DETAILED ACTION
Amendments made February 2, 2026 have been entered.
Claims 1, 3-5, and 7-19 are pending.
Claim 15 has been withdrawn.
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 .
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.
Specification
The objections to the disclosure and the abstract of the disclosure have been withdrawn in light of applicant’s amendments made February 2, 2026.
Claim Rejections - 35 USC § 112
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The rejection of claim 3, 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35 U.S.C. 112, the applicant), regards as the invention, due to reciting both a plural and singular salt has been withdrawn in light of applicant’s amendments made February 2, 2026.
Claims 1, 3-5, 7-14, and 16-19 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 “allowing the particles to harden to achieve their final hardness”. It is unclear as to what the term “final hardness” means as food containing moisture could lose or absorb moisture overtime, and no indication of when a “final” time for measuring the hardness has been given. For example, it is unclear as to if the “final hardness” would be before the particles are used in a further food product, or until the moisture content balances with the surrounding atmosphere, until the food is packaged, until the food is consumed, etc.
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, 3, 8, 9, 11-14, and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Ballard et al (US 2003/0211228) in view of Kweldam (NL 1008364 machine translation) and Schmidt et al (US 4,603,054).
Regarding claims 1-3, 9, 11, and 17, Ballard et al (Ballard) teaches a process for preparing a vegan edible product by teaching of preparing a texturized meat analog wherein no animal products are required (all). Ballard teaches that the process comprises:
Providing a malleable mass, i.e. one that is pliable and can be shaped, comprising:
12-95% meat which encompasses meat analogs including vegetable proteins (paragraphs 11 and 37);
0.5-12% alginate, such as PROTANAL LF which is sodium alginate (paragraphs 37 and 38), which encompasses a water soluble organic polymeric gelling agent capable of being gelled by calcium ions and which is a polysaccharide bearing carboxyl groups or a water-soluble salt thereof, including a salt of alginic acid;
1-10% calcium sulfate which is sparingly soluble, and thus a calcium salt in retarded form, which releases its calcium ions in a delayed manner, and which contributes about 0.294-2.94% elemental calcium (calcium sulfate has a molecular weight of about 136.14g/mol of which calcium is approximately 40.08g/mol or 29.4%) (paragraphs 37 and 41);
0.01-1.0% sodium tripolyphosphate which is an alkali metal phosphate (paragraph 37 and 41); and
Balance (0-86.49%) water (paragraphs 37 and 38);
Comminuting the malleable mass into particles and bringing the particles into contact with an aqueous solution of calcium salt to achieve hardening through mixing with a calcium chloride solution to cause localized gelling and form an outer layer to produce preformed pieces that are tumbled (paragraphs 43-54, 73, and 77-82);
Separating the aqueous solution from the particles through perforations in the drum (paragraphs 58 and 66); and
Subsequently allowing the particles to set, i.e. harden to a final hardness (paragraph 69).
Also see paragraphs 79-82 and claims 1-3 and 25-27.
Regarding the calcium salt as releasing calcium ions upon controlled heating and/or controlled lowering of the pH as recited in claim 1 steps i. d. and ii, and the solubility of the calcium salt as increased by an acid, wherein the release of calcium ions is effected by including an acid into the malleable mass as recited in claim 1 iv, although Ballard necessarily teaches release of the calcium ions from the calcium sulfate (calcium salt) in order to form the hardened/gelled product, Ballard is not specific to using controlled heating and/or lowering the pH as claimed. Schmidt et al (Schmidt) teaches a structured meat product formed from comminuted pieces, alginate, and calcium carbonate, wherein a slow release acid such as citric acid, lactic acid, and glucono-delta-lactone can be added to slowly lower the pH to not only improve the flavor of the meat and shelf life, but also to produce enough hydrogen ions to stimulate the release of sufficient calcium ions from the calcium salt to accelerate formation of an algin/calcium gel (abstract, column 1 lines 6-25, column 7 line 52 through column 8 line 11, and column 9 lines 6-21). It would have been obvious to one of ordinary skill in the art for the process of forming the calcium alginate gel meat along of Ballard to include lowering the pH in a controlled manner through the slow release of acid, such as citric acid, lactic acid, and glucono-delta-lactone, in order to improve flavor and shelf life, and accelerate the formation of the algin/calcium gel by releasing the calcium ions as taught by Schmidt.
Regarding the solubility of the calcium salt as less than 1g/L as recited in claim 1iv, and the salt as selected from the group consisting of calcium carbonate, dicalcium phosphate, tricalcium phosphate, and dicalcium phosphate as recited in claim 3, as discussed above, Ballard teaches alginate gels used to form a structed meat product. Ballard teaches the gel as comprising a sparingly soluble salt as source of metal ions and exemplifies it as calcium sulfate (paragraph 37), however is silent to the solubility of the salt or to the salt as one selected from the claimed group.
