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 .
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-2, 8, 10, 15-17, 19, 21, 23, 36, 38-44 in the reply filed on February 9, 2026 is acknowledged. The traversal is on the ground(s) that the analysis does not establish that the shared feature is obvious. Applicant argued that the combination of art lacks evidence that desulfoferrodoxin would function as a red pigment at the described levels. Applicant argues that there is no teaching Frasier to substitute a non-heme iron-binding protein for Fraser’s colorants (Remarks, p. 2, ¶ 5- p. 3, ¶ 1).
This argument has been considered. However, as described in the Restriction Requirement, Fraser teaches a meat substitute ([0017]) comprising natural coloring agents ([0065]). The Examiner maintains that one of ordinary skill would have found it obvious to include desulfoferrodoxin from Anaerotigmum lactatifermentans because Tavares teaches that desulfoferrodoxin has a pink or grey color, and would thus constitute a natural food colorant. It is well known in the art that uncooked meat and meat substitutes have a red color.
Applicant further argued that Tavares is a report of desulfoferrodoxin from Desulfovibrio desulfuricans and that Tavares does not teach any food use, suitability, or efficacy of desulfoferrodoxin (Remarks, p. 3, ¶ 2).
This argument has been considered. However, Fraser teaches that the heme protein extracts of the present invention may comprise non-heme proteins ([0039]). Thus, Fraser implicitly discloses that non-heme proteins may be included is food use. Therefore, one of ordinary skill would have included desulfoferrodoxin in the composition of Fraser as both the non-heme protein and a natural food colorant because desulfoferrodoxins, as described above, are known in the art to produce a grey/pink color.
Applicant also argued that UniProt only discloses a sequence and organism metadata and does not suggest food pigment applications (Remarks, p. 3, ¶ 3).
This argument has been considered. However, UniProt is not relied upon to teach using the claimed desulfoferrodoxin as a food pigment, the inclusion levels, or the performance in meat substitutes. UniProt is merely relied upon to teach a desulfoferrodoxin that has a 100% identity with SEQ ID 2 of the claimed invention. The Examiner maintains that one of ordinary skill would have included the desulfoferrodoxin of UniProt as the non-heme protein in Fraser because Tavares teaches that desulfoferrodoxin has a pink or grey color (p. 10504, col. 1, ¶ 1).
Applicant also argued that the combination of references provides no basis that the combined reference would have had a reasonable expectation of success as a pigment in a meat substitute (Remarks, p. 3, ¶ 4).
This argument has been considered. However, MPEP §2143.02(I) states “The reasonable expectation of success requirement refers to ‘the likelihood of success’ in combining or modifying prior art disclosures to meet the limitations of the claimed invention. See Elekta Ltd. v. ZAP Surgical Sys., Inc., 81 F.4th 1368, 1375, 2023 USPQ2d 1100 (Fed. Cir. 2023) and Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1367, 119 USPQ2d 1171, 1176 (Fed. Cir. 2016).” The Examiner maintains that one of ordinary skill in the art would have had a reasonable expectation of success in including desulfoferrodoxin as the non-heme protein in the composition of Fraser. Furthermore, MPEP §2143.02(II) states “Obviousness does not require absolute predictability, but at least some degree of predictability is required. Evidence showing there was no reasonable expectation of success may support a conclusion of nonobviousness.” In the instant case, Applicant has not demonstrated any evidence showing that reasonable expectation of success would not be achieved.
Applicant lastly argued that Groups I and II share a special technical feature, and thus should be recognized as forming a single general inventive concept (Remarks, p. 3, ¶ 5- p. 4, ¶ 1).
This argument has been considered. However, for the reasons described above, the Examiner maintains that the shared technical feature of a meat substitute comprising 0.1% to 10.0% by weight of a non-heme iron-binding protein with a sequence at least 90% identical to at least one of SEQ ID Nos: 2, 9, and 10 is not a special technical feature because it does not make a contribution over the prior art in view of Fraser and UniProt as evidenced by Tavares.
The requirement is still deemed proper and is therefore made FINAL.
Claim 31 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected process, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on February 9, 2026.
