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 Boursier et al. (US 2015/0237885 A1) and Gallardo et al. (US 2017/0156388 A1).
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., 70 wt% (column 11 table 3), water (column 9 line 29-30), and protein from lentils, chick peas and peas (column 3 lines 45-59), where the composition is free from egg-derived ingredients (column 8 lines 39-41).
Bialek et al. does not teach the protein has been treated to a hydrolyzation step.
Boursier et al. teaches a food composition comprising pea protein hydrolysate, where the hydrolyzation includes either enzymatic or chemical hydrolysis, where said hydrolysates comprise a higher proportion of peptides of various sizes and of free amino acids than the original composition (paragraph 69). Hydrolysis is a well-known method for improving protein solubility, where “it is observed that the solubility increases with the degree of hydrolysis” (paragraph 157). While the above citation to the well-known method is directed to enzymatic hydrolysis, one of ordinary skill would have reasonably expected similar improvement in solubility with chemical hydrolysis, particularly since the reference establishes equivalency between the methods i.e., “hydrolyzates are defined as preparations obtained by enzymatic hydrolysis or chemical hydrolysis”.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the composition of Bialek et al. to use protein which has been subjected to hydrolyzation since the reference already teaches wanting to denature the proteins (column 7 lines 38-42), since using hydrolyzed pea proteins is known in the art, to obtain a composition having a higher proportion of peptides and amino acids, as well as enhanced solubility, and to apply a known technique to improve similar products in the same way, see MPEP 2143 I.(C).
Regarding the protein that has been treated to a hydrolyzation step being selected from the group consisting of the recited protein alternatives, the alternative “pea protein” is chosen for examination.
Boursier et al. further teaches “in particular one pea protein” and “pea protein hydrolysate” (paragraph 69).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the composition of Bialek et al. to use only pea protein for the protein that has been hydrolyzed since there is no evidence of record indicating criticality or unexpected results associated with the claimed feature, as a selection from art recognized hydrolyzed protein sources, for the same advantages stated in the combination above, and in order to obtain an emulsion having desired flavor, texture/mouthfeel, aroma, and nutritional profile.
The combination of Bialek et al. Boursier et al. applied above teaches pea protein that has been treated to a hydrolyzation step, but does not teach said 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 at the time of the 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 at the time of the 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, the combination of Bialek et al. and Boursier et al. applied to claim 1 teaches hydrolyzed pea protein.
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 pea protein, where the DH can be varied as desired.
It would have been obvious to one of ordinary skill in the art at the time of the 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% as stated for claim 1.
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 at the time of the invention to modify the pH as a based on 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 between 100-3,500 Pa (column 4 lines 32-33), such as 1610 Pa (column 11 line 25).
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. Determining the G’ values based on the claimed measurement parameters 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 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 Boursier et al. and 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 at the time of the 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 Amendment
The declaration under 37 CFR 1.132 filed 6/16/2025 is insufficient to overcome the rejection of claims 1, 3 and 5-11 based upon 35 USC 103 as set forth in the last Office action because:
The results are not commensurate in scope with the claimed composition, and it is not clear if criticality is limited to the claimed range of DH values. The DH values used in experiments a-d are, respectively, 6%, 2.8%, 3.7% and 0% (non-hydrolyzed). Evaluation includes rheological properties, glossiness, color, and emulsification properties, where DH 0% and DH 6% obtained different, unsatisfactory results as compared to DH 2.8% and DH 3.7% (items 8-13).
While the results associated with DH 2.8% and 3.7% are acknowledged, the issue lies in comparative DH values used to obtain the results. Specifically, the issue relates to determination of whether Applicant’s alleged results are observed in compositions comprising hydrolyzed pea protein, where the DH is outside of the claimed range i.e., just above 0% to just below 2.2% and just above 4%. Experiment d (DH 0%) does not utilize hydrolyzed protein, and therefore cannot be used to determine if the results are observed in a composition comprising hydrolyzed protein with DH below 2.2%. Likewise, it is unclear if compositions having protein with DH values just outside of the claimed range (e.g., 4.1%) exhibit the same instability and undesired results as experiment d (DH 6%).
Applicant concludes compositions comprising pea protein with DH of greater than 5% were not stable and hand no glossy appearance, and compositions with DH of less than 1% were not glossy.
However, it is unclear where the DH values 5% and 1% were obtained. Experiments a and d use DH 6% and DH 0%, respectively. There is no evidence which would indicate unexpected results are observed below 5% and above 1%. Further, the conclusion is not commensurate in scope with the claimed values of 2.2% to 4%. Applicant states “hydrolysed pea protein with DH between 2 and 4 are stable and glossy” (item 14 part 3), which appears to indicate that the lower claimed range of DH 2.2% is actually not critical.
Response to Arguments
Applicant’s arguments, see page 5, filed 12/8/2025, with respect to the rejection of claim 1 under 35 USC 103 has been fully considered and are persuasive. Bialek teaches that it is not desirable to subject the pulse seed to enzymatic hydrolysis (column 7 lines 38-42). Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made. While Bialek teaches against enzymatic hydrolysis, the reference does not disclose or otherwise indicate chemical hydrolysis cannot be used. Boursier teaches either enzymatic or chemical hydrolysis can be used as stated for claim 1. Therefore, Bialek is modified to use chemical hydrolysis rather than enzymatic hydrolysis.
Applicant argues Gallardo warns against hydrolysis, which would discourage one of ordinary skill from applying hydrolyzed proteins to Bialek’s system.
This is not persuasive since 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. Further, the reference teaches the DH can be “about 3” or “about 4%”, which is within Applicant’s claimed range. Regarding the argument of achieving a glossy texture, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Applicant argues the claimed DH range of 2.2-4% is critical for stabilizing high oil content emulsions, where the specification demonstrates unexpected results for “high oil content emulsions” (more than 70 wt%) and a DH of “4% or higher, the composition may become quite thin”, thereby establishing criticality of the claimed range.
This is not persuasive since the cited portions do not actually indicate criticality, and appear to contradict Applicant’s assertion that the claimed DH range of 2.2-4% is actually critical. Page 4 line 35 to page 5 line 12 of the specification associate desired results with a range of DH values that are broader than the claimed range (i.e., less than 5% and more than 1%). Likewise, the “undesired” result of a “thin” composition is disclosed to include the upper claimed DH value of 4%, and it is thus unclear if a DH value of 4% is actually critical. The same passage states “high oil levels (more than 70 wt%)”, but the claim recites an oil content as low as 65 wt%, and it is unclear if the alleged unexpected results are obtained with oil contents of 70 wt% or less.
Applicant argues that improvement in glossiness at high oil levels was only seen with a DH at 2.8% and 3.7%, but not in compositions wherein hydrolyzation was below 1% or higher than 5%, and therefore confirms the criticality of the claimed range of 2.2-4%.
The argument is not persuasive for the same reasons stated for the declaration, as well as the argument above. Furthermore, the prior art recognizes explicit DH values within Applicant’s claimed range i.e., “about 3%” and “about 4%”. One of ordinary skill in the art would have reasonably expected similar properties of glossiness at high oil levels in the prior art composition having the pea protein with the same DH levels.
Applicant argues Folmer is directed to double emulsions with different structural requirements than the emulsions of claim 11.
However, the reference is cited to show that the prior art recognizes droplet size within an emulsion can be controlled based on parameters such as homogenization speed and duration of shearing and mixing, where droplet size is controlled based on desired texture and consistency of the final emulsion.
Applicant’s argument against the dependent claims is not persuasive for the same reasons stated above.
Conclusion
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/BRYAN KIM/Examiner, Art Unit 1792