DETAILED ACTION
This Office action is responsive to communications filed on 08/06/2026. Claims 1, 11, 17, 36, & 39 have been amended. Claims 7, 9-10, 12, 16, 18, 22-24, 28, 31-35, 37, & 40 canceled. Presently, Claims 1-6, 8, 11, 13-15, 17, 19-21, 25-27, 29-30, 36, & 38-39 remain pending and are hereinafter examined on the merits.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Previous claim objections are withdrawn in view of the amendments filed on
Previous rejections under 35 USC § 101 are withdrawn in view of the amendments filed on
Applicant’s arguments with respect to claim(s) have been considered but are moot because the new ground of rejection does not rely on Fuha (JP 2014073294 A1) alone as applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The new grounds of rejection now relies on: Fuha (JP 2014073294 A1) in view of Shaw (US 5809597 A).
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 6, 8, 11, 13-15, 19-21, 25, 29-30, 36, & 39 are rejected under 35 U.S.C. 103 as being unpatentable over Fuha (JP 2014073294 A1) in view of Shaw (US 5809597 A).
Claim 1: Fuha discloses, A head support comprising: (¶Abstract, ¶0001, ‘FIELD An embodiment of the present invention relates to an RF coil device and a magnetic resonance imaging device.’, ¶0014, ‘Hereinafter, embodiments of an RF coil device and an MRI device will be described with reference to the accompanying drawings. The first to third embodiments relate to an RF coil device, and the fourth embodiment relates to an MRI apparatus equipped with the RF coil device of any of the first to third embodiments.’; ¶0015, ‘The RF coil device 100A of the first embodiment is attached to the head of a subject P in an MRI, and transmits RF pulses to the subject P and receives MR signals from the subject P. The RF coil device 100A has a detachable structure including a base member 102 that is brought into contact with the back of the head of the subject P, and a cover member 104 that covers the face of the subject P. That is, the housing of the RF coil device 100A is constructed by detachably connecting the cover member 104 to the base member 102.’)
a frame (RF coil device 100A, ¶0015) and an inflatable bladder (FIG. 9, ¶0084, ‘The contact portion 140c is a bag body, and expands when air is injected into it by the air pump 200.’,¶0091, ‘instead of the two-layer structure of the root portion 140a and the close contact portion 140c, the entire forehead pad 140' may be formed from a bag that can be inflated and deflated by the air pump 200, resulting in a single-layer structure.’, ¶0092, ‘The same applies to the occipital pad 110. That is, only the contact portion 110b may be formed from a bag similar to that described above, or the base portion 110a and the contact portion 110b may be formed from a bag having a two-layer structure similar to that described above. Alternatively, the entire occipital pad 110 may be formed from a bag body having a single layer structure.’; ¶0093, ‘The same applies to the neck pad 112. That is, only the contact portion 112b may be formed of a bag similar to that described above, or the base portion 112a and the contact portion 112b may be formed of a bag having a two-layer structure similar to that described above. Alternatively, the entire neck pad 112 may be formed from a single-layered bag.’ -Therefore, note; as written “a” means one or more. The claim does not require a single inflatable bladder.); wherein:
the frame comprises a cover portion (forehead pad 104’, FIG. 9) and a base portion (base member 102), the cover portion and base portion being reversibly moveable with respect to each other between:
an open position within the base portion, wherein the opening position comprises a head locatable area; (FIG. 11B)
a closed position in which the cover portion and base portion are securable together to encircle a portion of an exterior surface of the head locatable area; (FIG. 11A)
(¶0097, ‘FIG. 11A shows a state in which a cover member 104'' is closed relative to a base member 102'', that is, a state during image capture. 11B shows a state in which the connection between the connection portion 120b of the base member 102'' and 134b of the cover member 104'' has been released from the state shown in FIG. 11A, and the cover member 104'' has been opened by 90 degrees by the hinge 230.’; ¶0098, ‘When wearing the device, the cover member 104 ″ is opened by 90° or more as shown in FIG. 11B, and the subject P places his/her head face up in the recess of the base member 102 . Thereafter, the cover member 104'' is closed and connected to the base member 102 by the connecting portions 120b and 134b (see FIG. 11A).’)
-In the closes position the cover portion and the base portion are securable (capable of being secured) together via the hinge 230 to encircle or otherwise enclose the subject P which includes an exterior surface of the body part locatable within the base portion during image capture.
the inflatable bladder being mounted by a superior end but not an inferior end but not an inferior end of the inflatable bladder on the base portion of the frame (occipital pad 110-contact portion 110b/ contact portion 110b & base portion 110a and/or the neck pad 112, FIG. 9 – these are one or more of the inflatable bladder. Neck pad 112 has a surface of the superior end that is mounted on the base portion. The apex/tip of this neck pad 112 closest to the patient is an inferior end. The interior end does not have a surface mounted directly on the base portion. ), such that inflation of the inflatable bladder causes a reduction of a gap formed between an interior of the frame and the encircled portion of the exterior surface of the head locatable area; (FIG. 9)
-140c is a bag body, and expands when air is injected into it by the air pump 200. The act of expanding 140c causes a reduction of a gap formed between an interior of the frame and the encircled portion of the exterior surface of the body part locatable within the base portion, as it takes up more volume, ¶0084-0089, ¶0091. The amount of air inject at this time may be adjusted according to the shape and size of the subject P’s head, ¶0089. Note; the ¶0021, ‘In the second embodiment, only the intimate contact portion 140c of the forehead pad 140' is formed as a bag that can be inflated and deflated by the air pump 200. However, the second embodiment is not limited to this. The embodiment of the present invention is not limited to this aspect. The base portion 140 a of the forehead pad 140 ′ may also be a bag that can be inflated and deflated by the air pump 200 in the same manner. Alternatively, instead of the two-layer structure of the root portion 140a and the close contact portion 140c, the entire forehead pad 140' may be formed from a bag that can be inflated and deflated by the air pump 200, resulting in a single-layer structure.’; ¶0092, ‘The same applies to the occipital pad 110. That is, only the contact portion 110b may be formed from a bag similar to that described above, or the base portion 110a and the contact portion 110b may be formed from a bag having a two-layer structure similar to that described above. Alternatively, the entire occipital pad 110 may be formed from a bag body having a single layer structure.’; ¶0093, ‘The same applies to the neck pad 112. That is, only the contact portion 112b may be formed of a bag similar to that described above, or the base portion 112a and the contact portion 112b may be formed of a bag having a two-layer structure similar to that described above.’). Accordingly, the same principle applied to contact portion 140c applies to both the occipital pad 110 and neck pad 112 in the same embodiment.
