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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-15) in the reply filed on 3/2/26 is acknowledged.
Claims 16-19 (Group II) and Claim 20 (Group III) are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/2/26.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/19/24 is being considered by the examiner.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“stimulation device” in claims 1, 2, and 12.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
For a “stimulation device” in claims 1, 2, and 12, and all dependent claims thereof, the specification discloses “the stimulation device may include a permanent magnet” (¶28), “the stimulation device may include a piezoelectric material” (¶39), “the stimulation device may include an eccentric rotating mass” (¶40), and “the stimulation device 12 may include a transducer” (¶85). Therefore, the Examiner is interpreting a stimulation device to be a permanent magnet, a piezoelectric material, an eccentric rotating mass, a transducer, or any equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 3-13 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 3 includes the limitation of “an inductive coil placed against the patient's skin.” As such, the limitation requires that an inductive coil would encompass being in contact with a patient (human organism) under the broadest reasonable interpretation. Applicant should be recommended to change the claimed limitation to –an inductive coil configured to be placed against the patient’s skin-- in order to overcome this 101 rejection.
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 and 14 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 device 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 device (¶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 device 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 device 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).
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 device 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 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 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 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 device (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 device 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 device comprises an eccentric rotating mass.
Ilan teaches wherein the stimulation device 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 device comprises an eccentric rotating mass of Ilan in order to apply a mechanical stimulation (Ilan, ¶29) or an electrical stimulation (Ilan, ¶30).
Conclusion
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/LAURA HODGE/Examiner, Art Unit 3792