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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/3/2025 has been entered.
Status of Action/Claims
Receipt of Remarks/Amendments filed on 11/3/2025 is acknowledged. Claims 1-2, 5, 7, 9, 23-27, 29-31, 33-39 are currently pending. Claim 23 has been withdrawn. Accordingly, claims 1-2, 5, 7, 9, 24-27, 29-31, 33-39 are currently under examination.
Receipt of Declaration of John Nolan under 37 C.F.R. 1.132 is acknowledged.
Rejection(s) not reiterated from the previous Office Action are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set of rejections presently being applied to the instant application.
Information Disclosure Statement
The IDS filed on 6/3/2025 has been considered. See the attached PTO 1449 form.
New/Maintained Claim Rejections
Claim Rejections - 35 USC § 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, 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. 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 1-2, 5, 7, 9, 24-27, 29-31, 33-36, 39 are rejected under 35 U.S.C. 103 as being unpatentable over Bone et al. (Nutrition & Metabolism, 2007, 4:12) in view of Mukherjee et al. (Journal of Nutrition and Metabolism, vol. 2018, Mar. 1, 2018), Sanders et al. (WO 99/47001; Sept. 23, 1999), Tanner et al. (US 6,217,902 B1; Apr. 17, 2001) (previously cited), Gullapalli (Journal of Pharmaceutical Sciences, vol. 99, no. 10, oct. 2010), Galvez (Nutrition Research 25 (2005) 631-640), Bunea (Not Bot Horti Agrobo, 2014, 42(2):310-324) and NIH (NIH, National Eye Institute, Oct. 12, 2001) as evidenced by Now Foods (Now Foods; Lecithin and Phosphatides).
Bone throughout the reference teaches macular pigment response to a supplement containing meso-zeaxanthin, lutein and zeaxanthin. Particularly, Bone teaches supplement composition for treating age related macular degeneration wherein the composition is in the form of gel capsules comprising 14.9 mg of meso-zeaxanthin (MZ), 5.5 mg of lutein (L) and 1.4 mg of zeaxanthin (Z) as a suspension in soybean oil (soybean oil reads on the carrier recited in claim 36). Also, these amounts disclosed in Bone read on the ratio/amounts recited in instant claim 29. Bone teaches lutein (L) is present as a 3R,3’R,6R stereoisomer and zeaxanthin as 3R,3’R isomer. Thus, Bone teaches the composition comprising meso-zeaxanthin, 3R,3’R,6R-lutein and 3R,3’R-zeaxanthin as recited in the instant claims. (see: abstract; background; methods section). As mentioned above, Bone discloses the gel capsules comprising the components as a suspension and Bone does not teach the composition having micelles, and thus, the composition of Bone reads on the instantly claimed limitation wherein the composition does not comprise micelles and the composition is not an emulsion.
The teachings of Bone have been set forth above.
Bone does not teach meso-zeaxanthin, 3R,3’R,6R-lutein and 3R,3’R-zeaxanthin in ester form and particularly diacetate as recited in the instant claims. However, this deficiency is cured by Mukherjee. Also, as discussed supra, Bone teaches the composition is in the form of gel capsules comprising 14.9 mg of meso-zeaxanthin (MZ), 5.5 mg of lutein (L) and 1.4 mg of zeaxanthin (Z) as a suspension in soybean oil (soybean oil reads on the carrier recited in claim 36). Bone does not teach a xanthophyl carotenoid diacetate fully dissolved in a carrier. However, Galvez, Bunea and Mukherjee address this deficiency.
Mukherjee is also directed towards carotenoids and particularly diacetate ester of macular carotenoids and effect of supplementation on macular pigment. Mukherjee teaches that the macular carotenoids, or xanthophylls, lutein (L), zeaxanthin (Z), and meso-zeaxanthin (MZ) in diacetate form being more effective at raising macular pigment optical density (MPOD) than unesterified form and that these particular ester having more bioavailability than unesterified counterparts. (see: Abstract; Intro; Conclusion; Entire document). Mukherjee also suggests the higher bioavailability is due to better dispersion, solubilization and incorporation of ester form into micelles formed in the digestive process, compared with free form (see: Intro).
