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
The amendment of 02/20/2026 has been entered. Claims 1-3 and 5-17 are pending (claim set as filed on 02/20/2026). Claim 14 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election of invention Group 1, drawn to a process for co-fermentation of at least two fermentation products, of the primary fermentation product species ‘vitamin B2’, of the host cell species ‘Bacillus’, and of the ingredient species ‘encapsulation agents’ was made without traverse in the reply filed on 08/05/2025.
Claims 1-3 and 5-17 are currently under examination and were examined on their merits.
Information Disclosure Statement
The Information Disclosure Statements (IDS) filed on 02/19/2026 has been received and considered.
Withdrawn Rejections
The rejections of claims 1-2, 6, 9-10, and 12 under 35 U.S.C. 102(a) set forth in the previous Office action are withdrawn in light of the amendment filed on 02/20/2026, which narrowed the scope of base claim 1.
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.
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 7-8 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.
Claim 7 recites “the extracted secondary fermentation product” which is indefinite for lacking antecedent basis because ‘extracted secondary fermentation product' is not recited within the claim or in claim 1 from which claim 7 depends.
Claim 7 further recites “10 ng or less DNA per g of per g of vitamin K2”, which renders the claim indefinite since it is unclear if there is a typographical error in the claim causing duplication of “per g of”, or if the recited DNA amount refers to an additional component that has been omitted.
Claim 8 recites “the concentration of colony forming units” which is indefinite for lacking antecedent basis because ‘concentration of colony forming units’ is not recited within the claim or in claim 5 from which claim 8 depends.
One of ordinary skill in the art would not be able to determine the metes and bounds of claims 7 and 8, and thus, could not clearly determine how to avoid infringement of the claims.
In the interest of compact prosecution, claims 7and 8 are interpreted to the broadest embodiment claimed.
Claim Rejections - 35 USC § 112 (d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 10 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 10 recites “wherein the primary fermentation product is a water-soluble vitamin” (line 4), which broadens the claim limitation “wherein the primary fermentation product is a water-soluble vitamin selected from the group consisting of vitamin B2, BS, B6, B 12, B3, B 1, and B7” recited in base claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 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, 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.
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 factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 1-3, 9 and 15 are newly rejected as necessitated by amendment under 35 U.S.C. 103 as being unpatentable over Wang et al. (“Coproduction of menaquinone-7 and nattokinase by Bacillus subtilis using soybean curd residue as a renewable substrate combined with a dissolved oxygen control strategy”, published on 09/14/2018, Annals of Microbiology (2018), Vol. 68, pages 655–665), hereinafter ‘Wang’, in view of Hohmann et al. (US 6,322,995 B1, published on 11/27/2001), hereinafter ‘Hohmann’.
Wang’s general disclosure relates to the coproduction of menaquinone MK-7 and nattokinase by Bacillus subtilis (see entire document, including abstract).
Regarding claim 1, please note the election of the primary fermentation products species ‘vitamin B2’ under Claim Status above.
Pertaining to a process for co-fermentation, Wang teaches a process for co-fermentation of two fermentation products in a suitable host cell capable of co-production of a primary fermentation product and a secondary fermentation product (“Menaquinones, also named vitamin K2”, “menaquinone-7 (MK-7)”, “nattokinase (NK)” “production of MK-7 and NK by Bacillus subtilis”; see entire document including abstract and page 655, left column, paragraph 1), wherein the primary fermentation product is a water-soluble fermentation product (“water-soluble nature of NK”; page 656, left column, paragraph 2) and the secondary fermentation product is fat-soluble MK-7 (“fat-soluble nature of MK-7”; page 656, left column, paragraph 2; note, MK-7 is a vitamin K2 isoform).
Regarding claims 2 and 3, please note the election of the species ‘vitamin B2’ under Claim Status above.
Pertaining to the primary fermentation product, Wang teaches wherein the primary fermentation product is a water-soluble fermentation product (“water-soluble nature of NK”; page 656, left column, paragraph 2; see abstract).
Regarding claim 9, please note the elected host cell species ‘Bacillus’ under Claim Status above.
Pertaining to the host cell, Wang teaches wherein the host cell is the elected Bacillus (“Production of MK-7 and NK via fermentation …Pure cultured cells of Bacillus subtilis BN-P15-11-1 were inoculated”; page 657, left column, paragraphs 3-4).
Regarding claim 15, pertaining to Bacillus, Wang teaches wherein the Bacillus is Bacillus subtilis (see abstract).
In addition, Wang discloses wherein “[t]he production of two or more valuable products using a single production process is not only economically attractive but also produces less wastes and potentially decreases pollution.” (page 656, right column, paragraph 1).
Wang does not teach, wherein the primary fermentation product is a water-soluble vitamin selected from the group consisting of vitamins B2, B5, B6, B12, B3, B1, and B7 (instant claim 1), wherein the primary fermentation product is selected from B2, B5, B6, and B12 (instant claim 2), and wherein and wherein the primary fermentation product is selected from vitamin B2 (instant claim 3).
Hohmann’s general disclosure relates to a “recombinant bacterium for the over-production of riboflavin” (see entire document, including abstract).
Regarding claims 1-3, pertaining to the primary fermentation product, Hohmann teaches the fermentation product vitamin B2 (“Riboflavin (vitamin B2)”; “process for the production of riboflavin characterized therein that a recombinant bacterium as described above is grown under suitable growth conditions and the riboflavin secreted into the medium is isolated by methods known in the art”; column 3, lines 35-40).
In addition, Hohmann teaches wherein the host cell for producing vitamin B2 is Bacillus subtilis (“the present invention to provide a recombinant bacterium as described above which is E. coli or Bacillus, preferably Bacillus subtilis”; column 3, lines 31-33), that “riboflavin is essential to basic metabolism”, and that “[in] higher animals, insufficient riboflavin can cause loss of hair, inflammation of the skin, vision deterioration, and growth failure.” (column 1, lines 8-11).
