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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/04/2025 has been entered.
Status of the Claim
Claims 14-16 and 18-34 are pending. Claims 14-16, 18-20, 26 and 29-34 are under examination. Claims 21-25 and 27-28 are withdrawn from consideration. Any objections or rejections not repeated below have been withdrawn.
Claim Objections
Claim 34 is objected to because of the following informality:
Claim 34 in lines 1-2 recite, “the composition present”. In claim 14 line 3 it recites “the oat protein composition… has a mean particle size”. Although it is clear that the particle size range recited in claim 34 is the particle size of the oat protein composition, for matters of form the recitation should be amended to recite “the oat protein composition has.” Appropriate correction is required.
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 14-16, 18-20, 26 and 29-34 are rejected under 35 U.S.C. 103 as being unpatentable over Whalen US 20130183404.
Regarding claims 14, 20, 29, 34 Whalen discloses an oat protein composition (an oat protein and fiber product; Abstract, [0016]) wherein said composition does not contain traces of organic solvent (the protein extraction is obtained using an enzyme mixed with water and the oat material, followed by clarifying using a centrifuge, the slurry is then dried to form a dried product, therefore no organic solvent was used and no traces of organic solvent are present in the composition; [0016-0019]), as disclosed in claim 14.
Whalen teaches the oat protein composition has 5.5% residual lipid content (fat content), or 5.7% residual lipid content when calculated on a dry weight basis accounting for the removal of moisture from the composition (Fig. 1, Column: “Sample 1 (%), Row: Fat; [0157]). This is within the claimed range for claim 14 of below 10% residual lipid content by weight on a dry weight basis.
Whalen states the particle size is less than 150 microns (ground material that is larger than U.S. #100 mesh has been removed; [0045]), which overlaps the claimed range of a mean particle size of greater than 10 microns, as recited in claim 14, overlaps the claimed range of a mean particle size of greater than 20 microns and lower than 300 microns, as recited in claim 20, and encompasses the claimed range of a mean particle size greater than 40 microns and lower than 150 microns, as recited in claim 34. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Regarding the recitation within claim 14 in line 3, “determined by laser diffraction”, while the mean particle size of Whalen is not determined by laser diffraction, it is recognized there may be some variation as to the exact mean particle size. However, the claimed range of greater than 20 and lower than 300 microns, and the taught range of less than 150 microns, are both large and would necessarily have significant overlap even given the expected variation due to measurement methods. Therefore, even with the variation between the different methods one of ordinary skill in the art would still expect the range of Whalen to overlap with the instantly claimed range.
Whalen teaches an oat protein composition as defined above. Whalen is silent as to the molecular weight profile of the proteins within the composition, as required by claim 14 and claim 29. However, regarding the molecular weight profile of the proteins within the composition, the recitation that discloses the specific molecular weights of the protein profile present within the composition, which states in claim 14, “from 0.5 to 30% of proteins having a molecular weight of 300kDa and more”, “from 30 to 75% of proteins having a molecular weight of between 50 and 300kDa”, “from 10 to 50% of proteins having a molecular weight of between 10 and 50kDa” and “from 0.5 to 20% of proteins having a molecular weight of 10kDa and less;” and the more narrowed ranges in claim 29 which states, “from 5 to 15% of proteins having a molecular weight of 300kDa and more”, “from 45 to 65% of proteins having a molecular weight of between 50 and 300kDa”, “from 25 to 45% of proteins having a molecular weight of between 10 and 50kDa” and “from 1 to 10% of proteins having a molecular weight of 10kDa and less,” these recitations are directed toward properties of the claimed composition.
When comparing the process steps in the specification, paragraphs [0010] and [0043], to the process steps of Whalen, as shown in parentheses with citations, which both provide an oat flour (an oat material; [0024] of Whalen), add water and an enzyme to the oat flour (mix water and at least one enzyme, alpha amylase; [0016-0017], [0060-0061] of Whalen), and noting every type of amylase enzyme can be used like alpha amylase. Then separating by centrifugation the hydrolyzed protein rich suspension into a heavy fiber layer and a light protein layer, and lastly the optional drying of the protein containing layer (first solids slurry is recovered using a clarifying centrifuge and the first solids slurry is dried to form a dried product; [0018-0019] of Whalen). It would have been reasonable for one having ordinary skill in the art to expect that the substantially identical process steps of Whalen, produce a substantially identical product to the claimed product.
