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 .
The amendment filed October 6, 2025 is acknowledged. Claims 1, 3, and 5-18 are pending in the application. Claims 2, 4, and 19 have been cancelled.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114 was filed in this application after appeal to the Patent Trial and Appeal Board, but prior to a decision on the appeal. 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examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on October 6, 2025 has been entered.
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.
Claim 3 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites “the steps” at line 2, and this claim depends upon claim 1. This recitation lacks antecedent basis as there is no mention of steps in claim 1. Therefore, the scope of claim 3 is indefinite. For the purpose of the examination, the recitation of “obtained by the steps of” at line 2 of claim 3 (emphasis added) is interpreted as “obtained by”.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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, 3, 6, 7, and 10-18 are rejected under 35 U.S.C. 103 as being unpatentable over Beck et al. WO 2007045488 (hereinafter “Beck”) in view of Kis EP 1932520 (hereinafter “Kis”).
With respect to claim 1, Beck teaches powdered formulation (P1, L3 and P7, L4-9).
Regarding the recitation of comprising a spray-dried granulation product of an aqueous dispersion comprised of milled carotenoid crystals, at least one modified food starch, a glucose syrup, sucrose, and a water soluble antioxidant in claim 1, Beck teaches the powdered formulation is prepared by spray-drying an aqueous dispersion of a homogenized (milled) fat-soluble active ingredient such as carotenoids, modified starch, sugar including sucrose and glucose syrup, and water-soluble antioxidant (P3, L4-16; P4, L20-23; P5, L1-3 and 8-10; P7, L4-18 and 25-31; P10, L27-29; and P16-P17, Examples).
However, Beck does not expressly disclose the carotenoid is in crystal form.
Kis teaches granulated compositions comprising carotenoids. The carotenoids may be in crystalline form (Abstract; paragraphs [0021], [0024], and [0031]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, given the teachings of Kis, to select carotenoids in crystalline form in Beck with the expectation of successfully preparing a functional product. One of ordinary skill in the art would have been motivated to do so because Kis and Beck similarly teach preparations comprising carotenoids, Kis teaches the crystalline carotenoids lutein and zeaxanthin may be extracted from marigold flowers (paragraph [0021]), Beck teaches the carotenoids (fat-soluble active ingredients) may be extracted from plants (P4, L1-3), and said combination would amount to the use of a known element for its intended use in a known environment to accomplish entirely expected results. There would have been a reasonable expectation of success with said modification. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. (“Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle.” Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) See also In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960) (selection of a known plastic to make a container of a type made of plastics prior to the invention was held to be obvious)) (MPEP 2144.07).
Regarding the recitation of wherein the carotenoid selected from the group consisting of lutein, zeaxanthin and mixtures thereof in claim 1, Beck teaches the fat-soluble ingredient is lutein and/or zeaxanthin (P3, L4-23).
Regarding the recitation of wherein the milled carotenoid crystals have particle size distributions of D [3,2] in a range of 0.6 to 1.5 µm, and D [v, 0.5] in a range of 1.1 to 3.5 µm, and wherein the solid granules have particle size distributions of D [3,2] in a range of 200 to 300 µm and D [v,0.5] in a range of 220 to 320 µm, wherein all D values are measured by laser diffraction according to the Fraunhofer scattering model in claim 1, Beck teaches the fat-soluble active ingredient (homogenized carotenoid) has a D[3,2] is less than or equal to 1000 nm (1 µm) which overlaps with the presently claimed range (P3, L4-16; P7, L4-8 and 20-23; and P10, L1-10), and the powdered formulation has a mean particle size D [3,2] of from 200 to 400 µm, as measured by laser diffraction (P9, L8-11), and encompasses the presently claimed range. As set forth in MPEP 2144.05, in the case where the claimed range “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
However, Beck does not expressly disclose the D [v, 0.5] of the milled carotenoid or the powdered formulation.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to adjust the particle sizes of the milled carotenoid and powder formulation in modified Beck with the expectation of successfully preparing a functional product. One of ordinary skill in the art would have been motivated to do so because Beck teaches preparing a formulation of the fat-soluble active ingredient (carotenoid) with improved and high bioavailability (P7, L4-8; P9, L24-26; and P10, L1-5), and such a modification would have involved a mere change in the size (or dimension) of a component. There would have been a reasonable expectation of success. A change in size (dimension) is generally recognized as being within the level of ordinary skill in the art. In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955).
