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 .
Priority
The instant application, filed 10/08/2019, is a 371 filing of PCT/US2018/055153, filed 10/10/2018, which claims priority to provisional U.S. application number 62/570,313, filed 10/10/2017. Receipt is acknowledged of certified copies of papers required by 37 § CFR 1.55.
Amendments and Claim Status
The following amendment filed on 03/02/2026 is acknowledged and entered.
Claims 1, 2, 5, 7, 9, 11, 15, 16, and 19 are amended;
Claims 8, 21, 22, 26, 28, and 29 are cancelled;
Claims 1-7, 9-20, 23-25, 27, and 30 are pending and are under prosecution.
Response to arguments
Applicant’s arguments filed 03/02/2026 with respect to the claim objections and claim rejections under 35 U.S.C. §§ 112(b) and 103 have been fully considered.
Claims 1 and 15 are rejected under 35 U.S.C. § 112(b) as being indefinite, the removal of the terminology “hygroscopic antimicrobial ingredient,” resolves the indefiniteness and is sufficient to overcome the rejection. Accordingly, the rejection is hereby withdrawn.
With respect to the rejection of claims 1-3, 7, 8, 11, 13-18, 21-22, 25, and 27 under 35 U.S.C. § 103 as being unpatentable over Blanchard (EP 0838161) in view of Roozen (US 2017/0107468) and claims 1-3, 7, 8, 11, 13-18, 21-22, 25, 27, and 30 under 35 U.S.C. § 103 as being unpatentable over Blanchard in view of Roozen, and in further view of Finnegan (US 2017/0233773), the cancellation of claims 8, 21 and 22 render the rejection against said claims moot. Furthermore, the claim amendments made by Applicant have necessitated the inclusion of a new reference. The newly added reference meets all the limitations, and the rejection is not overcome by amendment. The arguments made by applicant are herein addressed as follows.
Applicant argues that the process taught by Blanchard cannot meet the amended claim limitation of “nitrite containing cultured celery juice concentrate” because beat extract and celery juice or distinct compositionally. Applicant contends that even if beet root inherently contains nitrite, the disclosure does not teach the specific use of cultured celery juice concentrate.
Applicant’s argument is found unconvincing because under 35 U.S.C. § 103, disclosure of the specific claimed embodiment is not required. A person of ordinary skill in the art would find it obvious to substitute celery juice for beat extract. Both are well-known to contain nitrite. As such, an additional reference has been incorporated into said rejection in order to accommodate the new limitation.
Applicant argues the example taught by Blanchard does not form a “liquid slurry composition” because the citric acid is added as an anhydrous solid, not a neutralized organic acid in an aqueous solution.
Applicant’s argument is unconvincing because Blanchard explicitly states that liquid beet extract was mixed with anhydrous citric acid and later spray dried (Blanche art, page 7, lines 41-43). The resulting mixture of concentrated liquid plant extract an organic acid constitutes a liquid slurry composition. The broadest reasonable interpretation of “aqueous solution to obtain a mixture in the form of a liquid slurry composition” does not require the organic acid to be pre-dissolved in pure water. The aqueous phase is provided by the liquid plant extract itself. With respect to the “neutralized acid,” Roozen teaches producing a neutralized organic acid (sodium acetate) by combining liquid vinegar with sodium hydroxide (Roozen claim 23).
Applicant argues the improved shelf stability regarding moisture resistance limitation reflects a genuine structural outcome produced by the claimed process, not merely a statement of intended comparison.
Applicant’s argument is not persuasive because the limitation within claims 1 and 15 merely states that the powder has improved shelf stability regarding moisture resistance compared to a composition prepared by separately drying and dry blending. Moreover, Blanchard directly teaches that the goal is to provide a stable composition (page 3, line 2), and of the organic acid improves the stability (page 4, lines 35-38). Roozen further teaches that incorporating a concentrated neutralized vinegar results in an extended shelf life and reduced microorganism growth (Roozen, paragraph [007]).
Applicant argues the claim process produces unexpected results—specifically, the formation of a glassy-crystal phase comprising anhydrous and hydrate form of the organic acid which requires the presence of a hygroscopic ingredient.
Applicant’s argument is not persuasive, to be persuasive, evidence of unexpected results must be objective (experimental data, comparative examples) commensurate in scope with the claims, and actually unexpected relative to the prior art (see MPEP §716.02 (b)). Applicant has submitted no comparative examples were experimental data worthy of secondary consideration. Moreover, any alleged unexpected results correspond only to dependent claims 11, 12, and 20. The results presented are not commensurate in scope with claims 1 and 15. Applicant has not demonstrated all brought embodiments within the scope of claims 1 and 15 produce the described crystal structure, and thus, any alleged unexpected results are not commensurate in scope with the independent claims. Furthermore, no additional data has been provided or discussed by Applicant to demonstrate any unexpected results. According to MPEP §716.02 (b) (I)
The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992) (Mere conclusions in appellants’ brief that the claimed polymer had an unexpectedly increased impact strength "are not entitled to the weight of conclusions accompanying the evidence, either in the specification or in a declaration."); Ex parte C, 27 USPQ2d 1492 (Bd. Pat. App. & Inter. 1992) (Applicant alleged unexpected results with regard to the claimed soybean plant, however there was no basis for judging the practical significance of data with regard to maturity date, flowering date, flower color, or height of the plant.). See also In re Nolan, 553 F.2d 1261, 1267, 193 USPQ 641, 645 (CCPA 1977) and In re Eli Lilly, 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) as discussed in MPEP § 716.02(c)
Thus, the burden is on the applicant to demonstrate that any asserted unexpected results are both significant and unexpected, and that they are directly attributable to the claimed invention. Importantly, the applicant must provide a comparison with the closest prior art. Mere attorney argument or conclusory statements without adequate supporting evidence or insufficient to rebut a prima facie case of obviousness.
Applicant argues Finnegan teaches the use of bacteria to produce 3HPA as a small molecule antimicrobial compound, and not to culture celery juice hygroscopic ingredient for antimicrobial powder.
Applicant’s argument is not persuasive because Finnegan is relied upon solely for its teaching of specific bacterial strains used in fermentation. Finnegan teaches Lactobacillus and Acetobacter lovaniesis as bacteria used in fermentation to produce antimicrobial agents or food products (Finnegan, example 12, paragraph [0079 and 0080]). These are among the species listed in instant claim 30. A person would have recognized these is known for great fermentation organisms applicable to culturing plant substrates including celery. The disclosure of 3HPA does not limit the relevance of Finnegan’s teaching of known bacterial strains for fermentation.
