DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The amendment filed December 4, 2025, has been received and entered.
Claims 2, 4, 6-10, 13, 15-17, and 23-38 are cancelled.
Claim 39 is new.
Claims 1, 3, 5, 11, 12, 14, 18-22, and 39 are pending.
Election/Restrictions
Applicant’s election of Group I, claims 1, 3, 5, 11, 12, 14, 18-22, and 39, in the reply filed on December 4, 2025, is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1, 3, 5, 11, 12, 14, 18-22, and 39 are examined on the merits.
Specification
The disclosure is objected to because of the following informalities:
Paragraphs [0158]-[0160] of the specification refer to Figures 3A and 3B, but the only drawings are Figures 1A and 1B.
Appropriate correction is required.
Claim Objections
Claims 1, 3, 5, 11, 12, 14, 18-22, and 39 are objected to because of the following informalities:
Claim 1 is objected to because the recitation “said first and said second fraction” in line 7 is not grammatically correct. Since the recitation is in reference to two fractions, then it should recite “said first and said second fractions” or “said first fraction and said second fraction.” Sine claim 1 is objected to, then its dependent claims, claims 3, 5, 11, 12, 14, 18-22, and 39, are objected to.
Claim 3 is objected to because it recites semicolons and commas inconsistently. In particular, items a) and b) are followed by semicolons, whereas items c), d), and e) are followed by commas. The punctuation after each item in lines 2-4 should be changed to only semicolons or only commas. Since claim 3 is objected to, then its dependent claim, claim 19, is objected to.
Claim 5 is objected to because it recites a semicolon after “derived from downstream food-related industries,” whereas the other items in the list are followed by a comma. For consistency, the semicolon should be changed to a comma.
Claim 39 is objected to because “endo-amalyase” in line 2 is a misspelling of the known term “endo-amylase.”
Also, claim 39 is objected to because “pectinase” is recited twice. See lines 1 and 2. The second instance of “pectinase” should be deleted.
Additionally, claim 39 is objected to because “arabinanase” in line 2 is the same enzyme as “arabanase” in line 3. See page 456, first paragraph of Okado (Food Science and Nutrition. 2020. 8: 456-478. Published December 17, 2019). One of the two recitations should be deleted so that the same enzyme is not recited twice.
Appropriate correction is required.
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 1, 3, 5, 11, 12, 14, 18-22, and 39 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.
Claim 1 is rendered indefinite by the recitation “said fraction” in line 8. It is unclear whether it is referring to the first fraction and/or the second fraction. Since claim 1 is indefinite, then its dependent claims, claims 3, 5, 11, 12, 14, 18-22, and 39, are rendered indefinite. Thus, claims 1, 3, 5, 11, 12, 14, 18-22, and 39 are rejected under 35 U.S.C. 112(b).
Claim 5 recites the limitation "said yeast" in lines 1-3. There is insufficient antecedent basis for this limitation in the claim. Parent claim 1 does not refer to a yeast, instead reciting a “yeast material.” Paragraph [075] of the specification defines the term “yeast material” as “any compound constituting, secreted, derived or produced by yeast.” Given this definition, “yeast material” encompasses embodiments not directed to yeast itself, such that “said yeast” in claim 5 lacks antecedent basis.
Also, claim 5 is rendered indefinite by the recitation “yeast being derived from downstream food-related industries” in lines 5-6. The word “being” makes the recitation confusing because it suggests that the yeast is being derived from downstream food-related industries during the claimed method (i.e., when performing the claimed steps). This rejection can be overcome by amending the recitation to “yeast derived from downstream food-related industries.”
Claim 11 is rendered indefinite by the recitation “said protein.” It is unclear whether it is referring to one of the soluble proteins, one of the insoluble proteins, or one of all proteins of the yeast material. It is unclear whether every protein of the yeast material is characterized by the claimed molecular weight.
Claim 12 is rendered indefinite by the recitation “said insoluble protein.” Parent claim 1 recites “insoluble proteins,” instead of a single insoluble protein. It is unclear whether only one, some, or all the insoluble proteins are characterized by an aqueous solubility of less than 300 g/L.
Claim 39 is rendered indefinite by the recitation “said enzyme.” Parent claim 1 does not recite a single enzyme, instead reciting two enzymes which are lipase and β-glucanase. Therefore, it is unclear whether “said enzyme” is the lipase or the β-glucanase. Moreover, it is unclear how a single enzyme (the lipase or the β-glucanase of claim 1) can further comprise one or any combination of the enzymes recited in claim 39 which are distinct from a lipase and a β-glucanase. Each enzyme (the lipase and the β-glucanase) comprises itself as an enzyme. For the purpose of applying prior art over claim 39, lines 4-5 of claim 1 is being interpreted as reciting “enzymes comprising lipase and β-glucanase” instead of “the enzymes: lipase and β-glucanase,” and line 1 of claim 39 is being interpreted as reciting “said enzymes further comprise” instead of “said enzyme further comprises.”
