DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 1 and 4 are objected to because of the following informalities:
In claim 1 “fir” should be changed to “for” to fix the typographical error.
In claim 4 “a the position of the end of the bed” should be changed to fix the typographical error.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 1-12, the claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
Regarding claim 1, there appears to be some conflicting in the claim language about the ends of the bed within the claim. One the one hand the magnetic structure is for imaging a patient's head and the "external end" is cantilevered and configured to oscillate to a position a patient’s inside the magnetic structure. On the other hand the patient's head positioning area of the bed is provided on an end "opposite the external end". Therefore, if the opposite end is what holds the patient's head and the external end is what goes into the magnetic structure for image acquisition, no imaging of the head within the magnetic structure can occur as is required by the claims. For examination purposes, a reference disclosing an arrangement similar to Figure 3 will be interpreted as meeting these limitations in the claims.
Additionally, the claim refers two extreme positions of oscillation of the bed, one where the external end is positioned in the magnetic structure and another where opposite end is positioned at a predetermined distance from the magnetic structure. These are not two extreme positions of oscillation since both can and do occur at the same time. Did the Applicant intend to refer to the external end being positioned in the magnetic structure and out of the magnetic structure as the two extreme positions of oscillation? Something else? Clarification is required. For examination purposes, a reference disclosing an arrangement similar to Figure 3 will be interpreted as meeting these limitations in the claims.
Regarding claim 2, the limitation "a rotation axis" has unclear antecedent basis. It is unclear how this rotation axis relates to the vertical axis of rotation set forth in claim 1. For examination purposes, this limitation will be interpreted as referring to the same rotation axis.
Regarding claim 5, the term “substantially horizontal” in the claim is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore it is unclear how horizontal the axis must be to be substantially horizontal.
Regarding claim 8, the limitation “a receiving coil” in the last line has unclear antecedent basis. It is unclear how this receiving coil relates to the receiving coil set forth earlier in the claim. For examination purposes, this limitation will be interpreted as referring to the same receiving coil.
Regarding claim 12, the claim recites the limitation “an intensity of the magnetic field […] is out of a 5Gauss equipotential line”. It is unclear how a magnetic field can be out of its own 5 gauss equipotential line. Clarification is required. For examination purposes, a reference disclosing performing surgery using a bed pivoted out of an MR imaging device will be interpreted as meeting this limitation in the claim.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Satragno et al. (US20100102814, hereafter Satragno).
Regarding claim 1, Satragno discloses in Figures 1-6 a system for acquiring images by intraoperative magnetic resonance imaging, including for acquiring progress state control images during brain surgery (Satragno, Para 66; “Referring to the figures, a Magnetic Resonance Imaging apparatus has a magnet structure 1 and a patient table 2.”), the system comprising:
a magnetic structure generating a static magnetic field and delimiting or surrounding, on at least some sides, a housing space for at least a patient's head (Satragno, Figures 1-6) (Satragno, Para 66; “Referring to the figures, a Magnetic Resonance Imaging apparatus has a magnet structure 1 and a patient table 2.”); and
a bed that is movable in different relative positions with respect to the magnetic structure, said positions being comprised between at least an end position, in which said bed is at least partially inside the housing space: and an outer end position in which said bed is outside said housing space and at a predetermined distance from the magnetic structure (Satragno, Figures 1-6 and 9-10) (Satragno, Para 70; “The magnet structure is provided in combination with a patient table 2 having a substantially horizontal patient bearing surface 102, which is respectively supported at the two opposite ends by a vertical support member 202, 302. These vertical support members are spaced at a distance that is greater than the horizontal size of at least the lower leg of the magnet structure 1. Therefore, the patient table has a bridge-like structure and the patient bearing surface is above the lower horizontal wall member 201. Thus, the patient table may be introduced in the patient receiving cavity CV by moving it transverse to its longitudinal extension so that it is set astride the lower horizontal leg of the magnet structure.”),