With respect to the rejection of claims 1-8, 11-22, 25, and 27 under 35 U.S.C. § 103 as being unpatentable over Boerefijn (US 2015/0225683) in view of Roozen and claims 1-25, 27, and 29 under 35 U.S.C. § 103 as being unpatentable over Boerefijn in view of Roozen, and in further view of King (Journal of Food Protection, Vol. 78, No. 5, 2015, Pages 946-53), the cancellation of claims 8, 21, and 22 are sufficient to render the rejection against these claims moot. Applicant’s arguments are addressed as follows.
Applicant argues Boerefijn is a vinegar on vinegar process in which vinegar serves as post a hygroscopic ingredient and the organic acid, and therefore cannot teach the instantly claimed composition of two distinct ingredients as recited in the instant claims. Applicant further argues that the interpretation of a fruit vinegar as a culture plant material solid is not the broadest reasonable interpretation of the claims.
Applicant’s argument is unpersuasive because Boerefijn is not relied upon to supply the celery juice concentrate limitation. In contrast, King explicitly discloses celery juice as a nitrite source combined with vinegar in food preservation (King, page 497, Table 2). The combination of Boerefijn, who teaches the power making process, with Roozen, who teaches improved shelf stability, and King, who teaches celery juice concentrate and vinegar combination, collectively teaches all the instant limitations.
Applicant argues Boerefijn does not form a liquid slurry composition as claimed because Boerefijn first spray dried is sodium acetate into a dry powder and then applies liquid vinegar to the powder, which is the reverse of the claimed process.
Applicant’s argument is not persuasive because example 1 of Boerefijn expressly discloses combining 300 g of concentrated grain vinegar in an aqueous solution, which forms a liquid slurry (pace that, paragraph [0069]). This liquid slurry is later spray dried. These initial steps form a liquid mixture of plant derived ingredient and neutralizing agent in an aqueous solution that is subsequently spray dried— directly meeting the claim limitations. When this process is modified by came to include celery juice concentrate as a hygroscopic ingredient, the combination constitutes the composition of the amended claims.
Applicant argues the weight limitation “1:100 to 100:100 w/w hygroscopic ingredient organic acid solids” cannot be mapped to Boerefijn, because Boerefijn uses a single material as both components.
Applicant’s argument is not persuasive because the teachings of Boerefijn are modified by King to include celery juice concentrate as a distinct hygroscopic ingredient to be combined with sodium acetate.
Applicant argues that neither Boerefijn nor Roozen discloses nitrite-containing cultured celery juice concentrate.
Applicant’s argument is not persuasive because the modifying reference, King, especially teaches celery juice as the nitrite source to be combined with vinegar.
Applicant argues there is no motivation to combine Boerefijn with the teachings of King, because King does not teach producing a powder or co-drying.
Applicant’s argument is not persuasive because the motivation to combine does not require each reference to teach the identical processes claimed. Both Boerefijn and Roozen are directed to the common field preserving food for human consumption using stabilizing agents. King teaches that celery juice combined with vinegar is an effective food preservation combination or process needs. A person having ordinary skill in the art seeking to produce a stable antimicrobial powder incorporating the known food preservation benefits celery juice nitrite and vinegar would have been directly motivated to combine the teachings.
Applicant argues the claimed process produces unexpected results, and that the trihydrate sodium acetate product taught by Boerefijn cannot accommodate hygroscopic components like celery juice because additional moisture would melt the trihydrate crystals.
Applicant’s argument is found unconvincing because no objective evidence has been submitted to support the claims. Additionally, applicant’s argument regarding addresses only specific embodiment, and does not address the initial liquid slurry formation and spray drying steps. The claimed liquid slurry and spray drying process meets the limitations, without requiring the trihydrate formation that Applicant criticizes.
Regarding claims 11, 12, and 20 which recites specific crystal structure ratios of anhydrous/hydrate forms, as well as claims 14 and 18 reciting specific water content property, while these claims are not expressly disclose in the cited prior art, because the claimed process is taught by the prior art, these properties would necessarily result from carrying out the disclose process, and represent routine optimization process conditions within the skill of the art.
Thus, all arguments presented by Applicants have been addressed and are found unpersuasive for the reasons presented herein and in the previous non-final rejection. Applicants are reminded that “attorney argument [is] not the kind of factual evidence that is required to rebut a prima facie case of obviousness.” In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997). The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965).
Claim Interpretation
The instant claims are subject to the following interpretations:
Independent claims 1 and 15 recite two distinct powders that may be produced by distinct processes; the first of which is the instantly claimed process of combining (A) a hygroscopic ingredient comprising a nitrite containing cultured celery juice with a (B) neutralized antimicrobial organic acid, and subsequently drying the composition. This process of mixing and later drying is what Applicant alleges to be distinct from a composition prepared by a process of: (i) separately drying the hygroscopic and neutralized antimicrobial organic acid, and (ii) combining the dry ingredients in a dry blending process. Under the broadest reasonable interpretation of the claims set forth in MPEP § 2111, the comparative composition only limits the instant claims insofar as the instant claimed process must result in a powder having "improved shelf stability regarding moisture resistance" compared to the shelf stability obtainable by separately drying and later combining in a dry blending process. The claimed inventive step of the instantly claimed process is interpreted to be: combining the ingredients, and then put drying them. Any reference to the “comparative composition” or the “comparative process” refers directly to a composition which is prepared by separately drying, and later combining the dried components.
The recitation of “flowable antimicrobial powder” is interpreted as an inherent property of the of the composition produced by the instantly claimed process. Where the prior art structure is capable of performing the instantly recited limitation, the limitation is satisfied (see section MPEP § 2163.07 (a) and the court decisions used therein).
Finally, there is no limitation of claim 1 or 15 to exclude other ingredients, such as carrier ingredients (i.e. liquid carrier solvents or solid carrier ingredients) as the method or process of claim 1 recites the transitional phrase “comprising,” allowing for additional steps and excipients in the claimed process. Thus, prior art disclosing plant solids, whether dispersed in a dry or liquid carrier, are interpreted to teach the limitation of claim 1. More specifically, the claim language “comprising” is an open transitional phrase, and the process reciting the instantly claimed process and resulting antimicrobial powder composition are interpreted as being inclusive, or open ended, not excluding additional, un-recited elements or method steps (see MPEP § 2111.03).
