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 October 21, 2025 is acknowledged.
Applicant has overcome the objections to the claims by virtue of amendment.
The status of the claims upon entry of the present amendments stands as follows:
Pending claims:
1-19, 21-22
Withdrawn claims:
None
Previously canceled claims:
None
Newly canceled claims:
20
Amended claims:
4-9
New claims:
21-22
Claims currently under consideration:
1-19, 21-22
Currently rejected claims:
1-19, 21-22
Allowed claims:
None
Claim Objections
Claim 22 is objected to because of the following informalities: “Staphylococcus carnosus” should be italicized to align with proper naming. Appropriate correction is required.
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.
Claims 21 and 22 are 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.
Regarding claim 21, the limitation requiring the fermentation to be derived from celery that has completed batch fermentation in line 2 does not have support in the original disclosure. MPEP 2163(I)(B) states, “To comply with the written description requirement of 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, or to be entitled to an earlier priority date or filing date under 35 U.S.C. 119, 120, 365, or 386, each claim limitation must be expressly, implicitly, or inherently supported in the originally filed disclosure.” Express, implicit, nor inherent support cannot be found in the originally filed disclosure for the limitation. Additionally, MPEP §2163.05(II) states “The introduction of claim changes which involve narrowing the claims by introducing elements or limitations which are not supported by the as-filed disclosure is a violation of the written description requirement of 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. See, e.g., Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 USPQ2d 1895, 1905 (Fed. Cir. 1996)”. Because the original disclosure only requires fermentation, there is insufficient support in the original disclosure for batch fermentation.
Regarding claim 21, the limitation requiring passing through an ultrafiltration membrane within 60 minutes of the first filtration in line 5 does not have support in the original disclosure. Express, implicit, nor inherent support cannot be found in the originally filed disclosure for the limitation. The original disclosure does not discuss the time period between the first and second filtrations.
Regarding claim 21, the limitation requiring the entire filtration sequence to be completed without addition of chemical preservatives or processing aids in line 11 does not have support in the original disclosure. Express, implicit, nor inherent support cannot be found in the originally filed disclosure for the limitation. MPEP 2173.05(i) states, “Any negative limitation or exclusionary proviso must have basis in the original disclosure. If alternative elements are positively recited in the specification, they may be explicitly excluded in the claims.” Because the original disclosure does not discuss chemical preservatives or processing aids, the limitation lacks support in the original disclosure.
Regarding claim 22, the limitation requiring that bacterial fermentation be performed with Staphylococcus carnosus does not have support in the original disclosure. The original disclosure does not list any specific bacteria used for fermentation. MPEP §2163.05(II) states “Applicant was not entitled to the benefit of a parent filing date when the claim was directed to a subgenus (a specified range of molecular weight ratios) where the parent application contained a generic disclosure and a specific example that fell within the recited range because the court held that subgenus range was not described in the parent application. In re Lukach, 442 F.2d 967, 169 USPQ 795 (CCPA 1971).” Because the disclosure only generically discusses bacterial fermentation, support is not found in the original disclosure for use of specifically Staphylococcus carnosus.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 21 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 21 recites the limitation “results in an injected meat product having an a* value increased by at least 25%”. This limitation renders the claim indefinite because it is not clear what the increase is a* value is relative to. For the purposes of examination, it is presumed that the a* value increases by 25% relative to the same meat product that has not been injected with the filtered food product resulting from the claimed method.
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 1-7 and 10-15 are rejected under 35 U.S.C. 103 as being unpatentable over Soma (US PGPub 2021/0386101 A1) in view of Garikipati (US 2014/0275465 A1).
Regarding claim 1, Soma teaches a fermentation process for converting nitrate to nitrite for use as food additives ([0026]) comprising providing a source material that comprises natural nitrates from plants such as lettuce or other vegetables (i.e., known food products; [0030]) and that the source material can be a liquid ([0031]). Soma also teaches that micro-organisms can be removed using filtration (i.e., passing the food product through a first filter; [0043]). Soma also teaches that the final processing module includes a drying step performed by spray drying ([0047]).
Soma does not teach passing the food product through a first filter and passing the food product through a second filter.
However, in the same field of endeavor, Garikipati teaches subjecting a fermentation broth to a first filtration and second filtration comprising nanofiltration ([0015]).
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 process taught by Soma with the addition of a second filtration step as taught by Garikipati. One of ordinary skill would be motivated to make this modification because Garikipati teaches that nanofiltration can separate out impurities that remain after other filtration steps ([0071]).
Regarding claim 2, Soma in view of Garikipati teaches all elements of claim 1 as described above. Soma also teaches that the nitrate containing plants as a source material includes celery and beets ([0030]).
Regarding claim 3, Soma in view of Garikipati teaches all elements of claim 1 as described above. Soma also teaches that the nitrate containing plants as a source material includes celery ([0030]).
Regarding claim 4, Soma in view of Garikipati teaches all elements of claim 1 as described above.
Soma does not teach wherein the step of passing the food product through a first filter includes the step of passing the food product through a ceramic membrane.
However, in the same field of endeavor, Garikipati teaches of subjecting a fermentation broth to separation using a first filtration via microfiltration or ultrafiltration ([0015]) and the both microfiltration and ultrafiltration use ceramic membranes ([0069], [0070]).
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 process taught by Soma with the use of a ceramic membrane for a first filtration as taught by Garikipati. One would be motivated to make this modification because Garikipati teaches that ceramic membranes are useful because they have long operating lifetimes of over 10 years ([0070]).
Regarding claim 5, Soma in view of Garikipati teaches all elements of claim 1 as described above.
Soma does not teach wherein the step of passing the food product through a first filter includes filtering through a ceramic filtration membrane that removes particles greater than approximately 0.005 microns.
However, in the same field of endeavor, Garikipati teaches that the first filtration can be ultrafiltration ([0015]) and that ultrafiltration uses ceramic membranes with a pore size from about 0.005 microns to 0.1 microns (which would remove particles greater than 0.005 microns and higher, [0070]), which falls in the claimed range of “greater than approximately 0.005 microns”.
