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 .
Status of the Claims
Claims 19-38 are currently pending and under examination (claim set as filed on 8/6/2026). Claims 1-18 are cancelled. Claim 22 is amended.
Priority
Applicant is advised of possible benefits under 35 U.S.C. 119(a)-(d) and (f), wherein an application for patent filed in the United States may be entitled to claim priority to an application filed in a foreign country.
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. EP 21185098.7, filed on 7/12/2021.
Although the applicant argues that an English translation is not required to be submitted, guidance from MPEP section 3204.01(c) states: “A certified translation of every foreign benefit application or Patent Cooperation Treaty (PCT) application not filed in English is required. If no certified translation is in the official record for the application, the examiner must require the applicant to file a certified translation. The applicant should provide the required translation if applicant wants the application to be accorded benefit of the non-English language application”.
Until such an English translation of the instant application is provided, the effective filing date remains 1/01/2024.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 1/1/2024, 8/20/2025, and 2/26/2026 were considered, initialed, and attached hereto. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Withdrawal of Objections/Rejections
Any objections of record and/or rejections of record not particularly addressed are withdrawn in light of the amendments and/or applicant’s comments.
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 19-38 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.
Regarding claim 19, the recitation of “treating the retentate of the microfiltration from step c) with a protease” in part (e) renders the claim indefinite. If the permeate of the microfiltration is ultrafiltered in part (d) and then the retentate of the ultrafiltration is separated and treated with protease, thus, it is unclear how step (e) treats the retentate of the microfiltration. It appears applicant is attempting to refer to the treating the ultrafiltrated retentate, not the microfiltrated retentate.
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.
Claims 19-23, 28, 30-33, and 36-37 are rejected under 35 U.S.C. 103 as being unpatentable over Pauly (Patent No. US 6,146,857 – date of patent 11/14/2000) and further in view of Miyagaki (Publication No. JP 5112941 B2 – date of publication 1/9/2013).
Pauly’s general disclosure relates to the extraction of saccharides and proteins from yeast cells; and specifically, the production of glycogen compositions from yeast cells using filtration methods (see abstract; col. 3, lines 38-42).
Regarding claim 19, Pauly teaches:
(a) - a yeast in suspension (see col. 4, lines 3-14)
(b) - where the yeast cells are physically digested by disintegration via mechanical means (see col. 3, lines 13-15)
(c) - where the digested yeast cells are subject to microfiltration (see col. 3, lines 38-42)
(d) - where the digested yeast cells are subject to at least one treatment of microfiltration and/or ultrafiltration (see col. 8, claim 7) to separate intracellular substances such as proteins (see col. 3, lines 38-49); therefore, it is reasonable to interpret that the yeast cells undergo microfiltration first and the permeate is then ultrafiltered to collect a protein phase.
(f) - where the freed intracellular substances such as mannan are subject to at least one precipitation treatment (see col. 8, claim 1) and teaches that precipitation is carried out at basic conditions (see col. 8, claim 9) and then acidic conditions (see col. 8, claim 10), and then separates a phase of a composition containing glucans (see col. 4, lines 33-46).
(e) - where the treatment is carried out at a basic pH (see col. 8, claim 9) and then separates a phase of a composition containing mannans (see col. 8, claim 1; see col. 4, lines 33-46).
However, Pauly does not teach treating the microfiltration retentate with a protease enzyme.
Miyagaki’s general disclosure relates to extracting and concentrating saccharides such as glycogen from yeast cells (see abstract).
Regarding claim 19, Miyagaki teaches microfiltration of yeast cells and a protease enzyme treatment (see pg. 5, claim 1(A)-(B)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the microfiltration and protease treatment steps as taught in Miyagaki with the basic pH conditions and mannan extraction as taught in Pauly and it would have been obvious to try a different arrangement of the steps disclosed in Miyagaki. The ordinary artisan would have been motivated to do so because Miyagaki discloses that this extraction process could be carried out under a basic pH (see Miyagaki pg. 7, ¶ 9) and that mannan was a byproduct of this process (see Miyagaki pg. 9, ¶ 7). The ordinary artisan would have been motivated to try arranging the microfiltration and protease treatment steps in a different order as they would be choosing from a finite number of arrangement of steps and would have had a reasonable expectation of success. Therefore, such use of the steps disclosed in Miyagaki would be considered an advantage in Pauly which also recognizes the need for a series of enzymatic treatments and filtration methods (see Pauly col. 8, claims 6-7).
Regarding claim 20, the combined references teach that the yeast suspension has a solids content within the range of 5-30% by weight (see Pauly col. 2, lines 27-31).