Claim Rejections - 35 U.S.C. § 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.
Claims 1-7, 10-20, 23-25, 27, and 30 are rejected under 35 U.S.C. § 112 (a), or 35 U.S.C. § 112 (pre-AIA ) first paragraph, because the specification, while being enabling for a process of producing a flowable antimicrobial powder comprising combining cultured celery juice concentrate a neutralized vinegar of an acetate salt, it does not reasonably provide enablement for the combination of celery juice with a neutralized organic acid of propanoic acid, citric acid, lactic acid, formic acid, glycolic acid, and malic acid. The specification does not provide sufficient information to support the claimed invention.
The instant specification fails to provide information that would allow the skilled artisan to fully practice the instant invention without undue experimentation. Attention is directed to In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
(1) the nature of the invention;
(2) the state of the prior art;
(3) the relative skill of those in the art;
(4) the predictability or unpredictability of the art;
(5) the breadth of the claims;
(6) the amount of direction or guidance presented;
(7) the presence or absence of working examples; and
(8) the quantity of experimentation necessary.
All of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below.
Nature of the invention: Claims 1-7, 10-20, 23-25, 27, and 30 of the instant application are drawn a process of producing a flowable antimicrobial powder comprising the mixing of nitrite-containing cultured celery juice concentrate with any neutralized antimicrobial acid in an aqueous solution.
Breadth of the claims: The complex nature of the subject matter of this invention is greatly exacerbated by the breadth of the claims. The rejected claims are extremely broad. Applicant claims that the long list of organic acids can be used in the process of producing a flowable antimicrobial powder. Thus the cited claims are deemed very broad since these claims read on multiple distinct neutralized organic acid salts, all of which have distinct pK values.
State of the Prior Art: There are no art recognized methods that could be used to establish that the instantly claimed process can be performed at the wide range of pK values and with the various types of neutralized antimicrobial acids. The instantly claimed acids span a wide range of acidity and complexity (Table 28.1). According to Selli & Kelebek (Organic acids, in Handbook of Food Analysis (3rd Ed.) CRC Press, published in 2015), the monoprotic acids (formic, glycolic, lactic, acetic, and propionic) have pK values ranging from 3.7 to 4.87 and each form only a single salt. The instantly claimed diprotic malic acid has two pK values: 3.46 and 5.21, while the protic citric acid can form multiple salt species depending on the degree of neutralization with pK values of 2.79, 4.30, and 5.65. The structural and chemical diversity means the acids behave fundamentally differently in aqueous solution, which extends to their antimicrobial activity and their hygroscopicity. This raises the question of whether a single process description can enable the full scope of the claim across all the enumerated acids.
Predictability/Unpredictability in the Art: The pharmaceutical arts, particularly the treatment of cancer, are well-recognized as highly unpredictable, requiring each embodiment to be individually assessed for physiological activity. In re Fisher, 427 F.2d 833, 166 USPQ 18 (CCPA 1970) indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute. The courts have upheld that in unpredictable arts, a greater degree of specificity is required to satisfy the enablement requirement.
The list of neutralized antimicrobial acids claimed comprises a heterogeneous group with distinct chemical properties. Furthermore, the antimicrobial efficacy of each acid depends on the concentration of its undissociated form, which is governed by its pK value and the pH of the system. Because the claimed acids span a wide range of pK values and include both monoprotic and polyprotic species, the proportion of undissociated (active) acid present in any given slurry made when combined with cultured celery juice concentrate will differ substantially from acid to acid.
Additionally, each acid salt is different hygroscopicity, water activity, and drying parameters. This means that the conditions required to produce a flowable powder via spray, drum, vacuum, or freeze drying would need to be individually optimized for each acid. The interaction of each acid salt with the nitrite-containing celery juice concentrate adds a further variable, as pH shifts caused by different neutralization states could accelerate or inhibit nitrite activity unpredictably. The person of ordinary skill could therefore not simply substitute one asset for another and expect equivalent results without significant experimentation.
Guidance of the Specification/Working Examples: Applicant has only provided working examples suggesting that only buffered vinegar powder was used in the creation of the liquid slurry (Tables 1 and 2, pages 17-19). Thus, the specification fails to provide sufficient evidence in support of the process across the full scope of neutralized organic acids as recited in the instant claims.
The Quantitation of Experimentation Required: In order to practice Applicants invention, it would be necessary for one to design and conduct an exhaustive amount of complex experiments to demonstrate that the large range of organic acids can be used in the instantly claimed process. Therefore, in order to practice the claimed invention, the amount of experimentation required would be considered undue and burdensome. Such experimentation would necessarily include the optimization of the instantly claimed process for the acid and the pH conditions that are desired to create a flowable antimicrobial powder. The specification provides only limited examples to describe to the numerous distinct formulations that are recited in the instantly claimed process. Accordingly, determining which organic acids may effectively produce a flowable powder would require extensive, individualized experimentation, amounting to undue burden.
In conclusion, Genentech, 108 F.3d at 1366, states that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable”. A process of producing a flowable antimicrobial powder comprising the use of the wide range of organic acids is not enabled by the instant specification.
Claims 7, 15-20 and 23-25 are rejected under 35 U.S.C. § 112 (a), or 35 U.S.C. § 112 (pre-AIA ) first paragraph, because the specification, while being enabling for a process of producing a flowable antimicrobial powder comprising combining cultured celery juice concentrate with a neutralized vinegar of acetate salt, it does not enable the combination of cultured juice with beet, cabbage, cucumber, eggplant, mushroom, lettuce, squash, zucchini, mixed salad greens, carrot, artichoke, green beans, lima beans, broccoli, cauliflower, collard greens, corn, mustard, okra, onion, chinese pea pods, black eyed peas, green peas, potatoes, turnips, radishes, spinach, swiss chard, apple, apricot, banana, bilberry, blackberry, blackcurrant, blueberry, coconut, currant, cherry, cherimoya, clementine, cloudberry, date, damson, durian, elderberry, fig, feijoa, gooseberry, grape, grapefruit, huckleberry, jackfruit, jambul, jujube, kiwifruit, kumquat, lemon, lime, loquat, lychee, mango, melon, cantaloupe, honeydew, watermelon, rock melon, nectarine, orange, passionfruit, peach, pear, plum, plumcot, prune, pineapple, pomegranate, pomelo, purple mangosteen, raisin, raspberry, rambutan, redcurrant, satsuma, strawberry, tangerine, tomato or ugli fruit with any a neutralized vinegar of acetate salt. The specification does not provide sufficient information to support the claimed invention.
