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 February 11, 2026 is acknowledged. Claims 1-17 are pending in the application. Claims 9-17 have been withdrawn from consideration.
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 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 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Nemzer et al., “Betalainic and nutritional profiles of pigment-enriched red beet root (Beta vulgaris L.) dried extracts” (hereinafter “Nemzer”).
With respect to claim 1, Nemzer teaches a beet root composition comprising betalains (Abstract).
Regarding the recitation of having the following feature: ratios of HPLC peak areas as detected with a DAD detector of: HPLC Ratio 1 ≥0.25 and HPLC Ratio 2 ≥ 0.25 in claim 1, it is noted that the peaks in Ʃarea504nm show a λmax in the UV-Vis spectrum between 502 nm and 510 nm which corresponds to 17-decarboxybetanin and 17-decarboxyisobetanin, the peaks in Ʃarea526nm show a λmax in the UV-Vis spectrum between 522 nm and 530 nm which corresponds to 15-decarboxybetanin, and the peaks in Ʃarea534nm show a λmax in the UV-Vis spectrum between 532 nm and 540 nm which corresponds to betanin and isobetanin (see P5, Table 1 of the instant specification). Nemzer teaches the composition comprises 17-decarboxybetanin (4) with a relative HPLC peak area of 19.7, 17-decarboxyisobetanin (4’) with a relative HPLC peak area of 15.5, 15-decarboxybetanin (5) with a relative HPLC peak area of 10.9, betanin (3) with a relative HPLC peak area of 26.1, and isobetanin (3’) with a relative HPLC peak area of 15.7 (P45, Chromatographic betalain analysis; P46, Table 1; and P47, Table 2: Sample SD-1). Thus, the calculated HPLC Ratio 1 = about 0.46 (calculated from [19.7 + 15.5]/[19.7 + 15.5 + 26.1 + 15.7]), which falls within the presently claimed range, and the calculated HPLC Ratio 2 = about 0.21 (calculated from 10.9/[10.9 + 26.1 + 15.7]).
The claimed HPLC Ratio 2 of ≥ 0.25 and the value of Nemzer of about 0.21 are close enough that one skilled in the art would have expected them to have the same color characteristics. Applicant is reminded a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%); In re Scherl, 156 F.2d 72, 74-75, 70 USPQ 204, 205-206 (CCPA 1946) (prior art showed an angle in a groove of up to 90° and an applicant claimed an angle of no less than 120°); and In re Brandt, 886 F.3d 1171, 1177, 126 USPQ2d 1079, 1082 (Fed. Cir. 2018)(the court found a prima facie case of obviousness had been made in a predictable art wherein the claimed range of "less than 6 pounds per cubic feet" and the prior art range of "between 6 lbs./ft3 and 25 lbs./ft3" were so mathematically close that the difference between the claimed ranges was virtually negligible absent any showing of unexpected results or criticality.)
Additionally, 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 HPLC Ratio 2 through routine experimentation with the expectation of successfully preparing an aesthetically desirable colorant composition. One of ordinary skill in the art would have been motivated to do so because Nemzer teaches heat treatment of a beetroot extract leads to thermal degradation of betanin and results in a reduction of betanin and the production of decarboxylated derivatives of betanin, degradation of the pigments is dependent upon temperature, duration of heat treatment, pH, and water activity, and the ratios depend on extract production (Abstract; P42-P44, Introduction; P48, left column; P49, bottom right column-P50, top left column; and P52, Conclusion), and the color of the beetroot composition is a matter of choice, does not change the material function of the composition, and does not provide a patentable feature over the prior art. 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). Matters relating to ornamentation only which have no mechanical function cannot be relied upon to patentably distinguish the claimed invention from the prior art. In re Seid, 161 F.2d 229, 73 USPQ 431 (CCPA 1947).
With respect to claim 2, Nemzer is relied upon for the teaching of the composition of claim 1 as addressed above.
Regarding the recitation of wherein HPLC Ratio 1 > 0.3 in claim 2, Nemzer teaches the calculated HPLC Ratio 1 is equal to about 0.46 as addressed above in claim 1.