Claim Status
The status of the claims upon entry of the present amendments stands as follows:
Pending claims:
1, 2, 8, 10, 15-17, 19, 21, 23, 31, 36, 38-44
Withdrawn claims:
31
Previously canceled claims:
3-7, 9, 11-14, 18, 20, 22, 24-30, 32-35, 37, 45
Newly canceled claims:
None
Amended claims:
None
New claims:
None
Claims currently under consideration:
1, 2, 8, 10, 15-17, 19, 21, 23, 36, 38-44
Currently rejected claims:
1, 2, 8, 10, 15-17, 19, 21, 23, 36, 38-44
Allowed claims:
None
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement filed February 9, 2026 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. The references lined through have not been considered. The NPL Feng et al. has not been provided with an English translation or statement of relevancy.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 2, 8, 10, 15-17, 19, 21, and 23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more.
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim is directed to patent eligible subject matter. Step 1 asks if a claim is directed to a statutory category of invention. Applicant’s claims are directed to a product; thus, the answer to Step 1 is Yes.
Step 2A, Prong One, asks if a claim recites to a product of nature. In this case, applicant’s claims recite a composition comprising at least 2.0% of a non-meat protein and 0.01% to 10.0% by weight of a non-heme iron-binding protein at least 80% identical to at least one of SEQ ID Nos: 2, 9, and 10. SEQ ID 2 has a 100% identity with desulfoferrodoxin from Anaerotignum lactatifermentans, which exists in nature. Thus, the claims do recite products of nature. MPEP § 2106.04(b) states that “When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A.”
MPEP § 2106.04(c)(I) states that “if the nature-based product limitation is not naturally occurring, for example due to some human intervention, then the markedly different characteristics analysis must be performed to determine whether the claimed product limitation is a product of nature exception…”. To perform the markedly different characteristic analysis, MPEP § 2106.04(c)(II) states “The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties…”.
In this case, a product comprising at 2.0% by weight of non-meat protein and desulfoferrodoxin from Anaerotignum lactatifermentans exists in nature. Therefore, the answer to Step 2A, Prong One, is Yes.
Thus, the analysis must move to Step 2A, Prong Two, which asks if the claim recites additional elements that integrate the judicial exception into a practical application. As discussed in MPEP § 2106.04(d)(2) this evaluation is performed by identifying whether there are additional elements recited in the claim beyond the judicial exception and evaluating these additional elements to determine whether the claim as a whole integrates the exception into a practical application. In this case, the claims do not recite any additional elements that integrate the product of natural into a practical application. Thus, the answer to Step 2A, Prong Two, is No.
The analysis must then move to Step 2B which asks if claims recite additional elements that amount to significantly more than the judicial exception. MPEP § 2106.05 states that this evaluation is performed by “Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself.” In this case, additional ingredients or limitations recited by the claims do not amount to significantly more than the judicial exception. As demonstrated below in the 35 USC 103 rejection of the claims, any additional components recited are routinely used in the art. Thus, the answer to Step 2B is No. Therefore, the claims are not directed to patent eligible subject matter.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2, 8, 10, 15, 16, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Fraser (US 2015/0351435 A1) in view of UniProt (A0A1M6L0Q2, UniProt, last updated March 15, 2017 [accessed online December 3, 2025]) as evidenced by Tavares (Tavares P. , et al. “Spectroscopic properties of desulfoferrodoxin from Desulfovibrio desulfuricans (ATCC 27774).”, Journal of Biological Chemistry, Volume 269, Issue 14, p. 10504-10510, published April 8, 1994 [accessed online December 3, 2025]).
Regarding claims 1 and 8, Fraser teaches of a food product such as a meat substitute ([0017]) comprising a non-heme protein from a source material such as bacterial proteins ([0039]) and natural coloring agents ([0065]). Fraser also teaches a replica burger comprising 3.86% pea vicilin (i.e., pea protein), 2.52% soy protein concentrate, 2% pea legumin (i.e., pea protein), and 4.68% soy protein isolate ([0079], Table 4), for a total of 13.06% plant protein (i.e., non-meat), which lies within the claimed range of “at least 2.0% by weight”.
Fraser does not teach the composition comprising 0.1% to 10.0% by weight of a non-heme protein iron-binding protein with a sequence at least 90% identical to at least one of SEQ ID Nos: 2, 9, and 10.
Regarding a non-heme protein iron-bringing protein with a sequence at least 80% identical (claim 1) and at least 90% identical (claim 8) to SEQ ID 2, 9, or 10, UniProt teaches of desulfoferrodextrin from Anaerotignum lactatifermentans (p. 1, Protein and Organism) which has a 100% identity with SEQ ID 2. Desulfoferrodoxin necessarily has a pink or gray color. Evidence to support that Desulfoferrodoxin has a pink or gray color is provided by Tavares. Tavares teaches that desulfoferrodoxin is a non-heme iron protein that has a pink and grey color (p. 10504, col. 1, ¶ 1).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the composition of Fraser with the use of a desulfoferrodoxin from Anaerotignum lactatifermentans taught by UniProt as the non-heme protein in Fraser. One of ordinary skill would have been motivated to make this modification because Tavares teaches that desulfoferrodoxin has a pink or grey color, so one would use it as a natural coloring agent.