wherein said magnetic structure has a cross-section that is U-shaped or C-shaped, in which the magnetic structure has at least one vertical connection element of two horizontal wall elements which are mutually vertically superimposed and are supported cantilevered and at a predetermined distance from each other by said vertical connection element, said vertical connection element eccentrically connecting, at a lateral edge, to said horizontal wall elements, said horizontal wall elements and said vertical connection element delimiting at a top, at a bottom and over at least one vertical lateral section a housing space for at least one portion of a patient's body, said horizontal wall elements carrying static magnetic field generating means that permeate said housing space (Satragno, Para 68; “Referring to the figures and to the above, the magnet structure or the magnet of a MRI apparatus has a C or open U shape with two horizontal legs spaced apart at one side by a vertical member 301. The two horizontal legs form wall members 101, 201 which delimit the upper and lower sides of a space CV in which a patient or a part thereof is received. Particularly, in the annexed figures, the two legs of the magnet structure are spaced to such an extent as to allow introduction of the patient trunk in the patient receiving space or cavity CV. These two legs are the horizontal legs of a yoke whose facing sides support magnetic field generating means, such as layers of magnetized material, pole pieces formed of ferromagnetic plates, several variable magnetic field generating coils, the so-called gradient coils, the coil for transmitting nuclear spin excitation pulses, and other operating units, such as shielding means, temperature measuring means, and other means. A static magnetic field Bo is generated between the two horizontal legs. The vertical wall member 301 is composed of a vertical yoke member and additional magnetized or ferromagnetic layers, which have the function to contribute to optimization of the static magnetic field Bo.”), and
wherein said bed has one end external to the magnetic structure and provided at a predetermined distance therefrom, said one end being supported cantilevered towards an opposite end by a column which is connected to the bed in an area of said external end and is rotatable about a vertical axis that coincides with or is parallel to an axis of said column, thereby enabling the bed to be continuously oscillated for a predetermined angular path between two extreme positions (Satragno, Figures 1-6 and 9-10) (Satragno, Para 70; “The magnet structure is provided in combination with a patient table 2 having a substantially horizontal patient bearing surface 102, which is respectively supported at the two opposite ends by a vertical support member 202, 302. These vertical support members are spaced at a distance that is greater than the horizontal size of at least the lower leg of the magnet structure 1. Therefore, the patient table has a bridge-like structure and the patient bearing surface is above the lower horizontal wall member 201. Thus, the patient table may be introduced in the patient receiving cavity CV by moving it transverse to its longitudinal extension so that it is set astride the lower horizontal leg of the magnet structure.”),
wherein in one of the two extreme positions, defined as an imaging position, an end of the bed opposite the external end being provided with a patient's head positioning area and said external end being positioned inside the patient's housing space of the magnetic structure with the patient's head in a correct image acquisition position with respect to the magnetic structure, and in the another one of those the two extreme positions, the said an end opposite to the external end is positioned at a predetermined distance from the magnetic structure and at the position of a surgical operating station (Satragno, Figures 1-6 and 9-10) (Satragno, Para 70; “The magnet structure is provided in combination with a patient table 2 having a substantially horizontal patient bearing surface 102, which is respectively supported at the two opposite ends by a vertical support member 202, 302. These vertical support members are spaced at a distance that is greater than the horizontal size of at least the lower leg of the magnet structure 1. Therefore, the patient table has a bridge-like structure and the patient bearing surface is above the lower horizontal wall member 201. Thus, the patient table may be introduced in the patient receiving cavity CV by moving it transverse to its longitudinal extension so that it is set astride the lower horizontal leg of the magnet structure.”), and
wherein the angular path of oscillation of the bed is less than 90⁰ and around only the vertical axis of rotation (Satragno, Para 127; “FIGS. 9, 10 and 11 also provide dimensions for the patient table, the magnet structure, the angular width of oscillation of the patient table and the maximum space requirements for use of the inventive apparatus, to allow access and passage of the operators along all the sides of the apparatus and about 50° outward angular oscillation of the patient table.”) (Satragno, Figures 1-6 and 9-10).