With respect to claim 3, Nemzer is relied upon for the teaching of the composition of claim 1 as addressed above.
Regarding the recitation of wherein HPLC Ratio 2 > 0.3 in claim 3, the claimed HPLC Ratio 2 of > 0.3 and the value of Nemzer of about 0.21 are close enough that one skilled in the art would have expected them to have the same color characteristics. Applicant is reminded a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%); In re Scherl, 156 F.2d 72, 74-75, 70 USPQ 204, 205-206 (CCPA 1946) (prior art showed an angle in a groove of up to 90° and an applicant claimed an angle of no less than 120°); and In re Brandt, 886 F.3d 1171, 1177, 126 USPQ2d 1079, 1082 (Fed. Cir. 2018)(the court found a prima facie case of obviousness had been made in a predictable art wherein the claimed range of "less than 6 pounds per cubic feet" and the prior art range of "between 6 lbs./ft3 and 25 lbs./ft3" were so mathematically close that the difference between the claimed ranges was virtually negligible absent any showing of unexpected results or criticality.)
Additionally, 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 HPLC Ratio 2 through routine experimentation with the expectation of successfully preparing an aesthetically desirable colorant composition. One of ordinary skill in the art would have been motivated to do so because Nemzer teaches heat treatment of a beetroot extract leads to thermal degradation of betanin and results in a reduction of betanin and the production of decarboxylated derivatives of betanin, degradation of the pigments is dependent upon temperature, duration of heat treatment, pH, and water activity, and the ratios depend on extract production (Abstract; P42-P44, Introduction; P48, left column; P49, bottom right column-P50, top left column; and P52, Conclusion), and the color of the beetroot composition is a matter of choice, does not change the material function of the composition, and does not provide a patentable feature over the prior art. 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). Matters relating to ornamentation only which have no mechanical function cannot be relied upon to patentably distinguish the claimed invention from the prior art. In re Seid, 161 F.2d 229, 73 USPQ 431 (CCPA 1947).
With respect to claims 4 and 5, Nemzer is relied upon for the teaching of the composition of claim 1 as addressed above.
Regarding the recitation of further having the flowing features: a λmax from 495 to 524 nm, measured in aqueous buffer solution at pH 6; and a hue angle h according to the CIE L*C*h* color space, from 5 to 55 in claim 4 and wherein λmax is from 504 to 520 nm; and the hue angle h is from 8 to 35 in claim 5, it is noted that this recitation relates to functional language. Applicant is reminded that language that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation. The following types of claim language may raise a question as to its limiting effect: (A) statements of intended use or field of use, including statements of purpose or intended use in the preamble, (B) "adapted to" or "adapted for" clauses, (C) "wherein" or "whereby" clauses, (D) contingent limitations, (E) printed matter, or (F) terms with associated functional language. See MPEP 2103 and 2111.04.
Absent any clear and convincing evidence to the contrary, the composition would naturally arrive at these claimed features since Nemzer teaches a composition that is substantially similar to the presently claimed composition as addressed above in claim 1, and Nemzer teaches heat treatment of a beetroot extract leads to thermal degradation of betanin and results in a reduction of betanin and the production of decarboxylated derivatives of betanin as well as degradation of the pigments is dependent upon temperature, duration of heat treatment, pH, and water activity (Abstract; P42-P44, Introduction; P48, left column; P49, bottom right column-P50, top left column; and P52, Conclusion). Additionally, the functional language is not considered to confer patentability to the claim. Matters relating to ornamentation only which have no mechanical function cannot be relied upon to patentably distinguish the claimed invention from the prior art. In re Seid, 161 F.2d 229, 73 USPQ 431 (CCPA 1947).
With respect to claim 6, Nemzer is relied upon for the teaching of the composition of claim 1 as addressed above.
Regarding the recitation of having a moisture content of less than 15 wt.% in claim 6, Nemzer teaches the composition has a moisture content within the range of 3-5% (P44, Sample material preparation procedures-Spray-drying process).
With respect to claim 7, Nemzer teaches a formulation (Abstract).
