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 .
DETAILED ACTION
Responsive to election of 5/8/2026 and supplemental response entered 6/4/2026
Claims pending 1-19
Claims currently under consideration 1-19
Priority
This application has a filing date of 04/02/2024 and is a 371 of
PCT/FI2022/050664 (aka WO2023057688) filed 10/05/2022.
Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d) to FINLAND document no. 20216030, filed 10/06/2021 Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Election/Restrictions
The restriction mailed 3/17/2026 is hereby withdrawn in view of Applicant’s persuasive arguments.
Claim Rejections - 35 USC § 102/103
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
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.
Claim 14 is rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Chevillotte et al (2008 Journal of Biotechnology 28:134-142 – IDS entry 4/2/2024).
For claim 14-, Chevillotte et al (see entire document) disclose a metabolically engineered Actinomycetes strain.
The product of Chevillotte et al meet all of the structural limitations of the claimed product (see above) except for the product-by-process limitations (i.e., obtainable by the method according to claim 1) and thus would either anticipate or render obvious the claimed composition. See MPEP § 2113, “‘[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.’ In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).” Here, Applicants’ claim is drawn to a Actinomycetes strain (i.e., a product), but are defined by method steps that produce such strain and, as a result, represents a product-by-process claim: the process limitations do not appear to provide any patentable weight to the claimed invention in accordance with MPEP § 2113. One of ordinary skill would expect such cells to be the same no matter how it was generated and/or prepared.
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.
Claims 14 and 1-8,18,19 are rejected under 35 U.S.C. 103 as being unpatentable over Chevillotte et al (2008 Journal of Biotechnology 28:134-142 – IDS entry 4/2/2024) in view of Liu et al (US AppPub 20190119668).
Chevillotte et al is relied upon as above regarding claim 14.
Concerning claims 1-8,14,18,19, Chevillotte et al teach throughout the document and especially the first two pages, last paragraph of the paper and figures 1-2, a method of metabolic engineering in Actinomycetes including steps of: necessarily identifying and selecting a promoter from a target gene or a gene involved in biosynthesis of a target product (e.g. tba encoding the ABC transporter of balhamycin); cloning the promoter (e.g. Ptba) into a reporter construct including as many as three reporters to control expression of a first reporter gene which is an antibiotic resistance gene and a second reporter gene encoding a fluorescent protein; transforming an Actinomycetes strain with the reporter construct; exposing the transformed Actinomycetes strain to conditions that induce random mutations for multiple rounds, thereby producing a mutant library; inherently transferring the mutant library into a liquid culture; necessarily adding an antibiotic corresponding to the antibiotic resistance gene to the liquid culture to induce selective pressure to enrich mutants in which transcriptional activity of the selected promoter has increased, thereby producing an enriched mutant library; and screening the mutant library with fragmented mycelia by fluorescent cell
sorting to obtain a metabolically engineered Actinomycetes strain that provides a fluorescent signal, wherein an extent of the fluorescent signal correlates with an expression level of the target gene and the gene involved in the biosynthesis of the target product. The foregoing reads on claim 1 (in part); and claims 2,3 and 14.
Chevillotte et al do not teach: fragmenting mycelia in a manner by which bacterial cell walls remain intact set forth in claim 1(vii) such as by ultrasonication of claims 4-5, nor kan aminoglycoside acyltransferase of claims 6,7,8 and hyg hygromycin phosphotransferase as markers of claims 18,19.
As in claim 1(vii); 4,5,6,7,8,18 and 19 Liu et al suggest, throughout the document and especially abstract + paragraphs 0083-0163: fragmenting mycelia in a manner by which bacterial cell walls remain intact by ultrasonication and the selsection markers kan and/or hyg.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have employed gentle ultrasonication and kan or hyg as markers suggested by Liu et al for monitoring gene expression in Actinomycetes like Chevillotte et al.
One of ordinary skill in the art would have been motivated to have employed gentle ultrasonication and kan or hyg markers suggested Liu et al for monitoring gene expression in Actinomycetes like Chevillotte et al since Actinomycetes promote plant growth, providing beneficial secondary metabolites that inhibit pathogens in crops: as interpreted in MPEP 2141 section III (C) the Supreme Court held under KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385, 1396 (2007) the use of a known technique (ultrasonication and/or utilizing marker genes common in the art such as kan or hyg.) to improve similar methods or products in the same way is obvious.
One of ordinary skill in the art would have had a reasonable expectation of success in monitoring Actinomycetes gene expression like Chevillotte et al with ultrasonication, substituting or adding kan or hyg markers as suggested by Liu et al, in so far as such techniques and genes are well within reach of the skilled artisan, having been used by bacteriologists for decades.
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.
Claims 15 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because as interpreted in MPEP 2173.05(q), the courts have held one cannot claim a new use (of an old product) per se, because it is not among the categories of patentable inventions specified in 35 U.S.C. § 101 "). In Ex parte Dunki, 153 USPQ 678 (Bd. App. 1967).
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 9-13,16-17 & 15 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 pre-AIA the applicant regards as the invention.
In accordance with MPEP 2173.05(q), attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under the second paragraph of 35 USC112. For example, a claim which read: "[a] process for using monoclonal antibodies of claim 4 to isolate and purify human fibroblast interferon" was held to be indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986).
Likewise here, claim 15’s “use of the method according to claim 1 for producing or increasing yield of an endogenous target protein or secondary metabolite, for replacing medium optimization in the production of a target protein or secondary metabolite, and for activating a silent target gene or a silent biosynthetic gene cluster” does not include any active positive steps, thus the metes and bound of how such elements are practiced is infinite.
Regarding claims 9,12,13,16-17, the term "preferably” renders each claim indefinite because it is unclear whether the limitations following the term constitute the metes and bounds of the claim or not, and thereby represent part of the claimed invention. See MPEP § 2173.05(d).
In accordance with MPEP 2173.02: If the language of the claim is such that a person of ordinary skill in the art could not interpret the metes and bounds of the claim so as to understand how to avoid infringement, a rejection of the claim under 35 U.S.C. 112, second paragraph, would be appropriate. See Morton Int ’l, Inc. v. Cardinal Chem. Co., 5 F.3d 1464, 1470, 28 USPQ2d 1190, 1195 (Fed. Cir. 1993).
In so far as the metes and bounds of the offending claim(s) may not be interpreted properly for the reasons above, all dependent claims therefrom claim 9 are rejected as being indefinite as well.
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 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER M GROSS whose telephone number is (571)272-4446. The examiner can normally be reached M-F 10-6.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Heather Calamita can be reached on (571)272-2876. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTOPHER M GROSS/Primary Examiner, Art Unit 1684
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