DETAILED ACTION
Response to Amendment
This Office Action is responsive to the Amendment filed 6 July 2026. Claims 36-57 are now pending. The Examiner acknowledges the amendments to claims 38, 40, 44, 46, 57.
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 .
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:
-Claim 43 recites “the forehead support structure” which is a generic placeholder. There is no sufficient structure for this limitation provided in the claims. The function of this limitation is to be positioned and to contact a forehead of a patient. According to the specification the forehead support structure includes [0037; “Preferably, the forehead support structure of the bracket structure comprises a band configured to extend along the forehead of the patient. Such band allows for a safe and easily adjustable implementation of the forehead support.”] and equivalents thereof.
-Claim 46 recites “first fastening member” and “second fastening member” which are generic placeholders. There is no sufficient structure for this limitation provided in the claims. The function of this limitation is a fixed state, in which the first coil unit is immovably fastened to the neck position guide section of the first frame portion, and in a loose state, in which the first coil unit is movable relative to the neck position guide section of the first frame portion. According to the specification the first fastening member includes [00115; “a first fastening screw 917”] and [00115; “second fastening screw 927”] and equivalents thereof.
-Claim 47 recites “two support structures” which is a generic placeholder. There is no sufficient structure for this limitation provided in the claims. The function of this limitation is to irreversibly block the position and orientation of the first coil unit and the second coil unit. According to the specification the locking mechanism include [00119; “the first and second support rods 918, 928”] and equivalents thereof.
-Claim 51 recites “locking mechanism” which is a generic placeholder. There is no sufficient structure for this limitation provided in the claims. The function of this limitation is to support the respiration promoting apparatus on a torso of the patient. According to the specification the two support structures include [0052; “The locking mechanism can be any suitable mechanism for stopping these movements. For example, the locking mechanism could be realized as a mechanical locking structure or an electrical locking arrangement.”] and equivalents thereof.
-Claim 53 recites “an active shielding member” which is a generic placeholder. There is no sufficient structure for this limitation provided in the claims. The function of this limitation is to shield the backward faces of the first coil unit and the second coil unit. According to the specification the active shielding member includes [0018; “The active shielding member can for example comprise coil windings configured to cancel out a field and/or change a field direction generated by the first coil unit and the second coil unit. For example, it can comprise one or more coil windings with a synchronized current in opposing direction of an underlying first or second coil winding of the first and second
coil unit.”] and equivalents thereof.
-Claim 55 recites “control unit” which is a generic placeholder. There is no sufficient structure for this limitation provided in the claims. The function of this limitation is to individually provide current to the first coil unity and to the second coil unit in accordance with signals received from the first biofeedback sensor and the second biofeedback sensor such that the diaphragm is uniformly activated. According to the specification the control unit includes [0054; “The control unit may comprise a switch for alternating a current supply
between the coil units.”] and equivalents thereof.
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 § 103
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 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) 36, 37, 38, 42, 43, 44, 45, 46, 47, 48, 50, 51, 52, 53, 54, 55, 56 is/are rejected under 35 U.S.C. 103 as being unpatentable over Borsody (U.S. 20130150653) in view of Dassau (WO 2008130533).
Regarding Claim 36, Borsody teaches a respiration promoting apparatus to coordinatedly stimulate two Phrenic nerves of a patient for activating a diaphragm of the patient, [0086]—reference to phrenic nerve target stimulation,
Comprising: a first coil unit having a first forward face configured to be positioned at the patient to stimulate a first Phrenic nerve of the two Phrenic nerves of the patient; [Fig. 12, elements 104 and 103 (internal and external EM coils)]
A second coil unit having a second forward face configured to be positioned at the patient to stimulate a second Phrenic nerve of the two Phrenic nerves of the patient; [Figs. 12; elements 104 and 103]—shown on adjacent side of the head strap. See annotated Fig. 12 below
And a bracket structure coupled to the first coil unit and the second coil unit, [Fig. 12, element 124 (head strap)]
Wherein the bracket structure is adjustable such that positions and orientations of the first coil unit and of the second coil unit are adaptable relative to the patient and relative to each other [0081]—reference to positioning components of the cap to orient the EM field.