While Wang does not teach wherein the primary fermentation product is a water-soluble vitamin selected from the group consisting of vitamins B2, B5, B6, B12, B3, B1, and B7 (instant claim 1), wherein the primary fermentation product is selected from B2, B5, B6, and B12 (instant claim 2), and wherein and wherein the primary fermentation product is selected from vitamin B2 (instant claim 3), 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 Wang’s process with Hohmann’s fermentation product vitamin B2, in order to create a process wherein the primary fermentation product is the water-soluble vitamin B2. One would have been motivated to do so since vitamin B2 is essential to basic metabolism (Hohmann; column 1, lines 8-11), and because the production of two valuable products using a single production process is economically attractive, produces less wastes, and potentially decreases pollution (Wang page 656, right column, paragraph 1). A skilled artisan would have reasonably expected success in combining Wang’s and Hohmann’s teachings since both references are directed to using Bacillus subtilis as a host cell.
Claims 1, 5, 12, 16 and 17 are newly rejected as necessitated by amendment under 35 U.S.C. 103 as being unpatentable over Wang et al. (“Coproduction of menaquinone-7 and nattokinase by Bacillus subtilis using soybean curd residue as a renewable substrate combined with a dissolved oxygen control strategy”, published on 09/14/2018, Annals of Microbiology (2018), Vol. 68, pages 655–665), hereinafter ‘Wang’, in view of Hohmann et al. (US 6,322,995 B1, published on 11/27/2001), hereinafter ‘Hohmann’, and in view of Fang et al. (“A simple and efficient preparative procedure for menaquinone-7 from Bacillus subtilis (natto) using two-stage extraction followed by microporous resins”, published on 05/05/2019, Process Biochemistry, Vol. 83 (2019), pages 183–188), hereinafter ‘Fang’.
Wang’s and Hohmann’s teachings have been set forth above.
Regarding claims 5, 12, 16 and 17, pertaining to extraction of the secondary fermentation product, Wang teaches extracting the secondary fermentation product from the fermentation medium (“MK-7 was extracted from the fermentation medium”; page 657, left column, paragraph 6).
Modified Wang does not expressly teach wherein the secondary fermentation product is extracted from a biomass generated during the fermentative production of the primary fermentation product (instant claim 5), wherein the process according to claim 1 comprises the extraction of vitamin K2 as secondary fermentation product in an aqueous solution with at least about 80% (wt/wt) ethanol (instant claim 12), wherein the process according to claim 1 comprises the extraction of vitamin K2 as secondary fermentation product in a hexane-free solvent (instant claim 16), wherein the extraction of the secondary fermentation product is performed in an aqueous solution with at least about 80% (wt/wt) ethanol (instant claim 17).
Fang’s general disclosure is related to “a simple and efficient procedure for preparation of MK-7 from Bacillus subtilis (natto) fermentation” (see entire document, including page 184, left column, paragraph 4; note, MK-7 is a vitamin K2 isoform).
Regarding claim 5, pertaining to extracting the secondary fermentation product, Fang teaches wherein the fermentation product menaquinone-7 (MK-7) is extracted from a biomass generated during fermentation (“MK-7 within the cells was extracted using a 25 ml ethanol.”; page 183, left column, paragraph 1; page 184, right column, paragraphs 2 and 7; see abstract).
Regarding claims 12, 16 and 17, pertaining to extracting the secondary fermentation product, Fang teaches extracting the MK-7 in ethanol (“MK-7 within the cells was extracted using a 25 ml ethanol.”; page 183, left column, paragraph 1; page 184, right column, paragraphs 2 and 7; see abstract).
In addition, Fang teaches recrystallizing vitamin K2 in 95% ethanol (see abstract). It is noted that 95% ethanol reads on aqueous solution with 95% ethanol.
While modified Wang does not teach wherein the secondary fermentation product is extracted from a biomass generated during the fermentative production of the primary fermentation product (instant claim 5), wherein the process comprises the extraction of vitamin K2 as secondary fermentation product in an aqueous solution with at least about 80% (wt/wt) ethanol (instant claim 12), wherein the process comprises the extraction of vitamin K2 as secondary fermentation product in a hexane-free solvent (instant claim 16), wherein the extraction of the secondary fermentation product is performed in an aqueous solution with at least about 80% (wt/wt) ethanol (instant claim 17), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have combined modified Wang’s process with Fang’s extraction method, in order to create a process wherein the secondary fermentation product MK-7 (vitamin K2 isoform) is extracted from a biomass generated during the fermentative production of the primary fermentation product and wherein the extraction of the secondary fermentation product MK-7 is performed in ethanol. One would have been motivated to do so in order to maximize the amount of recovered secondary fermentation product MK-7.
While modified Wang does not teach wherein the extraction of MK-7 is performed in an aqueous solution with at least about 80% (wt/wt) ethanol, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined modified Wang’s process with Fang’s teachings on 95% ethanol used for recrystallization of MK-7, to create a process wherein the extraction of MK-7 is performed in an aqueous solution with 95% (wt/wt) ethanol. On e would have been motivated to do so to maximize the amount of recovered secondary fermentation product menaquinone-7.
A skilled artisan would have reasonably expected success in combining Wang’s process and Fang’s extraction method, since both references are directed to the fermentation product menaquinone-7 (MK-7) produced by Bacillus subtilis.