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 process taught by Soma with the use of a ceramic ultrafiltration membrane for a first filtration as taught by Garikipati. One would be motivated to make this modification because Garikipati teaches the solids captured can include residual cell debris, DNA, and proteins ([0070]).
Regarding claim 6, Soma in view of Garikipati teaches all elements of claim 1 as described above.
Soma does not teach wherein the step of passing the food product through a first filter includes the step of passing the food product through a ceramic membrane to separate bacteria and solids, and produce a dark brown clear solution.
However, in the same field of endeavor, Garikipati teaches of subjecting a fermentation broth to separation using a first filtration via microfiltration or ultrafiltration ([0015]) and the both microfiltration and ultrafiltration use ceramic membranes ([0069], [0070]). Garikipati also teaches that the microfiltration can be used in separating cell (i.e., bacteria) and solids from the fermentation broth ([0069]).
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 process taught by Soma with the use of a ceramic membrane for a first filtration as taught by Garikipati. One would be motivated to make this modification because Garikipati teaches that ceramic membranes are useful because they have long operating lifetimes of over 10 years ([0070]).
Although the cited prior art does not teach that the first filtration results in a dark brown clear solution, this limitation is interpreted as a necessary result of performing the method as claimed. Therefore, because Soma in view of Garikipati teach the claimed method, the combination would necessarily result in the production of a dark brown clear solution. Evidence to support that producing a dark brown clear solution is a necessary result is provided by the instant specification. [0040] of the instant specification states that the ceramic membrane separates the bacteria and solids and produces a dark brown clear solution.
Regarding claim 7, Soma in view of Garikipati teaches all elements of claim 1 as described above.
Soma does not teach wherein the step of passing the food product through a second filter includes the step of passing the food product through an ultrafiltration membrane.
However, in the same field of endeavor, Garikipati teaches a process that comprises a first filtration and a second filtration ([0015]) and that multiple filtrations can be used in all combinations, including ultrafiltration ([0065]). Because Garikipati teaches that filtration can be used in all combinations, one of ordinary skill would recognize that ultrafiltration can be used as the second filtration.
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 process taught by Soma with the addition of a second filtration using ultrafiltration as taught by Garikipati. One of ordinary skill would be motivated to make this modification because Garikipati teaches that multiple filtrations can be useful to reduce fouling of membranes and aid in recovery of individual components of the fermentation broth ([0066]).
Regarding claims 10 and 11, Soma in view of Garikipati teaches all elements of claim 1 as described above.
Although the cited prior art does not teach wherein the food product is free from visible particles (claim 10) or wherein the filtered product is clear (claim 11), these limitations are interpreted as necessary results of performing the method as claimed. Therefore, because Soma modified by Garikipati teaches the claimed method, the combination would necessarily result in a food product that is free from visible particles (claim 10) and is clear (claim 11). Evidence to support that producing a product free from visible particles is provided in the instant specification. [0047] of the instant specification states that after the filtration method disclosed, the filtered food product is clear and free from visible particulates as perceived by the human eye.
Regarding claims 12-15, Soma in view of Garikipati teaches all elements of claim 1 as described above.
Although the cited prior does not teach wherein the filtered food product results in an injected meat or other food product having an increased a* value relative to the same food product without the injection (claim 12) or wherein the a* value is increased by approximately 10% (claim 13), 25% (claim 14), or 50% (claim 15), the claimed functional language is interpreted as necessary results of performing the method as claimed. Therefore, because Soma modified by Garikipati teaches the claimed method, the combination would necessarily result in the claimed increases to the a* value. Evidence to support that producing the product would necessarily lead to a food product having an increased a* value relative to the same food product without the injection (claim 12) or wherein the a* value is increased by approximately 10% (claim 13), 25% (claim 14), or 50% (claim 15) is provided by the instant specification. [0047]-[0048] of the instant specification states that after the disclosed filtration, the filtered food product is clear and notably results in an injected meat or other food product having an increased a* value relative to the same food product without the injection, where the a* value is increased by approximately 10%, 25% or most preferably 50%.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Soma (US PGPub 2021/0386101 A1) in view of Garikipati (US PGPub 2014/0275465 A1) as applied to claim 1 above, and further in view of El Menyawi (US PGPub 2023/0002444 A1) and Yamada (US PGPub 2015/0376669 A1).
Regarding claim 8, Soma in view of Garikipati teaches all elements of claim 1 as described above.
Soma does not teach wherein the step of passing the food product though a second filter includes the step of direct filtration after the end of fermentation with live bacteria, with the process control temperature not exceeding 50[Symbol font/0xB0]C, and when the proportion of filtrate volume reaches about 90%, initiating cleaning and washing with clear water, wherein the flow acceleration and filtration speed are approximately the same, and wherein the filtration is complete when the filtrate volume and stock liquid volume are equal.
Regarding the step of direct filtration after the end of fermentation with live bacteria, Garikipati teaches that the separation procedure, including the second filtration step, occurs after fermentation with an organism ([0015]) and that the organism can be bacteria ([0048]).
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 process taught by Soma with the use of a secondary filtration step immediately following fermentation with bacteria as taught by Garikipati. One of ordinary skill would have been motivated to make this modification because Garikipati teaches that the use of multiple filtrations after fermentation aid in recovering the individual components of the fermentation broth for recycle ([0066]).
Regarding the process control temperature not exceeding 50[Symbol font/0xB0]C, El Menyawi teaches a method of extracting proteins from precipitates (Abstract) where the protein comprising precipitate includes a fermentation broth ([0179]), the method comprising feeding the suspension into a filtration unit ([0013]) and further feeding that suspension into a second filtration unit ([0021]), where the temperature in the filtration units is controlled between 2[Symbol font/0xB0]C and 25[Symbol font/0xB0]C ([0087]), which falls within the claimed range of “not exceeding 50[Symbol font/0xB0]C”.
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 process of Soma with the use of filtration at a controlled temperature as taught by El Menyawi. One of ordinary skill would be motivated to make this modification because El Menyawi teaches that such temperatures ensure optimum extraction ([0087]).
Regarding initiating cleaning and washing with clear water, Yamada teaches a process of washing out a separation membrane by filtering the amount of washing water through the membrane ([0045]).