Borsody is silent on the bracket structure has a third forward face configured to be positioned at the patient, and the respiration promoting apparatus is configured to be arranged at a defined location of the patient when the first forward face, the second forward face and the third forward face are positioned at the patient. Dassau teaches the bracket structure has a third forward face configured to be positioned at the patient [Fig. 4, element 405 (headrest)], and the respiration promoting apparatus is configured to be arranged at a defined location of the patient when the first forward face, the second forward face and the third forward face are positioned at the patient [0044]—reference to desired position of the headrest and positioning of the magnetic coil in relation to the subject.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a feature that interfaces with the patient as taught by Dassau to allow for arrangement of the magnetic coils in a desired position as suggested by Borsody, as Borsody discusses using positioning components to provide stimulus energy directed to the facial nerve system [0072] with Dassau because Dassau teaches the use of articulating arms to fix the system in a desired position [0044].
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Regarding Claim 37, Borsody is silent on wherein the bracket structure comprises a first leg portion, a second leg portion and a hinge portion connecting the first leg portion and the second leg portion to each other, the first coil unit is coupled to the first leg portion and the second coil unit is coupled to the second leg portion, and a distance between the first coil unit and the second coil unit can be adjusted by pivoting the first leg portion and the second leg portion relative to each other about the hinge portion. Dassau teaches wherein the bracket structure comprises a first leg portion [Fig. 5c, element 571 (articulation)], a second leg portion [Fig. 5c, element 572 (articulation)] and a hinge portion [Fig. 5c, element 575 (single release mechanism)] and [0052]—reference to ball joints, connecting the first leg portion and the second leg portion to each other [0052], the first coil unit is coupled to the first leg portion and the second coil unit is coupled to the second leg portion [0052] and [Fig. 5c, element 555 (articulated arm)], and a distance between the first coil unit and the second coil unit can be adjusted by pivoting the first leg portion and the second leg portion relative to each other about the hinge portion [0052]—reference to rails and patient positioning in nearly any position in the three-dimensional space around a patient.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include allow for adjustment of the articulating arms as taught by Dassau to adjust aspects of the device as suggested by Borsody, as Borsody discusses adjustment based on dimensions of the patient head and/or neck of the subject [0059] with Dassau because Dassau teaches positioning the device in any three-dimensional space to accommodate patient comfort, coil positioning and other aspects [0049].
Regarding Claim 38, Borsody is silent on wherein the first leg portion of the bracket structure or the second leg portion of the bracket structure, or both the first leg portion and the second leg portion of the bracket structure are curved such that in any pivoting position of the first leg portion and the second leg portion relative to each other a free space is provided between the hinge portion and the first coil unit or between the hinge portion and the second coil unit, or both between the hinge portion and the first coil unit and between the hinge portion and the second coil unit; and/or wherein the first leg portion and the second leg portion of the bracket structure are curved such that a free space is provided between the patient and the first leg portion or between the patient and the second leg portion, or both between the patient and the first leg portion and between the patient and the second leg portion, when the respiration promoting apparatus is arranged at the defined location of the patient. Dassau teaches wherein the first leg portion of the bracket structure or the second leg portion of the bracket structure, or both the first leg portion and the second leg portion of the bracket structure are curved such that in any pivoting position of the first leg portion and the second leg portion relative to each other a free space is provided between the hinge portion and the first coil unit or between the hinge portion and the second coil unit, or both between the hinge portion and the first coil unit and between the hinge portion and the second coil unit; and/or wherein the first leg portion and the second leg portion of the bracket structure are curved such that a free space is provided between the patient and the first leg portion and/or between the patient and the second leg portion, or both between the patient and the first leg portion and between the patient and the second leg portion, when the respiration promoting apparatus is arranged at the defined location of the patient. See annotated Fig. 5c below.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include curvature between portions of the device as taught by Dassau to allow for arrangement of multiple magnetic coils around a patient as suggested by Borsody, as Borsody discusses arranging two EM coils used to activate the facial nerve system [0035] with Dassau because Dassau teaches positioning and fixation of a multitude of magnetic coils in nearly any position in the three-dimensional space surrounding a patient [0052]
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Regarding Claim 42, Borsody is silent on wherein the hinge portion of the bracket structure comprises the third forward face. Dassau teaches wherein the hinge portion of the bracket structure comprises the third forward face [Fig. 4, element 410 (hinge), and 405 (headrest)]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a feature that interfaces with the patient as taught by Dassau to allow for arrangement of the magnetic coils in a desired position as suggested by Borsody, as Borsody discusses using positioning components to provide stimulus energy directed to the facial nerve system [0072] with Dassau because Dassau teaches the use of articulating arms to fix the system in a desired position [0044].