-This establishes that the contact portion 140c of the forehead pad is formed as a bag body, the neck pad 112 (both 112a & 112b (i.e., entire neck pad)) that is already mounted to the base member 102 can be formed similar to that of the bag 140c (i.e., the inflatable bladder). When formed as bag like 140c, the neck pad would share the same material properties, meaning it would be designed to expand when air is injected into it by the air pump. Accordingly, the inflatable bladder is mountable to the base portion of the frame.
wherein the inflatable bladder is mountable on the base portion of the frame, such that inflation of the inflatable bladder causes the inflatable bladder to form a shape that causes a rotation of the head to be loaded into the base portion up and back into the frame; and
-Fuha discloses that the neck pad 112 is formed with a “triangular cross section” or a “mountain shape”, ¶0065, “The neck pad 112 has a triangular cross-section rather than a rectangular one, which makes it easier to fit into the hollow of the neck (the hollow between the back of the head and the back) when the subject P is lying on their back (see Figure 7). Thus, by shaping the neck pad 112 in a mountain shape so that it compresses the neck in the direction of the shape-restoring force PW3 indicated by the arrow in Figure 7, that is, in the upward direction of Figure 7, when the neck of the subject P rests on top of it, the chin will point upward (away from the throat). This makes it easier to fix the neck of subject P and to suppress cervical flexion and extension.”. This specific shape is designed so that it can easily fit into the depression in the neck, which is defined as the recessed area between the back of the head and the back of the neck when the subject is lying on their back, ¶0065.
-Fuha, as established above, teaches that this neck pad 112 can be constructed entirely from the inflatable bag 140c, ¶0093, ‘The same applies to the neck pad 112. That is, only the contact portion 112b may be formed of a bag similar to that described above, or the base portion 112a and the contact portion 112b may be formed of a bag having a two-layer structure similar to that described above.”. Because this inflatable pad is made of soft materials, they can deform to fit various shapes of the subject P’s head and neck, ¶0073, “By using a soft material on the subject P side, the forehead pad 140, occipital pad 110, and neck pad 112 deform to fit various shapes of the subject P's head and neck.”. When using the air pump, the amount of air injected to be, ¶0089, “appropriately adjusted according to the shape and size of the subject P's head.”. Therefore, Fuha teaches inflating the bag-like neck pad so that its triangular wedge shape deforms to fit the depression and shape of the individual patient’s neck (i.e., inflates to form a wedge configured to match a curve of a neck), as best understood under the broadest reasonable interpretation in view of the instant application’s specification which merely recites, at paragraph ¶0071, “The inflatable bladder 3 b is located beneath the lower skull and neck, it is substantially wedge shaped and formed to accommodate the general shape of the neck and lower skull.”.
Note: the location of the neck pad 112 when inflated, it logically and anatomical rotates the head to some degree. Specifically, the neck pad 112 is inflated, to compress the neck vertically upward PW3. Physically forcing the chin upward is defined as cervical retroflexion, ¶0005, ¶0065. Therefore, the inflatable bladder of Fuha would causes a rotation of the head to be loaded into the base portion up and back into the frame, under the broadest reasonable interpretation.
further comprising a deformable pad, mountable on an interior surface of the frame opposing the inflatable bladder. (FIG. 9, ¶0019, ‘The occipital pad 110 suppresses backward bending of the cervical spine’; ¶0056, ‘forehead pad 140 and the occipital pad 110 face each other’; ¶0060, ‘contact portion 110b has a smaller elastic modulus and is softer than base portion 110a.’; ¶0073, ‘By using a soft material on the subject P side, the forehead pad 140, the occipital pad 110, and the neck pad 112 can deform to fit various shapes of the subject P's head and neck.’)
Fuha fails to explicitly disclose: wherein the inferior end of the inflatable bladder tapers down to the superior end of the inflatable bladder such that inflation of the inflatable bladder causes the inflatable bladder to form a wedge configured to match a curve of a neck to cause a rotation of the head to be loaded up and back.
However, Shaw in the context of inflatable body supports discloses: wherein the inferior end of the inflatable bladder tapers down to the superior end of the inflatable bladder (FIG. 5 below)
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such that inflation of the inflatable bladder causes the inflatable bladder to form a wedge configured to match a curve of a neck (FIG. 5, a part of the inflatable bladder (support 10) inflates to form a wedge – this contoured slope presents a wedge profile where the highest point of support 10 fits directly under the curve of the neck, and then slopes downward towards the head/occipital. At the instance of Fig. 5 [Col. lines 63 to Col 7 l.1], “compartment 12 of the lower tier is substantially deflated while the intermediate compartments 14 and 20 are inflated to their maximum combined height h1 +h3. Compartment 18, upon which the occiput is supported, is inflated sufficiently to create the desired curvature of the cervical vertebrae overlying compartment 20;”. As can been seen in FIG. 5 the wedge profile is configured to match a curve of a neck.) to cause a rotation of the head to be loaded up and back (By elevating the neck, this upward displacement of the neck naturally causes the head/face to tilt or to rotate “up and back” (i.e., extension) relative to the neck, as seen in FIG. 5 -the head is extended backwardly).
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the inflatable bladder of Fuha to incorporate the teachings Shaw. The motivation to do this yield predictable results such as to improve the comfort and support of the subject, as suggested by Shaw, Col 8. The modified combination would disclose wherein the inferior end of the inflatable bladder tapers down to the superior end of the inflatable bladder such that inflation of the inflatable bladder causes the inflatable bladder to form a wedge configured to match a curve of a neck to cause a rotation of the head to be loaded into the base portion up and back into the frame.
Claim 2: Modified Fuha discloses all the elements above in claim 1, Fuha discloses, wherein the frame is formed from a material having a rigidity sufficient to resist deformation when the inflatable bladder is fully inflated. (FIG. 9; ¶0046, ‘The RF coil device 100A is made of insulating materials except for the coil elements 128a to 128j, the cable 126, the electrodes (not shown) in the connectors 120a, 120b, 134a, and 134b, the control circuit, and the internal wiring that electrically connects these.’; ¶0047, ‘The base member 102 and the cover member 104 are made of a non-deformable material such as FRP (Fiber Reinforced Plastics) or polyethylene. ¶0070, ‘Therefore, the head of the subject P can be comfortably fixed with a less uncomfortable means without increasing the size of the RF coil device 100A itself, and forward and backward bending of the cervical spine can be suppressed.’)
Claim 3: Modified Fuha discloses all the elements above in claim 1, Fuha discloses, wherein external surfaces of the head support separate from the head locatable area are shaped to conform to an interior surface of a magnetic resonance imaging head support within which the head support is locatable. (¶Abstract, ¶0001, ‘FIELD An embodiment of the present invention relates to an RF coil device and a magnetic resonance imaging device.’, ¶0014, ‘Hereinafter, embodiments of an RF coil device and an MRI device will be described with reference to the accompanying drawings. The first to third embodiments relate to an RF coil device, and the fourth embodiment relates to an MRI apparatus equipped with the RF coil device of any of the first to third embodiments.’; ¶0015, ‘The RF coil device 100A of the first embodiment is attached to the head of a subject P in an MRI, and transmits RF pulses to the subject P and receives MR signals from the subject P. The RF coil device 100A has a detachable structure including a base member 102 that is brought into contact with the back of the head of the subject P, and a cover member 104 that covers the face of the subject P. That is, the housing of the RF coil device 100A is constructed by detachably connecting the cover member 104 to the base member 102.’)
