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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 7, 2026 has been entered.
Claim Status
The status of the claims upon entry of the present amendments stands as follows:
Pending claims:
1-4, 8-16
Withdrawn claims:
9-16
Previously canceled claims:
None
Newly canceled claims:
5-7
Amended claims:
1
New claims:
None
Claims currently under consideration:
1-4, 8
Currently rejected claims:
1-4, 8
Allowed claims:
None
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 has been amended to recite the limitation “between 0.04 and 2.5% (w/w) of a source of anthocyanidin, wherein the source of anthocyanidin is red radish extract”. This limitation lacks support in the original disclosure of the application. Although the instant specification does state that the source of anthocyanidin may be may be from red radish extracts, the instant specification does not provide support for the source of anthocyanidin being present in an amount between 0.04 and 2.5% (w/w).
The instant specification states that the composition comprises a source of anthocyanidin, and that the source of anthocyanidins contains at least 0.3%, more preferably 0.5-10% of anthocyanidins (p. 11, lines 21-23). The only location in the instant specification that addresses the amount of red radish in the composition is Table 5 on p. 11. Table 5 states that experiments A and 1 comprised 0.3 and 0.2 wt% red radish powder (i.e., a red radish extract), respectively. Therefore, the instant specification only provides support for the composition comprising between 0.2 and 0.3 wt% a source of anthocyanidin, wherein the source of anthocyanidin is red radish extract.
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. 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 the composition comprising a source of anthocyanidins, wherein the source of anthocyanidin 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 in view of HDJ teaches all elements of claim 1 as described above.
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 in view of HDJ teaches all elements of claim 2 as described above.
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 in view of HDJ teaches all elements of claim 1 as described above. 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 in view of HDJ teaches all elements of claim 1 as described above. 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.
Response to Arguments
Claim Rejections – 35 U.S.C. §103 of claims 1-4 and 8 over Baublits and HDJ: Applicant’s arguments filed January 7, 2026 have been fully considered but they are not persuasive.
Applicant argued that because Baublits and HDJ do not describe red radish extract, a prima facie case of obviousness has not been established (Remarks, p. 5, ¶ 5).
Applicant' s arguments have been fully considered and are persuasive to the extent that the claims as presently amended would not be anticipated/obvious in view of Baublits and HDJ. However, upon further consideration, a new ground(s) of rejection is made in view of Baublits, Dias, and HDJ.
Applicant argued that the composition of the present invention provided unexpectedly better results (p. 6, ¶ 1- p. 7, ¶ 2).
This argument has been considered. However, the data provided for unexpected results is not commensurate in scope with the claimed invention. Claim 1 is merely directed to “a composition”, whereas all of the data provided is only for applying said composition to 70% pork (see Table 1 of instant specification). No data is provided for the performance of the composition across different products. Furthermore, the data provided does not span the entire range of data provided in claim 1. 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).” Thus, the applicant has not successfully demonstrated a showing of unexpected results of the claimed invention.
The rejections of claims 1-4 and 8 have been maintained herein
Conclusion
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/A.S.H./Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793