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 Application
Claims 1-23 are pending and under examination
The following Office Action is in response to Applicant's communication dated 01/31/2024.
Claim Objections
Claim 16 objected to because of the following informalities: claim 16 recites “one or more biomolecules of interesting”, which appear to be a typographical or grammatical error.
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 16 is rejected under 35 U.S.C. 101 because the claimed recitation of a use, without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101. See for example Ex parte Dunki, 153 USPQ 678 (Bd.App. 1967) and Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966). See MPEP 2173.05(q).
Claim(s) 23 depend from claim 16 and is/are therefore similarly rejected.
Claim Rejections - 35 USC § 112(b)
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.
Claim(s) 5 and 16-23 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.
Regarding claim 5 it is unclear how plasmid of claim 1 comprises sequences “encoding” all of biomolecules in claim 5, including non-encodable molecules such as “an organic molecule, a small molecule”.
Claim 16 provides for the use of directed evolution of one or more biomolecules, however, since the claim does not set forth any steps involved in the method/process, it is unclear what method/process applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced. See MPEP 2173.05(q).
Regarding claim 17 recites both “lipofecting circular plasmid DNA into mammalian cells and screening lipofected mammalian cells” and “lipofecting circular DNA into mammalian cells and screening lipofected mammalian cells”. It is unclear whether “circular plasmid DNA” is intended to be different from “circular DNA” , whether the claim requires two separate lipofection and screening steps, or whether the second recitation is duplication of the first. The specification repeats both phrases but does not distinguish “circular plasmid DNA” from “circular DNA” or explain whether two separate lipofection/screening steps are required. For purposes of examination, the two recitations are interpreted as one lipofection/screening step. This interpretation is adopted solely for examination and does not resolve the lack of clarity in the claim language.
Claim(s) 17-23 depend from claim 16 and is/are therefore similarly rejected.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-5, 13, 15, 16, and 23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yi et al. (Sci. Adv.7,eabg8712(2021)).
Regarding claims 1 and 16, Yi discloses a method/system for directed evolution of one or more biomolecules of interest, the system comprising: a DNA polymerase fused to a DNA binding protein, wherein the DNA polymerase lacks editing activity; (e.g. fusing an error-prone DNA polymerase to Rep helicase (Rep helicase binds to DNA) [page 1])
a plasmid comprising one or more promoters for transcription and translation in a host cell, and one or more polynucleotide sequences encoding one or more biomolecules of interest to be evolved, (e.g. target plasmid comprises Tac promoter a tetA(C) (encode for tetracycline efflux pump)/KanR/GFP [page 7])
wherein the system evolves the one or more biomolecules of interest by introducing one or more mutations into the one or more polynucleotide sequences encoding the one or more biomolecules of interest. ( Examiner notes that this limitation does not impose a further structural limitation of the claimed system. This language recites the intended use, purpose, or result of the claimed system, e.g. for mutation purposes. Such language must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Furthermore, as per MPEP § 2115, “[i]nclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims.” In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935) (as restated in In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963)), and that the manner or method in which a machine is to be utilized is not germane to the issue of patentability of the machine itself. See also MPEP § 2111.02, citing In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962) (statement of intended use in an apparatus claim did not distinguish over the prior art apparatus), MPEP § 2114 "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990), and MPEP § 2112.01 citing In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) stating that “discovery of an unobvious property and use does not overcome the statutory restraint of section 102 when the claimed composition is known”. Nevertheless, the reference discloses this limitation, e.g. the fusion system copies target plasmid with errors and introduce mutations into plasmid borne genes of interest [Abstract])
Regarding claim 2, Yi discloses the DNA polymerase fused to a DNA binding protein amplifies the plasmid in its entirety. (e.g. targeted artificial DNA replisome (TADR) replicate one strand of an entire plasmid with errors [Abstract]).