Claim 4: Modified Fuha discloses all the elements above in claim 1, Fuha discloses, wherein the cover portion and base portion are hingeably connected (hinge 230, FIG. 10-11), wherein a hingeable connection between the cover portion and base portion is located such that, in the closed position, at least one of the cover portion or base portion is configured to exert force transverse the head locatable area within the head support. (FIG. 7-PW1 pushing down and the occipital pad (PW2 pushing up, ¶0089, ‘Thereafter, air is injected into the contact portion 140c by the air pump 200, thereby expanding the contact portion 140c. The amount of air injected at this time may be appropriately adjusted according to the shape and size of the subject P's head. That is, the force applied between the forehead pad 140' and the occipital pad 110 to hold and fix the head should be such that the subject P does not feel uncomfortable.’; ¶0091, ‘only the intimate contact portion 140c of the forehead pad 140' is formed as a bag that can be inflated and deflated by the air pump 200.’; ¶0133, ‘These embodiments can be implemented in various other forms, and various omissions, substitutions, and modifications can be made without departing from the spirit of the invention. These embodiments and their variations are intended to be included in the scope of the invention and its equivalents as described in the claims, as well as in the scope and spirit of the invention.’)
Claim 6: Modified Fuha discloses all the elements above in claim 1, Fuha discloses, wherein the inflatable bladder is formed from a pliant material. (¶0084, ‘The contact portion 140c is a bag body, and expands when air is injected into it by the air pump 200. The adhesive portion 140c is formed into a bag shape from a resin such as polyethylene resin or vinyl chloride, or rubber.’)
Claim 8: Modified Fuha discloses all the elements above in claim 1, Fuha discloses, wherein the inflatable bladder comprises an opening configured to receive fluid from a fluid source, the opening further configured to allow exit of gas from the inflatable bladder. (FIG. 9, ¶0011, ‘The forehead pad is formed from a bag that can expand and contract by injecting gas or from an elastic material, and is positioned on the inner surface of the housing so that it abuts against the subject's forehead when the housing is attached to the head.’; ¶0084, ‘The contact portion 140c is a bag body, and expands when air is injected into it by the air pump 200.’; ¶0087, ‘the air pump 200 includes a cylinder 204 , a lever 208 , and a hose 212 . The air pump may have a structure similar to that of a manual air pump used to inflate bicycle tires or a manual air pump in a blood pressure measuring device. When the lever 208 is pressed, air is forced out of the cylinder 204 and injected into the contact portion 140c via the hose 212. This causes the contact portion 140c to expand.’; ¶0089, ‘Thereafter, air is injected into the contact portion 140c by the air pump 200, thereby expanding the contact portion 140c. The amount of air injected at this time may be appropriately adjusted according to the shape and size of the subject P's head. That is, the force applied between the forehead pad 140' and the occipital pad 110 to hold and fix the head should be such that the subject P does not feel uncomfortable.’)
Claim 11: Modified Fuha discloses all the elements above in claim 1, Fuha discloses, wherein the inflatable bladder comprises one of a pair of inflatable bladders (a inflatable bladders of Fuha can be defined under the broadest reasonable interpretation as one or more. Accordingly, Fuha discloses the inflatable bladder comprises a pair of inflatable bladders. The identified bladder of claim 1 shows all the structural limitations of claim 1, while the other inflatable bladder discussed below is one of the pair comprising the bladder of claim 1 and the bladder discussed below.) facing each other on the interior of the frame, and wherein inflation of the pair of bladders causes a reduction of a gap formed between the pair of inflatable bladders and the head locatable area within the base portion. (FIG. 9, ¶0084, ‘The contact portion 140c is a bag body, and expands when air is injected into it by the air pump 200.’,¶0091, ‘instead of the two-layer structure of the root portion 140a and the close contact portion 140c, the entire forehead pad 140' may be formed from a bag that can be inflated and deflated by the air pump 200, resulting in a single-layer structure.’, ¶0092, ‘The same applies to the occipital pad 110. That is, only the contact portion 110b may be formed from a bag similar to that described above, or the base portion 110a and the contact portion 110b may be formed from a bag having a two-layer structure similar to that described above. Alternatively, the entire occipital pad 110 may be formed from a bag body having a single layer structure.’; ¶0093, ‘The same applies to the neck pad 112. That is, only the contact portion 112b may be formed of a bag similar to that described above, or the base portion 112a and the contact portion 112b may be formed of a bag having a two-layer structure similar to that described above. Alternatively, the entire neck pad 112 may be formed from a single-layered bag.’; ¶0133, ‘These embodiments can be implemented in various other forms, and various omissions, substitutions, and modifications can be made without departing from the spirit of the invention. These embodiments and their variations are intended to be included in the scope of the invention and its equivalents as described in the claims, as well as in the scope and spirit of the invention.’)
-140c and 110 are a pair of inflatable bladders of one or more of the inflatable bladder & are both bag bodies, and expands when air is injected into it by the air pump 200. The act of expanding 140c and 110 would cause a reduction of a gap formed between an interior of the frame and the encircled portion of the exterior surface of the body part locatable within the base portion, as it takes up more volume, ¶0084-0089, ¶0091. The amount of air inject at this time may be adjusted according to the shape and size of the subject P’s head, ¶0089.
Claim 13: Modified Fuha discloses all the elements above in claim 11, Fuha discloses, wherein the pair of inflatable bladders are formed from a pliant material. (¶0084, ‘The contact portion 140c is a bag body, and expands when air is injected into it by the air pump 200. The adhesive portion 140c is formed into a bag shape from a resin such as polyethylene resin or vinyl chloride, or rubber.’) (¶0091, ‘instead of the two-layer structure of the root portion 140a and the close contact portion 140c, the entire forehead pad 140' may be formed from a bag that can be inflated and deflated by the air pump 200, resulting in a single-layer structure.’, ¶0092, ‘The same applies to the occipital pad 110. That is, only the contact portion 110b may be formed from a bag similar to that described above, or the base portion 110a and the contact portion 110b may be formed from a bag having a two-layer structure similar to that described above. Alternatively, the entire occipital pad 110 may be formed from a bag body having a single layer structure.’; ¶0093, ‘The same applies to the neck pad 112. That is, only the contact portion 112b may be formed of a bag similar to that described above, or the base portion 112a and the contact portion 112b may be formed of a bag having a two-layer structure similar to that described above. Alternatively, the entire neck pad 112 may be formed from a single-layered bag.’)
