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 Claims
Claims 1-15 and 21 are rejected. Claims 16-18 and 20 are withdrawn. Claim 19 is canceled.
Response to Arguments
Claim Interpretation
The previous claim interpretation has been withdrawn in view of the amendment.
Claim Rejections - 35 USC § 101
The previous 101 rejection of claim 3 has been withdrawn in view of the amendment.
Claim Rejections - 35 USC § 102 and 103
Applicant's arguments filed 6/17/26 have been fully considered but they are not persuasive.
Applicant asserts that Vrba does not disclose “a stimulation implant adapted for implantation near the patient’s hepatic neural plexus and to provide mechanical energy to the patient’s hepatic neural plexus.” However, the Examiner disagrees. Vrba teaches a stimulation implant adapted for implantation near the patient's hepatic neural plexus (¶51-delivering a neuromodulation catheter within a hepatic artery to a vicinity of a hepatic plexus of a subject; ¶36-modulating nerves of the hepatic plexus by causing RF, ultrasound, etc. energy to be emitted from one or more electrodes of the neuromodulation catheter, the step of modulating the nerves of the hepatic plexus comprises…stimulating parasympathetic nerves of the hepatic plexus) and to provide mechanical energy to the patient's hepatic neural plexus (¶576-the ultrasound transducer(s) can deliver ultrasonic energy to one or more target sites to modulate (e.g., ablate) sympathetic nerve fibers in the hepatic plexus); ¶47-a neuromodulation device consists or consists essentially only of four electrodes or transducers; ¶51).
Applicant asserts that the catheter components disclosed by Vrba do not include a stimulation implant that is implanted near the hepatic neural plexus. However, the Examiner disagrees. Vrba explicitly teaches delivering a neuromodulation catheter within a hepatic artery to a vicinity of a hepatic plexus of a subject and modulating nerves of the hepatic plexus (¶36).
Applicant asserts that a temporarily positioned catheter or catheter-mounted electrode/transducer is not the same as an implanted stimulation implant. However, the Examiner disagrees.
Based on Merriam-Webster, the definition of implant is defined as:
1 a: to fix or set securely or deeply
a ruby implanted in the idol's forehead
b: to set permanently in the consciousness or habit patterns : inculcate
implanted a love of reading in her students
2: to insert in living tissue (as for growth, slow release, or formation of an organic union)
subcutaneously implanted hormone pellets
Based on dicitionary.com, the definition of implant is defined as:
Something that is placed, usually surgically, within a living body, as grafted tissue or a medical device, such as a pacemaker.
The definitions relied upon are being furnished with this Office Action.
Based on these definitions, an implant reads on being a device inserted into a living body. There is nothing in the definition nor recited in the claim language regarding a duration of the implant. Vrba teaches delivering a neuromodulation catheter within a hepatic artery to a vicinity of a hepatic plexus of a subject and modulating nerves of the hepatic plexus (¶36). That catheter is implantable as it is inserted inside the body.
In the case that Applicant still does not agree with the teaching in Vrba, Belson (US 20140058372) explicitly teaches:
¶28-the electrode catheter and the electronic module can be temporarily or permanently implanted.
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.
(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.
Claims 1-2, 14, and 21 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Vrba (US 20190069949 filed on 2/3/15 as cited in the IDS).
Regarding claim 1, Vrba teaches a system adapted to modulate an hepatic neural plexus of a patient (¶36-modulating the nerves of the hepatic plexus; ¶8-hepatic modulation can be used for neuromodulating), the system comprising: a stimulation implant adapted for implantation near the patient's hepatic neural plexus (¶51-delivering a neuromodulation catheter within a hepatic artery to a vicinity of a hepatic plexus of a subject; ¶36-modulating nerves of the hepatic plexus by causing RF, ultrasound, etc. energy to be emitted from one or more electrodes of the neuromodulation catheter, the step of modulating the nerves of the hepatic plexus comprises…stimulating parasympathetic nerves of the hepatic plexus) and to provide mechanical energy to the patient's hepatic neural plexus (¶576-the ultrasound transducer(s) can deliver ultrasonic energy to one or more target sites to modulate (e.g., ablate) sympathetic nerve fibers in the hepatic plexus); ¶47-a neuromodulation device consists or consists essentially only of four electrodes or transducers; ¶51); a source of excitation energy adapted to provide excitation energy to the stimulation implant (¶592-the induction coil may be placed within a lumen of a catheter or sleeve having one or more windows configured to permit the selective delivery of energy to the target tissue, an induction coil is used in combination with any of the windowed catheter devices described herein; ¶551-deliver electrical energy from a generator or other energy source to activate the transducers 8310 to deliver acoustic energy; ¶738); and a controller operably coupled to the source of excitation energy (¶551-deliver electrical energy from a generator or other energy source to activate the transducers 8310 to deliver acoustic energy; ¶177-a controller (e.g., generator) positioned outside of a subject's body that is communicatively coupled (via wired or wireless connection) to an energy delivery device; ¶423-execution by a processor or other computing device, cause delivery of an energy protocol; ¶529-the energy delivery module 8015 includes a processor 8030 (for example, a processing or control unit) that is configured to regulate one or more aspects of the energy delivery system; ¶478; ¶585; ¶680) and adapted to control the source of excitation energy (¶551-deliver electrical energy from a generator or other energy source to activate the transducers 8310 to deliver acoustic energy; ¶177-a controller (e.g., generator) positioned outside of a subject's body that is communicatively coupled (via wired or wireless connection) to an energy delivery device; ¶99-the generator may be adapted to adjust a frequency of the energy being delivered by the at least one ultrasound transducer based on the mode of operation; ¶478-the delivery of energy may be controlled manually or automatically according to a preconfigured energy profile determined by a controller, processor or other computing device; ¶529-the energy delivery module 8015 includes a processor 8030 (for example, a processing or control unit) that is configured to regulate one or more aspects of the energy delivery system 8000).