The instant specification fails to provide information that would allow the skilled artisan to fully practice the instant invention without undue experimentation. Attention is directed to In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
(1) the nature of the invention;
(2) the state of the prior art;
(3) the relative skill of those in the art;
(4) the predictability or unpredictability of the art;
(5) the breadth of the claims;
(6) the amount of direction or guidance presented;
(7) the presence or absence of working examples; and
(8) the quantity of experimentation necessary.
All of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below.
Nature of the invention: Claims 7, 15-20 and 23-25 of the instant application are drawn a process of producing a flowable antimicrobial powder comprising the mixing of nitrite-containing cultured celery juice concentrate with cultured plant material solids obtained from beet, cabbage, cucumber, eggplant, mushroom, lettuce, squash, zucchini, mixed salad greens, carrot, artichoke, green beans, lima beans, broccoli, cauliflower, collard greens, corn, mustard, okra, onion, chinese pea pods, black eyed peas, green peas, potatoes, turnips, radishes, spinach, swiss chard, apple, apricot, banana, bilberry, blackberry, blackcurrant, blueberry, coconut, currant, cherry, cherimoya, clementine, cloudberry, date, damson, durian, elderberry, fig, feijoa, gooseberry, grape, grapefruit, huckleberry, jackfruit, jambul, jujube, kiwifruit, kumquat, lemon, lime, loquat, lychee, mango, melon, cantaloupe, honeydew, watermelon, rock melon, nectarine, orange, passionfruit, peach, pear, plum, plumcot, prune, pineapple, pomegranate, pomelo, purple mangosteen, raisin, raspberry, rambutan, redcurrant, satsuma, strawberry, tangerine, tomato or ugli fruit.
Breadth of the claims: The complex nature of the subject matter of this invention is greatly exacerbated by the breadth of the claims. The rejected claims are extremely broad. Applicant claims that the long list of cultured plant material solid sources can be used in the process of producing a flowable antimicrobial powder. Thus the cited claims are deemed very broad since these claims read on multiple distinct plant material solids, all of which have different ultrastructure and chemical properties.
State of the Prior Art: There are no art recognized methods that could be used to establish that the instantly claimed process can be performed using the wide range of instantly claimed plant material solids. The instantly claimed plant material solids encompass a wide range of individual species. According to Bahadoran et al (J Food Comp Anal, Volume 51, pages 93-105, published June 23, 2016), hereinafter Bahadoran, nitrate and nitrite content often varies dramatically across the plant kingdom. Specifically, the prior art demonstrates that high nitrate accumulating vegetables such as radish, beetroot, lettuce, and celery are capable of serving as meaningful nitrate precursors for bacterial conversion to nitrite (Abstract, page 94). However, the mass majority contain low nitrite levels, representing differences of one or two orders of magnitude compared to the high nitrite vegetables (Abstract, Tables 2-4). The prior art therefore establishes that the claimed range of plant material solids encompasses species that are fundamentally incapable of performing the core function of the invention as disclosed due to their fundamental and inherent differences in nitrite and nitrate concentrations.
Predictability/Unpredictability in the Art: The pharmaceutical arts, particularly the treatment of cancer, are well-recognized as highly unpredictable, requiring each embodiment to be individually assessed for physiological activity. In re Fisher, 427 F.2d 833, 166 USPQ 18 (CCPA 1970) indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute. The courts have upheld that in unpredictable arts, a greater degree of specificity is required to satisfy the enablement requirement.
The list of plant material solids claimed comprises a heterogeneous group with distinct chemical and physical properties. Furthermore, the nitrite content found within the wide range of plant material solids claimed is incredibly variable (Tables 2-4), and constitutes much unpredictability with respect to the development of an effective and flowable antimicrobial powder. This wide variation is not merely quantitative, but it is also functional. Because the antimicrobial nitrite results from bacterial fermentation of vegetable nitrate, substrates with negligible starting nitrate cannot yield a “nitrate-containing” concentrate, as required by the claim, regardless of the fermentation conditions employed. This raises the question of whether a single process can enable the full scope of the claim across all the enumerated plant material solids. The person of ordinary skill could therefore not simply substitute one asset for another and expect equivalent results without significant experimentation.
Guidance of the Specification/Working Examples: Applicant has only provided working examples suggesting that only cultured celery juice concentrate was used in the creation of the liquid slurry (Tables 1 and 2, pages 17-19). Thus, the specification fails to provide sufficient evidence in support of the process across the full scope of neutralized organic acids as recited in the instant claims.
The Quantitation of Experimentation Required: In order to practice Applicants invention, it would be necessary for one to design and conduct an exhaustive amount of complex experiments to demonstrate that plant material solids can be used in the instantly claimed process. Therefore, in order to practice the claimed invention, the amount of experimentation required would be considered undue and burdensome. Such experimentation would necessarily include the optimization of the instantly claimed process for each and every one of the instantly claimed plant materials desired to create a flowable antimicrobial powder. The specification provides only limited examples to describe to the numerous distinct formulations that are recited in the instantly claimed process. Accordingly, determining which plant material solids may effectively produce a flowable powder would require extensive, individualized experimentation, amounting to undue burden.
In conclusion, Genentech, 108 F.3d at 1366, states that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable”. A process of producing a flowable antimicrobial powder comprising the use of the wide range of cultured plant material solids is not enabled by the instant specification.
Claim Rejections - 35 U.S.C. § 103
The following is a quotation of pre-AIA 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.
Claims 1-3, 7, 11, 13-18, 25, and 27 are rejected under 35 U.S.C. § 103 as being unpatentable over Blanchard (EP 0838161 A2, published April 29, 1998) in view of Hwang et al, (Food Sci Biotechnol, Volume 26, Issue 4, pages 929–936, published August 14, 2017) hereinafter Hwang, in view of Roozen (US 20170107468 A1, published April 20, 2017).
The instant claims are drawn to a process of producing flowable antimicrobial powder comprising the combination of a cultured celery juice with a neutralized antimicrobial organic acid and subsequently drying the composition. The claims are further drawn to the creation of a powder which has improved shelf stability regarding moisture resistance to a composition prepared by separately drying the hygroscopic ingredient, and neutralized antimicrobial organic acid in a dry blending process.