Regarding claim 21, the combined references teach that the yeast cells in suspension are treated at a temperature within the range of 0-15[Symbol font/0xB0]C (see Pauly col. 4, lines 3-8).
Regarding claim 22, the combined references teach that the yeast suspension is washed with water before physical digestion of the yeast cells and wherein the water phase is replaced by another liquid phase (see Pauly col. 4, lines 3-9).
Regarding claim 23, the combined references teach that the cells in the yeast suspension are disintegrated by a homogenizer (see Pauly col. 3, lines 13-16).
Regarding claim 28, the combined references teach that the protein extracted from filtration methods such as ultrafiltration (see Pauly col. 3, lines 40-49) are subject to drying (see Pauly col. 4, lines 30-32).
Regarding claim 30, the combined references teach that the protease treatment lasts in the range of 10 minutes to 18 hours (see Pauly col. 2, lines 63-67).
Regarding claim 31, the combined references teach that the retained phase can undergo at least one interval of enzymatic treatments (see Pauly col. 4, lines 17-19) and that the treatment(s) are carried out within the time range of 1-5 hours and 0.5-2 hours, a temperature range of 40-95[Symbol font/0xB0]C and 50-95[Symbol font/0xB0]C, and a pH range of 7.5-11 and 2-6.5 (see Pauly col. 2, lines 62-67 and col. 3, lines 1-2). Both basic and acidic organic solvents are used in the interval treatments within the claimed range (see Pauly col. 3, lines 1-2).
Regarding claim 32, the combined references teach that the pH of the first interval is equal to the pH of the retained phase from protease treatment in claim 19(e) as they are carried out at the same conditions (see Pauly col. 2, lines 62-67). Pauly teaches a range of 60-180[Symbol font/0xB0]C for the enzymatic treatment intervals so it would be reasonable to interpret that the temperature for the first interval is lower than the second interval (see Pauly col. 2, lines 61-66).
Regarding claim 33, the combined references teach that mannan separation is done by membrane filtration (see Pauly col. 4, lines 30-31).
Regarding claim 36, the combined references teach that the extracts obtained by the filtration methods are in a dry state (see Pauly col. 4, lines 38-40).
Regarding claim 37, the combined references teach a brewer’s yeast (see Pauly col. 2, line 27).
Claims 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Pauly (Patent No. US 6,146,857 – date of patent 11/14/2000), in view of Miyagaki (Publication No. JP 5112941 B2 – date of publication 1/9/2013), and further in view of Ganeva (Ganeva et al., “Extraction of Proteins and Other Intracellular Bioactive Compounds From Baker’s Yeasts by Pulsed Electric Field Treatment”, 2020 Dec 15, Frontiers in Bioengineering and Biotechnology, 8, pgs. 1-11).
The general disclosure of the combined references has been set forth above.
Regarding claims 24-25, the combined references teach the yeast digestion method.
The combined references do not teach the physical digestion is done by pulsed electric fields and wherein the electric field strength is 1-30 kV/cm.
Ganeva’s general disclosure relates to using pulsed electric field treatment as a highly effective method for extracting proteins and saccharides from yeasts (see abstract and pg. 2, ¶ 6).
Regarding claims 24-25, Ganeva teaches that pulsed electric fields are used to extract proteins from yeast cells in a buffer solution which is a suspension (see pg. 11, conclusion). Ganeva discloses that the yeast cells received electric field pulses with a strength within the 1-30 kV/cm range (see pg. 3, ¶ 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the pulsed electric field digestion method at a strength of 1-30 kV/cm as taught by Ganeva with the saccharide and protein extraction method from yeast cells as taught in the combined references. The ordinary artisan would have been motivated to do so because Ganeva teaches that this pulsed electric field method is a more selective method of extracting compounds such as saccharides from yeast cells (see Ganeva pg. 2, ¶ 6), and that an electric field strength of 1-30 kV/cm is shown to be highly effective for the extraction of compounds from yeast cells (see Ganeva pg. 11, conclusion). Therefore, such use of the pulsed electric fields at a strength of 1-30 kV/cm would be considered an advantage in the combined references which also recognize the need for a more selective method of extracting saccharides from yeast cells (see Pauly col. 1, lines 18-25).
Claims 26 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Pauly (Patent No. US 6,146,857 – date of patent 11/14/2000), in view of Miyagaki (Publication No. JP 5112941 B2 – date of publication 1/9/2013), and further in view of Ivanova (Publication No. RU 2270246 C1 – date of publication 2/20/2006).
The general disclosure of the combined references has been set forth above.