Claim 14: Modified Fuha discloses all the elements above in claim 11, Fuha discloses, wherein each of the pair of inflatable bladders is independently inflatable. (FIG. 9, ¶0011, ‘The forehead pad is formed from a bag that can expand and contract by injecting gas or from an elastic material, and is positioned on the inner surface of the housing so that it abuts against the subject's forehead when the housing is attached to the head.’; ¶0084, ‘The contact portion 140c is a bag body, and expands when air is injected into it by the air pump 200.’; ¶0087, ‘the air pump 200 includes a cylinder 204 , a lever 208 , and a hose 212 . The air pump may have a structure similar to that of a manual air pump used to inflate bicycle tires or a manual air pump in a blood pressure measuring device. When the lever 208 is pressed, air is forced out of the cylinder 204 and injected into the contact portion 140c via the hose 212. This causes the contact portion 140c to expand.’; ¶0089, ‘Thereafter, air is injected into the contact portion 140c by the air pump 200, thereby expanding the contact portion 140c. The amount of air injected at this time may be appropriately adjusted according to the shape and size of the subject P's head. That is, the force applied between the forehead pad 140' and the occipital pad 110 to hold and fix the head should be such that the subject P does not feel uncomfortable.’) (¶0091, ‘instead of the two-layer structure of the root portion 140a and the close contact portion 140c, the entire forehead pad 140' may be formed from a bag that can be inflated and deflated by the air pump 200, resulting in a single-layer structure.’, ¶0092, ‘The same applies to the occipital pad 110. That is, only the contact portion 110b may be formed from a bag similar to that described above, or the base portion 110a and the contact portion 110b may be formed from a bag having a two-layer structure similar to that described above. Alternatively, the entire occipital pad 110 may be formed from a bag body having a single layer structure.’; ¶0093, ‘The same applies to the neck pad 112. That is, only the contact portion 112b may be formed of a bag similar to that described above, or the base portion 112a and the contact portion 112b may be formed of a bag having a two-layer structure similar to that described above. Alternatively, the entire neck pad 112 may be formed from a single-layered bag.’; ¶0133, ‘These embodiments can be implemented in various other forms, and various omissions, substitutions, and modifications can be made without departing from the spirit of the invention. These embodiments and their variations are intended to be included in the scope of the invention and its equivalents as described in the claims, as well as in the scope and spirit of the invention.’)
Claim 15: Modified Fuha discloses all the elements above in claim 11, Fuha discloses, wherein each of the pair of inflatable bladders comprises an opening configured to receive gas from a gas source. (FIG. 9, ¶0011, ‘The forehead pad is formed from a bag that can expand and contract by injecting gas or from an elastic material, and is positioned on the inner surface of the housing so that it abuts against the subject's forehead when the housing is attached to the head.’; ¶0084, ‘The contact portion 140c is a bag body, and expands when air is injected into it by the air pump 200.’; ¶0087, ‘the air pump 200 includes a cylinder 204 , a lever 208 , and a hose 212 . The air pump may have a structure similar to that of a manual air pump used to inflate bicycle tires or a manual air pump in a blood pressure measuring device. When the lever 208 is pressed, air is forced out of the cylinder 204 and injected into the contact portion 140c via the hose 212. This causes the contact portion 140c to expand.’; ¶0089, ‘Thereafter, air is injected into the contact portion 140c by the air pump 200, thereby expanding the contact portion 140c. The amount of air injected at this time may be appropriately adjusted according to the shape and size of the subject P's head. That is, the force applied between the forehead pad 140' and the occipital pad 110 to hold and fix the head should be such that the subject P does not feel uncomfortable.’) (¶0091, ‘instead of the two-layer structure of the root portion 140a and the close contact portion 140c, the entire forehead pad 140' may be formed from a bag that can be inflated and deflated by the air pump 200, resulting in a single-layer structure.’, ¶0092, ‘The same applies to the occipital pad 110. That is, only the contact portion 110b may be formed from a bag similar to that described above, or the base portion 110a and the contact portion 110b may be formed from a bag having a two-layer structure similar to that described above. Alternatively, the entire occipital pad 110 may be formed from a bag body having a single layer structure.’; ¶0093, ‘The same applies to the neck pad 112. That is, only the contact portion 112b may be formed of a bag similar to that described above, or the base portion 112a and the contact portion 112b may be formed of a bag having a two-layer structure similar to that described above. Alternatively, the entire neck pad 112 may be formed from a single-layered bag.’; ¶0133, ‘These embodiments can be implemented in various other forms, and various omissions, substitutions, and modifications can be made without departing from the spirit of the invention. These embodiments and their variations are intended to be included in the scope of the invention and its equivalents as described in the claims, as well as in the scope and spirit of the invention.’)
Claim 19: Modified Fuha discloses all the elements above in claim 1, Fuha discloses, wherein the head support comprises a fluid flow control manifold, coupleable to: (i) an inflatable bladder opening configured to receive fluid from a fluid source, and (ii) a fluid source.
-Fuha discloses, fluid is provided to 140c, specifically air. (FIG. 9, ¶0011, ‘The forehead pad is formed from a bag that can expand and contract by injecting gas or from an elastic material, and is positioned on the inner surface of the housing so that it abuts against the subject's forehead when the housing is attached to the head.’; ¶0084, ‘The contact portion 140c is a bag body, and expands when air is injected into it by the air pump 200.’; ¶0087, ‘the air pump 200 includes a cylinder 204 , a lever 208 , and a hose 212 . The air pump may have a structure similar to that of a manual air pump used to inflate bicycle tires or a manual air pump in a blood pressure measuring device. When the lever 208 is pressed, air is forced out of the cylinder 204 and injected into the contact portion 140c via the hose 212. This causes the contact portion 140c to expand.’; ¶0089, ‘Thereafter, air is injected into the contact portion 140c by the air pump 200, thereby expanding the contact portion 140c. The amount of air injected at this time may be appropriately adjusted according to the shape and size of the subject P's head. That is, the force applied between the forehead pad 140' and the occipital pad 110 to hold and fix the head should be such that the subject P does not feel uncomfortable.’)