With respect to claim 3, modified Beck is relied upon for the teaching of the solid granules of claim 1 as addressed above.
Regarding claim 3 and the recitation of “wherein the granules are obtained by …” in claim 3, it is noted that claim 3 refers to the process of producing the solid granules. The process as recited in the claim does not appear to produce a materially different product from the prior art. As demonstrated above in claim 1, modified Beck teaches a powdered formulation that is substantially similar to the solid granules as claimed. Applicant is reminded “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.”, (In re Thorpe, 227 USPQ 964,966). Once the Examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious different between the claimed product and the prior art product (In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983), MPEP 2113).
Additionally, regarding the recitation of a) providing an aqueous solution of the at least one modified food starch, the glucose syrup, the sucrose and the water soluble antioxidant; ESTRELLA et al. Page 3b) adding the carotenoid crystals to the solution of step a) to thereby obtain the aqueous suspension thereof; c) milling the suspension of step b) to obtain the milled carotenoid crystals having the particle size distributions of D [3,2] in the range of 0.6 to 1.5 µm, and D [v, 0.5] in the range of 1.1 to 3.5 µm; and d) spray-granulating the aqueous suspension of step c) to obtain the solid granules in claim 3, it is noted that these process limitations do not appear to impart distinctive structural characteristics to the final product. Also, Beck teaches providing the protective colloid (modified starch, glucose syrup, and sucrose) in a hydrophilic solvent such as water (step a), adding the fat-soluble active ingredient (carotenoid) (step b), homogenizing the combination (step c), and spray-drying the mixture (step d). The formulation additionally contains a water-soluble antioxidant (P3, L4-23; P4, L20-23; P5, L1-3 and 8-15; P7, L12-18; P7, L25-P8, L15; P10, L27-29; and P17). Therefore, since the solid granules as recited in claims 1 and 3 is the same as the powdered formulation disclosed by modified Beck, as set forth above, claim 3 is unpatentable even if the powdered formulation of modified Beck was made by a different process. In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983).
With respect to claim 6, modified Beck is relied upon for the teaching of the solid granules of claim 1 and has been addressed above.
Regarding the recitation of wherein the carotenoid is present in an amount of 1 to 30 weight-%, based on the total weight of the solid granules in claim 6, modified Beck teaches this limitation since Beck teaches the powdered formulation contain from 1 to 30 weight-% of the fat-soluble active ingredient, and the fat-soluble ingredient is a carotenoid (P3, L4-23; P4, L14-18; P9, L13-16; and P10, L27-29).
With respect to claim 7, modified Beck is relied upon for the teaching of the solid granules of claim 1 as addressed above.
Regarding the recitation of wherein the carotenoid is a mixture of lutein and zeaxanthin, and wherein a molar ratio of the lutein to the zeaxanthin is in a range of 20 : 1 to 2 : 1 in claim 7, Beck teaches the fat-soluble ingredient is carotenoids and includes a mixture of lutein and zeaxanthin (P3, L4-23).
However, Beck does not expressly disclose the claimed molar ratio of lutein to zeaxanthin.
