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
Claims 1-18, 21-22 are pending.
claim 18 is withdrawn. Claims 1-17 and 21-22 are for examination.
Applicants’ argument submitted on 12/07/2018 is considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.
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.
Claim(s) 1-15, 21-22 is/are rejected under 35 U.S.C. 102)(a) (1) as being anticipated by Billerbeck et a. ( Nature Comm., 2018, 9, pp 1-12, ids).
Regarding Claim 1, Billerbeck discloses a genetically-engineered cell (Functionality of peptide-GPCR pairs was assessed in a standardized workflow, in which codon-optimized GPCR genes were expressed in S. cerevisiae, Pg. 3, left column, first paragraph) expressing: (a) at least one heterologous G-protein coupled receptor (GPCR), wherein the amino acid sequence of the heterologous GPCR is at least about 95% homologous to an amino acid sequence comprising any one of SEQ IDNOs: 117-161 or an amino acid sequence provided In Table 11 and/or is encoded by a nucleotide sequence that is at least about 95% homologous to a nucleotide sequence comprising any one of SEQ ID NOs: 168-211 (Amino acid sequences of all GPCRs are listed in Supplementary Table 8, Pg. 9, left column, first full paragraph; Supplementary Table 8 discloses Code Sc; The amino acid sequence of code Sc of Supplementary Table 8 comprises 100% sequence identity to instant SEQ ID NO: 117); and/or (b) at least one heterologous secretable GPCR peptide ligand, wherein the amino acid sequence of the heterologous GPCR peptide ligand is at least about 95% homologous to an amino acid sequence comprising any one of SEQ ID NOs: 1-116 or an amino acid sequence provided In Table 12 and/or encoded by a nucleotide sequence that Is about 95% homologous to a nucleotide sequence comprising any one of SEQ ID NOs: 215-230 (The amino acid sequences of 15 peptides were cloned into a peptide secretion vector, designed based on the alpha-factor pre-pro-peptide architecture (Supplementary Figure 13, Supplementary Table 6), Pg. 5, left column, final paragraph; Code Sc of Supplementary Table 6 of Billerbeck comprises a DNA sequence 100% identical to instant SEQ ID NO: 226). Regarding Claim 2, Billerbeck discloses the genetically-engineered cell of claim 1, wherein the heterologous GPCR is selectively activated by a ligand (Next, we couple GPCR activation to peptide secretion to validate their functionality as orthogonal communication interfaces. Those interfaces are then used to assemble scalable communication topologies and eventually to establish peptide signal-based interdependence as a strategy to assemble multi-member microbial communities. Our language acquisition pipeline shows a hit rate of 71%. Out of 45 tested GPCRs, 32 are functionally expressed and activated by a peptide ligand that was correctly inferred from its genomic locus architecture, Pg. 2, right column, final full paragraph). Regarding Claim 3, Billerbeck discloses the genetically-engineered cell of claim 2, wherein the ligand Is selected from the group consisting of peptide, a protein or portion thereof, a toxin, a small molecule, a nucleotide, a lipid, a chemical, a photon, an electrical signal and a compound (Next, we couple GPCR activation to peptide secretion to validate their functionality as orthogonal communication interfaces. Those interfaces are then used to assemble scalable communication topologies and eventually to establish peptide signal-based interdependence as a strategy to assemble multi-member microbial communities. Our language acquisition pipeline shows a hit rate of 95%. Out of 45 tested GPCRs, 32 are functionally expressed and activated by a peptide ligand that was correctly inferred from its genomic locus architecture, Pg. 2, right column, final full paragraph).
Regarding Claim 4, Billerbeck discloses the genetically-engineered cell of claim 2, wherein the ligand comprises an amino acid sequence that is at least about 95% homologous to an amino acid sequence of any one of SEQ ID NOs: 1-116 or an amino acid sequence provided in Table 12 and/or encoded by a nucleotide sequence that is about 95% homologous to a nucleotide sequence comprising any one of SEQ ID NOs: 215-230 (The amino acid sequences of 15 peptides were cloned into a peptide secretion vector, designed based on the alpha-factor pre-pro-peptide architecture (Supplementary Figure 13, Supplementary Table 6), Pg. 5, left column, final paragraph; Code Sc of Supplementary Table 6 of Billerbeck comprises a DNA sequence 100% Identical to instant SEQ 1D NO: 226).
