If 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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the security arrangement must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “62” has been used to designate both the phrenic nerve(s) and the neck.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "12" and "21" have both been used to designate the second coil winding.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: "22" depicted in Figure 1.
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.
Claim Objections
Claims 66, 75, 83, 85-86, 88-90 are objected to because of the following informalities:
In claim 66, line 1, “claim 65, comprising” should read “claim 65, further comprising”
In claim 71, line 1, “The stimulation of claim 65” should read “The stimulation device of claim 65”
In claim 75, line 1, “claim 65, comprising: should read “claim 65, further comprising”
In claim 83, line 1, “claim 65, comprising: should read “claim 65, further comprising”
In claim 85, line 1, “claim 84, comprising: should read “claim 84, further comprising”
In claim 86, line 1, “claim 84, comprising: should read “claim 84, further comprising”
In claim 88, line 1, “claim 85, comprising: should read “claim 85, further comprising”
In claim 89, line 1, “claim 85, comprising: should read “claim 85, further comprising”
In claim 90, line 1, “claim 85, comprising: should read “claim 85, further comprising”
Appropriate correction is required.
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:
“security arrangement” in claims 75, 77, 79-82, equivalent structure disclosed in para. 0034. Therefore, the interpretation of “security arrangement” is best understood as a structure that has processors, sensors, support structures, and equivalents thereof.
“control unit” in claim 77, equivalent structure disclosed in paragraphs 0045-0046. Therefore, the interpretation of “control unit” is best understood as a computing device that may include a processor, data storage, communication interface, user interface, volatile and/or permanent memory, and equivalents thereof.
“measurement unit” in claim 79; no equivalent structure is recited in the specification.
“monitoring unit” in claim 80; no equivalent structure is recited in the specification.
“temperature sensing formation” in claims 81 and 90, equivalent structure disclosed in para. 0067. Therefore, the interpretation of “temperature sensing formation” is best understood as a structure and/or configuration designed to sense a temperature, and equivalents thereof.
“counter member” in claim 82, equivalent structure disclosed in para. 0071. Therefore, the interpretation of “counter member” is best understood as a splitter or plug. Nevertheless, it is unclear how a splitter or plug is capable of performing the claimed counting function.
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.
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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 79-80, 82, 85, and 88-90 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 85 further recites the limitation “the position” in line 6. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the claim will be read as if “the position” is indicative of the coil’s arrangement relative to the patient’s targeted nerves.
Claim 90 further recites the limitations “the first temperature sensing formation” and “the second temperature formation” in lines 10-12. There is insufficient antecedent basis for these limitations in the claim. For examination purposes, the claim will read as though the first and second temperature sensors of the first coil unit and second coil unit constitute the first temperature sensing formation and second temperature sensing formation, respectively.
Claim limitation "measurement unit" in claim 79, line 5, "monitoring unit" in claim 80, line 2, and "counter member” in claim 82, line 2 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification does not recite sufficient structure to perform the claimed function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
The dependent claims not specifically addressed above are rejected under 35 U.S.C. 112(b) as
indefinite due to their dependence from indefinite claims.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claim(s) 65-67, 71-74, 76, 78, 83-84, 86-87, and 91 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Simon et al. (US 2015/0165226).
Regarding claim 65, Simon et al. teaches a stimulation device to stimulate a first nerve and a second nerve in a human or animal body for activating a target tissue in the human or animal body (Abstract; para. 0023), comprising:
a first coil unit configured to be positioned at the human or animal body to stimulate the first nerve by applying an electric or electro-magnetic first field (paragraphs 0024, 0054-0056; Figs. 3C-3D, coil(s) 35);
a second coil unit configured to be positioned at the human or animal body to stimulate the second nerve by applying an electric or electro-magnetic second field (paragraphs 0024, 0054-0056; Figs. 3C-3D, coil(s) 35), wherein the first coil unit and the second coil unit are individually positionable at the human or animal body (para. 0079, “connect each of the toroids individually to the patient’s skin”); and
a connector (para. 0097, “lead wires”) connecting the first coil unit and the second coil unit such that the connector, the first coil unit and the second coil unit are electrically connected in series with each other (para. 0055).
Regarding claim 66, Simon et al. teaches the stimulation device according to claim 65 as stated above, further comprising a bracket structure (Fig. 3D, housing 37) holding the first coil unit (Fig. 3D, coil 35) and the second coil unit (Fig. 3D, coil 35),
wherein the bracket structure is configured such that a position of the first coil unit relative to the second coil unit is adjustable, and/or
wherein the first coil unit and the second coil unit are mechanically connected with each other only by the bracket structure (para. 0098).