Kis teaches dietary supplement compositions in the form of tablets (Abstract; and paragraphs [0012] and [0031]). The composition contains approximately 1 – 20 mg of lutein and approximately 0.1 – 2 mg of zeaxanthin (paragraphs [0023] and [0024]). Preferably, the composition contains 10 mg of lutein and 2 mg of zeaxanthin which is equal to a ratio of lutein to zeaxanthin of 5 : 1 (paragraph [0006]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select any portions of the disclosed ranges, including the instantly claimed molar ratio ranges, from the ranges disclosed in the prior art references. One of ordinary skill in the art would have been motivated to do so because Kis and Beck similarly teach tablet preparations comprising lutein and zeaxanthin, and Kis teaches the amount zeaxanthin present depends upon whether zeaxanthin is used to supplement or substitute and/or lutein (paragraph [0024]). There would have been a reasonable expectation of success. "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages " In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05.
With respect to claim 10, modified Beck is relied upon for the teaching of the solid granules of claim 1 and has been addressed above.
Regarding the recitation of wherein the water-soluble antioxidant is present in an amount in a range of 0.1 to 10 weight-% based on the total weight of the solid granules in claim 10, modified Beck teaches this limitation since Beck teaches the powdered formulation contains 0.1 to 20 weight-% of a water-soluble antioxidant (P9, L13 and 20-22; P10, L27-29; and P11, L1-3) and encompasses the presently claimed range. As set forth in MPEP 2144.05, in the case where the claimed range “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
With respect to claim 11, modified Beck is relied upon for the teaching of the solid granules of claim 1 and has been addressed above.
Regarding the recitation of wherein the milled carotenoid crystals, the at least one modified food starch, the glucose syrup, the sucrose and the water-soluble antioxidant are present in amounts which sum up to an amount of at least 90 weight-%, based on the total weight of the solid granules in claim 11, modified Beck teaches this limitation since Beck teaches the formulation comprises 1 to 30 weight-% of the fat-soluble active ingredient (milled carotenoid), 10-90 weight-% of protective colloid (modified starch, glucose syrup, and sucrose), and 0.1 to 20 weight-% of a water-soluble antioxidant and may optionally contain further ingredients (P3, L4-23; P4, L20-23; P5, L1-3 and 8-15; P7, L25-27; P9, L13-22; P10, L27-29; and P11, L1-3). The ranges taught in Beck overlap with the presently claimed range. As set forth in MPEP 2144.05, in the case where the claimed range “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
With respect to claim 12, modified Beck is relied upon for the teaching of the solid granules of claim 1 and has been addressed above.
Regarding the recitation of wherein the granules do not contain any oil in claim 12, modified Beck teaches this limitation since Beck teaches the formulation optionally contains oil (P5, L2-3).
With respect to claim 13, modified Beck is relied upon for the teaching of the solid granules of claim 1 and has been addressed above.
Regarding the recitation of wherein the granules do not comprise any compound selected from the group consisting of hydrolyzed lecithin products, gum arabic, fat-soluble antioxidants, isomalt, α-zeacarotene and β-zeacarotene in claim 13, modified Beck teaches this limitation since Beck teaches possible protective colloids include gum arabic and modified starch, but modified starch is the preferred protective colloid and it may further include sugar (sucrose and glucose syrups) (P4, L20-23; P5, L1-3 and 8-15). The composition preferably additionally contains water-soluble antioxidant OR fat-soluble antioxidant (P10, L27-29, emphasis added). While preferred examples of carotenoids include lutein, zeaxanthin, α-zeacarotene, β-zeacarotene, and any mixtures of them, lutein and zeaxanthin are the most preferred carotenoids used in the composition (P3, L4-23). Additionally, the disclosure of Beck is silent with respect to the composition comprising hydrolyzed lecithin products and isomalt.
With respect to claim 14, Beck teaches a dietary supplement comprising the powdered formulation (P1, L3-5; and P10, L23-25), and modified Beck is relied upon for the teaching of the solid granules according to claim 1 as addressed above.
With respect to claim 15, modified Beck is relied upon for the teaching of the dietary supplement of claim 14 as addressed above.
Regarding the recitation of further comprising vitamins, mineral salts, and/or trace elements in claim 15, modified Beck teaches this limitation since Beck teaches the composition may comprise vitamins and minerals (P1, L3-5; P3, L4-10; P10, L27-29; and P12, L23-28).
