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
Claims 1-8,10-18 and 21-23 submitted on 4/14/2026 are pending.
claim 18 is withdrawn. Claims 1-8,10-17 and 21-23 are for examination.
Applicants’ argument submitted on 4/14/2026 is considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.
Claim Rejection 35 U.S.C. 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.
Claim 1, 4, 7-8, 21, and 2-3, 5-6, 10-17 and 22-23 ( depend on claim 1) are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01.
Claims 1, 4, 7 , 21 are rejected being indefinite in reciting “Table 12” in the claim not reciting what are in the table because it is not clear what table 12 comprise.
Correction is required.
Claims 7 , 21 are rejected being indefinite in reciting “Table 11” and “Table 12” in the claim not reciting what are in the table because it is not clear what table 11 and table 12 comprise.
Correction is required.
Claim 8 are rejected being indefinite in reciting “derived from a eukaryotic organism” because it is not clear exactly what type of GPCR is because derive can comprise fragment, mutant or recombinant form . It should be obtained from a eukaryotic organism
Correction is required.
On 06/03/2026 Carolyn Pirraglia, Ph.D submitted amended claims as shown below via e-mail and also argument to see whather ODP rejection will be withdrawn and claim be allowed. Asked an interview.
WE discussed on the proposed amended claims and May be ODP rejection be withdrawn but still there is 112( b) issue remained. Applicant agreed to submit the amended claims argue firmally. Examiner will be submitting a non-final rejection. So that applicant formally submit amended claim and argue so that a possible allowance will be possible.
“
“Proposed amended claims via-email
AMENDMENTS TO THE CLAIMS
The listing of claims provided below will replace all prior versions, and listings, of claims in the application.
(Canceled) A genetically-engineered cell expressing:
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
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.
(Canceled) The genetically-engineered cell of claim 1, wherein the at least one heterologous GPCR is selectively activated by a ligand and wherein the at least one heterologous secretable GPCR peptide ligand is expressed upon activation of the at least one heterologous GPCR.
(Currently Amended) The genetically-engineered cell intercellular signaling system of claim [[2]]8, wherein the exogenous 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.
(Currently Amended) The genetically-engineered cell intercellular signaling system of claim [[2]]8, wherein the exogenous 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.
(Currently Amended) The genetically-engineered cell intercellular signaling system of claim [[1]]7, wherein the first genetically-engineered cell and/or second genetically-engineered cell is:
(a) a fungal cell;
(b) a fungal cell from the phylum Ascomycota; and/or
(c) a fungal cell selected from the group consisting of Saccharomyces cerevisiae, Saccharomyces castellii, Vanderwaltozyma polyspora, Torulaspora delbrueckii, Saccharomyces kluyveri, Kluyveromyces lactis, Zygosaccharomyces rouxii, Zygosaccharomyces bailii, Candida glabrata, Ashbya gossypii, Scheffersomyces stipites, Komagataella (Pichia) pastoris, Candida (Pichia) guilliermondii, Candida parapsilosis, Candida auris, Yarrowia lipolytica, Candida (Clavispora) lusitaniae, Candida albicans, Candida tropicalis, Candida tenuis, Lodderomyces elongisporous, Geotrichum candidum, Baudoinia compniacensis, Schizosaccharomyces octosporus, Tuber melanosporum, Aspergillus oryzae, Schizosaccharomyces pombe, Aspergillus (Neosartorya) fischeri, Pseudogymnoascus destructans, Schizosaccharomyces japonicus, Paracoccidioides brasiliensis, Mycosphaerella graminicola, Penicillium chrysogenum, Aspergillus nidulans, Phaeosphaeria nodorum, Hypocrea jecorina, Botrytis cinereal, Beauvaria bassiana, Neurospora crassa, Sporothrix scheckii, Magnaporthe oryzea, Dactylellina haptotyla, Fusarium graminearum, Capronia coronate and combinations thereof.
(Canceled) An intercellular signaling system comprising two or more, three or more, four or more or five or more genetically-engineered cells of claim 1.
(Currently Amended) An intercellular signaling system comprising:
(i) (a) a first genetically-engineered cell expressing at least one secretable heterologous G-protein coupled receptor (GPCR) ligand or comprising a nucleic acid encoding the at least one secretable heterologous GPCR ligand; and
(b) a second genetically-engineered cell expressing at least one heterologous GPCR or comprising a nucleic acid encoding the 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 (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
wherein the at least one secretable GPCR ligand of the first genetically-engineered cell selectively activates the at least one heterologous GPCR of the second genetically-engineered cell; or
(ii) (a) a first genetically-engineered cell comprising: (i) a nucleic acid encoding a first heterologous G-protein coupled receptor (GPCR); and (ii) a nucleic acid encoding a first secretable GPCR ligand; and
(b) a second genetically-engineered cell comprising: (i) a nucleic acid encoding a second heterologous GPCR,
wherein (i) the first heterologous GPCR and/or the second 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 (ii) the first and/or second 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
wherein the first secretable GPCR ligand of the first genetically-engineered cell selectively activates the second heterologous GPCR of the second genetically-engineered cell.