Regarding claim 67, Simon et al. teaches the stimulation device according to claim 65 as stated above wherein the connector comprises an electrical conduct directly connecting the first coil unit and the second coil unit (Fig. 1; paragraphs 0054 “a magnetic stimulator coil 340 coupled via wires [i.e., electrical conduct] to impulse generator 310”; para. 0055, “coil 340 actually contains two coils that may be connected either in series or in parallel [via wires] to the impulse generator 310”).
Regarding claim 71, Simon et al. teaches the stimulation device according to claim 65 as stated above wherein the first coil unit is configured to generate the first field independent from the second coil unit generating the second field (para. 0025).
Regarding claim 72, Simon et al. teaches the stimulation device according to claim 65 as stated above wherein the first coil unit comprises a first coil winding for generating the first field and the second coil unit comprises a second coil winding for generating the second field (para. 0025), wherein the first coil winding of the first coil unit and the second coil winding of the second coil unit are wound axially in opposite directions (paragraphs 0031, 0097-0098; Fig. 1 and para. 0055, the winding of coil(s) 340).
Regarding claim 73, Simon et al. teaches the stimulation device according to claim 65 as stated above wherein the first coil unit and the second coil unit are substantially axially arranged (para. 0031, “oriented parallel to a long nerve”).
Regarding claim 74, Simon et al. teaches the stimulation device according to claim 65 as stated above wherein in an axial view a stimulation current flows through the first winding and the second winding in opposite directions (paragraphs 0031, 0092, and 0097).
Regarding claim 76, Simon et al. teaches the stimulation device according to claim 65 as stated above wherein the first coil unit and the second coil unit are arranged such that a sum of the first field generated by the first coil unit and the second field generated by the second coil unit is about zero (paragraphs 0028, 0070, “zero,” and 0077).
Regarding claim 78, Simon et al. teaches the stimulation device according to claim 65 as stated above wherein the stimulation device is configured to activate the first coil unit and the second coil unit by supplying a stimulation current to the first coil unit and the second coil unit (paragraphs 0029-0031).
Regarding claim 83, Simon et al. teaches the stimulation device according to claim 65 as stated above, further comprising a button (para. 0103, “on/off switch”) configured to, when activated, operate the first coil unit to induce a pulse of the first field and operate the second coil unit to induce a pulse of the second field (Fig. 5; para. 0103, where the circuit control box 38 contains the electronic components that active the stimulation), and/or wherein the first coil unit and the second coil unit are in at least five degrees of freedom individually positionable at the human or animal body.
Regarding claim 84, Simon et al. teaches a method of stimulating first and second nerves in a human or animal body for activating a target tissue in the human or animal body, comprising the steps of (Abstract; paragraphs 0023 and 0027):
individually positioning (para. 0079, “connect each of the toroids individually to the patient’s skin”) a first coil unit at the first nerve of the human or animal body to stimulate the first nerve by applying an electric or electro-magnetic first field (paragraphs 0055-0056);
individually positioning (para. 0079, “connect each of the toroids individually to the patient’s skin”) a second coil unit at the second nerve of the human or animal body by applying an electric or electro-magnetic second field (paragraphs 0055-0056), the first coil unit and the second coil unit being electrically connected in series by means of a connector (paragraphs 0055 and 0097, “lead wires”); and
supplying a stimulation current to the first coil unit and the second coil unit via the connector (Fig. 1; paragraphs 0054 “a magnetic stimulator coil 340 coupled via wires [i.e., electrical conduct] to impulse generator 310”; para. 0055, “coil 340 actually contains two coils that may be connected either in series or in parallel [via wires] to the impulse generator 310”; para. 0019, “impulse generator may produce, discharge currents…which is passed through the stimulator coil”).
Regarding claim 86, Simon et al. teaches the method according to claim 84 as stated above, further comprising substantially axially arranging the first coil unit and the second coil unit (para. 0031, “oriented parallel to a long nerve”), wherein the first coil unit comprises a first winding wound in a first direction, the second coil unit comprises a second winding wound in a second direction and the first direction is opposite to the second direction (paragraphs 0025, 0031, 0097-0098; Fig. 1 and para. 0055, the winding of coil(s) 340), wherein an angle between an axis of the first coil unit and an axis of the second coil unit is 100 or less, or 50 or less (para. 0036, Fig. 6 where the coils are adjacent to each other and parallel to the neck region).