Regarding claim 2, Vrba teaches the system of claim 1, wherein the stimulation implant is adapted to provide mechanical energy to the patient's hepatic neural plexus by undergoing physical movement (¶220-the selective modulation or disruption of nerve fibers may be performed through mechanical or physical disruption, such as, but not limited to, cutting, severing, ripping, tearing, transecting, or crushing; ¶221-a mechanical compressive force or crushing force may be applied to a nerve, such as a sympathetic nerve in the hepatic plexus; ¶222-these compressive forces may be effected by the various embodiments of mechanical neuromodulation devices).
Regarding claim 14, Vrba teaches the system of claim 2, wherein the stimulation implant comprises a piezoelectric material (¶549-the transducers 8210 have a width of 0.5-2 mm, a length of between 4-6 mm, a spacing of 2-3 mm in the energy delivery configuration and a thickness of half a wavelength using the speed of sound in a piezoelectric crystal; ¶47-a neuromodulation device consists or consists essentially only of four electrodes or transducers) and the source of excitation energy comprises a source of electricity (¶551-deliver electrical energy from a generator or other energy source to activate the transducers 8310 to deliver acoustic energy; ¶214; ¶738).
Regarding claim 21, Vrba teaches the system of claim 1, wherein the stimulation implant is adapted to be secured to anatomy near the patient's hepatic neural plexus (¶248-one or more electrodes can be positioned so as to be in contact with the inner walls (e.g., intima) of the blood vessel (e.g., common hepatic artery or proper hepatic artery) at one or more target ablation sites adjacent the autonomic nerves to be disrupted or modulated, thereby providing intravascular energy delivery. In some embodiments, the electrodes are coupled to expandable and collapsible structures (e.g., self-expandable or mechanically expandable) to facilitate contact with an inner vessel wall. The expandable structures can comprise coils, springs, prongs, tines, scaffolds, wires, stents, balloons, cages, baskets and/or the like, the electrodes can be needle electrodes configured to penetrate through a wall of a blood vessel (e.g., a hepatic artery) to deliver energy extravascularly to disrupt sympathetic nerve fibers (e.g., the hepatic plexus)).
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 3 and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Vrba in view of Caparso (US 20220176141 filed on 4/1/20).
Regarding claim 3, Vrba teaches the system of claim 2, wherein: the stimulation implant comprises a permanent magnet (¶357-a neuromodulation device (e.g., ablation catheter) is comprised of at least an electrode 3215 , a flexible shaft 3210 , and a segment or element 3218 that is capable of carrying a magnetic field (for example, a ferromagnetic material) and that is significantly close to the electrode to effect movement of the electrode in response to one or more applied magnetic field, the magnetic segment 3218 comprises a ferromagnet and/or electro-magnet). While Vrba teaches an induction coil (¶592), Vrba does not explicitly teach the source of excitation energy comprises an inductive coil that is configured to be placed against the patient's skin in order to provide excitation energy to the permanent magnet.
Caparso teaches the source of excitation energy comprises an inductive coil that is configured to be placed against the patient's skin in order to provide excitation energy to the permanent magnet (¶63-the external device contains an inductive coil, that is configured to produce the one or more corresponding magnetic fields to interact with the highly magnetic permeable material within the microstimulator; Figs. 3a-3b where inductive coil 110 is right near living body 140).
Caparso generally relates to neural stimulation in a living body. More specifically, the embodiments of the present invention relate to wireless neural stimulation with a wearable controller and an implantable device (¶2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Vrba to include the source of excitation energy comprises an inductive coil that is configured to be placed against the patient's skin in order to provide excitation energy to the permanent magnet of Caparso in order to cause neural stimulation within the stimulation area of the tissue (Caparso, ¶11).