Claim 20: Modified Fuha discloses all the elements above in claim 19, Fuha discloses, wherein the fluid flow control manifold comprises one or more valves reconfigurable to allow or prevent fluid flow from the fluid source to the inflatable bladder. (FIG. 9, ¶0011, ‘The forehead pad is formed from a bag that can expand and contract by injecting gas or from an elastic material, and is positioned on the inner surface of the housing so that it abuts against the subject's forehead when the housing is attached to the head.’; ¶0084, ‘The contact portion 140c is a bag body, and expands when air is injected into it by the air pump 200.’; ¶0086, ‘The release valve 140d is disposed as a part of the sealing portion 140c. By opening the release valve 140d, the air inside the contact portion 140c is released, and the contact portion 140c can be contracted’; ¶0087, ‘the air pump 200 includes a cylinder 204 , a lever 208 , and a hose 212 . The air pump may have a structure similar to that of a manual air pump used to inflate bicycle tires or a manual air pump in a blood pressure measuring device. When the lever 208 is pressed, air is forced out of the cylinder 204 and injected into the contact portion 140c via the hose 212. This causes the contact portion 140c to expand.’; ¶0088, ‘When wearing the mask, for example, the air in the contact portion 140c is released to some extent to contract the contact portion 140c, and then the release valve 140d is closed.’ ¶0089, ‘Thereafter, air is injected into the contact portion 140c by the air pump 200, thereby expanding the contact portion 140c. The amount of air injected at this time may be appropriately adjusted according to the shape and size of the subject P's head. That is, the force applied between the forehead pad 140' and the occipital pad 110 to hold and fix the head should be such that the subject P does not feel uncomfortable.’)
Claim 21: Modified Fuha discloses all the elements above in claim 19, Fuha discloses, wherein the fluid flow control manifold comprises a pressure meter. (FIG. 9, ¶0011, ‘The forehead pad is formed from a bag that can expand and contract by injecting gas or from an elastic material, and is positioned on the inner surface of the housing so that it abuts against the subject's forehead when the housing is attached to the head.’; ¶0084, ‘The contact portion 140c is a bag body, and expands when air is injected into it by the air pump 200.’; ¶0086, ‘The release valve 140d is disposed as a part of the sealing portion 140c. By opening the release valve 140d, the air inside the contact portion 140c is released, and the contact portion 140c can be contracted’; ¶0087, ‘the air pump 200 includes a cylinder 204 , a lever 208 , and a hose 212 . The air pump may have a structure similar to that of a manual air pump used to inflate bicycle tires or a manual air pump in a blood pressure measuring device. When the lever 208 is pressed, air is forced out of the cylinder 204 and injected into the contact portion 140c via the hose 212. This causes the contact portion 140c to expand.’; ¶0088, ‘When wearing the mask, for example, the air in the contact portion 140c is released to some extent to contract the contact portion 140c, and then the release valve 140d is closed.’ ¶0089, ‘Thereafter, air is injected into the contact portion 140c by the air pump 200, thereby expanding the contact portion 140c. The amount of air injected at this time may be appropriately adjusted according to the shape and size of the subject P's head. That is, the force applied between the forehead pad 140' and the occipital pad 110 to hold and fix the head should be such that the subject P does not feel uncomfortable.’)
Claim 25: Modified Fuha discloses all the elements above in claim 1, Fuha discloses, wherein the head support comprises a pressure sensor associated with the inflatable bladder. (FIG. 9, ¶0011, ‘The forehead pad is formed from a bag that can expand and contract by injecting gas or from an elastic material, and is positioned on the inner surface of the housing so that it abuts against the subject's forehead when the housing is attached to the head.’; ¶0084, ‘The contact portion 140c is a bag body, and expands when air is injected into it by the air pump 200.’; ¶0086, ‘The release valve 140d is disposed as a part of the sealing portion 140c. By opening the release valve 140d, the air inside the contact portion 140c is released, and the contact portion 140c can be contracted’; ¶0087, ‘the air pump 200 includes a cylinder 204 , a lever 208 , and a hose 212 . The air pump may have a structure similar to that of a manual air pump used to inflate bicycle tires or a manual air pump in a blood pressure measuring device. When the lever 208 is pressed, air is forced out of the cylinder 204 and injected into the contact portion 140c via the hose 212. This causes the contact portion 140c to expand.’; ¶0088, ‘When wearing the mask, for example, the air in the contact portion 140c is released to some extent to contract the contact portion 140c, and then the release valve 140d is closed.’ ¶0089, ‘Thereafter, air is injected into the contact portion 140c by the air pump 200, thereby expanding the contact portion 140c. The amount of air injected at this time may be appropriately adjusted according to the shape and size of the subject P's head. That is, the force applied between the forehead pad 140' and the occipital pad 110 to hold and fix the head should be such that the subject P does not feel uncomfortable.’)
Claim 29: Modified Fuha discloses all the elements above in claim 1, Fuha discloses, wherein the head support comprises a magnetic resonance imaging head support. (¶Abstract, ¶0001, ‘FIELD An embodiment of the present invention relates to an RF coil device and a magnetic resonance imaging device.’, ¶0014, ‘Hereinafter, embodiments of an RF coil device and an MRI device will be described with reference to the accompanying drawings. The first to third embodiments relate to an RF coil device, and the fourth embodiment relates to an MRI apparatus equipped with the RF coil device of any of the first to third embodiments.’; ¶0015, ‘The RF coil device 100A of the first embodiment is attached to the head of a subject P in an MRI, and transmits RF pulses to the subject P and receives MR signals from the subject P. The RF coil device 100A has a detachable structure including a base member 102 that is brought into contact with the back of the head of the subject P, and a cover member 104 that covers the face of the subject P. That is, the housing of the RF coil device 100A is constructed by detachably connecting the cover member 104 to the base member 102.’)
Claim 30: Modified Fuha discloses all the elements above in claim 1, Fuha discloses, wherein the head support is wholly formed from magnetic resonance imaging compatible materials. (¶Abstract, ¶0001, ‘FIELD An embodiment of the present invention relates to an RF coil device and a magnetic resonance imaging device.’, ¶0014, ‘Hereinafter, embodiments of an RF coil device and an MRI device will be described with reference to the accompanying drawings. The first to third embodiments relate to an RF coil device, and the fourth embodiment relates to an MRI apparatus equipped with the RF coil device of any of the first to third embodiments.’; ¶0015, ‘The RF coil device 100A of the first embodiment is attached to the head of a subject P in an MRI, and transmits RF pulses to the subject P and receives MR signals from the subject P. The RF coil device 100A has a detachable structure including a base member 102 that is brought into contact with the back of the head of the subject P, and a cover member 104 that covers the face of the subject P. That is, the housing of the RF coil device 100A is constructed by detachably connecting the cover member 104 to the base member 102.’)
