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 1-18 are cancelled. New claims 19-38 are pending (claim set as filed on 01/01/2024).
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.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
This application filed on 01/01/2024 claims benefit to foreign application no. 18/575,874 filed on 07/12/2021, however no certified English translation was included in the instant application. Therefore, the effective filing date of the application is 01/01/2024. Applicant must supply certified English translation in order to claim benefit to the earlier priority date of 7/12/2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 01/01/2024, 01/01/2024, and 8/20/2025 are considered, initialed, and attached hereto. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The use of the term PEF Pilot Dual, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
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.
Claim 19 recites the limitation “treating the retentate of the microfiltration from step c) with a protease” in part (e) of the claim. 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. Further clarification is requested.
Claim 22 recites the limitation "the liquid phase of the yeast suspension" in the last line of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claims 20-21 and 23-38 are included in this rejection for depending on rejected independent claim and failing to resolve the noted deficiency.
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.
Claims 19-23, 28, 30-33, and 36-37 are rejected under 35 U.S.C. 103 as being unpatentable over Pauly (US Patent No. 6,146,857 – date of patent on 11/14/2000) in view of Miyagaki (Publication No. JP 5112941 B2 – date of patent on 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:
(claim 19(a)) a yeast in suspension (see col. 4, lines 3-14)
(claim 19(b)) where the yeast cells are physically digested by disintegration via mechanical means (see col. 3, lines 13-15)
(claim 19(c)) where the digested yeast cells are subject to microfiltration (see col. 3, lines 38-42)
(claim 19(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
(claim 19(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)
(claim 19(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(e), 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 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, Pauly teaches that the yeast suspension has a solids content within the range of 5-30% by weight (see col. 2, lines 27-31).
Regarding claim 21, Pauly teaches that the yeast cells in suspension are treated at a temperature within the range of 0-15[Symbol font/0xB0]C (see col. 4, lines 3-8).
Regarding claim 22, Pauly teaches 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 col. 4, lines 3-9).
Regarding claim 23, Pauly teaches that the cells in the yeast suspension are disintegrated by a homogenizer (see col. 3, lines 13-16).
Regarding claim 28, Pauly teaches that the protein extracted from filtration methods used such as ultrafiltration (see col. 3, lines 40-49) are subject to drying (see col. 4, lines 30-32).
Regarding claim 30, Pauly teaches that the protease treatment lasts in the range of 10 minutes to 18 hours (see col. 2, lines 63-67).
Regarding claim 31, Pauly teaches that the retained phase can undergo at least one interval of enzymatic treatments (see 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 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 col. 3, lines 1-2).
Regarding claim 32, Pauly teaches 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 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 col. 2, lines 61-66).
Regarding claim 33, Pauly teaches that mannan separation is done by membrane filtration (see col. 4, lines 30-31).
Regarding claim 36, Pauly teaches that the extracts obtained by the filtration methods are in a dry state (see col. 4, lines 38-40).
Regarding claim 37, Pauly teaches a brewer’s yeast (see col. 2, line 27).
Claims 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Pauly in view of Miyagaki and in further 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 combined teachings of modified-Pauly-Miyagaki have been set forth.
However, modified-Pauly-Miyagaki does not teach claims 24-25.
Ganeva’s general disclosure relates to using pulsed electric field treatment as a method for extracting proteins from yeasts (see abstract).
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 modified-Pauly-Miyagaki. 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 modified-Pauly-Miyagaki which also recognizes 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 in view of Miyagakiand in further view of Ivanova (Publication No. RU2270246C1 – date of patent on 2/20/2006).
The combined teachings of modified-Pauly-Miyagaki have been set forth.
However, modified-Pauly-Miyagaki does not teach claims 26 and 34.
Ivanova’s general disclosure relates to extraction of proteins by autolyzing yeast extracts (see pg. 1, abstract and description).
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 modified-Pauly-Miyagaki. 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 modified-Pauly-Miyagaki which also recognizes 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 in view of Miyagaki and in further view of Pall (Pall Corporation, “Highest Quality Yeast Extract Manufacturing with Membralox®IC Ceramic Systems”, 2012 Aug, Enabling a Greener Future, https://www.pall.com/content/dam/pall/food-beverage/literature-library/non-gated/application-bulletin/FBABYEEN.pdf, pgs. 1-3).
The combined teachings of modified-Pauly-Miyagaki have been set forth.
Modified-Pauly-Miyagaki does not teach claims 27 and 35.
Pall’s general disclosure relates to the digestion of yeast cells and the purification of the yeast extracts.
Regarding claims 27 and 35, Pall teaches that the microfiltration is carried out as diafiltration (see pg. 2, ¶ 2 and pg. 3, ¶ 1). Applicant 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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(see pg. 2, Figure 2)
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 modified-Pauly-Miyagaki 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 modified-Pauly-Miyagaki which also recognizes 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 in view of Miyagaki and in further view of Bergmaier (US Patent No. 8,361,778 B2 – date of patent 1/29/2013).
The combined teachings of modified-Pauly-Miyagaki have been set forth.
However, modified-Pauly-Miyagaki does not teach claims 29 and 38.
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 modified-Pauly-Miyagaki and to optimize the protease enzyme as taught by modified-Pauly-Miyagaki 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 is within the skill of an ordinary artisan to manipulate the extract conditions to disintegrate the cell wall (see Pauly col. 3, lines 16-21).
Conclusion
No claims are allowed.
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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/E.R.W./ Examiner, Art Unit 1653
/SHARMILA G LANDAU/ Supervisory Patent Examiner, Art Unit 1653