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 .
DETAILED ACTION
2. Applicant's election with traverse of Group I , claims 1-12 in the reply filed on 3/26/2026 is acknowledged.
3. Claim 13-15 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
It is to be noted that applicant’s argued that “ Applicant timely traversed the restriction (election) requirement in the reply filed on 3/26/2026.The traversal is on the ground(s) that (i) the claims of Groups I and II are related as a process of making an oat protein composition and an oat protein composition per se, and (ii) there is no search burden because a search of, for example, either claim 1 or claim 13 would uncover any prior art directed to both Groups”. In response, this is not found persuasive because independent non -elected claim 13 recites at least, more particularly, “a starch: soluble fiber mass ratio above 1” and “has a mean particle size d-50 greater than 10 microns” in addition to “protein amount” in the oat protein composition. The requirement is still deemed proper and is therefore made FINAL.
Status of the application
4. Claims 1-15 are pending in this office action.
Claims 13-15 are withdrawn.
Claims 1-12 have been rejected.
Claim Objections
5. Claims 13-15 objected to because of the following informalities: Claims of Group II, claims 13-15 are non-elected invention. Therefore, the status of the claims 13-15 should be withdrawn as mentioned by the applicant’s arguments filed 3/26/2026 (Under Remarks, page 1, lines 1-4). Accordingly, the status of the claims 13-15 are considered as withdrawn claims. Appropriate correction for the withdrawn claims 13-15 with correct status identifier is required.
Claim Rejections - 35 USC § 112
6. 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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
7. Claims 1-12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, 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, 2, 3, 4,5,6,7,8 recite the term “preferably” which makes the claims indefinite.
8. 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, independent claim 1 recites the broad recitation pH from 5.8 – 8.0 and the claim also recites preferably “pH 6-7” which is the narrower statement of the range/limitation. The similar is the situation for dependent claims 3-8. Claim 5 is related to mass value, claim 6 is related to ratio and claim 7 is related to temperature range value and claim 8 is related to time. The claim(s) are 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. Therefore, the claims should be amended to overcome 112 second paragraph rejection.
Claim Rejections - 35 USC § 103
9. 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.
10. 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.
11. 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.
12. Claim(s) 1- 8, 11, 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lenz et al. EP 0619950 A1.
13. Regarding claim 1,Lenz et al. discloses a process of preparing an aqueous slurry comprising water and an oat substrate that an insoluble solid fraction, an insoluble liquid fraction, a stable, soluble oat protein fraction, a soluble oat fat fraction, and a soluble oat carbohydrate fraction and c) removing the insoluble liquid fraction and the insoluble solid fraction from the slurry, thereby recovering a final transparent, low fat, stable aqueous solution comprising water and a stable, soluble oat protein fraction, a soluble oat fat fraction, and a soluble oat carbohydrate fraction (at least col 6 lines 40-58, col 7 lines 1- 2, col 9 lines 33-34, and claim 1 of Lenz et al.). Lenz et al. also discloses the method can further be processed comprising as solid, soluble oat protein containing mixture of pure form (col 7 lines 3-5).
Lenz et al. also discloses that oat fat is minimized by dissociating fat from oat in the initial aqueous slurry (col 10 lines 36-45) which makes soluble oat protein stable also (col 10 lines 49-50).
Lenz et al. also discloses that the insoluble solid fraction is primarily starch and insoluble liquid fraction is lipid ( col 12 lines 26, 32-33) which are removed from the
slurry (col 13 lines 1-2).
Lenz et al. also discloses that insoluble solid fraction (starch) is separated by physical separation method e.g. by centrifugation ( col 13 lines 11-15) followed by removing fat from soluble liquid fraction (col 13 lines 39-43) and insoluble fat can also be converted to soluble fatty acid by lipase treatment also ( col 13 lines 46-50).
Then the soluble protein fraction is used for concentrating further having 50-60% protein with less than 1% fat ( col 19, lines 18-20) and spray- dried to make final product (at least in col 19 lines 20-25). Therefore, Lenz et al. meets the steps of claim 1 (a) and (b) and optional step of spray-drying.
