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 .
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, 3 and 5-10 are rejected under 35 U.S.C. 103 as being unpatentable over Bialek et al. (US 8,883,241 B2) in view of Gallardo et al. (US 2017/0156388 A1). Boursier et al. (US 2015/0237885 A1) is relied on as evidence.
Regarding claim 1, Bialek et al. teaches edible oil-in-water emulsions (abstract) comprising vegetable oil (column 8 lines 4-8), where the oil is present in an amount of 20-85 wt% of the emulsion (column 9 lines 27-28) e.g., 50 wt% (column 11 table 1), water (column 9 line 29-30), and protein from lentils, chick peas and peas (column 3 lines 45-59; examples 1-5), where the composition is free from egg-derived ingredients (column 8 lines 39-41). Regarding the protein being treated to a hydrolyzation step, Bialek et al. teaches the emulsions, containing lentil and chickpea proteins, are treated with protease (column 5 lines 62-63; column 6 lines 8-15; column 12 example 5 and table 5). Protease is known to cause hydrolyzation of proteins, including lentil and pea proteins as evidenced by Boursier et al. (paragraphs 41 and 70).
Bialek et al. does not teach said hydrolyzed protein has degree of hydrolyzation of 2.2 to 4%, according to the TCA test, interpreted in view of the specification to be the trichloroacetic acid soluble nitrogen test (page 5 lines 1-2).
Gallardo et al. teaches a nutrient delivery system (abstract), which can be in the form of an emulsion (paragraph 60), comprising hydrolyzed pea protein having a DH of between 0-60 (paragraph 19), such as “about 3” or “about 4%” (paragraphs 153-154). A DH in the disclosed range improves digestibility and increases the solubility of the protein in the formula, which in turn increases the emulsion capacity of and mineral delivery by the formula, without introducing detrimental features (paragraph 40). Gallardo et al. further teaches that a tradeoff is required between favorable features (i.e., emulsion capacity, digestibility, and mineral delivery) and unfavorable features (i.e., compromised sensory quality and poor functionality), where a balance may exist between solubility and DH of the protein with regard to increasing favorable features and decreasing unfavorable features of the protein (paragraph 157).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of Bialek et al. such that the hydrolyzed protein has a DH of 2.2-4% since the prior art acknowledges such values for hydrolyzed protein used in edible emulsions, to provide the same advantages taught by Gallardo et al., and since the claimed values would have been used during the course of routine experimentation and optimization procedures due to the factors disclosed by Gallardo et al.
Regarding the claimed DH values based on the TCA test, the limitation does not impart a structure or material function to the claimed composition. Determining the DH values based on the TCA test would have been readily obvious to one of ordinary skill in the art at the time of the invention as a preferred method of determining the DH, and to ensure a desired DH is achieved for product consistency.
Regarding claim 3, Bialek et al. teaches globulins and albumins typically represent a major part of the protein contained in the pulse seed, such as up to 95 wt%, where the ratio of globulins to proteins can be 10:1 (column 6 lines 50-57). Further, the globulins legumin and vicilin together represent up to 75 wt% of the protein in the seed (column 6 lines 60-62).
While the reference does not explicitly state the globulin level in the protein is more than 80 wt% based on the weight of the protein, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of Bialek et al. to have the claimed globulin level since the reference already teaches that the protein comprises mostly globulins, and since the claimed values would have been used during the course of routine experimentation and optimization procedures due to factors such as protein source e.g., pea, lentil, etc.
Regarding claim 5, Bialek et al. teaches the emulsion can include peas, and therefore pea proteins, where the emulsion is subjected to hydrolyzation by protease as stated for claim 1.
Bialek et al. does not teach the hydrolyzed protein consists of pea protein.
Gallardo et al. teaches the protein of the composition is selected from a closed group of alternatives including pea protein (paragraph 19), which suggests only pea protein can be used.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of Bialek et al. such that the hydrolyzed protein consists of pea protein since the reference does not recite or otherwise indicate that the emulsion must include multiple protein sources, since emulsions containing hydrolyzed pea proteins are recognized by the prior art, since the evidence of record does not indicate criticality or unexpected results associated with using only pea protein, and based on routine experimentation and optimization due to factors such as desired flavor, aroma, mouthfeel/texture, nutritional profile, and dietary restrictions/preferences of the consumer.
Regarding claim 6, Bialek et al. does not teach the amount of hydrolyzed protein is between 0.66 and 1 wt%, based on the weight of the composition.
However, the combination applied to claim 1 teaches using hydrolyzed protein, where the DH can be varied as desired.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of Bialek et al. to have the claimed amount of hydrolyzed protein since there is no evidence of criticality or unexpected results associated with the claimed feature, and since the values would have been used during the course of routine experimentation and optimization procedures due to factors such as desired peptide content, nutritional content, protein solubility, and mouthfeel/texture.
Regarding claim 7, Bialek et al. teaches the oil content can be about 70 wt% (column 11 table 3 composition “E”).