Regarding claim 2, Satragno discloses all of the limitations of claim 1 as discussed above.
Satragno further discloses wherein a distance of a rotation axis with reference to the vertical axis of the magnetic structure is selected to an extent causing, when the bed is rotated to the position inside the magnetic structure, the patient's head positioning area is positioned relatively to the magnetic structure such as to be coincident with an imaging volume, the imaging volume comprising a portion of an overall volume of the housing space of the patient, in which the static magnetic field generated by permanent magnets has sufficient homogeneity characteristics in order to obtain high-quality diagnostic images and thus positioning the patient's head lying on the bed in a position coincident with the imaging volume (Satragno, Figure 1 and Figure 4) (Satragno, Para 114-115; “With the patient table outwardly pivoted, as shown in FIG. 1 and FIG. 9, the patient may lie on the patient table either from the side opposite the magnet structure or the side facing it. Furthermore, for patient positioning, the operators may operate alternately or even simultaneously from both opposite longitudinal sides of the patient table, thereby effectively assisting the patient to lie in the proper position and being able to work in pairs and have maximum accessibility to all patient table parts and to the patient receiving cavity. The patient is moved into the patient receiving cavity with the receiving coil or the limb or anatomic region to be examined in a centered position with respect to the imaging volume VI by simply pivoting the patient table towards the magnet structure 1.”), and
wherein said distance and angular amplitude of rotation of the bed about the vertical axis are selected to cause, in an extreme external position, a bed end associated with the patient's head positioning area can assume a position with respect to the magnetic structure such that an influence of the static magnetic field permeating off said magnetic structure lies below a predetermined intensity value and does not generate interference with equipment and operating units whose presence is required for execution of surgery (Satragno, Figure 2) Satragno is interpreted as disclosing this limitation in the claim because it is consistent with Figure 3 and pages 11-12 of the specification which states that this arrangement results in these outcomes.
Regarding claim 3, Satragno discloses all of the limitations of claim 1 as discussed above.
Satragno further discloses wherein the bed is supported to be vertically liftable and lowerable by bi-directional lifting means (Satragno, Para 76; “the patient bearing surface 102 may be arranged to be fixed to the vertical support member 202 associated to the axis of oscillation using means for restricted displacement of said patient bearing surface 102 with respect to the vertical support member 102, which means may be combinations of guides and slides. These means may be configured to allow unidirectional translational motion, such as longitudinal to the patient table and/or parallel to the axis that joins the axis of oscillation of the patient table and the central vertical axis of the patient receiving cavity CV or the imaging volume VI. Displacement means may be further provided which also allow limited translational movements transverse to the patient table and/or perpendicular to the axis that joins the axis of oscillation of the patient table and the central vertical axis of the patient receiving cavity CV or the imaging volume VI or parallel to the direction in which the central vertical axis of the patient receiving cavity CV or the imaging volume is joined to the central axis of the vertical wall member 301 or an axis parallel to such axis”).
Regarding claim 4, Satragno discloses all of the limitations of claim 1 as discussed above.
Satragno further discloses wherein the bed is provided with a means configured for extending and shortening, or linearly translating the bed with respect to the column, thereby varying, according to a user's choice, an overall length and/or a path of the end of the bed intended to enter the magnetic structure, further varying the position of the end of the bed associated with the head with respect to the column (Satragno, Para 76; “the patient bearing surface 102 may be arranged to be fixed to the vertical support member 202 associated to the axis of oscillation using means for restricted displacement of said patient bearing surface 102 with respect to the vertical support member 102, which means may be combinations of guides and slides. These means may be configured to allow unidirectional translational motion, such as longitudinal to the patient table and/or parallel to the axis that joins the axis of oscillation of the patient table and the central vertical axis of the patient receiving cavity CV or the imaging volume VI. Displacement means may be further provided which also allow limited translational movements transverse to the patient table and/or perpendicular to the axis that joins the axis of oscillation of the patient table and the central vertical axis of the patient receiving cavity CV or the imaging volume VI or parallel to the direction in which the central vertical axis of the patient receiving cavity CV or the imaging volume is joined to the central axis of the vertical wall member 301 or an axis parallel to such axis”).