Schmidt teaches a structured meat product formed from comminuted pieces, alginate, and calcium salt which releases calcium ions to from an algin/calcium gel (abstract). Schmidt teaches that the salts which can yield cations and are capable of gelatinizing alginates are most preferably salts with calcium which are insoluble or slightly soluble in water (column 7 lines 32-36). Schmidt teaches that calcium carbonate is highly preferred but that other calcium salts work equally well, including calcium sulfate, tricalcium phosphate, and dicalcium phosphate (column 7 lines 37-46).
Thus, the use of calcium carbonate, tricalcium phosphate, and dicalcium phosphate in gelatinizing the alginate and forming the gel of Ballard would have been the obvious as the substitution of one functional equivalent, i.e. calcium sulfate, for another functional equivalent insoluble or sparingly soluble source of calcium ions in view of Schmidt. Furthermore, as Schmidt teaches that calcium carbonate was highly preferred it would have been further obvious to specifically use calcium carbonate as the calcium salt. As the prior art teaches of the same chemical as claimed, i.e. calcium carbonate, or tricalcium phosphate, or dicalcium phosphate, the chemical of the prior art would have the same properties, i.e. the claimed solubility, as the claimed salt. The position is further supported as Schmidt teaches that said salts were low solubility or had no solubility in water.
Regarding the malleable mass as comprising 1-15% plant fat or oil as recited in claim 1 step i, b, Ballard is silent to the inclusion of fat. Kweldam teaches an animal protein free meat substitute for vegetarians formed from with an alginate and calcium gel composition, wherein the mixture for forming the product comprises 1-10% vegetable fat or oil (abstract and page 2 paragraphs 8 and 13). Kweldam teaches that although the fat is not necessary, the addition has the advantage that a better texture and taste are obtained (page 2 paragraph 13). It would have been obvious for the product mixture, i.e. the malleable mass of Ballard to comprise 1-10% vegetable fat or oil for better texture and/or taste in view of Kweldam.
Regarding the amount of the retarded calcium salt in the malleable mass as such that the weight ratio of calcium ions to the sodium salt of the water soluble organic polymeric gelling agent is in the range of 1:45 to 1:2 as recited in claim 8, as discussed above, Ballard teaches of the same calcium salt (calcium sulfate) and the same gelling agent (alginate) within the same ranges as claimed and disclosed. Thus, the teachings of Ballard would encompass, or at least make obvious a ratio of calcium ions to sodium salt as claimed. Furthermore, as the calcium ions and sodium salt were taught to react and form a gel, it would have been obvious to optimize the ratio for the desired gel.
Regarding step ii as comprising forming particles of the malleable mass and subsequently introducing them into the aqueous calcium salt solution as recited in claim 12, or comminuting the malleable mass in the aqueous solution of calcium salt as recited in claim 13, to switch the order of performing process steps would be obvious absent any clear and convincing evidence and/or arguments to the contrary (MPEP 2144.04 [R-1]). “Selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results”. As discussed above, Ballard teaches comminuting the malleable mass into particles and bringing the particles into contact with an aqueous solution of calcium salt to achieve hardening by teaching of mixing with a calcium chloride solution to cause localized gelling and form an outer layer to produce preformed pieces that are tumbled (paragraphs 43-53 and 79-82). Thus, the teachings of Ballard are considered to encompass or alternatively make obvious the limitations as claimed.
Regarding the particles as brought into contact with the aqueous solution of the calcium salt for 10 seconds to 60 minutes at a temperature of 0-90C, followed by separating the curing the particles outside the solution as recited in claim 14, preferably wherein the particles are in contact with the aqueous calcium salt solution for 0.5-15 minutes as recited in claim 18, as discussed above, Ballard teaches comminuting the malleable mass into particles and bringing the particles into contact with an aqueous solution of calcium salt to achieve hardening by teaching of mixing with a calcium chloride solution to cause localized gelling and form an outer layer to produce preformed pieces that are tumbled, followed by separating the particles from the solution and curing (paragraphs 43-53, 58, 66, 69, and 79-82). As Ballard does not teach heating or cooling, processing at room temperature, i.e. about 20-25C, would have been encompassed. Additionally, Ballard teaches the calcium slurry as applied with a bath for a predetermined about of time, e.g. 3 minutes (paragraph 45). Thus, the teachings of Ballard are considered to encompass or alternatively make obvious the limitations as claimed.
