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 .
Status of the Application
Receipt of the Response and Amendment after Non-Final Office Action filed 16 April 2026 is acknowledged.
Applicant has overcome the following by virtue of amendment of the claims: (1) the 112(b) rejection of claim 14 has been withdrawn.
The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 14-36
Withdrawn claims: 28-36
Previously canceled claims: None
Newly canceled claims: 1-13
Amended claims: 14
New claims: 15-36
Claims currently under consideration: 14-27
Currently rejected claims: 14-27
Allowed claims: None
Claim Objections
Claim 26 is objected to because of the following informalities:
In claim 26, line 3, it appears that “…a molecular weight of 300 kDa” should read, “…a molecular weight of 300 kDa and more” based on the limitations of claim 27 and support found in the specification at paragraph [0034].
Appropriate correction is required.
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 14-25 are rejected under 35 U.S.C. 103 as being unpatentable over Whalen (US 2013/0183404 A1) in view of Cloeter (Cloeter, E. (2017, December 18). 4 Ways Fiber Benefits Your Health. University of Michigan School of Public Health. https://sph.umich.edu/pursuit/2017posts/fiber-benefits.html), Harasym et. al (WO 2011/078711 A1, cited on the IDS filed on 3 July 2023), and Hw wHe et al. (He, C., Zheng, J., Liu, F., Woo, M. W., Xiong, H., & Zhao, Q. (2020). Fabrication and characterization of oat flour processed by different methods. Journal of Cereal Science, 96, 103123. https://doi.org/10.1016/j.jcs.2020.103123).
Regarding claim 14, Whalen discloses an oat protein composition (an oat protein and fiber product; Abstract, [0016], claim 22) wherein the oat protein composition is a protein concentrate or a protein isolate, and wherein said oat protein composition comprises, by weight, at least 50% oat protein – “An oat protein and fiber product…wherein the oat protein and fiber product has a protein concentration of between about 30 weight percent and about 90 weight percent and a total dietary fiber concentration of less than about 5 weight percent, wherein the oat protein and fiber product has a moisture content of between about 5 percent and about 10 percent.” (claim 22). Claim 23 of Whalen further specifies a protein concentration of between about 50 weight percent and about 60 weight percent.
Paragraphs [0016] and [0017] of the instant specification provide:
[0016] In the present application, "protein concentrate" must be understood as an oat protein composition which contains from 50% to 70%, by weight of protein on dry matter based on the total dry weight of the oat protein composition.
[0017] In the present application, "protein isolate" must be understood as an oat protein composition which contains more than 70%...
Therefore, Whalen teaches an oat protein composition that is an oat protein concentrate. Whalen also provides for embodiments wherein the oat protein composition is an oat protein isolate; The claimed range of more than 70 wt% protein overlaps with the disclosed range of about 30 to about 90 wt%. In a case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists, MPEP § 2144.05(I).
less than 10% extractable lipids – 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 of less than 10 wt% extractable lipids.
Whalen teaches that the composition comprises a total dietary fiber concentration of less than about 5 weight percent (claim 22). Whalen teaches that the starting oat flours contain beta-glucan ([0033], Table 1, [0040], Table 2), which is a soluble fiber ([0032]).
Whalen does not discuss that the composition comprises a ratio of oat insoluble fiber/ß-glucan of at least 5, and a mean particle size greater than 20 microns.
However, Cloeter teaches that insoluble fiber is beneficial to humans because it promotes regularity of bowel movements, relieving constipation and irritable bowel syndrome, and reducing the risk for hemorrhoids and diverticular disease (p. 2, ¶ 1). Cloeter further discloses that it is recommended that people up to age 50 consume 38 grams of fiber a day for men or 25 grams a day for women, and for people older than 50, 30 grams a day for men or 21 grams a day for women (p. 2, ¶ 2).
Harasym teaches a method for fractionating oats into a beta-glucan fraction, an insoluble fiber fraction, and a protein fraction (claim 2). Harasym teaches that these components are useful in the food industry, for example as dietary supplements (p. 1, ¶ 1). As such, Harasym teaches that it was known to isolate oat insoluble fiber for use in food products as a dietary supplement.
Regarding particle size, in the same field of endeavor, He teaches an enzyme-treated spray-dried oat flour (ESOF) (p. 2, col 2, ¶ 2). He states, “The particle size pattern of ESOF was similar to Gaussian distribution in the range of 10.10–262.38 µm and the distribution was largest at 67.52 µm, which indicated that the particle size distribution of ESOF was the most uniform and is more suitable for commercial standardization.” (p. 6, col 1, ¶ 1; see also p. 5, Fig. 3d).