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 process of Soma to include a step of washing the filtration unit after filtration as taught by Yamada. One would be motivated to make this modification because Yamada teaches that washing enables a long-lasting separation membrane ([0044]).
Although the cited prior art does not teach initiating cleaning and washing when the proportion of filtrate volume reaches about 90%, one of ordinary skill in the art would have adjusted the point at which cleaning and washing begins during routine optimization to determine when in the process to start washing. 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).
Furthermore, although the cited prior art does not teach that the cleaning and washing is carried out at the same flow acceleration and filtration speed, one of ordinary skill in the art would have adjusted the flow acceleration and flow speed during routine optimization to determine the best acceleration and speed for washing the filter. 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).
Although the cited prior art does not teach wherein the filtration is complete when the filtrate volume and stock liquid volume are equal, one of ordinary skill would fine carrying out the filtration until all of the original liquid has exited the system to be obvious.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Soma (US PGPub 2021/0386101 A1) in view of Garikipati (US PGPub 2014/0275465 A1) as applied to claim 1 above, and further in view of El Menyawi (US PGPub 2023/0002444 A1), Yamada (US PGPub 2015/0376669 A1) and Tapia (Tapia-Quiros, Paulina, et al. “Recovery of Polyphenols from Agri-Food By-Products: the Olive Oil and Winery Industrial Cases”, Foods, Vol. 11, article 362, published January 26, 2022 [accessed online July 14, 2025]).
Regarding claim 9, Soma in view of Garikipati teaches all elements of claim 1 as described above.
Soma does not teach wherein the step of passing the food product though a second filter includes the step of direct filtration after the end of fermentation with live bacteria, with the process control temperature not exceeding 35[Symbol font/0xB0]C, and the membrane pressure being approximately 10MPa, and when the filtrate volume reaches 90% of the stock solution, the filtrate is washed with clear water until the volume of the transmitted liquid is equal to the volume of the stock solution.
Regarding the step of direct filtration after the end of fermentation with live bacteria, Garikipati teaches that the separation procedure, including the second filtration step, occurs after fermentation with an organism ([0015]) and that the organism can be bacteria ([0048]).
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 process taught by Soma with the use of a secondary filtration step immediately following fermentation with bacteria as taught by Garikipati. One of ordinary skill would have been motivated to make this modification because Garikipati teaches that the use of multiple filtrations after fermentation aid in recovering the individual components of the fermentation broth for recycle ([0066]).
Regarding the process control temperature not exceeding 35[Symbol font/0xB0]C, El Menyawi teaches a method of extracting proteins from precipitates (Abstract) where the protein comprising precipitate includes a fermentation broth ([0179]), the method comprising feeding the suspension into a filtration unit ([0013]) and further feeding that suspension into a second filtration unit ([0021]), where the temperature in the filtration units is controlled between 2[Symbol font/0xB0]C and 25[Symbol font/0xB0]C ([0087]), which falls within the claimed range of “not exceeding 35[Symbol font/0xB0]C”.
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 process of Soma with the use of filtration at a controlled temperature as taught by El Menyawi. One of ordinary skill would be motivated to make this modification because El Menyawi teaches that such temperatures ensure optimum extraction ([0087]).
Regarding the membrane pressure being approximately 10MPa, Tapia teaches extraction and purification of polyphenols from winery residues (i.e., a food product; abstract) comprising membrane separation following extraction (i.e., membrane filtration as a second filtration), which includes reverse osmosis at 35-100 bar (equivalent to 3.5-10 MPa, which includes the claimed value of “approximately 10 MPa”; p. 16, ¶ 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 modify the process of Soma with the use of reverse osmosis as a second filtration step as taught by Tapia. One of ordinary skill would have been motivated to make this modification because Tapia teaches that reverse osmosis is used for purification purposes (p. 17, ¶ 2).
Regarding initiating cleaning and washing with clear water, Yamada teaches a process of washing out a separation membrane by filtering the amount of washing water through the membrane ([0045]).
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 process of Soma to include a step of washing the filtration unit after filtration as taught by Yamada. One would be motivated to make this modification because Yamada teaches that washing enables a long-lasting separation membrane ([0044]).
Although the cited prior art does not teach initiating cleaning and washing when the proportion of filtrate volume reaches about 90%, one of ordinary skill in the art would have adjusted the point at which cleaning and washing begins during routine optimization to determine when in the process to start washing. 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).
Furthermore, although the cited prior art does not teach that the cleaning and washing is carried out at the same flow acceleration and filtration speed, one of ordinary skill in the art would have adjusted the flow acceleration and flow speed during routine optimization to determine the best acceleration and speed for washing the filter. 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).
Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Soma (US PGPub 2021/0386101 A1) in view of Garikipati (US PGPub 2014/0275465 A1) as applied to claim 1 above, and further in view of Asaoka (US 2019/0105274 A1).
Regarding claim 16, Soma in view of Garikipati teaches all elements of claim 1 as described above.
The cited prior art does not teach wherein the step of optionally spray drying the food product at high-temperature includes the step of spray drying via a centrifugal spray dryer.
However, in the same field of endeavor, Asaoka teaches the process of making a tablet (abstract) using arginine produced by fermentation ([0030]) following by spray drying ([0037]), where the atomizer for the spray dryer performs atomization by centrifugal force (i.e., a centrifugal spray dryer; [0039]).
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 process taught by Soma with the addition of centrifugal spray drying as taught by Asaoka after filtration because Asaoka teaches that spray drying can make minute droplets in a short time and make particles that are rich in flowability ([0034]).
Regarding claim 17, Soma in view of Garikipati and Asaoka teaches all elements of claim 1 as described above.
Soma does not teach wherein the step of controllably spray drying the food product at high-temperature results in a Karl Fischer moisture content of less than approximately 2% without materially altering the flavor profile and/or the nutritional profile of the food product.
However, in the same field of endeavor, Asaoka teaches that the moisture content of the powder obtained by spray drying is measured using Karl Fischer’s method has a moisture content of not more than 4 mass% ([0043]), which encompasses the claimed range of “less than approximately 2%.
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 process taught by Soma with the addition of centrifugal spray drying as taught by Asaoka after filtration because Asaoka teaches that spray drying can make minute droplets in a short time and make particles that are rich in flowability ([0034]).