‘Regarding Claim 5, Billerbeck discloses the genetically-engineered cell of claim 1, wherein the genetically-engineered cell is selected from the group consisting of a mammalian cell, a plant cell and a fungal cell (Functionality of peptide-GPCR pairs was assessed in a standardized workflow, in which codon-optimized GPCR genes were expressed in S. cerevisiae, Pg. 3, left column, first paragraph).
Regarding Claim 6, Billerbeck discloses the genetically-engineered cell of claim 1, discloses an intercellular signaling system comprising two, three or more, four or more or five or more genetically-engineered cells.
Regarding Claim 7, Billerbeck discloses an intercellular signaling system (Here, we present a modular, scalable, intercellular signaling language in yeast based on fungal mating peptide/G-protein-coupled receptor (GPCR) pairs harnessed from nature, Abstract) comprising: (a) a first genetically-engineered cell expressing at least one secretable G-protein coupled receptor (GPCR) ligand (We examined peptide secretion in liquid culture by co-culturing a secreting... strain, Pg. 9, right column, final paragraph; yNA899 was transformed with the appropriate peptide secretion plasmids and used as secreting strains, Pg. 9, right column, third full paragraph); and (b) a second genetically-engineered cell expressing at least one heterologous GPCR (We examined peptide secretion in liquid culture by co-culturing... a sensing strain, Pg. 9, right column, final paragraph; JTy014 was transformed with the appropriate GPCR expression plasmid, and resulting strains were used as sensing strains, Pg. 9, right column, third full paragraph), wherein (i) the amino acid sequence of the heterologous GPCR Is at least about 95% homologous to an amino acid sequence comprising any one of SEQ ID NOs: 117- 161 or an amino acid sequence provided in Table 11 and/or is encoded by a nucleotide sequence that is at least about 95% homologous to a nucleotide sequence comprising any one of SEQ ID NOs: 168-211 (Amino acid sequences of all GPCRs are listed in Supplementary Table 8, Pg. 9, left column, first full paragraph; Supplementary Table 8 discloses Code Sc; The amino acid sequence of code Sc of Supplementary Table 8 comprises 100% sequence identity to instant SEQ ID NO: 117) and/or (ii) the amino acid sequence of the secretable GPCR ligand is at least about 95% homologous to an amino acid sequence comprising any one of SEQ ID NOs: 1-116 or an amino acid sequence provided in Table 12 and/or is encoded by a nucleotide sequence that is about 95% homologous to a nucleotide sequence comprising any one of SEQ ID NOs: 215-230 (The amino acid sequences of 15 peptides were cloned into a peptide secretion vector, designed based on the alpha-factor pre-pro-peptide architecture (Supplementary Figure 13, Supplementary Table 6), Pg. 5, left column, final paragraph; Code Sc of Supplementary Table 6 of Billerbeck comprises a DNA sequence 100% Identical to instant SEQ ID:226.
Regarding Claim 8, Billerbeck discloses the intercellular signaling system of claim 7, wherein the secretable GPCR ligand and/or the heterologous GPCR Is identified and/or derived from a eukaryotic organism (Importantly, our set includes peptide-GPCR pairs derived from a wide range of species from the whole Ascomycete phylum, Pg. 2, right column, final full paragraph).
Regarding Claim 9, Billerbeck discloses the intercellular signaling system of claim 7, wherein (i) the secretable GPCR ligand of the first genetically-engineered cell selectively activates the heterologous GPCR of the second genetically-engineered cell and/or (ii) the secretable GPCR ligand of the first genetically-engineered cell does not activate the heterologous GPCR of the second genetically-engineered cell (Next, we couple GPCR activation to peptide secretion to validate their functionality as orthogonal communication interfaces. Those interfaces are then used to assemble scalable communication topologies and eventually to establish peptide signal-based interdependence as a strategy to assemble multi-member microbial communities. Our language acquisition pipeline shows a hit rate of 71%: Out of 45 tested GPCRs, 32 are functionally expressed and activated by a peptide ligand that was correctly inferred from its genomic locus architecture, Pg. 2, right column, final full paragraph). Regarding Claim 10, Billerbeck discloses the intercellular signaling system of claim 7, wherein the second genetically-engineered cell further expresses at least one secretable GPCR ligand and/or the first genetically-engineered cell further expresses at least one heterologous GPCR (We combined the two-cell links into rings of increasing size, from two to six members (Fig. 3c, topologies 1-6). Information flow was started by cell c1 constitutively secreting the peptide sensed by cell c2 through GPCR g2. Peptide sensing in cell c2 was coupled to secretion of peptide p3 sensed by cell c3 through GPCR g3, Pg. 5, right column, final partial paragraph; Fig. 3c discloses ells comprising both a GPCR and a GPCR ligand).