Regarding Claim 43, Borsody further teaches wherein the bracket structure comprises a first frame portion, a second frame portion and a forehead support structure, the first coil unit is coupled to the first frame portion and the second coil unit is coupled to the second frame portion, the first frame portion and the second frame portion are connected via the forehead support structure, and the forehead support structure is configured to be positioned at and to contact a forehead of the patient [Fig. 12]—with particular reference to the head strap and the first frame portion is interpreted to be the one half of the head strap and the second frame portion is the second corresponding half of the head strap.
Regarding Claim 44, Borsody further teaches wherein the bracket structure comprises an overhead arch having a first tangential end being tangential to the first frame portion and a second tangential end being tangential to the second frame portion, the first frame portion is mounted to the first tangential end of the overhead arch, and the second frame portion is mounted to the second tangential end of the overhead arch, or wherein the bracket structure comprises an overhead arch having a first tangential end being tangential to the first frame portion and a second tangential end being tangential to the second frame portion, the first frame portion is mounted to the first tangential end of the overhead arch, and the second frame portion is mounted to the second tangential end of the overhead arch, wherein the bracket structure is configured such that a distance between the overhead arch and the first coil unit and a distance between the overhead arch and the second coil unit are adjustable. See annotated Fig. 12 below and [0059]—which discusses adjusting any dimension of the accessory devices including the forehead strap and the overhead arch.
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Regarding Claim 45, Borsody further teaches wherein the forehead support structure of the bracket structure is configured to be adjusted in accordance with a size of the forehead of the patient, and/or wherein the forehead support structure of the bracket structure comprises a band configured to extend along the forehead of the patient, and/or wherein the forehead support structure of the bracket structure comprises a pad configured to contact the forehead of the patient [0059].
Regarding Claim 46, Borsody is silent on wherein each of the first frame portion and the second frame portion comprise a neck position guide section to which the first coil unit and the second coil unit, respectively, are movably mounted such that the first coil unit and the second coil unit can be varyingly positioned about a neck of the patient, or wherein each of the first frame portion and the second frame portion comprise a neck position guide section to which the first coil unit and the second coil unit, respectively, is movably mounted such that the first coil unit and the second coil unit can be varyingly positioned about a neck of the patient, and wherein the first coil unit is mounted to the neck position guide section of the first frame portion by a first fastening member configured to be in a fixed state, in which the first coil unit is immovably fastened to the neck position guide section of the first frame portion, and in a loose state, in which the first coil unit is movable relative to the neck position guide section of the first frame portion, and the second coil unit is mounted to the neck position guide section of the second frame portion by a second fastening member configured to be in a fixed state, in which the second coil unit is immovably fastened to the neck position guide section of the second frame portion, and in a loose state, in which the second coil unit is movable relative to the neck position guide section of the second frame portion.