Regarding claims 1 and 15, Blanchard teaches a method of producing a dry powder, comprising a combination of beet extract (claim 13) and an organic acid (claim 14), to obtain a liquid slurry (claim 13), which is subsequently subjected to spray drying (claim 17) or freeze drying (claim 18). The beet extract is obtained by fermentation (i.e. culture). The details of the culturing process are not repeated in Blanchard, but fermentation taught by von Elbe et al. (US 4027042 A, published May 31, 1977), henceforth von Elbe, who teaches a process of beet fermentation by bacteria (claim 5) is referenced. Beets are a root vegetable, thus the limitations of plant material solids obtained from vegetable root is met by the art. Furthermore, Blanchard teaches that well-known procedures such as spray drying drum drying or freeze drying may be utilized to produce the dry powder (page 6, lines 8-9). As recited in the claim interpretation section, the antimicrobial nature of the powder is regarded as an inherent property. With regard to the recitation of a hygroscopic ingredient, the art does not necessarily describe the plant material as hygroscopic, but, in citing Albaum et al. (US 4339451 A), hereinafter Albaum, Blanchard specifically describes the beet extract specifically as hygroscopic, with a focus on reducing hygroscopicity using salts (page 2 lines 51-55 of Blanchard). For clarification, von Elbe and Albaum are directly cited by Blanchard, and do not modify the reference, but rather provide details incorporated by reference. Furthermore, Blanchard specifically teaches that the goal of the invention is to provide a stable composition (page 3, line 2), and further teaches hat the organic acid improves the stability and cold water solubility of the composition (page 4, lines 35-38). With respect to the limitation, “wherein the hygroscopic antimicrobial ingredient contains nitrite,” within the disclosure by Blanchard, it is taught that beet roots contain nitrite: “A fermentation process, such as that disclosed by von Elbe may be employed, if desired, to remove carbohydrates, nitrates, nitrites and protein from the liquid beet extract and may be practiced in conjunction with the present invention” (page 6, line 20-21). Thus, beets inherently contain nitrite and meet the limitations of the instant claims.
Further regarding claims 1 and 15, the claims recite that “the powder has improved shelf stability regarding moisture resistance compared to a composition prepared by separately drying the hygroscopic ingredient and the neutralized antimicrobial organic acid, and combining the dry ingredients in the blending process.” However, this limitation merely sets forth a statement of intended comparison, and does not define the structural distinction over the prior art. Moreover, the claims fail to specify the particular antimicrobial acid, the type of hygroscopic ingredient, or the relative amounts thereof used in either composition. As such, the recited comparison is between two compositions that are not clearly commensurate in scope, and the limitation is considered broad with respect to the comparison between the compositions. Nevertheless, Blanchard directly teaches a process of producing a “co-dried” material, which comprises the organic material i.e. the beet extract in combination with an organic acid act an adjusted pH, co-dried to produce the composition taught (claim 1). Within comparative example I, it is clear that the liquid beat extract concentrate was mixed with the anhydrous citric acid and later spray dried (page 7, lines 41-43). Therefore, the instantly claimed process is very clearly and expressly taught by the prior art, and a resulting powder with improved shelf life compared to a powder produced by a different process would necessarily be created as a result.
Further regarding claim 15, the claim recites an additional limitation addressed in a previous office action, but is herein included for completeness: The limitation of organic acid a ratio of between 1:5 to 5:1 parts w/w anhydrous form to hydrate form, is not explicitly disclosed in a single embodiment by Blanchard. However, because the claimed process is taught by the cited prior art, such limitation regarding the anhydrous and hydrate forms limitations would necessarily be present in the cited prior art that teaches the claimed method. The claimed process discloses the formation of an antimicrobial powder, which is taught by the cited prior art and accordingly, the ratio of anhydrous and hydrate forms would be necessarily present in the prior art.
Although Blanchard teaches the use of beet extract within the process to produce the dry powder, Blanchard fails to teach the use of cultured celery juice concentrate within the disclosure of the process.
The deficiencies of Blanchard are remedied by Hwang, who teaches that red beets are used as an alternative to celery juice concentrate as a source of nitrite. The disclosure establishes that celery juice concentrate is unknown validated nitrite source in meat products, and that it effectively suppresses anaerobic accounts (page 933) and lowers pH (page 931).The data by Hwang demonstrates that red beets introduce significant color changes significantly increase redness values and alter the color of the final product (page 929).
Prior to the effective filing date of the instant claims, a person having ordinary skill in the art would be motivated to substitute beet extract for celery juice concentrate in order to avoid pigments within the beets that increase redness values and alter color in the final product—an undesirable aesthetic outcome in many meat applications of antimicrobial powders which utilize beet extract. Celery juice, by contrast, delivers nitrite without the pigment load, making it a more commercially neutral ingredient. The person of ordinary skill in the art would recognize celery juice as the cleaner, more versatile nitrite source, and would be motivated to select it precisely to avoid the color and sensory complications that red beets introduce. Furthermore, both Blanchard and Hwang are commonly directed to the field of developing methods using plant materials for safe consumption, thus directly supporting the rationale to combine them.
Although Blanchard and Hwang teaches that the goal of the invention is to provide a stabilized product and food compositions, there is no express suggestion of improving shelf stability regarding moisture resistance relative to other compositions.
The deficiencies of Blanchard and Hwang are remedied by Roozen. The disclosures of Blanchard, Hwang, and Roozen are directed to the common field of developing methods using plant materials for safe consumption, thus directly supporting the rationale to combine them. Blanchard teaches a flavor-stabilizing and moisture-releasing amount of a mixture of fluid acceptable metallic compounds, combined with food acceptable organic acid to create a co-dried food color composition (claim 1). Similar to Blanchard, the disclosure by Roozen concerns the field of food preservation products such as neutralized concentrated vinegar products (title and paragraph [0001]).
