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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 2-10, 15-19 and 26-29 in the reply filed on 06/17/2026 is acknowledged. Claims 11-12, 14 and 20-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim.
Claim status
The examiner acknowledged the claims filed 06/17/2026.
Claims 2-12 and 14-29 are pending in the application. Claims 2-10, 15-19 and 26-29 are previously presented. Claims 11-12, 14 and 20-25 are withdrawn without traverse in response to the restriction requirement. Claims 2-10, 15-19 and 26-29 are hereby examined on the merits.
Claim Objections
Claim 1 is objected to because of the following informalities: “ a hydroxide/oxide metal” in line 2 should read “a hydroxide/oxide of the metal”; “coupling Atrorosin to ions of the metal by lowering a pH slowly to a value ranging from 3.5 to 4.5” in line 4 should read “mixing Atrorosin dye with the hydroxide/oxide of the metal and lowering a pH of the mixture slowly to a value ranging from 3.5 to 4.5 to couple the Atrorosin dye to ions of the metal”; “phase separating precipitate and liquid; and reducing particle size” in line 6-7 should read “phase separating precipitate and liquid; collecting the precipitate; and reducing particle size of the precipitate”; and “a ratio of Atrorosin to the metal is between 1:1 to 1:3 on a molar basis” in the end should read “a ratio of Atrorosin dye to the metal is between 1:1 to 1:3 on a molar basis” . Claims 10 and 15 are objected for the same reason. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-10, 15-19 and 26-29 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 2 recites “coupling Atrorosin dye to ions of the metal by lowering a pH slowly to a value ranging from 3.5 to 4.5”. However, given that “slowly” a relative term, thus absent a standard, it is unclear what rate of lowering pH is considered slow. Appropriate correction is required.
Claim 2 recites “wherein at least 50-95% of the Atrorosin lake remains dispersed in water-based solution” in line 7-8. It is unclear whether the scope of the claim requires the presence of a water-based solution. For the purpose of the examination, the limitation is interpreted to mean that wherein the Atrorosin lake has the property that when dispersed in an water-based solution, at least 50-95% of the Atrorosin lake remains dispersed in the water-based solution. Appropriate correction is required.
Claim 2 recites “wherein a ratio of Atrorosin to the metal is between 1:1 to 1:3 on a molar basis” in the end. It is unclear whether the ratio is for the coupling reaction mixture, or the final Atrorosin lake. For the purpose of examination, the former interpretation is assumed. Appropriate correction is required.
Claims 3-9 and 16-19 ultimately depend from claim 2 and therefore necessarily incorporate the indefinite subject matter therein. Appropriate correction is required.
Claims 10 and 15 are rejected for the same reason as set forth above. Claims 26-29 depend from claim 15 and therefore necessarily incorporate the indefinite subject matter therein. Appropriate correction is required.
Claim 4 recites “The Atrorosin lake according to claim 2, further comprising a stabilizing agent”. It is unclear whether the stabilizing agent is added in the process of making the lake, or the stabilizing agent is part of the final Atrorosin lake. The examiner notes that page 7, line 20-27 of the instant specification or instant claim 17/27 recites that the stabilizing agent is included in the step of reducing the size (e.g., milling) of the precipitate, therefore, for the purpose of examination, claim 4 is interpreted to mean that a stabilizing agent is added to the precipitate in the step of reducing the size.
Claims 5-6 depend from claim 4 and therefore necessarily incorporate the indefinite subject matter therein. Appropriate correction is required.
Claim 6 depends from claim 4 and recites that the ratio of stabilizing agent solution to Atrorosin lake ranges from 10:1 to 1:10 by weight. However, since claim 4 does not recite a solution of the stabilizing agent, it is unclear whether the scope of the claim 7 requires that the stabilizing agent exists in a solution, and it is unclear whether it is the stabilizing agent or the solution of the stabilizing agent has the aforementioned ratio. The examiner notes that page 8, line 5-6 of the instant specification recites that the ratio of the stabilizing agent to Atrorosin lake is 1:10-10:1 by weight). For the purpose of examination, claim 6 is interpreted to mean that ratio of the stabilizing agent to the precipitate is 1:10-10:1 by weight. Clarification is required.