Regarding Claim 9, Billerbeck discloses the genetically-engineered cell of claim 7, further discloses an intercellular signaling system comprising two, three or more, four or more or five or more genetically-engineered cells (Here, we present a modular, scalable, intercellular signaling language in yeast based on fungal mating peptide/G-protein-coupled receptor (GPCR) pairs harnessed from nature, Abstract; Experiments were performed by combinatorial co-culturing of strains constitutively secreting one of the indicated peptides and strains expressing one of the indicated GPCRs using GPCR-controlled fluorescent as read-out, Pg. 4, Fig. 2).
Regarding Claim 10, Billerbeck discloses the intercellular signaling system of claim 7, wherein the heterologous GPCR is activated by an exogenous ligand (Next, we couple GPCR activation to peptide secretion to validate their functionality as orthogonal communication interfaces. Those interfaces are then used to assemble scalable communication topologies and eventually to establish peptide signal-based interdependence as a strategy to assemble multi-member microbial communities. Our language acquisition pipeline shows a hit rate of 71%. Out of 45 tested GPCRs, 32 are functionally expressed and activated by a peptide ligand that was correctly inferred from its genomic locus architecture, Pg. 2, right column, final full paragraph).
Regarding Claim 11, Billerbeck discloses the intercellular signaling system of claim 10, wherein: (a) the secretable GPCR ligand expressed by the second genetically-engineered cell is different from the secretable GPCR ligand expressed by the first genetically-engineered cell, e.g., selectively activate different GPCRs; (b) the secretable GPCR ligand expressed by the second genetically-engineered cell does not activate the heterologous GPCR expressed by the second genetically-engineered cell; (c) the heterologous GPCR expressed by the first genetically-engineered cell is different from the heterologous GPCR expressed by the second genetically-engineered cell, e.g., are selectively activated by different ligands; (d) the secretable GPCR ligand expressed by the first genetically-engineered cell does not activate the heterologous GPCR expressed by the first genetically-engineered cell; (e) the secretable GPCR ligand of the first genetically-engineered cell selectively activates the heterologous GPCR of the second genetically-engineered cell; (f) the secretable GPCR ligand of the first genetically-engineered cell does not activate the heterologous GPCR of the second genetically-engineered cell; (g) the secretable GPCR ligand expressed by the second genetically-engineered cell selectively activates the heterologous GPCR expressed by the first genetically-engineered cell; (h) the secretable GPCR ligand expressed by the second genetically-engineered cell does not activate the heterologous GPCR expressed by the first genetically-engineered cell; and/or (i) the secretable GPCR ligand expressed by the second genetically-engineered cell and/or the first genetically-engineered cell selectively activates a GPCR expressed by a third cell (First, we combined the established two-cell communication links into a scalable paracrine ring topology.... We combined the two-call links Into rings of increasing size, from two to six members (Fig. 3c, topologies 1-6). Information flow was started by cell c1 constitutively secreting the peptide sensed by cell c2 through GPCR g2. Peptide sensing In cell c2 was coupled to secretion of peptide p3 sensed by cell c3 through GPCR g3, Pg. 5, right column, final partial paragraph; Fig. 3 c discloses a second secretable GPCR ligand expressed by a second genetically-engineered cell activates a GPCR expressed by a third cell).
Regarding Claim 12, Billerbeck discloses the intercellular signaling system of claim 7, wherein: (a) one or more endogenous GPCR genes of the first genetically-engineered cell and/or the second genetically-engineered cell are knocked out; (b) one or more endogenous GPCR ligand genes of the first genetically-engineered cell and/or the second genetically-engineered cell are knocked out; (c) the first genetically-engineered cell and/or the second genetically-engineered cell further comprises a nucleic acid that encodes a product of interest; (d) the first genetically-engineered cell and/or the second genetically-engineered cell further comprises a nucleic acid that encodes a sensor; and/or (e) the first genetically-engineered cell and/or the second genetically-engineered cell further comprises a nucleic acid that encodes a detectable reporter (We engineered a read-out strain for our fluorescence assay by deleting both endogenous mating GPCR genes (STE2 and STE3), Pg. 3, left column, first paragraph).