Regarding claim 87, Simon et al. teaches the method according to claim 84 as stated above wherein the first coil unit and the second coil unit are arranged such that a sum of the first and second fields generated by the first coil unit and the second coil unit is about zero (paragraphs 0028, 0070, “zero,” and 0077).
Regarding claim 91, Simon et al. teaches the method according to claim 84 as stated above wherein a stimulation device is used to perform the method, the stimulation device comprising (Abstract; paragraphs 0023 and 0027):
a first coil unit configured to be positioned at the human or animal body to stimulate the first nerve by applying an electric or electro-magnetic first field (paragraphs 0024, 0054-0056; Figs. 3C-3D, coil(s) 35);
a second coil unit configured to be positioned at the human or animal body to stimulate the second nerve by applying an electric or electro-magnetic second field (paragraphs 0024, 0054-0056; Figs. 3C-3D, coil(s) 35), wherein the first coil unit and the second coil unit are individually positionable at the human or animal body (para. 0079, “connect each of the toroids individually to the patient’s skin”); and
a connector (para. 0097, “lead wires”) connecting the first coil unit and the second coil unit such that the connector, the first coil unit and the second coil unit are electrically connected in series with each other (para. 0055).
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.
Claim(s) 68-70 is/are rejected under 35 U.S.C. 103 as being unpatentable over Simon et al. in view of Niemi (US 4,548,208).
Regarding claim 68, Simon et al. teaches the stimulation device according to claim 65 as stated above. Simon et al. fails to teach wherein the connector comprises a splitter, a first electrical cable connecting the splitter with the first coil unit and a second electrical cable connecting the splitter with the second coil unit.
Niemi teaches an analogous magnetic field generating device wherein the connector comprises a splitter (Col. 7, lines 53-55, “voltage divider”), a first electrical cable (Col. 3, lines 41-47, “line”) connecting the splitter with the first coil unit (Fig. 3a, coil 7, terminal of coil L1) and a second electrical cable (Col. 3, lines 41-47, “line”) connecting the splitter with the second coil unit (Fig. 3a, coil 8, terminal of coil L2).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the
effective filing date of the claimed invention, to have modified the stimulation device of Simon et al. with the splitter (voltage divider) of Niemi. Incorporating a voltage divider provides useful overcurrent detect and latch circuitry that may disable the coils when dangerous, overcurrent conditions are indicated (Niemi, Col. 7, lines 45-68 and Col. 8, lines 1-15).
Regarding claim 69, Simon et al. in view of Niemi teaches the stimulation device according to claim 68 as stated above configured to provide a first voltage from the splitter to the first coil unit, a second voltage from the first coil unit to the splitter, the second voltage from the splitter to the second coil unit and a third voltage from the second coil unit to the splitter (Niemi, Col. 10, lines 48-68, “
V
D
S
V
C
S
V
D
D
”).
Regarding claim 70, Simon et al. in view of Niemi teaches the stimulation device according to claim 69 as stated above wherein the second voltage is about half of the first voltage (Niemi, Col. 5, lines 61-62) and/or the third voltage is about zero.
Claim(s) 75, 77, 79-80, 82, 85, and 88-89 is/are rejected under 35 U.S.C. 103 as being unpatentable over Simon et al. in view of Savage (WO 2008/051790), further in view of Casse et al. (US 2017/0225004).
Regarding claim 75, Simon et al. teaches the stimulation device according to claim 65 as stated above. Simon et al. fails to teach a security arrangement configured to ensure compliance with a security policy during stimulation of the first nerve by means of the first coil unit and of the second nerve by means of the second coil unit, wherein, the security policy comprises cancelling an electric or electro-magnetic field in a region offset the first and second nerves when the first coil unit and the second coil unit are applying the first field and the second field, and/or the security arrangement comprises a support structure substantially axially arranging the first coil unit and the second coil unit, wherein the first coil unit comprises a first winding wound in a first direction, the second coil unit comprises a second winding wound in a second direction and the first direction is opposite to the second direction, wherein the first coil unit and the second coil unit are adjustable relative to the support structure such that an angle between an axis of the first coil unit and an axis of the second coil unit is 10° or less, or 5° or less.