Claim 36: Fuha discloses, A method configured for supporting a head (Subject P) comprising: (¶Abstract, ¶0001, ¶0014-¶0015)
providing a head support (¶Abstract, ¶0001, ¶0014-¶0015),
a frame (RF coil device 100A, ¶0015), and
an inflatable bladder (FIG. 9, ¶0084, ‘The contact portion 140c is a bag body, and expands when air is injected into it by the air pump 200.’,¶0091, ‘instead of the two-layer structure of the root portion 140a and the close contact portion 140c, the entire forehead pad 140' may be formed from a bag that can be inflated and deflated by the air pump 200, resulting in a single-layer structure.’, ¶0092, ‘The same applies to the occipital pad 110. That is, only the contact portion 110b may be formed from a bag similar to that described above, or the base portion 110a and the contact portion 110b may be formed from a bag having a two-layer structure similar to that described above. Alternatively, the entire occipital pad 110 may be formed from a bag body having a single layer structure.’; ¶0093, ‘The same applies to the neck pad 112. That is, only the contact portion 112b may be formed of a bag similar to that described above, or the base portion 112a and the contact portion 112b may be formed of a bag having a two-layer structure similar to that described above. Alternatively, the entire neck pad 112 may be formed from a single-layered bag.’),
the frame comprising a cover portion (forehead pad 104’, FIG. 9) and a base portion (base member 102), the cover portion and base portion being reversibly moveable with respect to each other between an open position and a closed position (FIG. 11A-11B);
moving the frame to the closed position and securing the cover portion and base portion together to encircle at least a portion of an exterior surface of a head locatable area (FIG. 11A);
(¶0097, ‘FIG. 11A shows a state in which a cover member 104'' is closed relative to a base member 102'', that is, a state during image capture. 11B shows a state in which the connection between the connection portion 120b of the base member 102'' and 134b of the cover member 104'' has been released from the state shown in FIG. 11A, and the cover member 104'' has been opened by 90 degrees by the hinge 230.’; ¶0098, ‘When wearing the device, the cover member 104 ″ is opened by 90° or more as shown in FIG. 11B, and the subject P places his/her head face up in the recess of the base member 102 . Thereafter, the cover member 104'' is closed and connected to the base member 102 by the connecting portions 120b and 134b (see FIG. 11A).’)
-In the closes position the cover portion and the base portion are secured together via the hinge 230 to encircle or otherwise enclose the subject P which includes an exterior surface of the body part locatable within the base portion during image capture.
inflating the inflatable bladder mountable on a base portion of the frame (occipital pad 110-contact portion 110b/ contact portion 110b & base portion 110a and/or the neck pad 112, FIG. 9. Neck pad 112 has a surface of the superior end that is mounted on the base portion. The apex/tip of this neck pad 112 closest to the patient is an inferior end. The interior end does not have a surface mounted directly on the base portion.) to cause a reduction of a gap formed between an interior of the frame and the encircled portion of the exterior surface of the head locatable area within the base portion; (FIG. 9)
-140c is a bag body, and expands when air is injected into it by the air pump 200. The act of expanding 140c causes a reduction of a gap formed between an interior of the frame and the encircled portion of the exterior surface of the body part locatable within the base portion, as it takes up more volume, ¶0084-0089, ¶0091. The amount of air inject at this time may be adjusted according to the shape and size of the subject P’s head, ¶0089. Note; the ¶0021, ‘In the second embodiment, only the intimate contact portion 140c of the forehead pad 140' is formed as a bag that can be inflated and deflated by the air pump 200. However, the second embodiment is not limited to this. The embodiment of the present invention is not limited to this aspect. The base portion 140 a of the forehead pad 140 ′ may also be a bag that can be inflated and deflated by the air pump 200 in the same manner. Alternatively, instead of the two-layer structure of the root portion 140a and the close contact portion 140c, the entire forehead pad 140' may be formed from a bag that can be inflated and deflated by the air pump 200, resulting in a single-layer structure.’; ¶0092, ‘The same applies to the occipital pad 110. That is, only the contact portion 110b may be formed from a bag similar to that described above, or the base portion 110a and the contact portion 110b may be formed from a bag having a two-layer structure similar to that described above. Alternatively, the entire occipital pad 110 may be formed from a bag body having a single layer structure.’; ¶0093, ‘The same applies to the neck pad 112. That is, only the contact portion 112b may be formed of a bag similar to that described above, or the base portion 112a and the contact portion 112b may be formed of a bag having a two-layer structure similar to that described above.’). Accordingly, the same principle applied to contact portion 140c applies to both the occipital pad 110 and neck pad 112 in the same embodiment.
-This establishes that the contact portion 140c of the forehead pad is formed as a bag body, the neck pad 112 (both 112a & 112b (i.e., entire neck pad)) that is already mounted to the base member 102 can be formed similar to that of the bag 140c (i.e., the inflatable bladder). When formed as bag like 140c, the neck pad would share the same material properties, meaning it would be designed to expand when air is injected into it by the air pump. Accordingly, the inflatable bladder is mountable to the base portion of the frame.
wherein the inflatable bladder is mountable on the base portion of the frame, such that inflation of the inflatable bladder causes the inflatable bladder to form a shape that causes a rotation of the head to be loaded into the base portion up and back into the frame; and
-Fuha discloses that the neck pad 112 is formed with a “triangular cross section” or a “mountain shape”, ¶0065, “The neck pad 112 has a triangular cross-section rather than a rectangular one, which makes it easier to fit into the hollow of the neck (the hollow between the back of the head and the back) when the subject P is lying on their back (see Figure 7). Thus, by shaping the neck pad 112 in a mountain shape so that it compresses the neck in the direction of the shape-restoring force PW3 indicated by the arrow in Figure 7, that is, in the upward direction of Figure 7, when the neck of the subject P rests on top of it, the chin will point upward (away from the throat). This makes it easier to fix the neck of subject P and to suppress cervical flexion and extension.”. This specific shape is designed so that it can easily fit into the depression in the neck, which is defined as the recessed area between the back of the head and the back of the neck when the subject is lying on their back, ¶0065.
-Fuha, as established above, teaches that this neck pad 112 can be constructed entirely from the inflatable bag 140c, ¶0093, ‘The same applies to the neck pad 112. That is, only the contact portion 112b may be formed of a bag similar to that described above, or the base portion 112a and the contact portion 112b may be formed of a bag having a two-layer structure similar to that described above.”. Because this inflatable pad is made of soft materials, they can deform to fit various shapes of the subject P’s head and neck, ¶0073, “By using a soft material on the subject P side, the forehead pad 140, occipital pad 110, and neck pad 112 deform to fit various shapes of the subject P's head and neck.”. When using the air pump, the amount of air injected to be, ¶0089, “appropriately adjusted according to the shape and size of the subject P's head.”. Therefore, Fuha teaches inflating the bag-like neck pad so that its triangular wedge shape deforms to fit the depression and shape of the individual patient’s neck (i.e., inflates to form a wedge configured to match a curve of a neck), as best understood under the broadest reasonable interpretation in view of the instant application’s specification which merely recites, at paragraph ¶0071, “The inflatable bladder 3 b is located beneath the lower skull and neck, it is substantially wedge shaped and formed to accommodate the general shape of the neck and lower skull.”.
