need not be deposited unless access to such material is necessary for the satisfaction of the statutory requirements for patentability under 35 U.S.C. §112 and that access is not otherwise available in the absence of a deposit."
MPEP 2404.01 states, in part: "In an application where the invention required access to specific biological material, an applicant could show that the biological material is accessible because it is known and readily available to the public...By showing that a biological material is known and readily available or by making a deposit in accordance with these rules, applicant does not guarantee that such biological material will be available forever. Public access during the term of the patent may affect the enforceability of the patent. Although there is a public interest in the availability of a deposited biological material during and after the period of enforceability of the patent, there should not be any undue concern about continued access to the public."
To overcome this rejection, Applicant may attempt to demonstrate (by means of argument or evidence) that the modified C. vulgaris strains designated YC06, YC03, YC10, YC18, YC24, YC14 and YC20 are known and readily available to the public or that the strains have been deposited according to the deposit rules (37 CFR 1.801- 1.809).
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.
Claim 65 is 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.
Claim 65 recites the food grade microalgae product or flour of claim 64, characterised in that the specific temperature is above 28°C. However, there is no recitation of a specific temperature in the claims from which it depends. Claim 65 is indefinite, because it recites insufficient, improper or unclear antecedent basis for the limitations in the claim; and because the metes and bounds of the claimed subject matter are not clear.
Claim Rejections - 35 U.S.C. § 103
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 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 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 39-42, 47, 51-57 and 62-63 are rejected under 35 U.S.C. §103 as being unpatentable over Brooks et al. (US 2016/0324167 A1).
Regarding claim 39, pertaining to a food grade microalgae product or flour comprising a homogenate of microalgae biomass,
Brooks et al. shows compositions of microalgae-derived flour from multiple genera, species, and strains of edible microalgae (pg.1, para. [0009]). In a first aspect, the microalgal flour comprises a homogenate of microalgal biomass (pg. 1, para. [0010]).
Brooks et al. teaches that the microalgae biomass can be from a single algal source (e.g., strain) or algal biomass from multiple sources (e.g., different strains) (pg. 29, para. [0304]). Some pigments, such as chlorophyll, can also create undesirable taste profiles. Use of reduced pigment microalgal biomass expands the range of food products that can be manufactured with healthy lipid profiles (pg. 7, para. [0057]). The described invention further includes unique and novel strains of microalgae that have been subjected to non-transgenic methods of mutation sufficient to reduce the coloration of biomass produced by the strains (pg. 7, para. [0057]). 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] [200ppm = 0.2mg/g; 2ppm = 0.002 mg/g]).
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 the species selected from a group which includes C. vulgaris (including strains CCAP 211/11K, CCAP 211/80, vulgaris f. tertia and vulgaris f. viridis) (pg. 17, para. [0192]).
Brooks et al. teaches that one method for generating such microalgae strain lacking in or has significantly reduced pigmentation is through mutagenesis and then screening for the desired phenotype. Several methods of mutagenesis are known and practiced in the art. For example, Urano et al. describes yellow and white color mutants of Chlorella generated using UV irradiation (pg. 18, para. [0200] [Urano et al., J. Biosci. Bioeng. 2000, 90(5): 567-569 (provided here)]).
Brooks et al. does not teach working examples in which Chlorella vulgaris is incorporated into a food grade microalgae product or flour [Claim 39].
However, 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 food grade microalgae product or flour comprising a homogenate of microalgae biomass, by including in the product or flour a modified wild-type strain of Chlorella vulgaris comprising a chlorophyll content in a range of 0.001 to 0.5 mg/g dry cell weight, instead of or in addition to including C. protothecoides in the product or flour, as exemplified by Brooks et al., with a reasonable expectation of success, because Brooks et al. teaches that microalgae from the genus Chlorella are generally useful in the methods of the described invention, and teaches an extensive list of different Chlorella species which would be suitable (including C. vulgaris) (pg. 16, para. [0191] thru pg. 17, para. [0192]) (MPEP 2143 (I)(B)(3)(G)).