Dassau teaches wherein each of the first frame portion and the second frame portion comprise a neck position guide section to which the first coil unit and the second coil unit, respectively, is movably mounted such that the first coil unit and the second coil unit can be varyingly positioned about a neck of the patient [Fig. 5c, element 590 (rail)], or wherein each of the first frame portion and the second frame portion comprise a neck position guide section to which the first coil unit and the second coil unit, respectively, is movably mounted such that the first coil unit and the second coil unit can be varyingly positioned about a neck of the patient, and wherein the first coil unit is mounted to the neck position guide section of the first frame portion by a first fastening member configured to be in a fixed state [Fig. 5c, element 590, 595 (horizontal), and 535 (clamps)], in which the first coil unit is immovably fastened to the neck position guide section of the first frame portion, and in a loose state, in which the first coil unit is movable relative to the neck position guide section of the first frame portion, and the second coil unit is mounted to the neck position guide section of the second frame portion by a second fastening member configured to be in a fixed state, in which the second coil unit is immovably fastened to the neck position guide section of the second frame portion [0051]—reference to locking means interpreted to be immovably fastened, and in a loose state, in which the second coil unit is movable relative to the neck position guide section of the second frame portion [0050]—reference to the clamps being used to position and fix the articulation arms.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide support to the neck of the patient as taught by Dassau to promote respiration and musculoskeletal support as suggested by Borsody, and as Borsody stimulating the cranial nerves through the neck [0085] with Dassau because Dassau teaches supporting the chin, and back of the neck [0065].
Regarding Claim 47, Borsody is silent on wherein the bracket structure comprises two support structures configured to support the respiration promoting apparatus on a torso of the patient.
Dassau teaches wherein the bracket structure comprises two support structures configured to support the respiration promoting apparatus on a torso of the patient [Fig. 6a, element 615]—depicting a backrest also referred to a patient positioning device.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide support to the patient as taught by Dassau to promote respiration and musculoskeletal support as suggested by Borsody, and as Borsody mentions the use of the device positioned around and on the back of the patient [0086] with Dassau because Dassau teaches stimulating a region of a subject by using the patient positioning device [0054].
Regarding Claim 48, Borsody is silent on wherein one of the two support structures is comprised by the first frame portion and the other of the two support structures is comprised by the second frame portion and/or wherein one of the two support structures comprises a first support bar movably connected to the first frame portion and the other of the two support structures comprises a second support bar movably connected to the second frame portion.
Dassau teaches wherein one of the two support structures is comprised by the first frame portion and the other of the two support structures is comprised by the second frame portion and/or wherein one of the two support structures comprises a first support bar movably connected to the first frame portion and the other of the two support structures comprises a second support bar movably connected to the second frame portion [Fig. 5b, element 525 (rail), 530 and 535 (clamps)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide adjustability for patient positioning as taught by Dassau that adds flexibility as suggested by Borsody as Borsody discloses the use of a flexible housing of the coil that restricts movement of the two coils [0062] with Dassau because Dassau teaches additional flexibility through the use of these structural elements [0050].
Regarding Claim 50, Borsody further teaches wherein the first coil unit has a non-flat first coil winding formed from a conductive elongate component [Fig. 12, element 103]—depicting a cone shape internal EM coil and [0016], and the second coil unit has a non-flat second coil winding formed from a conductive elongate component [See second internal EM coil unit located on the adjacent side of the head strap] and [0016].
Regarding Claim 51, Borsody is silent on comprising a locking mechanism to block the positions and orientations of the first coil unit and the second coil unit relative to each other in a target configuration, or comprising a locking mechanism to block the positions and orientations of the first coil unit and the second coil unit relative to each other in a target configuration, wherein the locking mechanism is configured to irreversibly block the positions and orientations of the first coil unit and the second coil unit relative to each other in the target configuration. Dassau teaches comprising a locking mechanism to block the positions and orientations of the first coil unit and the second coil unit relative to each other in a target configuration [0051]—reference to locking means, or comprising a locking mechanism to block the positions and orientations of the first coil unit and the second coil unit relative to each other in a target configuration [0050], wherein the locking mechanism is configured to irreversibly block the positions and orientations of the first coil unit and the second coil unit relative to each other in the target configuration [0050].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a locking mechanism as taught by Dassau to fix and position the structure in coordination with the patient as suggested by Borsody, as Borsody discusses fixing the EM coil to a rigid housing [0073] with Dassau because Dassau teaches fixing the coil at a desired location relative to a subject [0049].
Regarding Claim 52, Borsody further teaches wherein the first coil unit and the second coil unit are detachably coupled to the bracket structure [0078]—reference to blocking EM coils removed from the contact surface (interpreted to be the contact surface of the head strap) and from the contact surface of the stimulating coils.
