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 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), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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 35, 44, and 46 are objected to because of the following informalities:
In claim 44, line 1, “claim 28, comprising” should read “claim 28, further comprising”
In claim 46, line 2, “other +/- 20°” should read “other at an angle of +/- 20°”
Appropriate correction is required.
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 34, 41 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 34 recites the limitation “equivalent spherical diameter” in line 3. There is insufficient antecedent basis for this limitation in the claim, and the specification does not define the term. For examination purposes, the claim is treated as requiring the straight-lined side’s length to amount to at least half of the curved section’s diameter.
Claim 41 recites the limitation “essentially” in line 2. The term “essentially” is a relative term which renders the claim indefinite. It is unclear how similar the two coil windings of each of the first and second coils must be in order to be regarded as identical. For examination purposes, the claims will be read as if the two coil windings are identical in form.
Claim 42 recites the limitation “essentially” in line 3. The term “essentially” is a relative term which renders the claim indefinite. It is unclear how level the two coil windings of each of the first and second coils must be in order to be regarded as flat. For examination purposes, the claims will be read as if the two coil windings are flat.
Claim 42 further recites the limitation “such as” in line 4. Because of the claim language it is unclear whether the claim necessitates only one of the options listed, as suggested by “such as” or if additional non-flat shapes, not recited by name, are practical alternatives. For examination purposes, the claim is construed to refer to any non-flat shape.
Claim 45 recites the limitation “essentially” in line 2. The term “essentially” is a relative term which renders the claim indefinite. It is unclear how differing the forward faces of the first and second coils must be in order to be regarded as opposing. For examination purposes, the claims will be read as if the two coils are symmetrical duplicates, mirrored over the y-axis, in which the forward face of the first coil opposes the forward face of the second coil.
Claim 47 recites the limitation “essentially” in line 2. The term “essentially” is a relative term which renders the claim indefinite. It is unclear how level at least one side of the two coil windings of each of the first and second coils must be in order to be regarded as straight. For examination purposes, the claims will be read as if one side of the coil windings is straight-lined.
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) 28-34, 36-38, 41-47 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nagano et al. (JP H07171220), citing to attached translation.
Regarding claim 28, Nagano et al. teaches a stimulation device (Abstract) to stimulate a first Phrenic nerve and a second Phrenic nerve (based on the orientation in Fig. 7, the phrenic nerves can be targeted) in a human or animal body for activating a target tissue such as a diaphragm in the human or animal body, comprising (page 2, para. 8, “stimulation target site of the living body, the nerves, muscles, etc.”):
a first coil unit configured to be positioned at the human or animal body to stimulate the first Phrenic nerve (Fig. 7, first coil 10a; page 3, para. 3, “first and second coils 10a and 10b); and
a second coil unit configured to be positioned at the human or animal body to stimulate the second Phrenic nerve (Fig. 7, second coil 10b; page 3, para. 3, “first and second coils 10a and 10b),
wherein each of the first and second coil units comprises at least two coil windings being wound with a variable radius into a spiral (page 3, para. 10, “the winding…includes a main magnetic field generating portion 12…and a magnetic flux compressing portion 14 having a diameter gradually reduced”; Fig. 1, where the winding of 13 progresses into a spiral), and
wherein the at least two coil windings of each of the first and second coil units are stacked on top of each other (Fig. 1, main magnetic field generating portion 12 and the magnetic flux compressing portion 13 are stacked together).
Regarding claim 29, Nagano et al. teaches the stimulation device according to claim 28 as stated above wherein the at least two coil windings of each of the first and second coil units are D-shaped or teardrop-shaped (see Modified Figure 1, windings 12 and 13 form a D-shaped coil).
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Modified Figure 1
Regarding claim 30, Nagano et al. teaches the stimulation device according to claim 28 as stated above wherein the at least two coil windings of each of the first and second coil units have two straight-lined sides (see Modified Fig. 6).
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Modified Figure 6
Regarding claim 31, Nagano et al. teaches the stimulation device according to claim 30 as stated above wherein the two straight-lined sides of the at least two coil windings of each of the first and second coil units are substantially parallel to each other (Fig. 6, where the winding 12 of coils 10a and 10b are parallel).
Regarding claim 32, Nagano et al. teaches the stimulation device according to claim 30 as stated above wherein the two straight-lined sides of the at least two coil windings of each of the first and second coil units are parallel to each other and not in one plane (page 6, paragraphs 15 & 16, "the distance between 10a and 10b can be changed, and efficient stimulation can be performed according to the size of the living body"; Fig. 7 depicts the coils in different planes).