With respect to claim 16, modified Beck is relied upon for the teaching of the dietary supplement of claim 14 as addressed above.
Regarding the recitation of wherein the dietary supplement is in the form of a tablet in claim 16, modified Beck teaches this limitation since Beck teaches the formulation may be in the form of tablets (P1, L20-26; and P10, L20-25).
With respect to claim 17, modified Beck teaches the dietary supplement in the form of a tablet as addressed above in claim 16.
Regarding the recitation of wherein the tablet has a compression loss of less than 12% carotenoid, based on the total amount of the carotenoid in claim 17, modified Beck teaches this limitation since Beck teaches the formulations shows a loss of carotenoid of ≤ 10% when pressed to tablets (P1, L20-26; and P3, L4-23).
With respect to claim 18, modified Beck teaches the dietary supplement in the form of a tablet as addressed above in claim 16.
Regarding the recitation of wherein the tablet has a hardness as crushing force of at least 160 N when a compression force of 20-25 kN is applied in claim 18, modified Beck does not expressly disclose this feature.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the hardness of the tablet of modified Beck through routine experimentation with the expectation of successfully preparing a functional product. One of ordinary skill in the art would have been motivated to do so because the hardness of the tablet is a function of the ingredients present which have been shown to be obvious in view of modified Beck, the hardness of the tablet may be adjusted contingent upon the particular end use of the final tablet product, and Beck teaches different types of tablets can be prepared (P14, L7-19). There would have been a reasonable expectation of success. “[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) (MPEP 2144.05 II).
Claims 5, 8, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Beck et al. WO 2007045488 (hereinafter “Beck”) in view of Kis EP 1932520 (hereinafter “Kis”) as applied to claim 1 above, and further in view of Kuhny et al. WO 03015537 (hereinafter “Kuhny”).
With respect to claims 5, 8, and 9, modified Beck is relied upon for the teaching of the solid granules of claim 1 as addressed above.
Regarding the recitation of wherein the sucrose is present in an amount of 0.1 to 40 weight-% based on the total weight of the solid granules in claim 5, wherein the modified food starch is present in an amount in a range of 10 to 50 weight-% based on the total weight of the solid granules in claim 8, and wherein the glucose syrup is present in an amount in a range of 0.1 to 40 weight-% based on the total weight of the solid granules in claim 9, Beck teaches the powdered formulation also comprises 10-90 weight-% of protective colloid. A mixture of modified starch and sugar is used as the protective colloid, and the sugar includes sucrose and glucose syrups (P4, L20-23; P5, L1-3, 8-15; P9, L13 and 16-18; P10, L27-29; and P17).
However, Beck does not expressly disclose the claimed quantities of modified starch, glucose syrup, and sucrose.
Kuhny teaches a powder composition comprising carotenoids, such as lutein and/or zeaxanthin. The powder comprises about 0 to about 40 wt.-% of a mono-or disaccharide such as sucrose, about 0 to about 50 wt.% starch, and about 0 to about 40 wt.-% of a starch hydrolysate such as glucose syrup (P1, L1-4; P2, L1-3, 10-15, and 28-29; and P3, L4 and 9-12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to select any portions of the disclosed ranges, including the instantly claimed ranges of modified starch, glucose syrup, and sucrose, from the ranges disclosed in the prior art references. One of ordinary skill in the art would have been motivated to do so because Beck and Kuhny similarly teach powdered preparations comprising similar ingredients, Kuhny teaches the composition comprises finely dispersed carotenoids that can be used in food, beverages, animal feeds, cosmetics, or drugs (P1, L1-4; P2, L28-29; and P4, L10-11), and Beck teaches a mixture of modified starch and sugar (sucrose and glucose syrup) is used as the protective colloid (P4, L20-24; and P5, L1-3 and 8-15). There would have been a reasonable expectation of success. "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages " In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05.