In addition, Brooks et al. teaches that Kamiya (Kamiya, Plant Cell Physiol. (1989) v. 30(4): 513-521) describes a colorless strain of Chlorella vulgaris 11h (M125) (pg. 18, para. [0200] [Kamiya et al., Plant Cell Physiol. 1989, 30(4): 513-521 (provided here)]) (MPEP 2143 (I)(G)). That is, a strain of C. vulgaris can be obtained which exhibits low chlorophyll content, which describes the microalgae in the compositions shown by Brooks et al. (MPEP 2143 (I)(G)).
One of ordinary skill in the art would have been motivated to have made that modification, because one of ordinary skill in the art of producing a food grade product or flour comprising microalgae would have included particular strains, depending on the desired properties or characteristics of the product or flour being produced. For example, Brooks et al. teaches that Chlorella protothecoides is a preferred microorganism for use in the described methods because of its high composition of lipid (pg. 17, cont. para. [0191]). Therefore, if, for example, the producer of a food grade product or flour would have desired a product or flour with minimal lipid content, a different species of Chlorella (e.g., Chlorella vulgaris) might preferably have been utilized.
Regarding claim 40, 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 41, 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] [200ppm = 0.2mg/g; 2ppm = 0.002 mg/g]).
Regarding claim 42, pertaining to the modified strain of Chlorella vulgaris has a white colour, Brooks et al. teaches that several methods of mutagenesis are known and practiced in the art. Urano et al. describes yellow and white color mutants of Chlorella generated using UV irradiation (pg. 18, para. [0200] [Urano et al., J. Biosci. Bioeng. 2000, 90(5): 567-569 (provided here)]).
Regarding claim 47, pertaining to the modified strain of Chlorella vulgaris has a chlorophyll content lower than a chlorophyll content of the wild-type strain from which it was derived, Brooks et al. teaches that, in various embodiments, the biomass is derived from a single strain of microalgae. 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]). It is noted that claim 47 recites the term "optionally". The limitations following this term is not required for the applicability of prior art.
Regarding claim 51, Brooks et al. teaches that the described invention provides a food ingredient composition comprising microalgal biomass having a triglyceride oil content of at least 16% by weight in the form of whole cell flakes or whole cell powder. In some cases, the biomass comprises at least 40% protein by dry weight (pg. 4, para. [0033]).
Regarding claim 52, the algal biomass is derived from algae cultured heterotrophically (pg. 10, para. [0092]).
Regarding claims 53, 54 and 55, when grown in heterotrophic conditions where the carbon source is a fixed carbon source and in the absence of light, the normally green colored microalgae has a yellow color, lacking or is significantly reduced in green pigmentation (pg. 18, para. [0199]). lnoculum for each fermentor was Chlorella protothecoides (UTEX 250), prepared in two flask stages using the medium and temperature conditions of the fermentor inoculated. Three lab scale fermentors were held at 28oC for the duration of the experiment. Fermentation cultures were cultivated for 11 days (pg. 36, para. [0353]).
Regarding claim 56, the fixed carbon source is a key component of the medium. Suitable fixed carbon sources for purposes of the described invention, include for example, minimally, glucose, fructose, sucrose and/or acetate (pg. 19, para. [0210]).
Regarding claim 57, colonies with the desired phenotype are then streaked out on plates and reisolated to ensure that the mutation is stable from one generation to the next and that the colony is pure and not of a mixed population (pg. 18, para. [0201]).
Claims 62 and 63 recite product-by-process language. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. However, the structure implied by the process steps should be considered when assessing patentability over the prior art where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product (MPEP 2113 (I)). Therefore, the product-by-process limitations will be addressed at the discretion of the Examiner.
Regarding claim 62, Brooks et al. teaches that one method for generating such microalgae strain lacking in or has significantly reduced pigmentation is through mutagenesis and then screening for the desired phenotype (pg. 18, para. [0200]).