Regarding claim 12, the combination of Vrba and Caparso teaches the system of claim 3, wherein the controller is adapted to provide an alternating current to the inductive coil in order to generate an alternating magnetic field that provides the excitation energy to the stimulation implant (Caparso, ¶31-each coil can be configured to drive multiple frequencies of the magnetic field and be electrically controlled to provided time varying and alternating magnetic fields that produce different types of electrical fields with the body, which will interact differently with the microstimulator; ¶10-the time-varying magnetic field causes an elevated electrical current density in a stimulation area of the tissue proximate the implantable microstimulator, causing neural stimulation within the targeted stimulation area of the tissue).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Vrba to include wherein the controller is adapted to provide an alternating current to the inductive coil in order to generate an alternating magnetic field that provides the excitation energy to the stimulation implant of Caparso in order to cause an elevated electrical current density in a stimulation area of the tissue proximate the implantable microstimulator, causing neural stimulation within the targeted stimulation area of the tissue (Caparso, ¶10) and produce different types of electrical fields with the body, which will interact differently with the microstimulator (Caparso, ¶31).
Regarding claim 13, the combination of Caparso and Vrba teaches the system of claim 12, wherein the controller is adapted to provide an alternating current to the inductive coil at an AC frequency ranging from 30 Hertz (Hz) to 20,000 Hz (Caparso, ¶31-each coil can be configured to drive multiple frequencies of the magnetic field and be electrically controlled to provided time varying and alternating magnetic fields; ¶44-frequencies between 1 and 10,000 Hz).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Vrba to include wherein the controller is adapted to provide an alternating current to the inductive coil at an AC frequency ranging from 30 Hertz (Hz) to 20,000 Hz of Caparso in order to cause an elevated electrical current density in a stimulation area of the tissue proximate the implantable microstimulator, causing neural stimulation within the targeted stimulation area of the tissue (Caparso, ¶10) and produce different types of electrical fields with the body, which will interact differently with the microstimulator (Caparso, ¶31).
Claims 4-11 are rejected under 35 U.S.C. 103 as being unpatentable over Vrba in view of Caparso as applied to claim 3 above, and further in view of Jiang (NPL “A Versatile Hermetically Sealed Microelectronic Implant for Peripheral Nerve Stimulation Applications” published in 2021).
Regarding claim 4, the combination of Vrba and Caparso teaches the system of claim 3. However, the combination of Vrba and Caparso does not teach wherein the permanent magnet comprises a neodymium magnet.
Jiang teaches wherein the permanent magnet comprises a neodymium magnet (page 2, right col., last ¶-the implantable stimulator comprises a hybrid unit, where the stimulation electronics are mounted and sealed inside a ceramic package, a Rx coil printed circuit board (PCB) with a solenoid coil and tuning capacitors for inductive coupling, and three miniature connectors for connecting electrode arrays, the Rx coil PCB also has a neodymium rare earth magnet (8 mm × 3 mm, Duratool); Fig. 1).
Jiang relates to a versatile neurostimulation platform featuring a fully implantable multi-channel neural stimulator (Abstract).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Vrba to include wherein the permanent magnet comprises a neodymium magnet of Jiang in order to aid alignment with the coil outside the body (Jiang, page 2, right col., last ¶) and provide inductive coupling (Jiang, page 2, right col., last ¶).
Regarding claim 5, the combination of Vrba and Caparso teaches the system of claim 3. However, the combination of Vrba and Caparso does not teach wherein the permanent magnet comprises a hermetically encapsulated permanent magnet.
Jiang teaches wherein the permanent magnet comprises a hermetically encapsulated permanent magnet (page 2, left col., last ¶-a hermetically sealed, fully implantable stimulator; page 2, right col., last ¶- the implantable stimulator comprises a hybrid unit, where the stimulation electronics are mounted and sealed inside a ceramic package, a Rx coil printed circuit board (PCB) with a solenoid coil and tuning capacitors for inductive coupling, and three miniature connectors for connecting electrode arrays. The Rx coil PCB also has a neodymium rare earth magnet (8 mm × 3 mm, Duratool); Fig. 1-shows implantable stimulator with an encased magnet).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Vrba to include wherein the permanent magnet comprises a hermetically encapsulated permanent magnet of Jiang in order to ensure the suitability of the stimulator for chronic implantation (Jiang, page 3, right col., ¶1).
