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 .
Status of the Application
Receipt of the Response and Amendment after Non-Final Office Action filed May 19, 2026 is acknowledged.
The status of the claims upon entry of the present amendments stands as follows:
Pending claims:
1-4, 8-18
Withdrawn claims:
9-16
Previously canceled claims:
5-7
Newly canceled claims:
None
Amended claims:
1
New claims:
17-18
Claims currently under consideration:
1-4, 8, 17-18
Currently rejected claims:
1-4, 8, 17-18
Allowed claims:
None
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-4, 8 are rejected under 35 U.S.C. 103 as being unpatentable over Baublits (US PGPub 2009/0098254 A1)(IDS Reference filed 04/16/2025) in view of Dias (Dias, Sandra, et al. “Natural Pigments of Anthocyanin and Betalain for Coloring Soy-Based Yogurt Alternative”, Foods 2020, 9, 771, published June 11, 2020 [accessed online February 10, 2026]) and HDJ (EP 3170403 A1)(IDS Reference filed 12/22/2022).
Regarding claim 1, Baublits teaches a composition for improving sensory and shelf life characteristics of raw meat products comprising an organic acid and bioflavonoid compound (Abstract), where the organic acid can be any organic acid or salt thereof suitable for meat products, including acetic acid, at an amount from 0.01 to about 35 wt.% ([0018], which overlaps with the claimed range of “between 30 and 80% (w/w)”) and that the bioflavonoid may be anthocyanidins present in an amount from 0.01 to about 35 wt% ([0018], which overlaps with the claimed range of “between 0.04 and 2.5%”). Although Baublits does not explicitly teach that the composition does not comprise a nitrite or salt thereof, Baublits is silent regarding any addition of a nitrite or salt thereof and does not suggest the inherent inclusion of a nitrite or salt thereof.
Baublits does not teach wherein the source of anthocyanidins is red radish extract or the composition comprising both acetate and lactate in a molar ratio of lactic acid equivalent to acetic acid equivalent of 0.5:1 to 1.7:1.
Regarding the composition comprising a source of anthocyanidins, wherein the source of anthocyanidin is red radish extract, Dias teaches of natural food pigments (Abstract). Dias teaches using extract from red radish as a pigment (Abstract).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the composition of Baublits with the use of a pigment derived from Dias. One of ordinary skill would have been motivated to make this modification because Dias teaches that red radish extract is rich in anthocyanins (Abstract), and that anthocyanins have colorimetric potential as well as enormous benefits for health (p. 2, ¶ 1). Anthocyanins are known in the art to comprise anthocyanidin. Evidence to support that anthocyanins comprise anthocyanidin is provided by the instant specification, which teaches that anthocyanins are glycosylated anthocyanidins (p. 6, line 34).
Although the cite prior art does not disclose including the source of anthocyanidin in the claimed amount, Baublits states that the composition contains enough plant extract product in an amount sufficient to provide the flavonoid concentrations. Therefore, one of ordinary skill in the art would have adjusted the amount of the source of anthocyanidin provided during routine optimization to find the amount that resulted in the desired concentration of anthocyanidin. MPEP §2144.05(II) states where 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). The claimed range would thus be obvious.
Regarding the composition comprising both acetate and lactate in a molar ratio of lactic acid equivalent to acetic acid equivalent of 0.5:1 to 1.7:1, HDJ teaches a food preservative system comprising an alkanoate component such as acetic acid or salts thereof ([0001]) and additionally comprises a component chosen from lactic acid or a salt thereof ([0034]). HDJ further teaches a lactate and acetate component comprising 49.5% sodium lactate (i.e., a salt of lactic acid) and 49.5% sodium acetate (i.e., a salt of acetic acid; [0100]), which is the equivalent of a 1:1 ratio of lactate to acetate by weight. The molar mass of sodium lactate is 112.06 g/mol, and the molar mass of sodium acetate is 82.03 g/mol.
112.06
g
m
o
l
:
82.03
g
m
o
l
=
1.366
g
m
o
l
:
1
g
m
o
l
=
0.73
m
o
l
g
:
1
m
o
l
g
0.73
m
o
l
g
:
1
m
o
l
g
*
1
g
:
1
g
=
0.73
m
o
l
:
1
m
o
l
Therefore, the molar ratio of the sodium lactate to sodium acetate in the composition is 0.73:1, which falls within the claimed range of “0.5:1 to 1.7:1”.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to substitute the acetic acid of Baublits with the 0.73:1 molar ratio composition of sodium lactate and sodium acetate taught by HDJ. Because Baublits says that the salt of organic acids are also suitable for use, one of ordinary skill would recognize that a composition with sodium acetate and sodium lactate would be an art suitable equivalent for an organic acid to preserve a meat product. One of ordinary skill would have then been capable of performing the simple substitution of sodium lactate and sodium acetate in place of the organic acid, including acetic acid, in the composition of Baublits and yield predictable results of a meat preservative composition. The claim would have been obvious because one of ordinary skill in the art would have been able to make this simple substitution of one known element for another and yield predictable results to one of ordinary skill in the art, see MPEP §2143(B).