Claims 1 and 6 are newly rejected as necessitated by amendment under 35 U.S.C. 103 as being unpatentable over Wang et al. (“Coproduction of menaquinone-7 and nattokinase by Bacillus subtilis using soybean curd residue as a renewable substrate combined with a dissolved oxygen control strategy”, published on 09/14/2018, Annals of Microbiology (2018), Vol. 68, pages 655–665), hereinafter ‘Wang’, in view of Hohmann et al. (US 6,322,995 B1, published on 11/27/2001), hereinafter ‘Hohmann’, and in view of Sato et al. (“Production of Menaquinone (Vitamin K2)-7 by Bacillus subtilis”, published in 2001, Journal of Bioscience and Bioengineering, Vol. 91, Issue 1, pages 16-20),hereinafter ‘Sato’.
Wang’s and Hohmann’s teachings have been set forth above.
Regarding claim 6, pertaining to extraction of vitamin K2, Wang discloses extracting vitamin K2 from the fermentation medium (“MK-7 was extracted from the fermentation medium”; page 657, left column, paragraph 6).
In addition, Wang teaches wherein menaquinone-7 (MK-7) reduces vascular calcification, and that MK-7 may be a potential therapy for Alzheimer’s and Parkinson’s disease (see abstract).
Modified Wang does not teach wherein the process according to claim 1 comprises extraction of the secondary fermentation product with a percentage of at least about 80% (wt/wt) of MK-7 isoform (instant claim 6).
Sato’s general disclosure relates to “suitable conditions for the production of MK by a unique mutant of a natto-producing B. subtilis that exhibited decreased production of MK-6 (page 16, right column, paragraph 1).
Regarding claim 6, pertaining to the MK-7 content of recovered vitamin K2, Sato teaches extraction of the fermentation product Vitamin K2 (menaquinones) (page 16, left column, paragraph 5), and wherein the MK-7 content of recovered vitamin K2 from a fermentation process is 96.9 % (page 16, left column, paragraph 1; page 17, left column, paragraph 5; see Table 1 on page 17).
While modified Wang does not teach wherein the process according to claim 1 comprises extraction of the secondary fermentation product with a percentage of at least about 80% (wt/wt) of MK-7 isoform (instant claim 6), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have combined modified Wang’s process with Sato’s teachings on MK-7 content in vitamin K2, in order to have created a process wherein the process according to claim 1 comprises extraction of the secondary fermentation product with a percentage of 96.9 % (wt/wt) of MK-7 isoform. One would have been motivated to do so in order to maximize the amount of recovered vitamin K2 having a high content of MK-7, since MK-7 reduces vascular calcification and may be used as a potential therapy for Alzheimer’s and Parkinson’s disease (see Wang, abstract). A skilled artisan would have reasonably expected success in combining modified Wang’s and Sato’s teachings, since Wang and Sato are both directed to the fermentation product menaquinone-7 (MK-7) produced by Bacillus subtilis.
Claims 1 and 7 are newly rejected as necessitated by amendment under 35 U.S.C. 103 as being unpatentable over Wang et al. (“Coproduction of menaquinone-7 and nattokinase by Bacillus subtilis using soybean curd residue as a renewable substrate combined with a dissolved oxygen control strategy”, published on 09/14/2018, Annals of Microbiology (2018), Vol. 68, pages 655–665), hereinafter ‘Wang’, in view of Hohmann et al. (US 6,322,995 B1, published on 11/27/2001), hereinafter ‘Hohmann’, and in view of Mehta et al. (“Performance Characteristics of Host-Cell DNA Quantification Methods”, published in Oct 2007, BioProcess International, Vol. 5, No. 9, pages 44-58), hereinafter ‘Mehta’.
Wang’s and Hohmann’s teachings have been set forth above.
Regarding claim 7, please note the 112b rejection above.
Pertaining to the extracted secondary fermentation product, Wang discloses extracting the secondary fermentation product vitamin K2 from the fermentation medium (“MK-7 was extracted from the fermentation medium”; page 657, left column, paragraph 6).
Modified Wang does not teach wherein the concentration of DNA in the extracted secondary fermentation product is about 10 ng or less DNA per g of vitamin K2 (instant claim 7).
Mehta’s general disclosure is related to “current methods available for host-cell DNA (HCD) determination”, and the “growing need in industry for detailed information on their performance characteristics.” (see entire document, including page 44, left column, paragraph 2 - page 44, center column, paragraph 1).
Regarding claim 7, pertaining to the concentration of DNA in the extracted secondary fermentation product, Mehta teaches wherein host cell DNA can be measured by PCR (page 46, left column, paragraph 1), and further discloses: “Biopharmaceutical products are produced by fermentation using either microbial or eukaryotic cells grown in complex media. Crude preparations of drug substance from fermentation contain a number of biological molecules derived from the host expression cells, which are present as impurities. These impurities can be present as HCD, among other materials, and they may be copurified with the drug substance during product purification. It is known that certain host-cell–derived biological molecules may have toxic activity. Therefore, removal of the host cell materials is desirable to prevent potential adverse effects (2).” (page 44, center column, paragraph 2 - page 44, right column, paragraph 1; note: HCD, host-cell DNA).
While modified Wang does not teach the concentration of DNA in the extracted secondary fermentation product is about 10 ng or less DNA per g of vitamin K2 (instant claim 7), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined modified Wang’s process for producing vitamin K2 with Mehta’s teachings on quantifying host-cell DNA and on possible adverse effects of residual host cell DNA in biological products, in order to have created a process wherein the concentration of DNA in the extracted secondary fermentation product is minimal. One would have been motivated to do so in order to reduce possible adverse effects caused by host-cell DNA (Mehta, page 44, center column, paragraph 2 - page 44, right column, paragraph 1). A skilled artisan would have reasonably expected success in combining modified Wang’s and Mehta’s teachings, since both are directed to fermentation products.