Regarding the recitation of comprising 5 to 70 wt.%, based on the weight of the formulation, of the beetroot composition according to claim 1, and a carrier or solvent in claim 7, Nemzer is relied upon for the teaching of the claimed beetroot composition as addressed above in claim 1, and the reference additionally teaches the formulation comprises 50% of the beetroot composition. Nemzer also teaches the formulation comprises a carrier agent (P44, Sample material preparation procedures-Spray-drying process).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Nemzer et al., “Betalainic and nutritional profiles of pigment-enriched red beet root (Beta vulgaris L.) dried extracts” (hereinafter “Nemzer”) as applied to claim 1 above, and further in view of Pietrzkowski US 20110190230 (hereinafter “Pietrzkowski’).
With respect to claim 8, Nemzer teaches food (P47, bottom right column; and P52, Conclusion).
Regarding the recitation of comprising 0.01 to 15 wt.%, based on the weight of the foodstuff, of the beetroot composition according to claim 1, wherein the foodstuff is a beverage, a dairy, product, a chocolate product, a savoury product, or a confectionary in claim 8, Nemzer is relied upon for the teaching of the claimed beetroot composition as addressed above in claim 1, and the reference additionally teaches food containing the beetroot composition (P47, bottom right column; and P52, Conclusion).
However, Nemzer does not expressly disclose the quantity of beetroot composition in the foodstuff or the particular foodstuff selected.
Pietrzkowski teaches a beetroot compositions comprising betalains. The composition may be used in food, such as drinks and confectionaries, in an amount of at least 2 wt% to at most 20 wt% (Abstract; and paragraphs [0011], [0022]-[0026], and [0030]-[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 Pietrzkowski, to select drinks and confectioneries based in their suitability for their intended purpose as well as to select any portions of the disclosed range of composition, including the instantly claimed range, from the ranges disclosed in the prior art reference, with the expectation of successfully preparing a functional product. One of ordinary skill in the art would have been motivated to do so because Pietrzkowski and Nemzer similarly teach food comprising betalain containing beetroot compositions, Nemzer teaches the beetroot composition can be used as healthy pigments in food and pharmaceutical industry (P52, Conclusion), 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 an 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). "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 Arguments
Applicant’s remarks filed February 11, 2026 are acknowledged.
Applicant’s arguments with respect to the 35 USC 102 rejection in the previous Office Action have been fully considered and are persuasive (P8, bottom-P9). Therefore, the 35 USC 102 rejection of claims 1-7 over Nemzer has been withdrawn. However, the 35 USC 103 rejection of claims 1-7 over Nemzer is maintained.
Applicant’s arguments with respect to Nemzer have been fully considered, but they are unpersuasive.
Applicant argues the claimed HPLC ratios are not present in Nemzer. The value for HPLC Ratio 2 based on data in Nemzer is outside the value of claim 1. A composition of the invention cannot be achieved according to the process of Nemzer, both in terms of HPLC Ratio 1 and 2, as well as λmax and hue angle (optical properties, claims 4 and 5). The effect of these features is a beetroot composition having a specific bright red color shade that is stable over a pH range from 3 to 7. The skilled person cannot derive this composition or a method for obtaining the composition from Nemzer. Nemzer neither discloses nor inherently yields the specific compositional features required by claim 1, and no teaching or suggestion is provided that would enable or motivate modification of the disclosed process to arrive at the claimed composition. A composition may be patentable if the color is tied to specific, structural or compositional features such as a defined combination of beetroot pigments (e.g., betalains) at particular ratios or concentrations (claim 1). A composition that produces a specified color under defined conditions (pH, solvent, substrate, processing conditions) may also be patentable, as is a composition where the color reflects a functional technical effect (e.g., improved stability, lightfastness, heat resistance, or reduced browning compared to the prior art). Although certain individual compounds may overlap, including 17-decarboxybetanin, the mere presence of some common constituents is insufficient to establish identity of composition or inherency of properties. The overall compositional profile, which governs the optical characteristics of the composition, differs, as evidenced by the distinct HPLC chromatograms. These differences in composition directly result in the observed differences in λmax and hue angle and confirm that the claimed properties are not inevitable or inherent outcomes of the Nemzer disclosure. Nemzer provides no teaching, suggestion, or motivation to modify its process to obtain a composition having the claimed optical parameters of claims 4 and 5, nor does it provide any reasonable expectation of success in doing so (P6-P13).