Savage teaches an analogous magnetic field generator further comprising a security arrangement (see Modified Figure 1 below) configured to ensure compliance with a security policy (para. 0022, “The microcontroller 14 contains executable code which runs a routine 16”; paragraphs 0023-0024) during stimulation of the first nerve (Abstract, “living being”; Fig. 3, where the magnetic field generator can be incorporated into a headband, pendent, watch, or earrings which is positioned near nerves) by means of the first coil unit (para. 0025, “number of coils”) and of the second nerve (Abstract, “living being”; Fig. 3, where the magnetic field generator can be incorporated into a headband, pendent, watch, or earrings which is positioned near nerves) by means of the second coil unit (para. 0025, “number of coils”),
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have combined the stimulation device of Simon et al. with the security arrangement configured to ensure compliance with a security policy of Savage. With a security arrangement, the device may be able to perform autonomous operations, i.e., systematically modulate the frequency of a waveform driving current into a coil. Furthermore, by implementing a security policy (executable code that runs the system’s routine), determinations may be executed based on feedback received from coupled sensors and control devices. This combination may ultimately create an intuitive and safeguarded magnetic field generator capable of emulating therapeutic electromagnetic frequency ranges (paragraphs 0010, 0022, 0025-0026, and 0048-0052).
While Savage teaches the security arrangement configured to ensure compliance with a security policy, the combination of Simon et al. and Savage fails to disclose wherein the security policy comprises cancelling an electric or electro-magnetic field in a region offset the first and second nerves when the first coil unit and the second coil unit are applying the first field and the second field, and/or
the security arrangement comprises a support structure substantially axially arranging the first coil unit and the second coil unit, wherein the first coil unit comprises a first winding wound in a first direction, the second coil unit comprises a second winding wound in a second direction and the first direction is opposite to the second direction, wherein the first coil unit and the second coil unit are adjustable relative to the support structure such that an angle between an axis of the first coil unit and an axis of the second coil unit is 10° or less, or 5° or less.
Casse et al. teaches an analogous magnetic stimulator wherein, the security policy (para. 0023, “smart algorithms to provide feedback control to optimize stimulation”) comprises cancelling an electric or electro-magnetic field in a region offset the first and second nerves when the first coil unit and the second coil unit are applying the first field and the second field (paragraphs 0024, 0037, and 0061), and/or
the security arrangement comprises a support structure substantially axially arranging the first coil unit and the second coil unit, wherein the first coil unit comprises a first winding wound in a first direction, the second coil unit comprises a second winding wound in a second direction and the first direction is opposite to the second direction, wherein the first coil unit and the second coil unit are adjustable relative to the support structure such that an angle between an axis of the first coil unit and an axis of the second coil unit is 10° or less, or 5° or less.
Therefore, it would have been obvious to someone of ordinary skill in the art, before the
effective filing date of the claimed invention, to have combined the stimulation device of Simon et al. in view of Savage with the security policy comprising cancelling an electric or electromagnetic field of Casse et al. Implementing a security policy, that has the ability to cancel electric or electromagnetic fields, facilitates tailored, localized stimulations, accompanied with enhanced depth control and the ability to target specific nerve fascicles via complex stimulation patterns, the security policy may predictably limit the spread of electrical currents into off-target regions (Casse et al., paragraphs 0023-0024 0061).
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Modified Figure 1
Regarding claim 77, Simon et al. in view of Savage, further in view of Casse et al. teaches the stimulation device according to claim 75 as stated above. Simon et al. further teaches a control unit (paragraphs 0057-0058; Fig. 1, control unit 330); however, Simon et al. does not specifically disclose a security arrangement wherein the control unit of the security arrangement is configured to detect a non-compliance with the security policy and to prevent activation of the first coil unit and the second coil unit when the non-compliance is detected, and/or the control unit is configured to activate the first coil unit and the second coil unit in case the security policy is met.
Savage teaches an analogous magnetic field generator wherein the security arrangement comprises a control unit (Fig. 4, charger/tester 86 includes a microcontroller 98 and dot matrix liquid crystal display 112; paragraphs 0049 and 0051), wherein,
the control unit of the security arrangement is configured to detect a non-compliance with the security policy and to prevent activation of the first coil unit and the second coil unit when the non-compliance is detected (Figures 5a-5b; para. 0018; para. 0057), and/or
the control unit is configured to activate the first coil unit and the second coil unit in case the security policy is met (paragraphs 0050-0053, 0056, “flashes the mode LED 100 with a green illumination”).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the
effective filing date of the claimed invention, to have further combined the stimulation device of Simon et al. with the security arrangement comprising the control unit of Savage. With a control unit that doubles as a charger for the power source, the stimulation device has the competence to simultaneously charge and test the magnetic field emitted by the magnetic field generator according to feedback gathered from the system’s operational routine (Savage, paragraphs 0049-0053).