Regarding claim 5, Satragno discloses all of the limitations of claim 1 as discussed above.
Satragno further discloses wherein the bed is provided with rotatable support joints configured so that the bed can rotate about a substantially horizontal axis, from top to bottom and vice versa (Satragno, Para 80; “In one more embodiment, not shown, one or both the vertical support members 202 and 302 are extendable for raising or lowering the corresponding end of the patient bearing surface 102, the latter being tilted about a horizontal axis oriented in the direction of the width of the patient bearing surface.”).
Regarding claim 7, Satragno discloses all of the limitations of claim 1 as discussed above.
Satragno further discloses wherein movements of the bed according to different degrees of freedom can be controlled by a motorized actuator: and/or a hydraulic or pneumatic actuator, or manually and can be executed at least partially simultaneously or in sequence and/or at partially overlapping times (Satragno, Para 49; “Further advantages consist in that, as positioning occurs by manual means and using the patient table that is displaceable relative to the magnet structure, the operating personnel can watch a real time image of the proper frame of the organ or anatomic region to be imaged. Such image is displayed over the magnet structure and does not require the operating personnel to leave the structure and reach an image display station, as required in prior art MRI apparatus. This highlights the synergistic integration of this feature with the apparatus having a pivoting patient table as described above”) (Satragno, Para 123; “According to a further advantageous feature, in addition to display means 10, such as a small LCD screen, one, two or more input means, generally designated by numeral 11, may be provided on the front side of the magnet structure, which allow operators to adjust certain imaging parameters and/or store data and recall information from a memory, to simplify manual positioning operations and avoid the need for the operator to run or frequently move between the magnet structure and the MRI apparatus console”).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 6 is rejected under 35 U.S.C. 103 as being unpatentable over Satragno and Hoult et al. (US5735278, hereafter Hoult).
Regarding claim 6, Satragno discloses all of the limitations of claim 1 as discussed above.
Satragno does not clearly and explicitly disclose wherein an end zone of the bed opposite to the column is formed by a terminal zone, which is hinged in an oscillating manner about a horizontal axis and orthogonal with respect to a longitudinal extension of the bed, whereby said terminal zone oscillates about said horizontal axis upwards and/or downwards with respect to a remaining part of the bed.
In an analogous surgical bed used in conjunction with an MRI field of endeavor Hoult discloses wherein an end zone of a bed opposite to a column is formed by a terminal zone, which is hinged in an oscillating manner about a horizontal axis and orthogonal with respect to a longitudinal extension of the bed, whereby said terminal zone oscillates about said horizontal axis upwards and/or downwards with respect to a remaining part of the bed (Hoult, Figure 8) (Hoult, Col 8, lines 3-21; “In FIG. 8, the patient is shown lying supine. In order to achieve the required height of the head of the patient above the heart of the patient, the table top is adjusted relative to the pin 36 so that the main portion of the table top is horizontal. In this position however the beam portion 45F is adjusted about the pin 46 so that it is cranked upwardly by an angle of the order of 10° thus lifting the head of the patient supported on the beam, as described hereinafter, relative to the thorax of the patient which remains lying on the horizontal table top. For this purpose the pin 46 is located approximately midway along the length of the beam so that it is positioned just forwardly of or underneath the part of the thorax where the heart is located. The adjustment of the angle of the portion 45F lifts the junction between the beam portions 45E and 45F upwardly to a height approximately equal to the main portion of the beam so that the beam can just be inserted into the magnet while just clearing the lowermost surface of the magnet, again reaching the head of the patient to a position centrally of the magnet.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Satragno wherein an end zone of the bed opposite to the column is formed by a terminal zone, which is hinged in an oscillating manner about a horizontal axis and orthogonal with respect to a longitudinal extension of the bed, whereby said terminal zone oscillates about said horizontal axis upwards and/or downwards with respect to a remaining part of the bed in order to adjust a patient’s head position as needed to improve imaging as taught by Hoult (Hoult, Col 2, lines 46-55).