Although the cited prior art does not teach the amount of a non-heme iron-binding protein, Fraser teaches that the composition can comprising coloring agents ([0065]). Therefore, one of ordinary skill in the art would have adjusted the amount of non-heme iron-binding protein during routine optimization to find the amount of protein to provide the desired color of the composition. MPEP §2144.05(II) states where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The claimed range would thus be obvious.
Regarding claim 2, although the cited prior art does not explicitly state that the meat substitute has increased red color relative to an equivalent meat substitute lacking the non-heme iron-binding protein, this limitation would be an inherent property of the meat substitute. Evidence to support that the meat substitute has increased red color relative to an equivalent meat substitute lacking the non-heme iron-binding protein is provided by the instant specification. The instant specification discloses that adding a pigment composition comprising a non-heme iron-binding polypeptide to a non-meat protein forms a meat substitute with increased red color prior to cooking relative to an equivalent meat substitute without the pigment composition ([0066]). Furthermore, MPEP §2112.01(II) states that a chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties the applicant discloses and/or claims are necessarily present.
Regarding claim 10, Fraser also teaches that the protein of the composition can be from pea, soybeans (i.e., soy), corn, chickpea, or wheat ([0032]).
Regarding claim 15, Although the cited prior art does not teach the amount of a non-heme iron-binding protein, Fraser teaches that the composition can comprising coloring agents ([0065]). Therefore, one of ordinary skill in the art would have adjusted the amount of non-heme iron-binding protein during routine optimization to find the amount of protein to provide the desired color of the composition. MPEP §2144.05(II) states where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The claimed range would thus be obvious.
Regarding claim 16, Fraser also teaches that the burgers comprise 35.52% of the ingredients listed in Table 4 and that the remainder was water ([0077]-[0079]; Table 4). Thus, the replica burgers comprise 64.48% water, which falls within the claimed range of “between 50% and 80%”.
Regarding claim 21, Fraser also teaches the composition comprising 4.68% soy protein isolate ([0079]; Table 4), which falls within the claimed range of “between 0.5% and 8%”.
Claims 17, 19, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Fraser (US 2015/0351435 A1) and UniProt (A0A1M6L0Q2, UniProt, last updated March 15, 2017 [accessed online December 3, 2025]) as evidenced by Tavares (Tavares P. , et al. “Spectroscopic properties of desulfoferrodoxin from Desulfovibrio desulfuricans (ATCC 27774).”, Journal of Biological Chemistry, Volume 269, Issue 14, p. 10504-10510, published April 8, 1994 [accessed online December 3, 2025]) as applied to claim 1 above, and further in view of Xu (US 2021/0092978 A1).
Regarding claim 17, Fraser also teaches that the food product may comprise a flavor precursor such as coconut oil, palm oil, sunflower oil, soy oil, or canola oil ([0019]; [0021]).
Fraser does not teach the composition comprising between 1% and 10% of a lipid composition.
However, in the same field of endeavor, Xu teaches a meat analogue comprising 10% vegetable oil ([0115]), which falls within the claimed range of “between 1% and 10%”.
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 meat analog composition of Fraser with the use of vegetable oil in the amount taught by Xu. The claim would have been obvious because all 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 function, and the combination yielded nothing more than predictable results to one of ordinary skill in the art, see MPEP §2143(A).
Regarding claim 19, Fraser teaches a meal analog comprising 3.86% pea vicilin (i.e., pea protein), 2% pea legumin (i.e., pea protein), 2.52% soy protein concentrate, and 4.68% soy protein isolate ([0079], Table 4) for a total of 13.06% protein, which falls within the claimed range of “between 5% and 30%”.
Fraser does not teach that the plant protein is a textured plant-based protein comprising textured pulse protein, textured pea protein, textured soy flour, textured soy concentrate, textured wheat protein, potato protein, or combinations thereof.
However, in the same field of endeavor, Xu teaches a meat analog comprising textures pea protein or textured soy protein ([0076]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to substitute the pea protein and soy protein of Fraser with the use of textured pea protein and textured soy protein as taught by Xu. The claim would have been obvious because one of ordinary skill in the art would have been able to make this simple substitution of one known element for another and yield predictable results to one of ordinary skill in the art, see MPEP §2143(B).
