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 .
This office action is in response to the application filed on March 22, 2024 and to the Response to Restriction Requirement filed on February 17, 2026.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-11, in the reply filed on February 17, 2026 is acknowledged.
Claims 12-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d) with a filing date of December 15, 2021. The certified copy of EP 21214655.9 has been filed in the present application, received on March 22, 2024.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
The present application is a 371 National Stage Application of PCT/US2022/076790 which has a filing date of September 21, 2022.
Status of Application
Claims 1-21 were originally presented and subject to a restriction requirement. Claims 1-20 are pending; claims 12-20 are withdrawn; claim 21 is canceled. Claims 1-11 are presented for examination.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it contains the implied phrase of “the invention relates to” multiple times. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 1 and 10 are objected to because of the following informalities: Each claim recites a lettered list (a, b, c, etc.) where the first word of each is capitalized. Since a claim is only one sentence, the capitalization of words that are not proper nouns is improper. Each of these recited words should be in the lowercase. Appropriate correction is required.
Claim Interpretation
The preamble of claim 1 recites that the product is “substantially free” of methylcellulose and derivatives thereof. The instant specification defines “substantially free” as that “no quantity of either methylcellulose or any derivatives thereof is present in traceable amounts in the meat substitute product” [0047] and as recited in claim 1 and defined in [0047].
Claim 4 recites a “high-moisture textured plant protein” and claim 5 recites a “dry textured plant protein.” The instant specification defines a high-moisture textured plant protein to be “plant protein that has been extruded or texturized using a wet process” [0051] and a dry textured plant protein to be “plant protein means plant protein that has been extruded or texturized using a dry process[” [0052]. The instant specification does not give examples as to these wet and dry processes; however, it is understood, and interpreted as, that high-moisture extrusion and low-moisture extrusion processes (as one example for each) would produce the respective high-moisture and dry textured plant proteins.
Claim Rejections - 35 USC § 112
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.
Claims 1-11 are 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 1 recites the term “plant-based,” which is unclear and thus renders the claim indefinite. It is unclear is a “plant-based” fiber can be composed of only plant ingredients, or if the component could also include ingredients from animals and animal products. Neither the claims nor the specification define or specify the term “plant-based” and as such, the meaning is not clearly delineated. There is no requirement by the claims that the ingredients have to be plant-based, so what makes the fiber product be plant-based? Does a certain percent (e.g., 50%) of the ingredients by weight have to be derived from plants? Do all of the ingredients have to be derived from plants? Therefore, the claim does not clearly define the scope of the limitation and is thereby rendered indefinite.
Claim 2 recites “from 0.3 to 6 wt.%” with no component recited. It’s assumed that the “psyllium” was deleted erroneously and the claim is intended to be “from 0.3 to 6 wt.% psyllium;” the claim will be interpreted as such.
Claims 4 and 5 are rendered indefinite because it’s unclear if the product further comprises high-moisture or dry textured plant protein at the claimed amounts or if the plant protein as recited in claim 1 is the high-moisture or dry textured plant protein. For the purposes of examination, the claim will be interpreted that the plant protein is the high-moisture or dry textured plant protein.
Claim 6 recites that the “one or more plant proteins are selected from low temperature gelling proteins” which renders the claim indefinite because it recites that the proteins are “selected from” but only one selection is offered (low temperature gelling proteins). Clarity could be improved by reciting that the plant proteins are low temperature gelling proteins.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 8 recites the broad recitation “from 0.2 to 9 wt.%,” and the claim also recites “preferably 0.4 to 6 wt.%,” which is the narrower statement of the range/limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claim.
Regarding claim 10, the phrase "for instance" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 10 recites the limitation "the transglutaminase" in part i. There is insufficient antecedent basis for this limitation in the claim because the claim depends on claim 1 and not on claim 9 where transglutaminase was already recited.
Claim 11 recites that the meat substitute product is, among others, a sausage, cold-cuts, nuggets, or crumbles., It is unclear how a meat substitute can be these products, as all are meat products, thus rendering the claim indefinite. For the purposes of examination, the claim will be interpreted as that the meat substitute product is in the form of a sausage, cold-cut, etc.
