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 Invention I and Species with the following subspecies: 1L and 2D in the reply filed on May 11, 2026 is acknowledged. Claims 136-152 are pending under examination. Claims 153 and 154 are cancelled.
Drawings
The drawings are objected to because:
Reference character “TEW” in Figure 11 should read TEN as used in the specification [0339].
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 136, 138, 141-145, 149-150, and 152 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Forsell (US 2011/0087337).
In re claim 136, Forsell discloses a system for treating a patient having a disorder related to a patient's intestine [2110], comprising
a plurality of electrical stimulation devices [2138],
wherein each of the electrical stimulation devices comprises
one or more electrodes [2138] for electrically stimulating muscle or neural tissue of the intestine [2138] and
a wireless energy receiver configured to receive energy [4027] for stimulating the muscle or neural tissue wirelessly ([4028]: “deliver the electrical pulses”).
In re claim 138, Forsell discloses wherein the wireless energy receiver is configured to receive the via RFID pulses ([3654]: “second coil of the energy transmitter transmits wireless energy which is received by the first coil of the energy receiver”; Note: Applicant’s instant specification discloses that transferring energy by RFID using primary and secondary coils is known [013]).
In re claim 141, Forsell discloses the system configured to electrically stimulate, by means of the electrodes of the electrical stimulation devices, the muscle or neural tissue sufficiently for a muscle of the intestine to contract to an extent such that the intestine constricts [2396].
In re claim 142, Forsell discloses wherein the system is configured to be applied to a reservoir section of the intestine [2112] which is formed from surgically modified intestine that has been cut along a mutual contact line of laterally adjacent sections of a bent portion of intestine and connected so that the upper and lower halves of the cut intestine form an intestinal wall of the reservoir section [2115].
In re claim 143, Forsell discloses wherein at least the electrodes of the electrical stimulation devices are configured to be implanted in surgically created folds of the patient's intestine [4055].
In re claim 144, Forsell discloses the system comprising at least one mechanical or hydraulic constriction device [4059] configured to be implanted outside the patient's intestine in close proximity thereto for constricting the intestine from the outside thereof [4059].
In re claim 145, Forsell discloses the system configured to electrically stimulate, by means of the electrodes of the electrical stimulation devices, the muscle or neural tissue in an area of the intestine constricted by the at least one mechanical or hydraulic constriction device sufficiently for increasing blood flow through the tissue of the intestine [2949, 2950].
In re claim 149, Forsell discloses wherein the electrical stimulation devices are configured such that at least two of the electrodes can be arranged on opposing sides of the patient's intestine ([2929]: “plurality of electrodes preferably mounted on one or more holding devices” and “holding devices can then be arranged… preferably on two opposing sides”).
In re claim 150, Forsell discloses the system configured to control the electrodes such that the tissue is stimulated by a series of electrical pulses [2927].
In re claim 152, Forsell discloses wherein the system makes part of:
(a) an artificial sphincter [0139] which is configured, when implanted, to act on a wall of an intestine of a patient so as to restrict flow of intestinal contents through the intestine ([0139]: “flatten a portion of the intestines to at least almost completely stop the fecal flow”) or
(b) an emptying device ([0288]: “constriction and stimulation devices”; Note: the Applicant’s instant specification states the electrical stimulation devices and constriction devices can work together to form an emptying device [026]) which is configured, when implanted, to act on a wall of an intestine of a patient so as to advance intestinal contents contained in the intestine out of the intestine ([0288]: “release the portion of the intestines and cease the stimulation, whereby intestinal contents may pass the portion of the intestines”).
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.
Claims 137, 139, and 140 are rejected under 35 U.S.C. 103 as being unpatentable over Forsell (US 2011/0087337) in view of Ram Rakhyani et al. (US 2017/0239484).
In re claim 137, Forsell discloses comprising
an individual wireless energy transmitter for the electrical stimulation devices ([3669]: “external energy transmitter that transmits wireless energy”) and
configured to transfer energy to the respective one of the electrical stimulation devices [3657]: “energy transmitter transmits wireless energy which is received… by the energy receiver”; [3659]: “energy receiver may comprise a constant voltage circuit… for supplying energy… to the constriction/stimulation unit”).
Forsell lacks
an individual wireless energy transmitter for each one of the electrical stimulation devices
Ram Rakhyani teaches a neurostimulation system that uses a micro particle, or other neural stimulator, to stimulate tissue at a target location [0009], such as the small intestine [0054]. The system can include a single central controller or multiple central controllers and a single micro particle or multiple micro particles [0023]. The central controller has a transceiver, or a transmitter and receiver (fig. 2: 124, 130; [0028]) for wirelessly transmitting energy [0035]. Each micro particle also includes its own transceiver (fig. 3: 220) that can both receive and transmit signals to communicate with the central controller [0034].
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the system of Forsell with having the ability to have multiple controllers and stimulation devices that each have a transmitter as taught by Ram Rakhyani, as using multiple controllers and stimulation devices that each have their own transmitter would allow for energy and signal transmission to occur between specific stimulation devices and controllers depending on which part of the body is being stimulated, the function of the body part being stimulated, and depending on the overall power of the controller.
In re claim 139, Forsell discloses wherein the electrical stimulation devices comprises an internal controller ([3669]: “internal control unit, which may include a microprocessor, for controlling the constriction and stimulation devices”).
Forsell lacks
wherein each of the electrical stimulation devices comprises an internal controller.