Regarding claim 33, Nagano et al. teaches the stimulation device according to claim 28 as stated above wherein the at least two coil windings of the first coil unit are wound in a first direction, the at least two coil windings of the second coil unit are wound in a second direction, and the first direction is opposite to the second direction (Fig. 6, where the first coil 10a is duplicated and reflected over an imaginary axis to produce the arrangement of the second coil 10b; page 6, para. 3, “arranging the two stimulation coils 10a and 10b to face each other”).
Regarding claim 34, as best understood in light of the rejection under 35 U.S.C. 112(b), Nagano et al. teaches the stimulation device according to claim 28 as stated above wherein at least one straight-lined side of the at least two coil windings each of the first and second coil units has a length that is greater than a half of the equivalent spherical diameter of the at least two coil windings (see Modified Figure 1 such that the spherical region’s (depicted with a solid line) diameter is visibly smaller than the straight-lined side’s length (depicted with a dashed line)).
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Modified Figure 1
Regarding claim 36, Nagano et al. teaches the stimulation device according to claim 28 as stated above wherein the at least two coil windings of the first and second coil units are electronically connected with each other in series (page 7, para. 1, “the stimulation coils 10a and 10b are connected in parallel or in a series to the drive circuit”).
Regarding claim 37, Nagano et al. teaches the stimulation device according to claim 28 as stated above wherein the first and second coil units are individually positionable at the human or animal body and/or are substantially axially arranged (as shown in Fig. 6, the coils 10a and 10b are separate assemblies that are axially (horizontal axis) arranged; page 6, para. 5, “they [coils 10a and 10b] may be arranged with a predetermined angle”; page 6, the entirety of para. 6, “magnetic flux generated between the opening 14…”).
Regarding claim 38, Nagano et al. teaches the stimulation device according to claim 28 as stated above further comprising a control unit (Fig. 10; page 2, para. 2, “circuit configuration”) configured to initiate the stimulation in accordance with a predefined security policy including conditions to activate or prevent the stimulation (page 2, para. 15, “power supply circuit for supplying a high voltage signal to the coil in a predetermined state”, the “predetermined state” equates to the conditions that activate the stimulation; page 4, para. 2, “by supplying a current to the stimulation coil…a predetermined magnetic flux is generated by the coil 10 toward the…nerves”).
Regarding claim 41, as best understood in light of the rejection under 35 U.S.C. 112(b), Nagano et al. teaches the stimulation device according to claim 28 as stated above wherein the at least two coil windings of each of the first and second coil units have an essentially identical form (Figures 6-8, the windings 12 and 13 of coil 10a is the same, just orientated differently when compared to coil 10b).
Regarding claim 42, as best understood in light of the rejection under 35 U.S.C. 112(b), Nagano et al. teaches the stimulation device according to claim 28 as stated above wherein each of the at least two coil windings of each of the first and second coil units is: essentially flat, non-flat such as conical or bent, and/or bent in a radius between 4 cm and 20 cm, or between 6 cm and 12 cm (page 5, para. 10, “conical shape”).
Regarding claim 43, Nagano et al. teaches the stimulation device according to claim 28 as stated above wherein the stimulation device is configured to: generate time-variant currents in the first and second coil units being in timely synchrony, such that an induced current in the first coil unit is the same as an induced current in the second coil unit, and/or induce impulses generated by one current (page 4, para. 1, “current supplied from the drive circuit”, “frequency of several tens of times per second”; page 4, para. 2, “by supplying a current to the stimulation coil…a predetermined magnetic flux is generated by the coil 10 toward the…nerves”; page 7, para. 11, “the drive circuit shown in Fig. 9 or 10 is provided with two stimulation coils”).
Regarding claim 44, Nagano et al. teaches the stimulation device according to claim 28 as stated above further comprising a stimulator unit configured to induce currents in the first and second coil units (Fig. 10, coils 10a and 10b are connected in a series to the DV power supply 1, capacitor 3, switch 2 and 4).
Regarding claim 45, Nagano et al. teaches the stimulation device according to claim 28 as stated above wherein the first and second coil units have two forward faces essentially opposing each other or opposing each other in an angle of +/- 20° or less (Fig. 6, where the end potion 14 of coil 10a is facing the end portion 14 of coil 10b).
Regarding claim 46, Nagano teaches the stimulation device according to claim 28 as stated above wherein the first and second coil units have two forward faces opposing each other in an angle of +/- 20° (Fig. 6, where the end portion(s) 14 of coils 10a and 10b are parallel to each other; i.e., 0°).
