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 .
Response to Arguments
Applicant’s arguments filed 1/2/2026 with respect to the rejection of independent Claim 1 under 35 USC 103 as being unpatentable over US 2018/0304086 A1 to Shellhammer et al. (“Shellhammer”) in view of WO 2020/206332 A1 to Robinson et al. (“Robinson”), US 2018/0353095 A1 to Boesen (“Boesen”) and US 2015/0174418 A1 to Tyler et al. (“Tyler”) have been fully considered and are persuasive. The Examiner agrees that the combination of Shellhammer, Robinson, Boesen and Tyler does not teach “wherein each of the plurality of implantable devices are configured to deliver stimulation after a predefined period of time elapse from receiving the instruction.” Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of US 2013/0261703 A1.
Applicant’s arguments regarding dependent Claims 2-15 are based on Applicant’s arguments regarding Independent Claim 1. Applicant’s arguments have been fully considered and are persuasive for the same reasons as explained above. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of US 2013/0261703 A1.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 recites “a predefined period of time elapse” at Ln. 19, but should recite --a predefined period of time elapsed--. Appropriate correction is required.
Election/Restrictions
Newly submitted claims 27-40 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Claims 27-33 (Invention II) and Claims 34-40 (Invention III) are related to the originally claimed invention of Claims 1-15 (Invention I) as combination (Invention I) and subcombination (Inventions II and III), and Claims 27-33 (i.e., Invention II) are related to Claims 34-40 (Invention III) as combination (Invention II) and subcombination (Invention III). See MPEP 806.05(c). “To support a requirement for restriction between combination and subcombination inventions, both two-way distinctness and reasons for insisting on restriction are necessary….” MPEP 806.05(c). “The inventions are distinct if it can be shown that a combination as claimed: (A) does not require the particulars of the subcombination as claimed for patentability (to show novelty and unobviousness), and (B) the subcombination can be shown to have utility either by itself or in another materially different combination.” Id. “Where a combination as claimed does not require the details of the subcombination as separately claimed and the subcombination has separate utility, the inventions are distinct and restriction is proper….” MPEP 806.05(c)(II)(A) (emphasis in original).
In the instant claim set, the combination (i.e., Invention I) broadly recites both subcombinations (i.e., Inventions II and III), but the combination (i.e., Invention I) does not require the specific characteristics required by the subcombinations (i.e., Inventions II and III). Since claims to both the subcombination and combination are presented, the omission of details of the claimed subcombination in the combination claim is evidence that the combination does not rely upon the specific limitations of the subcombination for its patentability. More specifically:
Invention I requires that “each of the plurality of implantable devices are configured to deliver stimulation after a predefined period of time elapse from receiving the instruction,” whereas Inventions II and III do not.
Invention II requires that “the plurality of implantable devices are configured to emit a plurality of electrical signals with different frequencies and the plurality of electrical signals overlap to stimulate a target region by interference, and the interference is produced by controlling a relative timing of an electrical field generated by the plurality of implantable devices.” Invention I does not require these specifics, but requires more broadly that “the plurality of implantable devices are configured to emit a plurality of electrical signals with different frequencies and the plurality of electrical signals constructively interfere to stimulate a target region.” Emission of such electrical signals as required by Invention II is a subset of emission of such electrical signals as required by Invention I: thus, the emission of Invention I is a broad recitation of the specific emission of Invention II, but the emission of Invention I does not require the specifics of Invention II. Invention II has separate utility by itself, for example utility in applications wherein it is desired to deliver stimulation to a target without affecting intermediate locations which may be differently impacted by a particular frequency.
The combination (i.e., Invention I) as claimed does not require the details of the subcombination (i.e., Invention II) as separately claimed, and the subcomination (i.e., Invention II) has separate utility. Restriction is thus proper.
Invention III requires that the recited transceiver “transmit, based on the identifier, an instruction including an implant stimulation protocol specific to a first implantable device of the plurality of implantable devices for delivering stimulation to a target tissue at one or more stimulation times, wherein a second implantable device records the one or more stimulation times at which the first implantable device delivers the stimulation to the target tissue” and that the recited “one or more sensors that are physically connected or wirelessly connected to the base station access a physiological signal, wherein a prediction of whether or a degree to which the implant stimulation protocol results in a target effect is facilitated based on one or more select portions of the physiological signal, where each portion has a start time corresponding to a stimulation time of the one or more stimulation times.” The transmission of Invention III is a subset of the transmission of Invention I, and the sensor function of Invention III is a subset of the sensor function of Invention I: thus, the emission of Invention I is a broad recitation of the specific emission of Invention III, but the emission of Invention I does not require the specifics of Invention III. Invention III has separate utility by itself, for example use in a closed loop treatment system.
