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 .
Applicant’s election without traverse of Group I: Claims 1-14, drawn to a method of inducing a response and cation or anion influx or efflux in a cell in the reply filed on 01/20/2026 is acknowledged.
Claims 15-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/20/2026.
Priority
Acknowledgement is made of Applicants’ claim for benefit to prior filed US Provisional Application 63112256, filed on 11/11/2020.
This application claims the benefit of priority to Patent Application PCT/US2021/058708. Acknowledgement is made of Applicants’ claim for benefit to prior filed to Patent Application Number PCT/US2021/058708, filed on 11/10/2021.
Information Disclosure Statement
The Information Disclosure Statements filed 05/10/2023, 10/14/2024, 02/05/2025, and 01/20/2026 have been considered by the Examiner.
Status of Claims
Claims 1-14 are under examination.
Claims 15-25 are withdrawn.
Claim Objections
Claim 4 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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.
Claims 1-3 and 5-14 are rejected under 35 U.S.C. 103 as being unpatentable over Chalasani et al. (US20160220672A1) in view of Procko et al. (bioRχiv, 2020).
Regarding claim 1, Chalasani et al. teach a mechanosensitive (e.g., mechanotransduction channel) channel that is activated (opened) by treatment with ultrasound.
Chalasani et al. teach the mechanotransduction channel is heterogeneously expressed in a cell. Chalasani et al. teach the ultrasound treatment induces cation or anion influx or efflux in the cell (page 10, paragraph 0061). Chalasani et al. teach TRP-4 is a pore-forming subunit of a mechanotransduction channel which sensitizes cells to an ultrasound stimulus resulting in calcium influx (page 10, paragraph 0061). Chalasani et al. further teach bacterial MscL and MscS channels different sensitivities to membrane stretch and are selective for different ions to be utilized (page 15, paragraph 0094).
Chalasani et al. do not specifically teach mechanosensory polypeptide selected from the group consisting of DmFLYC1, DmFLYC2, DcFLYC1.1, DcFLYC1.2, and DmOSCA, or a variant thereof.
Procko et al. teach members of the FLYC and OSCA families of ion channels as candidate mechanosensors in rapid touch sensation in carnivorous plants (page 12, Procko et al. teach FLYCATCHER1 (FLYC1) is an MSL homolog (page 13, paragraph 1). Procko et al. teach that FLYC1 transcripts are localized to mechanosensory cells within the trigger hair, transfecting FLYC1 induces chloride-permeable stretch-activated currents in naïve cells, and transcripts coding for FLYC1 homologs are expressed in touch-sensing cells of Cape sundew, a related carnivorous plant of the Droseraceae family (page 1, abstract). Procko et al. teach the mechanism of prey recognition in carnivorous Droseraceae evolved by co-opting ancestral mechanosensitive ion channels to sense touch (page 1, abstract).
It would have been obvious to one of ordinary skill in the art to exchange the channel of Chalasani for a functionally equivalent channel found in the Venus flytrap taught by Procko et al. It would have been obvious to try an ortholog of the mechanosensory polypeptides. One of ordinary skill in the art would have had a reasonable expectation of success combining Chalasani et al. and Procko et al. because FLYC1 and MSL are functionally equivalent.
Regarding claims 2 and 3, Chalasani et al. teach the invention is based, at least in part, on the discovery that misexpression ofTRP-4, a pore-forming subunit of a mechanotransduction channel, sensitizes cells to an ultrasound stimulus resulting in calcium influx and motor outputs (page 10 paragraph 0060).
Regarding claim 5, Chalasani et al. teach a method for initiating or inducing a cellular response to mechanical deformation or stretch caused by ultrasound (page 13, paragraph 0082). Chalasani et al. teach a method which includes transducing a cell to express a heterologous, mechanosensory polypeptide TRP-4 (page 10, paragraph 0061). Chalasani et al. teach applying ultrasound to the cell which initiates a cellular response to mechanical deformation or stretch caused by ultrasound (page 13, paragraph 0082). Chalasani et al. further teach bacterial MscL and MscS channels different sensitivities to membrane stretch and are selective for different ions to be utilized (page 15, paragraph 0094).
Chalasani et al. do not specifically teach mechanosensory polypeptide selected from the group consisting of DmFLYC1, DmFLYC2, DcFLYC1.1, DcFLYC1.2, and DmOSCA, or a variant thereof.
Procko et al. teach members of the FLYC and OSCA families of ion channels as candidate mechanosensors in rapid touch sensation in carnivorous plants (page 12, Procko et al. teach FLYCATCHER1 (FLYC1) is an MSL homolog (page 13, paragraph 1). Procko et al. teach that FLYC1 transcripts are localized to mechanosensory cells within the trigger hair, transfecting FLYC1 induces chloride-permeable stretch-activated currents in naïve cells, and transcripts coding for FLYC1 homologs are expressed in touch-sensing cells of Cape sundew, a related carnivorous plant of the Droseraceae family (page 1, abstract). Procko et al. teach the mechanism of prey recognition in carnivorous Droseraceae evolved by co-opting ancestral mechanosensitive ion channels to sense touch (page 1, abstract).
It would have been obvious to one of ordinary skill in the art to exchange the channel of Chalasani for a functionally equivalent channel found in the Venus flytrap taught by Procko et al. It would have been obvious to try an ortholog of the mechanosensory polypeptides. One of ordinary skill in the art would have had a reasonable expectation of success combining Chalasani et al. and Procko et al. because FLYC1 and MSL are functionally equivalent.
Regarding claim 6, Chalasani et al. teach the polypeptide is encoded by a polynucleotide sequence codon-optimized for expression in a mammalian or human cell and is non-naturally occurring (page 27 claim 6).
Regarding claim 7, Chalasani et al. teach Stable expression of a transfected gene can further be accomplished by infecting a cell with a lentiviral vector (page 6, paragraph 0019).
Regarding claim 8, Chalasani et al. teach the cell is transduced by a lentivirus vector (page 6, paragraph 0019).
Regarding claim 9, Chalasani et al. teach the cell is muscle cell, cardiac muscle cell, neuron, motor neuron, sensory neuron, interneuron, or insulin secreting cell (page 1, paragraph 6).
Regarding claim 10, Chalasani et al. teach the ultrasound has a frequency of about 0.8 MHz to about 4 MHz which falls within 0.2 MHz to about 20 MHz (page 27, claim 8).
Regarding claim 11, Chalasani et al. teach the ultrasound has a focal zone of about 1 cubic millimeter to about 1 cubic centimeter (page 27, claim 9).
Regarding claim 12, Chalasani et al. teach contacting the cell with a microbubble prior to applying ultrasound (page 27 claim 10).
Regarding claim 13, Chalasani et al. teach cell is in vitro or in vivo (page 27, claim 11).
Regarding claim 14, Chalasani et al. teach the cell is in a subject (page 27, claim 13).
Conclusion
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/C.L.M./Examiner, Art Unit 1638
/Anna Skibinsky/
Primary Examiner, AU 1635
Prosecution Insights