DETAILED ACTION
Background
The amendment dated November 12, 2025 (amendment) amending claims 33 and 41 has been entered. Claims 33-36, 39, 41, 43 and 63 as filed with the amendment have been examined. Claims 13-32, 37-38, 40, 42 and 44-62 have been canceled. Claims 1-12 have been withdrawn from consideration. In view of the amendment, all outstanding claim objections have been withdrawn.
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 .
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 33-36, 39,41,43 and 63 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.
In claim 33, at the 2nd to last line the recited % (percent) is indefinite because it does not provide a unit for the percent. Does the Applicant intend to claim a weight %, a volume%, a mass% or some other unit of percent?
In claim 33, at the 2nd to last line, the recited moisture content, expressed as a % (percent) has no basis or denominator for the percent. Does applicant intend to claim a moisture content on the basis of the total amount of the single cell protein composition, total single cell protein solids or some other basis for determining the content?
The Office interprets the recited moisture content as a wt% of moisture, based on the total weight of the single cell protein composition.
Claims 34-36, 39,41,43 and 63 are rejected as depending from a rejected base claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 33-36, 39, 41, 43 and 63 are rejected under 35 U.S.C. 103 as being unpatentable over US 9708208B2 to Remmereit et al. (Remmereit) in view of KR20090020450 A to Shim (Shim), both of record, and CN107125457 A to Tan et al (Tan).
All references to Tan refer to the Clarivate machine translation, a copy of which is included with this Office action.
The Office interprets the recited moisture content as a wt% of moisture, based on the total weight of the single cell protein composition.
Regarding instant claims 33-36, Remmereit at Abstract discloses culturing (“a) fermenting”) a biomass material with a hyperthermophilic organism. Further, Remmereit at col. 7, lines 40-55 discloses fermenting to degrade the biomass and resulting products comprising proteins for use in animal feeds. At column 10, lines 30-45, Remmereit discloses optimal fermentation conditions for growing cells of the genus Pyrococcus and Thermotoga (claim 36) as, respectively 100°C and 80°C. Further, at col. 11, lines 15-10, Remmereit discloses fermenting with cells of the genus Pyrococcus and Thermotoga to degrade waste products including fish innards (“fish waste” - claim 34), to provide (at col. 10, lines 30-41) a cell culture of peptone and a yeast extract comprising the hyperthermophilic organisms at a cell density reaching 1 X 108 Pyrococcus cells/ml and 2 X 108 Thermotoga cells/ml; and, at col. 14, lines 6-19 Remmereit discloses growth of cells of the genus Pyrococcus and Thermotoga at a cell density of 1 x 108 cells/ml in fish innards. In addition, the Office considers the claimed fish sludge comprising fish feces and uneaten fish feed in claim 35 as including the fish innards of Remmereit.
The Office considers the recited fermentation culture “consisting essentially of the hyperthermophilic organism” to include the culture and product disclosed at each of col. 10, lines 30-41 and at col. 14, lines 6-19 of Remmereit and all of its components. Absent a clear showing as to how the recited single cell protein composition excludes any part of the composition of Remmereit as materially affecting the basic and novel characteristics of the claimed invention, the Office interprets a single cell protein composition to include any composition comprising a population of hyperthermophilic cells as claimed and any other ingredients remaining in the Remmereit product. See MPEP 2111.03.III.
Remmereit does not disclose b) recovering a single cell protein from its hyperthermophilic fermentation culture consisting essentially of a hyperthermophilic organism, does not disclose c) drying the recovered single cell protein composition so that the composition has a moisture content of less than 8 wt% of the total single cell protein composition, and does not disclose a single cell protein composition that has a total protein content of from about 5 to about 99 wt% by weight of the total single cell protein composition.
Regarding instant claim 41, Remmereit does not disclose the recovering further comprising the concentrating the recovered protein composition by a process selected from the group consisting of coagulation, flocculation, direct drying, spraying drying and vacuum drying and combinations thereof to provide a powder.
Shim at Abstract on page 1 discloses a method of recycling food waste biomass via fermentation for use as fodder or feed. At the bottom part of page 5, in item 6) in Experimental Example 1, Shim discloses that after fermentation of the biomass using archaea (“hyperthermophilic organisms”), the product is leached to remove water (“recovering a single cell protein composition consisting essentially of a hyperthermophilic organism”) and then dried to concentrate the product including the protein in the product and then pelletized for use as or in animal feed. The Office considers the drying disclosed in Shim to comprise direct drying a single cell protein as in claim 41. Further, in the text accompanying Table 2 on the last 2 lines of page 10 and the first 4 lines of page 11 of Shim discloses that Thermotoga maritima, the same strain used in Remmereit, produces degrading glycolytic enzymes which are proteins.
