DETAILED ACTION
Response to Amendment
This action is in response to the amendment after non-final filed 30 March 2026. Claims 1-20 are pending.
Response to Arguments
Applicant’s arguments filed with respect to the rejection(s) of claim(s) 1, 2, 5, 7-16, 19, and 20 under 35 USC 103 as being unpatentable over Fletcher et al. (US Publication no. 2016/0001079) in view of Fattouh et al. (US Patent no. 8,135,477) have been fully considered and are persuasive. Neither reference is found to teach the newly incorporated limitations. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Fletcher et al. (US Publication no. 2016/0001079 – disclosed by Applicant) in view of Fattouh et al. (US Patent no. 8,135,477 – disclosed by Applicant), further in view of Libbus et al. (US Publication no. 2015/0321001). Additionally, the rejection of claim 11 has been updated commensurate with the claim amendments.
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, 2, 5, 7-16, 19 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fletcher et al. (US Publication no. 2016/0001079 – disclosed by Applicant) in view of Fattouh et al. (US Patent no. 8,135,477 – disclosed by Applicant), further in view of Libbus et al. (US Publication no. 2015/0321001).
In regard to claims 1 and 16, Fletcher et al. describe a system and a method for inserting a neurostimulator 22 with lead 24 sized and dimensioned into the pterygopalatine fossa of a patient (para 42, figures 1 and 2A-B). The lead contains a plurality of individually addressable electrodes 26 (para 30). Fletcher et al. also include a remote transducer 50 that electrically communicates with and transmits power to the neurostimulator and when activated and brought into close proximity to the patient’s head causes the neurostimulator to deliver an electrical signal to a target neural structure (e.g., pterygopalatine ganglion) of the pterygopalatine fossa to treat a medical condition (para 31, 32, 34, 35, and 43).
Fletcher et al. is considered to substantially describe the invention as claimed, however does not teach that the neurostimulator has a plurality of expandable electrical leads disposed within the sheath’s inner lumen in a non-deployed configuration and splaying radially outward from the distal end of the sheath’s inner lumen in a deployed configuration. Fattouh et al. shows a neurostimulation lead comprising a sheath 103 having an inner lumen containing central and second expandable leads 101 and 102 bearing electrodes with a proximal end and a distal end (figure 1), wherein the plurality of expandable leads 102 are disposed within the lumen of sheath 103 in a non-deployed configuration and are configured to splay radially outward from the distal end of the sheath 103 when deployed (figure 3, col 7 line 56 – col 8 line 4), wherein the leads 102 are deployed with the sheath 103 is moved proximally along the lead. The lead of Fattouh et al. is configured to neurostimulation. Thus Fattouh et al. demonstrate that the lead configuration as claimed is known in the art. Though the dimensions may not permit the lead of Fattouh et al. for the intended use of the claimed invention, it is considered that one of ordinary skill in the art would take size constraint in consideration upon design.
Modification of the lead in Fletcher et al. to incorporate features of lead in Fattouh et al. is considered to have been obvious to one of ordinary skill in the art at the time the invention as filed since Fattouh et al. demonstrates that neurostimulation leads comprising the claimed features was known in the art at the time of the invention for providing the benefit of preventing lead migration due to movement, provide wider coverage of treatment to a target area, and allow for placement of multiple electrodes in a target location without requiring additional leads.
Additionally, Fletcher et al. fail to teach the sheath having an inner lumen with a proximal end and distal end for disposing the plurality of electrical contacts. Fattouh et al. teaches that the lead may be implanted via needle (col 9 lines 10-24). Modification to include an insertion tool comprising an inner lumen with a proximal end and distal end such as conduit 103/203/3033 of Fattouh since Fattouh teaches that the conduit helps control branching of the leads during insertion, wherein a tool such as the conduit is considered to be conventional in the art for inserting percutaneous devices.
Finally in regard to claims 1 and 16, neither Fletcher et al. nor Fattouh et al. teach the limitation for one or more sensors configured to detect a physiological parameter indicative of the medical condition, wherein the neurostimulator is configured to automatically activate in response to the detected physiological parameter to deliver an electrical signal to a target neural structure located within the PPF to treat the medical condition. For this, the Examiner looks to Libbus et al. which discloses a neurostimulation device comprising a physiological sensor configured to acquire a physiological signal from the patient, monitor a response signal acquired by the physiological sensor, and adjust one or more parameters of the stimulation signal to deliver the stimulation signal in the patient (para 8 and 9). Modification of Fletcher et al. and Fattouh et al. to incorporate a sensor for sensing physiological signals and initiating or adapting electrical stimulation therapy is considered to have been obvious to one of ordinary skill in the art since the feature is explicitly taught by Libbus et al. for efficiently providing neurostimulation therapy, wherein the modification is considered to comprise the application of a known technique to improve similar devices and techniques in a predictable manner.
In regard to claims 2 and 19, Fletcher al. teaches that the lead and neurostimulator are dimensioned appropriately to contact the sphenopalatine ganglion (para 42). The neurostimulator of Fletcher et al. as modified with a dimensionally appropriate lead of Fattouh et al. would partially encapsulate the target site when deployed.
In regard to claim 5, Fattouh et al. a conduit introducer with a needle assembly to insert the lead, wherein the conduit introducer comprises a mechanism to retract the biocompatible conduit/sheath in a proximal direction to expose leads 102 (col 9 lines 10-38).
