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 of group I in the reply filed on 3/4/26 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
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 3, 14, 40, 42 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 3 recites “heating the second solution” during the mixing or exerting steps. However, the second solution is not created until the first solution has been ejected. It is not clear when the heating occurs, or to what material.
Claim 14 recites “the plant protein is from at least one of… nutritional yeast,… or mycoprotein”. It is not clear if the claim should be “is selected from at least…”, or not. Also, mycoprotein and yeast are microorganisms, not plants. It is not clear if other non-plant proteins would qualify as “plant proteins”, or not. It is not clear what proteins would be considered “plant” proteins.
Claim 40 recites the limitation "the collection of fibers". There is insufficient antecedent basis for this limitation in the claim. It is not clear if claim 40 should include a “collecting” step, or not.
Claim 42 recites “the plant protein is from at least one of… nutritional yeast,… or mycoprotein”. It is not clear if the claim should be “is selected from at least…”, or not. Also, mycoprotein and yeast are microorganisms, not plants. It is not clear if other non-plant proteins would qualify as “plant proteins”, or not. It is not clear what proteins would be considered “plant” proteins.
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.
Claims 1-2, 7-8, 12, 14-15, 17 are rejected under 35 U.S.C. 103 as being unpatentable over Boulet-Audet et al [US 2022/0330575A1] in view of Howsam [US 6,635301B1].
Boulet-Audet et al teach a method of making a meat fiber analog product by mixing raw materials to form a solution (Figure 4, #402-403; paragraph 0082), the raw materials including plant proteins and polysaccharides (paragraph 0045-0046), exerting force to eject a solution jet from a spinneret to form fibers (Figure 4, #405-407), collecting the jet fibers in a precipitation bath (Figure 4, #408), drying the fibers by squeezing/pressing on a drum (Figure 4, #422, 424; paragraph 0087), adding fat and flavoring to the dried fibers (Figure 4, #426, 428; paragraph 0088), the polysaccharides including alginates, pectin, starch, and/or methylcellulose (paragraph 0046), no disclosure of adding oil (ie 0%) to the raw mixture (see whole document), the plant proteins including soy, peas, rice, seitan, lentil, bean, and/or quinoa proteins (paragraph 0045), oils and fats in the fibers (paragraph 0045), the oils/fats including sunflower, flaxseed, canola, olive, and coconut oil (paragraph 0055), a solvent in the form of water at 70-80% of the produced fiber (paragraph 0038), the produced fiber being 15-25% protein on a wet basis and up to 83% protein on a dry basis (paragraph 0038), and the fiber having 5-10% fat (paragraph 0038).
Boulet-Audet et al do not explicitly recite the solution having 15-40% composition (claim 1), and pulling apart the fibers (claim 1).
Howsam teaches a method for making a meat fiber analog product by providing 40-55% plant protein material (ie defatted soy flour), 0-5% polysaccharide (ie cellulose), and 35-60% water (Figure 1, #12, 14, 16, 30; column 4, lines 28-45), mixing and extruding the ingredients with a twin-screw extruder (Figure 1, #22), pulling apart/shredding the extrudate to form a shredded meat analog product (Figure 1, #48; column 9, line 9), and the shredded product having 25-35% protein, 0-10% fat, 5-20% carbohydrate, and 40-60% moisture (column 9, Table 1).
It would have been obvious to one of ordinary skill in the art to incorporate the claimed composition amount and pulling apart of fibers into the invention of Boulet-Audet et al, in view of Howsam, since both are directed to methods of making meat fiber analog products, since Boulet-Audet et al already included a solvent in the form of water at 70-80% of the produced fiber (paragraph 0038) but simply did not mention the amount of composition used in the initial mixture, since meat fiber analog systems commonly used an initial mixture with 40-55% plant protein material (ie defatted soy flour), 0-5% polysaccharide (ie cellulose), and 35-60% water (Figure 1, #12, 14, 16, 30; column 4, lines 28-45) as shown by Howsam; since the claimed composition amount would have been used during the course of normal experimentation and optimization procedures due to factors such as the desired texture and flavor properties of the end product and/or the types of plant proteins and polysaccharides used by Boulet-Audet et al, in view of Howsam; since many consumers desired shredded/pulled apart meat product such as pulled pork and shredded beef, since meat fiber analog systems commonly used a step of shredding/pulling apart of the fibers as shown by Howsam, and since providing the meat fiber analog product of Boulet-Audet et al in a shredded/pulled apart-form, in view of Howsam, would have enabled greater interest and sales to consumers.
Claim(s) 3-4, 6, 19, 40-42, 45 are rejected under 35 U.S.C. 103 as being unpatentable over Boulet-Audet et al, in view of Howsam, as applied above, and further in view of Lange [US 3,800,053].
