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 .
Claim Objections
Claims 4 and 5 are objected to because of the following informalities: claims 4 and 5 do not have any units associated with the “%”. Appropriate correction is required.
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, 4-12 and 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 was amended to require the plant-based cheese product comprise a protein component in an amount of about 1-25% w/w of the product and also require the product comprise a protein content of 10% w/w or less. Paragraph [0016] is cited as support for amendments to the claims and states the following:
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Claim 1, as amended, requires the protein component in an amount of 1-25w/w% of the product and also that the product comprise less than 10w/w% protein content. While the claim refers to “protein component” and “protein content”, based upon the support from paragraph 16, it appears to indicate that both phrases are directed to the amount of protein in the product. Further, claim 1 recites that the protein component “consists” of low solubility albumin- or globulin-based proteins. Thus, no other material may be present as the “protein component”. As best understood, this is taken to mean that “protein component” is the same as “protein content”. Here, the claim has two conflicting ranges, 1-25w/w% and 10w/w% or less. The claim is indefinite as it is not clear which range of protein is required, 1-25 or 10 or less (which encompasses values below 1 and above zero.
Claim 4 requires “wherein the protein component comprises at least about 70% protein”. Claim 1 was amended to limit the protein component to “consist” of low solubility albumin- or globulin-based proteins, thus it is not clear how claim 4 allows for the presence of up to 30% of other material. In other words, the scope of claim 4 conflicts with the scope of claim 1.
Claim 5 requires “the protein component comprises less than about 20% of a non-amylopectin starch”. Claim 1 was amended to limit the protein component to “consist” of low solubility albumin- or globulin-based proteins, thus it is not clear how claim 5 allows for the presence of starch as part of the protein component. While starch is present in claim 1, it is not clearly indicated to be part of the “protein component”.
Dependent claims are rejected for the same reasoning as given for claim 1.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 4-10 and 19 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 2023/0114609 (Moca) alone or alternatively as evidenced by Tang (Plant Protein versus Dairy Protein) or Juandoo (Solubility and Dispersion Viscosity of Soy Protein Isolates).
Regarding claims 1 and 19, Moca teaches a plant-based cheese with a protein content of about 10-25wt% (within the range of 1-25wt%), a waxy starch having at least 70wt% amylopectin and fat (abstract). The waxy starch includes at least 80wt% amylopectin or at least 90wt% amylopectin [0022]. The starch is present within a range of 10-20wt% which falls within the claimed range of about 5-50wt% [0025]. Considering the amount of starch that may be added is 10-20wt%, the amount of carbohydrate is expected to also be met. Furthermore, the carbohydrate amount is a combination of carbohydrates from the protein as well as the starch (see instant specification [0066]) thus the threshold of 10wt% is considered met. The fat may be present in an amount of 15-30wt% which meets the claimed range of 10-30wt% with sufficient specificity [0032] and a narrower range of 19-27wt% that falls within the claimed range. The moisture content is exemplified in Table 3 at 48 or 49wt% which falls within the claimed range of 45-65wt%. The protein component may be a protein isolate such as faba, lupin, soy, lentil, chickpea, pea, and mung bean [0017]. These protein sources are consistent with the sources of low solubility albumin- or globulin-based protein given in [0014] of the instant specification and are reasonably expected to provide the low solubility claimed since they are the same material.
Moreover, Tang discloses that soy protein isolate (SPI) and pea protein isolate (PPI) and have a solubility of less than about 30% at pH of 4-6 (Figure 7) (below).
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Moreover, Juandoo discloses the solubility of SPI in water (line A) in Figure 5 (below) which is consistent with the solubility profile of Tang.
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Thus, the SPI (soy protein isolate) and PPI (pea protein isolate) of Moro is reasonably expected to exhibit a solubility of less than about 30% at a pH of 4-6.
Regarding claims 1, 4, and 5, the protein component of the isolate is considered to consist of the protein itself.
Regarding claim 6, Moro teaches that any suitable fat may be used including coconut (saturated), she, palm, sunflower (unsaturated), cocoa, cottonseed and gives an example of a combination of coconut and sunflower [0027]. Thus, unsaturated, saturated and a mixture may be used.
Regarding claim 7, the hardness is within the range of 15-118N which falls within the range claimed.
Regarding claim 8, the tan value at 80C may be greater than 0.4 [0065].
Regarding claim 9, the stretch may be at least 30 or at least 35mm [0067].
Regarding claim 10, Table 2 indicates a melt% of 151% and 183% which was measured at 232C [0094].