While modified Wang does not teach wherein the concentration of DNA in the extracted secondary fermentation product is about 10 ng or less DNA per g of vitamin K2 (instant claim 7), the recited range would have been within the realm of routine experimentation of a skilled artisan. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to identify concentrations of host cell DNA that do not cause any adverse effects as taught by Mehta (page 44, center column, paragraph 2 – page 44, right column, paragraph 1). Further, one would expect success since Mehta’s teachings are directed to DNA derived from different host cell types (page 44, center column, paragraph 2 – page 44, right column, paragraph 1), and therefore, manipulation of the DNA concentration would be within the purview of an artisan. Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA1955). See MPEP § 2144.05 part II A
Claims 1, 5 and 8 are newly rejected as necessitated by amendment under 35 U.S.C. 103 as being unpatentable over Wang et al. (“Coproduction of menaquinone-7 and nattokinase by Bacillus subtilis using soybean curd residue as a renewable substrate combined with a dissolved oxygen control strategy”, published on 09/14/2018, Annals of Microbiology (2018), Vol. 68, pages 655–665), hereinafter ‘Wang’, in view of Hohmann et al. (US 6,322,995 B1, published on 11/27/2001), hereinafter ‘Hohmann’, in view of Fang et al. (“A simple and efficient preparative procedure for menaquinone-7 from Bacillus subtilis (natto) using two-stage extraction followed by microporous resins”, published on 05/05/2019, Process Biochemistry, Vol. 83 (2019), pages 183–188), hereinafter ‘Fang’, and in view of Pratbernou et al. (US 2014/0017383 A1, published on 01/16/2014), hereinafter ‘Pratbernou’.
Wang’s, Hohmann’s and Fang’s teachings have been set forth above.
Fang further teaches wherein the vitamin K2 isoform MK-7 has nutraceutical and pharmacological properties (see abstract).
Modified Wang does not teach wherein the concentration of colony forming units in the extracted secondary fermentation product is less than about 1 colony forming unit (CFU) production strain per 1 g of vitamin K2 (instant claim 8).
Pratbernou’s general disclosure relates to “to shelf-stable edible products” (see entire document, including paragraph [0001]).
Regarding claim 8, please note the 112(b) rejection above.
Pertaining to the secondary fermentation product, Pratbernou teaches wherein a product is devoid of bacteria if it contains less than 1 cfu/g of bacteria (“The edible product of the invention is devoid of bacteria if it contains less than 10 cfu/g of bacteria or less than 1 cfu/g of bacteria.”; paragraph [0061]).
In addition, Pratbernou teaches wherein bacteria can cause spoilage of edible products (“Each microorganism present in a product can be a problem, because it can spoil the food product, or create a health damages.”; paragraph [0009]).
While modified Wang does not teach wherein the concentration of colony forming units in the extracted secondary fermentation product is less than about 1 colony forming unit (CFU) production strain per 1 g of vitamin K2 (instant claim 8), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined modified Wang’s process with Pratbernou’s teachings on bacterial contamination of edible products, in order to have created a process wherein the concentration of colony forming units in the extracted secondary fermentation product is less than about 1 colony forming unit (CFU) production strain per 1 g of vitamin K2. One would have been motivated to do so in order to protect the secondary fermentation product vitamin K2 from spoilage and to prevent health damages (see Pratbernou, paragraph [0009]). A skilled artisan would have reasonably expected success in combining modifies Wang’s and Pratebernou’s teachings since both references are directed to edible products.
Claims 1 and 11 are newly rejected as necessitated by amendment under 35 U.S.C. 103 as being unpatentable over Wang et al. (“Coproduction of menaquinone-7 and nattokinase by Bacillus subtilis using soybean curd residue as a renewable substrate combined with a dissolved oxygen control strategy”, published on 09/14/2018, Annals of Microbiology (2018), Vol. 68, pages 655–665), hereinafter ‘Wang’, in view of Hohmann et al. (US 6,322,995 B1, published on 11/27/2001), hereinafter ‘Hohmann’, in view of Fang et al. (“A simple and efficient preparative procedure for menaquinone-7 from Bacillus subtilis (natto) using two-stage extraction followed by microporous resins”, published on 05/05/2019, Process Biochemistry, Vol. 83 (2019), pages 183–188), hereinafter ‘Fang’, in view of Sato et al. (“Production of Menaquinone (Vitamin K2)-7 by Bacillus subtilis”, published in 2001, Journal of Bioscience and Bioengineering, Vol. 91, Issue 1, pages 16-20),hereinafter ‘Sato’, and in view of Mehta et al. (“Performance Characteristics of Host-Cell DNA Quantification Methods”, published in Oct 2007, BioProcess International, Vol. 5, No. 9, pages 44-58), hereinafter ‘Mehta’.
Wang’s and Hohmann’s teachings have been set forth above.
Regarding claim 11, pertaining to the production of bio-based vitamin K2, Wang teaches the production of bio-based vitamin K2 according to claim 1 (“production of MK-7 and NK by Bacillus subtilis”; page 655, left column, paragraph 1; page 656 left column, paragraph 2; see abstract).
In addition, Wang discloses extracting vitamin K2 from the fermentation medium (“MK-7 was extracted from the fermentation medium”; page 657, left column, paragraph 6), and that fermentation was conducted with Bacillus subtilis (see abstract).
Regarding claim 11, pertaining to recombinant DNA, Hohmann teaches wherein the Bacillus subtilis comprises recombinant DNA (see abstract).
Modified Wang does not expressly teach the process comprising a step of recovery/extraction from genetically modified biomass (instant claim 11), and does not teach wherein the recovered vitamin K2 has a content of MK-7 in the range of at least about 80% (wt/wt) and maximal content of about 10 ng recombinant DNA per g vitamin K2 as measured by PCR (instant claim 11).