However, Lenz et al.is specifically silent about rest of the required steps of (c)-(f) of claim 1.
14. Regarding the step of claim 1(c), Whalen discloses that oat in the form of flour ([0035], [0039])) can be made slurry with water ([0051]) can be used to make oat based food products including oat syrup, oat protein etc. (at least in [0034] and claim 1 of Whalen et al.).
Whalen et al. broadly discloses many embodiments.
For example,
(i) Whalen et al. discloses that starch source may be mixed with oat material ([0050]). It is to be noted that oat material can broadly be interpreted as anything derived from oat including oat protein solution also.
(ii) Whalen et al. discloses that starch source can be hydrolyzed starch containing glucose, dextrose and it can be in soluble form as (at least in [0112]) soluble glucose , dextrin etc. ([0117]), therefore, can be with soluble protein solution.
(iii) Whalen also discloses that the starch material as solid starch ([0050]) can be mixed after the hydrolysis with the enzymes ([0057]) in order to have oat -based syrup with desired sweetness as required ([0057]).
Therefore, even if Whalen does not explicitly teach the claimed step of adding a starch hydrolysate, to the soluble protein fraction, however, if we consider the above disclosures of Whalen et al., one of ordinary skill in the art may consider to include starch hydrolysate with desired sweetness property to combine/mix with soluble oat protein solution as additive to provide desired sweetening property containing oat- based protein solution.
One of ordinary skill in the art may do so with a reasonable expectation of success to have oat protein based syrup containing food product e.g. in order to make desired type of food e.g. cereal bar ([0108]) from the mixed oat protein solution with starch (as hydrolysate) because the teachings of Whalen et al. encourage to combine separately made starch as starch hydrolysate with oat material ([0050]) and oat material can be in soluble fraction because Whalen’s product permits to have residual starch as starch hydrolysate in the soluble fraction (at least in [0112]) as soluble glucose , dextrin etc. ([0057], [0117]), as discussed above. Therefore, it meets part of claim 1 (c ). Polysorbate is addressed below.
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Lenz et al. by including the teaching of Whalen et al. to consider enzymatically hydrolysed starch hydrolysate ([0057]) to be combined with soluble fraction ( [0050], [0057], [0108], [0112]) in order to make desired type of protein food including e.g. oat protein based syrup, with desired sweetness ([0057]) and e.g. cereal bar ([0108]) from oat protein.
Regarding “polysorbate”, Lenz et al. and Whalen et al. are silent about polysorbate in the soluble fraction and polysorbate.
Altemueller et al. discloses that polysorbate can be considered as additive for such a composition which provides mouthfeel modifying agent ([0060]). Therefore, one of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Lenz et al. in view of Whalen et al. by including the teaching of Altemueller et al. to consider polysorbate can be as additive for such an oat protein composition in order to serve as mouthfeel modifying agent ([0060]) when used the protein solution or used to provide protein -containing drink ([0060]).
It is to be noted that Lenz et al. in view of Whalen and further in view of Altemueller et al. disclose the steps of hydrolyzed starch and starch can be added to oat material (Whalen et al. [0050], [0057]) as discussed in detail above in thi office action.
However, Lenz et al. in view of Whalen and further in view of Altemueller et al.
teach substantially the same product produced by substantially the same method as instantly claimed by applicant; where the claimed and prior art products are produced by substantially identical processes, a prima facie case of obviousness has been established. To switch the order of performing process steps, i.e. the order of the addition of the ingredients into the final mixture, would be obvious absent any clear and convincing evidence and/or arguments to the contrary (MPEP 2144.04 [R-1]). “Selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results". Therefore, absent evidence to the contrary, it would have been obvious to one of ordinary skill in the art to add the starch hydrolysate to the protein soluble fraction.
15. Regarding the step of claim 1(d), it is to be noted that Whalen et al. also discloses that oat based functional syrup (i.e. soluble oat protein plus additives containing starch hydrolysate with glucose, dextrin ) can be heated to 50 degree C that increase solid content by reducing moisture in such a product ([0081]). It is to be noted that even if Whalen et al. does not specifically mention this heating step to the soluble oat containing fraction as claimed in claim 1, however, the above discussed disclosed step correlates with the equivalent to an implicit disclosures of reducing oat based functional syrup ([0081]). Therefore, one of ordinary skill in the art would have been motivated to do this heating at the step of additive containing soluble protein in order to achieve desired concentrated “additive containing soluble oat protein” having good syrup consistency ([0081]) with minimal/nil flavor defect ([0055]).