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.
Claims 1, 4-13 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Grzanich (WO 2015/127388) (as evidenced by ELIANE 100 for claim 1, and Tang (Plant Protein versus Dairy Protein) or Juandoo (Solubility and Dispersion Viscosity of Soy Protein Isolates) for claim 2) in view of US 2019/0037872 (Bergsma).
Regarding claims 1, 4, 5, and 19, Grzanich teaches a soy-based cheese comprising a protein isolate such as a soy protein, lentil protein, pea protein, pea vicilin, pea legumin, soy conglycinin, or a soy glycinin (page 4). These proteins are consistent with those listed in the specification as being globulin-based (see instant specification [0014]). Moreover, Grzanich teaches the use of isolated protein where the term isolated indicates that the preparation is up to 99% pure. This is consistent with applicant’s description of a protein component having high purity as described in [0015] of the instant specification and thus is considered “low-solubility albumin protein” as the same type of protein and purity is disclosed by Grzanich as that which is disclosed.
The protein is combined with a fat component and a starch component and water (examples). The starch component may be potato starch, corn starch, tapioca, rice starch, pea starch or arrowroot starch, and specifically may be amylopectin potato starch (page 3) which is considered to have an amylopectin content greater than 80wt% as evidenced by the use of Eliane 100 (Examples 1 and 3) which is known to be a waxy potato starch with more than 95% amylopectin (See ELIANE 100).
Grzanich discloses that the cheese may have a protein component of up to 10wt%, up to 15wt% or up to 19wt% (pages 4 and 6). The carbohydrate content can be 4-7wt% and the fat content may be 16-22wt%. The protein and fat content overlap or fall within the claimed range, but the carbohydrate amount does not overlap. Grzanich also does not teach a moisture content, but does indicate that minimal (less than 5%) moisture loss is desired (Example 5).
Bergsma discloses a plant-based cheese comprising plant protein, starch and fat. Bergsma notes that at concentrations below 17wt% starch, the cheese analogue becomes softer and more difficult to shred, this indicating that hardness is a result effective variable dependent on the amount of starch added [0012]. One of ordinary skill would have found it obvious to increase the starch amount, and thus increasing the carbohydrate amount, to increase the hardness thus making the cheese easier to shred. Note that Grzanich discloses that the cheese may be sliced, grated or cubed (abstract). Bergsma also teaches a water content for a cheese that contains only water, starch protein and fat, the water is present in an amount of 35-74.5wt% [0027]. This is seen to provide the level of ordinary skill for the amount of water in a cheese analogue having only these components which is similar to the cheese analogue of Grzanich. Bergsma provides examples (Table 2) falling within the claimed range and also providing a cheese with good stretch. Thus, one of ordinary skill would have found it obvious to provide the water in amounts such as those taught by Bergsma in the cheese analogue of Grzanich with a reasonable expectation of successfully providing a cheese analogue with good stretch.
Tang discloses that soy protein isolate (SPI) and pea protein isolate (PPI) and have a solubility of less than about 30% at pH of 4-6 (Figure 7) (below).
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Moreover, Juandoo discloses the solubility of SPI in water (line A) in Figure 5 (below) which is consistent with the solubility profile of Tang.
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Thus, the SPI (soy protein isolate) and PPI (pea protein isolate) of Grzanich is reasonably expected to exhibit a solubility of less than about 30% at a pH of 4-6.
Regarding claim 6, examples of oil include canola oil (examples 1-2) and coconut oil (example 7), each of which include saturated and unsaturated fatty acids. These oils are also listed in the instant specification ([0020]).
Regarding claims 7-10, Grzanich does not expressly teach the hardness, tan delta, stretch or increase in diameter at temperatures above 200C. However, Grzanich teaches a plant-based cheese composition having the same composition as that claimed (SPI or PPI having the same solubility profile, similar starch and fat components in similar amounts) as modified above. Thus, one of ordinary skill would reasonably expect the properties of the cheese of Grzanich as modified above to fall within or overlap with the claimed property ranges. Moreover, as indicated by Bergsma, the amount of starch can be adjusted to change the hardness. The claimed ranges are open ended ranges for tan, stretch, and diameter increase) and the hardness range encompasses a wide breadth of hardnesses (15-120N) which encompasses a wide range of hardness for cheese. Also, with regard to stretch, Bergsma indicates materials with the amounts commensurate with the claimed ranges have good stretch which falls in the claimed range (Table 2).