Examiner disagrees. The claimed composition is obvious in view of Nemzer, and there is ample motivation within the reference to arrive at the presently claimed invention. Applicant is reminded that obviousness can 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. In re Kahn, 441 F.3d 977, 986, 78 USPQ2d 1329, 1335 (Fed. Cir. 2006).
As addressed above, Nemzer teaches the claimed HPLC 1 ratio. Although the calculated HPLC Ratio 2 of Nemzer is outside of the claimed range, the claimed HPLC Ratio 2 of ≥ 0.25 and the value of Nemzer of about 0.21 are close enough that one skilled in the art would have expected them to have the same color characteristics since Nemzer teaches the composition comprises chemical compounds (15-decarboxybetanin, betanin, and isobetanin) that are identical to those in the claimed beetroot composition. Applicant is reminded a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); In re Scherl, 156 F.2d 72, 74-75, 70 USPQ 204, 205-206 (CCPA 1946); and In re Brandt, 886 F.3d 1171, 1177, 126 USPQ2d 1079, 1082 (Fed. Cir. 2018).
Also, one of ordinary skill in the art would have been motivated to optimize the HPLC Ratio 2 through routine experimentation with the expectation of successfully preparing an aesthetically desirable colorant composition because Nemzer teaches heat treatment of a beetroot extract leads to thermal degradation of betanin and results in a reduction of betanin and the production of decarboxylated derivatives of betanin, degradation of the pigments is dependent upon temperature, duration of heat treatment, pH, and water activity, and the ratios depend on extract production (Abstract; P42-P44, Introduction; P48, left column; P49, bottom right column-P50, top left column; and P52, Conclusion), and the color of the beetroot composition is a matter of choice, does not change the material function of the composition, and does not provide a patentable feature over the prior art. “[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). Matters relating to ornamentation only which have no mechanical function cannot be relied upon to patentably distinguish the claimed invention from the prior art. In re Seid, 161 F.2d 229, 73 USPQ 431 (CCPA 1947).
Additionally, the claimed λmax and the hue angle h relate to functional language, and the functional language is not considered to confer patentability to the claim. Applicant is reminded that language that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation. See MPEP 2103 and 2111.04. Absent any clear and convincing evidence to the contrary, the composition would naturally arrive at these claimed features since Nemzer teaches a composition that is substantially similar to the claimed composition and comprises chemical compounds (17-decarboxybetanin, 17-decarboxyisobetanin, 15-decarboxybetanin, betanin, and isobetanin) that are identical to those in the claimed composition, and Nemzer teaches heat treatment of a beetroot extract leads to thermal degradation of betanin and results in a reduction of betanin and the production of decarboxylated derivatives of betanin as well as degradation of the pigments is dependent upon temperature, duration of heat treatment, pH, and water activity (Abstract; P42-P44, Introduction; P48, left column; P49, bottom right column-P50, top left column; and P52, Conclusion). Applicant is reminded that matters relating to ornamentation only which have no mechanical function cannot be relied upon to patentably distinguish the claimed invention from the prior art. In re Seid, 161 F.2d 229, 73 USPQ 431 (CCPA 1947).
Further, the features described by the Applicant are indeed expected in view of Nemzer since Nemzer teaches stable, red colorant compositions comprising chemical compounds (17-decarboxybetanin, 17-decarboxyisobetanin, 15-decarboxybetanin, betanin, and isobetanin) that are identical to those in the claimed composition (P42-P44, Introduction; P44-P45, Betalain-rich red beet extraction process; P46, Table 1; and P47, Table 2). Applicant is reminded that any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In other words, the unexpectedness must be sufficient “to secure the validity of the claims in suit.” Syntex (U.S.A.) LLC v. Apotex, Inc., 407 F.3d 1371, 1381 (Fed. Cir. 2005) and MPEP 716.02.
Conclusion
THIS ACTION IS MADE FINAL. 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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/T.L.M/Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793
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