Regarding claim 8, Bialek et al. teaches the emulsion can have a pH of 3-5 (column 1 lines 10-11), where the pH can be adjusted with vinegar (column 22 line 22).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pH to the claimed range based on the particular type of emulsion being made, desired flavor, aroma, and nutritional profile.
Regarding claim 9, the limitation “G’” is interpreted in view of the specification to be “elastic modulus” (page 7 lines 34-35). Bialek et al. teaches G’ at 20oC is generally between 100-3,500 Pa (column 4 lines 32-33), and can have a G’ of e.g., 3790 Pa for an emulsion treated with protease (column 13 table 8). Further, the protease treatment of the emulsion can be performed to obtain varying reductions of G’ (column 6 lines 1-7), and composition of the emulsion (column 12 table 5; column 13 table 8).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of Bialek et al. to have the claimed range of G’ since there is no evidence of criticality or unexpected results associated with the claimed values, and since the values would have been used during the course of routine experimentation and optimization based on the particular type of emulsion being made, the composition, desired mouthfeel/texture, and rheological characteristics.
With respect to the G’ “determined from oscillatory measurements performed at 1 Hz frequency; strain set to 0.1%, and recorded after 5 minutes”, the limitation does not impart a structure or material function for the claimed composition. Regardless, Bialek et al. teaches determining G’ at a frequency of 1 Hz and varying stresses (column 5 lines 29-33). Determining the G’ values based on the claimed measurement parameters would have been readily obvious to one of ordinary skill in the art before the effective filing date of the claimed invention as a preferred method of determining G’, and to ensure a desired G’ is achieved for product consistency.
Regarding claim 10, Bialek et al. teaches the emulsion contains no added water structuring agent, including gum (column 8 lines 50-56; column 10 lines 25-35).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Bialek et al. in view of Gallardo et al. as applied to claim 1 above, and further in view of Folmer et al. (US 2010/0233221 A1).
Regarding claim 11, the claim is construed to recite the oil droplet size in the emulsion product as disclosed by the specification (page 8 lines 30-34).
Bialek et al. does not teach the oil droplet size D3.2 is between 0.2 to 75 micron. However, the reference teaches the emulsion comprises 80-100 volume % of oil droplets having a diameter of less than 10 micron (column 9 lines 39-41).
Folmer et al. teaches emulsions (abstract), where conditions for forming emulsions are known to the skilled person, where homogenization speed and duration of shearing or mixing influence the size of the droplets, and thereby, on the texture and consistency of the final emulsion (paragraph 62). The conditions can be controlled such that the emulsion contains a desired droplet size (paragraph 63).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the product of Bialek et al. such that the oil droplet size has a D3.2 between 0.2 to 75 micron since the reference already contemplates wanting a high degree of uniformity with respect to droplet size, since droplet size is known to be controlled based on emulsifying parameters, since there does not appear to be evidence of criticality or unexpected results associated with the claimed feature, and since the values would have been used during the course of routine experimentation and optimization procedures due to factors such as the desired texture and consistency of the final emulsion.
Response to Arguments
Applicant’s arguments filed 6/16/2026 have been fully considered, but the instant Office Action relies on new grounds of rejection. Upon further consideration, Bialek was determined to teach enzymatic hydrolysis of the emulsion (and therefore the protein therein) using protease. Boursier is no longer relied upon in combination with Bialek, and is instead cited as evidence to show protease is known to hydrolyze lentil and pea proteins.
Applicant argues Bialek teaches away from enzymatic hydrolysis based on the disclosure that the proteins play an important structural role and are defined as “a linear polypeptide comprising at least 10 amino acid residues”, and that the reference prefers to not subject the finely ground pulse seed to enzymatic treatment as described in EP 2183983 A.
However, it appears that Bialek does teach embodiments in which the emulsion is subjected to hydrolysis by protease. The reference explicitly states “protease treatment of an oil-in-water emulsion according to the present invention results in a reduction of G’ of more than 40%...most preferably of more than 60”, and discloses a procedure in which the emulsion is mixed with protease solution and incubated at 40oC for 24 hours i.e., an enzymatic hydrolysis process (column 6 lines 1-15). Further, example 5 discloses treating mayonnaise of the invention to protease in order to reduce G’ and viscosity. The disclosure therefore suggests to one of ordinary skill that Bialek encompasses embodiments in which the proteins are hydrolyzed.
Examiner acknowledges that the reference states enzymatic hydrolysis (according to EP 2183983 A) is not preferred. However, this does not appear to be a teaching away, and is instead a non-preferred embodiment. MPEP 2123 I.-II. states the following.
"The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983)
Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). "A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use." In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994)
Applicant’s arguments against Gallardo and Folmer have been fully considered, but the new grounds of rejection presented herein relies on Bialek teaching enzymatic hydrolysis.
Gallardo explicitly states the issue can be offset i.e., “a balance my exist between solubility and degree of hydrolysis…with regards to increasing favorable features of the protein and decreasing unfavorable features of the protein”. This suggests to one of ordinary skill that the degree of hydrolysis can be optimized.
Conclusion
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/BRYAN KIM/Examiner, Art Unit 1792
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