Claim 18 depends from claim 2 and recites that “wherein Atrorosin lake material is washed prior to the reducing particle size”. It is unclear what the “Atrorosin lake material” is referring to. Is it the precipitate? Claim 28 is rejected for the same reason. Clarification is required.
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.
Claims 2-3, 7-9, 15-16, 18-19, 26 and 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Tolborg WO 2018/206590 A1 (cited in the IDS submitted 08/08/2024, hereinafter referred to as Tolborg) in view of Gan CN 1884389 A (cited in the IDS submitted 08/08/2024, English translation relied upon for reference, hereinafter referred to as Gan), McAllister US Patent No. 1,434,619 (hereinafter referred to as McAllister), Wou “Microstructure of aluminum hydroxides and the formation of aluminum dye lakes”, Journal of Pharmaceuticals Sciences, 1984, 73(12), pages 1738-1744 (hereinafter referred to as Wou), and Wongwad, “Preparation of lake pigment from Tai lac dye”, 2nd International Conference on Biomedical Engineering and Technology, PCBEE, 2012, vol. 34, pages 73-78 (hereinafter referred to as Wongwad).
Regarding claim 2-3, 7-9, 15-16, 18-19, 26 and 28-29, Tolborg teaches a class of azaphilone pigments named Atrorosins that are isolated from the filamentous fungus Talaromyces atroroseus. Atrorosins are similar to Monascus pigments because they have a similar azaphilone scaffold as the orange Monascus pigment PP-O, with a carboxylic acid group at C-1, but are unique by their incorporation of amino acids into the isochromene system (abstract; page 4, line 1-6; Fig. 1). Tolborg specifically teaches Atrorosin E which is water soluble (page 29, line 3). Tolborg teaches the Atrorosins can be used as a coloring agent in a food or non-food product (page 14, line 7-18).
Tolborg is silent regarding a lake of the Atrorosin E obtained by the method of priming a metal (e.g., Al, Cu, Ni, Co, Zn, etc.) to form hydroxide/oxide of the metal without use of sodium carbonate, coupling Atrorosin E with ions of the metal by lowering a pH to a value of 3.5-4.5 and maintaining Atrorosin/metal molar ratio of 1:1 to 1:3, separation of precipitate by filtration, and reducing the size of the precipitate. Tolborg is further silent regarding washing the precipitate.
Gan in the same field of endeavor teaches a method of preparing a lake of a Monascus pigment that is water soluble, comprising coupling the Monascus pigment with a metal such as calcium, zinc, barium, and magnesium, filtering to obtain the precipitate, drying, and milling the precipitate (pages 2-3, under “Summary of the Invention”; Examples 1-3). Further, Gan teaches that the coupling reaction occurs at a pH of 1-2, and a volume ratio of the pigment solution that has 2-20% pigment to the metal solution that has 5-85% metal is 1.5:1 (pages 2-3, under “Summary of the Invention”).
Further, Gan teaches that aluminum hydroxide (aluminum chloride and sodium bicarbonate as the matrix, which necessarily forms aluminum hydroxide) has been used to make a pigment lake (background).
McAllister teaches a method of making a lake of an azo dye, comprising coupling the azo dye with aluminum hydroxide to form a precipitate, followed by washing, filtering and drying of the result lake (claim 6).
Wou in the same field of endeavor teaches that amorphous aluminum hydroxide made from reacting aluminum sulfate and sodium bicarbonate can bused to make a pigment lake (Table I, #12, page 1742, right hand column, first para.; page 1744, right hand column, third para.).