Boulet-Audet et al and Howsam teach the above mentioned concepts. Boulet-Audet et al also disclose a fiber diameter of about 100 micrometer (paragraph 0043), the bath having salts, bases, and/or acids to a provide a pH shift for fiber precipitation (paragraph 0083), and an absence of woven fibers (see whole document).
Boulet-Audet et al do not explicitly recite heating the solution at 40-90C (claim 3), adding less than 5% acid to the solution (claim 4), adding less than 5% base to the solution (claim 6), the solution being acidic and the bath being a basic solution (claim 19), and less than 5% acetic acid (claim 40).
Lange teaches a process for preparing protein monofilaments (title) by providing defatted oilseed proteins (column 1, line 59), mixing with 25-60% water in an extruder (column 2, line 25-34), adding acetic acid or bases to the mixture (column 2, lines 35-46), heating in the extruder at 175-300F (column 3, lines 1-4), an example using less than 5% of a base such as NH4OH (column 3, Example I), and an example using less than 5% acetic acid (column 5, Example V).
It would have been obvious to one of ordinary skill in the art to incorporate the claimed heating and acid/base elements into the invention of Boulet-Audet et al, in view of Howsam and Lange, since all are directed to methods of making meat analog products, since Boulet-Audet et al already included the bath having salts, bases, and/or acids to a provide a pH shift for fiber precipitation (paragraph 0083) and simply did not mention the mixing conditions, since meat analog systems commonly included adding acetic acid or bases to the mixture (column 2, lines 35-46), heating in the extruder at 175-300F (column 3, lines 1-4), an example using less than 5% of a base such as NH4OH (column 3, Example I), and an example using less than 5% acetic acid (column 5, Example V) as shown by Lange; since heating was a common means for denaturing proteins, since Boulet-Audet et al already disclosed protein denaturing in the bath (paragraph 0083), since the claimed heating and acid/base elements would have enabled easier denaturing and/or precipitation of the product of Boulet-Audet et al, in view of Lange; and since the claimed features would have been used during the course of normal experimentation and optimization procedures due to factors such as the desired texture and flavor properties of the end product and/or the types of plant proteins and polysaccharides used by Boulet-Audet et al, in view of Lange.
Claims 9-11, 18, 20, 22 are rejected under 35 U.S.C. 103 as being unpatentable over Boulet-Audet et al, in view of Howsam, as applied above, and further in view of MacQueen et al [Muscle tissue engineering in fibrous gelatin: implications for meat analogs].
Boulet-Audet et al and Howsam teach the above mentioned concepts. Boulet-Audet et al also included scaffolding (paragraph 0059). Boulet-Audet et al do not explicitly recite adding biological cells (claim 9), anchorage-dependent cells (claim 10), mammalian muscle myoblasts (claim 11), water-ethanol exchange (claim 18), wet-spinning (claim 20), rotary jet spinning (claim 22).
MacQueen et al teach a method for making meat analog fibers by use of immersion rotary jet spinning (iRJS) which is a dry-jet wet spinning system (page 1, right column), spinning microfibrous gelatin scaffolds seeded with bovine aortic smooth muscle cells and rabbit skeletal myoblast cells, a precipitation bath with a water:ethanol mixture, the gelatin being porcine with acid treatment (page 2, left column), and iRJS working with other materials such as polysaccharides and plant-derived biomolecules (page 6, right column).
It would have been obvious to one of ordinary skill in the art to incorporate the claimed biological cell features and spinning features into the invention of Boulet-Audet et al, in view of Howsam and MacQueen et al, since all are directed to systems for making meat analog products, since Boulet-Audet et al already included spinnerets but simply did not describe it in detail, since Boulet-Audet et al also disclosed scaffolding (paragraph 0059), since many consumers desired a product with less or fewer animal ingredients but not fully vegetarian, since meat analog systems commonly included immersion rotary jet spinning which is a dry-jet wet spinning system (page 1, right column), spinning microfibrous gelatin scaffolds seeded with bovine aortic smooth muscle cells and rabbit skeletal myoblast cells, a precipitation bath with a water:ethanol mixture, the gelatin being porcine with acid treatment (page 2, left column), and iRJS working with other materials such as polysaccharides and plant-derived biomolecules (page 6, right column) as shown by MacQueen et al; since the incorporation of some animal-based ingredients would have provided a more realistic taste, texture, and flavor to the meat analog products of Boulet-Audet et al, since the iRJS spinning technology of MacQueen et al would have enabled a better quality product in the system of Boulet-Audet et al, and since the substitution of one known element (ie iRJS) for another (ie spinneret) would have yielded predictable results to one of ordinary skill in the art.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Boulet-Audet et al, in view of Howsam, as applied above, and further in view of Hayes Jr et al [US 3,870,812].
