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 .
Response to Arguments
Applicant’s arguments with respect to claim 21 has been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Election/Restrictions
Newly submitted claims 54-58 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Claim 21 and new claim 54 are each directed an assembly for providing a B0 magnetic field in a portable magnetic resonance imaging (MRI) system. Claim 21 requires “at least one axially extending gap formed in the non-ferromagnetic frame at a location spaced radially outward from the bore and dimensioned to receive a panel”, which is not required by new claim 54. New claim 54 requires “a first portion comprising a first array of ferromagnetic segments and a second portion comprising a second array of ferromagnetic segments, the first and second portions spaced apart from each other along a common axis and positioned on opposing sides of a central region for accommodating a patient's anatomy”, which is not required by claim 21. The inventions of claim 21 and new claim 54 therefore have a materially different design, mode of operation, function, or effect. The inventions of claim 21 and new claim 54 do not overlap in scope, i.e., are mutually exclusive, and the inventions as claimed are not obvious variants. At least in view of the different features recited in each of these claims, there would be a serious search and/or examination burden on the examiner at least because it is necessary to search for one of the inventions in a manner that is not likely to result in finding art pertinent to the other invention(s) (e.g., employing different search queries).
New claim 49 and new claim 54 are each directed an assembly for providing a B0 magnetic field in a portable magnetic resonance imaging (MRI) system. New claim 49 requires “a plurality of ferromagnetic segments disposed about a bore along a common longitudinal axis, wherein the ferromagnetic segments are arranged to accommodate a patient's anatomy within the bore during imaging by the portable MRI system” and “a non-ferromagnetic support frame fixedly securing the ferromagnetic segments and including one or more mounting features for non-rotational attachment to a support structure of the portable MRI system”, which are not required by new claim 54. New claim 54 requires “a first portion comprising a first array of ferromagnetic segments and a second portion comprising a second array of ferromagnetic segments, the first and second portions spaced apart from each other along a common axis and positioned on opposing sides of a central region for accommodating a patient's anatomy”, which is not required by new claim 49. The inventions of new claims 49 and 54 therefore have a materially different design, mode of operation, function, or effect. The inventions of new claims 49 and 54 do not overlap in scope, i.e., are mutually exclusive, and the inventions as claimed are not obvious variants. At least in view of the different features recited in each of these claims, there would be a serious search and/or examination burden on the examiner at least because it is necessary to search for one of the inventions in a manner that is not likely to result in finding art pertinent to the other invention(s) (e.g., employing different search queries).
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, new claim 54 and claims 55-58 depending therefore are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 21 and 41-48 are rejected under 35 U.S.C. 103 as being unpatentable over US 4,727,327 to Toyoshima et al. (Toyoshima).
Regarding claim 21, Toyoshima discloses an assembly for providing a B0 magnetic field in a magnetic resonance imaging (MRI) system, the assembly comprising:
a frame defining a bore along a common longitudinal axis (Toyoshima, e.g., Figs. 4-7 and 9, e.g., frame in the form of magnetic frame support frame means 37a-37c in combination with coupling rods 53 such as shown in Fig. 9); see, e.g., col. 5, lines 4-31; also see col. 6, lines 1-25);
a plurality of ferromagnetic segments disposed about the bore in spaced relation along at least a portion of a circumference of the bore and extending along the common longitudinal, axis, the ferromagnetic segments (i) having magnetization orientations that vary with their positions about the bore to provide a substantially homogeneous magnetic field within the bore (Toyoshima, e.g., Figs. 4-7 and 9, e.g., plurality of ferromagnetic segments in the form of three magnet rings 34a, 34b and 34c, each composed of eight anisotropic permanent magnet blocks 33; also see, e.g., col. 5, lines 4-31; also see, e.g., col. 8, lines 13-28, Nd-Fe-B magnets; see magnetization directions of magnet blocks 33 in Figs. 4 and 7, for example; note homogenous field static magnetic field 36 as shown in FIG. 7), and (ii) arranged so that the assembly, when part of the MRI system, accommodates insertion of a patient's shoulder within a perimeter of the bore (Toyoshima, e.g., Figs. 6-7, for example, examinee 47); and
at least one axially extending gap formed in the frame at a location spaced radially outward from the bore and dimensioned to receive a panel (Toyoshima, e.g., Fig. 9, note gaps in between magnetic frame support frame means 37a-37c, with the gap each having a dimension extending axially along the bore; the examiner notes that the language “to receive a panel” merely sets forth an intended use or purpose of the gap; because the claim language does not specify a size of the panel, the claim language has a scope of a gap dimensioned to receive a panel of any size, for any purpose; each of Toyoshima’s gaps having a dimension extending axially along the bore therefore falls withing the scope of the claim language).
