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 Claims
Claims 1-21 are pending and under examination.
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.
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.
Claims 3, 5, 7-8, 10-12, 16 and 19-21 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 3, 5, 7-8, 10-12, 16 and 19-21 recites “mg/g” and/or “ug/kg”. The claims clearly establish the item being weighted in the numerator. The claims do not establish the item in which the numerator is being compared to. For examination purposes, and in accordance with the teachings recited in the specification, it is interpreted that the denominator is referencing the weight of the protein source comprising prolamin. For example, “at least 90 mg/g of glutamic acid” is interpreted as “at least 90 mg per gram of the protein source comprising prolamin.
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(s) 1-16, 18-21 is/are rejected under 35 U.S.C. 102(a1) as being anticipated by Wen (CN 1218957), as evidenced by Gott.
With respect to claim 1: Wen teaches a method comprising washing a protein source comprising zein with a first solvent. [Claims 1-2 and Paragraphs 27-29] The protein source of Wen is corn gluten meal (CGM). [Claim 1] The zein protein of Wen is a prolamin. The first solvent used by Wen is ethanol. Wen also teaches at least a second washing with a second solvent. [Paragraph 32]. The second solvent used by Wen is also ethanol. The process of Wen results in a solid phase and at least two liquid phases.
In the instant case, Wen teaches the claimed invention. Therefore, the claimed invention is anticipated by Wen.
It is noted the claim recites “a solid phase as the animal feed”. This is an intended use of the solid and do not further limit the claim. Furthermore, it should be noted that Wen teaches a solid phase. Wen refers to the solid phase as “filter residue”.
It is further noted that the claim recites a wherein clause. It is noted that said wherein clause do not further limit the claim. MPEP 2111.04 states:
Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “adapted to” or “adapted for” clauses;
(B) “wherein” clauses; and
(C) “whereby” clauses.
In the instant case, said wherein clause do not limit the claim to a particular structure or active step to be performed. The wherein clause are merely directed toward describing the content of the solid and liquid obtained from performing the claimed process. furthermore, as noted above, Wen teaches the claimed process. Same method steps. Same solvent. Same solvent concentration, same washing duration and temperature disclosed in the specification. That is, the specification discloses “…organic solvent comprises at least 90% by weight of ethanol” [0099], “first washing is performed, i.e., conducted during at least half an hour and at a temperature of at least 20 degrees C” [00101], second solvent “comprises at least 42% by weight of ethanol” [00106] and “second washing is conducted during at least half an hour and at a temperature of at least 50 degrees C” [00107]. Same protein source. Same protein. Hence, the process of Wen would necessarily result in at least two liquid phases having the same product. This is further exemplified by the recitation of “thereby” in the claim.
It is noted that Wen does not state that the protein source contains mycotoxins. However, Gott notes that all samples of corn were found to be contaminated with at least 1 mycotoxin. Gott further note that all samples (100%) were found to be contaminated with both type B trichothecenes (B-Trich) and fumonisins (FUM). In view of the finding shared by Gott, the protein source of Wen, which is corn gluten meal, would necessarily contain at least 1 mycotoxin.
With respect to claim 2: the claim recites a wherein clause. It is noted that said wherein clause do not further limit the claim. MPEP 2111.04 states:
Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “adapted to” or “adapted for” clauses;
(B) “wherein” clauses; and
(C) “whereby” clauses.
In the instant case, said wherein clause do not limit the claim to a particular structure or active step to be performed. The wherein clause are merely directed toward describing the content of the solid and liquid obtained from performing the claimed process. furthermore, as noted above, Wen teaches the claimed process. Same method steps. Same solvent. Same solvent concentration, same washing duration and temperature disclosed in the specification. That is, the specification discloses “…organic solvent comprises at least 90% by weight of ethanol” [0099], “first washing is performed, i.e., conducted during at least half an hour and at a temperature of at least 20 degrees C” [00101], second solvent “comprises at least 42% by weight of ethanol” [00106] and “second washing is conducted during at least half an hour and at a temperature of at least 50 degrees C” [00107]. Same protein source. Same protein. Hence, the process of Wen would necessarily result in at least two liquid phases having the same product. This is further exemplified by the recitation of “thereby” in the parent claim.
With respect to claim 3: the claim recites a wherein clause. It is noted that said wherein clause do not further limit the claim. MPEP 2111.04 states:
Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “adapted to” or “adapted for” clauses;
(B) “wherein” clauses; and
(C) “whereby” clauses.