The combination (i.e., Invention I) as claimed does not require the details of the subcombination (i.e., Invention III) as separately claimed, and the subcomination (i.e., Invention III) has separate utility. Restriction is thus proper.
In the instant claim set, the combination (i.e., Invention II) broadly recites the subcombination (i.e., Inventions III), but the combination (i.e., Invention II) does not require the specific characteristics required by the subcombinations (i.e., Inventions III). Since claims to both the subcombination and combination are presented, the omission of details of the claimed subcombination in the combination claim is evidence that the combination does not rely upon the specific limitations of the subcombination for its patentability. More specifically:
Invention II requires that “the plurality of implantable devices are configured to emit a plurality of electrical signals with different frequencies and the plurality of electrical signals overlap to stimulate a target region by interference, and the interference is produced by controlling a relative timing of an electrical field generated by the plurality of implantable devices,” whereas Invention III does not.
Invention III requires that the recited transceiver “transmit, based on the identifier, an instruction including an implant stimulation protocol specific to a first implantable device of the plurality of implantable devices for delivering stimulation to a target tissue at one or more stimulation times, wherein a second implantable device records the one or more stimulation times at which the first implantable device delivers the stimulation to the target tissue” and that the recited “one or more sensors that are physically connected or wirelessly connected to the base station access a physiological signal, wherein a prediction of whether or a degree to which the implant stimulation protocol results in a target effect is facilitated based on one or more select portions of the physiological signal, where each portion has a start time corresponding to a stimulation time of the one or more stimulation times.” The transmission of Invention III is a subset of the transmission of Invention II, and the sensor function of Invention III is a subset of the sensor function of Invention II: thus, the emission of Invention II is a broad recitation of the specific emission of Invention III, but the emission of Invention II does not require the specifics of Invention III. Invention III has separate utility by itself, for example use in a closed loop treatment system.
The combination (i.e., Invention II) as claimed does not require the details of the subcombination (i.e., Invention III) as separately claimed, and the subcomination (i.e., Invention III) has separate utility. Restriction is thus proper.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
The inventions require different fields of search (i.e., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries). For example, Invention I requires unique text and image search in at least A61N 1/37223 for the particulars of a specific manner of delivering stimulation after a predefined period of time elapsed , whereas Inventions II and III do not. Invention II requires unique text and image search in at least A61N 1/3615 for a particular configuration wherein implantable devices are configured to emit a plurality of electrical signals with different frequencies which overlap in a particular manner to stimulate a target region by a particular type of interference, which interference is produced in a particular manner by controlling a relative timing, whereas Inventions I and III do not. Invention III requires unique text and image search in at least A61N 1/36139 for a particular stimulation protocol, a particular manner of recording, and a particular use of sensors for making a specific prediction, whereas Inventions I and II do not.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 27-40 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
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 1 and 8-15 are rejected under 35 U.S.C. 103 as being unpatentable over previously cited US 2018/0304086 A1 to Shellhammer et al. (“Shellhammer”) in view of previously cited WO 2020/206332 A1 to Robinson et al. (“Robinson”), previously cited US 2018/0353095 A1 to Boesen (“Boesen”), previously cited US 2015/0174418 A1 to Tyler et al. (“Tyler”) and US 2013/0261703 A1 to Chow et al. (“Chow”).
Regarding Independent Claim 1, Shellhammer teaches:
A system comprising: (Para. [0005], “A medical device, according to the disclosure, comprises…”);
a plurality of implantable devices, (Fig. 1, “medical implants 130;” Para. [0029], “Depending on the application, the wireless medical implant system may comprise hundreds or thousands of medical implants 130;” see Annotated Fig. 1, below);
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wherein each of the plurality of implantable devices includes: (Para. [0076] through [0078]; Fig. 9; see Annotated Fig. 9, below);
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a [transductive communication element]; (Fig. 9, “communication interface 930” and “antenna(s) 935;” Para. [0077]; see Annotated Fig. 9, above);
Shellhammer does not disclose such a “magnetoelectric film” as claimed, but teaches a similar transductive communication element. This deficiency is addressed below.