As stated in In re Best, 562 F.2d 1252, 1255 (CCPA 1977): Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. [citation omitted] Whether the rejection is based on "inherency" under 35 U.S.C. § 102, on “prima facie obviousness” under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO’s inability to manufacture products or to obtain and compare prior art products. (MPEP §2112.01 (I)).
Regarding claims 15-16 and 30-31, Whalen teaches the composition has a protein concentration of between about 30% to about 90%, which overlaps the claimed range of the composition containing from 40% to 70% as recited in claim 15, overlaps the claimed range of more than 70%, as recited in claim 16, encompasses the claimed range of 50% to 60% as recited in claim 30, and also overlaps the claimed range of more than 80% protein as recited in claim 31 (Claim 22, [0019]).
Regarding claims 18 and 32, Whalen teaches an oat protein composition as defined in claim 14. Whalen is silent as to the percent of starch in the oat protein composition. However, regarding the percent starch within the composition, specifically the recitation, “the composition comprises from 0.1 to 10% by weight of starch” this recitation is directed toward a property of the claimed composition.
As shown above in claim 14, the process steps in the instant specification outlined in paragraphs [0010] and [0043], are substantially identical to the process steps of Whalen shown in paragraphs [0016-0019], [0024], [0060-0061]. It would have been reasonable for one having ordinary skill in the art to expect that the substantially identical process steps of Whalen, produce a substantially identical product to the claimed product.
Since the product of Whalen is substantially identical to the claimed product, it is considered to possess the property of from 0.1 to 10% by weight of starch in the composition, as required by claim 18 and from 1 to 4% starch, as required by claim 32. See In re Best, 562 F.2d 1252, 1255 (CCPA 1977).
Regarding claims 19 and 33, Whalen states the dietary fiber concentration of the composition is less than about 5%, which overlaps the claimed range of dietary fiber from 0.1% to 10%, as recited in claim 19, and 1% to 4%, as recited in claim 33 (Claim 22, [0019]).
Regarding claim 26, Whalen teaches a use of the protein composition as defined in claim 14 which is capable of use in food (an oat derived food product capable of use in supplementing food formulations; [0002], [0013-0016]).
Response to Declaration
The declaration under 37 CFR 1.132 filed 08/04/2025 is insufficient to overcome the rejection of claims 14-16, 18-20, 26 and 29-34 based upon the reference applied under 35 U.S.C 103 as set forth in the last Office action.
I. The teachings found in Whalen cannot allow achieving oat protein compositions with less than 10% lipid content due to the following reasons:
1. Ineffectiveness of Lipid Removal Methods of Whalen
Declarant discusses the ineffectiveness of the lipid removal methods in Whalen and how the amount of lipid content would not be below 10% by weight. On pgs. 5-6 of the declaration, the Declarant states that the methods of Whalen are primarily effective at removing carbohydrates and sugars but not lipids, which are insoluble in water. The Declarant discloses that Whalen in [0106] says, “Both the decanter solids and the clarifying centrifuge solids contained between about 16 and 20 weight percent oat lipid (oat oil).” Declarant continues, stating that nothing in Whalen suggests it’s method can remove lipids and reduce the lipid content. However, the Office disagrees for the following reasons.
While the Declarant may not see anything in Whalen that suggests it’s method can remove lipids and reduce the lipid content below 10%, as the rejection above shows, with the citation of Fig. 1, Whalen teaches the oat protein composition has 5.5% residual lipid content (fat content), or 5.7% residual lipid content when calculated on a dry weight basis accounting for the removal of moisture from the composition (Fig. 1, Column: “Sample 1 (%), Row: Fat; [0157]). This is within the claimed range for claim 14 of below 10% residual lipid content by weight on a dry weight basis. Thus, the clarifying method steps and other method steps of Whalen are able to produce a product with a residual lipid content within the claimed range.
Regarding the Declarant’s recitation of Whalen [0106], it is noted that the amount of lipid in the decanter solids and the clarifying centrifuge solids noted in this step, is directed to intermediate compositions and not the final composition and is also directed to specific embodiments. The recitation of Whalen [0106] should not be taken for the final lipid content of the composition.
2. Protein Concentration does not Correlate with Lipid Reduction
Declarant discusses on pg. 6 the process of Whalen, which states water washing and re-centrifuging the protein-rich slurry can increase the protein concentration (e.g., up to 90% protein content). Declarant argues that the process of Whalen would not reduce the lipid content proportionally because lipids are not water-soluble and would remain in the protein fraction. Declarant continues stating that even at higher protein concentrations, the lipid content would remain above 10%. The Office disagrees for the following reasons.