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Satragno and Ortendahl et al. (US5085219, hereafter Ortendahl).
Regarding claim 8, Satragno discloses all of the limitations of claim 1 as discussed above.
Satragno does not clearly and explicitly disclose a position fixing device of the patient's head to the bed that can be applied permanently or replaceable to the bed, said position fixing device being provided in combination with a receiving coil of MRI signals, said receiving coil of MRI signals being formed by a single element or by a plurality of elements housing conductors forming a coil circuit or conductor segments which are electrically connected or connectable to each other, the element or plurality of elements being removably attachable to at least part of structural elements of the position fixing device at predetermined points thereof so as to configure, in a condition attached to the position fixing device and in a connected state of said conductor segments, a receiving coil for the head.
In an analogous patient holder for an MRI device field of endeavor Ortendahl discloses in Figure 1 a position fixing device of a patient's head to a bed that can be applied permanently or replaceable to the bed, said position fixing device being provided in combination with a receiving coil of MRI signals, said receiving coil of MRI signals being formed by a single element or by a plurality of elements housing conductors forming a coil circuit or conductor segments which are electrically connected or connectable to each other, the element or plurality of elements being removably attachable to at least part of structural elements of the position fixing device at predetermined points thereof so as to configure, in a condition attached to the position fixing device and in a connected state of said conductor segments, a receiving coil for the head (Ortendahl, Figure 1) (Ortendahl, Col 5, line 44 – Col 6, line 2; “With particular reference to FIG. 1 of the drawings, an exemplary holder for positioning and securing an MRI RF surface coil 14 (operatively connected to cable 15) in accordance with invention is shown generally at 10. Holder 10 includes a recessed base plate 12 which is adjustably mounted on a Plexiglas™ assembly plate 11 which typically forms a permanent part of the patient bed. In its mounted position on assembly plate 11, holder 10 may be moved in a direction parallel to the longitudinal Z axis by virtue of a plurality of rounded vertical projections on the underside of base plate 12 (see items 31a and 31b in FIG. 4). Base plate 12 is slidably mounted in opposing longitudinal slots 13a and 13b of assembly plate 11 to thereby permit the entire holder to move within opening 30. Preferably, plate 11 will be initially positioned (e.g., by securing it to the patient bed) before any other adjustments are made to the position of surface coil 14 as described in detail below. As FIG. 1 illustrates, the surface coil holder 10 in accordance with the invention includes six separate means for positioning the MRI RF surface coil 14 relative to the body part being examined, such as the temporomandibular joint or other areas of the human skull. As indicated above, four of those means serve to position and orient the surface coil itself, with the fifth being used to position the patient's head at a desired angle oblique to the longitudinal axis L of holder 10.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Satragno to include a position fixing device of the patient's head to the bed that can be applied permanently or replaceable to the bed, said position fixing device being provided in combination with a receiving coil of MRI signals, said receiving coil of MRI signals being formed by a single element or by a plurality of elements housing conductors forming a coil circuit or conductor segments which are electrically connected or connectable to each other, the element or plurality of elements being removably attachable to at least part of structural elements of the position fixing device at predetermined points thereof so as to configure, in a condition attached to the position fixing device and in a connected state of said conductor segments, a receiving coil for the head in order to more accurately position and secure a patient and therefore improve imaging as well making it more reproducible as taught by Ortendahl (Ortendahl, Col 1, lines 40-66).
Regarding claim 9, Satragno as modified by Ortendahl above discloses all of the limitations of claim 8 as discussed above.
Satragno does not clearly and explicitly disclose wherein some or all of the elements forming the receiving coil are stably hinged to a support base of the patient's head of said head fixing device or to other structural parts of said head fixing device, thereby housing said some or all of the elements and/or the support base of the patient's head and/or additional structural elements of the position fixing device equipped with receiver coil circuit segments that can oscillate in a position of mutual mechanical and electrical approach and connection in which the receiving coil is realized and in an open position: in which said some or all of the segments are mutually distant from each other and provide access to the patient's head.