Regarding claim 79, as best understood in light of the rejection under 35 U.S.C. 112(b), a modified Simon et al. in view of Savage, further in view of Casse et al. teaches the stimulation device according to claim 75 as stated above. Simon et al. fails to teach wherein the security arrangement comprises a sensor unit configured to determine positions of the first coil unit and the second coil unit relative to each other, wherein the security policy comprises the relative positions being within a predefined range, wherein,
the security arrangement comprises a measurement unit configured to measure a first magnetic flux of the first coil unit and a second magnetic flux of the second coil unit, wherein the security policy comprises preventing a sum of the first magnetic flux and the second magnetic flux exceeding a predefined threshold, the stimulation is configured to measure the first and second magnetic fluxes by measuring a current flowing through the first coil unit and the second coil unit, and/or the stimulation device is configured to measure the first and second magnetic fluxes by using a first part of a plurality of consecutive waveforms of a stimulation current, wherein the security arrangement is configured to deactivate stimulation when the sum of the first magnetic flux and the second magnetic flux exceeds the predefined threshold.
Savage teaches an analogous magnetic field generator wherein the security arrangement comprises a sensor unit (Fig. 1, motion sensor 30) configured to determine positions of the first coil unit and the second coil unit relative to each other (paragraphs 0013, 0025; Fig. 2a, step 32), wherein the security policy comprises the relative positions being within a predefined range (para. 0026, where the routine 16 and microcontroller 14 makes determinations; Fig. 2a), wherein,
the security arrangement comprises a measurement unit (Fig. 4, induction coil 104) configured to measure a first magnetic flux of the first coil unit and a second magnetic flux of the second coil unit (para. 0049), wherein the security policy comprises preventing a sum of the first magnetic flux and the second magnetic flux exceeding a predefined threshold (paragraphs 0034 and 0056-0057),
the stimulation is configured to measure the first and second magnetic fluxes by measuring a current flowing through the first coil unit and the second coil unit, and/or
the stimulation device is configured to measure the first and second magnetic fluxes by using a first part of a plurality of consecutive waveforms (para. 0050) of a stimulation current, wherein the security arrangement is configured to deactivate stimulation when the sum of the first magnetic flux and the second magnetic flux exceeds the predefined threshold (paragraphs 0055-0060, 0072; Figures 5a-5b).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the
effective filing date of the claimed invention, to have further combined the stimulation device of Simon et al. with the security arrangement comprising a sensor unit and measurement unit of Savage. Implementing a sensor unit creates an enhanced safety feature that ensures the magnetic stimulator is in proximity to a living being before employing a magnetic field. Additionally, a measurement unit allows the system to routinely detect and measure the emitted magnetic field to certify it is within the predefined threshold for effective stimulation (Savage, paragraphs 0026 and 0051).
Regarding claim 80, as best understood in light of the rejection under 35 U.S.C. 112(b), Simon et al. in view of Savage, further in view of Casse et al. teaches the stimulation device according to claim 75 as stated above. Simon et al. fails to teach wherein the security arrangement comprises a monitoring unit configured to detect a fault of the first coil unit and/or the second coil unit, wherein the security policy comprises the monitoring unit not detecting the fault of the first coil unit and/or the second coil unit.
Savage teaches an analogous magnetic field generator wherein the security arrangement comprises a monitoring unit (Fig. 1, current sense circuit 90) configured to detect a fault of the first coil unit and/or the second coil unit (paragraphs 0074-0081; specifically, para. 0078, “failure of a component within the magnetic field generator 10”), wherein the security policy comprises the monitoring unit not detecting the fault of the first coil unit and/or the second coil unit (Fig. 6; para. 0078, “performs steps 194, 196, 198, and 200”; para. 0081).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the
effective filing date of the claimed invention, to have further combined the stimulation device of Simon et al. with the security arrangement comprising a monitoring unit of Savage. The monitoring unit monitors and produces an analog voltage relative to the level of power source charging current, the circulating current is a good indicator that the coils are operating according to the system’s routine. Therefore, if an inapt amount of current is detected, the system may terminate the charging process; the termination functions as a safety precaution to avoid overcharging (paragraphs 0030, 0078, and 0081).
Regarding claim 82, as best understood in light of the rejection under 35 U.S.C. 112(b), Simon et al. in view of Savage, further in view of Casse et al. teaches the stimulation device according to claim 75 as stated above. Simon et al. fails to teach wherein the security arrangement comprises a counter member configured to count a number of pulses induced by the first coil unit and the second coil unit, wherein the security policy comprises the counted numbers of pulses being below a predefined threshold pulse number.