Fang’s general disclosure is related to “a simple and efficient procedure for preparation of MK-7 from Bacillus subtilis (natto) fermentation” (see entire document, including page 184, left column, paragraph 4).
Regarding claim 11, pertaining to extracting vitamin K2, Fang teaches wherein vitamin K2 is extracted from the biomass generated during fermentation (“Using ethanol to extract menaquinone-7 twice directly from the crude cells after fermentation produced a menaquinone-7 yield of 1.47mg/g.”; page 183, left column, paragraph 1; page 184, right column, paragraphs 2 and 7; see abstract).
In addition, Fang teaches wherein “MK-7 is considered the most effective form of VK2 in the human body, because it has a much longer half-life in human blood [2]” (page 183, left column, paragraph 1), and that MK-7 has many positive effects on health (page 183, left column, paragraph 2).
Sato’s general disclosure relates to “suitable conditions for the production of MK by a unique mutant of a natto-producing B. subtilis that exhibited decreased production of MK-6 (page 16, right column, paragraph 1).
Regarding claim 11, pertaining to the MK-7 content of recovered vitamin K2, Sato teaches wherein the MK-7 content of recovered vitamin K2 from a fermentation process is 96.9 % (page 16, left column, paragraph 1; page 17, left column, paragraph 5; see Table 1 on page 17).
Mehta’s general disclosure is related to “current methods available for host-cell DNA (HCD) determination”, and the “growing need in industry for detailed information on their performance characteristics.” (see entire document, including page 44, left column, paragraph 2 - page 44, center column, paragraph 1).
Regarding claim 11, pertaining to the DNA content of the recovered vitamin K2, Mehta teaches wherein host cell DNA can be measured by PCR (page 46, left column, paragraph 1), and further discloses: “Biopharmaceutical products are produced by fermentation using either microbial or eukaryotic cells grown in complex media. Crude preparations of drug substance from fermentation contain a number of biological molecules derived from the host expression cells, which are present as impurities. These impurities can be present as HCD, among other materials, and they may be copurified with the drug substance during product purification. It is known that certain host-cell–derived biological molecules may have toxic activity. Therefore, removal of the host cell materials is desirable to prevent potential adverse effects (2).” (page 44, center column, paragraph 2 - page 44, right column, paragraph 1; note: HCD, host-cell DNA).
While modified Wang does not expressly teach the process comprising a step of recovery/extraction from genetically modified biomass, and further does not teach wherein the recovered vitamin K2 has a content of MK-7 in the range of at least about 80% (wt/wt) (instant claim 11), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have combined modified Wang’s process with Fang’s extraction method and Sato’s teachings on MK-7 content in vitamin K2, in order to have created a process for production of bio-based vitamin K2 comprising a step of recovery/extraction from genetically modified biomass, wherein the recovered vitamin K2 has a content of MK-7 of 96.9 % (wt/wt). One would have been motivated to do so in order to maximize the amount of recovered vitamin K2 having a high content of MK-7, since MK-7 is considered the most effective form of VK2 and has many positive health effects (Fang, page 183, left column, paragraph 2). A skilled artisan would have reasonably expected success in combining modified Wang’s, Fang’s, and Sato’s teachings, since all references are directed to the fermentation product menaquinone-7 (MK-7) produced by Bacillus subtilis.
While modified Wang does not teach wherein the recovered vitamin K2 has a maximal content of about 10 ng of recombinant DNA per gram vitamin K2 as measured by PCR (instant claim 11), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined modified Wang’s process for producing vitamin K2 with Hohmann’s teachings on recombinant DNA comprised by the production strain and with Mehta’s teachings on quantifying host-cell DNA by PCR and on possible adverse effects of residual host cell DNA in biological products, in order to have created a process wherein the recovered vitamin K2 has a minimal content of recombinant DNA per g vitamin K2 as measured by PCR. One would have been motivated to do so in order to reduce possible adverse effects caused by host-cell DNA (see Mehta above). A skilled artisan would have reasonably expected success in combining modified Wang’s and Mehta’s teachings, since both are directed to fermentation products.
While modified Wang does not teach wherein the recovered vitamin K2 has a maximal content of 10 ng of recombinant DNA per g vitamin K2, the recited range would have been within the realm of routine experimentation of a skilled artisan. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to identify concentrations of host cell DNA that do not cause any adverse effects as taught by Mehta (see above). Further, one would expect success since Mehta’s teachings are directed to DNA derived from different host cell types (see above), and therefore, manipulation of the DNA concentration would be within the purview of an artisan. Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA1955). See MPEP § 2144.05 part II A.
Claims 1-3, 9-10, and 15 are newly rejected as necessitated by amendment under 35 U.S.C. 103 as being unpatentable over Takaoka (US 2001/046697 A1, published on 11/29/2001), hereinafter ‘Takaoka’, in view of Hohman et al. (US 6,322,995 B1, published on 11/27/2001), hereinafter ‘Hohmann’, as evidenced by Wang et al. (“Coproduction of menaquinone-7 and nattokinase by Bacillus subtilis using soybean curd residue as a renewable substrate combined with a dissolved oxygen control strategy”, published on 09/14/2018, Annals of Microbiology (2018), Vol. 68, pages 655–665), hereinafter ‘Wang’.
Takaoka’s general disclosure relates to a “food product containing a thrombolytic enzyme, nattokinase, but containing little or none of a blood coagulation factor, Vitamin K2.” (see entire document, including paragraph [0002]).
Regarding claim 1, please note the election of the primary fermentation products species ‘vitamin B2’ under Claim Status above.
