DETAILED ACTION
This Office action is responsive to communications filed on 04/13/2026. Claims 1-4, 11, 13, 17, 21, 36, 38-39 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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/13/2026 has been entered.
Response to Arguments
Previous rejections under 35 USC § 112(b) are withdrawn in view of the amendments filed on 04/13/2026.
Previous claim objections are withdrawn in view of the amendments filed on 04/13/2026.
Previous rejection under 35 USC § 101 for claim 36 is NOT withdrawn in view of the amendments filed on 04/13/2026. Claim 36 the limitation, line 1, “A method of supporting a head” should recite “A method configured for [[of]] supporting a head”.
The Applicant’s arguments with respect to rejections under 35 USC § 102 have been fully, considered, but are not persuasive.
The Applicant’s assertions that “As agreed during the interview” that the cited reference fails to disclose the asserted claim limitations on page 11 (last four lines) to page 12 (first three lines) is not accurate regarding the 35 USC § 102 rejections and/or the 35 USC § 103 rejections. The assertion is directed to the amendments filed on 04/13/2026, which were not discussed. However, the proposed amendments in the interview on 04/08/2026 were discussed. The proposed amendments in the interview on 04/08/2026 are not reflected in the claims filed on 04/13/2026. The rejection as set forth in the Office Action reflects the Examiner’s position, which the 35 USC § 102 & 103 are maintained.
The Applicant argues that Fuha fails to disclose multiple limitations of claim 1, including the frame configuration, open/closed positions, and the inflatable bladder arrangement. However, these arguments are presented in a conclusory manner and do not address the specific findings in the rejection. The Office Action identified the corresponding structures of Fuha, including the base member, and cover member forming a frame, and their hinge relationship permitting open and closed positions that receive and encircle the head of the subject P. The Applicant does not substantively rebut these mapping, but instead restates the claim language without addressing the cited disclosure. Accordingly, these arguments are unpersuasive.
With respect to “inflatable bladder [...] mountable on the base portion of the frame .. such that inflation [...] reduces a gap”. The Applicant acknowledges that Fuha discloses an inflatable bladder that expends to fill a gap between the device and the subject, page 11. The Applicants arguments on page 12 directed to the limitation requiring the inflatable bladder to “inflates to form a wedge configured to match a curve of a neck”, is unpersuasive. The Applicant asserts that Fuha discloses a discloses only a “static” triangular geometry and that the inflation merely forms a bag shape. This argument is not persuasive because it mischaracterizes the teachings relied upon. The rejection does not rely solely on a the triangular structure; rather, it relies on Fuha disclosure that the neck pad may be formed as an inflatable bag and is made of soft material that deforms to conform to the subject’s anatomy, with inflation adjustable based on the subject’s shape.
Specifically, 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.”
Thus, the cited reference Fuha teaches a structure that both has a wedge-like shape geometry and is capable of deformation upon inflation to conform the neck, as best understood under the broadest reasonable interpretation in light of the specification.
Additionally, the Applicant treats form[ing] a wedge shape as requiring that the wedge shape arise only upon inflation. The claim does not require such a distinction. Under the broadest reasonable interpretation, a structure that is wedge shape and inflatable such that it conforms to the neck stratifies the limitation. The Applicant’s argument relies on a narrower interpretation not supported by the claim language. The assertion that whether Fuha shows a “bag shape” versus a “wedge shape” mischaracterizes Fuha. Fuha teaches the neck pad has a triangular wedge like geometry and that it may be formed as an inflatable bag that deforms to fit the neck. The Applicant argument towards the bag shape in isolation does not address the teachings of the rejection.
For the reasons set forth, the rejection under 35 USC § 102 & 103 are maintained.
Claim Objections
The following claims are objected to because of the following informalities and should recite:
Claim 1: lines 9, “[[a]]the base portion of the frame”.
Claim 1: line 9, “[[a]]the base portion of the frame”.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 36 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). The following set for and positively recite human parts:
Claim 36 the limitation, line 1, “A method of supporting a head” should recite “A method configured for[[of]] supporting a head”.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4, 6, 8, 11, 13-15, 19-21, 25, 29-30, 36, & 39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fuha (JP 2014073294 A1).
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.’); 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 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), 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, located beneath a lower skull locatable area of the head locatable area and a neck locatable area of the head locatable area, and inflates to form a wedge configured to match a curve of a neck; 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.”.
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.’)
Claim 2: 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: 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: 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: 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: 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: Fuha discloses all the elements above in claim 1, Fuha discloses, wherein the head support comprises a pair of inflatable bladders locatable 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 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: 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: 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: 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: 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: 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: 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: 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: 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: 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 of 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) 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, located beneath a lower skull locatable area of the head locatable area and a neck locatable area of the head locatable area, and wherein the inflatable bladder inflates to form a wedge configured to match a curve of a neck; 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.”.
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.’)
Claim 39: Fuha discloses all the elements above in claim 1, Fuha discloses, wherein the inflatable bladder is attachable 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 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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Fuha (JP 2014073294 A1), as applied to Claim 1, in further view Lenkinski et al (US 5,435,302).
Claim 5: 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 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), as applied to Claim 1, in further view Wilkinson (US 2008/0028534 A1).
Claim 17: Fuha discloses all the elements above in claim 1, Fuha discloses, wherein the inflatable bladder being dimensioned to give the inflatable bladder a predetermined shape of a wedge comprising a top portion, a bottom portion, and an inclined surface that extends between the top portion and the bottom portion when fully inflated. (FIG. 9, ¶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.’)
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 inflatable bladder of 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), as applied to claim 1, in further view Moosmann et al (US 2019/0053871 A1).
Claim 26: 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 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: 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), as applied to Claim 1, in further view Charnitski (US 2006/0267392 A1).
Claim 38: 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 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
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/N.A.R./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
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