Ortendahl further discloses in Figure 1 wherein some or all of the elements forming a receiving coil are stably hinged to a support base of a patient's head of a head fixing device or to other structural parts of said head fixing device, thereby housing said some or all of the elements and/or the support base of the patient's head and/or additional structural elements of the position fixing device equipped with receiver coil circuit segments that can oscillate in a position of mutual mechanical and electrical approach and connection in which the receiving coil is realized and in an open position: in which said some or all of the segments are mutually distant from each other and provide access to the patient's head (Ortendahl, Figure 1) (Ortendahl, Col 5, line 44 – Col 6, line 2; “With particular reference to FIG. 1 of the drawings, an exemplary holder for positioning and securing an MRI RF surface coil 14 (operatively connected to cable 15) in accordance with invention is shown generally at 10. Holder 10 includes a recessed base plate 12 which is adjustably mounted on a Plexiglas™ assembly plate 11 which typically forms a permanent part of the patient bed. In its mounted position on assembly plate 11, holder 10 may be moved in a direction parallel to the longitudinal Z axis by virtue of a plurality of rounded vertical projections on the underside of base plate 12 (see items 31a and 31b in FIG. 4). Base plate 12 is slidably mounted in opposing longitudinal slots 13a and 13b of assembly plate 11 to thereby permit the entire holder to move within opening 30. Preferably, plate 11 will be initially positioned (e.g., by securing it to the patient bed) before any other adjustments are made to the position of surface coil 14 as described in detail below. As FIG. 1 illustrates, the surface coil holder 10 in accordance with the invention includes six separate means for positioning the MRI RF surface coil 14 relative to the body part being examined, such as the temporomandibular joint or other areas of the human skull. As indicated above, four of those means serve to position and orient the surface coil itself, with the fifth being used to position the patient's head at a desired angle oblique to the longitudinal axis L of holder 10.”) (Ortendahl, Col 9, lines 18-36; “FIGS. 4, 5 and 6 also illustrate the means (shown generally as 25) for pivotally adjusting the position of MRI RF surface coil 14.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Satragno wherein some or all of the elements forming the receiving coil are stably hinged to a support base of the patient's head of said head fixing device or to other structural parts of said head fixing device, thereby housing said some or all of the elements and/or the support base of the patient's head and/or additional structural elements of the position fixing device equipped with receiver coil circuit segments that can oscillate in a position of mutual mechanical and electrical approach and connection in which the receiving coil is realized and in an open position: in which said some or all of the segments are mutually distant from each other and provide access to the patient's head in order to more accurately position and secure a patient and therefore improve imaging as well making it more reproducible as taught by Ortendahl (Ortendahl, Col 1, lines 40-66).
Regarding claim 10, Satragno as modified by Ortendahl above discloses all of the limitations of claim 8 as discussed above.
Satragno does not clearly and explicitly disclose wherein the receiving coil has an annular shape and is provided with securing means to the head of the patient and/or to a craniostat, the securing means being selectable among clamping bands or belts, an inner diameter of the annular shape and a shape in plan thereof being configured to contain within an opening at least an operating field, making the operating field accessible even when the receiving coil is worn on the head of the patient.