Regarding Claims 13, Billerbeck discloses the intercellular signaling system of claims 18, wherein the product of interest is selected from the group consisting of hormones, toxins, receptors, fusion proteins, regulatory factors, growth factors, complement system factors, enzymes, clotting factors, anti-clotting factors, kinases, cytokines, CD proteins, interleukins, therapeutic proteins, diagnostic proteins, biosynthetic pathways, antibodies and combinations thereof (For example, we envision engineering sense-response consortia composed of yeast that sense a trigger, e.g., a pathogen, and yeast that respond, e.g., by killing the pathogen through secretion of an antimicrobial, Pg. 5, right column, third paragraph).
Regarding Claim 14, Billerbeck discloses the intercellular signaling system of claim 8, further comprising: (a) a third genetically-engineered cell; (b) a third genetically-engineered call and a fourth genetically-engineered cell; (c) a third genetically-engineered, a fourth genetically-engineered cell and a fifth genetically-engineered cell; (d) a third genetically-engineered, a fourth genetically-engineered cell, a fifth genetically-engineered cell and a sixth genetically-engineered cell; (e) a third genetically-engineered, a fourth genetically-engineered cell, a fifth genetically-engineered cell, a sixth genetically-engineered cell and a seventh genetically-engineered cell; or (f) a third genetically-engineered, a fourth genetically-engineered cell, a fifth genetically-engineered cell, a sixth genetically-engineered cell, a seventh genetically-engineered cell and an eighth genetically-engineered cell or more, wherein each genetically-engineered cell expresses at least one heterologous GPCR and/or at least one secretable GPCR ligand, wherein (i) each of the heterologous GPCRs are different, e.g., are selectively activated by different ligands, and/or each of the secretable GPCR ligands are different, e.g., selectively activate different GPCRs and/or (ii) one or more heterologous GPCRs are the same and/or one or more of the secretable GPCR ligands are the same (Fig. 3 Synthetic microbial communication: Two-cell communication links yield various communication topologies... c Overview of the implemented communication topologies. Gray nodes: cells are able to process one input (expressing one GPCR) giving one output (secreting one peptide). Blue nodes: cells are able to process two inputs (OR gates, expressing two GPCRs) giving one output (secreting one peptide). Orange nodes: cells constitutively secrete the peptide for the next clockwise neighbor, and report on ring closure via a fluorescent read-out upon receiving a peptide signal from the counter-clockwise neighbor. Red nodes: cells are able to receive a signal and respond via a fluorescent read-out, Pg. 6, Fig. 3; Fig. 3 c discloses at least 3 genetically-engineered cells that are single-input/single-output, double-Input/single-output, and single-input/read-out).
Regarding Claim 15, Billerbeck discloses the intercellular signaling system of claim 14, wherein the intercellular signaling system comprises a topology selected from the group consisting of a daisy chain network topology, a bus type network topology, a branched type network topology, a ring network topology, a mesh network topology, a hybrid network topology, a star type network topology and a combination thereof (Fig. 3 Synthetic microbial communication: Two-cell communication links yield various communication topologies.... ¢ Overview of the implemented communication topologies. Gray nodes: cells are able to process one input (expressing one GPCR) giving one output (secreting one peptide). Blue nodes: calls are able to process two inputs (OR gates, expressing two GPCRs) giving one output (secreting one peptide). Orange nodes: calls constitutively secrete the peptide for the next clockwise neighbor, and report on ring closure via a fluorescent read-out upon receiving a peptide signal from the counter-clockwise neighbor. Red nodes: cells are able to receive a signal and respond via a fluorescent read-out, Pg. 6, Fig. 3; Fig. 3 c discloses a bus and tree topology).