Ram Rakhyani teaches a neurostimulation system that uses a micro particle, or other neural stimulator, to stimulate tissue at a target location [0009]. The system can use more than one micro particle [0022]. An individual micro particle has a processor (fig. 3: 216) that can be used to control the overall operation of the micro particle [0032, 0033].
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the system of Forsell with each device used for stimulation having its own processor as taught by Ram Rakhyani, as each device having its own processor would allow each individual device to control when stimulation is provided through the electrodes.
In re claim 140, Forsell discloses wherein the internal controller can be controlled by an external controller or remote controller ([3669]: “external control unit in the form of a hand-held wireless remote control… the remote control is operable by the patient to control the internal control unit”).
Forsell lacks
wherein the internal controller includes an individual code by which it is individually addressable by an external controller or remote controller.
Ram Rakhyani teaches that each micro particle can be uniquely addressed by different methods including by being hard coded during fabrication [0043]. Due to the unique addressing, the central controller can send unique information signals to each individual micro particle [0043].
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the system of Forsell with each device used for stimulation being coded to be uniquely addressable by the controller as taught by Ram Rakhyani, as each device having its own unique address would allow the controller to send or receive information from each device which would ensure the desired devices in the target locations were being used.
Claim 146 is rejected under 35 U.S.C. 103 as being unpatentable over Forsell (US 2011/0087337) in view of Von Arx et al. (US 2005/0204134).
In re claim 146, Forsell lacks
wherein the system is configured such that at least one of:
- wireless communication from or to, or both from and to, a controller of the system is encrypted,
- data transmitted by a controller via wireless communication is signed, and
- authentication of a user of the system involves input of authentication data of the patient.
Von Arx teaches a system for securely authenticating a data exchange session with an implantable medical device (IMD) [0001] that can be used for neural stimulation [0035]. During a data exchange session, sensitive information can be wirelessly communicated through an IMD and an external source [0037]. The information can be sent in an encrypted form [0039] using a crypto key that encrypts and decrypts sensitive information transmitted or received wirelessly ([0043]; Note: Applicant’s instant specification discloses data may be signed using a private or public key [0431]). Before starting the data exchange session, patient/clinician authentication has to be secured [0037].
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the system of Forsell with encrypting the data being sent between the controller and the stimulation devices and ensuring the user is authenticated as taught by Von Arx, as encrypting data, signing the data, and only allowing data to be exchanged between devices after a user is authenticated protects the patient’s personal health information and prevents a user from exchanging data with the wrong patient or without the patient knowing.
Claim 147 is rejected under 35 U.S.C. 103 as being unpatentable over Forsell (US 2011/0087337) in view of Hincapie et al. (US 2021/0379373).
In re claim 147, Forsell lacks
wherein the one or more electrodes comprise a bare electrode portion configured to form a metal-tissue interface with the tissue, thereby allowing faradaic charge transfer to be the predominant charge transfer mechanism over said interface.
Hincapie teaches an implantable medical lead that has electrodes configured to stimulate body tissue [0002]. The implantable medical lead delivers electrical stimulation by using metal electrodes which carry current to biological tissue [0036]. The electrodes can be made of different metals and can be separated by insulator bands [0050].
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the system of Forsell by using an electrode with bare metal portions as taught by Hincapie, as using metal electrodes can carry current to biological tissue and would allow for faradaic charge transfer to be the predominant charge transfer over the electrode-tissue interface.
Claim 148 is rejected under 35 U.S.C. 103 as being unpatentable over Forsell (US 2011/0087337) in view of Zemel et al. (US 2015/0182282).
In re claim 148, Forsell lacks
wherein the one or more electrodes comprise an electrode portion at least partly covered by a dielectric material configured to form a dielectric-tissue interface with tissue, thereby allowing for a faradaic portion of the charge transfer mechanism over said interface to be reduced.
Zemel teaches a system for treating tissue using electrical fields [0003] while limiting the amount of electrical current that is generated within the tissue (abstract). Zemel teaches having a layer of dielectric material between tissue and electrodes to limit the conduction of current through the tissue [0047].
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the system of Forsell with covering the electrodes with dielectric material as taught by Zemel, which would reduce the faradaic portion of the charge transfer mechanism by reducing the conduction of current between the tissue and would reduce the chance of tissue damage or electrode corrosion.
Claim 151 is rejected under 35 U.S.C. 103 as being unpatentable over Forsell (US 2011/0087337) in view of Grossman et al. (US 2018/0280582).
In re claim 151, Forsell lacks
comprising an outer surface and a coating arranged on the outer surface.
Grossman teaches that implantable medical devices [0002] can have surfaces comprised of different material, such as metal or silicone [0016]. The implantable devices can have antimicrobial coatings dried on the surface [0016].
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the system of Forsell with an implantable medical device having an outer surface and a coating on that surface as taught by Grossman, as implants have an outer surface that interacts with the body and different materials can be selected for the outer surface that are known to be safe or commonly used; additionally, it is known to apply coatings to the outer surfaces of implants, such as an antimicrobial coating, which can lower infection risks after surgery.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Jaax et al. (US 2006/0161217) teaches a method for treating obesity by using stimulation (abstract). Multiple stimulators (fig. 9: 140-1, 140-2) and multiple external devices ([0052]: last sentence) can be used. The external devices an wirelessly transmit data or energy via wireless RF links [0052].
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HALEY N. PRUITT whose telephone number is (571)272-1955. The examiner can normally be reached M-T, 7:30 AM -5 PM. F, 7:30-4.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571)270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HALEY N PRUITT/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796
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