Regarding the ratio of insoluble fiber/ß-glucan, it would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the composition of Whalen with the teachings of and Cloeter and Harasym to add insoluble oat fiber to the composition of Whalen to prepare an oat and fiber composition comprising increased insoluble fiber. Where Whalen teaches that consumers are increasingly concerned about purchasing and consuming products they view as being more healthful, including products possessing higher levels of complex carbohydrates and fiber ([0003]), one of ordinary skill in the art would have been motivated to so modify Whalen in order to provide the additional health benefits of insoluble fiber as discussed by Cloeter to the oat protein and fiber composition of Whalen. One of ordinary skill in the art would have had a reasonable expectation of success in arriving at the claimed invention because Whalen teaches that the oat protein and fiber composition comprises a total dietary fiber concentration (which includes beta-glucan as a soluble fiber ([0032])) of less than about 5 weight percent (claim 22), that is 0 to about 5 weight percent, and in embodiments comprising no or a miniscule base amount of dietary fiber, the addition of insoluble fiber up to the disclosed 5 wt% would result in ratio of insoluble fiber to beta-glucan of “at least 5”. For example, 0.01 wt% base dietary fiber, comprising beta-glucan, and 4.99 wt% insoluble fiber yields an insoluble fiber to beta-glucan ratio of at least 499. This is within the scope of the teachings of the cited prior art. As such, the claimed range of at least 5 overlaps or lies inside ranges disclosed by the prior art. In a case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists, MPEP § 2144.05(I). Absent any evidence of criticality of the claimed range, this limitation is rendered obvious.
Regarding the particle size, it would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the oat protein and fiber product of Whalen with the teachings of He such that the mean particle size is about 67.5 µm. One of ordinary skill in the art would have been motivated to consult He because Whalen teaches that the composition is spray dried, but does not provide any information about the particle size. One of ordinary skill in the art would have had a reasonable expectation of success in arriving at the claimed invention because Whalen teaches enzymatic digestion of oat flour to form a dried oat protein and fiber product ([0016] – [0023]) and that the oat protein and fiber product is spray dried ([0105], [0144]), and He teaches that an enzyme-treated spray-dried oat flour has a particle size pattern similar to Gaussian distribution in the range of 10.10–262.38 µm and the distribution was largest at 67.52 µm, and that this particle size is more suitable for commercial standardization (p. 6, col 1, ¶ 1; see also p. 5, Fig. 3d). Therefore, one of ordinary skill in the art would have adjusted the spray drying parameters to provide a similar particle size to that of He, which is greater than 20 microns as claimed.
Claim 14 is therefore rendered obvious.
Regarding claim 15, Whalen teaches that the oat protein composition is an oat protein concentrate comprising from 50% to 70% oat protein by weight – claim 23 of Whalen teaches a protein concentration of between about 50 weight percent and about 60 weight percent.
Claim 15 is therefore rendered obvious.
Regarding claims 16-18, Whalen teaches that the oat protein composition is an oat protein isolate comprising more than 70% (re: claim 16), at least 80% (re: claim 17), and at least 85% (re: claim 18) oat protein by weight – Claim 22 of Whalen recites, “An oat protein and fiber product…wherein the oat protein and fiber product has a protein concentration of between about 30 weight percent and about 90 weight percent…”. The claimed ranges of more than 70 wt%, at least 80 wt%, and at least 85 wt% protein overlap with the disclosed range of about 30 to about 90 wt%. In a case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists, MPEP § 2144.05(I).
Claims 16-18 are therefore rendered obvious.
Regarding claims 19-20, Whalen teaches that the oat protein composition comprises less than 8% (re: claim 19) and less than 6% (re: claim 20) extractable lipids by weight – 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 of less than 8 wt% and less than 6 wt% extractable lipids.
Claims 19-20 are therefore rendered obvious.
Regarding claims 21-22, Whalen, Cloeter, Harasym, and He teach the method of claim 14.
By the same reasoning as described regarding claim 14, wherein the ratio of oat insoluble fiber to beta-glucan is at least 5, the cited prior art also renders obvious that the ratio of oat insoluble fiber to beta-glucan is at least 10 (re: claim 21) and at least 12 (re: claim 22) absent any evidence of criticality of the claimed ranges.
Claims 21-22 are therefore rendered obvious.