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.
Although the cited prior art does not state that the step of controllably spray drying the product does not materially alter the flavor profile and/or the nutritional profile of the food product, this limitation is interpreted as a necessary result of the method as claimed. Therefore, because Soma in view of Garikipati and Asaoka teach the method as claimed, the combination would necessarily result in a spray dried food product without materially altering the flavor profile and/or nutritional profile of the food product. Evidence to support that the limitation is necessary is provided in the instant specification. [0041] of the instant specification states that the spray drying method of the present invention do not materially alter the flavor profile and/or nutritional profile of the food product.
Claims 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Soma (US PGPub 2021/0386101 A1) in view of Garikipati (US PGPub 2014/0275465 A1) as applied to claim 1 above, and further in view of Gladue (US 6,372,460 B1).
Regarding claim 18, Soma in view of Garikipati teaches all elements of claim 1 as described above.
The cited prior art does not teach wherein the step of optionally spray drying the food product at high-temperature includes the step of spray drying via a pressure spray dryer.
However, in the same field of endeavor, Gladue teaches a fermentation product that is then spray dried under high pressure (i.e., a pressure spray dryer; col 6, lines 15-24).
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 process of Soma with the use of pressure spray drying as taught by Gladue. The claimed method would have been obvious because one of ordinary skill would have found it obvious to apply the known technique of pressure spray drying a fermented liquid to the known process taught by Soma. MPEP §2143(D) states “The rationale to support a conclusion that the claim would have been obvious is that a particular known technique was recognized as part of the ordinary capabilities of one skilled in the art. One of ordinary skill in the art would have been capable of applying this known technique to a known device (method, or product) that was ready for improvement and the results would have been predictable to one of ordinary skill in the art.”
Regarding claim 19, Soma in view of Garikipati and Gladue teaches all elements of claim 18 as described above.
Soma does not teach wherein the step of controllably spray drying the food product at high-temperature results in a Karl Fischer moisture content of less than approximately 2% without materially altering the flavor profile and/or the nutritional profile of the food product.
However, in the same field of endeavor, Gladue teaches that the dried mass recovered from the spray dryer has a moisture content ranging from 1-15% (col. 6, lines 28-30), which overlaps with the claimed range of “less than approximately 2%”.
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 process of Soma with the use of pressure spray drying as taught by Gladue. The claimed method would have been obvious because one of ordinary skill would have found it obvious to apply the known technique of pressure spray drying a fermented liquid to the known process taught by Soma. MPEP §2143(D) states “The rationale to support a conclusion that the claim would have been obvious is that a particular known technique was recognized as part of the ordinary capabilities of one skilled in the art. One of ordinary skill in the art would have been capable of applying this known technique to a known device (method, or product) that was ready for improvement and the results would have been predictable to one of ordinary skill in the art.”
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.
Although Gladue does not teach measuring the moisture content using the Karl Fischer measurement, this limitation is not considered to be a required step in the method of making the product as claimed. Additionally, any method of measuring moisture content would arrive at the same moisture content taught by the prior art.
Although the cited prior art does not state that the step of controllably spray drying the product does not materially alter the flavor profile and/or the nutritional profile of the food product, this limitation is interpreted as a necessary result of the method as claimed. Therefore, because Soma in view of Garikipati and Asaoka teach the method as claimed, the combination would necessarily result in a spray dried food product without materially altering the flavor profile and/or nutritional profile of the food product. Evidence to support that the limitation is necessary is provided in the instant specification. [0041] of the instant specification states that the spray drying method of the present invention do not materially alter the flavor profile and/or nutritional profile of the food product.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Soma (US PGPub 2021/0386101 A1) in view of Garikipati (US PGPub 2014/0275465 A1), Jiuwu Hitech (“CMF-19040-1200mm Ultrafiltration”, Jiangsu Jiuwu Hitech Co., LTD, version from October 22, 2020 [accessed online March 2, 2026] https://web.archive.org/web/20201022210732/https://www.jiuwumembrane.com/uploads/file/92020-cmf19040-20nm-1200mm.pdf), El Menyawi (US PGPub 2023/0002444 A1), Yamada (US PGPub 2015/0376669 A1), Tapia (Tapia-Quiros, Paulina, et al. “Recovery of Polyphenols from Agri-Food By-Products: the Olive Oil and Winery Industrial Cases”, Foods, Vol. 11, article 362, published January 26, 2022 [accessed online July 14, 2025]), and Gladue (US 6,372,460 B1).
Regarding claim 21, Soma teaches a fermentation process for converting nitrate to nitrite for use as food additives ([0026]) where the source material for fermentation includes celery ([0030]). Soma also teaches that the process is performed by inoculating a first batch, removing some of the fermented liquid, and replenishing the material with addition source material liquid ([0052]). Although Soma does not teach that fermentation is a batch fermentation in that one batch is completely fermented then removed, the source material is added to fermentation in batches. Thus, one of ordinary skill would recognize that the fermentation of Soma meets the claimed limitation.
Soma does not teach passing the fermentation liquid through a ceramic membrane filter comprising a-Alumina/Zirconia material having multi-channel tubular element construction with pore size between 0.005 and 2 microns; subsequently passing through an ultrafiltration membrane within 60 minutes of the first filtration, with process control temperature not exceeding 35°C and membrane pressure of approximately 10MPa; initiating washing with water when filtrate volume reaches 90% of stock solution volume; continuing filtration until the filtrate volume equals the stock liquid volume; and spray drying the filtered product using a pressure spray dryer with inlet temperature between 180-220C and outlet temperature between 100-1200C to achieve moisture content less than 2%, wherein the entire filtration sequence is completed without addition of chemical preservatives or processing aids, and wherein the filtered food product is clear and free from visible particulates as perceived by the human eye unmagnified and results in an injected meat product having an a* value increased by at least 25%.