Ortendahl further discloses in Figure 1 wherein a receiving coil has an annular shape and is provided with securing means to a head of a patient and/or to a craniostat, the securing means being selectable among clamping bands or belts, an inner diameter of the annular shape and a shape in plan thereof being configured to contain within an opening at least an operating field, making the operating field accessible even when the receiving coil is worn on the head of the patient (Ortendahl, Figure 1) (Ortendahl, Col 5, line 44 – Col 6, line 2; “With particular reference to FIG. 1 of the drawings, an exemplary holder for positioning and securing an MRI RF surface coil 14 (operatively connected to cable 15) in accordance with invention is shown generally at 10. Holder 10 includes a recessed base plate 12 which is adjustably mounted on a Plexiglas™ assembly plate 11 which typically forms a permanent part of the patient bed. In its mounted position on assembly plate 11, holder 10 may be moved in a direction parallel to the longitudinal Z axis by virtue of a plurality of rounded vertical projections on the underside of base plate 12 (see items 31a and 31b in FIG. 4). Base plate 12 is slidably mounted in opposing longitudinal slots 13a and 13b of assembly plate 11 to thereby permit the entire holder to move within opening 30. Preferably, plate 11 will be initially positioned (e.g., by securing it to the patient bed) before any other adjustments are made to the position of surface coil 14 as described in detail below. As FIG. 1 illustrates, the surface coil holder 10 in accordance with the invention includes six separate means for positioning the MRI RF surface coil 14 relative to the body part being examined, such as the temporomandibular joint or other areas of the human skull. As indicated above, four of those means serve to position and orient the surface coil itself, with the fifth being used to position the patient's head at a desired angle oblique to the longitudinal axis L of holder 10.”) (Ortendahl, Col 6, lines 42-46; “During imaging, the patient's head rests on a head support cushion 20 and may be secured into position prior to and during the imaging operation using chin strap 21 and forehead strap 22.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Satragno wherein the receiving coil has an annular shape and is provided with securing means to the head of the patient and/or to a craniostat, the securing means being selectable among clamping bands or belts, an inner diameter of the annular shape and a shape in plan thereof being configured to contain within an opening at least an operating field, making the operating field accessible even when the receiving coil is worn on the head of the patient in order to more accurately position and secure a patient and therefore improve imaging as well making it more reproducible as taught by Ortendahl (Ortendahl, Col 1, lines 40-66).
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Satragno and Krogmann et al. (US6246239, hereafter Krogmann).
Regarding claim 11, Satragno discloses all of the limitations of claim 2 as discussed above.
Satragno does not clearly and explicitly disclose wherein said system is provided in combination with a surgical operation station provided at a predetermined distance from the imaging system, the surgical station
In an analogous patient bed for an MRI device field of endeavor Krogmann discloses in Figure 2 wherein said system is provided in combination with a surgical operation station provided at a predetermined distance from the imaging system, the surgical stationthe patient with sensors and/or probes applied to the patient and connected by cables to a control unit, and/or a unit for administering one or more drugs during surgery with injectors connected to the patient via tubes and needles, wherein the bed being provided, along at least part of a surface extension thereof and/or along at least part of perimeter edges thereof, with removable fastenings or removable restraining elements of said cables and/or said tubes, said cables and/or said tubes being provided with a redundant length such as to enable said cables and/or said tubes to follow movements of the bed, including the rotation between said two extreme positions (Krogmann, Col 2, lines 5-24; “It is thus possible to conduct a surgical intervention in the relatively low amplitude stray field of the NMR device, whereby there is only a limited need for NMR-compatible operating instruments. Since the patient is freely accessible outside the NMR device, known and proven surgical methods can be used for carrying out the intervention”) (Krogmann, Figure 2) (Krogmann, Col 3, line 17 – Col 4, line 13; “FIG. 2 shows a front view of the NMR device 2 with the operating column 12 on which the patient bed 10 is detachably secured. The operating column includes a securely mounted base part 19 to which another part 21 is flexibly mounted. The interlocking mechanism for the patient bed 10 is located at the upper side of the part 21. A swinging mechanism 22 with a motor operator (possibly with a gear train or belt for swinging around a horizontal axis 24), and a lift mechanism 26 containing an electric drive, e.g. in the form of a rotatable spindle, and a tilt mechanism 28 with an electromotor drive, are schematically drawn in the operating column 12. The lifting path symbolized by a double arrow 30—for the patient bed 10 extends from the bottom of the assembly to a height of e.g. 75 cm to 1.10 m. […] FIG. 4 schematically shows a plan view of an expanded NMR device 2A with a superconducting tubular magnet. Besides the patient access no other lateral access to the imaging volume 6 is provided therein. Given utilization of an actively shielded magnet, the stray field in the exterior space falls off sharply so that an operating column 12 partially constructed of ferromagnetic materials can also be securely mounted therein at a distance from the NMR device 2A. […] The utilization of conventional, i.e. ferromagnetic, instruments is also possible therein. There is still space in a zone 34 between the operating column 12 and the NMR device 2A for anaesthesia devices and other monitoring devices in use during the operation.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Satragno wherein said system is provided in combination with a surgical operation station provided at a predetermined distance from the imaging system, the surgical stationextreme positions in order to improve functionality le as taught by Krogmann (Krogmann, Col 1, lines 5-10).