Regarding the limitation centered on improved shelf-life, Roozen discloses a method of incorporation of concentrated neutralized vinegar which results in an extended shelf-life and reduced outgrowth of microorganisms (yeasts, molds, fungi and or bacteria, (paragraph [0087]). The teachings of Roozen are applicable to the limitations of independent claims 1 and 15 to achieve the common properties of increased shelf-life and decreased microbial growth via moisture resistance. Regarding the limitation of preparing a dried antimicrobial organic acid, Roozen discloses producing a food preservation product comprising providing liquid vinegar, adding a base to reach a pH of 6 and then concentrating the vinegar to dry solid levels by evaporation (claim 23). Regarding the combining step ii) of independent claims 1 and 15, with a dried powdered antimicrobial ingredient, Roozen step d) of claim 23 discloses the dried vinegar product is combined with one or more organic acid salts, where in one embodiment, such organic salts is a SOLID citrate/lemon juice component (paragraph [0049]). Roozen discloses in an embodiment, a solid composition comprising lemon juice solids is provided in step d), where such lemon juice solids are characterized by a neutral like pH within the range of 6.7-7.6 (paragraph [0049]).
A person of ordinary skill in the art prior to the effective filing date of the instant claims have been directly motivated to combine the teachings of Blanchard and Hwang in creating a stabilized food composition using celery juice concentrate with Roozen who teaches an improved shelf life by incorporating a concentrated neutralized vinegar, to arrive at the instantly claimed process in order to obtain an antimicrobial powder with improved shelf stability and moisture resistance. Accordingly the KSR rationale to support a finding of obviousness are the combination of prior art elements according to known methods to yield predictable results arriving at a neutralized vinegar preservative composition with antimicrobial and shelf stable properties. Therefore, the claimed invention is prima facie obvious.
The claimed process is taught by Example II of Blanchard (page 9, lines 21-42), reproduced above as Table 1. Regarding the limitation of the instant claims 1 and 15 of mixing together the hygroscopic ingredient with a neutralized antimicrobial organic acid, and subsequently drying the liquid slurry example 2 explicitly states that the beet extract blend comprising a liquid beat extract concentrate mixed with citric acid was spray dried, which describes the instantly claimed process.
Table 1. Example II of Blanchard et al.
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Regarding claims 2 and 16 and the limitation of a weight ratio of 1:100 to 100:100 w/w antimicrobial hygroscopic solids to organic solids, Example II (reproduced above) discloses beet extract (i.e. hygroscopic ingredient solids) of 79.6% and citric solids (i.e. organic acid solids) of 10.4% total solids (Table 1, above or example II on page 9, lines 21-42).
Regarding claims 3, 13, and 17 where the antimicrobial powder comprises less than 91% of a carrier, in Example II (table 1) Blanchard discloses that the beet powder is less than 91%, where grams of solids was 589 grams, comprising 469 grams of solid beet extract, 61 grams of citric acid, 39 grams of CaCl2 and 20 grams of MgO.
Regarding claims 7 and 15 and the common limitation of cultured plant material solids obtained from one or more plant sources is combined with an organic acid, Blanchard discloses beet extract solids, which undergo fermentation (i.e., are cultured, pg. 6, lines 18-24). Further, the beet extract with solid percentage of 68% (469 grams of solids and % of total solids of 79.6% of total solids) was mixed with citric acid (see table 1).
Regarding claim 11, wherein the neutralized antimicrobial organic acid is present in both anhydrous and hydrate forms in a ratio of between 1:5 to 5:1 parts w/w anhydrous form to hydrate form: while such limitation is not necessarily disclosed by Blanchard, because the claimed process is taught by the cited prior art, such limitation regarding the anhydrous and hydrate forms limitations would necessarily be present in the cited prior art that teaches the claimed method.
Regarding claims 14 and 18 and, wherein the antimicrobial powder when stored at a temperature of about 20°C and about a 70% equilibrium relative humidity for at least 6 months has a water content of no more than about 5%.While such limitation is not necessarily disclosed in Blanchard, because the claimed process is taught by the cited prior art, such limitation regarding the property of the antimicrobial powder of the process when stored at the claimed conditions, would necessarily be present in the cited prior art that teaches the claimed method. As the claims are indefinite in the recitation of intended results of the claimed process, prior art teaching the process, such as Blanchard, will necessarily entail the teaching of the intended results of the claimed process.
Regarding claim 25, Blanchard discloses an invention that relates to a flavor-stabilized food colorant derived from beets (page 3, lines 30-35). A person having ordinary skill in the art would be motivated to substitute celery juice concentrate four beats, according to the rationale and teachings of Hwang, as applied above.
Regarding claim 27, Blanchard discloses a soft drink mix where the beet colorant is 0.1-5% of the total percent of soft drink powder, (page 6, lines 41-52). A person having ordinary skill in the art would be motivated to substitute celery juice concentrate four beats, according to the rationale and teachings of Hwang, as applied above.
The prior art is not anticipatory insofar as these combinations must be selected from various lists/locations in the reference. It would have been obvious, however, to make the combination since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art (see MPEP § 2143 (I)(A)).
Claim 30 is rejected under 35 U.S.C. § 103 as being unpatentable over Blanchard (EP 0838161 A2, published April 29, 1998) in view of Hwang et al, (Food Sci Biotechnol, Volume 26, Issue 4, pages 929–936, published August 14, 2017) hereinafter Hwang, in view of Roozen (US 20170107468 A1, published April 20, 2017)), and further in view of Finnegan (U.S. 2017/0233773 A1, published August 17, 2017).
In the interest of brevity, the teachings of Blanchard, Hwang, and Roozen are as applied supra (see previous 35 U.S.C. 103 rejection), and are herein incorporated by reference in their entirety.
As detailed below, teachings of Blanchard, Hwang, Roozen, and Finnegan are directed to the field of killing bacteria using antibacterial agents for the sterilization and preservation of food products (paragraph [0080] of Finnegan), thus supporting the rationale to combine them.
Blanchard, Hwang, and Roozen teach the limitations of the claims as described in the previous rejection, but fail to teach a specific bacterial strain used to culture the plant material solids. Furthermore, Blanchard references the fermentation procedure taught by von Elbe, who also fails to teach a specific bacterial strain used for the fermentation process (i.e., culturing).
Finnegan teaches a method for producing the antimicrobial 3-hydroxypropanal, also known as 3HPA, comprising culturing a bacterium in a growth medium containing nitrates (paragraph [0020]). Further, Finnegan teaches the use of freeze drying to recover alkaline earth salts of 3HPA (example 6, paragraph [0071]). Finnegan teaches the use of a bacterium a growth medium containing phosphate and nitrate, both of which can be reasonably obtained from fruit and vegetable solid materials.
Regarding claim 30, Finnegan teaches Lactobacillus and Acetobacter lovaniensis as the bacteria used in the process of fermentation (i.e. culture) to produce the and antimicrobial agent, 3HPA (example 12, paragraph [0079]).