Regarding Claim 53, Borsody further teaches wherein a backward face of the first coil unit and a backward face of the second coil unit are shielded or wherein a backward face of the first coil unit and a backward face of the second coil unit are shielded, wherein lateral faces of the first coil unit and the second coil unit are shielded. This limitation of the claim has not been interpreted due to this limitation being cited in the alternative.
and/or wherein the respiration promoting apparatus comprises an active shielding member configured to shield the backward faces of the first coil unit and the second coil unit [Fig. 11D, element 112 (EM blocking coil)].
Regarding Claim 54, Borsody further teaches wherein the bracket structure or a control unit of the respiration promoting apparatus, which is configured to coordinatedly provide current to the first coil unit and to the second coil unit, comprises a switch to direct current into either the first coil unit or the second coil unit to generate an alternating current supply in the first coil unit or the second coil unit [0069]—reference to a switch at the output source of the stimulus generator.
Regarding Claim 55, Borsody further teaches on comprising a first biofeedback sensor, a second biofeedback sensor and a control unit [0084]—reference to one or more sensor devices, wherein the first biofeedback sensor is associated with the first coil unit and coupled to the control unit [0084]—reference to stimulation controller, the second biofeedback sensor is associated with the second coil unit and coupled to the control unit [0084; “In some embodiments, a sensor is directed at or placed on the EM coil 100, …change or instruct the function of the stimulus generator 510, EM coil 100, or a positioning component.”]
Regarding Claim 56, Borsody further teaches adjusting the bracket structure of the respiration promoting apparatus such that the first forward face of the first coil unit of the respiration promoting apparatus can be positioned at and oriented to the patient to stimulate a first Phrenic nerve of the patient [0086]—reference to phrenic nerve target stimulation and [Fig. 12, elements 104 and 103 (internal and external EM coils)], and the second forward face of the second coil unit of the respiration promoting apparatus can be positioned at and oriented to the patient to stimulate a second Phrenic nerve of the patient [Figs. 12; elements 104 and 103]—shown on adjacent side of the head strap. See annotated Fig. 12 below;
Borsody is silent on arranging the respiration promoting apparatus at a defined location of the patient such that the first forward face, the second forward face and the third forward face provided at the bracket structure are in contact with the patient; and coordinatedly providing current to the first coil unit and the second coil unit such that the first Phrenic nerve and the second Phrenic nerve are stimulated to homogeneously activate a diaphragm of the patient. Dassau teaches arranging the respiration promoting apparatus at a defined location of the patient such that the first forward face, the second forward face and the third forward face provided at the bracket structure are in contact with the patient [Fig. 4, element 405 (headrest)] and [0017]; and coordinatedly providing current to the first coil unit and the second coil unit such that the first Phrenic nerve and the second Phrenic nerve are stimulated to homogeneously activate a diaphragm of the patient [0067].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a feature that interfaces with the patient as taught by Dassau to allow for arrangement of the magnetic coils in a desired position as suggested by Borsody, as Borsody discusses using positioning components to provide stimulus energy directed to the facial nerve system [0072] with Dassau because Dassau teaches the use of articulating arms to fix the system in a desired position [0044].
Claim(s) 39, 40, 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Borsody (U.S. 20130150653) in view of Dassau (WO 2008130533) and in further view of Schneider (U.S. 20140200388).
Regarding Claim 39, Borsody and Dassau are silent on wherein the bracket structure comprises a first pivoting coupler extending from the first leg portion and a second pivoting coupler extending from the second leg portion, and wherein the first coil unit is mounted to the first pivoting coupler and the second coil unit is mounted to the second pivoting coupler. Schneider teaches wherein the bracket structure comprises a first pivoting coupler extending from the first leg portion and a second pivoting coupler extending from the second leg portion, and wherein the first coil unit is mounted to the first pivoting coupler and the second coil unit is mounted to the second pivoting coupler. See annotated Fig. 12B below.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include coupling mechanisms and structures as taught by Dassau to allow for arrangement of multiple magnetic coils around a patient as suggested by Borsody and Dassau, as Borsody discusses arranging two EM coils (and up to 8 coils) used to activate the facial nerve system [0035] and Dassau which discloses the use of ball joints to lock and release by single mechanism [0052] with Schneider because Schneider teaches allowing for close fitting to the subject’s head when the seat is reclined [0076].