Regarding claim 63, in addition to mutagenesis by UV irradiation, chemical mutagenesis can also be employed in order to generate microalgae with reduced (or lacking in) pigmentation. Chemical mutagens such as, minimally, ethyl methanesulfonate (EMS) have been shown to be effective chemical mutagens on a variety of microbes including, minimally, microalgae (pg. 18, para. [0201]).
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 48 and 64 are rejected under 35 U.S.C. §103 as being unpatentable over Brooks et al., as applied to claims 39-42, 47, 51-57 and 62-63 above, and further in view of Shin et al. (J. Appl. Phycol. 2016, 28: 3193-3202).
Brooks et al. teaches that, 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] [200ppm = 0.2mg/g; 2ppm = 0.002 mg/g]).
Brooks et al. does not teach: the reduced chlorophyll content is associated with at least one of chlorophyll a (α-chlorophyll) and/or chlorophyll b (β-chlorophyll) and collectively [Claim 48]; and the non-lethal quantity of the mutagenic chemical is in a range of 0.1 to 1.0 M [Claim 64].
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.- Chlorella vulgaris strains
with reduced chlorophyll content using EMS mutagenesis]).
Regarding claim 48, 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).
Regarding claim 64, Chlorella vulgaris UTEX 265 cells were exposed to various concentrations (0.1, 0.19, 0.24, and 0.28 M) of EMS (pg. 3194, column 2, para.
2). Claim 64 recites product-by-process language. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. However, the structure implied by the process steps should be considered when assessing patentability over the prior art where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product (MPEP 2113 (I)).
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 food grade microalgae product or flour comprising a homogenate of microalgae biomass comprising one or more modified wild-type strains of Chlorella vulgaris, in turn comprising a chlorophyll content in a range of 0.001 to 0.5 mg/g dry cell weight, as shown by Brooks et al., as applied to claims 39-42, 47, 51-57 and 62-63 above, by including a C. vulgaris strain with reduced chlorophyll a (α-chlorophyll) and/or chlorophyll b (β-chlorophyll) content [Claim 48], as shown by Shin et al., with a reasonable expectation of success, because Shin et al. shows a(n) EMS mutagenized Chlorella vulgaris strain with reduced chlorophyll content, which is the modified strain of Chlorella vulgaris, shown by Brooks et al. (MPEP 2143 (l)(G)).
In addition, 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 algal compositions would have understood 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., would have included reduced amounts of chlorophyll a and/or chlorophyll b (MPEP 2143 (l)(G) and MPEP 2144 (I)).
It would have been further obvious to have used a non-lethal quantity of the mutagenic chemical in a range of 0.1 to 1.0 M [Claim 64], as shown by Shin et al., with a reasonable expectation of success, because Shin et al. shows a(n) EMS mutagenized Chlorella vulgaris strain with reduced chlorophyll content, which is the modified strain of Chlorella vulgaris, shown by Brooks et al. (MPEP 2143 (l)(G)).
In addition, Shin et al. teaches that it is known that there is an optimum dosage at which a mutagen can increase the mutation rate without killing all of the treated cells. To identify an appropriate concentration of EMS for the random mutagenesis of C. vulgaris, cell survival rates in the presence of different concentrations of EMS were examined. (pg. 3196, column 1, para. 1). Brooks et al. also shows that mutagenesis can also be carried out in several rounds, where the microalgae is exposed to the mutagen and then screened for the desired reduced pigmentation phenotype. Colonies with the desired phenotype are then streaked out on plates and reisolated to ensure that the mutation is stable from one generation to the next and that the colony is pure and not of a mixed population (pg. 18, para. [0201]). That is, both Shin et al. and Brooks et al. show a mutagenesis protocol in which appropriate levels of mutagen are determined so as to produce live C. vulgaris cells of the desired (reduced chlorophyll) phenotype (MPEP 2143 (l)(G)).