Regarding Claim 21, Billerbeck discloses the intercellular signaling system of comprising (a) the first secretable GPCR ligand of the first genetically-engineered cell selectively activates the second heterologous GPCR of the second genetically-engineered cell; (b) the second secretable GPCR ligand of the second genetically-engineered cell selectively activates the first heterologous GPCR of the first genetically-engineered cell; (c) the second secretable GPCR ligand of the second genetically-engineered cell selectively does not activate the first heterologous GPCR of the first genetically engineered cell; and/or (d) the first heterologous GPCR and the second heterologous GPCR are selectively activated by different ligands (In total, 14 out of 30 GPCRs were exquisitely orthogonal and only activated by their cognate peptide ligand, Pg. 5, left column, first partial paragraph). Billerbeck disclose said an intercellular signaling system (Here, we present a modular, scalable, intercellular signaling language in yeast based on fungal mating peptide/G-protein-coupled receptor (GPCR) pairs harnessed from nature, Abstract) comprising: (a) a first genetically-engineered cell comprising: (i) a nucleic acid encoding a first heterologous G-protein coupled receptor (GPCR); and/or (ii) a nucleic acid encoding a first secretable GPCR ligand (We examined peptide secretion in liquid culture by co-culturing a secreting... strain, Pg. 9, right column, final paragraph; yNA899 was transformed with the appropriate peptide secretion plasmids and used as secreting strains, Pg. 9, right column, third full paragraph; The actual sequences for the peptide ligands were inserted via a unique restriction site after the pre- and pro-sequences, thus the peptide DNA sequence could be swapped by Gibson assembly... using peptide-encoding oligos codon-optimized for expression in yeast, Pg. 9, left column, second full paragraph); and (b) a second genetically-engineered cell comprising: (i) a nucleic acid encoding a second heterologous GPCR; and/or (ii) a nucleic acid encoding a second secretable GPCR ligand (We examined peptide secretion in liquid culture by co-culturing... a sensing strain, Pg. 9, right column, final paragraph; JTy014 was transformed with the appropriate GPCR expression plasmid, and resulting strains were used as sensing strains, Pg. 9, right column, third full paragraph; Most GPCRs were codon-optimized for S. cerevisiae, DNA sequences were ordered as gBlocks, amplified with primers giving suitable homology overhangs, and Inserted into the linearized acceptor vector by Gibson assembly, Pg. 9, left column, first full paragraph), wherein (i) the first GPCR and/or the second GPCR is at least about 95% homologous to an amino acid sequence comprising any one of SEQ ID NOs: 117-161 or an amino acid sequence provided in Table 11 and/or is encoded by a nucleotide sequence that is at least about 95% homologous to a nucleotide sequence comprising any one of SEQ ID NOs: 168-211 (Amino acid sequences of all GPCRs are listed in Supplementary Table 8, Pg. 9, left column, first full paragraph; Supplementary Table 8 discloses Code Sc; The amino acid sequence of code Sc of Supplementary Table 8 comprises 100% sequence identity to instant SEQ ID NO: 117); and/or (ii) the first and/or second secretable GPCR peptide ligand is at least about 95% homologous to an amino acid sequence comprising any one of SEQ ID NOs: 1-116 or an amino acid sequence provided in Table 12 and/or is encoded by a nucleotide sequence that is about 95% homologous to a nucleotide sequence comprising any one of SEQ ID NOs: 215-230 (The amino acid sequences of 15 peptides were cloned into a peptide secretion vector, designed based on the alpha-factor pre-pro-peptide architecture (Supplementary Figure 13, Supplementary Table 6), Pg. 5, left column, final paragraph; Code Sc of Supplementary Table 6 of Billerbeck comprises a DNA sequence 100% identical to Instant SEQ ID NO: 226).
Regarding Claim 22, Billerbeck discloses the intercellular signaling system of claim 21, further comprising a third genetically-engineered call comprising a nucleic acid encoding a third heterologous GPCR and/or a nucleic acid encoding a third secretable GPCR ligand (We combined the two-cell links into rings of increasing size, from two to six members (Fig. 3c, topologies 1-6). Information flow was started by cell c1 constitutively secreting the peptide sensed by cell c2 through GPCR g2. Peptide sensing in cell c2 was coupled to secretion of peptide p3 sensed by cell c3 through GPCR g3, Pg. 5, right column, final partial paragraph; Fig. 3c discloses at least three cells expressing distinct GPCR ligands).
Claim(s) 16-18 is/are rejected under 35 U.S.C. 102)(a) (1) as being anticipated by The Trustees of Columbia University in the City of New York (hereinafter Columbia University) US 2017/0336407,23/11/2017 IDS).