In regard to claims 7 and 8, Fletcher et al. includes a tissue fixation device 28 for anchoring the neurostimulator to tissue (para 42). The anchoring is performed by screws. However a suture tab is considered to be an obvious equivalent suitable for substitution.
In regard to claims 9 and 10, the remote transducer 50 of Fletcher et al. is a handheld device with ergonomic design for placing in proximity to the neurostimulator (para 38). Fletcher et al. contemplates that any type of apparatus may be employed for such use (para 39). The present specification presents the cited as embodiments as examples for the form of the transducer without providing any critical teaching for the particular design. Therefore the design of the controller according to any of the claimed embodiments is considered obvious based on design choice.
In regard to claim 11, Fletcher et al. also include a remote transducer 50 that electrically communicates with and transmits power to the neurostimulator and when activated and brought into close proximity to the patient’s head causes the neurostimulator to deliver an electrical signal to a target neural structure (e.g., pterygopalatine ganglion) of the pterygopalatine fossa to treat a medical condition (para 31, 32, 34, 35, and 43).
In regard to claims 12-15, the system of Fletcher et al. includes a link to interface with a personal electronic device (para 65). Personal devices such as smartphone or tablets are considered capable of storing any type of information and sending control signals to other devices via wireless connections such as Bluetooth or internet. The features of the stored instructions and transmittal of instructions to the remote transducer are considered to comprise intended uses of the personal device. The personal device suggested by Fletcher et al. is considered structurally capable of performing the intended uses.
In regard to claim 20, Fletcher et al. is directed to treating headache (para 11 and 43).
Claims 3 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fletcher et al. (US Publication no. 2016/0001079 – disclosed by Applicant) in view of Fattouh et al. (US Patent no. 8,135,477 – disclosed by Applicant) and Libbus et al. (US Publication no. 2015/0321001), further in view of Ackermann et al. (US Publication no. 2013/0006326).
In regard to claim 3, Fletcher et al. and Fattouh et al. are considered to substantially suggest the invention as claimed however do not teach the plurality of expandable electrical leads comprises a proximal end in operable communication with a spring. Ackermann et al. describe an insertion tool for inserting a microstimulator. The insertion device 3800 is depicted in figure 38 comprising a housing shaft 3804 for mounting a microstimulator 3802 for insertion. A spring 3808 is formed near the proximal end of microstimulator 3802 in order to assisting in advancing the microstimulator out of the housing 3804 (para 193). While the spring is not operable engaged with the implant, the structure and function of the spring is similar to that as claimed for advancing the expandable electrical leads out of the lumen of the sheath. Moreover, the insertion tool of Ackermann et al. is considered to be an alternative device to the conduit of Fattouh for inserting implant devices. Therefore, it is considered to have been obvious to one of ordinary skill in the art to modify the insertion tool described therein to be a tool such as in Ackermann et al. to assist in delivery of the microstimulator to the target location.
In regard to claim 4, Fletcher et al. and Fattouh et al. are considered to substantially suggest the invention as claimed however do not teach the insertion device further comprising a trigger rod slidably extendable through the inner lumen of the sheath and longitudinally aligned with the spring, the trigger rod configured to compress the spring when urged distally to operably contact the spring. The insertion tool 3800 (figure 38) of Ackermann et al. includes a housing 3804, an implant 3802, a trigger member 3810 and a piston assembly aligned with the spring 3808 and implant 3802 (para 193). As the piston assembly (3806) moves forward, it may advance the microstimulator (3802) out of the housing (3804), thereby delivering the microstimulator (3802). Moreover, the insertion tool of Ackermann et al. is considered to be an alternative device to the conduit of Fattouh for inserting implant devices. Therefore, it is considered to have been obvious to one of ordinary skill in the art to modify the insertion tool described therein to be a tool such as in Ackermann et al. to assist in delivery of the microstimulator to the target location.
Claims 6, 17, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fletcher et al. (US Publication no. 2016/0001079 – disclosed by Applicant) in view of Fattouh et al. (US Patent no. 8,135,477 – disclosed by Applicant) and Libbus et al. (US Publication no. 2015/0321001), further in view of Mann et al. (US Publication no. 2011/0172739 – disclosed by Applicant).
In regard to claims 6 and 18, Fletcher et al. as modified by Fattouh et al. describes the invention as claimed. Fattouh et al. teaches that the lead may be implanted via needle (col 9 lines 10-24). Such technique is considered conventional in the art for inserting percutaneous devices. However neither reference teaches that the neurostimulator is sized and dimensioned to be inserted through a needle. Mann et al. teach an implantable stimulator is sized and dimensioned to be inserted into a patient through a needle (para 38, 75 and 79). Modifying the stimulator of Fletcher et al. to be implanted through a needle is considered to have been obvious to one of ordinary skill in the art at the time of the invention since needle inserted is a conventional technique in the art for inserting neurostimulators. The modification is motivated to provide a less invasive and less intrusive technique for inserting a device in the relatively small target area such as the pterygopalatine fossa.
In regard to claim 17, Mann et al. teach that paresthesia is a predictable effect from neurostimulation, and is considered to be desirable for neurostimulation based pain management. Selecting electrodes in Fletcher et al. based on paresthesia is considered to have been obvious to one of ordinary skill in the art since it is a desired and expected outcome of neurostimulation.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN T GEDEON whose telephone number is (571)272-3447. The examiner can normally be reached M-F 8:00 am to 5:30 PM ET.
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/BRIAN T GEDEON/Primary Examiner, Art Unit 3796 1 June 2026
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