Regarding passing the fermentation liquid through a ceramic membrane filter with a pore size between 0.005 and 2 microns and subsequently passing through an ultrafiltration membrane, Garikipati teaches of subjecting a fermentation broth to separation using a first filtration via microfiltration or ultrafiltration ([0015]) and the both microfiltration and ultrafiltration use ceramic membranes ([0069], [0070]). Garikipati also teaches that the first filtration can be ultrafiltration ([0015]) and that ultrafiltration uses ceramic membranes with a pore size from about 0.005 microns to 0.1 microns (which would remove particles greater than 0.005 microns and higher, [0070]), which falls in the claimed range of “greater than approximately 0.005 microns”. Garikipati also teaches a process that comprises a first filtration and a second filtration ([0015]) and that multiple filtrations can be used in all combinations, including ultrafiltration ([0065]). Because Garikipati teaches that filtration can be used in all combinations, one of ordinary skill would recognize that ultrafiltration can be used as the second filtration.
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 process taught by Soma with the use of a ceramic ultrafiltration membrane for a first filtration as taught by Garikipati. One would be motivated to make this modification because Garikipati teaches that ceramic membranes are useful because they have long operating lifetimes of over 10 years and that the solids captured can include residual cell debris, DNA, and proteins ([0070]).
Regarding the ceramic membrane filter comprising α-alumina/zirconia material having multi-channel tubular element construction, Jiuwu Hitech teaches of a ceramic filtration membrane (Product Name) made of α-alumina/zirconia (p. 1, Product Description, Raw Material) that is a tubular multi-channel configuration (p. 2, col. 1, Membrane Characteristics).
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 process of Soma in view of Garikipati with the use of Ceramfil inorganic ceramic membrane as taught by Jiuwu Hitech. One of ordinary skill would have been motivated to make this modification because Jiuwu Hitech teaches that Ceramfil is useful for clarification and solid-liquid separation (p. 1, Product Description, Major Applications).
Regarding the process control temperature not exceeding 35[Symbol font/0xB0]C and wherein the filtration sequence is completed without addition of chemical preservatives or processing aids, El Menyawi teaches a method of extracting proteins from precipitates (Abstract) where the protein comprising precipitate includes a fermentation broth ([0179]), the method comprising feeding the suspension into a filtration unit ([0013]) and further feeding that suspension into a second filtration unit ([0021]), where the temperature in the filtration units is controlled between 2[Symbol font/0xB0]C and 25[Symbol font/0xB0]C ([0087]), which falls within the claimed range of “not exceeding 35[Symbol font/0xB0]C”. El Menyawi also teaches that in one embodiment, a filter aid is not used in the process at all ([0130]). Furthermore, El Menyawi does not disclose any embodiments where the filtration uses chemical preservatives, so one of ordinary skill would not have been motivated to add a chemical preservative based on the disclosure of El Menyawi.
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 process of Soma with the use of filtration at a controlled temperature as taught by El Menyawi. One of ordinary skill would be motivated to make this modification because El Menyawi teaches that such temperatures ensure optimum extraction ([0087]).
Regarding the membrane pressure being approximately 10MPa, Tapia teaches extraction and purification of polyphenols from winery residues (i.e., a food product; abstract) comprising membrane separation following extraction (i.e., membrane filtration as a second filtration), which includes reverse osmosis at 35-100 bar (equivalent to 3.5-10 MPa, which includes the claimed value of “approximately 10 MPa”; p. 16, ¶ 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 modify the process of Soma with the use of reverse osmosis as a second filtration step as taught by Tapia. One of ordinary skill would have been motivated to make this modification because Tapia teaches that reverse osmosis is used for purification purposes (p. 17, ¶ 2).
Regarding initiating cleaning and washing with clear water, Yamada teaches a process of washing out a separation membrane by filtering the amount of washing water through the membrane ([0045]).
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 process of Soma to include a step of washing the filtration unit after filtration as taught by Yamada. One would be motivated to make this modification because Yamada teaches that washing enables a long-lasting separation membrane ([0044]).
Although the cited prior art does not teach initiating cleaning and washing when the proportion of filtrate volume reaches about 90%, one of ordinary skill in the art would have adjusted the point at which cleaning and washing begins during routine optimization to determine when in the process to start washing. 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).
Although the cited prior art does not teach wherein the filtration is complete when the filtrate volume and stock liquid volume are equal, one of ordinary skill would find carrying out the filtration until all of the original liquid has exited the system to be obvious.
Regarding spray drying the filtered product using a pressure spray dryer with an inlet temperature of temperature between 180-220C and outlet temperature between 100-1200C to achieve moisture content less than 2%, Gladue teaches a fermentation product that is then spray dried under high pressure (i.e., a pressure spray dryer; col 6, lines 15-24). Gladue also teaches that suitable inlet temperatures range between 300-400°F (corresponding to 148.9-204.4°C, which overlaps with the claimed range of “180-220°C”) and an outlet temperature of 180-240°F (corresponding to 82.2-115.6°C, which overlaps with the claimed range of “180-220°C”)(col. 6, lines 23-30). Gladue also teaches that the dried mass recovered from the spray dryer has a moisture content ranging from 1-15% (col. 6, lines 28-30), which overlaps with the claimed range of “less than approximately 2%”.
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 process of Soma with the use of pressure spray drying as taught by Gladue. The claimed method would have been obvious because one of ordinary skill would have found it obvious to apply the known technique of pressure spray drying a fermented liquid to the known process taught by Soma. MPEP §2143(D) states “The rationale to support a conclusion that the claim would have been obvious is that a particular known technique was recognized as part of the ordinary capabilities of one skilled in the art. One of ordinary skill in the art would have been capable of applying this known technique to a known device (method, or product) that was ready for improvement and the results would have been predictable to one of ordinary skill in the art.”
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.
Although the cited prior art does not teach the length of time between the first and second filtration steps, one of ordinary skill in the art would have adjusted the time between the first and second filtrations during routine optimization to arrive at the time between that resulted in the desired downtime between filtration steps. 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.
Although the cited prior art does not teach wherein the food product is clear and free from visible particles, this limitation is interpreted as necessary results of performing the method as claimed. Therefore, because the cited prior art teaches the claimed method, the combination would necessarily result in a food product that is clear free from visible particles as perceived by the human eye. Evidence to support that producing a product free from visible particles is provided in the instant specification. [0047] of the instant specification states that after the filtration method disclosed, the filtered food product is clear and free from visible particulates as perceived by the human eye.