See Para. [0046] of the Present Specification in support of this interpretation (“…the implantable device can include a magnetoelectric film that acts as a transducer…”).
an electrical circuit coupled to the magnetoelectric film; (Fig. 9, “processing unit(s) 910;” Para. [0078], “The processing unit(s) 910 may control the operation of the stimulator(s) 940, and may therefore control the timing, amplitude, and/or other stimulation provided by the stimulator(s) 940;” see Annotated Fig. 9, above);
and one or more electrodes, (Fig. 9, “stimulator(s) 940;” Para. [0078], “…stimulator(s) 940 may comprise an electrode, LED, and/or other component configured to provide electrical, optical, and/or other stimulation;” see Annotated Fig. 9, above);
wherein the plurality of implantable devices are configured to emit a plurality of electrical signals… (Para. [0078], “The stimulator(s) 940 of the medical implant 130 can enable the medical implant 130 to provide stimulation to a body part (e.g., biological tissue) in which the medical implant 130 is implanted. As such, the stimulator(s) 940 may comprise an electrode, LED, and/or other component configured to provide electrical, optical, and/or other stimulation.”);
a base station (Figs. 1 and 8, “interrogator device 140;” see Annotated Fig. 1, above);
that includes: a … generator; a … transceiver (Para. [0031], “A person of ordinary skill in the art will appreciate the basic hardware configuration of an interrogator device 140 and/or medical implant 130. This can include, for example, a power source, processing unit, communication bus, volatile and/or non-volatile memory (which may comprise a non-transitory computer-readable medium having computer code for execution by the processing unit), transceiver, antenna, etc.”);
Shellhammer differs from the Present Invention in that Shellhammer uses RF rather than electromagnetic power (see Shellhammer at Para. [0005]; Present Specification at Para. [0045]). Shellhammer’s device thus does not include a “magnetic field” generator or a “magnetic” transceiver, but employs similar components that are functionally equivalent but-for their use of RF rather than electromagnetic power. This deficiency is addressed below.
wherein the … transceiver is configured to: receive an uplink communication from each of the plurality of implantable devices, wherein the uplink communication includes an identifier associated with each of the plurality of the implantable devices, (Para. [0042], “FIG. 3 is an illustration of how operating frames 300-1 and 300-2 (collectively and generically referred to herein as operating frames 300) can be communicated and what they may comprise, according to some embodiments. As illustrated, operating frames 300 can include both downlink (interrogator device to medical implant) and uplink (medical implant to interrogator device) communications;” Para. [0052], “In some embodiments, each uplink trigger subframe 330 may include information such as a counter, medical device address, or other identifier to indicate its position in the operating frame 300 and/or indicate the medical device designated to provide an uplink subframe 340 in the following uplink slot.”);
As noted above, Shellhammer differs from the Present Invention in that Shellhammer uses RF rather than electromagnetic power (see Shellhammer at Para. [0005]; Present Specification at Para. [0045]). Shellhammer thus does not teach uplink/downlink communication being done via such a “magnetic” transceiver as claimed. This deficiency is addressed below.
and transmit, based on the identifier, an instruction including an implant stimulation protocol specific to each of the plurality of implantable devices; (Para. [0043], “Here, the downlink payload 320 can include information for the medical implants to, for example, control stimulation (turning it on/off, communicating a level of stimulation, etc.), brain function sensing, and/or other functionality. Again, and data can be encoded in pulse pairs, as previously described;” see also Para. [0053]).
Shellhammer does not disclose:
a magnetoelectric film (i.e., Shellhammer teaches a transductive communication element, but does not teach “wherein the transductive communication element is a magnetoelectric film).
with different frequencies and the plurality of electrical signals constructively interfere to stimulate a target region;
that includes: a magnetic field generator; a magnetic transceiver,
wherein the magnetic transceiver is configured to: (i.e., Shellhammer teaches similar uplink communication to that claimed, but Shellhammer’s device makes use of RF energy rather than magnetoelectric power)
wherein each of the plurality of implantable devices are configured to deliver stimulation after a predefined period of time elapse from receiving the instruction;
and one or more sensors that are physically connected or wirelessly connected to the base station
Robinson describes “Magnetoelectric data and power to miniature biodevices with tunable amplitude and waveform” (Title). Robinson is analogous art.