Additionally, claim 39 is indefinite because it is confusing how an enzyme can comprise “cellulose” recited in line 3. Cellulose is polysaccharide which is not known as an enzyme or a component of an enzyme.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3, 5, 11, 12, 14, 18-22, and 39 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The limitation in claim 1 of “a) breaking the cell wall of said yeast material by enzymatic reaction comprising contacting said yeast material with the enzymes: lipase and β-glucanase” is not supported by the specification as filed. When discussing breaking the cell wall, the specification discloses it as being performed to break the cell wall to a particle size suitable for enzymatic reaction (e.g., paragraphs [005] and [046]). Furthermore, the specification discloses enzymatic hydrolysis for the purpose of removing a fiber from the cell wall or portion thereof (e.g., paragraphs [019]-[020]). Although the specification discloses an example involving yeast in which enzymatic treatment is coupled with homogenization (paragraph [0160]), there is no teaching that the cell wall of the yeast material is broken by enzymatic reaction comprising contacting the yeast material with the enzymes. Homogenization is recognized for breaking the cell wall (e.g., paragraph [007]), so it is unclear that the enzymatic reaction itself of the example breaks the cell wall of yeast material.
While Applicant was in possession of a portion of the claimed invention, the full scope of the invention, specifically a method comprising breaking the cell wall of yeast material comprising a cell wall by enzymatic reaction comprising contacting said yeast material with the enzymes lipase and β-glucanase, is not fully described in the specification. As such, Applicant was not in possession of the full scope of the claimed invention at the time of filing. Because the specification as filed fails to provide clear support for the new claim language, a new matter rejection is clearly proper.
Notice Re: Prior Art Available Under Pre-AIA and AIA
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.
Claim Rejections - 35 USC § 103
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.
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, 5, 11, 12, 14, 18, 20-22, and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Kalum (US 2007/0292938) in view of Ason (JP 2013053083. Machine Translation cited below).
Kalum discloses a method for extracting one or more components from yeast cells, wherein the one or more components to be extracted comprises a protein (claims 1 and 8 of Kalum; paragraph [0007]). The method comprises treating yeast cells with a phospholipase (claim 1 of Kalum; paragraph [0003]). The phospholipase activity may be provided by enzymes having other activities as well, such as a lipase with phospholipase activity (paragraph [0024]). Yeast cells are directed to a ‘yeast material comprising a cell wall.’ Therefore, Kalum meets limitations of the claimed invention by disclosing contacting a yeast material comprising a cell wall with the enzyme lipase (lipase with phospholipase activity).
In extracting proteins and separating the one or more components (including protein) from the treated yeast cells (claims 1 and 8 of Kalum), then the method of Kalum is directed to a ‘method for optimizing a protein content extracted from a yeast material comprising a cell wall’ as claimed, wherein the steps result in ‘optimizing the protein content extracted from the yeast material comprising a cell’ as claimed.
Kalum differs from the claimed invention in that Kalum does not expressly disclose that their step of treating yeast cells with a lipase (a lipase with phospholipase activity) is a step of breaking the cell wall of the yeast material (the yeast cells) by enzymatic reaction comprising contacting the yeast material not only with the lipase but also with β-glucanase. Kalum further differs from the claimed invention in that Kalum does not disclose that after that step, there is a step of receiving a first fraction comprising soluble proteins and a second fraction comprising insoluble proteins, wherein each of said first and second fractions comprises a protein content between 10% and 90% by dry weight of each fraction.
Kalum discloses that in one or more embodiments, the one or more components to be extracted is a yeast extract (paragraph [0015]). Also, the value of yeast extracts depends to a high degree on the amount of protein in the extract, there is thus a desire to achieve the highest possible protein yield (paragraph [0015]).
Ason discloses a method for producing yeast protein comprising treating yeast cells with a cell wall lytic enzyme (page 3, second paragraph; claim 4 of Ason). The cell wall lytic enzyme has almost no protease activity and can be a β-glucanase (page 3, third paragraph). Thereafter, the method comprises heat treatment at 50ºC or higher (preferably 50 to 100ºC), and separation of a fraction containing mainly protein (page 3, fifth paragraph; abstract). The yeast protein obtained by the method can have a protein content of 60% or more, or 80% or more (page 3, seventh paragraph).