Also, one of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Lenz et al. to include the teaching of Whalen et al. to perform this heating at the step of additive containing soluble protein in order to achieve desired concentrated “additive containing soluble oat protein” having good syrup consistency ([0081]) with minimal/nil flavor defect ([0055]).
16. Regarding the step of claim 1 ( e ) and (f), and claim 11, Altemueller et al. discloses that the protein can be precipitated in order to make precipitated soy protein at around pH 4.5 ([0036]) to make soy curd ([0028]).
This can be considered as physical property. It is known and evidenced by applicants specification that oat protein is precipitated at pH 4.5-5.8 (in PGPUB [0080]).
However, examiner used another secondary prior art by Hohner et al. It is taught by Hohner et al. that the pH of oat protein is about 4.6 for maximum precipitation of the oat protein (col 5 lines 30-35).
Therefore, one of ordinary skill in the art would have been motivated to perform adjusting the pH of the concentrated heated additive at the isoelectric pH of oat protein in order to make concentrates further to make oat curd using the identical step applicable for oat curd, as disclosed by Altemueller et al. discloses that the protein can be precipitated in order to make precipitated soy protein at around pH 4.5 ([0036]) to make soy curd ([0028]). The reason is the method steps as disclosed by Altemueller et al. for soy protewin which is similar to oat protein is applicable for oat protein also , if we consider specific conditions e.g. in this instance isoelectric point of Oat protein. However, incidentally the isoelectric pH for both the soy and oat proteins are same (close match which is about pH 4.5).
According to MPEP 2143.01, “Obviousness can be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so. In re Kahn, 441 F.3d 977, 986, 78 USPQ2d 1329, 1335 (Fed. Cir. 2006) (discussing rationale underlying the motivation-suggestion-teaching test as a guard against using hindsight in an obviousness analysis)”.
Therefore, one of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Lenz et al. in view of Whalen et al. with the teaching of Altemueller et al. to make precipitated oat protein as curd form by adjusting the heated additive containing soluble protein at the isoelectric point pH value of oat protein (about pH 4.6) as disclosed by Hohner et al. (col 5 lines 30-35). in order to make precipitated curd ([0028], [0036]) . This also meets claim 11.
17. Regarding the optional step of spray drying and claim 12, it is to be noted that other steps including spray drying step is optional. However, claim 12 claims spray drying step. Therefore, it is addressed below.
Altemueller et al. also discloses in presence of solution comprising water ([0038]) for the production of suspension ([0028], [0038]). Altemueller et al. also discloses that [0041] heat treated soy protein curd suspension may then be dried (at least in [0028], [0041]).
Therefore, it can be applicable to oat protein also. It would have been obvious that this step to spray dry soy protein curd can be applicable to similar oat protein curd suspension also.
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Lenz et al. in view of Whalen et al. with the teaching of Altemueller et al. to dry protein curd suspension which can be soy or equivalent precipitated form of oat protein curd as taught by Hohner et al. col 5 lines 30-35).
It is to be noted that even if Altemueller et al. discloses soy protein, however, oat protein and soy protein can be considered equivalent in relation to the steps of purifying and making precipitated curd and further drying step to make dried protein curd from protein curd suspension.
According to MPEP 2143.01, “Obviousness can be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so. In re Kahn, 441 F.3d 977, 986, 78 USPQ2d 1329, 1335 (Fed. Cir. 2006) (discussing rationale underlying the motivation-suggestion-teaching test as a guard against using hindsight in an obviousness analysis)”.