Pertaining to a process for co-fermentation, Takaoka teaches a process for co-fermentation of at least two fermentation products in a suitable host cell capable of co-production of a primary fermentation product and a secondary fermentation product (“The culture medium obtained (cultured medium) contained 470 FU/ml of nattokinase and 55 µg of vitamin K2 per gram of the cultured medium”; paragraphs [0057]-[0058]), wherein the primary fermentation product is water-soluble (“nattokinase”; paragraph [0058]; note: nattokinase is water-soluble, as evidenced by Wang (“water-soluble nature of NK”, “nattokinase (NK)”; see page 656, left column, paragraph 2, and abstract); and the secondary fermentation product is fat-soluble vitamin K2 (“fat-soluble vitamin K2”; paragraph [0009]).
Regarding claims 2 and 3, please note the election of the species ‘vitamin B2’ under Claim Status above.
Pertaining to the primary fermentation product, Takaoka teaches wherein the primary fermentation product is water-soluble (“nattokinase”; paragraph [0058]; note: nattokinase is water-soluble, as evidenced by Wang (“water-soluble nature of NK”, “nattokinase (NK)”; see page 656, left column, paragraph 2, and abstract).
Regarding claim 9, please note the elected host cell species ‘Bacillus’ under Claim Status above.
Pertaining to the host cell, Takaoka teaches wherein the host cell is Bacillus (“Bacillus natto”; paragraph [0057]).
Regarding claim 10, please note the 112(d) rejection above.
Pertaining to the process, Takaoka teaches wherein the process comprises the steps of:
(a) cultivation of the host cell under suitable conditions and in a suitable culture medium suitable for production of the primary fermentation product (“The culture medium obtained (cultured medium) contained 470 FU/ml of nattokinase and 55 µg of vitamin K2 per gram of the cultured medium”; paragraphs [0057]-[0058]),
(b) isolation of the primary fermentation product from step ( a) from the production stream (“Bacillus natto culture extract and its powder having a high level of nattokinase activity and 0.1 lug or less of Vitamin K2/g dry weight can be obtained according to the present invention”; paragraphs [0027], [0029]-[0031], [0062], see claim 2 and Examples 1-3 in paragraphs [0059]-[0062]),
(c) recovery of the secondary fermentation product, wherein the secondary fermentation product is vitamin K2 (“a crude product containing vitamin K2 can be obtained by extracting it from the filtration residue in the chitosan treatment with an organic solvent”; see paragraph [0033] and Example 4 in paragraph [0065]).
Regarding claim 15, pertaining to the Bacillus, Takaoka teaches wherein Bacillus is Bacillus subtilis natto (see abstract and paragraph [0023]).
Takaoka does not teach wherein the primary fermentation product is a water-soluble vitamin selected from the group consisting of vitamins B2, B5, B6, B12, B3, B1, and B7 (instant claim 1), wherein the primary fermentation product is selected from B2, B5, B6, and B12 (instant claim 2), wherein the primary fermentation product is selected from vitamin B2 (instant claims 3 and 10).
Hohmann’s general disclosure relates to a “recombinant bacterium for the over-production of riboflavin” (see entire document, including abstract).
Regarding claims 1-3 and 10 pertaining to the primary fermentation product, Hohmann teaches the fermentation product vitamin B2 (“Riboflavin (vitamin B2)”; “process for the production of riboflavin characterized therein that a recombinant bacterium as described above is grown under suitable growth conditions and the riboflavin secreted into the medium is isolated by methods known in the art”; column 3, lines 35-40).
In addition, Hohmann teaches wherein the host cell for producing vitamin B2 is Bacillus subtilis (“the present invention to provide a recombinant bacterium as described above which is E. coli or Bacillus, preferably Bacillus subtilis”; column 3, lines 31-33), that “riboflavin is essential to basic metabolism”, and that “[in] higher animals, insufficient riboflavin can cause loss of hair, inflammation of the skin, vision deterioration, and growth failure.” (column 1, lines 8-11).
While Takaoka does not teach wherein the primary fermentation product is a water-soluble vitamin selected from the group consisting of vitamins B2, B5, B6, B12, B3, B1, and B7 (instant claim 1), wherein the primary fermentation product is selected from B2, B5, B6, and B12 (instant claim 2), and wherein the primary fermentation product is selected from vitamin B2 (instant claims 3 and 10), 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 Wang’s process with Hohmann’s fermentation product vitamin B2, in order to create a process, wherein the primary fermentation product is vitamin B2. One would have been motivated to produce vitamin B2 since vitamin B2 is essential to basic metabolism and has beneficial health effects (column1, lines 8-11). A skilled artisan would have reasonably expected success in combining Takaoka’s and Hohmann’s teachings since both references are directed to using Bacillus subtilis as a host cell, and since both, Takaoka’s nattokinase and Hohmann’s vitamin B2, are water-soluble fermentation products.
Claims 1 and 7 are newly rejected as necessitated by amendment under 35 U.S.C. 103 as being unpatentable over Takaoka (US 2001/046697 A1, published on 11/29/2001), hereinafter ‘Takaoka’, in view of Hohman et al. (US 6,322,995 B1, published on 11/27/2001), hereinafter ‘Hohmann’, as evidenced by Wang et al. (“Coproduction of menaquinone-7 and nattokinase by Bacillus subtilis using soybean curd residue as a renewable substrate combined with a dissolved oxygen control strategy”, published on 09/14/2018, Annals of Microbiology (2018), Vol. 68, pages 655–665), hereinafter ‘Wang’, in view of Mehta et al. (“Performance Characteristics of Host-Cell DNA Quantification Methods”, published in Oct 2007, BioProcess International, Vol. 5, No. 9, pages 44-58), hereinafter ‘Mehta’.
Takaoka’s and Hohman’s teachings have been set forth above.
Regarding claim 7, please note the 112(b) rejection above.