As stated in the above discussion and rejection, Whalen teaches the oat protein composition has 5.5% residual lipid content (fat content), or 5.7% residual lipid content when calculated on a dry weight basis accounting for the removal of moisture from the composition (Fig. 1, Column: “Sample 1 (%), Row: Fat; [0157]). Thus, the composition of Whalen does have a lipid content that is less than 10%.
3. Lack of Specific Steps to Target Lipid Removal
Declarant discloses on pgs. 6-7 of their declaration, that Whalen does not disclose any specific additive, such as surfactants, that would facilitate the removal of lipids from the oat protein composition. The declarant suggests that the absence of such steps would mean that the lipid content remains high in the final product. Declarant states that most of the lipids in oats are non-polar lipids and water washes would not be able to separate any of the non-polar lipids but would only potentially remove polar lipids which are not bound to the protein matrix. Declarant argues that the method disclosed by Whalen, even with a theoretical possibility that the non-bound polar lipids would be completely removed by water washes, the resultant wt.% of lipids would remain above the 10% limit of the compositions of claim 14. However, the Office disagrees for the following reasons.
As stated in the above discussion and rejection, Whalen teaches the oat protein composition has 5.5% residual lipid content (fat content), or 5.7% residual lipid content when calculated on a dry weight basis accounting for the removal of moisture from the composition (Fig. 1, Column: “Sample 1 (%), Row: Fat; [0157]). Thus, the composition of Whalen, using the method steps of Whalen, does achieve a lipid content that is less than 10%.
4. No pH Adjustment to Precipitate Protein
On pgs. 7-8 of the declaration, the Declarant argues that the present invention includes a step of adjusting the pH to between 4 and 6 and that the pH adjustment causes proteins to coagulate while leaving lipids in the soluble fraction, which can then be separated. Declarant states that Whalen does not disclose any such pH adjustment step, which declarant argues is essential for reducing lipid content. However, the Office disagrees for the following reasons.
As stated in the above discussion and rejection, Whalen teaches the oat protein composition has 5.5% residual lipid content (fat content), or 5.7% residual lipid content when calculated on a dry weight basis accounting for the removal of moisture from the composition (Fig. 1, Column: “Sample 1 (%), Row: Fat; [0157]). Thus, the composition of Whalen, using the method steps of Whalen, does achieve a lipid content that is less than 10%.
II. Whalen cannot disclose compositions with the molecular weight profile of claim 14.
On pgs. 8-9 of the declaration, the Declarant argues that Whalen does not disclose a step in which the pH is adjusted between 4 and 6 prior to separating the protein rich suspension by centrifugation. The Declarant discloses that the solubility of different oat proteins varies with pH according to their nature and molecular weight. Declarant states that low molecular weight proteins are soluble at pH close to their isoelectric pH and larger molecular weight proteins are insoluble at a pH close to the isoelectric pH. Declarant notes in their method that only certain proteins of a particular molecular weight precipitate, these are proteins that have a larger molecular weight and during centrifugation are found in the heavy phase. Declarant also notes the low molecular weight proteins are soluble at the pH range of between 4 to 6, and are found in the light layer containing soluble compounds. Declarant argues that the molecular weight profile present originally in oats is modified, and in particular, the quantity of low molecular weight proteins is reduced with the centrifugation step, which in turn, increases the quantities of proteins with larger molecular weights. Declarant believes the weight profile distribution defined in claim 14 cannot correspond to the molecular weight profile distribution of the compositions obtained by Whalen. The Office disagrees for the following reasons.
Regarding the Declarant’s statement that low molecular weight proteins do not precipitate when the pH is adjusted and are found in the “light layer” containing soluble compounds including lipids. Upon review of the specification, there is no mention of the light layer in step 7 containing protein. In paragraphs [0055-0056] of the instant specification, both paragraphs recite, “The supernatant, higher layer or light layer, which contains hydrolyzed starch and lipids is discarded.”