Robinson remedies the above-noted deficiency of Shellhammer (i.e., Shellhammer uses RF rather than electromagnetic power).
Robinson teaches:
a magnetoelectric film (Pg. 8, Ln. 26-31, “Certain embodiments include an apparatus comprising: a magnetic field generator and an implantable wireless neural stimulator, where the implantable wireless neural stimulator comprises: a magnetoelectric film; a first electrode coupled to the magnetoelectric film; a second electrode coupled to the magnetoelectric film; an electrical circuit coupled to the magnetoelectric film; a third electrode coupled to the electrical circuit; and a fourth electrode coupled to the electrical circuit.”);
that includes: a magnetic field generator; (Pg. 21, Ln. 1-3, “System 100 further comprises a magnetic field generator 130 comprising a permanent magnet 132 and an alternating current magnetic coil 134.”);
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the invention to modify the device of Shellhammer with the teachings of Robinson (i.e., to use such a magnetoelectric film as taught by Robinson in the device of Shellhammer, thereby enabling/requiring the concomitant adoption of such a magnetic field generator and magnetic transceiver as taught by Robinson and causing Shellhammer’s use of RF to be replaced by use of electromagnetic power in the manner of Robinson) in order to ameliorate miniaturization constraints imposed by RF technologies (Robinson at Pg. 24, Ln. 23-25), which miniaturization “is key to make devices wearable and to target difficult to reach areas of the body including deep brain areas and the periphery” (Robinson at Pg. 2, Ln. 30 through Pg. 3, Ln. 1).
It is noted that Robinson does not expressly disclose a “magnetic transceiver” (i.e., Robinson does not disclose “a magnetic transceiver” or “wherein the magnetic transceiver is configured to…”). This deficiency is addressed below.
Boesen describes “A wireless earpiece [which] includes a wireless earpiece housing, a processor, and a transceiver configured to produce electromagnetic pulses capable of reaching a brain of a user” (Abstract). Boesen is analogous art.
Boesen discloses:
a magnetic transceiver, (Para. [0038], “A transceiver 16 is operatively connected to the processor 14…. For example, the transceiver 16 may receive one or more signals from a mobile device or another wireless earpiece to stimulate the user's temporal lobes, and subsequently transmit a signal encoding the sensor readings or results to the same mobile device or wireless earpiece. In some embodiments, the transceiver 16 may be a near field magnetic induction transceiver (NFMI) and used both for NFMI communications and transcranial simulation;” Para. [0039], “…the transceiver 16 may represent a magnetic or other radio frequency transceiver.”);
wherein the magnetic transceiver is configured to… (Para. [0038], “A transceiver 16 is operatively connected to the processor 14…. For example, the transceiver 16 may receive one or more signals from a mobile device or another wireless earpiece to stimulate the user's temporal lobes, and subsequently transmit a signal encoding the sensor readings or results to the same mobile device or wireless earpiece. In some embodiments, the transceiver 16 may be a near field magnetic induction transceiver (NFMI) and used both for NFMI communications and transcranial simulation;” Para. [0054], “The wireless earpiece 10 may be part of a personal area network. The wireless earpieces may be utilized to control, communicate, manage, or interact with a number of other wearable devices, such as smart glasses, helmets, smart glass, watches or wrist bands, chest straps, implants, displays, clothing, or so forth.”);
and one or more sensors that are physically connected or wirelessly connected to the base station. (Para. [0041], “In addition to the earpiece housing 12, the processor 14, and the NFMI transceiver 16, the wireless earpiece 10 may further include a magnetic coil 18, a plurality of EEG sensors 20, one or more motion sensors 22, a differential amplifier 24, a microphone 26, a speaker 28, a memory 30, a bone conduction microphone 32, a wireless transceiver 34, a gesture interface 36, one or more LEDs 38, and an energy source 40. In some aspects of the present invention, the wireless earpiece may have additional sensors, such as environmental sensors 62, biological sensors 64, biometric sensors 66, neurological sensors 68, or physiological sensors 70.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Shellhammer and Robinson with the teachings of Boesen (i.e., to include such a magnetic transceiver as taught by Boesen in the base station of combined Shellhammer and Robinson) in order to facilitate wireless transmission of information (Boesen at Para. [0046]) and to enable use of the device as part of a wearable stimulation device (Boesen at Para. [0003]).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Shellhammer and Robinson with the teachings of Boesen (i.e., to include such sensors as taught by Boesen in the base station of combined Shellhammer and Robinson) in order to facilitate assessment of a user’s response to applied stimulation (Boesen at Paras. [0016] and [0043]).
