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 .
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-7, in the reply filed on December 11, 2025 is acknowledged. The traversal is on the ground(s) that Groups I and II are linked via linking claim 1, and that Groups I and II are not independent and distinct and do not constitute undue burden on the Office for examination. This is not found persuasive because the instant application is a 371 application; therefore, the restriction is based on 371 PCT lack of unity restriction practice and not U.S. restriction practice. Therefore, independent and distinct, and serious search burden, is not a requirement for 371 PCT restriction practice.
The requirement is still deemed proper and is therefore made FINAL.
Priority
The instant application filed on 06/28/2023 is a 371 of PCT/EP2022/025000 filed on 01/04/2022, which claims priority to EP21305001.6 filed on 01/04/2021. EP21305001.6 finds support for the instantly claimed invention; therefore, the effective filing date of the instant application is 01/04/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/28/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 4 is objected to because of the following informalities: “1 0kDa” should be “10kDa”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b), Indefiniteness
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.
Claims 1-7 are 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 (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1-7 recite the phrase “preferably”; however, it is unclear if the limitations recited after “preferably” are required or a preferred embodiment. For the purposes of applying prior art, the Examiner has interpreted the limitations recited after “preferably” to be preferred embodiments and are not part of the claimed invention.
Claim 1 recites “(d 50)”; however, it is unclear if what is recited in parentheses is a required limitation or a preferred embodiment. For the purposes of applying prior art, the Examiner has interpreted the limitations recited in the parentheses to be a preferred embodiment and are not part of the claimed invention.
Claim 4 recites the phrase “advantageously”; however, it is unclear if the limitations recited after “advantageously” are required or a preferred embodiment. For the purposes of applying prior art, the Examiner has interpreted the limitations recited after “advantageously” to be preferred embodiments and are not part of the claimed invention.
Claim 4 recites the total weight of proteins within the composition; however, it is unclear if all proteins with varying molecular weights are required because there is no and/or linking word between the recited weight limitations. For the purposes of applying prior art, the Examiner has interpreted all the proteins with the varying molecular weights to be required since all molecular weights should have a sum of 100%.
Claim Rejections - 35 USC § 103, Obviousness
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.
Claims 1-3 and 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Tupper (WO 01/21012; Date of Publication: March 29, 2001 – cited in the IDS filed on 06/28/2023) in view of Sjoo (US 2020/0368135; Date of Publication: November 26, 2020) and Weissbrodt (US 2016/0353773; Date of Publication: December 8, 2016).
Tupper’s general disclosure relates to “Methods of manufacturing a bran product derived from a grain, the method comprising the steps of: (a) providing a dehulled grain; (b) stabilising the dehulled grain; (c) pressing or rolling the stabilised dehulled grain to a thickness in a manner that allows minimal disruption to an outer bran layer thereof; (d) milling the pressed or rolled dehulled grain to produce a first grain flour and a coarse grain bran in a manner that allows minimal disruption to the outer bran layer; and (e) sieving and separating the first grain flour from the coarse grain bran; so as to provide a coarse grain bran product enriched with at least two components selected from the group consisting of beta -glucan, fats and fibre each of which being derived from the grain” (see, e.g., Tupper, abstract).
Regarding claim 1 pertaining to the oat protein composition, Tupper teaches an oat composition (see, e.g., Tupper, pg. 10, lines 12-15), and does not teach that the oat composition contains organic solvents and traces of polysorbate (see, e.g., Tupper, pg. 10, lines 12-35 & pg. 11, lines 1-7). Additionally, Tupper teaches oat compositions wherein the lipid content is below 10%, such as in groats, rolled oats, first pass oat bran, first pass oat flour, and second pass oat flour (see, e.g., Tupper, Table 2, pg. 21). Moreover, Tupper teaches that grinding and sieving the oats results in varying particle size 10 to 1000 µm (see, e.g., Tupper, pg. 8, lines 22-23 & Table 3, pg. 22).
Regarding claims 2-3 pertaining to the percentage of protein in the composition, Tupper teaches that the composition will contain 15-50% (w/w) of proteinaceous material (see, e.g., Tupper, pg. 14, lines 17-18). Moreover, Tupper teaches that the compositions contain proteinaceous material present in an amount greater than 15% (w/w) (see, e.g., Tupper, pg. 11, lines 16-17); therefore, one of ordinary skill in the art would readily understand that this can include proteinaceous material between 16% and 100%.