Regarding claim 23, Fraser does not teach the composition comprising methylcellulose in an amount between 0.1% and 2% by weight.
However, in the same field of endeavor, Xu teaches a meat analog comprising 0.2% methylcellulose ([0116]).
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 meat analog of Fraser with the addition of methylcellulose as taught by Xu. The claim would have been obvious because all 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 function, and the combination yielded nothing more than predictable results to one of ordinary skill in the art, see MPEP §2143(A).
Claims 36, 38, and 41-44 are rejected under 35 U.S.C. 103 as being unpatentable over Fraser (US 2015/0351435 A1) and UniProt (A0A1M6L0Q2, UniProt, last updated March 15, 2017 [accessed online December 3, 2025]).
Regarding claim 36, Fraser teaches that heme-containing proteins can be recombinantly produced using polypeptide expression techniques using fungal cells, plant cells, or animal cells ([0041]). Fraser also teaches that extracts of heme-containing proteins include one of more non-heme-containing protein from the source material ([0039]).
It would have been obvious to modify the product method of heme-containing proteins using polypeptide expression techniques to make a non-heme-protein. The claim would have been obvious because all 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 function, and the combination yielded nothing more than predictable results to one of ordinary skill in the art, see MPEP §2143(A).
Fraser does not teach that the non-heme iron-binding has a sequence at least 80% identical to at least one of SEQ ID Nos: 2, 9, and 10, or wherein the non-heme iron-binding polypeptide has an absorption spectrum maximum between 450 nm and 600 nm.
Regarding a non-heme protein iron-bringing protein with a sequence at least 80% identical (claim 1) and at least 90% identical (claim 8) to SEQ ID 2, 9, or 10, UniProt teaches of desulfoferrodextrin from Anaerotignum lactatifermentans (p. 1, Protein and Organism) which has a 100% identity with SEQ ID 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 composition of Fraser with the use of a desulfoferrodoxin from Anaerotignum lactatifermentans taught by UniProt as the non-heme protein in Fraser. The claim would have been obvious because all 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 function, and the combination yielded nothing more than predictable results to one of ordinary skill in the art, see MPEP §2143(A).
Although the cited prior art does not teach wherein the non-heme iron-binding polypeptide has an absorption spectrum maximum between 450 nm and 600 nm, MPEP §2112.01(II) states that a chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties the applicant discloses and/or claims are necessarily present.
Regarding claim 38, Fraser teaches that the source material containing non-heme-containing proteins can be plant ([0039]) that that proteins can be produced using polypeptide expression of plant cells ([0041]).
Regarding claim 41, Fraser teaches that the source material containing non-heme-containing proteins can be animal ([0039]) that that proteins can be produced using polypeptide expression of animal cells ([0041]).
Regarding claim 42, Fraser teaches that the source material containing non-heme-containing proteins can be insects ([0039]) that that proteins can be produced using polypeptide expression of insect cells ([0041]).
Regarding claim 43, Fraser teaches that polypeptide expression techniques can be done using mammalian cells and that in-vitro techniques can be used ([0041]).
Regarding claim 44, Fraser teaches a food product comprising heme-containing protein ([0017]) and that food products include meat substitutes ([0061]). Fraser also teaches the cell of claim 36 as described above.
Claims 39 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Fraser (US 2015/0351435 A1) and UniProt (A0A1M6L0Q2, UniProt, last updated March 15, 2017 [accessed online December 3, 2025]) as applied to claim 36 above, and further in view of Mellema (US 2020/0029591 A1).
Regarding claims 39 and 40, Fraser does not teach wherein the cell is an edible mushroom cell (claim 39) or wherein the edible mushroom cell is a Fusarium venenatum.
However, in the same field of endeavor, Mellema teaches of a meat analog comprising a fungal protein (Abstract) where examples of fungal protein include mushrooms or proteins obtained from Fusarium venenatum ([0069]). Although Mellema does not explicitly state that Fusarium venenatum, one of ordinary skill would recognize that mushrooms appropriate for use in a meat analog would necessarily be edible.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to substitute the fungal protein of Fraser with the use of proteins obtained from Fusarium venenatum as taught by Mellema. The claim would have been obvious because all 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 function, and the combination yielded nothing more than predictable results to one of ordinary skill in the art, see MPEP §2143(A).
Conclusion
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Emily Le can be reached at (571) 272-0903. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.S.H./Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793
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