One of ordinary skill in the art would have been motivated to have made that modification, because there is a concentration of EMS that does not result in viable algal cells (Shin et al., pg. 3196, column 1, para. 1), and, so, one of ordinary skill in the art would have been motivated to have set a range of ethyl methanesulfonate concentrations that would have produced viable mutagenized algal cells for downstream processing.
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 49 is rejected under 35 U.S.C. §103 as being unpatentable over Brooks et al., as applied to claims 39-42, 47, 51-57 and 62-63 above, and further in view of Cordero et al. (Mar. Drugs, 2011, 9: 1607-1624).
Regarding claim 49, Brooks et al. shows that, in some cases, the biomass has between 20-115 μg/g of total carotenoids, including 20-70 μg/g lutein (pg. 2, cont. para. [0010]).
Brooks et al. does not show: the modified strain of Chlorella vulgaris has a lutein content in a range of 3 to 10 mg/g dry cell weight [Claim 49].
Cordero et al. shows the screening of different species of microalgae for lutein production, including Chlorella sorokiniana and Chlorella vulgaris (pg. 1609, para. 2.1 and Table 1). Table 1 shows that C. sorokiniana had a lutein content of 24.0 mg/L, and C. vulgaris had a lutein content of 22.2 mg/L (pg. 1609, Table 1 thru pg. 1610, cont. Table 1 [nexus to Brooks et al.- Chlorella strains with a lutein content, incl. vulgaris]). High lutein yielding mutants of C. sorokiniana have been obtained by random mutagenesis, using N-methyl-N'-nitro-nitrosoguanidine (MNNG) as a mutagen (pg. 1607, Abstract).
Regarding claim 49, Table 7 shows the increase in lutein content of the best mutants of C. sorokiniana compared to the wild type strain. Table 7 shows that the cellular lutein content of the seven mutants ranged from 17 to 55 mg/g lutein by dry weight (pg. 1615, Table 7).
Cordero et al. does not specifically show a lutein content in a range of 3 to 10 mg/g DCW.
However, 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 food grade microalgae product or flour comprising a homogenate of microalgae biomass comprising one or more modified wild-type strains of Chlorella vulgaris, in turn comprising a chlorophyll content in a range of 0.001 to 0.5 mg/g dry cell weight, as shown by Brooks et al., as applied to claims 39-42, 47, 51-57 and 62-63 above, by including a modified C. vulgaris strain with a lutein content in a range of 3 to 10 mg/g dry cell weight, with a reasonable expectation of success.
Brooks et al. and Cordero et al. show that Chlorella algae produce lutein, pre-mutagenesis. In fact, Cordero et al. shows that Chlorella strains can be screened pre-mutagenesis in order to isolate those strains expressing naturally "high" lutein levels. In addition, Cordero et al. shows that these Chlorella (specifically, C. sorokiniana) microalgae can then be mutagenized and screened in order to isolate Chlorella strains which further produce yet higher levels of lutein.
Therefore, one of ordinary skill in the art of selecting and isolating algal cells expressing a specific desired range of lutein (e.g., 3 to 10mg/g dry cell weight (DCW) [Claim 49]) would have understood that it would have been possible to have: 1) selected low lutein-producing Chlorella strains, as shown by Brooks et al. (i.e., 20-70 μg/g lutein), prior to mutagenesis, in order to obtain a post-mutagenesis strain with the desired range of lutein; or 2) selected the post-mutagenesis "not best" strains (which were not shown by Cordero et al.) which produced the specific range of lutein of 3 to 10mg/g DCW (MPEP 2143 (l)(G)).