Pertaining to the secondary fermentation product, Takaoka teaches extraction of the secondary fermentation product vitamin K2 (“a crude product containing vitamin K2 can be obtained by extracting it from the filtration residue in the chitosan treatment with an organic solvent”; see paragraph [0033] and Example 4 in paragraph [0065]).
Modified Takaoka does not teach wherein the concentration of DNA in the extracted secondary fermentation product is about 10 ng or less DNA per g of vitamin K2 (instant claim 7).
Mehta’s general disclosure is related to “current methods available for host-cell DNA (HCD) determination”, and the “growing need in industry for detailed information on their performance characteristics.” (see entire document, including page 44, left column, paragraph 2 - page 44, center column, paragraph 1).
Regarding claim 7, pertaining to the DNA content of the secondary fermentation product, Mehta discloses: “Biopharmaceutical products are produced by fermentation using either microbial or eukaryotic cells grown in complex media. Crude preparations of drug substance from fermentation contain a number of biological molecules derived from the host expression cells, which are present as impurities. These impurities can be present as HCD, among other materials, and they may be copurified with the drug substance during product purification. It is known that certain host-cell–derived biological molecules may have toxic activity. Therefore, removal of the host cell materials is desirable to prevent potential adverse effects (2).” (page 44, center column, paragraph 2 – page 44, right column, paragraph 1; note: HCD, host-cell DNA). Mehta further teaches wherein the “FDA requirements state an upper limit of 100 pg per therapeutic dose (3) or up to 10 ng/dose in the case of some biopharmaceuticals requiring large doses” (page 44, right column, paragraph 1).
While modified Takaoka does not teach does not teach wherein the concentration of DNA in the extracted secondary fermentation product is about 10 ng or less DNA per g of vitamin K2 (instant claim 7), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined Takaoka’s process for producing the secondary fermentation product vitamin K2 with Mehta’s teachings on possible adverse effects of residual host cell DNA in biological products, in order to create a process does not teach wherein the concentration of DNA in the extracted secondary fermentation product is about 10 ng or less DNA per g of vitamin K2. One would have been motivated to do so in order to reduce possible adverse effects caused by host cell DNA (Mehta, page 44, center column, paragraph 2 - page 44, right column, paragraph 1). A skilled artisan would have reasonably expected success in combining Takaoka’s and Mehta’s teachings, since both are directed to fermentation products.
While modified Takaoka does not wherein the concentration of DNA in the extracted secondary fermentation product is about 10 ng or less DNA per g of vitamin K2, the recited range would have been within the realm of routine experimentation of a skilled artisan, since Mehta teaches adverse effects of host cell DNA (Mehta, page 44, center column, paragraph 2 - page 44, right column, paragraph 1). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to identify the concentration range of host cell DNA that does not cause any adverse effects. Further, one would expect success since Mehta’s teachings are directed to DNA derived from different host cell types (page 44, center column, paragraph 2 – page 44, right column, paragraph 1), and therefore, manipulation of the DNA concentration would be within the purview of an artisan. Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA1955). See MPEP § 2144.05 part II A.
Claims 1 and 13 are newly rejected as necessitated by amendment under 35 U.S.C. 103 as being unpatentable over Takaoka (US 2001/046697 A1, published on 11/29/2001), hereinafter ‘Takaoka’, in view of Hohman et al. (US 6,322,995 B1, published on 11/27/2001), hereinafter ‘Hohmann’, as evidenced by Wang et al. (“Coproduction of menaquinone-7 and nattokinase by Bacillus subtilis using soybean curd residue as a renewable substrate combined with a dissolved oxygen control strategy”, published on 09/14/2018, Annals of Microbiology (2018), Vol. 68, pages 655–665), hereinafter ‘Wang’, in view of Aukrust et al. (WO 2015/169816 A1, published on 11/12/2015), hereinafter ‘Aukrust’, and in view of Azevedo et al. (“Alginate/chitosan nanoparticles for encapsulation and controlledrelease of vitamin B2”, published on 05/23/2014, International Journal of Biological Macromolecules, Vol. 71, pages 141–146), hereinafter ‘Azevedo’.
Takaoka’s and Hohman’s teachings have been set forth above.
In addition, Takaoka teaches the isolation of vitamin K2 (paragraphs [0033] and [0065]), that “vitamin K2 can be added as necessary to the Bacillus natto culture extract obtained (the concentrated extract, paste, powder, and granule) to give the Bacillus natto culture extract enriched with vitamin K2” (paragraph [0064]), wherein “the combination is formed into capsules, tablets, drinkable preparations (beverages), and the like ” (paragraph [0064]).
Modified Takaoka does not teach wherein the process further comprises production of a nutritional product comprising mixing the fermentation products with encapsulation agents (instant claim 13). Please note the elected ingredient species ‘encapsulation agents’ under Claim Status above.
Aukrust’s general disclosure relates to “to new compositions of vitamin K compounds and provitamin and prodrug analogues thereof.” (see entire document, including page 1, lines 5-6), wherein “t]hese compositions can be used in multimineral products, such as nutraceuticals, e.g. for the fortification of foods or simply in supplements, or can be used in pharmaceuticals for the treatment of a variety of conditions known to benefit from the administration of vitamin K. (page 1, lines 6-9).
Regarding claim 13, pertaining to the production of a nutritional product, Aukrust teaches mixing vitamin K2 with encapsulation agents (column page 6, lines 22-26; page 10, lines 1-5; page 12, lines 25-26; page 13, lines 4-6).
In addition, Aukrust teaches that “it is a further object of the invention to provide new microcapsules with a content of a vitamin K product which microcapsules when formulated in a conventional dosage form, such as tablets, have good storage properties.” (page 5, lines 1-3).
Azevedo’s general disclosure relates to encapsulation and controlled release of vitamin B2 from alginate/chitosan nanoparticles (see entire document, including abstract).
