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 .
This office action is in regard to the application filed on June 21, 2021 and in response to Applicant’s Amendments and Arguments/Remarks filed on December 16, 2025.
Status of Application
The amendment filed December 16, 2025 has been entered. Claims 1, 3-13, 15-18, and 44-46 are currently pending in the application. Claim 1 has been amended; claims 2, 14, 19-43, and 47 are canceled. Claims 1, 3-13, 15-18, and 44-46 are hereby examined on the merits.
Claim Interpretation
Where claims 5-7 recite the amount of essential amino acids based on the total amount of protein in the Brassica plant protein concentrate, any one, or combination thereof, of the claimed essential amino acids meeting the claimed weight percent will be considered to meet the claim limitation. For example, a Brassica plant protein concentrate comprising an amount of 30% by weight arginine, based on the total amount of protein in the Brassica plant protein concentrate, meets instant claim 5.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 45 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 45 claims that the concentrate comprises 65-80% (w/w) Brassica plant protein, while claim 1, upon which claim 45 depends, claims that the Brassica plant protein concentrate comprises 65-77% (w/w) Brassica plant protein. Thus, claim 45 fails to further limit the subject matter of claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 3, 4, 12, 13, 15-18, 45, and 46 are rejected under 35 U.S.C. 103 as being unpatentable over Orban (US Patent 4,054,677).
Regarding claims 1, 3, 4, and 45, Orban discloses a proteinic concentrate derived from rapeseed (i.e., a Brassica plant protein concentrate) (col. 2 lines 31-35) comprising 20-95 wt.% protein, 0-45 wt.% fats, 1-60 wt.% carbohydrates, 2-13 wt.% moisture, and 2-13 wt.% ash (col. 4 lines 33-40)
Orban also teaches that the raw materials used to prepare the concentrate comprises a maximum of 5 wt.% fat substances (i.e., Brassica plant oil when the concentrate is derived from rapeseed) (col. 3 lines 47-49). Thus, the proteinic concentrate is considered to have 0-5 wt.% Brassica plant oil.
The ranges of protein, oil, carbohydrates, moisture, and ash taught by Orban overlap with or encompass the claimed ranges. 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). See MPEP 2144.05.I.
Regarding claim 12, Orban teaches that stachyose is harmful for the digestive system of the consumer and that the stachyose must be removed from the proteinic fraction (col. 3 lines 29-41). Thus, the protein concentrate is substantially free of the anti-nutritional constituent of stachyose.
Regarding claim 13, Orban teaches that cellulose polysaccharide (i.e., insoluble non-starch polysaccharide) must be removed from the proteinic fraction (col. 3 lines 24-41). Thus, the protein concentrate is substantially free of insoluble non-starch polysaccharides.
Regarding claims 15, 16, and 46, Orban is silent as to that the Brassica plant protein has an apparent digestibility coefficient (ADC) of at least 75%, 95%, or 99% as a percentage of dry matter in Atlantic salmon.
However, where the claimed and prior art products are identical or substantially identical in structure or composition, a prima facie case of obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). Since Orban teaches a plant protein concentrate that is substantially similar to that of the instant claim, it is presumed that the concentrate of Orban has the same properties and functions of the claimed concentrate. ADC is a value determined after the concentrate has been consumed by an animal and is a measured value of the digestibility function. Thus, it is presumed that the concentrate of Orban has the same ADC as the claimed concentrate after ingestion by the same animal and possesses the same functions and properties. Both the claimed and the prior art concentrates are a Brassica plant protein concentrate comprising the substantially similar values of Brassica plant protein, oil, carbohydrates, moisture, and ash. Thus, the concentrate of Orban renders obvious the instantly claimed concentrate.
Regarding claim 17, Orban teaches that the protein concentrate is derived from flours derived from rapeseed plant seeds (i.e., concentrate recovered from whole Brassica plant seeds) (col. 2 lines 30-35).
Regarding claim 18, Orban is silent as to that the protein concentrate is recovered from a press cake of a Brassica plant. Orban does teach that the protein concentrate is derived from rapeseed (i.e., Brassica plant) (col. 2 lines 30-35).
However, where the instant claims are directed to a final composition, the starting product does not hold patentable weight where the composition of the instant claims is substantially similar to the composition of the prior art and where the manufacturing process steps are not expected to impart distinctive structural characteristics to the final product. The determination of patentability is based on the product itself and does not depend on its method of production. In the instant case, where the product was derived from and how it was derived does not hold patentable weight where the final product is merely a protein concentrate. The prior art teaches the protein concentrate as claimed; the starting material of which does not change the composition of the concentrate.