Regarding claims 23-24, Whalen, Cloeter, Harasym, and He teach the method of claim 14.
Where it would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the oat protein and fiber product of Whalen with the teachings of He such that the mean particle size is about 67.5 µm as described regarding claim 14 above, such modification also renders obvious a mean particle size greater than 30 microns (re: claim 23) and greater than 40 microns (re: claim 24) for the same reasons and with the same expectation of success.
Claims 23-24 are therefore rendered obvious.
Regarding claim 25, Whalen, Cloeter, Harasym, and He teach the method of claim 14.
The cited prior art also discloses that the oat protein composition comprises at least 85% of oat protein by weight and the ratio of oat insoluble fiber to beta-glucan is at least 12 – Claim 22 of Whalen recites, “An oat protein and fiber product…wherein the oat protein and fiber product has a protein concentration of between about 30 weight percent and about 90 weight percent…”. The claimed range of at least 85 wt% protein overlaps with the disclosed range of about 30 to about 90 wt%. In a case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists, MPEP § 2144.05(I).
By the same reasoning as described regarding claim 14, wherein the ratio of oat insoluble fiber to beta-glucan is at least 5, the cited prior art also renders obvious the ratio of oat insoluble fiber to beta-glucan is at least 12 absent any evidence of criticality of the claimed range.
Claim 25 is therefore rendered obvious.
Claims 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Whalen in view of Cloeter, Harasym et. al, and Hw wHe et al. as applied to claim 14 above, and as evidenced by Zhou et al. (US 2022/0240540 A1, which, as evidence, need not be prior art. See MPEP § 2124).
Regarding claims 26-27, Whalen, Cloeter, Harasym, and He teach the method of claim 14.
The cited prior art does not discuss the molecular weight profile of the proteins within the composition, as required by claims 26 and 27.
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 26, “from 0.5 to 30% of proteins having a molecular weight of 300 kDa and more”, “from 30 to 75% of proteins having a molecular weight of between 50 and 300 kDa”, “from 10 to 50% of proteins having a molecular weight of between 10 and 50 kDa” and “from 0.5 to 20% of proteins having a molecular weight of 10 kDa and less;” and the more narrowed ranges in claim 27 which states, “from 5 to 15% of proteins having a molecular weight of 300 kDa and more”, “from 45 to 65% of proteins having a molecular weight of between 50 and 300 kDa”, “from 25 to 45% of proteins having a molecular weight of between 10 and 50 kDa” and “from 1 to 10% of proteins having a molecular weight of 10 kDa and less,” these recitations are directed toward properties of the claimed composition.
MPEP § 2112.01(I) states, “When the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). ‘When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.’ In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).”
Zhou provides evidence that an oat protein and fiber composition as prepared by Whalen has the protein molecular weight profile as claimed ([0094] – [0096], and Table 2). When comparing the process steps of Zhou ([0095) 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 (Liquozyme supra, an alpha-amylase) to the oat flour (mix water and at least one enzyme, alpha amylase; [0016-0017], [0060-0061] of Whalen). Then separating by centrifugation the hydrolyzed, protein rich suspension, collecting the underflow/heavy fraction comprising protein, and lastly the optional drying of the protein containing fraction (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). Table 2 of Zhou provides that an oat flour treated in such a way has a protein molecular weight profile of 10.64% of proteins having a molecular weight of 300 kDa and more, 52.69% of proteins having a molecular weight of between 50 and 300 kDa, 32.98% of proteins having a molecular weight of between 10 and 50 kDa and 3.69% of proteins having a molecular weight of 10 kDa and less. These values lie inside the ranges recited in instant claims 26 and 27.
Where the cited prior art teaches the structure of the oat protein composition of claim 14, and in light of the evidence provided by Zhou, it would have been reasonable for one of ordinary skill in the art to expect that the substantially identical process steps of Whalen, produce a substantially identical product to the claimed product, including the protein molecular weight profile as claimed.
Claims 26-27 are therefore rendered obvious.
Response to Arguments
Claim Rejections – 35 U.S.C. § 103: Applicant’s arguments filed on 16 April 2026 with respect to claim 14 have been considered but are moot because the new ground of rejection does not rely on any reference, apart from secondary reference Cloeter, applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Applicant’s arguments regarding Cloeter are toward its application to references no longer relied upon for the rejection of claim 14.
For the reasons presented hereinabove, claims 14-27 are rejected under 35 U.S.C. § 103.
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.
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/JAMES P. SHELLHAMMER/Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793
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