That is, one of ordinary skill in the art of screening for desired (mutant) algal cells would have known how to either optimize the mutagenesis protocol in order to obtain lutein-producing algal cells with the desired level of production or to merely isolate those algal cells, post-mutagenesis, which exhibit the desired level of lutein production, with a reasonable prediction of success (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 Cordero et al. teaches that lutein is a primary carotenoid, required for the structure and function of the light-harvesting complexes in photosynthesis (pg. 1621, para. 5, Conclusions). Therefore, in order to select algal cells which maintain reduced levels of chlorophyll (which is involved in photosynthesis), one of ordinary skill in the art would have been motivated to have kept the production of lutein, which is also involved in photosynthesis, at a reduced level in those cells (e.g., 3 to 10mg/g).
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 65 is rejected under 35 U.S.C. §103 as being unpatentable over Brooks et al., as applied to claims 39-42, 47, 51-57 and 62-63 above, and further in view of Doucha et al. (J. Appl. Phycol. 2012, 24:35-43).
Claim 65 recites product-by-process language. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. However, the structure implied by the process steps should be considered when assessing patentability over the prior art where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product (MPEP 2113 (I)).
Regarding claim 65, Brooks et al. shows that the inoculum for each fermentor was Chlorella protothecoides (UTEX 250), prepared in two flask stages using the medium and temperature conditions of the fermentor inoculated. Three lab scale fermentors were held at 28°C for the duration of the experiment. Fermentation cultures were cultivated for 11 days (pg. 36, para. [0353]).
Brooks et al. does not show the specific temperature above 28°C [Claim 65].
Doucha et al. shows that the freshwater microalga Chlorella vulgaris was grown heterotrophically in fed-batch fermenters at 36°C (pg. 35, column 1, Abstract [nexus to Brooks et al.- grow Chlorella vulgaris heterotrophically]).
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 food grade microalgae product or flour comprising a homogenate of microalgae biomass comprising one or more modified wild-type strains of Chlorella vulgaris, in turn comprising a chlorophyll content in a range of 0.001 to 0.5 mg/g dry cell weight, as shown by Brooks et al., as applied to claims 39-42, 47, 51-57 and 62-63 above, by including a C. vulgaris strain that is grown above 28°C [Claim 65], as shown by Doucha et al., with a reasonable expectation of success, because Doucha et al. shows the propagation of C. vulgaris at 36°C, which is one of the Chlorella strains shown by Brooks et al. (MPEP 2143 (l)(G)). In addition, both Doucha et al. and Brooks et al. show growing the C. vulgaris strain heterotrophically (MPEP 2143 (l)(G)).
Even in the absence of Doucha et al., it would have been obvious to one of ordinary skill in the art of propagating modified Chlorella strains (incl. vulgaris and protothecoides) to have used routine optimization in order to have determined the optimal temperature (e.g., above 28°C, such as 29°C) to grow any particular strain of Chlorella, in view of the information that Brooks et al. propagates the cited Chlorella strain(s) at 28°C- but also depending on the purpose for propagating the strain; e.g., in order to optimize (or decrease) the production of a specific compound produced by the Chlorella strain (MPEP 2144.05 (ll)(A) and (lll)(A)).
One of ordinary skill in the art would have been motivated to have made that modification, because Doucha et al. teaches that high growth rate of algae takes place up to high densities at optimum culture temperature 35–37°C and pH 6–7.5, if nutrients and oxygen concentration are adequately maintained (pg. 36, column 1, para. 2). That is, increasing the C. vulgaris cultivation temperature to above 28oC would optimize the microalgal output by producing high density cultures which would be desired in order to mass produce the microalgae for use in food products or flour.
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.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the "right to exclude" granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP 2159. See MPEP 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP 706.07(e) and 714.13.
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Claims 39-40, 47-48 and 62 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 46-48 and 56-57 of copending Application No. 17/999,955 in view of Brooks et al. (Pub. No. US 2016/0324167 A1).
The claimed subject matter of instant Application No. 17/295,949 is:
Claim 39. A food grade microalgae product or flour comprising a homogenate of microalgae biomass. The microalgae comprises one or more modified wild-type strains of Chlorella vulgaris, each strain comprising a chlorophyll content in a range of 0.001 to 0.5 mg/g dry cell weight. The modified strain of Chlorella vulgaris has a white, cream, yellow or golden colour.