Regarding claims 16-18, Columbia University discloses a kit (Furthermore, the present invention provides a kit for detecting the presence of an agent of interest, Para. [0022]) comprising: (a) a genetically modified cell comprising at least one heterologous G-protein coupled receptor (GPCR) and/or at least one heterologous secretable GPCR peptide ligand, wherein (i) the amino acid sequence of the heterologous GPCR is at least about 95% homologous to an amino acid sequence comprising any one of SEQ ID NOs: 117- 161 or an amino acid sequence provided in Table 11 and/or is encoded by a nucleotide sequence that is at least about 95% homologous to a nucleotide sequence comprising any one of SEQ ID NOs: 168-211; and/or (all) the amino acid sequence to the heterologous secretable GPCR peptide is at least about 95% homologous to an amino acid sequence comprising any one of SEQ ID NOs: 1-116 or an amino acid sequence provided in Table 12 and/or encoded by a nucleotide sequence that is about 95% homologous to a nucleotide sequence comprising any one of SEQ ID NOs: 215-230; (b) an intercellular signaling system comprising a first genetically-engineered cell expressing at least one secretable G-protein coupled receptor (GPCR) ligand; and a second genetically-engineered cell expressing at least one heterologous GPCR, wherein (i) the amino acid sequence of the heterologous GPCR is at least about 95% homologous to an amino acid sequence comprising any one of SEQ ID NOs: 117-161 or an amino acid sequence provided in Table 11 and/or is encoded by a nucleotide sequence that is at least about 95% homologous to a nucleotide sequence comprising any one of SEQ ID NOs: 168-211 and/or (ii) the amino acid sequence of the secretable GPCR ligand is at least about 95% homologous to an amino acid sequence comprising any one of SEQ ID NOs: 1-116 or an amino acid sequence provided In Table 12 and/or Is encoded by a nucleotide sequence that is about 95% homologous to a nucleotide sequence comprising any one of SEQ ID NOs: 215-230; and/or (c) an intercellular signaling system comprising a first genetically-engineered cell comprising: (i) a nucleic acid encoding a first heterologous G-protein coupled receptor (GPCR); and/or (ii) a nucleic acid encoding a first secretable GPCR ligand; and a second genetically-engineered cell comprising: (i) a nucleic acid encoding a second heterologous GPCR; and/or (il) a nucleic acid encoding a second secretable GPCR ligand, wherein (a) the first GPCR and/or the second GPCR is at least about 95% homologous to an amino acid sequence comprising any one of SEQ ID NOs: 117-161 or an amino acid sequence provided in Table 11 and/or is encoded by a nucleotide sequence that is at least about 75% homologous to a nucleotide sequence comprising any one of SEQ ID NOs: 168-211, and/or (b) the first and/or second secretable GPCR peptide ligand is at least about 95% homologous to an amino acid sequence comprising any one of SEQ ID NOs: 1-116 or an amino acid sequence provided in Table 12 and/or is encoded by a nucleotide sequence that is about 95% homologous to a nucleotide sequence comprising any one of SEQ ID NOs: 215-230 (comprising a sensor cell as described above, Para. [0022]; [A] sensor cell comprising a non-native G-protein coupled receptor (GPCR) that binds to an analyte indicative of the presence of the agent... In certain embodiments, the non-native GPCR receptor Is selected from the group consisting of the GPCRs listed in Tables 2 and 6, Para. [0012]; Table 2 discloses SEQ ID NO: 21; SEQ ID NO: 21 of Columbia University comprises 100% sequence identity to instant SEQ ID NO: 154).
Double Patenting Rejection
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the "right to exclude" granted by a patent and to prevent possible harassment by multiple assignees. See In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
The instant Claims are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-27 of US PAT11899014. An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim not is patentably distinct from the reference claim(s) because the examined claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985). Although the conflicting claims are not identical, they are not patentably distinct from each other.