Wongwad teaches a method of making a lake pigment from Tai lac dye comprising coupling the Tai lac dye with a metal salt solution that contains aluminum or calcium. Wongwad further teaches a coupling reaction pH of 3.5-4.5 is optimal for yield, and varying dye/metal ratios (such as 4), and teaches that both the pH and dye/metal ratio affects the yield (page 74, section 3.1.1, page 75, section 3.1.4).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified Tolborg by subjecting the Atrorosin E to a coupling reaction with a metal such as calcium, zinc, barium, and magnesium as disclosed by Gan or aluminum hydroxide as disclosed by Wou followed by washing and filtration and milling so as to make a clean water insoluble pigment. One of ordinary skill in the art, before the effective filing date of the claimed invention, would have had a reasonable expectation of success for choosing the aforementioned metals because prior art has established that those metals are art-recognized metals suitable for making a lake of a dye. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See MPEP 2144.07.
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have used both the metals of Gan and the aluminum hydroxide of Wou with reasonable expectation of success, because "it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). MPEP 2144.06.
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified pH and ratio of Atrorosin E/metal during coupling for obtaining desired yield for the lake.
Where Tolborg in view of Gan, McAllister, Wou and Wongwad arrives at the method, the dispersion property as recited in the claim is met by the prior art . See In re Best.
Further, where Tolborg teaches using the Atrorosin to color a base product (e.g., food or non-food), it would have been obvious to use the insoluble form of the Atrorosin (e.g., the lake) to color the base product.
Claims 4-6, 17 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Tolborg in view of Gan, McAllister, Wou and Wongwad as applied to claims 2 and 15 above, and further in view of Koehler WO 2016/008779 A1 (cited in the IDS submitted 08/08/2024, hereinafter referred to as Koehler).
Regarding claims 4-6, 17 and 27, Tolborg in view of Gan teaching milling the lake of Atrorosin the structure of which is similar to a Monascus piment, but is silent regarding that a stabilizing agent is added during milling.
Koehler in the same field of endeavor teaches adding a hydrocolloid a Monascus pigment to stabilize the pigment when the pigment forms a precipitate and is subjected to milling (Abstract; page 3, line 10-15), wherein the hydrocolloid is gum Arabic, nOSA starch or gelatin (page 3, line 17-19; page 5, line 25-28), and wherein the weight ratio of the nOSA starch to the Monascus pigment is 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5 and 4 (page 6, line 17-20), and the ratio of the gum Arabic to the Monascus pigment is 0.5-4 (Page 13, the table).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified Tolborg in view of Gan by adding nOSA starch or gum Arabic to the Atrorosin lake at the aforementioned ratios during milling so as to stabilize the pigment. nOSA starch has the commercial E-number of E1450 (page 5, line 25-28) which is known to derive from waxy starch.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Tolborg WO 2018/206590 A1 (cited in the IDS submitted 08/08/2024, hereinafter referred to as Tolborg) in view of Gan CN 1884389 A (cited in the IDS submitted 08/08/2024, English translation relied upon for reference, hereinafter referred to as Gan), McAllister US Patent No. 1434619 (hereinafter referred to as McAllister), Wou “Microstructure of aluminum hydroxides and the formation of aluminum dye lakes”, Journal of Pharmaceuticals Sciences, 1984, 73(12), pages 1738-1744 (hereinafter referred to as Wou), Wongwad, “Preparation of lake pigment from Tai lac dye”, 2nd International Conference on Biomedical Engineering and Technology, PCBEE 2012, vol. 34, pages 73-78 (hereinafter referred to as Wongwad), and Stangl US Patent Application Publication No. 2014/0272031A1 (hereinafter referred to as Stangl).
Regarding claim 10, Tolborg in view of Gan, McAllister, Wou and Wongwad as recited above teaches the Atrorosin lake of claim 2 (or claim 10), the entirety of which is incorporated herein by reference. Further, Stangl in the same field of endeavor teaches that a lake pigment is dispersed in water, and is applied to a base product (e.g., edible particle) to impart color (0016). Therefore, it would have been obvious to disperse the Atrorosin lake in water for imparting color to a base product.
Conclusion
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/CHANGQING LI/Primary Examiner, Art Unit 1791
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