Claim 11 recites “meat-like” and “seafood/poultry/breakfast meat/mincemeat alternatives” which renders the claim indefinite because it is unclear what is required for a product to be “meat-like” or an “alternative.” Does it need the same taste, texture, appearance, and/or flavor to be considered “meat-like,” or is there some other requirement?
Claim 11 recites “breakfast meat” which renders the claim indefinite because it’s unclear what is considered to be a breakfast meat. Is it a breakfast meat such as sausage or bacon as what is typically eaten in the United States, or is a breakfast meat something like cold-cuts as what is typically eaten in some European countries? Or is it all encompassing? Therefore, the claim is rendered indefinite.
Claims 3, 7, and 9 are rejected as being dependent on a rejected base claim.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, 6-8, 10, and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shivola (US PG Pub. 2005/0260325; cited on IDS dated March 22, 2024).
Regarding claim 1, Shivola discloses a meat substitute product ([0013]-[0015]) that does not contain methylcellulose or derivatives thereof (i.e., is substantially free of methylcellulose and derivates thereof) comprising:
psyllium;
textured soy protein (i.e., a plant protein); and
flour (i.e., a filler) (claim 8; Example 1).
Regarding claim 2, and as best understood with regard to the 112(b) rejection above, Shivola discloses that the meat substitute product comprises 5 liters water, 1100 grams textured soy protein concentrate flakes, 200 grams soy flour, 150 grams psyllium powder, 100 grams vegetable broth concentrate, and 10 grams white pepper, equaling to a total of 6560 grams (Example 1). Therefore, the meat substitute product comprises 2.3 wt.% psyllium, which lies within the claimed range of 0.3-6 wt.%.
Regarding claim 6, Shivola discloses soy protein (i.e., a plant protein) that can be in the form of a powder (i.e., soy protein powder) [0031]. The instant specification gives examples of low temperature gelling proteins as claimed as being potato protein powder or soy protein powder (Specification: [0016]), as well as that one preferable example of a low temperature gelling protein is oil seed protein (Specification: [0029]). Where soybeans are an oil seed, soy protein is an oil seed protein, and where Shivola discloses that the soy protein can be a powder, Shivola discloses two embodiments of the soy protein being oil seed protein in the form of textured soy protein concentrate flakes and soy protein powder. Therefore, where the instant specification defines low temperature gelling proteins as oil seed protein or soy protein powder, the soy protein disclosed by Shivola reads on the claimed low temperature gelling agents which gel at a temperature of 40-85°C.
Regarding claim 7, Shivola discloses textured soy protein in the meat substitute product, which is a plant protein (claim 8). Soy protein is derived from soybeans, which are legumes. Therefore, the plant protein is legume protein.
Regarding claim 8, Shivola discloses that the meat substitute product comprises 200 grams soy flour (i.e., a filler as defined by claim 1) in a total amount of 2560 grams (as set forth above in the rejection of claim 2) (Example 1). Therefore, the meat substitute product comprises 7.8 wt.% soy flour (i.e., a filler), which lies within the claimed range of 0.2-8 wt.%.
Regarding claim 10, Shivola discloses that the meat substitute product comprises textured soy protein (i.e., textured plant protein that is a legume protein since soybeans are legumes), fats/oils, water, spices, and herbs (i.e., flavoring components) (claim 8).
Regarding claim 11, and as interpreted with regard to the 112(b) rejection above, Shivola discloses that the meat substitute product is in the form of a vegetarian hamburger (i.e., vegetarian burger patty) [0015].
Claim Rejections - 35 USC § 103
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Shivola (US PG Pub. 2005/0260325; cited on IDS dated March 22, 2024).
Shivola discloses the meat substitute product as set forth above with regard to claim 1.
Shivola also discloses that the meat substitute product comprises 1100 grams textured soy protein concentrate flakes (i.e., plant protein) in a total amount of 6560 grams (as set forth above in the rejection of claim 2) (Example 1). Therefore, the meat substitute product comprises 16.7 wt.% textured soy protein, which lies slightly outside of the claimed range of 20-98 wt.%.