Toyoshima is not relied upon as explicitly disclosing that the frame in the form of magnetic frame support frame means 37a-37c in combination with coupling rods 53 such as shown in Fig. 9 is a non-ferromagnetic frame. The examiner takes Official notice of the fact that it was well-known and conventional in the MRI art that ferromagnetic structural components in MRI scanners should be avoided due to deleterious effects such components have on magnetic field homogeneity. At this in view of this knowledge, it 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 to modify Toyoshima such that the frame is non-ferromagnetic in order to maintain the magnetic field homogeneity to acceptable levels.
Regarding the term “portable”, the examiner notes that Toyoshima as modified and the claimed assembly are identical in terms of structure. For at least this reason, the examiner maintains that a prima facie case obviousness has been established. See, e.g., MPEP 2112.01.
Regarding claim 41, Toyoshima as applied to claim 21 discloses wherein the magnetization orientations are arranged in a Halbach or Halbach-like pattern (see Toyoshima as applied to claim 21, one of ordinary skill in the art would recognize from the magnetization directions of magnet blocks 33 in Figs. 4 and 7 and the resulting homogenous field static magnetic field 36 as shown in FIG. 7 that Toyoshima’s magnetization orientations are arranged in at least a Halbach-like pattern).
Regarding claim 42, Toyoshima is not relied upon as explicitly disclosing wherein the assembly weighs less than 120 kg. In this regard, Toyoshima does not disclose a weight of its magnet arrangement, and the examiner presumes from the size of Toyoshima’s apparatus relative to the examinee 47 (see, e.g., Fig. 6) that its weight is more than 120 kg. The examiner nonetheless takes Official notice of the fact that it was well-known in the MRI art that Halbach-like magnet arrangements of the type disclosed by Toyoshima are highly scalable in both size and weight from small to large depending on imaging needs (with Toyoshima being an example of a large configuration with a diameter large enough for whole-body scanning and a weight likely in excess of 120 kg). See, e.g., US 6,657,433 to Locatelli et al., col. 3, lines 3-22, volume of interest corresponds to a 15 mm diameter and 12 mm long cylinder, with a magnet weight of 5.4 kg; also see Cooley et al., Design of sparse Halbach magnet arrays for portable MRI using a genetic algorithm, IEEE Trans Magn. 54(1), Jan. 2018 (Cooley I), previously of record, bore diameter of 29 cm (Fig. 7) with a weight of 122 kg (page 9, bottom); also see US 2018/0325477 to Wang et al. Fig. 1 and paragraph 134, inner diameter of 30 cm, outer diameter of 60 cm, and a thickness of 5 cm, with total weight of 158 kg. It 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 that the size/weight of Toyoshima’s may be suitably scaled depending upon particular imaging needs, with magnet weights on the order of 120 kg or less being well-known and conventional in the art.
Regarding claim 43, Toyoshima discloses wherein the magnetization orientations vary according to both angular position around the bore (Toyoshima, e.g., Figs. 4, 7) and longitudinal position along the bore (Toyoshima, e.g., Figs. 10B-12 and col. 7, line 35 to col. 8, line 12, tangential/skew adjusting means 87, 88 is provided in association with each magnet block 33 on outer sides of each pair ring plates 59, 61 as shown in FIG. 9).
Regarding claim 44, Toyoshima as applied to claim 21 discloses wherein the gap has a width sized for a laminate coil panel between 4 mm and 12 mm (see Toyoshima as applied to claim 21; it is implicit in Figs. 4-7 and 9 that gaps in between magnetic frame support frame means 37a-37c are at 12 mm and therefore sufficient to receive a panel of any construction having a dimension between 4 mm and 12 mm).