In the instant case, said wherein clause do not limit the claim to a particular structure or active step to be performed. The wherein clause are merely directed toward describing the content of the solid and liquid obtained from performing the claimed process. furthermore, as noted above, Wen teaches the claimed process. Same method steps. Same solvent. Same solvent concentration, same washing duration and temperature disclosed in the specification. That is, the specification discloses “…organic solvent comprises at least 90% by weight of ethanol” [0099], “first washing is performed, i.e., conducted during at least half an hour and at a temperature of at least 20 degrees C” [00101], second solvent “comprises at least 42% by weight of ethanol” [00106] and “second washing is conducted during at least half an hour and at a temperature of at least 50 degrees C” [00107]. Same protein source. Same protein. Hence, the process of Wen would necessarily result in at least two liquid phases having the same product. This is further exemplified by the recitation of “thereby” in the parent claim.
With respect to claim 4: the claim recites a wherein clause. It is noted that said wherein clause do not further limit the claim. MPEP 2111.04 states:
Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “adapted to” or “adapted for” clauses;
(B) “wherein” clauses; and
(C) “whereby” clauses.
In the instant case, said wherein clause do not limit the claim to a particular structure or active step to be performed. The wherein clause are merely directed toward describing the content of the solid and liquid obtained from performing the claimed process. furthermore, as noted above, Wen teaches the claimed process. Same method steps. Same solvent. Same solvent concentration, same washing duration and temperature disclosed in the specification. That is, the specification discloses “…organic solvent comprises at least 90% by weight of ethanol” [0099], “first washing is performed, i.e., conducted during at least half an hour and at a temperature of at least 20 degrees C” [00101], second solvent “comprises at least 42% by weight of ethanol” [00106] and “second washing is conducted during at least half an hour and at a temperature of at least 50 degrees C” [00107]. Same protein source. Same protein. Hence, the process of Wen would necessarily result in at least two liquid phases having the same product.
With respect to claim 5, the claim recites a wherein clause. It is noted that said wherein clause do not further limit the claim. MPEP 2111.04 states:
Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “adapted to” or “adapted for” clauses;
(B) “wherein” clauses; and
(C) “whereby” clauses.
In the instant case, said wherein clause do not limit the claim to a particular structure or active step to be performed. The wherein clause are merely directed toward describing the content of the solid and liquid obtained from performing the claimed process. furthermore, as noted above, Wen teaches the claimed process. Same method steps. Same solvent. Same solvent concentration, same washing duration and temperature disclosed in the specification. That is, the specification discloses “…organic solvent comprises at least 90% by weight of ethanol” [0099], “first washing is performed, i.e., conducted during at least half an hour and at a temperature of at least 20 degrees C” [00101], second solvent “comprises at least 42% by weight of ethanol” [00106] and “second washing is conducted during at least half an hour and at a temperature of at least 50 degrees C” [00107]. Same protein source. Same protein. Hence, the process of Wen would necessarily result in at least two liquid phases having the same product.
With respect to claim 6, the claim recites a wherein clause. It is noted that said wherein clause do not further limit the claim. MPEP 2111.04 states:
Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “adapted to” or “adapted for” clauses;
(B) “wherein” clauses; and
(C) “whereby” clauses.
In the instant case, said wherein clause do not limit the claim to a particular structure or active step to be performed. The wherein clause are merely directed toward describing the content of the solid and liquid obtained from performing the claimed process. furthermore, as noted above, Wen teaches the claimed process. Same method steps. Same solvent. Same solvent concentration, same washing duration and temperature disclosed in the specification. That is, the specification discloses “…organic solvent comprises at least 90% by weight of ethanol” [0099], “first washing is performed, i.e., conducted during at least half an hour and at a temperature of at least 20 degrees C” [00101], second solvent “comprises at least 42% by weight of ethanol” [00106] and “second washing is conducted during at least half an hour and at a temperature of at least 50 degrees C” [00107]. Same protein source. Same protein. Hence, the process of Wen would necessarily result in the same animal feed.
With respect to claim 7, the claim recites a wherein clause. It is noted that said wherein clause do not further limit the claim. MPEP 2111.04 states:
Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “adapted to” or “adapted for” clauses;
(B) “wherein” clauses; and
(C) “whereby” clauses.
In the instant case, said wherein clause do not limit the claim to a particular structure or active step to be performed. The wherein clause are merely directed toward describing the content of the solid and liquid obtained from performing the claimed process. furthermore, as noted above, Wen teaches the claimed process. Same method steps. Same solvent. Same solvent concentration, same washing duration and temperature disclosed in the specification. That is, the specification discloses “…organic solvent comprises at least 90% by weight of ethanol” [0099], “first washing is performed, i.e., conducted during at least half an hour and at a temperature of at least 20 degrees C” [00101], second solvent “comprises at least 42% by weight of ethanol” [00106] and “second washing is conducted during at least half an hour and at a temperature of at least 50 degrees C” [00107]. Same protein source. Same protein. Hence, the process of Wen would necessarily result in the same animal feed.
