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 .
This is the First Office Action on the Merits of US 18/239,386 filed on 08/29/2023 which is a CON of PCT/CN2022/087093 filed on 04/15/2022. No English language translation of the foreign priority document CHINA 2021105559680 filed on 05/21/2021 is on record. The Filing Receipt filed on 09/12/2023 is controlling.
Claims 1-9 are pending.
Claims 6-9 are withdrawn.
Claims 1-5 are under examination.
Election/Restrictions
Applicant’s election without traverse of invention Group I (e.g., claims 1-5) in the reply filed on March 15, 2026 is acknowledged.
Claims 6-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention Group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on March 15, 2026.
Information Disclosure Statement
The IDS filed on 02/22/2024 has been considered by the examiner. Please note that the foreign language documents have only been considered to their English language Abstracts.
Claim Objections
Claims 1-2 and 4 are objected to because of the following informalities:
For improved clarity, claim 1 should be amended to clearly state an active method step. Suggested claim language may recite: A method for preparing an emulsion containing bean-derived polypeptides, the method comprising: homogenization and mixing of dual-functional bean-derived polypeptides and an oil phase, whereby the emulsion is obtained.
Regarding claim 2, for improved clarity, claim 2 should be amended to positively require the method steps 1-3. Suggested claim language may recite: The method according to claim 1, further comprising a method for preparing the dual-functional bean-derived polypeptides, the method comprising the following steps:……
For improved clarity, claim 4 should be amended to …a ratio of the bean raw material…
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jiang et al in “Preparation and Characterization of Emulsion Gels from Whole Faba Bean Flour” (Foods 2020 Vol 9, 755: pages 1-15).
Regarding claim 1, Jiang et al (2020) discloses a method for preparing emulsion containing bean-derived polypeptides, wherein the emulsion is obtained by homogenization and mixing of dual-functional bean-derived polypeptides and an oil phase. Jiang et al recite steps of thermal pre-treatment of faba beans, “dehullings, milling, adding plant oil, homogenization, prevention of starch gelatin, and inducing protein gelation”. (See entire article; Abstract, especially lines 1-6).
Thus, Jiang et al (2020) anticipates claim 1.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jiang et al in “Pea Protein Nanoemulsion and Nanocomplex as Carriers for Protection of Cholecalciferol (Vitamin D3)” (Food Bioprocess Technol. 2019, 12, 1031–1040).
Jiang et al (2019) disclose a pea protein isolate mixed and homogenized with an oil to prepare an emulsion. See Figure 1 just below.
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Thus, Jiang et al (2019) anticipates claim 1.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jarzebski et al in “Pea Protein for Hempseed Oil Nanoemulsion Stabilization” (Molecules 2019, Vol 24: 4288 pages 1-14, published November 25, 2019).
Regarding claim 1, Jarzebski et al discloses a method comprising mixing pea protein isolates with hempseed oil using homogenization and mixing of dual-functional bean-derived polypeptides and an oil phase to prepare a stable emulsion. See Title, Abstract, Section 2.3.1, para 1; entire article).
Thus, Jarzebski et al anticipates claim 1.
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 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Knowlton et al (CA 2710268 published 07/09/2009), in view of Malaki et al (WO 2021/150456 published July 29, 2021, filed on January 18, 2021), in view of Jiang et al in “Pea Protein Nanoemulsion and Nanocomplex as Carriers for Protection of Cholecalciferol (Vitamin D3)” (Food Bioprocess Technol. 2019, 12, 1031–1040).
Regarding claims 1-2, Knowlton et al discloses a method for preparing soybean derived polypeptides. Knowlton et al discloses that soy protein materials include soy flakes, soy grits, soy meal, soy flour, soy protein concentrates, and soy protein isolates”. (See page 1, para 4; Table 2). Knowlton et al discloses that methods preparing the soy protein isolates include heat conditioning, flaking and grinding, extrusion, solvent extraction, or aqueous soaking. (See page 27-28.)
Regarding claim 2, Knowlton et al discloses a method for preparing soybean-derived polypeptides comprises the following steps:
(1) extraction of a bean source protein isolate: subjecting a bean raw material to pulverizing and sifting, adding n-hexane for degreasing to obtain a degreased (aka defatted) bean powder, then extracting a protein from the degreased bean powder by an alkali-solution and acid-isolation method. (See pages 27-28, 34, 47, 50-51; Examples 2, 10, 11-12.)
(2) Knowlton et al discloses treating with controlled heat to remove the remaining hexane. (See page 28). In Example 10, page 48, Knowlton et al disclose the controlled heat is by microwave. However, Knowlton et al do not explicitly disclose subjecting the bean source protein obtained in step (1) to infrared heat treatment. Further, regarding the limitation of freeze-drying, Knowlton et al disclose the hot flakes are placed in a vacuum oven and “quickly cooled to about 50 degree C to produce high PDI flake”. Knowlton et al disclose that the preparation of the bean protein isolate includes flash vaporization, and that the heated bean curd was cooled and dried by flash vaporization. (See page 55, para 1; page 56, para 4). However, Knowlton et al does not explicitly recite the term “freeze-drying” to obtain a bean source protein isolate.
Malaki et al disclose both infrared treatment and freeze-drying in their methods of preparing bean protein isolates. Malaki recite the following in para 0005:
[0005] This invention also provides a method for producing an encapsulation particle, which includes the steps of (a) emulsifying an active material (e.g., a flavor), an unhydrolyzed rice, sunflower, or faba bean protein and a carrier to obtain a homogeneous aqueous slurry, wherein the active material and the unhydrolyzed rice, sunflower, or faba bean protein are provided at a ratio of 10:1 to 1:10; and (b) drying the homogeneous aqueous slurry, e.g., by spray drying, freeze drying, spray chilling, fluidized bed drying, drum drying, vacuum drying, film drying, belt drying, conduction drying, infrared drying, or a combination thereof.