Claim 45 recites wherein the panel comprises at least one of a gradient coil, a transmit RF coil, a receive RF coil, or a shim coil. As discussed above in connection with claim 21, the language “to receive a panel” merely sets forth an intended use or purpose of the gap. Neither claim 21 nor claim 45 affirmatively requires as an element of the assembly a panel or a panel that includes at least one of a gradient coil, a transmit RF coil, a receive RF coil, or a shim coil. Accordingly, claim 45 is non-limiting and carries no patentable weight.
Regarding claim 46, Toyoshima as applied to claim 21 discloses wherein the ferromagnetic segments are fixedly mounted to maintain their magnetization orientation pattern so as to eliminate the need to readjust/recalibrate the positioning of Toyoshima’s three magnet rings 34a, 34b and 34c).
Regarding claim 47, Toyoshima is not relied upon as explicitly disclosing wherein the substantially homogeneous magnetic field has a homogeneity of 100 ppm to 500 ppm over a volume having a diameter between 15 cm and 25 cm. Toyoshima instead discloses obtaining a homogeneous magnetic field with a difference between maximum and minimum field intensities held within 30 ppm inside a cylindrical plane with a radius of 175 mm from the center of each magnet ring. Toyoshima therefore discloses a substantially homogeneous magnetic field having a homogeneity of 30 ppm or less over a volume having a diameter of about 35 cm. At the time the invention was made, it would have been an obvious matter of design choice to a person of ordinary skill in the art to provide a substantially homogeneous magnetic field having a homogeneity of 100 ppm to 500 ppm over a volume having a diameter between 15 cm and 25 cm because applicant has not disclosed that such values provide an advantage, are used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected the assembly of Toyoshima, and applicant’s invention, to perform equally well with either the 30 ppm/35 cm values taught by Toyoshima or the claimed 100-500 ppm/15-25 cm values because both assemblies would perform the same function of producing B0 fields with suitable homogeneity for MRI imaging equally well.
Regarding claim 48, Toyoshima as applied to claim 21 discloses wherein the non-ferromagnetic frame fixedly secures the ferromagnetic segments and includes one or more mounting features for non-rotational attachment to a support structure of the portable MRI system (see Toyoshima as applied to claim 21, noting that Toyoshima’s magnetic frame support frame means 37a-37c in combination with coupling rods 53 such as shown in Fig. 9 fixedly secures the three magnet rings 34a, 34b and 34c and necessarily includes one or more mounting features for non-rotational attachment to a support structure of Toyoshima’s MRI system, e.g., a support structure in the form of mount 31).
Claims 49-52 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0313920 to Sotgiu (Sotgiu).
Regarding claim 49, Sotgiu discloses a magnetic assembly for providing a B0 magnetic field in a portable magnetic resonance imaging (MRI) system that is transportable between imaging locations without disassembly of the magnetic assembly, the magnetic assembly comprising:
a plurality of ferromagnetic segments disposed about a bore along a common longitudinal axis, wherein the ferromagnetic segments are arranged to accommodate a patient's anatomy within the bore during imaging by the portable MRI system (Sotgiu, e.g., Figs. 1a-1b and 3 and paragraph 8, Halbach rings each composed of 16 identical magnetic blocks; also see paragraph 34, utilized for the study of peripheral joints (hands, feet, knees etc.); also see paragraph 32; also see paragraph 1, a low weight and small magnet suitable for MRI for dedicated clinical applications such as the analysis of the peripheral joint, the analysis of the ocular region, and veterinary applications; at least in view of the low weight and small size of Sotgiu’s magnet arrangement, and in view of its construction as shown and described in connection with Figs. 1a-1b, one of ordinary skill in the art would understand that the MRI system in which the magnet arrangement is used is transportable between imaging locations without disassembly of the magnet arrangement);
wherein the ferromagnetic segments have magnetization orientations that vary with their positions about the bore to provide a substantially homogeneous magnetic field within an imaging region situated within the bore (Sotgiu, e.g., paragraph 8, Halbach rings each composed of 16 identical blocks as shown in FIG. 1a and FIG. 1b; also see Fig. 2 and paragraph 7); and
a non-ferromagnetic support frame fixedly securing the ferromagnetic segments
Sotgiu is not relied upon as explicitly disclosing the non-ferromagnetic support frame as including one or more mounting features for non-rotational attachment to a support structure of the portable MRI system. The use of support structures, e.g., tables, rolling platforms, for supporting medical instruments, especially those that are small and low in weight, were well-known and conventional before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. It 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 to modify Sotgiu such that Sotgiu’s non-ferromagnetic support frame includes one or more mounting features (e.g., bolt holes) for non-rotational attachment to a support structure (e.g., tables, rolling platforms). In this way, a suitable working height of the MRI system may be provided and/or portability of the MRI system may be enhanced.