Response to Amendment
The Declaration under 37 CFR 1.132 filed October 6, 2025 is insufficient to overcome the 35 USC 103 rejection over modified Beck as set forth in the last Office action because of the following:
The Declaration indicates the first Factual Declaration was submitted to inter alia establish that those skilled in the art would know that the techniques of Beck et al would necessarily result in amorphous carotenoids and not crystalline carotenoids that are milled (3rd paragraph).
It is noted that the 37 CFR 1.132 filed October 25, 2024 has been previously addressed in the Final Rejection of February 5, 2025. See P17-P19, paragraphs 59-62 of the Office Action dated 2/5/2025.
The Declaration indicates the liquid/liquid emulsion technique according to Beck et al would result in a formulation having fundamentally different properties as compared to the granular formulation of a spray-dried granulation product of a dispersion of milled carotenoid crystals according to the claims. A skilled person in this art would recognize that the granular formulations obtained according to the method of Beck et a would always be at least partially amorphous and could not be in the form of milled crystals as in the case with the invention. As can be seen from page 7 of Beck et al, the method described therein concludes according to step b) that the crystals of a carotenoid are used and dissolved. So, even if an ordinary skilled person were to substitute the amorphous carotenoid of Beck et al. with a crystalline carotenoid as a starting material and conduct the method as described by Beck et al, the result would necessarily always lead to a formulation containing amorphous carotenoid. Formulations in accordance with the presently claimed invention and a formulation obtained in accordance with the technique of Example 15 of Beck et al (but with a lutein content of 10%) were prepared and analyzed. As can be seen, the formulations have significantly different particle sizes, shapes, and particle size distributions as compared to one another. No crystalline carotenoid particles are visible in the formulations of Beck et al, but instead only starch particles are visible (4th-9th paragraphs).
It is Examiner’s position that the Declaration is unpersuasive. It is noted that in assessing the probative value of an expert opinion, the examiner must consider
1) the nature of the matter sought to be established,
2) the strength of any opposing evidence,
3) the interest of the expert in the outcome of the case, and
4) the presence or absence of factual support for the expert’s opinion.
Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 227 USPQ 657 (Fed. Cir. 1985), cert. denied, 475 U.S. 1017 (1986).”
The claimed invention relates to solid granules comprising a spray-dried granulation product of an aqueous dispersion comprised of milled carotenoid crystals, at least one modified starch, a glucose syrup, sucrose, and a water soluble antioxidant. As previously addressed, Beck teaches the powdered formulation is prepared by spray-drying an aqueous dispersion of a homogenized (milled) fat-soluble active ingredient such as carotenoids, modified starch, sugar including sucrose and glucose syrup, and water-soluble antioxidant (P3, L4-16; P4, L20-23; P5, L1-3 and 8-10; P7, L4-18 and 25-31; P10, L27-29; and P16-P17, Examples). Although Beck teaches the carotenoid may be dissolved, Beck is not limited to this embodiment since the reference also teaches preparing an aqueous dispersion comprising the carotenoid as well as spray drying (P7, L4-18 and 25-31). Applicant has not demonstrated that a spray dried, aqueous dispersion comprising a milled carotenoid as described in Beck is incapable of arriving at the claimed solid granules. “Applicant must look to the whole reference for what it teaches. Applicant cannot merely rely on the examples and argue that the reference did not teach others.” In re Courtright, 377 F.2d 647, 153 USPQ 735,739 (CCPA 1967). "The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983).
The Declaration indicates one would not obviously substitute the crystalline form of carotenoids as disclosed by Kis for the amorphous form of carotenoids as disclosed by Beck et al. The FloraGloTM products as disclosed by Kis are not lutein in a formulated composition with a protective colloid, or a coating as described in the present invention. And they are not milled together with a protective colloid. Kis does not provide any indication to formulate such crystalline lutein products with a hydrocolloid (such as modified food starch) to achieve a better flowability. If the formulation of Beck et al contained crystalline particles the coloring formulation would exhibit ringing or even staining which is perceived as a cosmetic flaw or even a quality issue by customers. Thus, one would not obviously substitute the amorphous carotenoids of Beck et al with the crystalline carotenoids of Kis (10th paragraph).