Regarding claims 26 and 34, the combined references teach the yeast digestion method.
The combined references do not teach wherein the microfiltration in step (c) is carried out with a filter having a pore size of 0.1-0.5 µm or wherein the ultrafiltration in step (d) is carried out with a filter having a pore size of less than 90 nm and/or an exclusion limit of 1-100 kDa.
Ivanova’s general disclosure relates to extraction of proteins by autolyzing yeast extracts (see pg. 1, abstract and description) and the microfiltration and ultrafiltration of the yeast suspension (see pg. 4, ¶ 4 and 7). Ivanova further discloses specified filter membrane sizes are able to reduce contamination of the extracts (see pg. 3, ¶ 1 and pg. 4, ¶ 4).
Regarding claims 26 and 34, Ivanova teaches that the yeast suspension is microfiltered through membrane with a pore size in the range of 0.1-0.5 µm (see pg. 4, ¶ 7). Ivanova discloses that the yeast suspension is then ultrafiltered through a UPM-5 membrane with an exclusion limit within the range of 1-100 kDa (see pg. 4, ¶ 4; see pg. 4, , ¶ 7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try the microfiltration and ultrafiltration membrane sizes as taught in Ivanova with the microfiltration and ultrafiltration methods taught in the combined references. The ordinary artisan would have been motivated to do so because Ivanova teaches that these membrane sizes are effective at reducing contamination of the yeast extract (see Ivanova pg. 3, ¶ 1 and pg. 4, ¶ 4). Therefore, such use of the membrane sizes would be an advantage in the combined references which also recognize the need for a high-quality final extract after filtering the yeast suspension (see Pauly col. 3, lines 38-42).
Claims 27 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Pauly (Patent No. US 6,146,857 – date of patent 11/14/2000), in view of Miyagaki (Publication No. JP 5112941 B2 – date of publication 1/9/2013), and further in view of Pall (Pall Corporation, “Highest Quality Yeast Extract Manufacturing with Membralox®IC Ceramic Systems”, 2012 Aug, Enabling a Greener Future, www.pall.com/content/dam/pall/food-beverage/literature-library/non-gated/application- bulletin/FBABYEEN.pdf, pgs. 1-3).
The general disclosure of the combined references has been set forth above.
Regarding claims 27 and 35, the combined references teach the yeast digestion method.
The combined references do not teach wherein the microfiltration and ultrafiltration is carried out as diafiltration wherein water is continuously supplied on the feed side.
Pall’s general disclosure relates to the digestion of yeast cells and the purification of the yeast extracts (see abstract and pg. 2, ¶ 2) using diafiltration which results in a high recovery of solids in the filtering process (see pg. 2, ¶ 2 and pg. 3, ¶ 1).
Regarding claims 27 and 35, Pall teaches that the microfiltration is carried out as diafiltration (see pg. 2, ¶ 2 and pg. 3, ¶ 1). The instant application defines “diafiltration” as the continuous supply of liquid on the feed side, which Pall discloses in their filtration method (see pg. 2, ¶ 2).
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645
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the further specification that the microfiltration method taught in the combined references was carried out as the diafiltration as taught in Pall. The ordinary artisan would have been motivated to do so because Pall teaches that the diafiltration method has a high percent recovery of solids from the filtration method (see Pall pg. 3, ¶ 1). Therefore, such use of the diafiltration method would be considered an advantage in the combined references which also recognize the need for a method to recover a high yield of yeast extracts (see Pauly col. 1, lines 18-25).
Claims 29 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Pauly (Patent No. US 6,146,857 – date of patent 11/14/2000), in view of Miyagaki (Publication No. JP 5112941 B2 – date of publication 1/9/2013), and in further view of Bergmaier (US Patent No. 8,361,778 B2 – date of patent 1/29/2013).
The general disclosure of the combined references has been set forth above.
Regarding claims 29 and 38, the combined references teach the yeast digestion method.
Bergamaier’s general disclosure relates to the enzymatic treatment of yeast cells with a subtilisin protease (see abstract and col. 17, claim 4), which at a specified pH and temperature allows for the breakdown of proteins in the yeast cell wall (see col. 2, lines 50-52).