Before the effective filing date of the claimed invention, it would have been obvious to the person of ordinary skill in the art to further include a β-glucanase with the lipase having phospholipase activity when performing the method of Kalum in order to also treat the yeast cells with a β-glucanase. One of ordinary skill in the art would have been motivated to do this because it would have enabled acquisition of yeast protein having a high protein content, as indicated in Ason; this would have been desirable for the invention of Kalum since Kalum recognizes the value of a yeast product having the highest possible protein yield (paragraph [0015]). There would have been a reasonable expectation of performing the invention of Kalum with the combination of the lipase and a β-glucanase since both Kalum and Ason disclose that yeast cells can successfully be treated with these enzymes for obtaining protein from yeast cells. Since β-glucanase is a cell wall lytic enzyme, then the treatment of the yeast cells with the combination of lipase and β-glucanase would have been expected to break the cell walls of the yeast cells by enzymatic reaction (at least by enzymatic reaction catalyzed by β-glucanase). Therefore, Kalum in view of Ason renders obvious step a) of instant claim 1.
Regarding step b) of instant claim 1, since Kalum in view of Ason renders obvious the same step a) of breaking the cell of yeast material comprising a cell wall of instant claim 1, then the resulting product is necessarily the same as recited in step b) of instant claim 1. In other words, since the same material (yeast material comprising a cell wall) undergoes the same treatment (enzymatic reaction comprising contacting said yeast material with the enzymes lipase and β-glucanase) as claimed when practicing the method rendered obvious by Kalum and Ason, then the resulting product of the method rendered obvious by Kalum and Ason necessarily is the same as claimed. In particular, the resulting product necessarily comprises soluble proteins and insoluble proteins, and the resulting product comprises a protein content between 10% and 90% by dry weight. It is noted that step b) of instant claim 1 does not require separation of the first fraction from the second fraction. Therefore, a product comprising both soluble proteins and insoluble proteins is directed to a first fraction comprising soluble proteins and a second fraction comprising insoluble proteins. As such, receiving the whole product from the enzymatic treatment of Kalum in view of Ason is directed to receiving a first fraction comprising soluble proteins and a second fraction comprising insoluble proteins, wherein each of the first and second fractions comprises a protein content between 10% and 90% by dry weight of each fraction. Moreover, there would have been a reasonable expectation that the protein content of the first fraction comprising soluble proteins and a second fraction comprising insoluble proteins (as present in a product comprising soluble proteins and insoluble proteins) each comprises a protein content falling within the claimed range of ‘between 10% and 90% by dry weight of said fraction’ because Ason teaches that their treatment involving β-glucanase resulted in yeast protein of a protein content of 60% or more, or 80% or more (page 3, seventh paragraph) which overlaps the claimed range.
Therefore, Kalum in view of Ason renders obvious instant claims 1 and 14.
Regarding instant claim 3, Ason teaches that following the reaction with the cell wall lytic enzyme, a heat treatment is performed preferably at 50 to 100ºC (page 3, fifth paragraph). In performing the method rendered obvious by Kalum in view of Ason, it would have been obvious to the person of ordinary skill in the art to further include this step after the enzyme treatment because it disclosed as an additional step for obtaining a yeast protein having a high protein content. Therefore, instant claim 3 (temperature between 50 ºC and 100 ºC) is rendered obvious.
Regarding instant claim 5, Kalum discloses that the yeast may be Saccharomyces cerevisiae and Candida utilis (paragraph [0005]). Therefore, instant claim 5 is rendered obvious.
Regarding instant claim 11, Kalum in view of Ason differs from the claimed invention in that they do not expressly disclose the molecular weight of any protein in the yeast protein. However, since Kalum in view of Ason renders obvious step a) of instant claim 1, then the resulting product necessarily possesses the same properties as claimed, including comprising at least one protein characterized by a molecular weight between 1 kDa and 250 kDa. Thus, instant claim 11 is rendered obvious.
Regarding instant claim 12, Kalum in view of Ason differs from the claimed invention in that they do not expressly the aqueous solubility of any insoluble protein in the yeast protein. However, since Kalum in view of Ason renders obvious step a) of instant claim 1, then the resulting product necessarily possesses the same properties as claimed, including comprising at least one insoluble protein characterized by an aqueous solubility of less than 300 g/L. Thus, instant claim 12 is rendered obvious.