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Regarding Claim 40, Borsody and Dassau are silent on wherein the first pivoting coupler is pivotably mounted to the first leg portion such that the first pivoting coupler can be pivoted relative to the first leg portion about an axis of the first leg portion, and respectively the second pivoting coupler is pivotably mounted to the second leg portion such that the second pivoting coupler can be pivoted relative to the second leg portion about an axis of the second leg portion and/or wherein the first coil unit is pivotably mounted to the first pivoting coupler such that the first coil unit can be pivoted relative to the first pivoting coupler about an axis of the first pivoting coupler, and the second coil unit is pivotably mounted to the second pivoting coupler such that the second coil unit can be pivoted relative to the second pivoting coupler about an axis of the second pivoting coupler, wherein the first pivoting coupler is pivotably mounted to the first leg portion such that the first pivoting coupler can be pivoted relative to the first leg portion about an axis of the first leg portion, and respectively the second pivoting coupler is pivotably mounted to the second leg portion such that the second pivoting coupler can be pivoted relative to the second leg portion about an axis of the second leg portion, and wherein the first coil unit is pivotably mounted to the first pivoting coupler such that the first coil unit can be pivoted relative to the first pivoting coupler about an axis of the first pivoting coupler, and the second coil unit is pivotably mounted to the second pivoting coupler such that the second coil unit can be pivoted relative to the second pivoting coupler about an axis of the second pivoting coupler, and wherein the axis of the first leg portion is essentially perpendicular to the axis of the first pivoting coupler and the axis of the second leg portion is essentially perpendicular to the axis of the second pivoting coupler.
Schneider teaches wherein the first pivoting coupler is pivotably mounted to the first leg portion such that the first pivoting coupler can be pivoted relative to the first leg portion about an axis of the first leg portion, and respectively the second pivoting coupler is pivotably mounted to the second leg portion such that the second pivoting coupler can be pivoted relative to the second leg portion about an axis of the second leg portion [0027]—where the pivoting about an axis of the first and second leg portion is accomplished by the sliding blocks and [0070; “This approach has the advantage that clamping force is applied directly to the sliding block regardless…providing five degrees of freedom controlled by one locking device.”]
and/or wherein the first coil unit is pivotably mounted to the first pivoting coupler such that the first coil unit can be pivoted relative to the first pivoting coupler about an axis of the first pivoting coupler, and the second coil unit is pivotably mounted to the second pivoting coupler such that the second coil unit can be pivoted relative to the second pivoting coupler about an axis of the second pivoting coupler, wherein the first pivoting coupler is pivotably mounted to the first leg portion such that the first pivoting coupler can be pivoted relative to the first leg portion about an axis of the first leg portion, and respectively the second pivoting coupler is pivotably mounted to the second leg portion such that the second pivoting coupler can be pivoted relative to the second leg portion about an axis of the second leg portion, and wherein the first coil unit is pivotably mounted to the first pivoting coupler such that the first coil unit can be pivoted relative to the first pivoting coupler about an axis of the first pivoting coupler, and the second coil unit is pivotably mounted to the second pivoting coupler such that the second coil unit can be pivoted relative to the second pivoting coupler about an axis of the second pivoting coupler, and wherein the axis of the first leg portion is essentially perpendicular to the axis of the first pivoting coupler and the axis of the second leg portion is essentially perpendicular to the axis of the second pivoting coupler. This limitation of the claim has not been interpreted due to this limitation being cited in the alternative.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include adjustment along axes as taught by Schneider to optimize EM field stimulation as suggested by Borsody and Dassau, as Borsody discusses EM coils arranged along an axis to reduce neutralize or counteract unwanted portions of the EM field [0078] and Dassau which discloses a sliding rail connected with the articulation [0052] with Schneider because Schneider teaches the joint being able to yaw, pitch and roll the coil to slide in the structure [0070].