Given that Lactobacillus and Acetobacter lovaniensis produce the broad spectrum antimicrobial 3HPA (paragraph [0080]) it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the antimicrobial powder taught in Blanchard, for the benefit of increasing the antimicrobial effect of the product to the sterilization and preservation of food products.
A person of ordinary skill in the art, prior to the effective filing date of the instantly claimed, would have found it obvious to combine the teachings of Blanchard, Hwang, Roozen, and Finnegan because of the references are directed to a common problem of producing an antimicrobial food compositions with improved stability and safety for human consumption. Blanchard teaches the use of plant derived extracts and organic acids to form stabilize powders. Roozen Teaches neutralized vinegar solids an extended shelf-life and provide moisture resistance. Finnegan teaches antimicrobial agents produced by bacterial fermentation for preserving food products. It would have been prima facie obvious to a skilled artisan to combine these teachings since each reference provides complementary techniques—stabilize plant extracts, neutralized vinegar powders, and bacterial to derive antimicrobials—that would predictably improve both antimicrobial efficacy and shelf stability of the resulting composition. The combination represents the use of known elements for their established functions to achieve a food preservative composition with enhanced ability and antimicrobial effect, which is no more than the predictable result of applying familiar methods according to the KSR rationale.
The prior art is not anticipatory insofar as these combinations must be selected from various lists/locations in the reference. It would have been obvious, however, to make the combination since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art (see MPEP § 2143 (I)(A)).
Claims 1-7, 11-20, 25, and 27 are rejected under 35 U.S.C. § 103 as being unpatentable over Boerefijn (US 20150225683 A1, published August 8, 2015) in view of Roozen (US 20170107468 A1, published April 20, 2017), in further view of King et al. (Journal of Food Protection, Vol. 78, No. 5, 2015, Pages 946–953), hereinafter King.
Regarding claim 1, Boerefijn teaches a method that produces a stable, free-flowing powdered vinegar used as a preservative (paragraph [0018]), where it is dried to a very low water content (paragraph [0018-0019]). Further, Boerefijn teaches a process of producing a powder where 300 grams of concentrated grain vinegar (low MW antimicrobial organic acid, with a free acid content = 28.9% wt) was combined with hygroscopic NaOH in an aqueous solution to obtain a liquid slurry mixture, to an adjusted pH of 7.0 so as to arrive at neutralized vinegar (example 1 paragraph [0069]). The neutralized vinegar is spray-dried to obtain a powder and combined in a fluidized bed dryer with “vinegar of about 28.9% wt dry solids content” that was sprayed onto the powder in a final ratio of about 83% powder to about 17% vinegar” (example 1 paragraph [0070]). With regard to component (A) and it being a cultured plant material, notice is given that the concentrated grain vinegar is obtained by culturing (i.e., fermenting) grain plant material and dried into plant material solid (paragraph [0028]). More specifically, examples of liquid vinegar are apple cider vinegar, and fruit vinegars. As stated in the claim interpretation section, there is no evidence that the flesh of the fruit or vegetable itself is not itself included in the amended claim limitations; thus the use of fruit vinegar meets the claim limitation. With regard to component (B) it is noted that the limitation of a low molecular organic acid in an aqueous solution is met by Example 1 (paragraphs [0069-0070]), where the spray dried powder is mixed with vinegar of about 28.9% wt dry solids content. Finally, Boerefijn discloses the spray drying of the liquid slurry with an atomizer (paragraph [0070]). Boerefijn describes the process as producing a stable, free flowing powder (vinegar), used as a food preservative, where it is dried to a very low water content (paragraph [0018-0019]).
Although Boerefijn teaches the instantly claimed process, there is no express suggestion of improving shelf stability regarding moisture resistance relative to other compositions.
The deficiencies of Boerefijn are remedied by Roozen. Both the disclosures of Blanchard and Roozen are directed to the common field of developing methods using plant materials for safe consumption, thus directly supporting the rationale to combine them. As detailed below, the both Boerefijn and Roozen are directed to the field of preserving foods for safe consumption, thus supporting the rationale to combine them. Boerefijn discloses it is directed to partly neutralized powdered vinegars, for use as a preservative for food and beverages (abstract). Similar to Boerefijn, Roozen discloses it concerns the field of food preservation products such as neutralized concentrated vinegar products (title and paragraph [0001]).
Roozen discloses its method of incorporation of concentrated neutralized vinegar results in an extended shelf-life and reduced outgrowth of microorganisms (yeasts, molds, fungi and or bacteria, (paragraph [0087]). Therefore, the teachings of Roozen will be applicable to the limitation of claims 1 and 15 to achieve the common properties of increased shelf life and decreased microbial growth via moisture resistance. Regarding the limitation of preparing a dried antimicrobial organic acid, Roozen discloses producing a food preservation product comprising providing liquid vinegar, adding a base to reach a pH of 6 and then concentrating the vinegar to dry solid levels by evaporation (claim 23). Regarding the combining step ii) of claims 1 and 18 with a dried powdered antimicrobial ingredient, Roozen step d) of claim 23 discloses the dried vinegar product is combined with one or more organic acid salts, where in one embodiment, such organic salts is a solid citrate/lemon juice component (paragraph [0049]). Roozen discloses in an embodiment, a solid composition comprising lemon juice solids is provided in step d), where such lemon juice solids are characterized by a neutral like pH within the range of 6.7-7.6 (paragraph [0049]).
A person of ordinary skill in the art, prior to the effective filing date of the instant claims would have found it obvious to combine the teachings of Boerefijn with Roozen because each reference addresses related problems in food preservation and antimicrobial stability. Boerefijn teaches the incorporation of antimicrobial organic acids while Roozen teaches producing stabilized vinegar silence with extended shelf life and reducing antimicrobial growth. It would have been obvious to a skilled artisan to combine the teachings in order to obtain a preservative composition expected to demonstrate both antimicrobial activity and improved shelf life and moisture resistance, in line with predictable results from the art to arrive at the instantly claimed. Accordingly the KSR rationale to support a finding of obviousness are the combination of prior art elements according to known methods to yield predictable results (arriving at a neutralized vinegar preservative composition with antimicrobial and shelf stable properties as per Boerefijn and Roozen). Therefore, the claimed invention is prima facie obvious.