Regarding claim 50, Sotgiu discloses wherein the magnetization orientations are arranged in a Halbach or Halbach like pattern (see Sotgiu as applied to claim 49, e.g., paragraph 8, Halbach rings each composed of 16 identical blocks as shown in FIG. 1a and FIG. 1b; also see Fig. 2 and paragraph 7).
Regarding claim 51, Sotgiu discloses wherein the ferromagnetic segments are fixedly mounted to maintain their magnetization orientation pattern during movement of the MRI system between imaging locations (see Sotgiu as applied to claim 49, Sotgiu, e.g., Fig. 1b and paragraph 17, Halbach rings are held rigidly in position by holding structures (3) connected among them by longitudinal bars not shown in the figure and by circular rings (4); all of these elements are made of aluminum).
Regarding claim 52, wherein the magnetization orientations vary according angular position around the bore (see Sotgiu as applied to claim 49, e.g., paragraph 8, Halbach rings each composed of 16 identical blocks as shown in FIG. 1a and FIG. 1b; also see Fig. 2 and paragraph 7). Although Sotgiu is not relied upon as explicitly disclosing that the magnetization orientations also vary according to longitudinal position along the bore, one of ordinary skill would understand that at least some degree of variation, however small, will necessarily exist between Sotgiu’s Halbach rings in a longitudinal direction along the bore, and that such variations and their effects may be accounted for through the use of appropriate shimming arrangements (e.g., shim rings and the like, see Sotgiu, e.g., Figs. 7-8).
Claim 53 is rejected under 35 U.S.C. 103 as being unpatentable over Sotgiu in view of Cooley et al., Design of sparse Halbach magnet arrays for portable MRI using a genetic algorithm, IEEE Trans Magn. 54(1), Jan. 2018 (Cooley I), previously of record.
Regarding claim 53, Sotgiu discloses a magnet arrangement is of a low weight and small, but is not relied upon as explicitly disclosing wherein the assembly weighs less than 120 kg. In closely related art, Cooley I discloses a Halbach magnet arrangement for portable MRI having a total weight of 122 kg (Cooley I, e.g., page 9, last 3 lines). It 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 to modify Sotgiu such that Sotgiu’s low weight and small magnet arrangement has a weight of 122 kg at least in view of Cooley I’s teachings that magnet arrangements with this weight are suitable for portable MRI. Sotgiu in view of Cooley I is not relied upon as explicitly disclosing magnet assembly that weighs less than 120 kg. At the time the invention was made, it would have been an obvious matter of design choice to a person of ordinary skill in the art to construct an assembly that weighs less than 120 kg because applicant has not disclosed that a weight of less than 120 Kg provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected the assembly of Sotgiu in view of Cooley I, and applicant’s invention, to perform equally well with either 122 kg magnet assembly weight taught by Sotgiu in view of Cooley I or the claimed less than 120 kg magnet assembly weight because both assemblies would perform the same function produce B0 fields with suitable homogeneity for MRI imaging equally well.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL R MILLER whose telephone number is (571)270-1964. The examiner can normally be reached 9AM-5PM EST M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lisa Caputo can be reached at (571) 272-2388. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIEL R MILLER/Primary Examiner, Art Unit 2863