Regarding claims 29 and 38, Bergmaier teaches the protease enzyme subtilisin (see col. 17, claim 4) and that the subtilisin treatment was carried out within the pH range of 7.5-13 and within a temperature range of 40-80[Symbol font/0xB0]C (see col. 3, lines 54-56). The order of the filtration of the yeast and application of enzyme (see col. 3, lines 54-67) are not specified in Bergmaier and so one could reasonably interpret that the filtration step occurs first and then the protease treatment occurs after.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to invention to utilize the percent weight range of protease as taught by Bergmaier as applied to the enzymatic treatment as taught by the combined references and to optimize the protease enzyme as taught by the combined references to a subtilisin protease enzyme at the pH and temperature ranges as taught in Bergmaier. The ordinary artisan would have been motivated to do so because this amount of protease is suitable for an effective hydrolysis rate (see Bergmaier col. 5, lines 1-12) and subtilisin at this pH and temperature range is capable of breaking down the proteins in the yeast cell wall (see Bergmaier col. 2, lines 50-52). Therefore, it would have been within the skill of an ordinary artisan to manipulate the extract conditions to disintegrate the cell wall (see Pauly col. 3, lines 16-21).
Response to Arguments
Applicant's arguments filed on 8/6/2026 have been fully considered but they are not persuasive.
The aforementioned 112b rejection was noted in the non-final Office Action and was not corrected to provide clarity as requested by the Examiner. As the microfiltration product in step (c) is ultrafiltered in step (d), then it can no longer be treated in step (e) since the microfiltered product no longer exists and is now the ultrafiltered product. It is suggested that the applicant move step (e) to occur directly after step (c), and then re-letter the steps so that step (e) is step (d) and that step (d) is step (e).
The applicant argues that the prior art reference Pauly does not disclose a process performed on the permeate or retentate of the treatments claimed. They argue nor does Pauly teach “ultrafiltration of the permeate of the microfiltration from step (c) wherein a phase with proteins as the main solid components is separated as the retentate of the ultrafiltration” as recited in claim 38 and the instant specification. The applicant argues that it is unreasonable to assume there is support in Pauly for the contention that the permeate of the microfiltration is then ultrafiltered to obtain a protein phase. Further, they argue that Pauly does not teach separating mannan or glucan as a main solid component, but rather glycogen and other accompanying substances.
Neither claim 38 nor claim 29 which it depends on recites the specified “ultrafiltration of the permeate of the microfiltration from step (c)…etc.” limitation and thus this argument is moot. The Examiner upholds that it would be reasonable to one of ordinary skill in the art to assume that the permeate of the microfiltration would then be ultrafiltered as both of these filtration processes were taught in the prior art. In the liquid separation filtration art, substances must be microfiltered before being ultrafiltered and as microfiltration produces a permeate, it is reasonably expected that the permeate would be the substance subsequently ultrafiltered. Furthermore, the prior art explicitly states that “the accompanying substances” comprises both glucans and mannans in the filtration processes (see Pauly col. 4, lines 44-49). Although the prior art does teach the glycogens and accompanying substances can have variable proportions, the taught percentage of these extracts can include up to 99.9% (see Pauly col. 4, lines 38-43) and thus this would read on the “main solid component” limitation.
Applicant argues that Pauly does not teach treating the retentate with a protease after separating a protein fraction. However as noted in the 112b rejection above, the recitation of “the retentate of the microfiltration” is unclear and renders the claim and step (e) indefinite. Thus the argument is moot.
The applicant further argues that Pauly does not teach the phase is treated first at basic then at acidic conditions but rather is treated with salts in one process and with alcohols in another process. The prior art teaches the phase is precipitated with a salt at a pH range of up to 9 which reads on a base (see Pauly col. 8, claim 9), and with an alcohol at a pH range down to 1 which reads on an acid (see Pauly col. 8, claim 10). Pauly also discloses that the precipitation process can be carried out at least once (see Pauly col. 8, claim 1). Thus, it would be obvious to the ordinary artisan to precipitate the phase one or more times as suggested with the disclosed basic and acidic buffers, and in doing so it would have only been a matter of routine experimentation to try a combination of first a base and then an acid buffer.
The applicant asserts that the secondary reference Miyagaki does not teach step (e) from claim 19 and merely describes removing mannan from the centrifuged supernatant. However, the secondary reference Miyagaki was not relied upon to teach the mannan limitation from step (e) but instead was used to teach the microfiltration of yeast cells and a protease enzyme treatment as indicated in the above rejection. This misconstrues the prior art combination rejection and the applicant is advised to refer back to the above rejection where the primary reference Pauly teaches the separation of mannan and the secondary reference Miyagaki teaches the aforementioned deficiencies.
As the rejections for claim 19 still stand, the rejections for dependent claims 20-38 stand as well.
Conclusion
No claims are allowed.
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.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Emmalee R. Williams whose telephone number is (571)272-5472. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached at (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMMALEE R WILLIAMS/ Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