Regarding claim 3, Yi discloses the DNA polymerase fused to a DNA binding protein amplifies about 0.1 kilobases of DNA to about 15 kilobases of DNA. (e.g. target plasmid with KanR/Tet(R) sequence is 4.3/4.8 kilobases respectively [supporting information pages 25-26])
Regarding claims 4 and 5, Yi discloses the plasmid comprises two biomolecules of interest to be evolved. (e.g. the target plasmid comprising multiple gene of interest, including kanR* gene together with the gene for green fluorescent protein. Both gene are expressed using TAC promoter. Reference further discloses TADR introduces high mutation rate throughout the plasmid demonstrates the ability to mutagenize multiple genes simultaneously.[pages 5 and 7])
Regarding claims 13 and 15, Yi discloses the plasmid comprises a bacterial expression plasmid (e.g. pACYC184 plasmid is expressed in E. coli [page 7])
Regarding claim 23, Yi discloses method does not comprise use of a virus or a viral vector. (Yi’s target plasmid is pACYC184 plasmid, a bacterial plasmid [page 7])
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.
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.
Yi et al. and Brummelkamp et al.
Claim(s) 6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yi et al. (Sci. Adv.7,eabg8712(2021), published July 2021) in view of Brummelkamp et al. (Science296,550-553(2002))
Regarding claim 6-8, Yi does not disclose the biomolecule of interest comprises guide RNA, which is able to knocks down gene expression.
Brummelkamp discloses vector system, pSUPER, for directs the synthesis of small interfering RNAs (siRNAs). pSUPER enable stable expression of siRNAs and specific down-regulation of gene expression, resulting in functional inactivation of the targeted genes [abstract].
As of the application’ s effective filing date, it would have been prima facie obvious to a person of ordinary skill in the art to apply Yi’s plasmid targeted mutagenesis/evolution system to plasmid encoded siRNA because Brummelkamp teaches that vector expressed siRNAs are functional RNA for target specific gene suppression and can be generated in large collections to carry out high-throughput genetic screens [page 552]. A skilled artisan would have been motivated to diversify plasmids encode siRNA sequences using Yi’s plasmid mutagenesis system to generate and screen variants having improved gene knockdown activity, with a reasonable expectation of success since Yi teaches that TADR is modular and transferable into other cell types and even cell-free systems because it does not depend on specific processes within the E. coli cell. And TADR’s low fidelity within the plasmid does not prevent evolution and supports mutagenesis of multiple pathways [page 6S]. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 — 97 (2007) (MPEP § 2143).
Yi et al. and McCafferty et al.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yi et al. (Sci. Adv.7,eabg8712(2021), published July 2021) in view of McCafferty et al. (Nature 348, 552–554 (1990))
Regarding claim 9, Yi does not disclose the biomolecule of interest comprises a full-length antibody, an antigen binding fragment of a full-length antibody, a Fab fragment, a single chain antibody (scFv), a diabody, a triabody, a minibody, a nanobody, a single-domain antibody, camelids, or any combination thereof.
McCafferty discloses screening plasmid libraries encoding single-chain Fv fragment (scFv) for improved binding. [page 552].
As of the application’ s effective filing date, it would have been prima facie obvious to a person of ordinary skill in the art to apply Yi’s plasmid targeted mutagenesis/evolution system to plasmid encoded siRNA because Yi’s plasmid mutagenesis system enables one of ordinary skill in the art to diversify phage display or phage-assist continuous evolution . A skilled artisan would have been motivated to diversify plasmids encode siRNA sequences using Yi’s plasmid mutagenesis system to generate and screen variants having improved binding affinity, with a reasonable expectation of success since Yi teaches that TADR is modular and transferable into other cell types and even cell-free systems because it does not depend on specific processes within the E. coli cell. And TADR’s low fidelity within the plasmid does not prevent evolution and supports mutagenesis of multiple pathways [page 6S]. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 — 97 (2007) (MPEP § 2143)
Yi et al. and Bryson et al.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yi et al. (Sci. Adv.7,eabg8712(2021), published July 2021) in view of Bryson et al. (Nat Chem Biol 13, 1253–1260 (2017))
Regarding claim 10, Yi does not disclose the biomolecule of interest comprises an enzyme that can perform novel protein, RNA, and/or DNA modifications, or can perform a combination of novel protein, RNA, and/or DNA modifications.