Savage teaches an analogous magnetic field generator wherein the security arrangement comprises a counter member (Fig. 1, microcontroller 14) configured to count a number of pulses induced by the first coil unit and the second coil unit (para. 0071), wherein the security policy comprises the counted numbers of pulses being below a predefined threshold pulse number (para. 0072).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the
effective filing date of the claimed invention, to have further combined the stimulation device of Simon et al. with the security arrangement comprising a counter member of Savage. A counter member may meter the charge pulses and execute various system routine changes/modifications in response to the counted pulse frequencies being outside or within a predefined range (Savage, paragraphs 0071-0072).
Regarding claim 85, as best understood in light of the rejection under 35 U.S.C. 112(b), Simon et al. teaches the method according to claim 84 as stated above. Simon et al. fails to teach ensuring compliance with a security policy during stimulation of the first and second nerves by means of the first coil unit and the second coil unit, wherein the security policy comprises cancelling an electric or electro-magnetic field in a region offset from the first and second nerves when the first coil unit and the second coil unit are applying the first and second fields, adjusting the position of the first coil unit and the second coil unit, and/or adjusting the stimulation current supplied to the first coil unit and the second coil unit.
Savage teaches an analogous magnetic field generator and method further comprising ensuring compliance with a security policy (para. 0022, “The microcontroller 14 contains executable code which runs a routine 16”; paragraphs 0023-0024) during stimulation of the first and second nerves (Abstract, “living being”; Fig. 3, where the magnetic field generator can be incorporated into a headband, pendent, watch, or earrings which is positioned near nerves) by means of the first coil unit and the second coil unit (para. 0025, “number of coils”),
adjusting the position of the first coil unit and the second coil unit (para. 0038), and/or adjusting the stimulation current supplied to the first coil unit and the second coil unit.
Therefore, it would have been obvious to someone of ordinary skill in the art, before the
effective filing date of the claimed invention, to have combined the method of Simon et al. with the security policy of Savage. By implementing a security policy (executable code that runs the system’s routine), determinations may be executed based on feedback received from coupled sensors and control devices. This combination may ultimately create an intuitive and safeguarded magnetic field generator capable of emulating therapeutic electromagnetic frequency ranges (paragraphs 0010, 0022, 0025-0026, and 0048-0052).
While Savage teaches the security policy, the combination of Simon et al. and Savage fails to disclose wherein the security policy comprises cancelling an electric or electro-magnetic field in a region offset from the first and second nerves when the first coil unit and the second coil unit are applying the first and second fields.
Casse et al. teaches an analogous magnetic stimulator and method wherein the security policy (para. 0023, “smart algorithms to provide feedback control to optimize stimulation”) comprises cancelling an electric or electro-magnetic field in a region offset from the first and second nerves when the first coil unit and the second coil unit are applying the first and second fields (paragraphs 0024, 0037, and 0061).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have combined the method of Simon et al. in view of Savage with the security policy comprising cancelling an electric or electromagnetic field of Casse et al. Implementing a security policy, that has the ability to cancel electric or electromagnetic fields, facilitates tailored, localized stimulations, accompanied with enhanced depth control and the ability to target specific nerve fascicles via complex stimulation patterns, the security policy may predictably limit the spread of electrical currents into off-target regions (Casse et al., paragraphs 0023-0024 0061).
Regarding claim 88, as best understood in light of the rejection under 35 U.S.C. 112(b), Simon et al. in view of Savage, further in view of Casse et al. teaches the method according to claim 85 as stated above. Simon et al. fails to disclose detecting a non-compliance with the security policy and preventing activation of the first coil unit and the second coil unit when the non-compliance is detected, activating the first coil unit and the second coil unit in case the security policy is met, and/or determining positions of the first coil unit and the second coil unit relative to each other, wherein the security policy comprises the relative positions being within a predefined range.
Savage teaches an analogous magnetic field generator and method further comprising:
detecting a non-compliance with the security policy and preventing activation of the first coil unit and the second coil unit when the non-compliance is detected (Figures 5a-5b; para. 0018; para. 0057),
activating the first coil unit and the second coil unit in case the security policy is met (paragraphs 0050-0053, 0056, “flashes the mode LED 100 with a green illumination”), and/or
determining positions of the first coil unit and the second coil unit relative to each other, wherein the security policy comprises the relative positions being within a predefined range.