Regarding claim 6 pertaining to the percentage of total dietary fibers, Tupper teaches oat compositions comprising total dietary fibers from 3.8% to 10%, such as rolled oats, first pass oat flour, and second pass oat flour (see, e.g., Tupper, Table 2, pg. 21).
Regarding claim 7 pertaining to the particle size, Tupper teaches that grinding and sieving the oats results in varying particle size 10 to 1000 µm (see, e.g., Tupper, pg. 8, lines 22-23 & Table 6, pg. 27). Moreover, Tupper teaches preparation of a fine grain bran concentrate that has an average particle diameter of about 20 to 150 µm (see, e.g., Tupper, pg. 9, lines 12-13).
However, Tupper does not teach: measuring the particle size using laser diffraction (claim 1).
Sjoo’s general disclosure relates to “the use of non-dissolved starch based particles, having a particle size of 0.2-4 pm and having a composition of 0.3-5% by weight of protein, 0.1-4% by weight of lipids, 0-1.6% by weight fibre and <0.45% by weight ash and the remaining part of the composition is carbohydrate adding up to 100% by weight, in cosmetic formulations” (see, e.g., Sjoo, abstract). Moreover, Sjoo discloses “a process for the preparation of said starch particle, comprising the following steps: subjecting dehulled grains or grain press cake to wet or dry milling for providing a flour with the size of 0.2-2.0 mm; mixing said flour with water for hydration during a period of 0.5-6 hours for efficient fibre separation; separation of a light phase comprising mainly starch and protein and a heavy phase comprising fibre; pH adjustment of light phase to pH 6-12; separation of proteins and starch from light phase based on density and size; and drying (see, e.g., Sjoo, [0014]-[0020]). Furthermore, Sjoo discloses “The starch particles according to the invention is from a botanical source chosen from quinoa, amaranth, tapioca, rice, oat, wheat, barley, millet, canihua, including waxy and high amylose varieties of any of the previously mentioned botanical sources” (see, e.g., Sjoo, [0029]).
Regarding claim 1 pertaining to laser diffraction, Sjoo teaches that the particle sizes of the starch granules were measured using laser diffraction (see, e.g., Sjoo, [0070]).
Weissbrodt’s general disclosure relates to “large agglomerate particles obtainable by spray-drying agglomeration” (see, e.g., Weissbrodt, abstract). Moreover, Weissbrodt discloses “an object of the present invention to provide large particles, more particularly agglomerate particles which are larger than 200 μm preferably larger than 300 μm. It is intended that the agglomerate particles be toxicologically safe for the foodstuff sector. It is a further object of the present invention to provide agglomerate particles which are stable and have a good solubility and low dust values when applied. It is likewise an object of the present invention to provide agglomerate particles which have a high load of active substances, such as flavourings for example” (see, e.g., Weissbrodt, [0005]). Additionally, Weissbrodt discloses that the agglomerate particles are preferably intermediate products and can be used in end products in the food sector, such as in oat protein drinks (see, e.g., Weissbrodt, [0061]).
Regarding claim 1 pertaining to laser diffraction, Weissbrodt teaches “The particle sizes of the agglomerates produced according to the invention were determined by means of a measurement by means of laser diffraction. The principle of laser diffraction is a distinctly flexible technique, having fundamentally the means of measuring the size of any material in another. The only conditions of the technique are that each phase is optically demarcated from the other and the medium is transparent for the laser wavelengths. This means that the refractive index of material and of the surrounding medium must differ. The measurement is achieved by introducing the sample into the laser beam by means of the corresponding modules for powders or emulsions/suspensions. The light scattered by the particles is detected. The entire laser output beamed towards the path from this system is measured and also allows the sample concentration to be inferred. The instrument available here (Malvern Mastersizer 2000 with Scirocco drying unit) provides the means of measuring powders up to a maximum particle size of 2 mm. With said instrument, it is possible to apply a dispersion pressure of from 0 to 4 bar to feed in the powder. However, care should be taken not to destroy the product while this is done, since, at the pressure set, suction is carried out against an impact plate during the feeding-in process” (see, e.g., Weissbrodt, [0081]-[0084]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce Tupper’s oat composition, wherein the particle size of the oat composition is measured using laser diffraction, as taught by Sjoo and Weissbrodt. One would have been motivated to do so because Sjoo teaches measuring the particle sizes of the starch granules were measured using laser diffraction (see, e.g., Sjoo, [0070]), wherein the starch granules can be derived from oat (see, e.g., Sjoo, [0029]). Moreover, Weissbrodt teaches that laser diffraction is a distinctly flexible technique, having fundamentally the means of measuring the size of any material in another, and laser diffraction provides the means of measuring powders up to a maximum particle size of 2 mm (see, e.g., Weissbrodt, [0081]-[0084]). Furthermore, Tupper teaches particles derived from an oat protein composition, wherein the particles have a diameter of 10 to 1000 µm due to grinding and sieving (see, e.g., Tupper, pg. 8, lines 22-23 & Table 3, pg. 22). Therefore, based on the teachings of Tupper, Sjoo, and Weissbrodt, it would have been obvious to use laser diffraction to measure the particle size within an oat protein composition. One would have expected success because Tupper, Sjoo, and Weissbrodt all teach particle compositions derived from oats or other plant sources, wherein the particles have varying diameters.