Regarding Claim 41, Borsody and Dassau are silent on wherein the first pivoting coupler is Y-like or U-like shaped having a stem portion and two branch portions, and the second pivoting coupler is Y-like or U-like shaped having a stem portion and two branch portions; wherein the stem portion of the first pivoting coupler is mounted to the first leg portion, and the stem portion of the second pivoting coupler is mounted to the second leg portion; and wherein the first coil unit is mounted between the two branch portions of the first pivoting coupler, and the second coil unit is mounted between the two branch portions of the second pivoting coupler. Schneider teaches wherein the first pivoting coupler is Y-like or U-like shaped having a stem portion and two branch portions, and the second pivoting coupler is Y-like or U-like shaped having a stem portion and two branch portions; wherein the stem portion of the first pivoting coupler is mounted to the first leg portion, and the stem portion of the second pivoting coupler is mounted to the second leg portion; and wherein the first coil unit is mounted between the two branch portions of the first pivoting coupler, and the second coil unit is mounted between the two branch portions of the second pivoting coupler. See annotated Fig. 12B below.
Or wherein the first pivoting coupler is ring-shaped having a ring portion with a ring opening, and further having a stem portion, and the second pivoting coupler is ring-shaped having a ring portion with a ring opening, and further having a stem portion; wherein the stem portion of first pivoting coupler is mounted to the first leg portion, and the stem portion of second pivoting coupler is mounted to the second leg portion; and wherein the first coil unit is mounted in the ring opening of the first pivoting coupler and the second coil unit is mounted in the ring opening of the second pivoting coupler. This limitation of the claim has not been interpreted due to this limitation being cited in the alternative.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a specific U-shape of the structure as taught by Schneider to optimize placement of the structure as suggested by Borsody and Dassau, as Borsody discusses shaping the device to fit the ear canal [0079] and Dassau which discloses designing the structure to support the subject’s anatomy [0011] with Schneider because Schneider teaches the use of the shape of the contact surface to direct the vector direction from the magnets [0004].
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Claim(s) 49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Borsody (U.S. 20130150653) in view of Dassau (WO 2008130533) and in further view of Royalty (U.S. 20070250162).
Regarding Claim 49, Borsody and Dassau are silent on wherein the first coil unit and/or the bracket structure comprises a vacuum device for fixing the first, second, and third forward faces, respectively, to the patient using a vacuum. Royalty teaches wherein the first coil unit and/or the bracket structure comprises a vacuum device for fixing the first, second, and third forward faces, respectively, to the patient using a vacuum [0025]—describes fixing the mat with the coil units to the diaphragm via suction.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a vacuum as taught by Royalty to fix and position the structure in coordination with the patient as suggested by Borsody and Dassau, as Borsody discusses fixing the EM coil to a rigid housing [0073] and Dassau which discloses fixing the structure using uncomfortable techniques [0065] with Royalty because Royalty teaches physically attaching the device to the patient to improve assistance to the patient [0025].
Claim(s) 57 is/are rejected under 35 U.S.C. 103 as being unpatentable over Borsody (U.S. 20130150653) in view of Dassau (WO 2008130533) and in further view of Zangen (U.S. 7976451).
Regarding Claim 57, Borsody and Dassau are silent on comprising: adjusting a distance between the first coil unit and the second coil unit by adjusting an angle between a first leg portion and a second leg portion, and adjusting an orientation of a first winding axis of a non-flat first coil winding of the first coil unity and an orientation of a second winding axis of a non-flat second coil winding of the second coil unit by adjusting the first coil unit and the second coil unit, such that the first winding axis and the second winding axis converge, and/or adjusting an orientation of a first winding axis of a non-flat first coil winding of the first coil unit and an orientation of a second winding axis of a non-flat second coil winding of the second coil unit by adjusting the first coil unit and the second coil unit such that the first winding axis and the second winding axis lie in a common plane.