It is Examiner’s position that this is unpersuasive. As previously addressed, modified Beck teaches the claimed invention. Beck does not expressly disclose the carotenoid is in crystal form. However, Kis is relied upon for this teaching (Abstract; paragraphs [0021], [0024], and [0031]). One of ordinary skill in the art would have been motivated to select carotenoids in crystalline form in Beck with the expectation of successfully preparing a functional product because Kis and Beck similarly teach preparations comprising carotenoids, Kis teaches the crystalline carotenoids lutein and zeaxanthin may be extracted from marigold flowers (paragraph [0021]), Beck teaches the carotenoids (fat-soluble active ingredients) may be extracted from plants (P4, L1-3), and said combination would amount to the use of a known element for its intended use in a known environment to accomplish entirely expected results. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. (“Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle.” Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) See also In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960) (selection of a known plastic to make a container of a type made of plastics prior to the invention was held to be obvious)) (MPEP 2144.07). Even though Kis does not disclose all the features of the presently claimed invention, Kis is used as teaching reference, and therefore, it is not necessary for this secondary reference to contain all the features of the presently claimed invention, In re Nievelt, 482 F.2d 965, 179 USPQ 224, 226 (CCPA 1973), In re Keller 624 F.2d 413, 208 USPQ 871, 881 (CCPA 1981).
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of the nonobviousness fails to outweigh the evidence of obviousness.
Response to Arguments
The remarks filed October 6, 2025 are acknowledged.
Due to Applicant’s remarks and the amendments to the claims, the claim objections and the 35 USC 112 rejection in the previous Office Action have been withdrawn (P5-P6).
Applicant’s arguments have been fully considered, but they are unpersuasive.
Applicant argues the first Schaefer Declaration was submitted to establish that those skilled in the art would know that the techniques of Beck et al would necessarily result in amorphous carotenoids and not crystalline carotenoids that are milled. Thus the evidence provided by the first Schaefer Declaration is submitted to be entirely probative to the issue of how an ordinary skilled person in this art would interpret the applied Beck et al reference (P7).
It is noted that the 37 CFR 1.132 filed October 25, 2024 has been previously addressed in the Final Rejection of February 5, 2025. See P17-P19, paragraphs 59-62 of the Office Action dated 2/5/2025.
Applicant argues an ordinarily skilled person in this art would recognize that the granular formulations obtained according to the method of Beck et al would always be at least partially amorphous and could not be in the form of milled crystals as in the case with the herein claimed invention. As noted in paragraph 4 of the second Schaefer Declaration, page 7 of Beck et al describes a method wherein which concludes according to step b? that the crystals of a carotenoid are used and dissolved. So, even if an ordinarily skilled person were to substitute the amorphous carotenoid of Beck et al with a crystalline carotenoid as a starting material and conduct the method as described by Beck et al, the result would necessarily always lead to a formulation containing amorphous carotenoid. Further evidence of the different properties achieved by Beck et al as compared to the presently claimed invention are evidenced by paragraphs 6-9 of the second Shaefer Declaration. One would not obviously substitute the crystalline form of carotenoids as described by Kis for the amorphous form of carotenoids as disclosed by Beck et al. The FloraGloTM products as disclosed by Kis are not lutein in a formulated composition with a protective colloid, or a coating as described in the presently claimed invention. And they are not milled together with a productive colloid. Kis does not provide any indication to formulate such crystalline lutein products with a hydrocolloid (such as modified food starch) to achieve a better flowability. If the formulation of Beck et al contained crystalline particles the coloring formulation would exhibit ringing or even staining which is perceived as a cosmetic flaw or even a quality issue by customers. Thus, one would not obviously substitute the amorphous carotenoids of Beck et al with the crystalline carotenoids of Kis as alleged by the Examiner (P7-P9).