Regarding claim 6, the combination of Vrba, Caparso, and Jiang teaches the system of claim 5, wherein the permanent magnet is hermetically encapsulated within a housing (Jiang, page 2, left col., last ¶-a hermetically sealed, fully implantable stimulator; page 2, right col., last ¶- the implantable stimulator comprises a hybrid unit, where the stimulation electronics are mounted and sealed inside a ceramic package, a Rx coil printed circuit board (PCB) with a solenoid coil and tuning capacitors for inductive coupling, and three miniature connectors for connecting electrode arrays. The Rx coil PCB also has a neodymium rare earth magnet (8 mm × 3 mm, Duratool); Fig. 1-shows implantable stimulator with an encased magnet).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Vrba to include wherein the permanent magnet is hermetically encapsulated within a housing of Jiang in order to ensure the suitability of the stimulator for chronic implantation (Jiang, page 3, right col., ¶1).
Regarding claim 7, the combination of Vrba, Caparso, and Jiang teaches the system of claim 6, wherein the housing is adapted to be laparoscopically implanted (Vrba, ¶14-minimally invasive surgical delivery (e.g., laparoscopic) of the neuromodulation system; ¶732-neurostimulation is provided using an implantable device; ¶93-the contact sensing unit may be positioned within the elongated shaft, the contact sensing unit is within a same housing as the power or energy source (e.g., RF generator); ¶552- the flexible circuit 8305 is reinforced with (e.g., affixed to the substrate) metallic, metallic alloy (e.g., Nitinol), ceramic or polymeric material, elements or structures to provide stability and strength and/or to provide further control over deployment and withdrawal and to provide more precision for a desired energy delivery configuration; ¶553).
Regarding claim 8, the combination of Vrba, Caparso, and Jiang teaches the system of claim 6, wherein the housing is adapted to be intravascularly implanted (Vrba, ¶12-a therapeutic neuromodulation or disruption system is delivered intravascularly through the venous system; ¶52-a device for hepatic neuromodulation is provided. In one embodiment, the device comprises a catheter body having a proximal end and a distal end and a lumen extending from the proximal end to the distal end and the catheter body is configured for percutaneous, intravascular placement within a hepatic artery branch; ¶552-553).
Regarding claim 9, the combination of Vrba, Caparso, and Jiang teaches the system of claim 6, wherein the housing is adapted to be implanted near the hepatic neural plexus of the patient (Vrba, ¶28-delivering an RF ablation catheter (e.g., hollow, solid, partially hollow, catheter, probe, shaft or other delivery device with or without a lumen) to a vicinity of a hepatic plexus of a subject; ¶51; ¶552-553).
Regarding claim 10, the combination of Vrba, Caparso, and Jiang teaches the system of claim 6, wherein the housing is adapted to be implanted within an hepatic portal vein of the patient (Vrba, ¶487-the second catheter may be inserted within an adjacent vessel, the second catheter can be inserted within…the portal vein; ¶718-an ablation catheter system may be delivered through the portal vein; ¶742-the stimulation lead is positioned in the portal vein and activated to stimulate nerve fibers surrounding the portal vein; ¶537; ¶552-553).
Regarding claim 11, the combination of Vrba, Caparso, and Jiang teaches the system of claim 6, wherein the housing is adapted to be implanted on or within a heptatoduodenal ligament of the patient (Vrba, ¶11-an ablation catheter system is advanced to the proper hepatic artery; ¶26-advancing the neuromodulation device from the femoral artery through an arterial system to a common or proper hepatic artery; ¶487-the second catheter may be inserted within an adjacent vessel, the second catheter can be inserted within…the portal vein; ¶718-an ablation catheter system may be delivered through the portal vein; ¶742-the stimulation lead is positioned in the portal vein and activated to stimulate nerve fibers surrounding the portal vein; ¶537; ¶552-553; The Examiner notes that the proper hepatic artery and portal vein are a part of the hepatoduodenal ligament).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Vrba in view of Ilan (US 20180185238 filed on 6/22/16).
Regarding claim 15, Vrba teaches the system of claim 2. However, Vrba does not teach wherein the stimulation implant comprises an eccentric rotating mass.
Ilan teaches wherein the stimulation implant comprises an eccentric rotating mass (¶26-the capsule or the belt are configured to apply a mechanical stimulation through rotation of the capsule or the belt, rotation frequency between values ranging from about 10,000 cycles/second to 1 cycle/minute).
Ilan relates to medical devices configured to stimulate the gastrointestinal tract and optionally other organs through various stimuli including mechanical and electrical stimuli (¶1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Vrba to include wherein the stimulation implant comprises an eccentric rotating mass of Ilan in order to apply a mechanical stimulation (Ilan, ¶29) or an electrical stimulation (Ilan, ¶30).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20100249873: ¶29-control of this portion of the sphincter complex may be managed by direct application of stimulation signals to the muscles that form it, or by applying stimulation to the nerves that innervate the muscle, i.e., nerves passing into, and out from the hepatic plexus.
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.
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/L.N.H./Examiner, Art Unit 3792
/AMANDA L STEINBERG/Examiner, Art Unit 3792
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