Although the cited prior art does not teach that the process results in an injected meat product having an a* value increased by at least 25% relative to the same food product without the injection, the claimed functional language is interpreted as a necessary result of performing the method as claimed. Because the cited prior art teaches the method as claimed, the combination would necessarily result in the claimed change in a* value. Evidence to support that producing the product would necessarily lead to a food product having an a* value increased by at least 25% is provided by the instant specification. [0047]-[0048] of the instant specification states that after the disclosed filtration, the filtered food product is clear and notably results in an injected meat or other food product having an increased a* value relative to the same food product without the injection, where the a* value is increased by approximately 25% or most preferably 50%.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Soma (US PGPub 2021/0386101 A1) in view of Garikipati (US PGPub 2014/0275465 A1), El Menyawi (US PGPub 2023/0002444 A1), Yamada (US PGPub 2015/0376669 A1), Tapia (Tapia-Quiros, Paulina, et al. “Recovery of Polyphenols from Agri-Food By-Products: the Olive Oil and Winery Industrial Cases”, Foods, Vol. 11, article 362, published January 26, 2022 [accessed online July 14, 2025]), Asaoka (US 2019/0105274 A1), and Hywell (“High-Speed Centrifugal Spray Dryer”, Hywell, version from February 1, 2023 [accessed online March 2, 2026] https://web.archive.org/web/20230201231122/https://www.hywellco.com/High-Speed-Centrifugal-Spray-Dryer-pd46345740.html).
Regarding claim 22, Soma teaches a fermentation process for converting nitrate to nitrite for use as food additives ([0026]) where the source material for fermentation includes celery ([0030]) and the celery juice is fermented using Staphylococcus carnosus ([0083]). Soma also teaches that the desired concentration of nitrites is achieved when at least 85% nitrates have been converted to nitrites.
Although Soma includes additional fermentation steps beyond those listed above, MPEP §2144.04(II)(A) states that “Ex parte Wu, 10 USPQ 2031 (Bd. Pat. App. & Inter. 1989) (Claims at issue were directed to a method for inhibiting corrosion on metal surfaces using a composition consisting of epoxy resin, petroleum sulfonate, and hydrocarbon diluent. The claims were rejected over a primary reference which disclosed an anticorrosion composition of epoxy resin, hydrocarbon diluent, and polybasic acid salts wherein said salts were taught to be beneficial when employed in a freshwater environment, in view of secondary references which clearly suggested the addition of petroleum sulfonate to corrosion inhibiting compositions. The Board affirmed the rejection, holding that it would have been obvious to omit the polybasic acid salts of the primary reference where the function attributed to such salt is not desired or required, such as in compositions for providing corrosion resistance in environments which do not encounter fresh water.).” Thus, one of ordinary skill would have omitted any steps beyond the minimum required to obtain a fermented product from celery using Staphylococcus carnosus.
Soma does not teach passing the fermentation liquid through a ceramic membrane filter having pore size between 0.005 and 0.05 microns at a temperature between 25-35°C; passing the filtered liquid through an ultrafiltration membrane at a membrane pressure of 10MPa; washing the ultrafiltration membrane with water when the filtrate volume reaches 90% of the stock solution, continuing until the volume of transmitted liquid equals the volume of stock solution; and spray drying the filtered liquid using a centrifugal spray dryer with air inlet temperature between 220-240C and air outlet temperature between 100-140°C to produce a powder having moisture content less than 2% as measured by Karl Fischer method.
Regarding passing the fermentation liquid through a ceramic membrane filter having pore size between 0.005 and 0.05 microns and passing the filtered liquid through an ultrafiltration membrane, Garikipati teaches of subjecting a fermentation broth to separation using a first filtration via microfiltration or ultrafiltration ([0015]) and the both microfiltration and ultrafiltration use ceramic membranes ([0069], [0070]). Garikipati teaches that the first filtration can be ultrafiltration ([0015]) and that ultrafiltration uses ceramic membranes with a pore size from about 0.005 microns to 0.1 microns (which would remove particles greater than 0.005 microns and higher, [0070]), which falls in the claimed range of “greater than approximately 0.005 microns”. Garikipati teaches a process that comprises a first filtration and a second filtration ([0015]) and that multiple filtrations can be used in all combinations, including ultrafiltration ([0065]). Because Garikipati teaches that filtration can be used in all combinations, one of ordinary skill would recognize that ultrafiltration can be used as the second filtration.
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 process taught by Soma with the addition of a second filtration using ultrafiltration as taught by Garikipati. One of ordinary skill would be motivated to make this modification because Garikipati teaches that multiple filtrations can be useful to reduce fouling of membranes and aid in recovery of individual components of the fermentation broth ([0066]).
Regarding passing through the membrane filter at a temperature between 25-35°C, El Menyawi teaches a method of extracting proteins from precipitates (Abstract) where the protein comprising precipitate includes a fermentation broth ([0179]), the method comprising feeding the suspension into a filtration unit ([0013]) and further feeding that suspension into a second filtration unit ([0021]), where the temperature in the filtration units is controlled between 2[Symbol font/0xB0]C and 25[Symbol font/0xB0]C ([0087]), which falls within the claimed range of “not exceeding 35[Symbol font/0xB0]C”.
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 process of Soma with the use of filtration at a controlled temperature as taught by El Menyawi. One of ordinary skill would be motivated to make this modification because El Menyawi teaches that such temperatures ensure optimum extraction ([0087]).
Regarding performing ultrafiltration at a pressure of 10 MPa, Tapia teaches extraction and purification of polyphenols from winery residues (i.e., a food product; abstract) comprising membrane separation following extraction (i.e., membrane filtration as a second filtration), which includes reverse osmosis at 35-100 bar (equivalent to 3.5-10 MPa, which includes the claimed value of “approximately 10 MPa”; p. 16, ¶ 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 modify the process of Soma with the use of reverse osmosis as a second filtration step as taught by Tapia. One of ordinary skill would have been motivated to make this modification because Tapia teaches that reverse osmosis is used for purification purposes (p. 17, ¶ 2).
Regarding initiating cleaning and washing with clear water, Yamada teaches a process of washing out a separation membrane by filtering the amount of washing water through the membrane ([0045]).