Note: the location of the neck pad 112 when inflated, it logically and anatomical rotates the head to some degree. Specifically, the neck pad 112 is inflated, to compress the neck vertically upward PW3. Physically forcing the chin upward is defined as cervical retroflexion, ¶0005, ¶0065. Therefore, the inflatable bladder of Fuha would causes a rotation of the head to be loaded into the base portion up and back into the frame, under the broadest reasonable interpretation.
wherein the head support further comprises a deformable pad, mounted on an interior surface of the frame opposing the inflatable bladder. (FIG. 9, ¶0019, ‘The occipital pad 110 suppresses backward bending of the cervical spine’; ¶0056, ‘forehead pad 140 and the occipital pad 110 face each other’; ¶0060, ‘contact portion 110b has a smaller elastic modulus and is softer than base portion 110a.’; ¶0073, ‘By using a soft material on the subject P side, the forehead pad 140, the occipital pad 110, and the neck pad 112 can deform to fit various shapes of the subject P's head and neck.’)
Fuha fails to explicitly disclose: wherein the inferior end of the inflatable bladder tapers down to the superior end of the inflatable bladder such that inflation of the inflatable bladder causes the inflatable bladder to form a wedge configured to match a curve of a neck to cause a rotation of the head to be loaded up and back.
However, Shaw in the context of inflatable body supports discloses: wherein the inferior end of the inflatable bladder tapers down to the superior end of the inflatable bladder (FIG. 5 below)
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such that inflation of the inflatable bladder causes the inflatable bladder to form a wedge configured to match a curve of a neck (FIG. 5, a part of the inflatable bladder (support 10) inflates to form a wedge – this contoured slope presents a wedge profile where the highest point of support 10 fits directly under the curve of the neck, and then slopes downward towards the head/occipital. At the instance of Fig. 5 [Col. lines 63 to Col 7 l.1], “compartment 12 of the lower tier is substantially deflated while the intermediate compartments 14 and 20 are inflated to their maximum combined height h1 +h3. Compartment 18, upon which the occiput is supported, is inflated sufficiently to create the desired curvature of the cervical vertebrae overlying compartment 20;”. As can been seen in FIG. 5 the wedge profile is configured to match a curve of a neck.) to cause a rotation of the head to be loaded up and back (By elevating the neck, this upward displacement of the neck naturally causes the head/face to tilt or to rotate “up and back” (i.e., extension) relative to the neck, as seen in FIG. 5 -the head is extended backwardly).
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the inflatable bladder of Fuha to incorporate the teachings Shaw. The motivation to do this yield predictable results such as to improve the comfort and support of the subject, as suggested by Shaw, Col 8. The modified combination would disclose wherein the inferior end of the inflatable bladder tapers down to the superior end of the inflatable bladder such that inflation of the inflatable bladder causes the inflatable bladder to form a wedge configured to match a curve of a neck to cause a rotation of the head to be loaded into the base portion up and back into the frame.
Claim 39: Modified Fuha discloses all the elements above in claim 1, Fuha discloses, wherein the inflatable bladder is attachable by the superior end, but not the inferior end of the inflatable bladder, (neck pad 112, FIG. 9. Neck pad 112 has a surface of the superior end that is mounted on the base portion. The apex/tip of this neck pad 112 closest to the patient is an inferior end. The interior end does not have a surface mounted directly on the base portion of the frame.) to the frame at a position selected such that inflation of the inflatable bladder causes the inflatable bladder to reduce a gap between the inflatable bladder and the head locatable area. Fuha discloses, “When subject P is lying on their back, the back of the head is in direct contact with the base member 102, but the neck is recessed, so there is a part of it that does not come into contact with the base member 102.”, ¶0066. This creates an empty space or a gap. The neck is to “fill[ing] the gap between the inner surface of the base member 102 and the subject P's neck.”, ¶0021, thereby suppressing movement of the subject’s neck in the head locatable area. When the neck pad is configured as a inflatable bad body, ¶0093, it expands when air is injected into it, ¶0089. Specifically, when using the air pump, the amount of air injected to be, ¶0089, “appropriately adjusted according to the shape and size of the subject P's head.”. Therefore, inflating the neck pad allows it to expand into that recessed area, effectively eliminating the gap between the patient’s neck and the housing frame to ensure a secure fit, ¶0065, ¶0093.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Fuha (JP 2014073294 A1) in view of Shaw (US 5809597 A), as applied to Claim 1, in further view Lenkinski et al (US 5,435,302).
Claim 5: Modified Fuha discloses all the elements above in claim 1, Fuha discloses, wherein the head support comprises one or more cooperating elements (hinge 230, FIG. 10-11) configured to connect the cover portion and base portion in the closed position. (¶0094, ‘base member 102'' and a cover member 104'' are connected by a hinge 230 in an openable and closable manner.’)
Fuha fails to disclose the cooperating elements configured to lock the cover portion and base portion in the closed position.
However, Lenkinski in the context of MRI apparatus discloses, the cooperating elements configured to lock the cover portion and base portion in the closed position. ([Col. 9, l.13-27], ‘In FIG. 4, flexible, conforming surface coil 24 is shown in the open position. Hinge 38 is fastened to both first half shell 26 and second half shell 28 such that coil 24 can be opened and closed around the patient's neck. Hinge 38 may be adapted so that coil 24 can accommodate patients with different sized necks. Hinge 38 may be constructed of a light weight and resilient material, for example plastic, and may be adapted to provide support for the weight of coil 24. In preferred embodiments, it is generally desired to provide fastening panels 40 attached to both first half shell 26 and second half shell 28 so that when coil 24 is in the closed position it is held securely about the patient's neck. The fastening panels may be provided with strips of VELCRO.RTM. so that they can be firmly secured.’)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the head support of Modified Fuha to include fastening panels configured to lock the cover portion and the base portion in the closed position as taught by Lenkinski. The motivation to do this yields predictable results such as securing the apparatus about the patient’s, [Col. 9, l.13-27] of Lenkinski.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Fuha (JP 2014073294 A1) in view of Shaw (US 5809597 A), as applied to Claim 1, in further view Wilkinson (US 2008/0028534 A1).
Claim 17: Modified Fuha discloses all the elements above in claim 1, Fuha fails to disclose, wherein the inflatable bladder comprises one or more cells, the one or more cells being dimensioned to cause the inflatable bladder, when inflated, to form the wedge having the inferior end tapering down to the superior end and comprising an inclined surface extending between the inferior end and the superior end.