Regarding claims 11 and 12, Grzanich teaches emulsifiers may be added and gives examples of carrageenan, gellan konjac, xanthan locus bean guar and Arabic gums (page 4) and examples of guar gum at 0.3% is given on page 16 for Example 4 and 0.1% for Example 6.
Regarding claim 13, Grzanich does not expressly teach the microstructure of the formed cheese. The instant specification attributes the homogenous microstructure of spherical elements to the use of a high purity low solubility protein component [0043]. Grzanich uses such a protein and also teaches using an immersion blender to ensure a homogeneous mixture (Example 7, page 21). Thus, one of ordinary skill would reasonably expect the microstructure of the cheese product of Grzanich to comprise spherical elements that are substantially evenly distributed throughout the product. Note that claim 13 does not quantify the extent of the presence of spherical elements, only that the cheese product must comprise the elements in a substantially evenly distribution throughout the product.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Grzanich and Bergsma and further in view of Upreti (WO 2023/052347).
Grzanich as modfied by Bergsma teaches the use of starch but does not specify a mixture of native and pregelatinized starch. Upreti teaches a non-dairy cheese composition including plant protein, fats and starches and explains that starch includes native starch, modified starch, flour, pre-gelatinized starch or cold swelling starch and combinations thereof (page 4). Upreti also discloses the properties of native and pregelatinized starch, such as crystallinity birefringence (page 5). It would have been obvious to one of ordinary skill in the art before the effective filing date to provide a combination of native and pregelatinized starch based upon the knowledge of their respective properties that are known to one of ordinary skill and based upon the teaching of a use of a combination of said starches by Upreti established a reasonable expectation of successfully using these starches in a non-dairy cheese product.
Response to Arguments
Applicant has renumbered the claims according to 37 CFR 1.126, thus the objection is withdrawn.
Applicant’s amendments overcome the 112(b) rejection of claims 2-5 and 12, thus the rejection is withdrawn.
However, a new 112(b) rejection is raised above with regard to the amended claims.
Applicant amended claim 1 to require the moisture content and carbohydrate content. Grzanich does not expressly disclose the moisture content or carbohydrate content. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made over Grzanich in view of Bergsma. Additionally, the search revealed new art to Moca.
Applicant argues that Grzanich teaches a soy-based cheese but does not teach a plant-based cheese having a protein component that consists of low solubility albumin- or globulin based proteins with the claimed solubility characteristics. Applicant states that Grzanich is based on soy milk and that the protein in soy milk has a solubility greater than 30%. Applicant refers to the Chen paper published in 2014 entitled “Protein particle and soluble protein structure in prepared soymilk”. However, Grzanich teaches the inclusion of soy or pea protein isolates as discussed above. The preamble of claim 1 included “comprising” language thus additional materials, including other proteins, may be present in addition to the protein component cited. In other words, the claim does not limit the protein in the cheese product to only that which is cited.
Applicant argues that Grzanich teaches making their cheese with heating to obtain curds and whey and that the only way to get curd formation or protein aggregation is to start with soy milk comprising a highly soluble protein fraction. As noted above, the claim is not closed to other materials being present.
Applicant argues the process of the invention is not made of curds and that the process induces gelatinization of the starch. The claims are to a process and are not limited by the process steps. Applicant argues that the Grzanich cheese is a solid cheese with poor melt and stretch properties while the claimed cheese product comprises gelatinized starch with greater melt and stretch properties. The properties and gelatinization are not recited in the independent claim and a new rejection has been made above with Bergsma and Moca.
Regarding Tang and Juandoo, applicant argues that they do not relate to the same soy protein since Grzanich relates to soy milk. However, Grzanich does add protein isolates to the cheese product, thus Tang and Juandoo are relied upon for evidence of the properties of these materials present in Grzanich.
Regarding claims 7-10, applicant argues process steps based upon gelatinization. However, the claims are to a product and there is no clear showing that the prior art is incapable of having the properties within the breadth of the claimed ranges.
Regarding claim 14, Grzanich teaches the presence of native starches and Upreti is relied upon to demonstrate that pre-gelatinized starches are known and have known effects that one of ordinary skill would be appraised of and thus demonstrate the level of ordinary skill and obviate the use of pre-gelatinized starch to gain the benefits thereof.
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 JENNIFER C MCNEIL whose telephone number is (571)272-1540. The examiner can normally be reached M-F 9-5.
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JENNIFER C. MCNEIL
Primary Examiner
Art Unit 1793
/Jennifer McNeil/Primary Examiner, Art Unit 1793