Claim 40. The modified strain of Chlorella vulgaris is a heterotroph.
Claim 47. The modified strain of Chlorella vulgaris has the chlorophyll content lower than a chlorophyll content of the wild-type strain of Chlorella vulgaris from which it is derived, when grown under the same conditions.
Claim 48. The reduced chlorophyll content is associated with at least one of chlorophyll a (α-chlorophyll) and/or chlorophyll b (β-chlorophyll) and collectively, the chlorophyll content is in a range of 0.001 to 0.5 mg/g dry cell weight.
Claim 62. The modified strain of Chlorella vulgaris is obtained by performing mutagenesis, or from a variation of the wild-type strain of Chlorella vulgaris, by performing mutagenesis.
The claimed subject matter of copending Application No. 17/999,955 is:
Claim 46. A modified strain of Chlorella vulgaris having a chlorophyll content in a range of 0.001 to 0.5 mg/g dry cell weight. 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 47. The modified strain of Chlorella vulgaris is a heterotroph.
Claim 48. The modified strain of Chlorella vulgaris is obtained from a wild-type strain of Chlorella vulgaris and/or a variation of the wild-type strain of Chlorella vulgaris by performing mutagenesis.
Claim 56. The modified strain of Chlorella vulgaris has the chlorophyll content lower than a chlorophyll content of the wild-type strain of Chlorella vulgaris from which it is derived, when grown under the same conditions.
Claim 57. The reduced chlorophyll content is associated with at least one of chlorophyll a (α-chlorophyll) and/or chlorophyll b (β-chlorophyll) and collectively, the chlorophyll content is in a range of 0.001 to 0.5 mg/g dry cell weight.
The claims of copending Application No. 17/999,955 do not show that: the one or more modified wild-type strains of Chlorella vulgaris are included in a food grade microalgae product or flour; and the modified strain of Chlorella vulgaris has a white, cream, yellow, or golden colour.
Brooks et al. shows compositions of microalgae-derived flour from multiple genera, species, and strains of edible microalgae. In one aspect, a microalgal flour comprising a homogenate of microalgal biomass is provided (pg. 1, para. [0009]-[0010]). 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] [200ppm = 0.2mg/g; 2ppm = 0.002 mg/g]). When grown in heterotrophic conditions where the carbon source is a fixed carbon source and in the absence of light, the normally green colored microalgae has a yellow color, is lacking or is significantly reduced in green pigmentation. Microalgae of reduced (or lacking in) green pigmentation can be advantageous as a food ingredient (pg. 18, para. [0199]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective date of the claimed invention to have modified the claims of copending Application No. 17/999,955, by including the modified strain of C. vulgaris in a food grade microalgae product or flour, the modified strain of C. vulgaris being yellow, as shown by Brooks et al., with a reasonable expectation of success, because Brooks et al. shows modified C. vulgaris strains which comprise a chlorophyll content of 0.001 to 0.5mg/g dry cell weight, which is the modified C. vulgaris strain recited in the claims of copending Application No. 17/999,955.
One of ordinary skill in the art would have been motivated to have made that modification because one could have modified the modified strain of C. vulgaris with the food product or flour and the yellow color with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection because the patentably distinct claims have not been patented.
Response to Arguments
Applicant’s arguments, pp. 7-10, filed on 20 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 claims 39 and 42 were amended, and new claims 62-67 were added.
1. Applicant remarks (pg. 7, para. 5) that claim 39 is herein amended to clarify embodiments reciting, in part, "food grade microalgae product or flour comprising a homogenate of microalgae biomass wherein the microalgae comprises one or more modified wild-type strains of Chlorella vulgaris each strain comprising a chlorophyll content in a range of 0.001 to 0.5 mg/g dry cell weight, wherein the modified strain of Chlorella vulgaris has a white, cream, yellow, or golden colour." Parks et al. is available as art after the filing date of the present application and therefore is not properly of use in the instant rejection including as motivation for making the substitution alleged by the Examiner.