With respect to claim 8, the claim recites a wherein clause. It is noted that said wherein clause do not further limit the claim. MPEP 2111.04 states:
Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “adapted to” or “adapted for” clauses;
(B) “wherein” clauses; and
(C) “whereby” clauses.
In the instant case, said wherein clause do not limit the claim to a particular structure or active step to be performed. The wherein clause are merely directed toward describing the content of the solid and liquid obtained from performing the claimed process. furthermore, as noted above, Wen teaches the claimed process. Same method steps. Same solvent. Same solvent concentration, same washing duration and temperature disclosed in the specification. That is, the specification discloses “…organic solvent comprises at least 90% by weight of ethanol” [0099], “first washing is performed, i.e., conducted during at least half an hour and at a temperature of at least 20 degrees C” [00101], second solvent “comprises at least 42% by weight of ethanol” [00106] and “second washing is conducted during at least half an hour and at a temperature of at least 50 degrees C” [00107]. Same protein source. Same protein. Hence, the process of Wen would necessarily result in the same animal feed.
With respect to claim 9, as noted above, Wen teaches corn gluten meal as the protein source containing prolamin.
With respect to claims 10-12, the claim recites a wherein clause. It is noted that said wherein clause do not further limit the claim. MPEP 2111.04 states:
Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “adapted to” or “adapted for” clauses;
(B) “wherein” clauses; and
(C) “whereby” clauses.
In the instant case, said wherein clause do not limit the claim to a particular structure or active step to be performed. The wherein clause are merely directed toward describing the content of the solid and liquid obtained from performing the claimed process. Furthermore, as noted above, Wen teaches the claimed process. Same method steps. Same solvent. Same solvent concentration, same washing duration and temperature disclosed in the specification. That is, the specification discloses “…organic solvent comprises at least 90% by weight of ethanol” [0099], “first washing is performed, i.e., conducted during at least half an hour and at a temperature of at least 20 degrees C” [00101], second solvent “comprises at least 42% by weight of ethanol” [00106] and “second washing is conducted during at least half an hour and at a temperature of at least 50 degrees C” [00107]. Same protein source. Same protein. Hence, the process of Wen would necessarily result in the solid and liquid phases.
With respect to claim 13, Wen teaches the use of 90% ethanol as the first solvent. [paragraph 50]
With respect to claim 14, Wen teaches the use of 60-95% ethanol as the second solvent. [Claim 1 and 2, paragraph 61]
With respect to claim 15, the claim recites a wherein clause. It is noted that said wherein clause do not further limit the claim. MPEP 2111.04 states:
Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “adapted to” or “adapted for” clauses;
(B) “wherein” clauses; and
(C) “whereby” clauses.
In the instant case, said wherein clause do not limit the claim to a particular structure or active step to be performed. The wherein clause are merely directed toward describing the content of the solid and liquid obtained from performing the claimed process. Furthermore, as noted above, Wen teaches the claimed process. Same method steps. Same solvent. Same solvent concentration, same washing duration and temperature disclosed in the specification. That is, the specification discloses “…organic solvent comprises at least 90% by weight of ethanol” [0099], “first washing is performed, i.e., conducted during at least half an hour and at a temperature of at least 20 degrees C” [00101], second solvent “comprises at least 42% by weight of ethanol” [00106] and “second washing is conducted during at least half an hour and at a temperature of at least 50 degrees C” [00107]. Same protein source. Same protein. Hence, the process of Wen would necessarily result in the solid and liquid phases products with the level of mycotoxin recited in the claim. Furthermore, the instant specification notes that washing with the organic solvent (ethanol) results in at least 30% reduction of mycotoxin in an animal feed. [00163]
With respect to claim 16, Wen teaches a duration of 60 minutes and a temp of 50 degrees C. [Paragraph 55]
the claim also recites a wherein clause. It is noted that said wherein clause do not further limit the claim. MPEP 2111.04 states:
Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “adapted to” or “adapted for” clauses;
(B) “wherein” clauses; and
(C) “whereby” clauses.
In the instant case, said wherein clause do not limit the claim to a particular structure or active step to be performed. The wherein clause are merely directed toward describing the content of the solid and liquid obtained from performing the claimed process. Furthermore, as noted above, Wen teaches the claimed process. Same method steps. Same solvent. Same solvent concentration, same washing duration and temperature disclosed in the specification. That is, the specification discloses “…organic solvent comprises at least 90% by weight of ethanol” [0099], “first washing is performed, i.e., conducted during at least half an hour and at a temperature of at least 20 degrees C” [00101], second solvent “comprises at least 42% by weight of ethanol” [00106] and “second washing is conducted during at least half an hour and at a temperature of at least 50 degrees C” [00107]. Same protein source. Same protein. Hence, the process of Wen would necessarily result in the solid and liquid phases products with the level of mycotoxin recited in the claim.