Tyler describes “A system for transcranial electrical stimulation…” (Abstract). Tyler is analogous art.
Tyler teaches:
with different frequencies and the plurality of electrical signals constructively interfere to stimulate a target region (Para. [0183], “…device components transmit pulsed or amplitude modulated or frequency modulated weak-electrical fields from different locations on the head such that constructive interference patterns provide an effective targeting of the electrical field.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Shellhammer, Robinson and Boesen with the teachings of Tyler (i.e., to modify the device of combined Shellhammer, Robinson and Boesen such that Shellhammer’s implantable devices emit different frequencies and its electric signals constructively interfere) in order to “provide an effective targeting of the electrical field” (Tyler at Para. [0183]).
Chow describes “POWERING MULTIPLE IMPLANTABLE MEDICAL THERAPY DELIVERY DEVICES USING FAR FIELD RADIATIVE POWERING AT MULTIPLE FREQUENCIES” (Title). Chow is analogous art.
Chow teaches:
wherein each of the plurality of implantable devices are configured to deliver stimulation after a predefined period of time elapsed from receiving the instruction; (Para. [0069], “…when the far field radiative signals 104 or wireless control signals are received, receipt of the far field radiative signals 104 or wireless control signals may cause the control unit 320 to initiate therapeutic stimulation without delay or according to a predetermined delay.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Shellhammer, Robinson, Boesen and Tyler with the teachings of Chow (i.e., to configure the implantable devices of combined Shellhammer, Robinson, Boesen and Tyler such that they deliver stimulation after a predefined period of time elapsed from receiving the instruction in the manner of Chow) in order to facilitate provision of treatment in accordance with circadian schedule or another predetermined treatment cycle (Chow at Para. [0068]).
Regarding Claim 8, the combination of Shellhammer, Robinson, Boesen, Tyler and Chow renders obvious the entirety of Claim 1 as explained above.
Robinson additionally discloses:
wherein the system includes a wearable component that includes the base station and the one or more sensors (Pg. 35, Ln. 29-31, “FIG. 16 panel (c) is a schematic showing potential application of fully implanted ME films with the magnetic field generated by an external coil that can be incorporated into a hat or visor”).
Regarding Claim 9, the combination of Shellhammer, Robinson, Boesen, Tyler and Chow renders obvious the entirety of Claim 8 as explained above.
Robinson additionally discloses:
wherein the wearable component is configured to be worn on a head of a user (Pg. 35, Ln. 29-31, “FIG. 16 panel (c) is a schematic showing potential application of fully implanted ME films with the magnetic field generated by an external coil that can be incorporated into a hat or visor”);
Regarding Claim 10, the combination of Shellhammer, Robinson, Boesen, Tyler and Chow renders obvious the entirety of Claim 8 as explained above.
Robinson additionally discloses:
wherein the wearable component is configured to be worn around a waist of a user (Pg. 54, Ln. 19-21, “The concept of a spinal cord stimulating system enabled by MagMote with a battery powered magnetic transmitter assembled on a wearable belt is shown in FIG. 33 (bottom left panel).”)
Regarding Claim 11, the combination of Shellhammer, Robinson, Boesen, Tyler and Chow renders obvious the entirety of Claim 8 as explained above.
Robinson additionally discloses:
wherein the wearable component is configured to be worn on around a neck of a user (Pg. 52, Ln. 22-24, “For example, a coil can be placed near the back for a spinal cord implant, in a neck band for a Vagus nerve implant, or in a visor around the head for a brain implant, as shown in FIG. 31 panels (a)-(c).”).
Regarding Claim 12, the combination of Shellhammer, Robinson, Boesen, Tyler and Chow renders obvious the entirety of Claim 1 as explained above.
Boesen additionally discloses:
wherein the one or more sensors includes at least one electroencephalography (EEG) electrode (Para. [0041], “In addition to the earpiece housing 12, the processor 14, and the NFMI transceiver 16, the wireless earpiece 10 may further include a magnetic coil 18, a plurality of EEG sensors 20….”);
Regarding Claim 13, the combination of Shellhammer, Robinson, Boesen, Tyler and Chow renders obvious the entirety of Claim 1 as explained above.