Examiner disagrees. The arguments presented are substantially similar to those found in the Declaration filed October 6, 2025, and these arguments have been addressed in the “Response to Amendment” section of this Office Action. Applicant is reminded if a prima facie case of obviousness is established, the burden shifts to the applicant to come forward with arguments and/or evidence to rebut the prima facie case. See, e.g., In re Dillon, 919 F.2d 688, 692, 16 USPQ2d 1897, 1901 (Fed. Cir. 1990) (en banc). Rebuttal evidence and arguments can be presented in the specification, In re Soni, 54 F.3d 746, 750, 34 USPQ2d 1684, 1687 (Fed. Cir. 1995), by counsel, In re Chu, 66 F.3d 292, 299, 36 USPQ2d 1089, 1094-95 (Fed. Cir. 1995), or by way of an affidavit or declaration under 37 CFR 1.132, e.g., Soni, 54 F.3d at 750, 34 USPQ2d at 1687; In re Piasecki, 745 F.2d 1468, 1474, 223 USPQ 785, 789-90 (Fed. Cir. 1984). However, arguments of counsel cannot take the place of factually supported objective evidence. See, e.g., In re Huang, 100 F.3d 135, 139-40, 40 USPQ2d 1685, 1689 (Fed. Cir. 1996); In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984).
As discussed above, the claimed invention relates to solid granules comprising a spray-dried granulation product of an aqueous dispersion comprised of milled carotenoid crystals, at least one modified starch, a glucose syrup, sucrose, and a water soluble antioxidant. Beck teaches the powdered formulation is prepared by spray-drying an aqueous dispersion of a homogenized (milled) fat-soluble active ingredient such as carotenoids, modified starch, sugar including sucrose and glucose syrup, and water-soluble antioxidant (P3, L4-16; P4, L20-23; P5, L1-3 and 8-10; P7, L4-18 and 25-31; P10, L27-29; and P16-P17, Examples). Although Beck teaches the carotenoid may be dissolved, Beck is not limited to this embodiment since the reference also teaches preparing an aqueous dispersion comprising the carotenoid as well as spray drying (P7, L4-18 and 25-31). Applicant has not demonstrated that a spray dried, aqueous dispersion comprising a milled carotenoid as described in Beck is incapable of arriving at the claimed solid granules. “Applicant must look to the whole reference for what it teaches. Applicant cannot merely rely on the examples and argue that the reference did not teach others.” In re Courtright, 377 F.2d 647, 153 USPQ 735,739 (CCPA 1967). "The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983).
While Beck does not expressly disclose the carotenoid is in crystal form, Kis is relied upon for this teaching (Abstract; paragraphs [0021], [0024], and [0031]). One of ordinary skill in the art would have been motivated to select carotenoids in crystalline form in Beck with the expectation of successfully preparing a functional product because Kis and Beck similarly teach preparations comprising carotenoids, Kis teaches the crystalline carotenoids lutein and zeaxanthin may be extracted from marigold flowers (paragraph [0021]), Beck teaches the carotenoids (fat-soluble active ingredients) may be extracted from plants (P4, L1-3), and said combination would amount to the use of a known element for its intended use in a known environment to accomplish entirely expected results. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. (“Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle.” Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) See also In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960) (selection of a known plastic to make a container of a type made of plastics prior to the invention was held to be obvious)) (MPEP 2144.07). Even though Kis does not disclose all the features of the presently claimed invention, Kis is used as teaching reference, and therefore, it is not necessary for this secondary reference to contain all the features of the presently claimed invention, In re Nievelt, 482 F.2d 965, 179 USPQ 224, 226 (CCPA 1973), In re Keller 624 F.2d 413, 208 USPQ 871, 881 (CCPA 1981).
Conclusion
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/T.L.M/Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793