Zangen teaches comprising: adjusting a distance between the first coil unit and the second coil unit by adjusting an angle between a first leg portion and a second leg portion, [Col 5, lines 11-14].
and adjusting an orientation of a first winding axis of a non-flat first coil winding of the first coil unity and an orientation of a second winding axis of a non-flat second coil winding of the second coil unit by adjusting the first coil unit and the second coil unit, [Col 6, lines 31-35].
Such that the first winding axis and the second winding axis converge, [Col 6, lines 59-61; “The remainder portions 34, 36 of these elements 26, 28 extend away from the base 12 and converge toward each 60 other.”]
and/or adjusting an orientation of a first winding axis of a non-flat first coil winding of the first coil unit and an orientation of a second winding axis of a non-flat second coil winding of the second coil unit by adjusting the first coil unit and the second coil unit such that the first winding axis and the second winding axis lie in a common plane [Col 9, lines 1-9; “Contacting return portion 315 is at the first level, that is, is approximately on the same plane as base portion 312, but is at a planar distance (in the x-z plane) from the target area. Windings 317 are designed to be in contact with the skull, and may either be pre-formed or malleable to accommodate the curved anatomy of the area on which it is to be placed.”]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to allow for adjustability of the support device as taught by Zangen to position coils around the subject as suggested by Borsody and Dassau, as Borsody discloses the use of positioning components and accessory devices to orient generated EM field [0081] and Dassau which discusses the patient positioning device supporting 4 to 10 transcranial magnetic stimulation coils [0017] with Zangen because Zangen teaches the described tangential stimulation patterns being advantageous for desired treatment effects [Col 9, lines 7-9].
Response to Arguments
Applicant's arguments filed 6 July 2026 with respect to the claim objections have been fully considered and are persuasive in light of the amendments.
Applicant's arguments filed 6 July 2026 with respect to 35 U.S.C. 112(b)
rejections have been fully considered and are persuasive.
Applicant’s arguments filed 6 July 2026 with respect to the rejection of
claims 36-57 under 35 U.S.C.103 have been fully considered but are not persuasive.
Regarding Claim 36, applicant contends that Borsody does not teach:
“a bracket structure which is adjustable”
“positions and orientations of the first coil unit and of the second coil unit are adjustable relative to the patient and relative to each other”
The examiner notes that regarding both portions of these teachings, paragraph [0081] and Fig. 12 were provided. Figure 12 shows a head mounted device with a strap, cable, coils and caps. These structures as combined and especially that of the head strap positioned around the patient’s head are interpreted to be that of a bracket structure. A bracket is interpreted to be a support and/or fixture to support a load or strengthen an angle. In summary, the head strap, caps and other associated elements in Fig. 12 comprise a bracket structure. Paragraph [0081] describes the cap positioned on the head strap that orients the EM fields in certain directions. This reference further describes that positioning components or accessory devices can be associated with the cap to position and orient EM fields.
Therefore, regarding argument I., the bracket structure shown in Fig. 12 is taught to be adjustable based on the description of the head strap and cap and in consideration of the positioning components or accessories as described.
Regarding argument II., Borsody describes the cap and head strap, which include the coil units, as positioned respective to each other and/or in combination with positioning components or accessories to orient the EM fields in certain directions which would include adjustability relative to the patient’s head. Further, the recitation of adaptable relative to the patient and relative to each other is also broadly interpreted as the headband or cap being moved around, taken, on and off, etc. In view of the foregoing, the previously presented rejections citing Borsody in view of Dassau are maintained for claims 36, 37, 38, 42, 43, 44, 45, 46, 47, 48, 50, 51, 52, 53, 54, 55, 56, citing Borsody in view of Dassau and in further view of Schneider for claims 39, 40, and 41, citing Borsody in view of Dassau and in further view of Royalty for claim 49, and citing Borsody, in view of Dassau and in further view of Zangen for claim 57.
Applicant also contends that Dassau does not teach the limitations mentioned above including “a bracket structure…” and “positions and orientations…”. Examiner notes that Dassau was not relied upon for this rejection and because of the discussion regarding the rejections of these limitations citing Borsody above, the rejection citing Borsody in view of Dassau is maintained.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/B.N.K./Examiner, Art Unit 3791
/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791
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