Galvez teaches esterification of xanthophylls and its effect on chemical behavior and bioavailability. Specifically, Galvez teaches that by esterification, the liposolubility of xanthophylls is increased and that carotenoids are more soluble when esterified. (see e.g., Abstract; Xanthophyll esterification section 2).
Bunea also teaches xanthophyll esters and specifically teaches that the esterification of xanthophyll decreases polarity and increases the solubility in lipids (see e.g., page 315 left column).
Mukherjee teaches the esterified form of carotenoids have higher bioavailability is due to better dispersion and solubilization compared with free form. Galvez teach esterified carotenoids having increased liposolubility and Bunea also teaches the esterification of xanthophyll decreases polarity and increases the solubility in lipids. As mentioned above, Bones teaches soybean oil as the carrier for the xanthophyll carotenoids and thus replacing the xanthophyll carotenoids in free form taught by Bone with esterified form would result in xanthophyll carotenoids diacetates being fully dissolved in a carrier because the Mukherjee, Galvez and Bunea teach the esterification of xanthophyll carotenoids decreases polarity and increases the solubility in lipids (such as soybean oil).
Bone also does not teach the composition comprising phospholipids such as the one recited in the instant claims and a surfactant. As such, Bone also does not teach an amount of the phospholipids and surfactant. However, this deficiency is cured by Sanders.
Sanders is also directed towards using lutein and zeaxanthin for macular related disorders and particularly teaches use of lecithin and lysolecithin (a surfactant), at concentration of about 5% to about 30%, to increase absorption and bioavailability of lutein and zeaxanthin in humans and poultry. (Abstract; Summary of Invention; Page 6). As evidenced by Now Foods reference, Lecithin includes phosphatidylcholine, phosphatidylethanolamine, phosphatidylinositol and phosphatidic acid. As such, Lecithin reads on the elected species of the phospholipids recited in instant claims.
Bones does not teach the composition further comprising transition metal salt such as zinc oxide and an antioxidant. However, this deficiency is cured by NIH.
NIH teaches antioxidant vitamins and zinc oxide reduce risk of vision loss from age related macular degeneration. NIH teaches the study involved administration of zinc as zinc oxide and antioxidants such as vitamin C and vitamin E. NIH also teaches the group treated with combination of antioxidants and zinc oxide had the lowest risk of developing advanced age related macular degeneration and accompanying visual loss. (see: Entire document).
Bone does not expressly teach wherein the composition is homogenous. However, as mentioned above, Bones teaches soybean oil as the carrier for the xanthophyll carotenoids and thus replacing the xanthophyll carotenoids in free form taught by Bone with esterified form would result in xanthophyll carotenoids diacetates being fully dissolved in a carrier because the Mukherjee, Galvez and Bunea teach the esterification of xanthophyll carotenoids decreases polarity and increases the solubility in lipids (such as soybean oil). Thus, xanthophyll carotenoid diacetate dissolved in the carrier would result in a solution which would be homogenous. Tanner also addresses this limitation wherein the composition is homogenous.
Tanner throughout the reference teaches soft gel capsules comprising suspension wherein Tanner teaches the suspension should be homogenous to allow encapsulation of the suspension in gel capsules. (see: see: Col. 5, lines 1-10; Col. 1, line 28-37; example 2).
Bone does not expressly teach wherein the composition comprises greater than 0% to less than or equal to about 5% w/w of water. However, Gullapalli cures this deficiency.