With regard to the additional limitation of claim 15, wherein the (B) neutralized antimicrobial organic acid is present in both anhydrous and hydrate forms in a ratio of between 1:5 to 5:1 parts w/w anhydrous form to hydrate form; while such limitation is not necessarily disclosed by Boerefijn, because the claimed process is taught by the cited prior art, such limitation regarding the anhydrous and hydrate forms limitations would necessarily be present in the cited prior art that recites the claimed method.
Regarding claims 2 and 16, the limitation of a weight ratio of 1:100 to 100:100 w/w antimicrobial hygroscopic solids to organic solids, Boerefijn discloses a spray dried powder of neutralized vinegar (sodium acetate) is then sprayed (combined) with liquid vinegar of 28.9 wt.% dry solids at a ratio of 83% neutralized vinegar powder to 17% liquid vinegar (paragraph [0069]).
Regarding claims 3, 13, and 17, Boerefijn discloses an embodiment the total combination of vinegar derived free and neutralized acids represents at least 50% (paragraph [0057]).
Regarding claim 4, Boerefijn teaches a need for its low molecular weight organic acid (vinegar) to be dried to a low water content (paragraphs [0019] and [0024]), where the pH is to be adjust from 5.5 to 7.0 and 6.0 to 7.0 (paragraph [0024]); the levels and hydration state of neutralized acids (vinegar) has water contents of various ranges 4-35 wt.%, more preferably 9-32 wt.%, or 4-20 wt.%, more particularly of 5-15 wt.% and even more particularly of 6-12 wt.% [paragraph 0062].
Regarding claim 5, Boerefijn discloses a pH of 6.0 to 7.0 achieved with its pH adjusting ingredients added to vinegar (paragraphs [0024], [0025] and [0035]).
Regarding claims 6 and 19, Boerefijn discloses its composition comprises NaOH and vinegar (which has the acetate), when combined results in a sodium acetate salt (paragraphs [0024], [0025], [0035], and [0069]).
Regarding claims 7 and 15 and the common limitation of cultured plant material solids obtained from one or more various fruits, Boerefijn discloses various fruit vinegars including apple cider vinegar and fruit vinegars (paragraph [0028]). Fruit vinegars are known to be fermented, i.e. cultured from fruit sources, thus the fruit vinegars of Boerefijn teach the claimed limitation.
Regarding claims 1, 9 and 23 and the common limitation of a sodium acetate (vinegar) and cultured celery juice (hygroscopic ingredient), King discloses combinations of celery juice (source of nitrates/nitrites) in combination with vinegar organic acids (ingredients and treatment combinations, page 947 of King).
Regarding claim 10 and the packaging of the antimicrobial powder in a container, it is noted that King discloses the use of packaging (abstract). While King does not necessarily explicitly recite packaging of an antimicrobial powder, the use of packaging to store compositions, is known to one of ordinary skill in the art, and the teaching of packaging by King would render claim 10 obvious.
Regarding the obviousness rejection and a rationale to combine cited prior art, it is noted that Boerefijn discloses the need for processing of meat for human consumption aims to provide processed meat products that combine an appealing appearance and flavor with microbial safety and prolonged shelf-life (paragraph [0002]).
Similar to Boerefijn and the need to preserve process meats for consumption, King is directed to the field of preserving deli-style turkey breast with antimicrobials (title). King discloses combinations of celery juice containing nitrites as claimed in combination with vinegar (table 2).
Regarding the limitation of claim 11, wherein the neutralized antimicrobial organic acid is present in both anhydrous and hydrate forms in a ratio of between 1:5 to 5:1 parts w/w anhydrous form to hydrate form, while such limitation is not necessarily disclosed by Boerefijn, because the claimed process is taught by the cited prior art, such limitation regarding the anhydrous and hydrate forms limitations would necessarily be present in the cited prior art that teaches the claimed method.
Regarding the limitations of claims 12 and 20, wherein the neutralized vinegar is sodium acetate and is present in the antimicrobial powder in a glassy-crystal phase of both anhydrous and tri-hydrate forms in a ratio of about 1:5 to 5:1 parts w/w anhydrous form to tri-hydrate form, while such limitation is not necessarily disclosed by Boerefijn, because the claimed process is taught by the cited prior art, such limitation regarding the anhydrous and hydrate forms limitations would necessarily be present in the cited prior art that teaches the claimed method.
Regarding claims 14 and 18, wherein the antimicrobial powder when stored at a temperature of about 20°C and about a 70% equilibrium relative humidity for at least 6 months has a water content of no more than about 5%, while such limitation is not necessarily disclosed by Boerefijn, because the claimed process is taught by the cited prior art, such limitation regarding the property of the antimicrobial powder of the process when stored at the claimed conditions, would necessarily be present in the cited prior art that teaches the claimed method.
Regarding claim 24 and the packaging of powder in a container, it is noted that King discloses the use of packaging (abstract). While King does not necessarily explicitly recite packaging of an antimicrobial powder, the use of packaging to store compositions is known to one of ordinary skill in the art, and the teaching of packaging by King would render claim 24 obvious. Further regarding claim 24, Boerefijn discloses an embodiment the total combination of vinegar derived free and neutralized acids represents at least 50% (paragraph [0057] of Boerefijn)
Regarding claim 25, Boerefijn discloses the use of its powdered vinegar product to preserve a meat product, a combination of the powder with edible or potable ingredients (paragraphs [0065] and [0067]).
Regarding claim 27, Boerefijn discloses wherein the powdered vinegar is combined with the one or more other edible or potable ingredients in an amount of 0.1-5% by weight of the foodstuff or the beverage (claim 26). Accordingly, the claimed invention is taught by the cited prior art.
A person of ordinary skill in the art would have found it obvious to combine the teachings of Boerefijn, Roozen, and King because each reference is directed to the common goal of preserving foods for human consumption through the use of antimicrobial agents in stabilizing components. Boerefijn describes a process of producing a stable, free flowing powder used as a food preservative. Roozen teaches stabilize vinegar and dried antimicrobial ingredients for moisture resistance, and King teaches combinations of celery juice (source of nitrates/nitrites) in combination with vinegar organic acids for the purposes of processed meats. In view of KSR, it would’ve been obvious to a skilled artisan to combine these no teachings, as doing so would represent the predictable use of prior art elements according to their established functions to yield a food preservative composition with improved antimicrobial efficacy and shelf stability.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new grounds of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Correspondence
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/SOPHIA P HIRAKIS/Examiner, Art Unit 1623
/CLINTON A BROOKS/ Supervisory Patent Examiner, Art Unit 1621
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