Regarding the particles as allowed to harden for at least 2.5 hours starting with the point in time when the conditions are applied which effect the release of the calcium ions from the retarded form of the calcium salt as recited in claim 19, Ballard teaches that the pieces are allowed to set for a predetermined period of time to allow the internal portion of each texturized piece to more fully gel and fold lines to become permanent (paragraph 69). Ballard is not specific to an amount of time for hardening, however in view of the teachings of Ballard it would have been obvious to allow hardening until the desired gel formation/hardness was achieved. Thus, the claimed limitation is considered obvious over the teachings of the prior art. Furthermore, as Ballard teaches that the pieces may be further processed with packaging (paragraph 69), as no step for stopping hardening is taught (all), and the Examiner takes official notice that packaging was known to be done for storage and distribution, one would expect that the particles of Ballard be hardened for at least 2.5 hours, i.e. a period of time for allow for packaging, storage, and distribution, as claimed.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Ballard et al (US 2003/0211228) in view of Kweldam (NL 1008364 machine translation) and Schmidt et al (US 4,603,054), further in view of Ma (WO 01/40370) and Bennett (EP 0345886).
As discussed above, Ballard teaches a process for preparing a texturized meat analog from calcium alginate gels, wherein it would have been obvious to include a slow-release acid of Schmidt et al (US 4,603,054). The references are not specific to the acid as coated acid or acid precursor, wherein the release of the calcium ions is effected by heating the malleable mass to at least 50C in step ii as recited in claim 4. However, Bennett shows that the slow-release acids of Schmidt et al (US 4,603,054) encompass encapsulated lactic acid (page 2 lines 44-55). Thus, as it would have been obvious to include the acid of Schmidt for its known benefits, and Bennett teaches that the acid of Schmidt would encompass coated lactic acid, the teachings of the prior art make obvious the instantly claimed limitation.
Regarding the release of the calcium ions is effected by heating the malleable mass to at least 50C in step ii as recited in claim 4, Ma teaches a method of controlling a rate of food gel formation for crosslinked gels for foods comprising alginate and calcium sulfate by varying gelation temperature (abstract, page 5 lines 6-10, page 6 lines 11-18 and 36-37, and page 12 lines 22-24). Ma teaches that the gelation rate may be selected as desired, wherein a slower rate can result in a more uniform gel with better mechanical properties, and a faster rate can reduce waiting time (page 7 line 23 through page 8 line 24). Ma taches a fast gel time was observed at 50C (Figure 4). To adjust the temperature, such as by heating, and effect the release of calcium ions was known and obvious in view of Ma. Specifically, it would have been obvious for step ii, forming of the particles of Ballard to be at a temperature of at least 50C so that a quicker gel processing time would be achieved in view of Ma.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Ballard et al (US 2003/0211228) in view of Kweldam (NL 1008364 machine translation) and Schmidt et al (US 4,603,054), further in view of Bennett (EP 0345886).
As discussed above, Ballard teaches a process for preparing a texturized meat analog from calcium alginate gels, wherein it would have been obvious to include a slow-release acid of Schmidt et al (US 4,603,054), including lactic acid for the known benefits of acid. The references are not specific to the acid as coated lactic acid as recited in claim 5. However, Bennett shows that the slow-release acids of Schmidt et al (US 4,603,054) encompass encapsulated lactic acid (page 2 lines 44-55). Thus, as it would have been obvious to include the acid of Schmidt for its known benefits, and Bennett teaches that the acid of Schmidt would encompass coated lactic acid, the teachings of the prior art make obvious the instantly claimed limitation.
Claims 7 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Ballard et al (US 2003/0211228) in view of Kweldam (NL 1008364 machine translation) and Schmidt et al (US 4,603,054), further in view of Wolf et al (WO 2020/236632).
As discussed above, Ballard teaches a process for preparing a texturized meat analog from treatment of a malleable mass with water soluble calcium salt alginate gels. Ballard is silent to the calcium salt as coated, wherein the release is effected by heating as recited in claim 7, wherein the calcium salt is selected from calcium chloride, calcium lactate, and calcium gluconate as recited in claim 7, preferably wherein the calcium salt is calcium lactate as recited in claim 16.
Wolf et al (Wolf) teaches plant-based food alternatives including a shellfish analog formed from pectin alginate compositions reacted under heat with calcium salt (paragraphs 3-5, 9, 13, and 30). Wolf teaches that encapsulating the calcium salt, calcium lactate, in a lipid prevents the interaction in its alginate environment until heating (paragraph 30). Thus, it would have been obvious for the plant based food alternative of Ballard to comprise calcium salt in the form of encapsulated calcium lactate, wherein heating was needed to effect the reaction between the alginate and calcium in order to control the start of the reaction in view of Wolf.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Ballard et al (US 2003/0211228) in view of Kweldam (NL 1008364 machine translation) and Schmidt et al (US 4,603,054), further in view of Rose et al (US 2015/0351427).