Gullapalli throughout the references discuss soft gel capsules. Gullapalli teaches soft gel capsules can have water content as little as 0.5% or less. Gullapalli teaches that soft gel with too much water may result in very soft gels that become tacky and stick to each other. On the other hand, soft gel with too little water can become hard and brittle that have a higher propensity to develop cracked shells. (see: page 4112).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bone to incorporate the teachings of Mukherjee, Galvez and Bunea and include meso-zeaxanthin, 3R,3’R,6R-lutein and 3R,3’R-zeaxanthin carotenoids in the form of diacetate as taught by Mukherjee. One would have been motivated to do so because Mukherjee also teaches use of these carotenoids in age related macular degeneration and Mukherjee provides a strong motivation wherein the macular carotenoids, or xanthophylls, lutein (L), zeaxanthin (Z), and meso-zeaxanthin (MZ) in diacetate form were more effective at raising macular pigment optical density (MPOD) than unesterified form and that these particular ester have more bioavailability than unesterified counterparts. Thus, one skilled in the art would have been strongly motivated to use the carotenoids in Bone’s composition in the form of ester and particularly as diacetates.
Regarding the limitation wherein xanthophyll carotenoid diacetate is fully dissolved in a carrier, Mukherjee teaches the esterified form of carotenoids have higher bioavailability is due to better dispersion and solubilization compared with free form. Galvez teach esterified carotenoids having increased liposolubility and Bunea also teaches the esterification of xanthophyll decreases polarity and increases the solubility in lipids. As mentioned above, Bones teaches soybean oil as the carrier for the xanthophyll carotenoids and thus replacing the xanthophyll carotenoids in free form taught by Bone with esterified form would result in xanthophyll carotenoids diacetates being fully dissolved in a carrier because Mukherjee, Galvez and Bunea teach the esterification of xanthophyll carotenoids decreases polarity and increases the solubility in lipids (such as soybean oil which is taught by Bone and also recited as the carrier in instant claims).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bone to incorporate the teachings of Sanders and include Lecithin and lysolecithin (surfactant), and the amounts thereof, in the composition of Bone. One would have been motivated to do so because Sanders teaches that absorption and bioavailability of carotenoids (lutein and zeaxanthin) is enhanced with the use of lecithin and lysolecithin. Since Bone also teaches the composition comprises lutein and zeaxanthin carotenoids and the composition used for treatment of macular disorder, one skilled in the art would have been strongly motivated to include lecithin and lysolecithin in Bone’s composition for enhanced absorption and bioavailability of the carotenoids.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bone to incorporate the teachings of NIH and further include antioxidants such as vitamin C and vitamin E along with zinc oxide as taught by NIH to treat age related macular degeneration. One would have been motivated to do so because, as discussed supra, Bone teaches supplement composition for treating age related macular degeneration and NIH also teaches antioxidant vitamins and zinc oxide reduce risk of vision loss from age related macular degeneration. As a general principle 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, the idea of combining them flows logically from their having been individually taught in the prior art. See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) MPEP 2144.06.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bone to incorporate the teachings of Tanner and make the composition of Bone as a homogenous composition. One would have been motivated to do so because, as discussed supra, Bone teaches the supplementations in gel capsules containing the ingredients as suspension and Tanner teaches soft gel capsules comprising suspension wherein Tanner teaches the suspension should be homogenous to allow encapsulation of the suspension in gel capsules. Thus, it would have been obvious to one skilled in the art to make the suspension of Bone as homogenous to allow for encapsulation of the suspension in gel capsules. Further, as discussed above, Bones teaches soybean oil as the carrier for the xanthophyll carotenoids and thus replacing the xanthophyll carotenoids in free form taught by Bone with esterified form would result in xanthophyll carotenoids diacetates being fully dissolved in a carrier because the Mukherjee, Galvez and Bunea teach the esterification of xanthophyll carotenoids decreases polarity and increases the solubility in lipids (such as soybean oil). Thus, xanthophyll carotenoid diacetate dissolved in the carrier would result in a solution which would be homogenous.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bone to incorporate the teachings of Gullapalli and include water in the amounts taught by Gullapalli. Gullapalli teaches that soft gel with too much water may result in very soft gels that become tacky and stick to each other. On the other hand, soft gel with too little water can become hard and brittle that have a higher propensity to develop cracked shells. Gullapalli also teaches soft gel capsules can have water content as little as 0.5% or less. (see: page 4112). Since Bone teache the composition is in the form of gel capsules, it would have been obvious to one skilled in the art to include water in amount that would yield gel capsules with optimal results as disclosed by Gullapalli.