However, where Shivola teaches that some amount of the water evaporates during manufacture of the product [0044], the final product would thus have an amount of plant protein within the claimed range, as the concentration of the plant protein increases while the concentration of the water decreases. Therefore, Shivola renders obvious the instant claim limitation.
Alternatively, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). See MPEP 2144.05.I. The difference between the claimed range and that taught by Shivola is virtually negligible absent any showing of unexpected results or criticality. One of ordinary skill in the art would have expected the final composition to have the same properties as a composition with the claimed amounts. Therefore, Shivola renders obvious the instant claim.
Shivola also teaches that the meat substitute product comprises 10-30 wt.% textured soy protein (i.e., plant protein), which overlaps with the claimed range of 20-98 wt.%. Where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). See MPEP 2144.05.I.
Claims 4, 5, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Shivola (US PG Pub. 2005/0260325; cited on IDS dated March 22, 2024) as applied to claim 1 above, and further in view of Mueller et al. (US PG Pub. 2008/0254168), herein after referred to as Mueller.
Shivola discloses the meat substitute product as set forth above with regard to claim 1.
Regarding claim 4, Shivola discloses that the meat substitute product comprises 10-30 wt.% of textured soy protein (claim 5), which overlaps with the claimed range of 25-98 wt.%. Where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). See MPEP 2144.05.I.
Shivola is silent as to that the textured soy protein is a high-moisture textured plant protein.
Mueller, in the same field of invention, teaches a food product that simulates a dried meat product (i.e., a meat substitute) [0130] where in the method of making the product, a protein mixture undergoes conditioning to form a high-moisture pre-mix, which is then fed into an extruder where the proteins are texturized ([0082]; [0085]). The extrudate is then formed into the final food product ([0103]-[0109]). Thus, Mueller teaches that the meat substitute product comprises high-moisture textured plant protein.
Therefore, as it was known in the art to produce meat substitutes with texturized plant protein, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to have made a meat substitute product with the composition as claimed by modifying the textured plant protein of Shivola, as Mueller teaches that meat substitutes are known to be made with high-moisture textured plant protein.
Regarding claim 5, Shivola discloses that the meat substitute product comprises 10-30 wt.% of textured soy protein (claim 5), which overlaps with the claimed range of 20-35 wt.%. Where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). See MPEP 2144.05.I.
Shivola is silent as to that the textured soy protein is a dry textured plant protein.
Mueller teaches a food product that simulates a dried meat product (i.e., a meat substitute) [0130] where in the method of making the product, a protein mixture undergoes conditioning to form a low-moisture pre-mix, which is then fed into an extruder where the proteins are texturized. Mueller also teaches that this low-moisture pre-mix is also called a dry pre-mix ([0082]; [0085]). The extrudate is then formed into the final food product ([0103]-[0109]). Thus, Mueller teaches that the meat substitute product comprises dry textured plant protein.
Therefore, as it was known in the art to produce meat substitutes with texturized plant protein, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to have made a meat substitute product with the composition as claimed by modifying the textured plant protein of Shivola, as Mueller teaches that meat substitutes are known to be made with low-moisture/dry textured plant protein.
Regarding claim 9, Shivola is silent as to that the meat substitute product further comprises transglutaminase. Shivola does disclose that the meat substitute product is gluten free [0031].
Mueller teaches a food product that simulates a dried meat product (i.e., a meat substitute) [0130] comprising transglutaminase. Mueller offers the motivation that transglutaminase is a suitable edible cross-linking agent that is utilized to form filaments in gluten-free embodiments of the meat substitute product [0030]. Therefore, where Shivola discloses a gluten-free meat substitute, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have incorporated the transglutaminase of Mueller into the meat substitute product of Shivola, thereby arriving at the claimed invention. One would have been motivated to make this modification for the benefit of facilitating filament formation in gluten-free meat substitute products.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAURA E SWEENEY whose telephone number is (571)272-0244. The examiner can normally be reached M-F 9:00-6:00 EST.
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/M.E.S./Examiner, Art Unit 1791
/Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791