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 Claims
The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 1-14
Withdrawn claims: 1-13
Previously canceled claims: None
Newly canceled claims: None
Amended claims: 14
New claims: None
Claims currently under consideration: 14
Currently rejected claims: 14
Allowed claims: None
Election/Restrictions
Applicant's election with traverse of Group II, claim 14 in the reply filed on 8 September 2025 is acknowledged. The traversal is on the ground(s) that first, the groups are not independent and distinct and second, the invention lacks a serious search burden (p. 6, ¶ 4 – p. 7, ¶ 1).
First, Applicant asserted that the groups are not independent and distinct. However, establishing the inventions as independent and distinct is required for the “independent and district” restriction analysis for any application filed under 35 U.S.C. § 111(a) such as a CON or CIP of an international application filed under the PCT, or a CON, CIP, or DIV of a national stage application submitted under 35 U.S.C. § 371, or U.S. restriction practice for applications filed under 35 U.S.C. § 121. The instant application is a regular application filed as a 371 under the PCT. Therefore, the argument that the groups are not independent and distinct is not persuasive due to relying on incorrect restriction provisions.
Secondly, applicant asserts that there is no serious search burden. However, establishing a search burden is only required for U.S. restriction practice for applications filed under 35 U.S.C. § 121. The Instant application is filed as a 371 under the PCT. Therefore, the argument that there is no search burden is not persuasive due to relying on incorrect restriction provisions.
Applicant also argues that claim 14 is an allowable linking claim (p. 6, ¶ 2, p. 7). See MPEP § 809: Linking Claims, which states, “There are a number of situations which arise in which an application has claims to two or more properly divisible inventions, so that a requirement to restrict the claims of the application to one would be proper, but presented in the same case are one or more claims (generally called "linking" claims) which, if allowable, would require rejoinder of the otherwise divisible inventions”. A linking claim does not affect a proper restriction and becomes relevant pertaining to the rejoinder process if the claim is on condition for allowance. However, claim 14 is not allowable over Brückner-Gühmann et al. in view of Xia et al., Cloeter, and Shen et al. (references in rejection below). Therefore, Applicant’s argument is moot.
MPEP § 1850(II): Determination of “Unity of Invention” states, “An international application should relate to only one invention or, if there is more than one invention, the inclusion of those inventions in one international application is only permitted if all inventions are so linked as to form a single general inventive concept (PCT Rule 13.1). With respect to a group of inventions claimed in an international application, unity of invention exists only when there is a technical relationship among the claimed inventions involving one or more of the same or corresponding special technical features. The expression "special technical features" is defined in PCT Rule 13.2 as meaning those technical features that define a contribution which each of the inventions, considered as a whole, makes over the prior art. The determination is made on the contents of the claims as interpreted in light of the description and drawings (if any).” As stated in the Requirement for Unity of Invention filed on 9 July 2025, the shared technical feature of claim 14 amongst Groups I-II is not a special technical feature in view of Kaukovirta-Norja et al. (EP 2120604 B1, cited on the IDS filed on 3 July 2023) and therefore lacks unity of invention.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 8 September 2025.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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.
Claim 14 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claim 14 recites the broad recitation, “a ratio of insoluble fiber/ß-glucan of at least 5”, and the claim also recites, “preferably at least 5, at least 7, at least 8, at least 9% at least 10, at least 11 or at least 12”, which is the narrower statement of the range/limitation.
Claim 14 also recites the broad recitation, “a mean particle size greater than 20 microns”, and the claim also recites, “preferably greater than 30 microns, more preferably greater than 40 microns”, which is the narrower statement of the range/limitation.