With respect to the ratios of the xanthophyll carotenoid diacetates recited in instant claim 30, Bone teaches the xanthophyll carotenoids disclosed are used for treating age related macular degeneration (abstract). Therefore, absence any criticality or unexpectedness, it would have been obvious to one skilled in the art to manipulate the amount/ratio of the xanthophyll carotenoids during routine experimentation and determine an optimal amount/ratio that would treat age related macular degeneration in the patient population. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature 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 (CCPA 1955).
With respect to the concentration of the carrier recited in instant claim 39, it would have been obvious to one skilled in the art to determine an optimal amount of carrier needed in the composition which would depend on the amounts of xanthophyll carotenoids and other components included in the composition. Further, as discussed supra, Mukherjee teaches the esterified form of carotenoids have higher bioavailability due to better dispersion and solubilization and Galvez and Bunea teach the esterification of xanthophyll carotenoids increases the solubility in lipids (e.g. soybean oil). As such, it would have been obvious to manipulate the amount of the carrier (e.g. soybean oil) and determine an amount which is optimal for solubilizing the esterified xanthophyll carotenoids.
From the combined teaching of the cited references, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Bone et al. (Nutrition & Metabolism, 2007, 4:12) in view of Mukherjee et al. (Journal of Nutrition and Metabolism, vol. 2018, Mar. 1, 2018), Sanders et al. (WO 99/47001; Sept. 23, 1999), Tanner et al. (US 6,217,902 B1; Apr. 17, 2001) (previously cited), Gullapalli (Journal of Pharmaceutical Sciences, vol. 99, no. 10, oct. 2010), Galvez (Nutrition Research 25 (2005) 631-640), Bunea (Not Bot Horti Agrobo, 2014, 42(2):310-324) and NIH (NIH, National Eye Institute, Oct. 12, 2001) as evidenced by Now Foods (Now Foods; Lecithin and Phosphatides) as applied to claims 1-2, 5, 7, 9, 24-27, 29-31, 33-36, 39 above and further in view of Patel (J Pharm Bioallied Sci. 2012 Mar; 4(Suppl 1):S98-S100).
The teachings of references previously cited above have been set forth.
The references cited above do not teach the specific carrier recited in claim 37. However, Patel cures this deficiency.
Patel teaches soft gelatin capsule formulation. Patel teaches soybean oil and bees wax used as a vehicle (carrier) to solubilize hydrophobic Lumefantrin and oil soluble Artemether drug components. (see: entire document).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of the previously cited reference above and Patel and substitute soybean oil with bees wax as the carrier/vehicle to solubilize the xanthophyll carotenoid diacetate. As discussed supra, Mukherjee teaches the esterified form of carotenoids have higher bioavailability due to better dispersion and solubilization and Galvez and Bunea teach the esterification of xanthophyll carotenoids increases the solubility in lipids (e.g. soybean oil). Patel teaches soybean oil and bees wax are used as a vehicle (carrier) to solubilize hydrophobic Lumefantrin and oil soluble Artemether drug components. It would have been obvious to one skilled in the art to substitute the soybean oil with bees wax because both can act as carriers/vehicle in gel capsules to solubilize hydrophobic or oil soluble components. see MPEP 2141 KSR International CO. v. Teleflex Inc. 82 USPQ 2d 1385 (Supreme Court 2007).