Boulet-Audet et al in view of Howsam teach the above mentioned concepts. Boulet-Audet et al do not explicitly recite adding a salt, thiol, or mercaptoethanol to cleave disulfide bonds (claim 16). Hayes Jr et al teach a method for modifying protein gels by use of an agent to break the disulfide bonds of protein (abstract), using the protein in meat substitutes (column 1, line 8), the proteins including soybeans, peanuts, cottonseed, sesame, and sunflower (column 2, line 48), a reduction viscosity due to the disulfide bond cleaving which results in a softer gel (column 1,line 60-65; column 3, lines 1-10), and the agents including lower alkyl mercaptans and thio acids, such as cystine, cysteine, and their salts (column 3, lines 28-39). It would have been obvious to one of ordinary skill in the art to incorporate the claimed cleaving feature into the invention of Boulet-Audet et al, in view of Hayes Jr et al, since both are directed to methods of processing plant proteins, since meat substitute systems commonly used an agent to break the disulfide bonds of protein (abstract) and the agents including lower alkyl mercaptans and thio acids, such as cystine, cysteine, and their salts (column 3, lines 28-39) as shown by Hayes Jr et al; and since the cleaving of disulfide bonds in the protein of Boulet-Audet et al, in view of hayes Jr et al, would have enabled greater control over the final texture of the meat analog product.
Claims 43-44 are rejected under 35 U.S.C. 103 as being unpatentable over Boulet-Audet et al, in view of Howsam and Lange, as applied above, and further in view of MacQueen et al [Muscle tissue engineering in fibrous gelatin: implications for meat analogs].
Boulet-Audet et al, Lange, and Howsam teach the above mentioned concepts. Boulet-Audet et al also included scaffolding (paragraph 0059). Boulet-Audet et al do not explicitly recite adding biological cells (claim 43), mammalian muscle myoblasts (claim 44).
MacQueen et al teach a method for making meat analog fibers by use of immersion rotary jet spinning which is a dry-jet wet spinning system (page 1, right column), spinning microfibrous gelatin scaffolds seeded with bovine aortic smooth muscle cells and rabbit skeletal myoblast cells, a precipitation bath with a water:ethanol mixture, the gelatin being porcine with acid treatment (page 2, left column), and iRJS working with other materials such as polysaccharides and plant-derived biomolecules (page 6, right column).
It would have been obvious to one of ordinary skill in the art to incorporate the claimed biological cell features into the invention of Boulet-Audet et al, in view of Howsam, Lange, and MacQueen et al, since all are directed to systems for making meat analog products, since Boulet-Audet et al also disclosed scaffolding (paragraph 0059), since many consumers desired a product with less or fewer animal ingredients but not fully vegetarian, since meat analog systems commonly included spinning microfibrous gelatin scaffolds seeded with bovine aortic smooth muscle cells and rabbit skeletal myoblast cells, (page 2, left column) and iRJS working with other materials such as polysaccharides and plant-derived biomolecules (page 6, right column) as shown by MacQueen et al; and since the incorporation of some animal-based ingredients would have provided a more realistic taste, texture, and flavor to the meat analog products of Boulet-Audet et al.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-4, 6-12, 14-20, 22, 40-45 (particularly claim 1) are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 52-76 (particularly claim 52) of copending Application No. 19/237,512 in view of Boulet-Audet et al and Howsam. The ‘512 application does not claim pulling apart fiber, and adding fat and flavoring. Boulet-Audet et al and Howsam teach the above mentioned concepts. It would have been obvious to one of ordinary skill in the art to incorporate the claimed pulling apart of fibers and addition of fats and flavorings into the invention of ‘512, in view of Boulet-Audet et al and Howsam, since all are directed to methods of making meat fiber analog products, since ‘521 already claimed collecting fibers (claim 1), since many consumers desired shredded/pulled apart meat product such as pulled pork and shredded beef, since meat fiber analog systems commonly used a step of shredding/pulling apart of the fibers as shown by Howsam, since providing the meat fiber analog product of ‘521 in a shredded/pulled apart-form, in view of Howsam, would have enabled greater interest and sales to consumers, since meat fiber analog products commonly included a step of adding fat and flavoring to the dried fibers (Figure 4, #426, 428; paragraph 0088) as shown by Boulet-Audet et al, since many consumers desired food products with appealing tastes and flavors, and since the claimed fat and flavoring would have enabled a wider range of tastes and flavors in the system of ‘521 and thus provided increased consumer appeal.
This is a provisional nonstatutory double patenting rejection.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Huang, Levinson, Hartman, Yamakami, Sawada, Akinson, Rekhif, Margolis, Betz, Wemmer, Hayes teach methods of making meat analogs.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DREW E BECKER whose telephone number is (571)272-1396. The examiner can normally be reached 8am-5pm Monday-Friday.
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/DREW E BECKER/Primary Examiner, Art Unit 1792
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