Bryson discloses screening aminoacyl-tRNA synthetases libraries to enables site-specific installation of noncanonical amino acids (ncAAs) into proteins. The evolution comprises generating randomized mutation at multiple positions [abstract and page 1253].
As of the application’ s effective filing date, it would have been prima facie obvious to a person of ordinary skill in the art to apply Yi’s plasmid targeted mutagenesis/evolution system to plasmid encoded aminoacyl-tRNA synthetases because Yi’s plasmid mutagenesis system enables one of ordinary skill in the art to diversify aminoacyl-tRNA synthetases screening library for evolution . A skilled artisan would have had a reasonable expectation of success since Yi teaches that TADR is modular and transferable into other cell types and even cell-free systems because it does not depend on specific processes within the E. coli cell. And TADR’s low fidelity within the plasmid does not prevent evolution and supports mutagenesis of multiple pathways [page 6]. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 — 97 (2007) (MPEP § 2143).
Yi et al. and Tournier et al.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yi et al. (Sci. Adv.7,eabg8712(2021), published July 2021) in view of Tournier et al.(Nature 580, 216–219 (2020))
Regarding claim 11, Yi does not disclose the biomolecule of interest comprises an enzyme for degrading plastic or waste products, thereby forming useful molecules, or an enzyme for degrading carbon dioxide or other gases to create synthetically useful molecules and reduce greenhouse gases.
Tournier discloses screening PET hydrolase libraries to enables PET depolymerization into monomers, with a productivity of 16.7 grams of terephthalate per litre per hour, which outperforms all PET hydrolases reported so far.[abstract]
As of the application’ s effective filing date, it would have been prima facie obvious to a person of ordinary skill in the art to apply Yi’s plasmid targeted mutagenesis/evolution system to plasmid encoded aminoacyl-tRNA synthetases because Yi’s plasmid mutagenesis system enables one of ordinary skill in the art to further diversify PET hydrolase screening library for activity enhancement. A skilled artisan would have had a reasonable expectation of success since Yi teaches that TADR is modular and transferable into other cell types and even cell-free systems because it does not depend on specific processes within the E. coli cell. And TADR’s low fidelity within the plasmid does not prevent evolution and supports mutagenesis of multiple pathways [page 6]. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 — 97 (2007) (MPEP § 2143).
Yi et al. and Castle et al.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yi et al. (Sci. Adv.7,eabg8712(2021), published July 2021) in view of Castle et al. (Science304,1151-1154(2004))
Regarding claim 12, Yi does not disclose the biomolecule of interest improves disease resistance, increases and/or enhances immunity to pests and/or pathogens, improves yield, increases and/or enhances tolerance to abiotic stress, increases and/or enhances tolerance to drought, increases and/or enhances resistance to one or more herbicides, increases and/or enhances photosynthesis or the rate of photosynthesis, improves biomass, increases and/or enhances nutritional content, improves tolerance to temperature, ultraviolet radiation, and/or other abiotic factors, or any combination thereof, in a crop of interest or a crop having commercial, economic, and/or social value.
Castle discloses screening glyphosate N-acetyltransferase (GAT) libraries to increase glyphosate tolerance to Escherichia coli, Arabidopsis, tobacco, and maize. The evolution comprises generating randomized mutation at multiple positions [abstract and page 1153].
As of the application’ s effective filing date, it would have been prima facie obvious to a person of ordinary skill in the art to apply Yi’s plasmid targeted mutagenesis/evolution system to plasmid encoded glyphosate N-acetyltransferase because Yi’s plasmid mutagenesis system enables one of ordinary skill in the art to diversify glyphosate N-acetyltransferase screening library for evolution . A skilled artisan would have had a reasonable expectation of success since Yi teaches that TADR is modular and transferable into other cell types and even cell-free systems because it does not depend on specific processes within the E. coli cell. And TADR’s low fidelity within the plasmid does not prevent evolution and supports mutagenesis of multiple pathways [page 6]. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 — 97 (2007) (MPEP § 2143).