Boesen additionally discloses:
wherein the one or more sensors includes a heartrate monitor, an accelerometer, and/or an optode (Para. [0044], “The motion sensors 22 may include a MEMS gyroscope 40, a magnetometer 42, or an electronic accelerometer 44.”).
Regarding Claim 14, the combination of Shellhammer, Robinson, Boesen, Tyler and Chow renders obvious the entirety of Claim 1 as explained above.
Robinson additionally discloses:
wherein the electrical circuit further comprises a resonant frequency modulator configured to modulate a resonant frequency of the magnetoelectric film by applying different electric loading conditions that change a property of the magnetoelectric film. (Pg. 2, Ln. 18-25, “Exemplary embodiments rely on an alternating magnetic field produced by a magnetic field driver that modulates a high frequency (e.g. 20-500 KHz) magnetic field delivered by an electromagnetic coil. This magnetic field is at or near the resonant frequency of a magnetoelectric film, which can typically be placed several centimeters from away from the coil. The film (a laminate of piezoelectric and magnetoelectric materials) can transform the magnetic field into a high frequency, high voltage electrical signal. Exemplary embodiments attach circuit elements to the film to alter the voltage waveform (e.g. to rectify and cap the voltage and current to a stable level for the desired application).”).
Regarding Claim 15, the combination of Shellhammer, Robinson, Boesen, Tyler and Chow renders obvious the entirety of Claim 1 as explained above.
Robinson additionally discloses:
“wherein each of the plurality of implantable devices is configured to detect an activation field and establish a bi-directional communication link with the base station when the base station is positioned proximate to plurality of the implantable devices” (Pg. 21, Ln. 31 through Pg. 22, Ln. 4, “In specific embodiments, when the ME film is brought into contact with an alternating magnetic field produced by the driver and a permanent bias magnet or DC bias coils, the film will resonate and generate up to 50V peak-to-peak. The appropriate circuitry can be electrically coupled to the film to obtain the desired output voltage waveform, including examples discussed below;” Pg. 45, Ln. 30 through Pg. 46, Ln. 1, “As shown in FIG. 23, the ASIC can cycle through a charging step 261, a data receiving step 262, and a stimulation step 263. In particular embodiments, downlink data transfer will be performed with amplitude shift keying (ASK) modulation of the magnetic field (shown in FIGS. 21 and 22A). Received data can be used to program system operation and stimulation modes.”).
Robinson’s film resonates when “brought into contact with an alternating magnetic field produced by the driver.” This resonating is such “detect[ing] an activation field” as claimed.
All of Robinson’s resonating, “a data receiving step 262,” “stimulation step 263” and “downlink data transfer” are such “a bi-directional communication link” as claimed.
Claims 2-6 are rejected under 35 U.S.C. 103 as being unpatentable over previously cited US 2018/0304086 A1 to Shellhammer et al. (“Shellhammer”) in view of previously cited WO 2020/206332 A1 to Robinson et al. (“Robinson”), previously cited US 2018/0353095 A1 to Boesen (“Boesen”), previously cited US 2015/0174418 A1 to Tyler et al. (“Tyler”) and US 2013/0261703 A1 to Chow et al. (“Chow”) as applied to Claim 1 above, and further in view of previously cited US 2023/0144885 A1 to Zhang et al. (“Zhang”).
Regarding Claim 2, the combination of Shellhammer, Robinson, Boesen, Tyler and Chow renders obvious the entirety of Claim 1 as explained above.
Boesen additionally discloses:
“wherein the base station further includes electronics configured to: … access a physiological signal collected by the one or more sensors;” (Para. [0070], “In step 208 a plurality of EEG sensors 20 receives electrical signals from the user's brain in response to the electromagnetic pulse. A differential amplifier may be used to remove common mode gains and filter extraneous electrical signals from the wireless earpiece or other electrical objects from the electrical signals of the user's brain. The received signals may be processed in any number of ways including neurological analysis.”);
The combination of Shellhammer, Robinson, Boesen, Tyler and Chow does not disclose:
“record one or more stimulation times at which each of the plurality of the implantable devices delivers stimulation to a plurality of target tissues;”
“identify one or more select portions of the physiological signal, where each portion has a start time corresponding to a stimulation time of the one or more stimulation times;”
“facilitate predicting, based on the one or more select portions, whether or a degree to which the implant stimulation protocol is resulting in a target effect;”
“and facilitate modifying the implant stimulation protocol based on the prediction.”