Regarding claim 12, Satragno discloses all of the limitations of claim 2 as discussed above.
Satragno does not clearly and explicitly disclose wherein the extreme external position of the bed, at the end of which the patient's head positioning area is provided, is coinciding with an operating position in a surgical operation station, and wherein, at the extreme position of the patient's head positioning area and of the surgical operation station, an intensity of the magnetic field permeating out of a gantry of the magnetic structure is out of a 5 Gauss equipotential line of the magnetic field generated by the magnetic structure.
In an analogous patient bed for an MRI device field of endeavor Krogmann discloses wherein the extreme external position of the bed, at the end of which the patient's head positioning area is provided, is coinciding with an operating position in a surgical operation station, and wherein, at the extreme position of the patient's head positioning area and of the surgical operation station, an intensity of the magnetic field permeating out of a gantry of the magnetic structure is out of a 5 Gauss equipotential line of the magnetic field generated by the magnetic structure (Krogmann, Col 2, lines 5-24; “It is thus possible to conduct a surgical intervention in the relatively low amplitude stray field of the NMR device, whereby there is only a limited need for NMR-compatible operating instruments. Since the patient is freely accessible outside the NMR device, known and proven surgical methods can be used for carrying out the intervention”) (Krogmann, Figure 2) (Krogmann, Col 3, line 17 – Col 4, line 13; “FIG. 2 shows a front view of the NMR device 2 with the operating column 12 on which the patient bed 10 is detachably secured. The operating column includes a securely mounted base part 19 to which another part 21 is flexibly mounted. The interlocking mechanism for the patient bed 10 is located at the upper side of the part 21. A swinging mechanism 22 with a motor operator (possibly with a gear train or belt for swinging around a horizontal axis 24), and a lift mechanism 26 containing an electric drive, e.g. in the form of a rotatable spindle, and a tilt mechanism 28 with an electromotor drive, are schematically drawn in the operating column 12. The lifting path symbolized by a double arrow 30—for the patient bed 10 extends from the bottom of the assembly to a height of e.g. 75 cm to 1.10 m. […] FIG. 4 schematically shows a plan view of an expanded NMR device 2A with a superconducting tubular magnet. Besides the patient access no other lateral access to the imaging volume 6 is provided therein. Given utilization of an actively shielded magnet, the stray field in the exterior space falls off sharply so that an operating column 12 partially constructed of ferromagnetic materials can also be securely mounted therein at a distance from the NMR device 2A. […] The utilization of conventional, i.e. ferromagnetic, instruments is also possible therein. There is still space in a zone 34 between the operating column 12 and the NMR device 2A for anaesthesia devices and other monitoring devices in use during the operation.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Satragno wherein the extreme external position of the bed, at the end of which the patient's head positioning area is provided, is coinciding with an operating position in a surgical operation station, and wherein, at the extreme position of the patient's head positioning area and of the surgical operation station, an intensity of the magnetic field permeating out of a gantry of the magnetic structure is out of a 5 Gauss equipotential line of the magnetic field generated by the magnetic structure in order to improve functionality le as taught by Krogmann (Krogmann, Col 1, lines 5-10).
Conclusion
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/JOHN D LI/Primary Examiner, Art Unit 3798
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