However, Shaw in the context of inflatable body supports discloses: wherein the inflatable bladder comprises one or more cells, the one or more cells being dimensioned to cause the inflatable bladder, when inflated, to form the wedge having the inferior end tapering down to the superior end and comprising an inclined surface extending between the inferior end and the superior end. (FIG. 5 below)
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(FIG. 5, a part of the inflatable bladder (support 10) inflates to form a wedge – this contoured slope presents a wedge profile where the highest point of support 10 fits directly under the curve of the neck, and then slopes downward towards the head/occipital. At the instance of Fig. 5 [Col. lines 63 to Col 7 l.1], “compartment 12 of the lower tier is substantially deflated while the intermediate compartments 14 and 20 are inflated to their maximum combined height h1 +h3. Compartment 18, upon which the occiput is supported, is inflated sufficiently to create the desired curvature of the cervical vertebrae overlying compartment 20;”. As can been seen in FIG. 5 the wedge profile is configured to match a curve of a neck. These compartments constitutes as one or more cells.) (By elevating the neck, this upward displacement of the neck naturally causes the head/face to tilt or to rotate “up and back” (i.e., extension) relative to the neck, as seen in FIG. 5 -the head is extended backwardly).
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the inflatable bladder of modified Fuha to incorporate the teachings Shaw. The motivation to do this yield predictable results such as to improve the comfort and support of the subject, as suggested by Shaw, Col 8.
Fuha fails to disclose: the inflatable bladder comprises one or more cells in fluid communication with each other,
However, Wilkinson in the context of adjustable inflatable devices, discloses, the inflatable bladder comprises one or more cells in fluid communication with each other, (¶0003, ‘Inflatable cushioning devices for use with body supports, such as a mattress, sofa, seat, or the like may included a plurality of air cells or bladders that are inflated to support a person. The air cells provide support to the person, and can be inflated to a desired pressure level to provide the person with a predetermined level of comfort and support.’)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to one or more cells of modified Fuha to include the teachings of Wilkinson. The motivation to do this yields predictable results such as providing support and comfort to the person, as suggested by Wilkinson, ¶0003.
Claims 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Fuha (JP 2014073294 A1) in view of Shaw (US 5809597 A), as applied to claim 1, in further view Moosmann et al (US 2019/0053871 A1).
Claim 26: Modified Fuha discloses all the elements above in claim 1, Fuha discloses, wherein the head support comprises at least one deformable pad (FIG. 9, ¶0019, ‘The occipital pad 110 suppresses backward bending of the cervical spine’; ¶0056, ‘forehead pad 140 and the occipital pad 110 face each other’; ¶0060, ‘contact portion 110b has a smaller elastic modulus and is softer than base portion 110a.’; ¶0073, ‘By using a soft material on the subject P side, the forehead pad 140, the occipital pad 110, and the neck pad 112 can deform to fit various shapes of the subject P's head and neck.’)
Fuha fails to disclose the at least one deformable pad slidably mountable on the frame.
However, Moosmann in the context of head stabilizers suitable for MRI discloses a pad slidably mountable on the frame (¶0126, ‘pads (614) that are slidable relative to a support assembly (612).’)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the deformable pad of Modified Fuha to be slidably mountable on the frame as taught by Moosman. The motivation to do this yields predictable results such as enabling adjustable, comfortable, and secure positioning for different patients, while maintaining stability of the anatomy.
Claim 27: Modified Fuha discloses all the elements above in claim 26, Fuha discloses, wherein the inflatable bladder and at least one deformable pad are dimensioned to be mountable at positions on the frame in which there is a space between the inflatable bladder and the at least one deformable pad. (FIG. 9, ¶0084, ‘The contact portion 140c is a bag body, and expands when air is injected into it by the air pump 200.’,¶0091, ‘instead of the two-layer structure of the root portion 140a and the close contact portion 140c, the entire forehead pad 140' may be formed from a bag that can be inflated and deflated by the air pump 200, resulting in a single-layer structure.’, ¶0092, ‘The same applies to the occipital pad 110. That is, only the contact portion 110b may be formed from a bag similar to that described above, or the base portion 110a and the contact portion 110b may be formed from a bag having a two-layer structure similar to that described above. Alternatively, the entire occipital pad 110 may be formed from a bag body having a single layer structure.’; ¶0093, ‘The same applies to the neck pad 112. That is, only the contact portion 112b may be formed of a bag similar to that described above, or the base portion 112a and the contact portion 112b may be formed of a bag having a two-layer structure similar to that described above. Alternatively, the entire neck pad 112 may be formed from a single-layered bag.’)
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Fuha (JP 2014073294 A1) in view of Shaw (US 5809597 A), as applied to Claim 1, in further view Charnitski (US 2006/0267392 A1).
Claim 38: Modified Fuha discloses all the elements above in claim 1, Fuha discloses wherein the inflatable bladder comprises a bladder which, when inflated, is configured reduce a gap between the bladder and the head locatable area.
-Fuha discloses, “When subject P is lying on their back, the back of the head is in direct contact with the base member 102, but the neck is recessed, so there is a part of it that does not come into contact with the base member 102.”, ¶0066. This creates an empty space or a gap. The neck is to “fill[ing] the gap between the inner surface of the base member 102 and the subject P's neck.”, ¶0021, thereby suppressing movement of the subject’s neck in the head locatable area. When the neck pad is configured as a inflatable bad body, ¶0093, it expands when air is injected into it, ¶0089. Specifically, when using the air pump, the amount of air injected to be, ¶0089, “appropriately adjusted according to the shape and size of the subject P's head.”. Therefore, inflating the neck pad allows it to expand into that recessed area, effectively eliminating the gap between the patient’s neck and the housing frame to ensure a secure fit, ¶0065, ¶0093.
Fuha fails to disclose, wherein the inflatable bladder comprises a bifurcated bladder
However, Charnitski in the context of adjustable inflatable neck support devices, an inflatable bladder comprises a bifurcated bladder (FIG. 7, ¶0048, ‘The head rest 10b may be disposed between the person's head and an upper portion of a reclined seat. More particularly, the bottom of the head rest 10b may rest on the person shoulder's or be located above the shoulders, and the center of the head rest 10b may be aligned to the person's neck or the lower portion or base of a person's head. The first inflatable compartment 12b may apply a forward right force at the rear left base of the person's head, and the second inflatable compartment 14b may apply a forward left force at the rear right base of the person's head. The forward forces applied to the person's head via the first and second inflatable compartments 12b, 14b may help maintain the person's head away from the seat upper portion. The left and right forces may be equal to each other to stabilize the person's head in the middle of the first and second inflatable compartments 12b, 14b such that the person's head does not roll off of the head rest 12b.’)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the inflatable bladder of Modified Fuha to comprise a bifurcated bladder as taught by Charnitski. The motivation to do this yields predictable results such as stabilizing the persion’s head in the middle such that the persion’s head does not roll off, ¶0048 of Charnitski.
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 Nicholas Robinson whose telephone number is (571)272-9019. The examiner can normally be reached M-F 9:00AM-5:00PM EST.
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/N.A.R./Examiner, Art Unit 3798