The Declarant stated on pg. 9 that lower molecular weight proteins are soluble at a pH close to their isoelectric point and larger molecular weight proteins are insoluble at a pH close to their isoelectric point. However, the Office has not seen evidence that this is true, but has found that proteins, regardless of their molecular weight, are insoluble at a pH close to their isoelectric point (pI). Evidentiary reference, Li et al., Sensitivity of oat protein solubility to changing ionic strength and pH, Journal of Food Science, Vol. 86 Iss. I, 2021, states on pg. 83, first paragraph of 3.3.1 Solubility, “At pH close to the pI (5.0), protein molecules will bear no net charge and the intermolecular electrostatic repulsions are diminished. This is a favorable condition for the entropy driven occurrence of protein aggregation and precipitation.” Thus, the Office has found that regardless of molecular weight, oat protein will become insoluble at a pH close to the pI (5.0). For at least this reason, Declarant’s arguments regarding pH adjustment are unavailing.
Additionally, the burden of proof lies with the declarant/applicant to demonstrate that the claimed invention is not obvious over the prior art. The declarant hasn’t compared the closest prior art, specifically the molecular weights of the oat protein in the product of Whalen, to the claimed product. The Office is unable to do an analysis of the molecular weight profile of the proteins present in the composition and until the applicant has a reasonable case for obviousness the burden is on the declarant/applicant to show otherwise. Thus absent any evidence to the contrary, the product of Whalen is considered substantially identical to the claimed product, as taught above, and is considered to possess the property of the molecular weight profile as claimed. See In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (MPEP §2112.01 (I)).
Moreover, the molecular weight profile ranges claimed in claim 14 are very wide. Lower molecular weight proteins, less than 10 kDa, can be in the composition from 0.5% to 20%. The other ranges are as follows, 10-50% for proteins having a molecular weight of between 10-50 kDa, 30-75% for proteins having a molecular weight between 50-300 kDa, and 0.5-30% for proteins having a molecular weight of between 300 kDa and more. Thus, with these broad ranges and no convincing arguments showing that Whalen cannot have an oat protein composition with the claimed molecular weights, the composition of Whalen is still considered to have the molecular weight profile distribution within the claimed ranges, since it has a substantially similar composition to the claimed composition, as shown in the above rejection.
On pgs. 9-10 of the declaration, the Declarant argues that heating may coagulate proteins, but said coagulation would not be selective on the basis of protein molecular weight. Declarant states that the teachings of Whalen do not intend and cannot suggest how to obtain the particular molecular weight profile of the oat protein compositions of claim 14. However, the Office disagrees for the following reasons.
The instant specification states in [0055], “during step 7… heat may also be applied to help coagulate” the proteins. As noted by the Declarant, the coagulation from heating the oat protein would not be selective based on the protein molecular weight, see pg. 10 of declaration. Since the instant specification indicates heating is performed before centrifugation [0055], proteins of all molecular weights would coagulate and be collected in the heavy layer after centrifugation. The instant specification also states, that after centrifugation, the supernatant, or lighter layer contains hydrolyzed starch and lipids, but does not mention lower weight molecular proteins [0055]. The method steps of Whalen also use heating to coagulate proteins (Abstract, [0104]). Thus, since both the instant specification and Whalen apply heat to coagulate proteins, the overall molecular weight profile of the proteins in the final composition of Whalen is considered to be substantially identical to the claimed product.
Response to Arguments
Applicant's arguments filed August 4, 2025 have been fully considered but they are not persuasive.
35 U.S.C. § 103 REJECTIONS
Applicant argues, on pgs. 7-10 of their remarks, that the submitted declaration is appropriate evidence that Whalen is not an enabling prior art reference for disclosing compositions with a residual lipid content below 10% by weight, and neither for disclosing the molecular weight profile of the compositions of claim 14. The Applicant restates arguments from the declaration regarding Whalen not providing compositions with a lipid content below 10 wt. %. Applicant also restates arguments from the declaration regarding Whalen not providing compositions with the molecular weight profile of claim 14. However, the Office disagrees for the following reasons.
The Applicant’s arguments, which rely on the statements from the declaration filed 08/04/2025, have been addressed and fully answered in the Response to Declaration section above. The Examiner maintains that Whalen is enabled for and does disclose an oat composition comprising a residual lipid content below 10% by weight. The Examiner also maintains that Whalen is enabled for and does disclose an oat composition which is substantially identical to the claimed composition and is considered to possess the property of the molecular weight profile defined in claim 14.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHANIE GERLA whose telephone number is (571)270-0904. The examiner can normally be reached Mon.-Wed. and Fri. 7-12 pm; Th. 7-2pm.
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/S.R.G./Examiner, Art Unit 1791
/ELIZABETH GWARTNEY/Primary Examiner, Art Unit 1759