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 process of Soma to include a step of washing the filtration unit after filtration as taught by Yamada. One would be motivated to make this modification because Yamada teaches that washing enables a long-lasting separation membrane ([0044]).
Although the cited prior art does not teach initiating cleaning and washing when the proportion of filtrate volume reaches about 90%, one of ordinary skill in the art would have adjusted the point at which cleaning and washing begins during routine optimization to determine when in the process to start washing. 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).
Although the cited prior art does not teach wherein the filtration is complete when the filtrate volume and stock liquid volume are equal, one of ordinary skill would find carrying out the filtration until all of the original liquid has exited the system to be obvious.
Regarding spray drying the filtered liquid using a centrifugal spray dryer to produce a powder having moisture content less than 2% as measured by Karl Fischer method,
Asaoka teaches the process of making a tablet (abstract) using arginine produced by fermentation ([0030]) following by spray drying ([0037]), where the atomizer for the spray dryer performs atomization by centrifugal force (i.e., a centrifugal spray dryer; [0039]). Asaoka teaches that the moisture content of the powder obtained by spray drying is measured using Karl Fischer’s method has a moisture content of not more than 4 mass% ([0043]), which encompasses the claimed range of “less than approximately 2%.
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 process taught by Soma with the addition of centrifugal spray drying as taught by Asaoka after filtration because Asaoka teaches that spray drying can make minute droplets in a short time and make particles that are rich in flowability ([0034]).
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 the spray dryer having an air inlet temperature between 220-240°C and air outlet temperature between 100-140°C, Hywell teaches high speed centrifugal spray dryers with air inlet temperatures of 100-280°C, which encompasses the claimed range of “220-240°C”, and an outlet temperature of 60-130°C, which overlaps with the claimed range of “100-140°C” (p. 4, High-Speed Centrifugal Spray Dryer Specifications, lines 2-3).
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 process of Soma in view of Asaoka to use a centrifugal spray dryer with an inlet and outlet temperature as taught by Hywell. One of ordinary skill would have been motivated to make this modification because Hywell teaches that the centrifugal dryers can be used to produce dry powder particles of controllable size (p. 6, Advantages, no. 6).
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 Objections: Applicant has overcome the objections to the claims based on amendments in the Claims. Accordingly, the objections have been withdrawn.
Claim Rejections – 35 U.S.C. §103 of claims 1-7 and 10-15 over Soma and Garikipati; claim 8 over Soma, Garikipati, El Menyawi, and Yamada; claim 9 over Soma, Garikipati, El Menyawi, Yamada, and Tapia; claims 16 and 17 over Soma, Garikipati, and Asaoka; and claims 18 and 19 over Soma, Garikipati, and Gladue: Applicant’s arguments filed October 21, 2025 have been fully considered but they are not persuasive.
Applicant argued that the Examiner has failed to establish a prima facie case of obviousness and that the Office Action contains no discussion regarding the level of ordinary skill in the art. (Remarks, p. 7, ¶ 3- p. 8, ¶ 1).
This argument has been considered. However, MPEP §2141.03(I) states “The person of ordinary skill in the art is a hypothetical person who is presumed to have known the relevant art at the relevant time. Factors that may be considered in determining the level of ordinary skill in the art may include: (A) "type of problems encountered in the art;" (B) "prior art solutions to those problems;" (C) "rapidity with which innovations are made;" (D) "sophistication of the technology; and" (E) "educational level of active workers in the field. In a given case, every factor may not be present, and one or more factors may predominate." In re GPAC, 57 F.3d 1573, 1579, 35 USPQ2d 1116, 1121 (Fed. Cir. 1995); Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962, 1 USPQ2d 1196, 1201 (Fed. Cir. 1986); Environmental Designs, Ltd. V. Union Oil Co., 713 F.2d 693, 696, 218 USPQ 865, 868 (Fed. Cir. 1983).” Additionally, MPEP §2141(II)(C) states “Office personnel may rely on their own technical expertise to describe the knowledge and skills of a person of ordinary skill in the art.” The Examiner maintains that fermentation of plant material and filtration are both well-known processes by one of ordinary skill in the art. Thus, one of ordinary skill in the art would have been capable of combining the disclosure of Soma and Garikipati with nothing less than a reasonable expectation of success.
Applicant further argued that Soma and Garikipati operate in fundamentally different contexts (Remarks, p. 8, ¶ 2).
This argument has been considered. However, Soma are Garikipati are relied upon for their respective technical contexts. Soma is silent regarding the filtration process that may be used following fermentation of the meat curing agent. Thus, the Examiner properly relies on Garikipati to teach a filtration process described for use of fermented liquid. Although Garikipati is directed to solving a different problem than that of Soma, one of ordinary skill in the art would have been capable of combining Soma and Garikipati before the effective filing date of the instant application to arrive at the claimed method with nothing less than a reasonable expectation of success.
Applicant argued that Soma does not teach the claimed two filter system and merely discloses a single filtration (Remarks, p. 8, ¶ 3- p. 9, ¶ 1).
This argument has been considered. However, Soma is not relied upon to teach the first and second filtration as required by claim 1. As described above, Garikipati discloses a first filtration followed by a second filtration as claimed. Thus, the combination of Soma and Garikipati together teach the invention of claim 1. The Examiner maintains that one of ordinary skill would have had a reasonable expectation of success when combining Soma and Garikipati.
Applicant further argued that the proposed combination of Soma and Garikipati would render both references inoperable because the filtration system of Garikipati would destroy the flavor profile of the fermented food product (Remarks, p. 9, ¶ 2- p. 10, ¶ 2).
This argument has been considered. However, Soma is silent regarding any required flavor profile or nutritional composition of the fermented food product. Thus, one of ordinary skill would have been motivated apply the filtration method of Garikipati to the product of Soma to obtain a filtered fermentation broth. Although Soma does not disclose purifying the fermentation liquid, Soma does teach that microorganisms and insoluble solids may be removed by filtration ([0045]). The Examiner maintains that the product of Soma would still be useful as a meat curing agent after being filtered by the methods disclosed by Garikipati. Additionally, it is noted that the features upon which applicant relies (i.e., essential flavor compounds in fermented celery products) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant argued that Garikipati is non-analogous art (Remarks, p. 10, ¶ 3).