Claims 5-10 are rejected under 35 U.S.C. 103 as being unpatentable over Orban (US Patent 4,054,677) as applied to claim 1 above, and further in view of Tang (US PG Pub 2010/0136173; cited on PTO-892 dated Feb. 14, 2024).
Orban teaches the Brassica plant protein concentrate as set forth above with regard to claim 1.
Regarding claims 5-9, Orban is silent as to that the total amount of protein in the protein concentrate contains at least 30, 35, or 40 wt.% essential amino acids, as well as being silent as to that the total amount of protein in the protein concentrate contains at least 3 or 5 wt.% lysine.
Tang, in the same field of invention, teaches a canola (i.e., Brassica) protein concentrate wherein the total amount of protein in the protein concentrate contains 8.40 wt.% arginine, 2.48 wt.% histidine, 4.61 wt.% isoleucine, 8.35 wt.% leucine, 5.47 wt.% lysine, 2.03 wt.% methionine, 4.84 wt.% phenylalanine, 4.61 wt.% threonine, 1.49 wt.% tryptophan, and 5.5 wt.% valine (Table 29), equaling to ~48 wt.% essential amino acids, which meets the claim limitations of instant claims 5-9.
Tang teaches an amino acid profile for Brassica plant protein concentrates where Orban is silent, thereby offering a guideline as to a suitable and expected amount of essential amino acids. Tang also offers the motivation that the canola protein concentrate is of high nutritional quality and provides adequate amounts of all essential amino acids ([0806]). Therefore, where both Orban and Tang teach a Brassica protein concentrate, one of ordinary skill in the art would have had the reasonable expectation that the protein concentrate taught by Orban would necessarily possess the amino acid profile taught by Tang, thereby arriving at the claimed invention. Thus, the instant claim limitations are rendered obvious by the teachings of Orban in view of Tang.
Regarding claim 10, Orban is silent as to that the protein in the protein concentrate contains at least 7 wt.% lysine.
Tang teaches a Brassica protein concentrate where the total amount of protein in the protein concentrate contains 5.47 wt.% lysine (Table 29). The lysine content of 5.47 wt.% lies slightly below the claim limitation of at least 7 wt.%, however, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). See MPEP 2144.05.I. A difference of only 1.53 wt.% would not be expected to impart a significant change to the composition absent any showing of unexpected results or criticality. One of ordinary skill in the art would have expected the final composition to have the same properties as a composition with 7 wt.% lysine.
Tang teaches an amount of lysine in Brassica plant protein concentrates where Orban is silent, thereby offering a guideline as to a suitable and expected amount of lysine in the protein. Therefore, where both Orban and Tang teach a Brassica protein concentrate, one of ordinary skill in the art would have had the reasonable expectation that the protein concentrate taught by Orban would necessarily possess the amount of lysine taught by Tang, thereby arriving at the claimed invention. Thus, the instant claim limitations are rendered obvious by the teachings of Orban in view of Tang.
Claims 11 and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Orban (US Patent 4,054,677) as applied to claim 1 above, and further in view of Wnukowski et al. (US PG Pub 2015/0073127; listed in IDS dated Feb. 16, 2023), herein after referred to as Wnukowski.
Orban teaches the Brassica plant protein concentrate as set forth above with regard to claim 1.
Regarding claims 11 and 44, Orban is silent as to that the Brassica plant proteins are substantially non-denatured and in that they substantially retain their secondary and/or tertiary three-dimensional structures.
Wnukowski, in the same field of invention, teaches a plant protein concentrate derived from rapeseed (i.e., a Brassica plant protein concentrate) [0023] wherein the Brassica plant proteins are non-denatured and that they retain their protein tertiary structure as a result of the proteins being maintained as non-denatured proteins (i.e., the Brassica plant proteins are non-denatured in that they retain their tertiary three-dimensional structures). Wnukowski offers the motivation that non-denatured proteins prevents phenolic compounds to form irreversible complexes with proteins. Wnukowski also teaches that non-denatured proteins are achieved by selecting suitable processing conditions [0026]. Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to have modified the process of Orban to have suitable processing conditions in order to maintain non-denatured proteins and the proteins’ tertiary structure as taught by Wnukowski, thereby arriving at the claimed invention. One would have been motivated to make this modification for the benefit of preventing phenolic compounds in the protein concentrate.
Response to Arguments
Applicant’s arguments, see pages 6-9, filed December 16, 2025, with respect to the rejections of claims 1 and 47 under 35 U.S.C. 103 have been fully considered but are moot given applicant’s claim amendments. The new ground of rejection relies on a newly found prior art reference (Orban, US Patent 4,054,677) and does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAURA E SWEENEY whose telephone number is (571)272-0244. The examiner can normally be reached M-F 8:00-5:00 EST.
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/M.E.S./Examiner, Art Unit 1791
/Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791