Regarding instant claim 18, Kalum discloses that the skilled person will known how to adjust parameters such as pH to achieve the desired results when discussing suitable conditions under which to perform the treatment of phospholipase (paragraph [0072]). In one embodiment of the invention, treatment with phospholipase is conducted at a pH between 2 and 10, such as between 3 and 9 (paragraph [0072]). Additionally, in the examples of Ason, the treatment with β-glucanase (FiltraseBRX, Denateam GEL) was performed at pH 4.5 and pH 6.0 (page 3, last paragraph; page 4, second paragraph; page 3, third paragraph for names of the β-glucanase of the examples). In performing the method rendered obvious by Kalum in view of Ason, it would have been obvious to the person of ordinary skill in the art to perform the enzyme treatment at a pH suitable for both phospholipase and β-glucanase as taught in Kalum and Ason, including pH 4.5 and pH 6.0 which fall within the claimed range of between 3.5 and 7. Therefore, instant claim 18 is rendered obvious.
Regarding instant claim 20, Kalum teaches that if spent yeast is used for their invention, it is often subjected to debittering to remove bitter flavours, e.g. by washing at pH 8-9, before production of the extract (paragraph [0016]). Thus, instant claim 20 (at least ‘washing’) is rendered obvious.
Regarding instant claim 21, Kalum teaches that their final product is usually sold as a liquid, paste, or powder (paragraph [0021]). Thus, instant claim 21 is rendered obvious.
Regarding instant claim 22, Kalum teaches separating the desired one or more components from the treated yeast cells, wherein the desired one or more components can comprise a protein (claims 1 and 8 of Kalum). Also, Kalum teaches that the extract will usually be concentrated (paragraph [0021]). Therefore, Kalum teaches at least concentrating a protein from said first fraction (as provided in the whole product), said second fraction (as provided in the whole product), or both (the whole product). Thus, instant claim 22 (at least ‘concentrating’) is rendered obvious.
Regarding instant claim 39, Ason discloses that the cell wall lytic enzyme used in their method includes glucanase and mannanase (page 3, third paragraph). In performing the method rendered obvious by Kalum in view of Ason, it would have been obvious to the person of ordinary skill in the art to further include mannanase with the lipase and the β-glucanase because Ason recognizes mannanase as a cell wall lytic enzyme useful for obtaining a yeast protein having a high protein content. It would have been an obvious matter of combining enzymes recognized for the same purpose of obtaining yeast protein. As set forth in MPEP 2144.06(I), ‘"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art."’ Thus, instant claim 39 (mannanase) is rendered obvious.
Claims 3 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Kalum and Ason as applied to claims 1, 3, 5, 11, 12, 14, 18, 20-22, and 39 above, and further in view of Barbieru (Proceedings. 2020. 57, 75. Published November 13, 2020. Listed on IDS filed 12/4/25) and Liu (Innovative Food Science and Emerging Technologies. 2016. 36: 181-192. Listed on IDS filed 7/23/24).
As discussed above, Kalum in view of Ason renders obvious claims 1, 3, 5, 11, 12, 14, 18, 20-22, and 39. The references differ from claim 19 in that they do not expressly disclose repeating applying pressure between 150 bars and 1500 bars.
Barbieru discloses optimizing the extraction of yeast proteins through enzymatic treatment coupled with high pressure homogenization (second paragraph). The yeast was pre-treated with a β-glucanase for one hours at 50ºC, and then lysed through a homogenizer at different pressure levels and different number of passes (second paragraph). It was determined that pressure and β-glucanase concentration were highly significant (second paragraph).
Liu discloses yeast cell disruption methods (abstract). These methods include high pressure homogenization (HPH) (page 185, left column, second paragraph). The literature includes using HPH at a pressure up to 100 MPa with two-stage homogenizing valves to achieve high energy production efficiency using yeast as a biomass source (page 185, left column, second paragraph). 100 MPa converts to 1000 bars.
Before the effective filing date of the claimed invention, it would have been obvious to the person of ordinary skill in the art to further treat the yeast cells with multiple passes of high pressure homogenization up to 1000 bars after enzyme treatment when performing the method rendered obvious by Kalum in view of Ason. One of ordinary skill in the art would have been motivated to do this because it would have optimized the extraction of yeast proteins. There would have been a reasonable expectation of success in doing this because Barbieru teaches that combining high pressure homogenization after β-glucanase treatment can be used for optimizing yeast protein extraction. A pressure of up to 1000 bars overlaps the claimed pressure range. Thus, the references render obvious instant claim 19, as well as rendering obvious an additional embodiments of instant claim 3 (pressure between 150 bars and 1500 bars; high-pressure homogenization).
Conclusion
No claims are allowed.
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Sef
/SUSAN E. FERNANDEZ/ Examiner, Art Unit 1651