The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Brückner-Gühmann et al. (Brückner-Gühmann, M., Heiden-Hecht, T., Sözer, N., & Drusch, S. (2018). Foaming characteristics of oat protein and modification by partial hydrolysis. Eur Food Res Technol, 244, 2095-2106. https://doi.org/10.1007/s00217-018-3118-0, cited on the IDS filed on 3 July 2023) in view of Xia et al. (Xia, Z., Cholewa, J.M., Dardevet, D. et al. (2018). Effects of oat protein supplementation on skeletal muscle damage, inflammation and performance recovery following downhill running in untrained college men. Food Funct, 9, 4720-4729. https://doi.org/10.1039/C8FO00786A), 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), and Shen et al. (Shen, Y., Tang, X., & Li, Y. (2021). Drying methods affect physicochemical and functional properties of quinoa protein isolate. Food Chem, 339, 1-9. https://doi.org/10.1016/ j.foodchem.2020.127823, Available online 14 August 2020).
Regarding claim 14, Brückner teaches an oat protein isolate (OPI) that contains approximately 83% protein, 1.5% starch, 6.5% fat, 2% ash, 3% moisture, and 4% total dietary fiber. The OPI was obtained by diluting and alkaline extracting oat protein concentrate (OPC), and lyophilizing the resulting extraction supernatant (p. 2096, col. 1, “Materials”).
Therefore, Brückner teaches an oat protein composition wherein it comprises, by weight, at least 50% protein, less than 10% extractable lipids.
Brückner does not discuss a ratio of insoluble fiber/ß-glucan of at least 5, and a mean particle size greater than 20 microns.
However, Xia teaches an oat protein composition comprising 91.7% protein given as a dietary supplement at 25 g per day (p. 4722, col. 1, ¶ 2) for 19 days markedly alleviated eccentric exercise induced skeletal muscle soreness, significantly inhibited limb edema following damaging exercise, and lessened adverse effects on muscle strength, knee-joint range of motion, and vertical jump performance (Abstract). 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). Together, Xia and Cloeter teach that oat protein and insoluble fiber are important dietary supplements, and oat protein is beneficial when supplemented at 25 grams per day, and (insoluble) fiber may be supplemented up to 30 grams per day.
Additionally, Shen teaches that freeze-drying quinoa (plant) proteins leads to a larger particle size (44.24 µm) than spray drying (10.43 µm) or vacuum drying (38.25µm) (p. 4, col. 1, ¶ 4).
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 Brückner with the teachings of Xia and Cloeter to add insoluble fiber to the composition of Brückner to prepare a nutritional composition comprising oat protein and insoluble fiber. First, Brückner teaches that the oat protein composition comprises about 4% dietary fiber. As evidenced by the instant specification, beta-glucan is a dietary fiber ([0027]). It is noted that claim 14 does not require any amount of beta-glucan. It is therefore considered that even if the composition of Brückner comprises no beta-glucan, any amount of insoluble fiber would result in a ratio of “at least 5”. Even if all of the dietary fiber in the composition of Brückner were beta-glucan, addition of insoluble fiber to the composition in an amount greater than or equal to 20% of the composition would result in the claimed ratio of insoluble fiber to beta-glucan of at least 5. Xia teaches dietary supplementation with oat protein at 25 g per day, and Cloeter teaches that insoluble fiber is important in promoting bowel regularity and reducing the risk of bowel diseases and complications, and that fiber is recommended from 21 – 38 grams per day. Therefore, Xia and Cloeter suggest that oat protein and insoluble fiber could be added to the diet in approximately equal amounts, (i.e., 50%). As such, one of ordinary skill in the art would have been motivated to add insoluble fiber to the composition of Brückner in an amount of up to about 40% of the composition to provide an oat protein composition with enhanced ability to promote movement of food through the digestive system and reduce risk of bowel diseases and complications. One of ordinary skill in the art would have had a reasonable expectation of success in doing so because Xia and Cloeter teach that dietary supplementation of oat protein and insoluble fiber are beneficial to human health. In doing so, one of ordinary skill in the art would have arrived at an oat protein composition with a ratio of insoluble fiber/ß-glucan of at least 10.
Regarding the particle size, where Brückner teaches that the oat protein isolate was lyophilized (i.e., freeze dried), and where Shen teaches that freeze dried plant proteins have a particle size on the order of about 44 microns, it would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have produced an oat protein composition having a mean particle size greater than 20 microns as claimed.
Claim 14 is therefore rendered obvious.
Conclusion
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/JAMES P. SHELLHAMMER/Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793