Regarding claim 13, pertaining to the production of a nutritional product, Azevedo teaches mixing vitamin B2 with encapsulation agents (page 142, right column, paragraph 1).
In addition, Azevedo teaches wherein encapsulated vitamin B2 nanostructures “may be used in different food and/or beverage products for human nutrition, while contributing to increase vitamin stability in food matrices” (page 146, left column, paragraph 5).
While modified Takaoka does not teach wherein the process further comprises production of a nutritional product comprising mixing fermentation products with the ingredient encapsulation agents (instant claim 13), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have combined modified Takaoka’s process and teachings on preparing drinkable preparations (beverages), with Aukrust’s on encapsulating vitamin K2 and with Azevedo’s teachings on encapsulating vitamin B2, in order to a create a process further comprising production of a nutritional product comprising mixing the fermentation products with encapsulation agents. One would have been motivated to do so, in order to create a process for producing superior nutritional products comprising vitamin K2 and/or vitamin B2, that have improved storage properties and provide vitamin stability (Aukrust, page 5, lines 1-3; Azevedo, page 146, left column, paragraph 5). A skilled artisan would have reasonably expected success in combining modified Takaoka’s, Aukrust’s, and Azevedo’s teachings, since the references are directed to nutritional products..
Response to Arguments
Applicant has traversed the previous rejections of claims 1-2, 6, 9-10 and 12 under 35 U.S.C. 102 (a)(1), and claims 3-5, 7-8, 11 and 13 under 35 U.S.C. 103 (remarks, pages 5-15) in the reply field on 02/20/2026. As discussed above, the previous rejections under §102 (a)(1) have been withdrawn, and new rejections have been presented in light of Applicant’s amendment of 02/20/2026. Wang, Takaoka, Hohmann, Pratbernou, Fang, Mehta, Sato, and Aukrust are still relied upon in the above rejections. Applicant's arguments filed on 02/20/2026 have been fully considered but they are not persuasive.
In Applicant’s reply, Applicant states that the Office Action's proposed combination of Wang and Hohmann (remarks, page 6),and the combination of Wang and Fang are based on improper hindsight (remarks, page 7-8).
The Examiner responds that it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In this case, Wang provides a Bacillus subtilis fermentation process to produce a water-soluble fermentation product and fat-soluble vitamin K2, and further discloses the economic and environmental advantages of producing two or more valuable products using a single production process. Hohmann provides a Bacillus subtilis fermentation to produce water-soluble vitamin B2. Fang provides ethanol extraction of vitamin K2 from biomass.
Applicant describes that the claimed DNA amount in claim 7 is not obvious over Takaoka in view of Mehta (remarks, pages 8-10).
In response to Applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the Examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Takaoka in view of Hohmann provides a fermentation process for producing and extracting vitamin K2, and Mehta teaches on removal of host-cell material including host-cell DNA from fermentation products to prevent potential adverse effects. One would have been motivated to have combined Takaoka’s and Mehta’s teachings to minimize the amount of residual host-cell DNA in the extracted vitamin K2 to prevent any adverse effects from the host-cell-DNA. It is further noted that the recited DNA amounts in the extracted vitamin K2 implicitly result from performing the instantly claimed method steps. Takaoka in view of Hohmann teaches the method steps in claim 7, and thus inherently teaches the recited DNA amounts.
Applicant explains that claim 8 is not obvious from Takaoka in view of Pratbernou (remarks, pages 10-12).
The Examiner responds that Applicant’s arguments with respect to Takaoka’s teachings regarding claim 8 have been considered but are moot because the new ground of rejection due to Applicant’s amendment does not rely on Takaoka applied in the prior rejection of claim 8. As discussed above in the rejection of claim 8, Wang in view of Hohman and Fang provides the process of claim 8, and Pratbernou discloses less than 1 CFU/g of bacteria in an edible product, and further teaches that bacteria can cause spoilage of edible products. One would have been motivated to combine modified Wang’s and Pratbernou’s teachings on CFU in edible products to reduce spoilage of extracted Vitamin K2 and thus prevent health damages, since vitamin K2 is a nutraceutical. It is further noted that the recited CFU concentration in claim 8 implicitly results from performing the instantly claimed method steps in claim 8. Modified Wang teaches the method steps in claim 8 and as such inherently teaches the recited CFU concentration in claim 8.
Applicant states that claim 13 is not obvious from Takaoka in view of Aukrust” (remarks, pages 12-13).
The Examiner responds that, as discussed above, obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. In this case, Takaoka in view of Hohmann provides the process for producing the fermentation products vitamins K2 and B2, and Aukrust and Azevedo provide mixing of vitamin K2 and vitamin B2, respectively, with encapsulation agents for vitamin stabilizing and improved storage properties.
Applicant describes that claim 11 is not obvious over Wang in view of Fang, Sato, Mehta, and Song (remarks, pages 14-15).
The Examiner notes that claim 11 has been amended, and that the rejection of the claims no longer recites Song as an evidentiary reference.
The Examiner responds that, as discussed above, obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. In this case, Wang provides a Bacillus subtilis fermentation process to produce a water-soluble fermentation product and fat-soluble vitamin K2, and further discloses the economic and environmental advantages of producing two or more valuable products using a single production process. Hohmann teaches fermentation of B. subtilis comprising recombinant DNA to produce water-soluble vitamin B2, Fang provides extraction of vitamin K2 from B. subtilis biomass, Sato provides MK-7 content of recovered vitamin K2 from B. subtilis, and Mehta teaches on removal of host-cell material including host-cell DNA from fermentation products to prevent potential adverse effects, and further discloses that host-cell DNA can be determined by PCR.
.
Conclusion
No claims are allowed.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
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/SANDRA ZINGARELLI/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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