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have further combined the method of Simon et al. with the detecting and activating steps of Savage. These steps safeguard the stimulation device’s application; effectively, the security policy guarantees the coil units are not operating during compromised conditions, that would otherwise create a hazardous environment for the patient (Savage, paragraphs 0026, 0038, 0052-0053, and 0073).
Regarding claim 89, as best understood in light of the rejection under 35 U.S.C. 112(b), Simon et al. in view of Savage, further in view of Casse et al. teaches the method according to claim 85 as stated above. Simon et al. fails to teach measuring a first magnetic flux of the first coil unit and a second magnetic flux of the second coil unit, wherein, the security policy comprises preventing a sum of the first magnetic flux and the second magnetic flux exceeding a predefined threshold, the first and second magnetic fluxes are measured by measuring a current flowing through the first coil unit and the second coil unit, and/or the method comprises measuring the first and second magnetic fluxes by using a first part of a plurality of consecutive waveforms of a stimulation current, and deactivating stimulation when the sum of the first magnetic flux and the second magnetic flux exceeds the predefined threshold.
Savage teaches an analogous magnetic field generator and method further comprising measuring a first magnetic flux of the first coil unit and a second magnetic flux of the second coil unit (para. 0049), wherein,
the security policy comprises preventing a sum of the first magnetic flux and the second magnetic flux exceeding a predefined threshold (paragraphs 0034 and 0056-0057),
the first and second magnetic fluxes are measured by measuring a current flowing through the first coil unit and the second coil unit, and/or
the method comprises measuring the first and second magnetic fluxes by using a first part of a plurality of consecutive waveforms (para. 0050) of a stimulation current, and deactivating stimulation when the sum of the first magnetic flux and the second magnetic flux exceeds the predefined threshold (paragraphs 0055-0060, 0072; Figures 5a-5b).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the
effective filing date of the claimed invention, to have further combined the method of Simon et al. with the measuring step of Savage. Measuring the magnetic fluxes of the coil units allows the system to routinely detect and quantity the emitted magnetic fields to ensure they are within the predefined threshold for effective stimulation (Savage, paragraphs 0051).
Claim(s) 81 and 90, as best understood in light of the rejection under 35 U.S.C. 112(b) is/are rejected under 35 U.S.C. 103 as being unpatentable over Simon et al. in view of Savage and Casse et al., further in view of Zangen et al. (WO 2019/150378).
Regarding claim 81, Simon et al. in view of Savage, further in view of Casse et al. teaches the stimulation device according to claim 75 as stated above. Simon et al. further teaches a thermistor or thermocouple probe (para. 0138) but does not specifically disclose wherein the security arrangement comprises a first temperature sensing formation and a second temperature sensing formation, and wherein the first coil unit comprises the first temperature sensing formation and the second coil unit comprises the second temperature sensing formation, wherein, the first temperature sensing formation comprises a first temperature sensor and a second temperature sensor, and wherein the second temperature sensing formation comprises a first temperature sensor and a second temperature sensor, wherein the security policy comprises current consumptions of the first temperature sensor of the first temperature sensing formation, of the second temperature sensor of the first temperature sensing formation, of the first temperature sensor of the second temperature sensing formation, and of the second temperature sensor of the second temperature sensing formation being within a predefined threshold range of current consumption, and/or the security policy comprises temperatures measured by the first temperature sensing formation and by the second temperature sensing formation being below a predefined threshold temperature.
Zangen et al. teaches an analogous an electromagnetic generating assembly wherein the security arrangement comprises a first temperature sensing formation and a second temperature sensing formation (see Modified Figure 1; page 8, lines 19-23), and wherein the first coil unit comprises the first temperature sensing formation and the second coil unit comprises the second temperature sensing formation (page 15, lines 14-17, “coils”), wherein,
the first temperature sensing formation comprises a first temperature sensor and a second temperature sensor (Fig. 1, temperatures sensors 14; page 11, lines 20-25, “one or more temperature sensors”), and wherein the second temperature sensing formation comprises a first temperature sensor and a second temperature sensor (Fig. 1, temperature sensors 14; page 11, lines 20-25, “one or more temperature sensors”), wherein the security policy comprises current consumptions of the first temperature sensor of the first temperature sensing formation, of the second temperature sensor of the first temperature sensing formation, of the first temperature sensor of the second temperature sensing formation, and of the second temperature sensor of the second temperature sensing formation being within a predefined threshold range of current consumption, and/or
the security policy comprises temperatures measured by the first temperature sensing formation and by the second temperature sensing formation being below a predefined threshold temperature (page 19, lines 28-31).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the stimulation device of Simon et al. in view of Savage, further in view of Casse et al. with the temperature sensing formations of Zangen et al. The various temperature sensors facilitate real-time monitoring of the coil units and aid in the prevention of the coil units overheating and inducing adverse effects near the application region (Zangen et al., page 15, lines 14-17; page 24, lines 10-17).