As discussed above, Ballard teaches a process for preparing a texturized meat analog from treatment of a malleable mass with calcium alginate gels. Ballard is silent to the malleable mass as containing 0.01-1% methylcellulose as recited in claim 10.
Rose et al (Rose) teaches of meat substitutes formed from treating a malleable mass of water and vegetable fat/oil comprising protein, sodium alginate, and methylcellulose with metal cations (abstract). Rose teaches that the use of methylcellulose with alginate gives a very positive fiber structure and yield (paragraph 23) and better control of the fiber structure (paragraph 39). Rose teaches the concentration of methylcellulose influences the fibers formed, wherein an increase brings about an increase in the yield and gives softer fibers similar to chicken or fish meat, and a reduction brings firmed fibers similar to beef (paragraphs 24, 25, and 41).
Regarding the malleable mass as containing 0.01-1% methylcellulose as recited in claim 10, it would have been obvious for the alginate meat substitute of Ballard to comprise methylcellulose as Rose teaches that the use of methylcellulose with alginate gives a very positive fiber structure and yield (paragraph 23) and better control of the fiber structure (paragraph 39). It would have been further obvious to adjust the amount of methylcellulose depending on the desired texture in view of Rose, wherein an increase in concentration would give a softer fiber similar to chicken or fish, and a decrease a firmed fiber, more similar to beef.
Response to Arguments
Applicant's arguments filed February 2, 2026 have been fully considered but they are not persuasive.
Applicant argues that the term “final hardness” would be understood by one skilled in the art as a hardness suitable for further use as detailed in the specification in the paragraph bridging claims 4-5. This argument is not convincing as it is not commensurate in scope with the claims. There is nothing claimed or required that establishes the “final hardness” to a hardness level which can be packaged, or used in a manner disclosed. Thus, the term remains unclear for the reasons presented previously, and above. It is suggested applicant delete the phrase “to achieve their final hardness”.
Applicant argues that the Ballard does not teach a malleable mass comprising an edible fat or oil of plant origin. This argument is not convincing as Kweldam was relied upon for teaching the argued limitation. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Applicant argues that the Ballard does not teach a calcium salt according to claim 1, but rather calcium sulfate which has a higher solubility and was deleted from the Markush group in the dependent claim 3. This argument is not convincing to withdraw the rejection as the use of the claimed salt would have been obvious in view of Schmidt for the reasons presented above. It is noted that this is a newly applied grounds of rejection in response to the claim amendment which limited the solubility of the salt (claim 1), as well as the Markush group of salts for use (claim 3).
Applicant argues that Ballard does not teach the release of calcium ions of the retarded calcium salt released while chopping of the malleable mass or contacting the preformed pieces with a calcium chloride solution. This argument is not convincing. First it is noted that the claim recites comminuting the malleable mass into particles and bringing the particles into contact with an aqueous solution of calcium salt to achieve hardening. Ballard teaches gelling, i.e. hardening, due to a calcium solution and calcium ions added from calcium sulphate, i.e. a retarded calcium salt (paragraphs 46-48, 53, and 73). Ballard also teaches the pre-formed pieces in the transfer tube which contains the calcium solution (paragraph 77) and thus the particles would be in contact with the solution of calcium salt to achieve hardening.
Applicant argues that Ballard fails to teach effecting the release of calcium ions by lowering pH or heating. This argument is not convincing as Schmidt was relied upon for teaching the argued limitation. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Applicant argues that Schmidt does not teach effecting the release of calcium ions by lowering pH or heating while chopping. This argument is not convincing. As discussed above, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In the instant case, Ballard is relied upon for teaching the release of calcium ions, and Schmidt is relied upon for teaching the benefits of acid addition, i.e. lowering the pH, when gelling, i.e. releasing calcium ions.
Applicant argues that Schmidt’s process is substantially different from the claimed process and also the claimed process because it does not teach all the limitations of the claim, and includes meat pieces. This argument is not convincing as the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Additionally, it is noted the disclosed invention, Ballard, and Schmidt all teaches of gelled structures for meat products (Schmidt title and Ballard abstract). Furthermore, Ballard specifically teaches that in providing such compositions one would understand that meat or meat analog compositions could be used (paragraph 37).
Applicant argues that Kweldam’s process does not teach all the limitations of the claim. This argument is not convincing as the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KELLY BEKKER whose telephone number is (571)272-2739. The examiner can normally be reached Monday-Friday 8am-3:30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Erik Kashnikow can be reached at 571-270-3475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
KELLY BEKKER
Primary Patent Examiner
Art Unit 1792
/KELLY J BEKKER/Primary Patent Examiner, Art Unit 1792
Prosecution Insights