From the combined teaching of the cited references, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Bone et al. (Nutrition & Metabolism, 2007, 4:12) in view of Mukherjee et al. (Journal of Nutrition and Metabolism, vol. 2018, Mar. 1, 2018), Sanders et al. (WO 99/47001; Sept. 23, 1999), Tanner et al. (US 6,217,902 B1; Apr. 17, 2001) (previously cited), Gullapalli (Journal of Pharmaceutical Sciences, vol. 99, no. 10, oct. 2010), Galvez (Nutrition Research 25 (2005) 631-640), Bunea (Not Bot Horti Agrobo, 2014, 42(2):310-324) and NIH (NIH, National Eye Institute, Oct. 12, 2001) as evidenced by Now Foods (Now Foods; Lecithin and Phosphatides) as applied to claims 1-2, 5, 7, 9, 24-27, 29-31, 33-36, 39 above and further in view of Mesic et al. (US2009/0221687A1).
The teachings of references previously cited above have been set forth.
The references cited above do not teach the specific carrier (sunflower oil) recited in claim 38. However, Mesic cures this deficiency.
Mesic teaches pharmaceutical formulations comprising pharmaceutically acceptable carrier wherein sunflower oil and soybean oil are taught as carriers which can be used in pharmaceutical formulations. (see e.g., para 0124).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of the previously cited reference above and Mesic and substitute soybean oil with sunflower oil as the carrier to solubilize the xanthophyll carotenoid diacetate. As discussed supra, Mukherjee teaches the esterified form of carotenoids have higher bioavailability due to better dispersion and solubilization and Galvez and Bunea teach the esterification of xanthophyll carotenoids increases the solubility in lipids (e.g. soybean oil). It would have been obvious to one skilled in the art to substitute the soybean oil with sunflower oil because both can act as carriers in pharmaceutical formulations and both are lipids that would solubilize xanthophyll carotenoids. see MPEP 2141 KSR International CO. v. Teleflex Inc. 82 USPQ 2d 1385 (Supreme Court 2007).
From the combined teaching of the cited references, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Response to Argument/Declaration
Applicant argued the absence of a discussion about micelles in Bone is not the same as a recitation that therein disclosed composition is free of micelles.
In response, it is argued that Bone does not teach there being any presence of micelles in the composition disclosed and applicant have not provided any evidence to show that the composition of Bone does contain micelles. Further, the combination of the cited prior art teaches the esterified xanthophyll carotenoid dissolved in a carrier (soybean oil) and applicant have not shown how the prior art would have micelles but the claimed composition does not.
Applicant argued that NIH is silent with regard to carotenoids and so it remains unclear why the skilled artisan would have a reasonable expectation of success in using the additive of NIH with the carotenoids of Bone.
In response, as discussed supra, Bone teaches supplement composition for treating age related macular degeneration and NIH also teaches antioxidant vitamins and zinc oxide reduce risk of vision loss from age related macular degeneration. As a general principle 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, the idea of combining them flows logically from their having been individually taught in the prior art. See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) MPEP 2144.06.
Applicant argued that Tanner is silent with regard to carotenoids and so it remains unclear why the skilled artisan would have reasonable expectation of success in homogenizing a carotenoid containing composition.
In response, as discussed supra, Bone teaches the supplementations in gel capsules containing the ingredients as suspension and Tanner teaches soft gel capsules comprising suspension wherein Tanner teaches the suspension should be homogenous to allow encapsulation of the suspension in gel capsules. Thus, it would have been obvious to one skilled in the art to make the suspension of Bone as homogenous to allow for encapsulation of the suspension in gel capsules. Further, as discussed above, Bones teaches soybean oil as the carrier for the xanthophyll carotenoids and thus replacing the xanthophyll carotenoids in free form taught by Bone with esterified form would result in xanthophyll carotenoids diacetates being fully dissolved in a carrier because the Mukherjee, Galvez and Bunea teach the esterification of xanthophyll carotenoids decreases polarity and increases the solubility in lipids (such as soybean oil). Thus, xanthophyll carotenoid diacetate dissolved in the carrier would result in a solution which would be homogenous.