In view of the high skill level in the art of preparing bean protein isolates before the effective filing date of the presently claimed invention it is considered that one of ordinary skill in the art having the Knowlton et al and Malaki et al references would have been motivated to use routine lab procedures including infrared heat and freeze-drying in the methods of preparing a bean protein isolate for the rationale of preserving nutritional value of the food preparation. It would have been obvious to use infrared heat and freeze-drying in the methods of preparing a bean protein isolate because Malaki et al suggests doing such.
Further, Knowlton et al disclose (3) preparation of a polypeptide includes dissolving the bean protein powder obtained in step (2) in deionized water to prepare a solution having a substrate concentration of 5-20%, adjusting the pH value, adding a protease to carry out an enzymolysis reaction, and after the reaction is completed, performing enzyme deactivation at a high temperature, followed by centrifugation to collect a polypeptide solution. (See Example 15-16.)
Regarding claim 3, Knowlton et al discloses that the bean raw material comprises one or more of protein-rich soybeans. (See pages 27-28, 34, 47; Example 10.)
Regarding claim 4, step (1) of claim 2, Knowlton et al discloses a ratio of the hexane solvent: soybean flake material is 3:1 during the degreasing which meets the limitation of soybean material to hexane of 1:3 to 1:10 (g/mL). See page 47, Example 10, para headed “Production of White flake”. See also Example 12 “Large Scale Soy protein isolate preparation” stating that the HO defatted soy flour is extracted with water having a pH of from 6.5 to 10 and preferably extracted with aqueous sodium hydroxide solution having a pH from about 8 to about 10. Further, in page 51, para 2 it states that after extraction, the method includes centrifugation and pH is adjusted to about pH 4 to pH5 using hydrochloric acid.
Also, regarding claim 4, Knowlton et al discloses that the alkali-solution and acid-isolation method specifically comprises: dissolving the degreased bean powder in deionized water to obtain a solution. (See page 48, para 1.) Knowlton et al disclose adjusting the pH value of the solution to 7.2 with sodium hydroxide, (page 48, line 11) stirring at a constant temperature of 25-50°C for about 15 minutes. Note that about 15 minutes is interpreted to render obvious 30 minute limitation of the present claim 4. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP § 2144.05. Knowlton et al discloses the general conditions of about 15 minutes. Therefore, the claimed limitation of 30 minutes is considered optimization through routine experimentation, and would be obvious to one of ordinary skill in the art. A prima facie case of obviousness based on optimization may only be rebutted by evidence showing that the claimed range is critical, generally by proof that the claimed range achieves unexpected results relative to the prior art. See MPEP § 2144.05. Further, Knowlton et al discloses by centrifugation to obtain a supernatant, then adjusting the pH value to 2.0-5.5 with hydrochloric acid, repeating the above steps for 2-3 times to obtain a precipitate, and washing the precipitate to neutral with deionized water. (See pages 48-49.)
Regarding claim 5 (step (3) of claim 2), Knowlton et al discloses using the protease bromelain on the soy protein material. (See pages 54-56, Examples 15-16.) Knowlton et al disclose that the bromelain having an activity of about 2400 TU/g is added which meets the limitation of in an amount of 500-5,000 U/g protein powder. Knowlton et al disclose that the enzymolysis reaction is carried out at a temperature of about 55 C to 60 C which meets the 35-65°C and a pH value of from 7.5 to 8.1 which meets the limitation of pH value of 4.5-7.5. Knowlton et al disclose that the enzymolysis reaction is carried out for about 15 to 65 minutes, preferably 20 to 45 minutes, which meets the limitation of 0.5-8 h. (See Example 15).
However, Knowlton et al do not explicitly disclose making an emulsion with the bean protein isolate.
Jiang et al (2019) disclose a pea protein isolate mixed and homogenized with an oil to prepare an emulsion. See Figure 1 just below.
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Jiang et al suggest using such nanoemulsions and nanocomplexes as carriers for protection of cholecalciferol (Vitamin D3) in prepared food products (See Title, Abstract, entire document).
The level of skill in the art was high before the effective filing date of the presently claimed invention.
One of ordinary skill in the art would have been motivated to combine the elements of making soy protein isolates from soybean derived polypeptides as disclosed in Knowlton et al with the method of preparing an emulsion containing such bean-derived polypeptides by homogenization and mixing of the bean-derived polypeptides and an oil phase as disclosed in Jiang et al for the rationale provided by Jiang et al to preserve nutrients in the bean preparation.
It would have been obvious to one of ordinary skill in the art having the cited references before the effective filing date to make an emulsion with the bean protein isolates because the references are in the same field of research and development of making food products using bean-derived polypeptides.
In view of the high skill level in the art it is considered that one of ordinary skill in the art having the cited references would have had a reasonable expectation of success to combine the elements of the cited references to arrive at the presently claimed invention.
Conclusion
No claim is allowed.
Related art which may be applied in a future office action if appropriate:
Han et al “Coating of Peanuts with Edible Whey Protein Film Containing alpha-Tocopherol and Ascorbyl Palmitate” (JFS 2008 Vol 73, No. 8, pages E349-E355).
Kahn et al “Trypsin Inhibitor Isolated From Glycine max (Soya Bean) Extraction, Purification, and Characterization” (Dose-Response: October-December 2022: pages 1-10).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE S HIBBERT whose telephone number is (571)270-3053. The examiner can normally be reached M-F 8:00-5:00.
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CATHERINE S. HIBBERT
Primary Examiner
Art Unit 1658
/CATHERINE S HIBBERT/Primary Examiner, Art Unit 1658
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