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Tupper, Sjoo, and Weissbrodt as applied to claims 1-3 and 6-7 above, and further in view of Bruckner-Guhmann (Foaming characteristic of oat protein and modification by partial hydrolysis; 2018 – cited in the IDS filed on 06/28/2023).
The teachings of Tupper, Sjoo, and Weissbrodt, herein referred to as modified-Tupper-Sjoo-Weissbrodt, are discussed above as it pertains to an oat protein composition.
However, modified-Tupper-Sjoo-Weissbrodt does not teach: wherein said composition comprises, based on the total weight of proteins in the composition: from 0.5 to 30% of proteins having a molecular weight of 300kDa and more, advantageously from 5 to 15%; from 30 to 75% of proteins having a molecular weight of between 50 and 300kDa, advantageously from 45 to 65%; from 10 to 50% of proteins having a molecular weight of between 10 and 50kDa, advantageously from 25 to 45%; from 0.5 to 20% of proteins having a molecular weight of 10kDa and less, advantageously from 1 to 10%; the sum making 100% (claim 4).
Bruckner-Guhmann’s general disclosure relates to “Foaming ability of oat protein isolate (OPI) was analysed at pH 4 and 7. Foaming properties were influenced by partial hydrolysis with trypsin (OPT) and alcalase (OPA)” (see, e.g., Bruckner-Guhmann, abstract). Moreover, Bruckner-Guhmann discloses “The aim of this study was to develop a systematic understanding of the foaming characteristics of OPI and to evaluate the impact of enzymatic hydrolysis on both the foaming properties and interfacial rheology” (see, e.g., Bruckner-Guhmann, Introduction, pg. 2096).
Regarding claim 4 pertaining to the total weight of proteins in the composition, Bruckner-Guhmann teaches at pH 7 that an oat protein isolate has approximately 10% of proteins with a molecular weight >300 kDa, approximately 2% of proteins with a molecular weight of 50-300 kDa, approximately, 28% of proteins with a molecular weight of 10-50 kDa, and approximately 60% of proteins with a molecular weight <10 kDa (see, e.g., Bruckner-Guhmann, Figure 1C). However, Bruckner-Guhmann teaches that the use of alcalase and trypsin at pH 7 results in an increase in the percentage of proteins with a molecular weight <10 kDa (see, e.g., Bruckner-Guhmann, Figure 1C). Furthermore, at pH 4, Bruckner-Guhmann teaches that the percentage of proteins with a molecular weight between 5-20 kDa increases to approximately 90% in the oat protein isolate, while the percentage of proteins <2 kDa decreases to approximately 10% in the oat protein isolate (see, e.g., Bruckner-Guhmann, Figure 1D). Therefore, from these results, one of ordinary skill in the art would readily understand that the use of alcalase and trypsin for enzymatic hydrolysis, as well as altering the pH of the composition, results in varying protein molecular weights within the oat protein concentrate.
Regarding claim 5 pertaining to the percentage of starch in the oat protein composition, Bruckner-Guhmann teaches an oat protein isolate with 1.3
±
0.04% starch (see, e.g., Bruckner-Guhmann, Table 1). .
