DETAILED ACTION
Response to Amendment
This Office Action is in response to the amendment filed 04/29/2026. Claims 28-48 are acknowledged as pending with claims 34, 41-42, and 44-47 being currently amended and claim 48 being new.
The drawing and claim objections and the rejections under 35 U.S.C. 112(b) are withdrawn as having been overcome by the amendment. The rejections under 35 U.S.C. 102(a)(1) and 103 mailed in the Non-Final Rejection on 01/29/2026 are maintained, but have been adjusted as necessitated by the amendment.
Response to Arguments
Applicant's arguments filed 04/29/2026 have been fully considered but they are not persuasive.
With respect to Nagano et al. (see Applicant’s response, page 8, “Rejections Under 35 U.S.C. 102”), applicant argues that the examiner has failed to make a prima facie case of anticipation for claim 28. The requirements for anticipation rejection are discussed in MPEP § 2131. MPEP § 2131 notes that “To reject a claim as anticipated by a reference, the disclosure must teach every element required by the claim under its broadest reasonable interpretation.” In the most recent office action, multiple rejections under 35 U.S.C. 102 with specific mappings addressing every element of the claimed invention for the pertinent claims was provided.
On pages 8-9 of Applicant’s response, applicant argues that the main magnetic field generating unit 12 and the magnetic flux compression unit 13 of Nagano et al. does not meet the claimed “at least two coil windings”. MPEP § 2111 discusses proper claim interpretation, including giving claims their broadest reasonable interpretation in light of the specification during examination. Under broadest reasonable interpretation, the words of a claim must be given their plain meaning unless such meaning is inconsistent with the specification, and it is improper to import claim limitations from the specification into the claim. The requirements for anticipation are discussed in MPEP § 2131. MPEP § 2131 notes that “To reject a claim as anticipated by a reference, the disclosure must teach every element required by the claim under its broadest reasonable interpretation.” As stated in the previous office action, Nagano et al. teaches a coil 10 formed by a winding a wire material for several tens of turns (page 3, para. 10, “This stimulation coil 10 has a cylindrical magnetic material 11 having an end formed with a winding formed by winding a wire material for several tens of turns. It is what In this case, the winding of this example includes a main magnetic field generating portion 12 wound around the outer circumference of the magnetic material 11 with the same diameter, and a magnetic flux compressing portion 13 having a diameter gradually reduced from the main magnetic field generating portion 12”). The coiled wire includes: 1) a main field generating unit 12 comprising multiple ‘windings’ with a constant diameter and, 2) a magnetic flux compression unit 13 comprising multiple ‘windings’ with a gradually converging diameter. The BRI of claim 1 does not preclude that the “at least two coil windings” be separate structures, physically detached from each other. Therefore, the main field generating unit 12 and the magnetic flux compression unit 13 of Nagano et al. is considered to meet the claimed “at least two coil windings”. It is improper to import limitations from the specification into the claim. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Therefore, Nagano et al.’s main field generating unit 12 comprising multiple windings and magnetic flux compression unit 13 comprising multiple windings does meet the broadest reasonable interpretation of the “at least two coil windings”, and the rejection of claim 28 as being anticipated by Nagano et al. is maintained.
On page 9 of Applicant’s response, applicant argues that the relationship between the main magnetic field generating portion 12 and the magnetic flux compression portion 13 of Nagano et al. does not meet the claimed “stacked on top of each other”. As noted similarly for the arguments for Nagano et al. above, MPEP §§ 2111, 2131 respectively address claim interpretation and anticipation. The BRI of claim 28 does not specify the orientation of the “at least two coil windings…stacked on top of each other”. While the examiner appreciates that the disclosed invention may have the at least two coil windings vertical stacked on top of each other, this is not commensurate with the scope of the claim. Instead, the plain meaning of “stacked on top of each other” would merely require one coil winding to be positioned directly above or below the coil winding beneath it. Figure 6 shows the coil windings of the main magnetic field generating unit 12 and magnetic flux compression unit 13 stacked together and oriented along horizontal axis, if someone skilled in the art were to rotate coil 10a or 10b ninety degrees clockwise, the windings of 12 and 13 would be vertically stacked on top of each other. Accordingly, the arrangement of the windings can be view or projected as either stacked side-by-side or arranged vertically depending on viewer’s perspective. Therefore, Nagano et al.’s main magnetic field generating unit 12 and magnetic flux compression unit 13 do meet the broadest reasonable interpretation of “stacked on top of each other”. The rejection of claim 28 as being anticipated by Nagano et al. is maintained.