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Modified Figure 1
Regarding claim 90, as best understood in light of the rejection under 35 U.S.C. 112(b), Simon et al. in view of Savage, further in view of Casse et al. teaches the method according to claim 85 as stated above further comprising:
detecting a fault of the first coil unit and/or the second coil unit (Savage, paragraphs 0074-0081; specifically, para. 0078, “failure of a component within the magnetic field generator 10”), wherein the security policy comprises not detecting the fault of the first coil unit and/or the second coil unit (Savage, Fig. 6; para. 0078, “performs steps 194, 196, 198, and 200”; para. 0081),
counting a number of pulses induced by the first coil unit and the second coil unit (), wherein the security policy comprises the counted numbers of pulses being below a predefined threshold pulse number (Savage, 0071-0072),
manually operating the first coil unit to induce a pulse of the first field and the second coil unit to induce a pulse of the second field (Simon et al., paragraphs 0058 and 0103-0104; Fig. 6).
Simon et al. in view of Savage, further in view of Casse et al. does not specifically disclose sensing a temperature at the first coil unit and a temperature at the second coil unit, wherein the security policy comprises the sensed temperatures being below a predefined threshold temperature,
providing the first coil unit with a first temperature sensor and a second temperature sensor, and providing the second coil unit with a first temperature sensor and a second temperature sensor, wherein the security policy comprises current consumptions of the first temperature sensor of the first temperature sensing formation, of the second temperature sensor of the first temperature sensing formation, of the first temperature sensor of the second temperature sensing formation, and of the second temperature sensor of the second temperature sensing formation being within a predefined threshold range current consumption.
Zangen et al. teaches an analogous an electromagnetic generating assembly further comprising sensing a temperature at the first coil unit and a temperature at the second coil unit (page 15, lines 14-17, “coils”), wherein the security policy comprises the sensed temperatures being below a predefined threshold temperature (page 19, lines 28-31),
providing the first coil unit with a first temperature sensor and a second temperature sensor (Fig. 1, temperatures sensors 14; page 11, lines 20-25, “one or more temperature sensors”), and providing the second coil unit with a first temperature sensor and a second temperature sensor (Fig. 1, temperature sensors 14; page 11, lines 20-25, “one or more temperature sensors”), wherein the security policy comprises current consumptions of the first temperature sensor of the first temperature sensing formation, of the second temperature sensor of the first temperature sensing formation, of the first temperature sensor of the second temperature sensing formation, and of the second temperature sensor of the second temperature sensing formation being within a predefined threshold range current consumption (page 6, lines 26-30 “communicate signals generated by the temperature sensors to external devices (e.g., control unit)”; page 4, lines 17-22, where the control unit regulates the electric current supplied to the windings. The temperature sensor and control unit are in communication, the temperature sensors generate measurement data/signals indicative of the temperature of the coil windings. An increase in current directly relates to an increase in temperature; consequently, the temperature sensors act as a current consumption indicator).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the stimulation device of Simon et al. in view of Savage, further in view of Casse et al. with the temperature sensing formations of Zangen et al. The various temperature sensors facilitate real-time monitoring of the coil units and aid in the prevention of the coil units overheating and inducing adverse effects near the application region (Zangen et al., page 15, lines 14-17; page 24, lines 10-17).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Frimerman et al. (US 2004/0077923) teaches an apparatus for generating localized magnetic fields inside a living body; the apparatus comprises a bracket structure supporting two coils. Lin et al. (2000) investigates various magnetic stimulation coil designs and analyzes the resultant generated magnetic fields. Herbst (US 2005/0216062) discloses a multi-functional electrical stimulation system that is intended to be used in conjunction with a magnetic stimulation device to provide systematical feedback. MacLean (US 3,658,051) discloses a method of treatment that incorporates a mechanically supported magnetic field pulsing device comprising electromagnets. Tepper et al. (EP 1,442,766) teaches a PEMF therapy system that utilizes a coil with biphasic pulse characteristics. Seltmann et al. (WO 2011/009502) discloses an electrical circuitry for an object producing a magnetic field.
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/B.R.L./Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791