Zhang describes “Systems and methods for closed-loop control of electrostimulation while avoiding, or maintaining a substantially low level of, evoked neural activity…” (Abstract). Zhang is analogous art.
Zhang discloses:
“record one or more stimulation times at which each of the plurality of the implantable devices delivers stimulation to a plurality of target tissues;” (Para.. [0093], “A stimulation pulse train is delivered during the stimulation surveillance phase, and evoked responses to respective pulses in the stimulation pulse train are evaluated to determine if a detectable evoked neural activity (e.g., ECAP) has been elicited by the stimulation pulse train. The stimulation surveillance phase can be pre-scheduled, or alternatively be triggered by a specific event. The GUI 900, which is an example of the GUI 64 of the CP 50, can include UI control elements that allow a user to scheduling and configuring the surveillance phase using one or more programmable or selectable surveillance parameters.”);
“identify one or more select portions of the physiological signal, where each portion has a start time corresponding to a stimulation time of the one or more stimulation times;” (Para. [0096], “The surveillance mode/trigger selector 930 allows a user to set how often, or under what condition, the surveillance stimulation/sensing is performed. One example of the surveillance mode is a constant surveillance, in which the surveillance is performed constantly or periodically according to a pre-determined schedule. Alternatively, the surveillance mode can be one of event-triggered modes, in which the surveillance is activated only responsive to certain events, such as therapy rating change, stimulation artifact change, lead impedance change, among other events.”);
“facilitate predicting, based on the one or more select portions, whether or a degree to which the implant stimulation protocol is resulting in a target effect;” (Para. [0012], “…the subject matter of any one or more of Examples 1-2 optionally includes the controller that can be configured to: determine one or more reference stimulation levels each corresponding to respective evoked neural activity detectabilities or patient perception of stimulation; receive from the user interface a target stimulation level relative to the one or more reference stimulation level….”);
“and facilitate modifying the implant stimulation protocol based on the prediction.” (Para. [0012], “Para. [0012], “…and adjust the one or more stimulation parameters to achieve the target stimulation level.”)
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Shellhammer, Robinson, Boesen, Tyler and Chow with the teachings of Zhang (i.e., to modify the device of combined Shellhammer, Robinson, Boesen, Tyler and Chow such that it performs such a closed-loop stimulation algorithm as taught by Zhang comprising such recording stimulation times at which stimulation is delivered, identifies portions of the recorded signal corresponding to said times, facilitates predicting whether a target effect has been achieved, and facilitates modifying the stimulation protocol based on that prediction) in order to facilitate more efficient therapy optimization (Zhang at Para. [0006]).
Regarding Claim 3, the combination of Shellhammer, Robinson, Boesen, Tyler, Chow and Zhang renders obvious the entirety of Claim 2 as explained above.
Zhang additionally discloses:
“wherein: the prediction facilitation and the modification facilitation are performed automatically using the electronics.” (Para. [0010], “…and a controller configured to: detect an evoked neural activity from the sensed respective evoked responses; in response to the evoked neural activity satisfying a detection criterion, recursively adjust the one or more stimulation parameters, deliver a modified stimulation pulse train in accordance with the recursively adjusted one or more stimulation parameters, and re-detect an evoked neural activity from respective evoked responses to the modified stimulation pulse train, until the re-detected evoked neural activity fails to satisfy the detection criterion….;” Para. [0076], “For example, the clinician programming software 66 can automatically determine durations and amplitudes for both of the pulse phases 30 a and 30 b (e.g., each having a duration of PW, and with opposite polarities +A and −A).”).
Regarding Claim 4, the combination of Shellhammer, Robinson, Boesen, Tyler, Chow and Zhang renders obvious the entirety of Claim 2 as explained above.
Zhang additionally discloses:
“wherein facilitating modifying the implant stimulation protocol includes identifying a new schedule as to when each of the plurality of the implantable devices delivers stimulation” (Para. [0093], “The stimulation surveillance phase can be pre-scheduled, or alternatively be triggered by a specific event.”).
Regarding Claim 5, the combination of Shellhammer, Robinson, Boesen, Tyler, Chow and Zhang renders obvious the entirety of Claim 2 as explained above.