The claims 1-27 of US PAT11899014 are directed to sensor fungal cell comprising a fungal non-native G-protein coupled receptor (GPCR) that binds to a peptide analyte derived from an agent, wherein the wherein the non-native fungal GPCR is a GPCR comprising an amino acid sequence selected from the group consisting of SEQ ID NOs: 6, 9, 12, 15, 18, 21, 50, 52, 54, 56, 58, 60, 62, 64, 66, 68, 70, 72, 74, 76, 78, 80, 82, 84, 86, 88, 90, 92, 94, 96, 98, 100, 102, 104, 106, 108, 110, 112 and 222. The Instant claims also are directed to genetically-engineered cell expressing:
(a) at least one heterologous G-protein coupled receptor (GPCR), wherein the amino acid sequence of the heterologous GPCR is at least about 95% homologous to an amino acid sequence comprising any one of SEQ ID NOs: 117-161 or an amino acid sequence provided in Table 11 and/or is encoded by a nucleotide sequence that is at least about 95% homologous to a nucleotide sequence comprising any one of SEQ ID NOs: 168-211; and/or and (b) at least one heterologous secretable GPCR peptide ligand, wherein the amino acid sequence of the heterologous GPCR peptide ligand is at least about 95% homologous to an amino acid sequence comprising any one of SEQ ID NOs: 1-116 or an amino acid sequence provided in Table 12 and/or encoded by a nucleotide sequence that is about 95% homologous to a nucleotide sequence comprising any one of SEQ ID NOs: 215-230. The specification that teach genetically-engineered cell expressing heterologous G-protein coupled receptor (GPCR), wherein the amino acid sequence of the heterologous GPCR as disclosed in claim 6 of patent can also teach in different embodiment the genetically-engineered cell expressing heterologous G-protein coupled receptor (GPCR), wherein the amino acid sequence of the heterologous GPCR in the instant claims of the instant application. It would have been obvious to one of ordinary skill in the art to select this specific embodiment of the genera of cell expressing said GPCR that practiced for the claims of that patent to that of instant claims. Therefore claims 1-17 of instant application are obvious over claims 1-27 US PAT 11899014.
The instant Claims are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-32 of US PAT 10725036. An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim not is patentably distinct from the reference claim(s) because the examined claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985). Although the conflicting claims are not identical, they are not patentably distinct from each other.
The claims 1-32 of US PAT 10725036 are directed to method of use of sensor fungal cell comprising a fungal non-native G-protein coupled receptor (GPCR) that binds to a peptide analyte derived from an agent, wherein the wherein the non-native fungal GPCR is a GPCR comprising an amino acid sequence selected from the group consisting of SEQ ID NOs: 6, 9, 12, 15, 18, 21, 50, 52, 54, 56, 58, 60, 62, 64, 66, 68, 70, 72, 74, 76, 78, 80, 82, 84, 86, 88, 90, 92, 94, 96, 98, 100, 102, 104, 106, 108, 110, 112 and 222. The Instant claims also are directed to genetically-engineered cell expressing: (a) at least one heterologous G-protein coupled receptor (GPCR), wherein the amino acid sequence of the heterologous GPCR is at least about 95% homologous to an amino acid sequence comprising any one of SEQ ID NOs: 117-161 or an amino acid sequence provided in Table 11 and/or is encoded by a nucleotide sequence that is at least about 95% homologous to a nucleotide sequence comprising any one of SEQ ID NOs: 168-211; and/or and (b) at least one heterologous secretable GPCR peptide ligand, wherein the amino acid sequence of the heterologous GPCR peptide ligand is at least about 95% homologous to an amino acid sequence comprising any one of SEQ ID NOs: 1-116 or an amino acid sequence provided in Table 12 and/or encoded by a nucleotide sequence that is about 95% homologous to a nucleotide sequence comprising any one of SEQ ID NOs: 215-230. The specification that teach genetically-engineered cell expressing heterologous G-protein coupled receptor (GPCR), wherein the amino acid sequence of the heterologous GPCR as disclosed in claim 6 of patent can also teach in different embodiment the genetically-engineered cell expressing heterologous G-protein coupled receptor (GPCR), wherein the amino acid sequence of the heterologous GPCR in the instant claims of the instant application. It would have been obvious to one of ordinary skill in the art to select this specific embodiment of the genera of cell expressing said GPCR that practiced for the claims of that patent to that of instant claims. Therefore claims 1-17 of instant application are obvious over claims 1-32 of US PAT 10725036.
TD submission would overcome the above ODP rejections.
Conclusion
Claims 1-17 and 21-22 are rejected. No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMMAD Y MEAH whose telephone number is (571)272-1261. The examiner can normally be reached on monday-friday (8-7).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Mondesi can be reached on 4089187584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/MOHAMMAD Y MEAH/ Examiner, Art Unit 1652