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
This Non-Final Office Action is responsive to the communication received 8/25/2022.
Claims 1-14, 17-18, 20 and 22-24 are pending.
Claims 1-14, 17-18, 20 and 22-24 are under examination in this Office Action.
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 1-14, 17-18, 20 and 22-24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to nonstatutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is directed to a judicial exception, an abstract idea, without significantly more. Claims 2-14, 17-18, 20 and 22-24 depend directly or indirectly from claim 1.
The claim 1 limitations directed to mental processes are determining whether the one or more protein of interest exhibits the desired phenotype.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim recites additional elements that consist of well understood, routine, conventional activity already engaged in by the scientific community.
The claim 1 limitations directed to well understood, routine, conventional activity already engaged in by the scientific community are a method for screening using an in vitro transcription/translation (TXTL) system, comprising: (a) providing a library of genetic candidates to be screened, each genetic candidate encoding one or more protein of interest; (b) expressing each genetic candidate in an in vitro transcription/translation (TXTL) system, thereby producing a plurality of compositions each comprising the one or more protein of interest; and (c) subjecting the plurality of compositions to an assay for assessing a desired phenotype. Labaer et al (11/24/2025) US Patent Application Publication 2005/0260653 A1 (hereinafter known as "Labaer") teaches a method for screening using an in vitro transcription/translation (TXTL) system, comprising: (a) providing a library of genetic candidates to be screened, each genetic candidate encoding one or more protein of interest; (b) expressing each genetic candidate in an in vitro transcription/translation (TXTL) system, thereby producing a plurality of compositions each comprising the one or more protein of interest; and (c) subjecting the plurality of compositions to an assay for assessing a desired phenotype (see [0391] to [0794]).
Claim Rejections - 35 USC § 102
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.
Claims 1-14, 17-18, 20 and 22-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Labaer et al (11/24/2025) US Patent Application Publication 2005/0260653 A1 (hereinafter known as "Labaer").
With regards to claims 1-14, 17-18, 20 and 22-24, Labaer teaches:
a) as in claims 1-14, 17-18, 20 and 22-24, a method for screening using an in vitro transcription/translation (TXTL) system, comprising: (a) providing a library of genetic candidates to be screened, each genetic candidate encoding one or more protein of interest; (b) expressing each genetic candidate in an in vitro transcription/translation (TXTL) system, thereby producing a plurality of compositions each comprising the one or more protein of interest; and (c) subjecting the plurality of compositions to an assay for assessing a desired phenotype, thereby determining whether the one or more protein of interest exhibits the desired phenotype; wherein the library comprises at least 2 genetic candidates; wherein the library comprises a genome of an organism of interest; wherein the library comprises a plurality of homologs; wherein the library comprises a plurality of variants; wherein each genetic candidate is a gene; wherein each gene is engineered to be under the control of the same promoter; wherein each genetic candidate comprises a linear DNA; wherein step (b) comprises substantially simultaneously expressing all genetic candidates; wherein step (c) comprises substantially simultaneously subjecting the plurality of compositions to the assay; wherein the assay comprises an organism, wherein the organism is an insect; wherein the desired phenotype comprises death or growth of the organism; wherein the subjecting step comprises feeding or injecting each composition to the organism; wherein the desired phenotype is insecticide; further comprising comparing the plurality of compositions to one another to identify a final composition having a desired characteristic; wherein the desired characteristic is production amount; wherein the genetic candidates are variants having alternate codons encoding the same protein, and wherein the library is used for codon optimization and/or identification of internal translation sites; wherein the genetic candidates are variants encoding the same protein, and wherein the library is used to discover domain-shuffled variants; wherein the genetic candidates are engineered genes having different genetic elements, and wherein the library is used to identify optimal transcription and/or translation regulatory units; further comprising purifying the one or more proteins of interest and subjecting the purified proteins to the assay (see [0391] to [0794]).
Thus, Labaer anticipates the present claims.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Christian Boesen whose telephone number is 571-270-1321. The Examiner can normally be reached on Monday-Friday 9:00 AM to 5:00 PM.
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/CHRISTIAN C BOESEN/Primary Examiner, Art Unit 1684
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