Regarding claim 47, as best understood in light of the rejection under 35 U.S.C. 112(b), Nagano et al. teaches the stimulation device according to claim 28 as stated above wherein the at least two coil windings of each of the first and second coil units comprises at least one essentially straight-lined side (see Modified Figure 6, the main magnetic field generating portion winding 12 contains a straight-lined side).
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Modified Figure 6
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) 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nagano et al. in view of Goetz et al. (DE 102014008820), citing to attached translation.
Regarding claim 35, Nagano teaches the stimulation device according to claim 28 as stated above. Nagano further teaches a spiral isolation member for supporting the coil windings (page 3, para. 14, “non-magnetic material”) but does not specifically disclose that the spiral isolation member is configured to hold the respective at least two coil windings electrically isolated from each other.
Furthermore, Nagano fails to teach wherein each of the first and second coil units comprises a housing for embracing the respective at least two coil windings.
Goetz et al. teaches an analogous magnetic stimulator wherein each of the first and second coil units comprises a housing for embracing the respective at least two coil windings (Fig. 5, housing 506), and
wherein each housing of the first and second coil units comprises a spiral isolation member (Fig. 5, solid connection 503) configured to hold the respective at least two coil windings electrically isolated from each other (page 5, para. 2, “the individual turns of the conductor (501) are electrically isolated”).
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 Nagano with the housing and isolation member of Goetz et al. Providing the coil units with a housing effectively reinforces and stiffness the coil windings, as such the coils are protected from the surrounding environment (page 16, para. 5, “The housing can follow either an…”; page 5, para. 5, “the housing encloses the coil”). Furthermore, by incorporating a spiral isolation member between the electrically isolated coil windings, each winding is mechanically connected to the other winding in spite of the nonappearance of physical contact (page 5, para. 2, “The individual turns of the conductor (501) …”).
Claim(s) 39-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nagano et al. in view of Schwarz et al. (US 9,919,161).
Regarding claim 39, Nagano teaches the stimulation device according to claim 28 as stated above. Nagano fails to teach wherein the stimulation device is configured such that each of the first and second coil units generates biphasic impulses.
Schwarz et al. teaches an analogous magnetic stimulation apparatus wherein the stimulation device is configured such that each of the first and second coil units generates biphasic impulses (Col. 24, lines 29-34; claim 5 positively recites biphasic impulses).
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 Nagano with the generated biphasic impulses of Schwarz et al. Performing the stimulation with a time-varying magnetic field wherein the pulse is biphasic induces a motor-threshold stimulus, this stimulus produces muscle contraction which is important for activating the diaphragm (Schwarz et al., Col. 22, lines 8-32; Col. 24, lines 29-34).
Regarding claim 40, Nagano teaches the stimulation device according to claim 28 as stated above. Nagano fails to teach wherein the at least two coil windings of each of the first and second coil units are formed by the same litz wire.
Schwarz et al. teaches an analogous magnetic stimulation apparatus wherein the at least two coil windings of each of the first and second coil units are formed by the same litz wire (Fig. 10; Col. 24, lines 36-40).
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 Nagano with the litz wire of Schwarz et al. A separately insulated litz wire leads to a significant reduction of the induced eddy currents; furthermore, because of the incorporation of the litz wire, the self-heating of the coil is reduced (Schwarz et al., Col. 24, lines 36-50).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Rafferty et al. (2000) investigated neonate’s diaphragm function through cervical and anterior magnetic stimulation of the phrenic nerves. Simon et al. (US 8,972,004) discloses a magnetic stimulation device for simulating tissue and/or one or more nerve fibers within a patient. The magnetic stimulation device comprises a magnetically permeable toroidal core and a coil. Cadwell (US 5,078,674) teaches numerous magnetic stimulator coils with splayed coil windings. Aliverti et al. (US 2012/0016280) discloses placing magnetic coils over the C7 vertebra and the inferior-anterior-lateral neck on both the right and left sides to stimulate the phrenic nerves. Davey (WO 9616692) teaches a magnetic nerve stimulator in which a core, shaped like a “C”, is coupled to a coil winding. Pan et al. (WO 2014/022236) teaches a magnetic stimulator that comprises two opposing coils that are positioned non-parallel.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROGAN R LANDEEN whose telephone number is (571)272-1390. The examiner can normally be reached Monday - Friday 8:00am - 5:30pm.
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/B.R.L./Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791