With respect to the overlapping ranges, MPEP §2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
Regarding claim 2, Baublits does not teach the composition comprising both acetate and lactate in a molar ratio of lactic acid equivalent : acetic acid equivalent of 0.6:1 to 1.65:1.
However, in the same field of endeavor of meat preservation, HDJ teaches a food preservative system comprising an alkanoate component such as acetic acid or salts thereof ([0001]) and additionally comprises a component chosen from lactic acid or a salt thereof ([0034]). HDJ further teaches a lactate and acetate component comprising 49.5% sodium lactate (i.e., a salt of lactic acid) and 49.5% sodium acetate (i.e., a salt of acetic acid; [0100]), which is the equivalent of a 0.73:1 molar ratio, which falls within the claimed range of “0.6:1 to 1.65:1”.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to substitute the acetic acid of Baublits with the 0.73:1 molar ratio composition of sodium lactate and sodium acetate taught by HDJ. Because Baublits says that the salt of organic acids are also suitable for use, one of ordinary skill would recognize that a composition with sodium acetate and sodium lactate would be an art suitable equivalent for an organic acid to preserve a meat product. One of ordinary skill would have then been capable of performing the simple substitution of sodium lactate and sodium acetate in place of the organic acid, including acetic acid, in the composition of Baublits and yield predictable results of a meat preservative composition. The claim would have been obvious because one of ordinary skill in the art would have been able to make this simple substitution of one known element for another and yield predictable results to one of ordinary skill in the art, see MPEP §2143(B).
Regarding claim 3, Baublits does not teach the composition comprising both acetate and lactate in a molar ratio of lactic acid equivalent : acetic acid equivalent of 0.7:1 to 1.6:1.
However, in the same field of endeavor of meat preservation, HDJ teaches a food preservative system comprising an alkanoate component such as acetic acid or salts thereof ([0001]) and additionally comprises a component chosen from lactic acid or a salt thereof ([0034]). HDJ further teaches a lactate and acetate component comprising 49.5% sodium lactate (i.e., a salt of lactic acid) and 49.5% sodium acetate (i.e., a salt of acetic acid; [0100]), which is the equivalent of a 0.73:1 molar ratio, which falls within the claimed range of “0.7:1 to 1.6:1”.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to substitute the acetic acid of Baublits with the 0.73:1 molar ratio composition of sodium lactate and sodium acetate taught by HDJ. Because Baublits says that the salt of organic acids are also suitable for use, one of ordinary skill would recognize that a composition with sodium acetate and sodium lactate would be an art suitable equivalent for an organic acid to preserve a meat product. One of ordinary skill would have then been capable of performing the simple substitution of sodium lactate and sodium acetate in place of the organic acid, including acetic acid, in the composition of Baublits and yield predictable results of a meat preservative composition. The claim would have been obvious because one of ordinary skill in the art would have been able to make this simple substitution of one known element for another and yield predictable results to one of ordinary skill in the art, see MPEP §2143(B).
Regarding claim 4, Baublits also teaches the inclusion of a bioflavonoid that may be anthocyanidins, and are present in an amount from about 0.001 to about 7.5 wt.% ([0020], which encompasses the claimed range of “between about 0.08 and 1.2% (w/w)”).
With respect to the overlapping ranges, MPEP §2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
Regarding claim 8, Baublits also teaches the invention comprises at least one bioflavonoid (Abstract), where bioflavonoids are a type of polyphenol. One of ordinary skill in the art would have found it obvious to include other bioflavonoids in addition to the anthocyanidin as discussed above. Therefore, it would have been obvious for the composition of Baublits to comprise 0.001 to 7.5 wt.% of polyphenols as bioflavonoids ([0020]), which encompasses the claimed range of “200-10000 mg/kg” (equivalent to 0.02-1%).
With respect to the overlapping ranges, MPEP §2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Baublits (US PGPub 2009/0098254 A1)(IDS Reference filed 04/16/2025) in view of Dias (Dias, Sandra, et al. “Natural Pigments of Anthocyanin and Betalain for Coloring Soy-Based Yogurt Alternative”, Foods 2020, 9, 771, published June 11, 2020 [accessed online February 10, 2026]) and HDJ (EP 3170403 A1)(IDS Reference filed 12/22/2022) as applied to claim 1 above, and further in view of Mane (US 2015/0017303 A1).
Regarding claim 17, the cited prior art does not teach wherein the red radish extract comprises spray dried red radish juice.
However, in the same field of endeavor, Mane teaches of an anthocyanidin colorant composition (Abstract) produced from red radish ([0005]) that can be present in a powder ([0044]; [0101], Table 4).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to substitute the red radish extract of Dias with the use of a powdered red radish colorant as taught by Mane with a reasonable expectation of success. The claim would have been obvious because one of ordinary skill in the art would have been able to make this simple substitution of one known element for another and yield predictable results to one of ordinary skill in the art, see MPEP §2143(B).