(Original) The intercellular signaling system of claim 7, wherein (i) the secretable GPCR ligand and/or the heterologous GPCR is identified and/or derived from a eukaryotic organism and/or (ii) the heterologous GPCR is activated by an exogenous ligand.
(Canceled)
(Currently Amended) The intercellular signaling system of claim 7, wherein the second genetically-engineered cell of (i) further expresses at least one secretable GPCR ligand or comprises a nucleic acid encoding the at least one secretable GPCR ligand and/or the first genetically-engineered cell of (i) further expresses at least one heterologous GPCR or comprises a nucleic acid encoding the at least one heterologous GPCR.
(Previously Presented) The intercellular signaling system of claim 10, wherein:
(a) the first heterologous GPCR expressed by the first genetically-engineered cell is different from the second heterologous GPCR expressed by the second genetically-engineered cell; and/or
(b) the first secretable GPCR ligand expressed by the first genetically-engineered cell does not activate the first heterologous GPCR expressed by the first genetically-engineered cell.
(Previously presented) The intercellular signaling system of claim 7, wherein:
one or more endogenous GPCR genes of the first genetically-engineered cell and/or the second genetically-engineered cell are knocked out;
one or more endogenous GPCR ligand genes of the first genetically-engineered cell and/or the second genetically-engineered cell are knocked out;
the first genetically-engineered cell and/or the second genetically-engineered cell further comprises a nucleic acid that encodes a product of interest;
the first genetically-engineered cell and/or the second genetically-engineered cell further comprises a nucleic acid that encodes a sensor;
the first genetically-engineered cell and/or the second genetically-engineered cell further comprises a nucleic acid that encodes a detectable reporter; and/or
(f) the second genetically-engineered cell further expresses a second secretable GPCR ligand or comprises a nucleic acid encoding the second secretable GPCR ligand.
(Original) The intercellular signaling system of claim 12, 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.
(Currently Amended) The intercellular signaling system of claim 7 further comprising:
a third genetically-engineered cell;
a third genetically-engineered cell and a fourth genetically-engineered cell;
a third genetically-engineered, a fourth genetically-engineered cell and a fifth genetically-engineered cell;
a third genetically-engineered, a fourth genetically-engineered cell, a fifth genetically-engineered cell and a sixth genetically-engineered cell;
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
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.
(Previously Presented) The intercellular signaling system of claim 14, wherein the intercellular signaling system comprises a topology selected from the group consisting of 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.
16. (Currently Amended) A kit comprising the intercellular signaling system of claim 21the genetically-engineered cell of claim 1.
17. (Original) A kit comprising the intercellular signaling system of claim 7.
18. (Withdrawn and Previously Presented) A method of using the intercellular signaling system of claim 7 for one or more of the following:
(a) for spatial control of gene expression and/or temporal control of gene expression;
(b) for the generation of pharmaceuticals and/or therapeutics;
(c) for performing computations;
(d) as a biosensor; and
(e) for the generation of a product of interest.
19. (Canceled)
20. (Canceled)
21. (Currently Amended) An intercellular signaling system comprising:
(a) a first genetically-engineered cell expressing (i) expressing a first secretable G-protein coupled receptor (GPCR) ligand or comprising a nucleic acid encoding the at least one secretable GPCR ligand, wherein 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 (ii) expressing a first heterologous 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
(b) a second genetically-engineered cell expressing a second heterologous 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,
wherein the first heterologous GPCR expressed by the first genetically-engineered cell is different from the second heterologous GPCR expressed by the second genetically-engineered cell, and
wherein the first secretable GPCR ligand expressed by the first genetically-engineered cell upon activation of the first heterologous GPCR selectively binds to and activates the second heterologous GPCR expressed by the second genetically-engineered cell.
22. (Currently Amended) The intercellular signaling system of claim 21, wherein the second genetically-engineered cell further (i) expresses a second secretable GPCR ligand, wherein the product of interest is expressed upon activation of the second heterologous GPCR and/or (ii) comprises a nucleic acid that encodes a product of interest, wherein the product of interest is expressed upon activation of the second heterologous GPCR.
23. (Previously Presented) The intercellular signaling system of claim 22, wherein:
(a) the second secretable GPCR ligand expressed by the second genetically-engineered cell is different from the first secretable GPCR ligand expressed by the first genetically-engineered cell;
(b) the second 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 second secretable GPCR ligand expressed by the second genetically-engineered cell selectively activates the heterologous GPCR expressed by the first genetically-engineered cell;
(d) the second 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
(e) the second secretable GPCR ligand expressed by the second genetically-engineered cell selectively activates a GPCR expressed by a third cell. “
Above proposed amended claims are not accepted it just presented above for discussion.
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 1-8,10-17 and 21-23 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 1-8,10-17 and 21-23 of instant application are obvious over claims 1-32 of US PAT 10725036.
TD submission would overcome the above ODP rejections.
Until TD submitted or claims substantially amended as discussed during the Interview ODP rejection remained.
Conclusion
Claims 1-8,10-17 and 21-23 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.
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/MOHAMMAD Y MEAH/ Examiner, Art Unit 1652
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