Yi et al.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yi et al. (Sci. Adv.7,eabg8712(2021), published July 2021)
Regarding claim 14, Examiner notes that this limitation does not impose a further structural limitation of the claimed system. Rather, this language recites a performance characteristic/ result of using the system under particular mutagenesis conditions. Such language must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Furthermore, as per MPEP § 2115, “[i]nclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims.” In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935) (as restated in In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963)), and that the manner or method in which a machine is to be utilized is not germane to the issue of patentability of the machine itself. See also MPEP § 2111.02, citing In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962) (statement of intended use in an apparatus claim did not distinguish over the prior art apparatus), MPEP § 2114 "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990), and MPEP § 2112.01 citing In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) stating that “discovery of an unobvious property and use does not overcome the statutory restraint of section 102 when the claimed composition is known”.
Nevertheless, the reference reports 264 mutations across three samples of an entire plasmid. Given the plasmid is ~4.5 kilobases, this mutation rate corresponds to 1 mutation per 51 bp [page 8 and supporting information pages 25-26]. Yi further teaches that mutation rate is tunable by changing expression of fusion protein and repressing TADR activity with glucose [page 5]. As of the application’ s effective filing date, it would have been prima facie obvious to a person of ordinary skill in the art to adjust such known result effective variables, including expression level, induction conditions, time/generation of mutagenesis to obtain desired mutation frequency within the claimed range. See MPEP § 2144.05 (II) "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Yi et al., Tu et al., Ho et al., and Maurisse et al.
Claim(s) 17, 18, and 20-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yi et al. (Sci. Adv.7,eabg8712(2021), published July 2021) in view of Tu et al. (Sci Rep 6, 24648 (2016)), Ho et al. (Biotechnol. 2010;10:9), and Maurisse et al. (Biotechnol. 2010;10:9)
Regarding claim 17, Yi discloses preparing a DNA library by performing error prone PCR mutagenesis (e.g. targeted artificial DNA replisome (TADR) using a three-protein complex of a viral nickase, bacterial Rep helicase, and an error-prone DNA polymerase to copy one strand of a target plasmid with errors. [Page 1]). Yi also teaches screening bacteria by plating on kanamycin or tigecycline, grow selected colonies in liquid culture, and purifies selected plasmid using QIAprep Spin Miniprep Kit (Qiagen). Although Yi discloses TADR is modular and transferable into other cell types (e.g. mammalians) and even cell-free systems because it does not depend on specific processes within the E. coli cell [page 6], Y does not disclose the detailed mammalian-cell expression, sorting, plasmid recovery, and rescreening steps recited in claim 17. Yi also does not disclose circularizing plasmid DNA by electroporating linear plasmid DNA in bacteria.
Tu discloses bacterial competent cells are routinely used for cloning, construction of DNA libraries, mutagenesis in every molecular biology laboratory, and electroporation is found to own the best transformation efficiency [abstract]. Tu further discloses a linear backbone and PCR products can be co-electroporated into E. coli GB2005 expressing the recET recombinase to generate the recombinant plasmids, followed by selection on antibiotic plates and plasmid DNA preparation from picked clones [Methods section].
Ho teaches a mammalian cell display workflow for antibody engineering. The mammalian cells are grown, transfected with plasmid DNA encoding antibody variants, screened/cell sorted for desired display, selected variants are recovered and identified by DNA sequencing [Abstract and Methods]. Ho further teaches Lipofectamin mediated transfection of mammalian cells, thus teaching lipofecting circular DNA into mammalian cells and screening lipofected mammalian cells. To the extend Ho uses lipofection rather than electroporation for the initial DNA transfecting steps, Maurisse discloses electroporation/nucleofection and lipofectamine of HEK 293 were known alternative transfection techniques and essentially equivalent in terms of toxicity and efficiency [abstract]. Thus, it would be obvious to one of ordinary skill in the art to use electroporation or lipofection since this is a simple substitution of equally effective methods to transfect DNA into mammalian cells. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 — 97 (2007) (MPEP § 2143, B).