Although Mane does not teach that the extract comprises spray dried red radish juice, this limitation is a product-by-process limitation. MPEP §2113 states “[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, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). “The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product.” The structure imparted by the recited spray drying process is a powdered red radish extract. Thus, Mane is sufficient to teach the claimed red radish extract.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Baublits (US PGPub 2009/0098254 A1)(IDS Reference filed 04/16/2025) in view of Dias (Dias, Sandra, et al. “Natural Pigments of Anthocyanin and Betalain for Coloring Soy-Based Yogurt Alternative”, Foods 2020, 9, 771, published June 11, 2020 [accessed online February 10, 2026]), HDJ (EP 3170403 A1)(IDS Reference filed 12/22/2022) and Mane (US 2015/0017303 A1) as applied to claim 17 above, and further in view of Robbins (US 2015/0374009 A1).
Regarding claim 18, the cited prior art does not teach the red radish extract comprising maltodextrin.
However, in the same field of endeavor, Robbins teaches mixing anthocyanidin colorants with maltodextrin to facilitate use ([0075]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the red radish extract of Mane and Dias to also include maltodextrin as taught by Robbins. One of ordinary skill would have been motivated to make this modification because Robbins teaches that maltodextrin is a known additive to colorants to facilitate use ([0075]).
Although Robbins does not teach that the red radish extract is spray dried onto maltodextrin, this limitation is a product-by-process limitation. MPEP §2113 states “[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, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). “The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product.” The structure imparted by the recited spray drying process is a powdered red radish extract with maltodextrin. Thus, the cited prior art is sufficient to teach the claimed invention.
Response to Arguments
Claim Rejections - 35 U.S.C. §112(a): Applicant has overcome the 35 U.S.C. § 112(a) rejections of claim 1 based on amendments to the claims and/or cancelation. Accordingly, the 35 U.S.C. § 112(a) rejections have been withdrawn.
Claim Rejections – 35 U.S.C. §103 of claims 1-4 and 8 over Baublits, Dias, and HDJ: Applicant’s arguments filed May 19, 2026 have been fully considered but they are not persuasive.
Applicant argued that the cited references do not provide a proper motivation for selecting a red radish extract for the claimed invention and that Dias does not suggest that the pigment would work in a different food system (Remarks, p. 6, ¶ 3- p. 7 ¶ 2, p. 7, ¶ 4).
This argument has been considered. However, there is no evidence in Dias or provided by the applicant to suggest that the usefulness of red radish extract for pigmentation and health benefits is unique to use in the yogurt product of Dias. Red radish extract as a pigment is well known in the art to be useful in many different food products. Therefore, the Examiner maintains that is would have been obvious to one of ordinary skill in the art to use the red radish extract disclosed by Dias as the source of anthocyanidins in the composition of Baublits to provide both pigmentation and additional health benefits.
Applicant further argued that HDJ does not supply the missing motivation (Remarks, p. 7, ¶ 3)
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant further argued that there is no reasonable expectation of success in combining the red radish pigment of Dias with the invention of Baublits (Remarks, p. 8, ¶ 1-5).
This argument has been considered. However, there is no evidence in Dias or provided by the applicant to suggest that red radish extract will only work in the product of Dias. Red radish extract as a pigment is well known in the art to be useful in many different food products. Therefore, the Examiner maintains that is would have been obvious to one of ordinary skill in the art to use the red radish extract disclosed by Dias as the source of anthocyanidins in the composition of Baublits to provide both pigmentation and additional health benefits.
Applicant also argued that the combination of references fails to teach the composition of new claims 17 and 18 (Remarks, p. 8, ¶ 6- p. 9, ¶ 2).
Applicant' s argument is persuasive to the extent that the new claims 17 and 18 are not taught by Baublits, Dias, and HDJ. However, as described in the rejection above, claim 17 is rendered obvious over Baublits, Dias, HDJ, and Mane and claim 18 is rendered obvious by Baublits, Dias, HDJ, Mane, and Robbins.
Applicant further argued that the specification provides evidence of unexpected results for the claimed invention (Remarks, p. 9, ¶ 3- p. 11, ¶ 1).
This argument has been considered. However, the Examiner maintains that the data provided is not commensurate in scope with the claimed invention. Claim 1 is directed merely to “a composition”. The data provided in the instant specification is directed specifically to a composition that is applied to 70% pork. There is no data provided for the performance of the composition across different uses or products. Furthermore, the data provided does not encompass the claimed range. Even when only considering the results of red radish powder compared to other sources of anthocyanidin, the use of red radish powder is not tested over the entire claimed range.
MPEP §716.02(d) states that “Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980)” and “To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960).”
The rejections of claims 1-4, 8, 17-18 have been maintained herein.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amanda S Hawkins whose telephone number is (703)756-1530. The examiner can normally be reached M-Th 8:00a-4:00p, F 8:00a-1:00p ET.
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/A.S.H./Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793
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