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 .
This office action is in response to the application filed on March 8, 2024.
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-9 and 21, in the reply filed on March 5, 2026 is acknowledged. The traversal is on the ground(s) that Forss does not provide a concrete example with a protein content of at least 61%. This is not found persuasive because there does not need to be an example in order to anticipate the special technical feature. Additionally, Applicant has already withdrawn the non-elected claims.
The requirement is still deemed proper and is therefore made FINAL.
Claims 10-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on March 5, 2026.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d) with a filing date of September 10, 2021. The certified copy of FI 20215955 has been filed in the present application, received on March 8, 2024.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
The present application is a 371 National Stage Application of PCT/FI2022/050605 which has a filing date of September 9, 2022.
Status of Application
Claims 1-21 were originally presented and subject to a restriction requirement. Claims 1-21 are pending; claims 10-20 are withdrawn. Claims 1-9 and 21 are presented for examination.
Claim Objections
Claim 21 is objected to because of the following informalities: The claim recites “an edible composition as defined in claim 20,” which is improper as claim 20 has been withdrawn. Appropriate correction is required.
Claim Interpretation
Claim 8 recites that the fungal biomass is “essentially free from solids that are insoluble in a feedstock comprising one or more dissolved carbon sources.” The instant specification defines “essentially free” as containing less than 1 wt.%, preferably less than 0.5 wt.%, and more preferably 0 wt.% (p. 14 [0050]). As such, the claim will be interpreted such that “essentially free” is less than 1 wt.%.
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 7 and 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 7 recites the broad recitation “3-8 wt.%,” and the claim also recites “preferably 4-7 wt.%,” which is the narrower statement of the range/limitation.
The claims are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
For the purposes of examination, claim 7 will be interpreted as being limited to the 3-8 wt.% range.
Claim 21 recites “as or in foodstuff” which renders the claim indefinite because the meaning of this phrase is unclear. It’s assumed that the claim is intending to claim “use of a fungal biomass as defined in claim 1, or an edible composition as defined in claim 20, in foodstuff,” and for the purposes of examination, will be interpreted as such.
Claim 21 is a use claim with no active method steps, which renders the claim indefinite as it’s unclear what is needed in order to meet the claim. It cannot be ascertained how the fungal biomass/edible composition is “used” in foodstuff or otherwise or what is required in order to meet this limitation.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 21 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim does not fall within at least one of the four categories of patent eligible subject matter because the claim is a use claim, which is not one of the four categories of patent eligible subject matter.
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 1-5, 8, 9, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Forss et al. (US Patent 3,809,614; listed on IDS dated March 8, 2024), herein after referred to as Forss.
Regarding claims 1-4, Forss teaches a proteinaceous substance manufactured from a species of a mycelium-growing microorganism (i.e., fungal biomass) (col. 1 lines 15-20) comprising a fungi species of Paecilomyces variotii (i.e., a filamentous fungi) (claim 9), wherein the mycelium (i.e., fungal biomass) has a crude protein content of 45-65 wt.% (col. 2 lines 11-15).
The range of protein taught by Forss overlaps with the claimed ranges of at least 61 wt.% of instant claim 1 and 61-70 wt.% of instant claim 2. Where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). See MPEP 2144.05.I.
Regarding claim 5, while the filamentous fungi used in Forss is not identified as the claimed Paecilomyces variotii strain KCL-24, Forss teaches fungi of the same genus and species (claim 9) that performs similar, if not the same, functions as those claimed. It is therefore reasonable to conclude that the prior art fungi and claimed fungi are the same, unless shown otherwise.
Regarding claim 8, Forss does not teach that the fungal biomass comprises solids that are insoluble in a feedstock comprising one or more dissolved carbon sources (claim 1), as defined in the instant specification, and thereby teaches that the fungal biomass is essentially free of these solids.
Regarding claims 9 and 21, Forss teaches that the biomass is suitable for use as foodstuffs (col. 1 lines 15-20), thereby teaching that the fungal biomass is edible.
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Forss et al. (US Patent 3,809,614; listed on IDS dated March 8, 2024) as evidenced by Hooft et al. (“Paecilomyces variotii (PEKILO®) in novel feeds for Atlantic salmon: Effects on pellet quality, growth performance, gut health, and nutrient digestibility and utilization,” Aquaculture, volume 589, August 2024, 740905), herein after referred to as Hooft.
Forss teaches the fungal biomass as set forth above with regard to claim 1.
Regarding claims 6 and 7, Forss teaches that the fungal biomass is made from Paecilomyces variotii (claim 9).
Forss is silent as to the content of water, fiber, β-glucan, ash, and fat in the fungal biomass.
However, as evidenced by Hooft, a mycoprotein (i.e., biomass) made from Paecilomyces variotii contains 92.52 wt.% dry matter, equating to 7.48 wt.% moisture (water), ~27.5 wt.% fiber, 9.23 wt.% ash, 0.75 wt.% lipids (i.e., fat) (Table 1), and 10-15 wt.% β-glucan (p. 2, left column, last three lines). Therefore, it is reasonable to conclude that the fungal biomass of Forss will also be composed of this composition.
The amounts of water, fiber, β-glucan, and ash taught by Forss as evidenced by Hooft lie within the claimed respective ranges of 0.5-10 wt.% (3-8 wt.% for instant claim 7), 10-35 wt.%, 10-25 wt.%, and 1-10 wt.%.
The taught amount of ash, 0.75 wt.%, lies slightly outside of the claimed range of 1-10 wt.%. However, per MPEP 2144.05.I., a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). The difference between the claimed range and that taught by Forss as evidenced by Hooft is virtually negligible absent any showing of unexpected results or criticality. One of ordinary skill in the art would have expected the final composition to have the same properties as a composition with the claimed amounts. Therefore, Forss as evidenced by Hooft renders obvious the instant claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAURA E SWEENEY whose telephone number is (571)272-0244. The examiner can normally be reached M-F 9:00-6:00 EST.
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/M.E.S./Examiner, Art Unit 1791
/Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791