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce modified-Tupper-Sjoo-Weissbrodt’s oat protein composition, wherein the composition contains 0.1 to 10% starch, as taught by Bruckner-Guhmann. One would have been motivated to do so because Bruckner-Guhmann teaches that the oat protein isolate containing approximately 1.5% starch was produced from an oat protein concentrate that contains approximately 33% starch, wherein the concentrate was subsequently diluted and the pH was adjusted (see, e.g., Bruckner-Guhmann, Materials, pg. 2096). Moreover, modified-Tupper-Sjoo-Weissbrodt teaches “A key characteristic of oat bran is that unlike most other cereal brands, it contains large amounts of adhering endosperm with accompanying significant concentrations of β-glucan and starch” (see, e.g., Tupper, pg. 1, lines 31-34). Additionally, modified-Tupper-Sjoo-Weissbrodt teaches that starch contributes to the viscosity of an oat gel powder (see, e.g., Tupper, pg. 13, lines 29-31); therefore, one of ordinary skill in the art would readily understand that increasing the starch percentage will increase the viscosity of an oat gel powder. Therefore, based on the teachings of modified-Tupper-Sjoo-Weissbrodt and Bruckner-Guhmann, it would have been obvious to produce an oat protein composition, wherein the composition comprises starch from 0.1 to 10%. One would have expected success because modified-Tupper-Sjoo-Weissbrodt and Bruckner-Guhmann all teach oat protein compositions comprising starch.
Regarding claim 4’s concentration limitations, those working in the biological and/or pharmaceutical arts would understand that the adjustments of particular conventional working conditions (e.g., concentration, percentages, amounts, etc.) is deemed a matter of judicious selection and routine optimization, which is within the purview of the skilled artisan (see, e.g., MPEP 2144.05). For example, Bruckner-Guhmann teaches that the protein composition within an oat protein isolate varies based on the pH of the composition, as well as whether alcalase and/or trypsin is used (see, e.g., Bruckner-Guhmann, Figures 1C-1D). Therefore, one of ordinary skill in the art would reasonably understand that addition of alcalase and/or trypsin for enzymatic hydrolysis will increase the percentage of small molecular weight proteins, and decreasing the pH (i.e., addition of an acidic solution) will result in a decrease in high molecular weight proteins, as taught by Bruckner-Guhmann. This is motivation for someone of ordinary skill in the art before the effective filing date of the claimed invention to practice or test the parameter(s) widely to find those that are functional or optimal which then would be inclusive or cover the steps as instantly claimed. Absent any teaching of criticality by the Applicant concerning the percentage of protein with specific molecular weights, it would be prima facie obvious that one of ordinary skill in the art would recognize these limitations are result effective variables which can be met as a matter of routine optimization
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-14 of copending Application No. 18/259,957 (reference application; herein referred to as “App’957”).
Although the claims at issue are not identical, they are not patentably distinct from each other because App’957 claims: A powder of an oat protein composition wherein said composition does not contain any traces of organic solvent, has protein content higher than 55%, has a extractable lipid content below 10% by weight on dry matter based on the total dry weight of the oat protein composition, a starch: soluble fiber mass ratio above 1 and has a mean particle size d-50 greater than 10 microns (see, e.g., App’957, claim 13); and wherein the composition contains more than 70% by weight of protein on dry matter based on the total dry weight of the oat protein composition, preferably more than 80% by weight (see, e.g., App’957, claim 14).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14-16 and 18-20 of copending Application No. 17/597,222 (reference application; herein referred to as “App’222).
Although the claims at issue are not identical, they are not patentably distinct from each other because App’222 claims: An oat protein composition wherein said composition does not contain traces of organic solvent, has residual lipid content below 10% by weight on dry matter based on the total dry weight of the oat protein composition and has a mean particle size (d 50), determined by laser diffraction, greater than 10 microns; and wherein said oat protein composition comprises, based on the total weight of proteins in the composition: 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, from 0.5 to 20% of proteins having a molecular weight of l0kDa and less, the sum making 100% (see, e.g., App’222, claim 14); wherein said oat protein composition contains from 40% to 70% by weight of protein on dry matter based on the total dry weight of the oat protein composition (see, e.g., App’222, claim 15); wherein said oat protein composition contains more than 70% by weight of protein on dry matter based on the total dry weight of the oat protein composition (see, e.g., App’222, claim 16); wherein the oat protein composition comprises from 0.1 to 10% by weight of starch on dry matter based on the total dry weight of the oat protein composition (see, e.g., App’222, claim 18); wherein the oat protein composition comprises a total dietary fiber going from 0.1 to 10% by weight of the dietary fiber on dry matter based on the total dry weight of the oat protein composition (see, e.g., App’222, claim 19); and wherein the oat protein composition has a mean particle size greater than 20 microns, and a mean particle size lower than 300 microns (see, e.g., App’222, claim 20).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-7 are rejected.
No claims are allowed.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATALIE IANNUZO whose telephone number is (703)756-5559. The examiner can normally be reached Mon - Fri: 8:30-6:00 EST.
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/NATALIE IANNUZO/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653