However, in response to Applicant, the reference of Parks et al. was cited in the Non-Final Office Action mailed 18 September 2025 as an evidentiary reference, and, therefore, is not required to have a publication date prior to the instant effective filing date. See MPEP 2124. On the other hand, this argument is moot because Parks et al. is not cited in this Office Action.
2. Applicant remarks (pg. 8, lines 3-14) that Chlorella vulgaris, has been identified as a superfood and is not subject to Novel Food Regulation (EC), and is, therefore, considered safe to eat for both humans and animals both as a whole food and as an ingredient. This is in contrast to other related microalgae, specifically Chlorella sorokiniana and now Auxenochlorella (previously Chlorella) protothecoides, neither of which species appears in the novel foods catalogue nor do they appear on the China list or European list for approved cosmetic ingredients. One of skill in art would not have substituted Auxenochlorella protothecoides for strains of Chlorella vulgaris, to be modified reducing chlorophyll and generating a food grade microalgae product or flour.
However, in response to Applicant, the primary reference of Brooks et al. shows the incorporation of Chlorella protothecoides into a food product as high oil algal flakes (pg. 37, para. [0357], Example 4) and shows the absence of algal toxins in dried C. protothecoides biomass (pg. 37, para. [0359], Example 5). Therefore, although this specific Chlorella species does not appear on any official "approved" food list, Brooks et al. shows that it is edible and generally recognized as safe (GRAS). Brooks et al. shows various recipes in which algal flakes can be used, including as an egg replacer, and describes the benefits of including said algal flakes in a food product (e.g., yellow cake; pg. 42, para. [0398]).
Since Chlorella vulgaris has long been known to be an edible microalgae, as indicated by Applicant above, it would have been obvious to have either substituted the modified Chlorella protothecoides, exemplified by Brooks et al., with a modified Chlorella vulgaris, as taught by Brooks et al., or to have included the modified C. vulgaris, taught by Brooks et al., in a composition containing C. protothecoides, because both species of Chlorella are edible and can be mutagenized to produce strains that are low in chlorophyll content (e.g., in a range of 0.001 to 0.5mg/g DCW).
3. Applicant remarks (pg. 8, para. 1) that while Chlorella vulgaris and Auxenochlorella protothecoides may be "similar" based solely on open reading frames, A. protothecoides is unique that when exposed to glucose has the ability to "de-green" or "etiolize." In contrast, the Applicants disclose a stable modified microalgae, which is not possible with A. protothecoides, which loses and gains green pigment depending on growing conditions. Starting with Chlorella vulgaris resulted in a modified strain of Chlorella vulgaris with a stable phenotype (e.g., a lack of green colour) whereas starting A. protothecoides would provide no expectation success given the variable phenotype (e.g., a lack of green colour) depending on growing conditions.
However, in response to Applicant, Brooks et al. also teaches that the algae, in general, can be cultured heterotrophically (i.e., in presence of glucose & absence of light) (pg. 2, para. [0012]; and pg. 3, para. [0024]). Doucha et al. (cited above in the 103 rejection) shows the heterotrophic propagation of C. vulgaris. Therefore, modified strains of C. vulgaris and C. protothecoides can be stably generated.
4. Applicant remarks (pg. 9), with regard to the rejections of the dependent claims, that some of the cited claims have been canceled, and that none of the secondary references (e.g., Cordero et al. and Doucha et al.) remedy the deficiency of Brooks et al. and Canada.
However, in response to Applicant, the references of Canada and Shi et al. are not cited in this Office Action. In addition, the references of Cordero et al. and Doucha et al. were cited to address the limitations which were previously cited in claim 49, and which are now recited in new claim 65, respectively. Claim 39 is rejected by Brooks et al. with no deficiencies.
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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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/SMP/Examiner, Art Unit 1657