18. Regarding claim 2, Lenz et al. discloses that the starting material can include oat flour also ( col 7 lines 25-27).
19. Regarding claim 3, Lenz et al. discloses that the fractionation of oat can be performed by making oat slurry at a pH with sufficient base or acid to adjust the pH of the aqueous slurry outside the isoelectric pH range (at least col 8 lines 57-58) (col 9 lines 33-34). Therefore, it meets claimed pH range of claim 3.It is to be noted that the claimed pH range of claim 3 is outside isoelectric pH of oat protein meets claimed pH range of claim 3. Hohner et al. discloses that the isoelectric point (pH) of oat protein is about 4.6 for maximum precipitation of the oat protein (col 5 lines 30-35). It shows prima facie case of obviousness according to MPEP 2144.05. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
20. Regarding claim 4, Lenz et al. also discloses that insoluble solid fraction (starch) is separated by physical separation method e.g. by centrifugation ( col 13 lines 11-15).
21. Regarding claim 5, Altemueller et al. also discloses that polysorbate is mouthfeel modifying agent and can be used in an amount from 0.01 to 15 wt.% by weight ([0060], [0061]). Also, sweeteners can be used 0.5-5.0 wt.% ([0063]). Therefore, it would have been obvious that the disclosed low amounts of total mass content of starch hydrolysate and polysorbate added in step c), based on the total mass of dry matter of the soluble fraction, overlaps the range amount of between 0.5 and 10%” as claimed in claim 5. It shows prima facie case of obviousness according to MPEP 2144.05. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)
22. Regarding claim 6, Altemueller et al. also discloses that polysorbate is mouthfeel modifying agent and can be used in an amount from 0.01 to 15 wt.% by weight ([0060], [0061]). Also, sweeteners can be used 0.5-5.0 wt.% ([0063]). Therefore, it meets the claimed range amount of “wherein the starch hydrolysate: polysorbate ratio added in step c) in a mass ratio going from 0,66 to 15, by example, from 1 to 10, preferably from 2 to 8” as claimed in claim 6.
23. Regarding claims 7-8, it is to be noted that the heating temperature as discussed for claim 1 (d) using Whalen et al. is applicable for claim 7. However, the time of heating is optimizable because it is based on optimizing the time with respect to the temperature including claimed temperature range value in order to achieve temperature the desired degree of concentrated product.
Absent showing of unexpected results, the specific amount of time is not considered to confer patentability to the claims. As the desired concentrated form by removing desired amount of moisture content are variables that can be modified, among others, by adjusting the amount of time at a given temperature the precise amount would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed amount cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the amount of time in Lenz et al. to amounts, including that presently claimed, in order to obtain the desired effect e.g. desired reduction of moisture content (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
24. Claims 9, 10 are rejected under 35 U.S.C. 103 as being unpatentable over Lenz et al. EP 0619950 A1 in view of Whalen (US 2013 /0183404 A) and further in view of Altemueller et al. US 2007 /0014910 A 1 and further in view of Hohner et al. USPN 4028468. As applied to claim 1 and further in view of Chen et al. (CN 1974602 A)
25. Regarding claims 9, 10, Altemueller et al. discloses that the extracted protein curd can be suspended in wash solution ([0035]). Altemueller et al. also discloses that the precipitated soy protein curd with a sufficient amount of hydrating solution comprising water ([0038]).
It is to be noted that one of ordinary skill in the art may consider with reasonable expectation of success to wash with water prior making curd suspension in order to wash specifically protein curd further in order to remove any contaminants present in the protein curd.
However, they are specifically silent about claimed step of washing protein curd as claimed in claim 10.
Chen et al. discloses that “the purified protein acid precipitation (i.e. isoelectric acidic pH) , can be further separated and centrifuging, washing to neutral (Under Description, #8)”.
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Lenz et al. in view of Whalen et al. and Altemueller et al. to include the teaching of Chen et al. to perform protein curd to centrifuging, washing (Under Description, #8)” steps for further removal of contaminants.
Conclusion
26. Any inquiry concerning the communication or earlier communications from the examiner should be directed to Bhaskar Mukhopadhyay whose telephone number is (571)-270-1139.
If attempts to reach the examiner by telephone are unsuccessful, examiner’s supervisor Erik Kashnikow, can be reached on 571-270-3475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BHASKAR MUKHOPADHYAY/
Examiner, Art Unit 1792
Prosecution Insights