As of the application’ s effective filing date, it would have been prima facie obvious to a person of ordinary skill in the art to combine references to generate a diverse error-prone plasmid library, recover PCR-generated linear products as circular plasmid in bacteria, and introduce variant plasmid into mammalian cells for display screening, sorting, recovery, re-screening, and sequencing of improved variants. Yi provides TADR platform as a tool to generate error-prone mutants and motivation to extend its TADR platform to cell free environment (e.g. PCR). Although Yi’s system was done in vitro generating circular plasmids, a POSITA applying Yi’s mutagenesis concept in PCR environment would have understood that the whole plasmid PCR produces linear constructs and must be cyclized before propagation and expression. Tu discloses a known in the art method for acquiring circularized plasmid for propagation and expression.
A skilled artisan would have also been motivated to apply the resulting plasmid library to Ho’s mammalian cell display workflow because the references address complementary parts of a predictable direct evolution workflow progress: generating diverse biomolecule variants and screening those variants in a biologically relevant cellular environment. Ho teaches that mammalian cells can be used to display single chain antibody fragments (scFvs) for affinity maturation. Ho further teaches mammalian cell display promote very high levels of antibody expression, especially human antibodies that contain the required posttranslational modifications, and mammalian cell display can express the recombinant antibody fragments that cannot be expressed in E. coli [pages 1 and 2]. Thus, a POSITA would have been motivated to broaden antibody variant library using Yi’s error prone mutagenesis and apply Ho’s mammalian cell display workflow to identify variants having improved affinity, expression, display, or mammalian cell function. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 — 97 (2007) (MPEP § 2143).
Regarding claim 18, Yi discloses repeating the error prone PCR mutagenesis one or more times. (e.g. two rounds of experimental evolution [page 5 and 8].
Regarding claims 20 and 21, the claims re cites “ the method uses less than 5 hours of hands-on experiment time.” And “The method eliminates about 70% of hands-on experiment time when compared to a traditional method of directed evolution.” These limitations do not add further method steps, but recite a result, advantage, or performance characteristics of the method. Even if given patentable weight, under BRI, reducing hands on time would have been an obvious optimization of known laboratory variables such as: batching, available automation instruments, sample number, incubation timing, concentrations, choice of known transfection/recovery/screening method procedures, and even the operator skill level. Since the claimed steps are disclosed by prior art, optimizing the amount of “hands-on” time to a workable desired value would have been routine optimization. See MPEP § 2144.05 (II) "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); and KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 — 97 (2007) (MPEP § 2143).
Regarding claim 22, Ho discloses method does not comprise use of a virus or a viral vector. (e.g. screening plasmid is pDisplay-derived plasmids, a mammalian expression plasmid vector, not a viral vector [page 2])
Yi et al., Tu et al., Ho et al., Maurisse et al., and Yuan et al.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yi et al. (Sci. Adv.7,eabg8712(2021), published July 2021) in view of Tu et al. (Sci Rep 6, 24648 (2016)), Ho et al. (Biotechnol. 2010;10:9), Maurisse et al. (Biotechnol. 2010;10:9), and Yuan et al. (Biomed Pharmacol J 2018;11(2), disclosed in IDS)
Regarding claim 19, Ho teaches mammalian cells are HEK293T cells [abstract] instead of the claimed HEK293A. However, HEK293A is also a known HEK293 derived cell line, especially for their more flat and better adhesion characteristic compare to HEK293T variant, disclosed by Yuan [pages 2-4]. A POSITA would have found it obvious to use HEK293A cells instead of HEK293T where mammalian screening workflow requires stronger cell attachment during imaging, screening, and handling.
Conclusion
No claims are allowed
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Khai Quynh Tien Pham whose telephone number is (571)272-6998. The examiner can normally be reached M-T, 9-4 ET.
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/KHAI QUYNH TIEN PHAM/Examiner, Art Unit 1684
/JEREMY C FLINDERS/Primary Examiner, Art Unit 1684
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