Applicant in the remarks and declaration argued that free forms of lutein zeaxanthin and meso-zeaxanthin as discussed in Bone differ significantly from their corresponding diacetates in chemical structure, which causes important variations in their physical and chemical properties. As such, it is incorrect to assume that the free forms of lutein, zeaxanthin, and meso-zeaxanthin as discussed in Bone can be readily interchanged with ester or diacetate forms.
In response, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). 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, Mukherjee teaches that the macular carotenoids, or xanthophylls, lutein (L), zeaxanthin (Z), and meso-zeaxanthin (MZ) in diacetate form being more effective at raising macular pigment optical density (MPOD) than unesterified form (free form) and that these particular ester having more bioavailability than unesterified counterparts. (see: Abstract; Intro; Conclusion; Entire document). Mukherjee also suggests the higher bioavailability is due to better dispersion, solubilization and incorporation of ester form into micelles formed in the digestive process, compared with free form (see: Intro). Thus, one skilled in the art would have been motivated to use the carotenoids in Bone’s composition in the form of ester and particularly as diacetates rather than free form which is taught in Bone.
Applicant in the remarks and declaration also argued that lutein and zeaxanthin diacetates are not completely soluble in oil and that only a fraction of lutein and zeaxanthin diacetate are dissolvable in oil, while the rest remains as suspended crystals. Thus, Mukherjee fails to discloses xanthophyll carotenoid diacetate fully dissolved in a carrier.
In response, as discussed supra, Mukherjee teaches the esterified form of carotenoids have higher bioavailability is due to better dispersion and solubilization compared with free form. Galvez teach esterified carotenoids having increased liposolubility and Bunea also teaches the esterification of xanthophyll decreases polarity and increases the solubility in lipids (e.g., soybean oil). As mentioned above, Bones teaches soybean oil as the carrier for the xanthophyll carotenoids and thus replacing the xanthophyll carotenoids in free form taught by Bone with esterified form would result in xanthophyll carotenoids diacetates being fully dissolved in the carrier (soybean oil) because Mukherjee, Galvez and Bunea teach the esterification of xanthophyll carotenoids decreases polarity and increases the solubility in lipids (such as soybean oil which is taught by Bone and also recited as the carrier in instant claims). “The arguments of counsel cannot take the place of evidence in the record.” In re Schulze, 346 F.2d 600, 145 USPQ 716, 718 (CCPA 1965), In re Huang, 40 USPQ 2d 1685 (Fed. Cir. 1996), In re De Blauwe et al., 222 USPQ 191, (Fed. Cir. 1984). Applicant has not provided any factual evidence establishing that lutein and zeaxanthin diacetate are not completely soluble in oil when the art of record suggests that esterified form increases liposolubility or solubility in lipids. Moreover, the instant claims also recite the diacetate or esterified form dissolved in a carrier which includes soybean oil and applicant have not shown how the claimed xanthophyll carotenoid diacetates are fully dissolved in carrier such as soybean oil but not the ones taught in the prior art. Applicant in the declaration argued that complete dissolution of the diacetate species was a surprising result of also incorporating the phospholipids with the diacetate species and further the transition metal salts. In response, the examiner reiterates that “The arguments of counsel cannot take the place of evidence in the record.” In re Schulze, 346 F.2d 600, 145 USPQ 716, 718 (CCPA 1965), In re Huang, 40 USPQ 2d 1685 (Fed. Cir. 1996), In re De Blauwe et al., 222 USPQ 191, (Fed. Cir. 1984). Applicant has not provided any evidence such as comparative data to show that complete dissolution of diacetate species only occurs by incorporating the phospholipids with the diacetate species and further the transition metal salts, and that such dissolution would not occur with only diacetate species in oil as the carrier.
Conclusion
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/A.S/ Examiner, Art Unit 1616
/SUE X LIU/ Supervisory Patent Examiner, Art Unit 1616