Tan at Abstract on page 2 discloses a method for making a fermented feed comprising combining distillers spent grain, bean pulp, dry grass and fermenting bacteria, fermenting and then drying to form granular feed pellets having a water content of less than 5 wt%.
Before the effective date of the present invention, the ordinary skilled artisan would have found it obvious in view of Shim for Remmereit to recover a single cell protein or microbial protein from its hyperthermophilic fermentation culture as by leaching it in Shim, and to dry the recovered protein composition by a process selected from the group consisting of coagulation, flocculation, direct drying, spraying drying and vacuum drying and combinations thereof as in Shim to provide a single cell protein composition consisting essentially of a hyperthermophilic organism as a powder as in claim 41. Both references are drawn to the culturing of waste biomass using a hyperthermophilic organism to produce food or feed products. The ordinary skilled artisan working with Remmereit would have desired to recover, dry and concentrate its degraded biomass including the bacteria as single cell proteins as in Shim because Shim discloses that compositions of cultured hyperthermophilic bacteria as in Remmereit produce proteins and that a single cell containing the microbes is suitable for use as a protein food or feed product or additive.
The Office considers the dried composition of Remmereit as modified by Shim to be substantially the same thing as the claimed single cell protein composition. Accordingly, absent a clear showing as to how the protein content of the single cell protein composition of Remmereit as modified by Shim differs from that as claimed, the Office considers the dried single cell protein composition of Remmereit at col. 10, lines 30-41 and at col. 14, lines 6-19 in view of Shim at page 5, in item 6) in Experimental Example 1 to have a total protein content of from 5% to 99% on a dry w/w basis as in claim 33. See MPEP 2112.01.I.
Before the effective filing date of the present invention, the ordinary skilled artisan would have found it obvious in view of Tan for Remmereit as modified by Shim to dry its feed or feed additive to the claimed moisture content of less than 8 wt%, based on the weight of a single cell protein composition. All references disclose fermented animal feed from fermented waste. The ordinary skilled artisan in Remmereit as modified by Shim would have desired to dry its product to the claimed moisture content as in Tan to provide or easily processed granular feed or feed ingredient.
Regarding instant claims 39 and 63, at col. 14, lines 6-19 Remmereit discloses microbial fermentation products, which the Office considers as including DNA, RNA and lipids as in claim 39 and proteins, such as enzymes and single cell proteins, from the biomass material on which hyperthermophilic organisms are cultured as in claim 63.
Regarding instant claim 43, Remmereit at col. 7, lines 50-55 discloses a food or feed comprising a protein composition recovered from its hyperthermophilic fermentation culture.
Response to Arguments
The positions taken in the remarks accompanying the amendment dated November 12, 2025 (Reply) have been fully considered but are not found persuasive for the following reasons:
Regarding the position taken in the Reply that the culture in Remmereit would only have contained a small amount of the Archaea, the Office finds that Remmereit disclose at col. 10, lines 30-41 and at col. 14, lines 6-19 of numbers of the claimed bacteria of at least 108 cells/ml. Accordingly, the evidence does not support the position taken in the Reply.
Regarding the position taken in the Reply that three hours as in Shim at Experimental Example 1 is a very short culture time with the inoculated Archea and would result in little, if any growth or replication of the inoculated Archea in the culture and certainly not enough to provide a single cell protein composition consisting essentially of the hyperthermophilic organism as required by the claims, respectfully the Office respectfully disagrees and finds the fermentation time or conditions in Shim to be irrelevant to the recited number of bacteria disclosed in Remmereit at col. 10, lines 30-41 and at col. 14, lines 6-19 of Remmereit or the fermentation conditions disclosed in Remmereit. Remmereit does not use the term “single cell protein” in its disclosure; however, the Office relies on Remmereit, not Shim to provide cell composition and amount of hyperthermophilic bacteria in its product; and, the number of such hyperthermophilic bacteria in Remmereit falls within the scope of the claims.
Regarding the position taken in the Reply that the recited “consisting essentially of” language distinguishes the instant claims over the art, respectfully this is not found persuasive. The record contains no reason or evidence that any materials or steps in Remmereit “materially affect the basic and novel characteristic(s)" of the claimed invention and therefore does not distinguish the claims over the composition disclosed in Remmereit, particularly when recovered and dried as in Shim. See MPEP 2111.03.III.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW E MERRIAM whose telephone number is (571)272-0082. The examiner can normally be reached M-H 8:00A-5:30P and alternate Fridays 8:30A-5P.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Nikki H Dees can be reached on (571) 270-3435. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.E.M./ Examiner, Art Unit 1791
/Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791