This argument has been considered. However, the Examiner maintains that Garikipati is analogous art because the disclosure of Garikipati is directed towards filtering a fermentation broth (Abstract). Because the instant claims are directed towards a method of filtering a fermentation broth, Garikipati analogous art and thus suitable for reliance upon in obviousness rejections. Although Garikipati is primary focused on one particular instant of fermentation, the filtration methods in Garikipati can reasonably be applied to fermentation products and obtain the same result of a purified fermented product.
Applicant argued that the Examiner’s reliance on inherency lacks evidentiary support, and that the information in the instant specification is directed towards a specific process not taught by Soma and Garikipati (Remarks, p. 11, ¶ 2- p. 12, ¶ 2).
This argument has been considered. However, the combination of Soma and Garikipati teach the method of the claimed invention. Thus, the product of the combination of prior art references would necessarily result in the same reduction of a* value as is claimed. MPEP §2112.01(I) states “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). ‘When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.’ In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.” Because the combination of Soma and Garikipati results in a meat curing agent that has been made by the same/similar process to that of the claimed invention, a prima facie case of obviousness has been properly established. The applicant has failed to show that the prior art product would not necessarily possess the same characteristics as that of the claimed invention.
Applicant argued that there is no motivation to combine Soma and Garikipati. Applicant states that Garikipati’s chemical product removes everything other than the target composition, whereas the complex mixture of natural compounds is essential to the product of Soma (Remarks, p. 12, ¶ 3- p. 13, ¶ 1).
This argument has been considered. However, Garikipati discloses that the amount of impurities removed from the product can reflect the application for which the 1,4-BDO is to be used ([0194]). Thus, one of ordinary skill would have been motivated to modify the filtration process to not strip out every compound that is present in the fermentation. Furthermore, Soma is silent regarding the required composition of the meat curing agent, other than the present of nitrites (Abstract). Thus, one of ordinary skill would have used a fermentation method of Garikipati that did not strip out the essential nitrites. The Applicant has not provided citations to the prior art where there is alleged disclosure that would lead to a lack of motivation. Thus, the Examiner maintains that the motivation to combine Soma and Garikipati would have existed to one of ordinary skill in the art prior to the effective filing date of the claimed invention.
Applicant argued that the secondary references do not cure the deficiencies of Soma and Garikipati and that the office action provides no explanation for why would one combine the cited prior art (Remarks, p. 13, ¶ 2-3).
This argument has been considered. 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). Examiner maintains that the prior art references are adequate for all that is relied on in the present claim rejections, and the combination of references is adequate to deem the present claims obvious. With respect to the argument that the office action provides no explanation for why one would combine the teachings, the Examiner has properly followed all requirements of forming a prima facie case of obviousness. For each reference used in the rejection of the above claims, a reasoning for the motivation to combine the references has been provided. Thus, the rejections are maintained.
New claims 21 and 22: Applicant’s arguments filed October 21, 2025 have been fully considered but they are not persuasive.
It is noted that in the Remarks filed 10/21/2025, the Applicant refers to new claims “20 and 21”. However, the two new claims are claims 21 and 22. For the remainder of this response to arguments, the Examiner will address the claims according to the current numbers.
Applicant argued that new claim 20 is not taught by the cited prior art (Remarks, p. 14, ¶ 1).
Applicant's arguments have been fully considered and are persuasive to the extent that the claim would not be anticipated/obvious in view of the previously cited prior art. However, claim 21 is rejected above in view of Soma, Garikipati, Jiuwu Hitech, El Menyawi, Yamada, Tapia, and Gladue.
Applicant argued that new claim 22 cannot be met by the prior art because of the use of “consisting of” (Remarks, p. 14, ¶ 2- p. 15, ¶ 2).
This argument has been considered. However, Soma is relied upon for the teaching of provided a fermented food broth from celery using Staphylococcus carnosus. MPEP §2144.04(II)(A) states that “Ex parte Wu, 10 USPQ 2031 (Bd. Pat. App. & Inter. 1989) (Claims at issue were directed to a method for inhibiting corrosion on metal surfaces using a composition consisting of epoxy resin, petroleum sulfonate, and hydrocarbon diluent. The claims were rejected over a primary reference which disclosed an anticorrosion composition of epoxy resin, hydrocarbon diluent, and polybasic acid salts wherein said salts were taught to be beneficial when employed in a freshwater environment, in view of secondary references which clearly suggested the addition of petroleum sulfonate to corrosion inhibiting compositions. The Board affirmed the rejection, holding that it would have been obvious to omit the polybasic acid salts of the primary reference where the function attributed to such salt is not desired or required, such as in compositions for providing corrosion resistance in environments which do not encounter fresh water.).” The Examiner maintains that one of ordinary skill would have omitted additional steps such as continuous monitoring and withdrawal of fermented material prior to complete conversion if those steps were not desired in the process of fermenting celery with Staphylococcus carnosus.
Applicant further argued that objective evidence supports nonobviousness, and that there has been a long-felt but unresolved need for the product resulting from the claimed method (Remarks, p. 15, ¶ 3- p. 16, ¶ 1).
This argument has been considered. However, MPEP §716.04(I) states “Establishing long-felt need requires objective evidence that an art recognized problem existed in the art for a long period of time without solution. The relevance of long-felt need and the failure of others to the issue of obviousness depends on several factors. First, the need must have been a persistent one that was recognized by those of ordinary skill in the art. In re Gershon, 372 F.2d 535, 539, 152 USPQ 602, 605 (CCPA 1967).” The Applicant has failed to provide objective evidence of a long-felt need in the art that has not been satisfied by another before the invention of the claimed method.
Applicant argued that the technical solution of the claimed invention represents unexpected results in the support of nonobviousness (Remarks, p. 16, ¶ 2).
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 instant specification does not provide sufficient data to demonstrate a showing of unexpected results. Additional data would be required to demonstrate unexpected results.
The rejections of claims 1-19, 21, and 22 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 Generally available M-Th 8:00a-5:00p, F 8:00-2:00.
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/A.S.H./Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793