With respect to claim 18, Wen teaches ethanol as a solvent. Ethanol inherently has a dielectric constant of 24.5.
With respect to claims 19-21, the specification shows that Applicant obtained the claimed composition by practicing the method of claim 1. As established earlier, Wen anticipates the invention encompassed by claim 1. Therefore, it logically follows that Wen teaches the claimed composition.
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.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wen in view of Hueze (Heuzé V., Tran G., Sauvant D., Renaudeau D., Lessire M., Lebas F., 2018. Corn gluten meal. Feedipedia, a programme by INRAE, CIRAD, AFZ and FAO. https://www.feedipedia.org/node/715 Last updated on July 4, 2018, 16:45.) and further view of Holding (Holding, Recent advances in the study of prolamin storage protein organization and function. Front Plant Sci. 2014 Jun 20; 5:276.)
Wen does not teach drying of the filter residue, which is corn gluten meal without the zein protein.
However, Hueze teaches that corn gluten meal is a protein-rich feed. And, Holding teaches that Zein and kafirin proteins are packaged into protein bodies that are inherently recalcitrant to digestion.
Given the teachings of Hueze and Holding, it would have been obvious for one of ordinary skill in the art before the effective filing date to have dried the zein free corn gluten meal of Wen. One of ordinary skill in the art before the invention was filed would have been motivated to do so to make a corn gluten meal feed with higher digestibility. One of ordinary skill in the art would have had a reasonable expectation of success for doing so because drying is routinely practiced in the art.
Response to Arguments
Regarding the 112b rejection of claims 3, 5, 7-8, 10-12, 16 and 19-21, Applicant points to claim 7, which recites “animal feed” in a wherein clause, as an example, to exemplify that it would be obvious for a skilled person in the art that the described content in a given claim is related to the total content of the animal feed.
Applicant’s argument has been considered, however, it is not found persuasive. Following Applicant’s lead with claim 7, it should be noted that claim 7 recites, wherein the animal feed comprises: a concentration of glutamic acid of at most 120 mg/g; listen of at least 7 mg/g; and mycotoxins of at most 400 ug/kg. In the instant case, each unit of measurement in the denominator can refer to the total content of the animal feed, as Applicant asserted, or a specific component or combination of components within the animal feed. If it is the total weight of the animal feed, then, Applicant is invited to amend claim 7 to clarify that the denominator is directed toward the total content of the animal feed. For example, a concentration of glutamic acid of at most 120 mg/g of the animal feed would be sufficient to overcome the rejection. However, in the absence of an amendment that provides clarity to the claim, the rejection is maintained for claim 7. Same analysis is applicable for the remaining claims.
In response to the obviousness rejection against claims 1-21, Applicant argues that Wen is “silent regarding a first washing, wherein the first solvent comprises at least 90% by weight of ethanol.”
Applicant’s argument has been considered, however, it is not found persuasive. As Applicant acknowledged in their later arguments, on the last page of the 08/05/2026 filing, Wen teaches a second washing. And, to have a second washing, Wen would necessarily have taught a first washing. In the instant case, the absence of labeling a washing as a “first” washing does not equate to an absence of teaching. Wen clearly teaches multiple washings, as summarized in the rejection. More specifically, at paragraph 28, Wen teaches adding ethanol to corn gluten meal. At paragraph 29, Wen teaches centrifugation of the solution containing ethanol and corn gluten meal to obtain zein. At paragraph 32, Wen teaches that the filter residue from the centrifugation step may be washed with an appropriate amount of ethanol solution and then centrifuged to increase the yield of zein. While Wein may not refer to the initial washing as a “first washing”, it remains that Wen teaches multiple washings, wherein the initial washing is the “first washing”.
With respect to the obviousness rejection against claims 4, 6 and 10, Applicant argues that the second washing in Wen’s patent is performed to the zein fraction, namely the precipitated fraction after the first precipitate that is received from the liquid of the extraction as opposed of the second washing of the present invention which is done on the residual protein source in the present invention to further purify the zein.
Applicant’s argument has been considered, however, it is not found persuasive. At paragraph 32, Wen teaches “the filter residue in the second step may be washed…to increase yield of zein”. The second step of Wen is the centrifugation of the zein protein that was dissolved into solution with the initial washing of the corn gluten meal. In the instant case, precipitation of the zein protein does not occur until later.
Conclusion
THIS ACTION IS MADE FINAL. 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 Emily M Le whose telephone number is (571)272-0903. The examiner can normally be reached M-F, 8 am-4:30pm.
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/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793