Zhang additionally discloses:
“wherein facilitating modifying the implant stimulation protocol includes identifying a new intensity for stimulation that is generated by an implantable device of the plurality of implantable devices.” (Para. [0081], “At 710, a stimulation pulse train may be delivered to a neural target in accordance with one or more stimulation parameters. Examples of the stimulation parameters can include stimulation waveform dosing parameters such as amplitude (e.g., current amplitude), pulse width, pulse rate or frequency, pulse pattern, pulse waveform, among others;” Para. [0088], “The stimulation pulse train can then be delivered to the neural target 710 in accordance with the adjusted stimulation parameters. The adjustment of stimulation parameter at 780 can be carried out automatically via a feedback control circuit, or at least partially activated in response to a user input, such as a confirmation of the automatically generated recommendation for stimulation parameter adjustment.”).
Regarding Claim 6, the combination of Shellhammer, Robinson, Boesen, Tyler, Chow and Zhang renders obvious the entirety of Claim 2 as explained above.
Zhang additionally discloses:
“wherein the electronics are further configured to: access a secondary signal collected by an input component of the base station; and identify one or more select portions of the secondary signal, wherein each portion has a start time relative to a stimulation time of the one or more stimulation times; and the prediction of whether or the degree to which the implant stimulation protocol is resulting in the target effect is further based on the one or more secondary select portions.” (Para. [0012], Para. [0093], [0096], Para. [0059], “Stimulation in the IPG 10 is typically provided by pulses, as shown in FIG. 2 . Stimulation parameters typically include the amplitude of the pulses (A; whether current or voltage); the frequency (F) and pulse width (PW) of the pulses; the electrodes 16 (E) activated to provide such stimulation; and the polarity (P) of such active electrodes, i.e., whether active electrodes are to act as anodes (that source current to the tissue) or cathodes (that sink current from the tissue). These stimulation parameters taken together comprise a stimulation program that the IPG 10 can execute to provide therapeutic stimulation to a patient.”).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over previously cited US 2018/0304086 A1 to Shellhammer et al. (“Shellhammer”) in view of previously cited WO 2020/206332 A1 to Robinson et al. (“Robinson”), previously cited US 2018/0353095 A1 to Boesen (“Boesen”), previously cited US 2015/0174418 A1 to Tyler et al. (“Tyler”), US 2013/0261703 A1 to Chow et al. (“Chow”) and previouslycited US 2023/0144885 A1 to Zhang et al. (“Zhang”) as applied to Claim 6 above, and further in view of previously cited US 2023/0226358 A1 to Lebaron et al. (“Lebaron”).
Regarding Claim 7, the combination of Shellhammer, Robinson, Boesen, Tyler, Chow and Zhang renders obvious the entirety of Claim 6 as explained above.
The combination of Shellhammer, Robinson, Boesen, Tyler, Chow and Zhang does not disclose:
“wherein the secondary signal was generated based on backscattering of a magnetic field applied by the magnetic field generator of the base station”
Lebaron describes “Neural Stimulator Impedance Control And Matching” (Title). Lebaron is analogous art.
Lebaron discloses:
“wherein the secondary signal was generated based on backscattering of a magnetic field applied by the magnetic field generator of the base station” (Para. [0033], “Further, the neural simulator 114 may also communicate with the external controller 101 via a backscatter signal 116. For instance, the external antenna 110 radiates an RF transmission signal (e.g., radiative signal 112) that is modulated and encoded by the transmitter 106. The neural stimulator 114 contains one or more antennas (e.g., a dipole or patch or other antenna design);” Para. [0047]).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Shellhammer, Robinson, Boesen, Tyler, Chow and Zhang with the teachings of Lebaron (i.e., to use such a signal generated based on backscattering of a magnetic field applied by the magnetic field generator of the base station as taught by Lebaron as the second signal of combined Shellhammer, Robinson, Boesen, Tyler, Chow and Zhang) because such a modification entails only a simple substitution of one known element for another to obtain predictable results.
The prior art device of combined Robinson, Boesen, Tyler, Chow and Zhang differs from the claimed invention only in that the recited second signal is generated based on backscattering of a magnetic field applied by the magnetic field generator rather than a signal generated via a sensor.
The substituted second signal generated based on backscattering of a magnetic field applied by the magnetic field generator is known in the art. For example, Lebaron discloses use of such a signal in the relevant context.
One of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable.
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.
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/C.J.M./Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
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