On page 11 of Applicant’s response, applicant argues that the main magnetic field generating portion 12 and the magnetic flux compression portion 13 of Nagano et al. does not meet the claimed “wound with a variable radius into a spiral”). Nagano et al. discloses the magnetic flux compressing unit 13 wherein the diameter of the windings is gradually reduced from the main magnetic field generation unit 12 to the opening 14 (page 3, para. 10, “a magnetic flux compression unit 13 having a diameter gradually reduced from the main magnetic field generating portion 12”; page 5, para. 10, “conical shape”) Additionally, Figure 1 depicts the magnetic flux compression unit 13 wherein the windings extend outward from the opening 14. The rejection of claim 28 being anticipated by Nagano et al. is maintained.
On page 11 of Applicant’s response, Applicant argues that Nagano et al. does not teach a stimulation device to stimulate the first and second phrenic nerve. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2111.02(II). In the instant case, Applicant has provided no evidence that the stimulating coil arrangement of Nagano et al. could not stimulate the phrenic nerves. Nagano et al. discloses stimulating a nerve (page 4, para. 2, “By supplying a current to the stimulation coil 10 in this manner, a predetermined magnetic flux is generated by the coil 10 toward the target site, and nerves or the like in the target site can be stimulated”; page 6, para. 2, “nerve to be the target site”); therefore, there does not appear to by any structure within Nagano et al.’s magnetic stimulation apparatus that would prevent the coils from stimulating the phrenic nerves. Hence, the apparatus of Nagano et al. appears to be capable of performing the intended use set forth in claim 28. The rejection of claim 28 as being anticipated by Nagano et al. is maintained.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/03/2026 was filed after the mailing date of the Non-Final Office Action on 01/29/2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 40 and 45 are objected to because of the following informalities:
In claim 40, line 1, “stimulation device claim” should read “stimulation device of claim”
In claim 45, line 1, “stimulation device or claim” should read “stimulation device of claim”
Appropriate correction is required.
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, 41-48 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 13 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 Annotated Figure 1, windings of 12 and 13 form a D-shaped coil).
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Annotated 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 Annotated Fig. 6).
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Annotated 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, 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 a diameter of a curved portion of the at least two coil windings (see Annotated Figure 1A such that the curved region’s (depicted with a solid line) radius is visibly smaller than the straight-lined side’s length (depicted with a dashed line)).
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Annotated Figure 1A
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, 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 identical form (Figures 6-8, the windings 12 and 13 of coil 10a are the same as coil 10b, just orientated differently).
Regarding claim 42, 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: flat, non-flat (page 5, para. 10, “conical shape”; Fig. 1, wherein the windings of the magnetic flux compression portion 13 gradually converge to the opening 14; visually, the windings of 13 resemble a cone; page 3, para. 12, “the magnetic flux compression section 13 is constructed so that the diameter of the opening 14 is about half the diameter of the main magnetic field generation section 12”), or bent in a radius between 4 cm and 20 cm, or between 6 cm and 12 cm.
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 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, 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 straight-lined side (see Annotated Figure 6, the winding of the main magnetic field generating portion 12 contains a straight-lined side).
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Annotated Figure 6
Regarding claim 48, 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 unit is conical (page 5, para. 10, “conical shape”; Fig. 1, wherein the windings of the magnetic flux compression portion 13 gradually converge to the opening 14; visually, the windings of 13 resemble a cone; page 3, para. 12, “the magnetic flux compression section 13 is constructed so that the diameter of the opening 14 is about half the diameter of the main magnetic field generation section 12”) or bent.
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
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.
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 8:30am - 6:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached at (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/B.R.L./Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
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