DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9/12/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-13 and 18-19 in the reply filed on 5/26/2026 is acknowledged.
Claims 14-17 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/26/2026.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-13 and 18-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Regarding claim 1, the claim contains subject matter that does not appear enabled by the disclosure. Specifically, claims 1, 18 and 19 include the recitation (emphasis added):
“ A magnetic resonance imaging (MRI) system comprising: a magnet opening having a ratio of an opening length over an opening diameter, the ratio being smaller than 1.2; and a plurality of electromagnetic coils configured to generate a static magnetic field within a field of view (FOV), wherein the FOV is a non-spherical shape, and wherein the static magnetic field within the FOV has a measure of homogeneity better than 100 parts per million.”
As best understood, the invention is directed to MRI systems including magnets exhibiting bore length and bore diameter. The Specification explains that its advantageous to increase bore diameter and shortening scanner bore length in said systems (paragraph 0002). The Specification describes that reducing bore length and bore opening may be achieved by “relaxing” the constraints of imaging volume or effective field of view to allow for the FOV to be defined by a non-spherical volume (paragraph 0025). The Specification also describes the use of common ellipsoidal or oblate spheroidal harmonics to “relax” imaging FOV requirements (paragraphs 0025 and 0030).
However, the Specification doesn’t appear to sufficiently enable a person skill in the art to be able to configure an MRI system with electromagnetic coils configured to generate a static magnetic field within an FOV having a non-spherical shape with a measure of homogeneity better than 100 parts per million as claimed. As best understood, a critical step in designing the disclosed system so that it may generate a non-spherical shape static magnetic field of view and provide the recited measure of homogeneity (100 parts per million as recited in claim 1) involves determining the placement of coils as well as each coils’ current density directions. However, the Specification doesn’t provide any description about how the positions and current density directions are determined. For instance, paragraph 0066 in the Specification (emphasis added) states:
[0066] As a non-limiting example, the positions and current density directions of 14 coils were optimized or tuned to increase homogeneity within an ellipsoid FOV. The ellipsoid was defined as a spheroid with a sagittal and coronal length of 35 cm (a = b = 35 cm) and an axial or transverse length of 3.5 cm (c = 3.5 cm). The static field strength was defined as 0.5 T. The wire diameter was predefined based on iterative experimentation. The tuned position and current density of each coil is listed in Table I below. Table I provides the positions and current densities of seven of the 14 coils, the other seven coils are placed symmetrically along the Z- axis or across the center transverse plane. Once the positions and current densities are determined for each coil, individual coil elements were modeled to determine the inner radius, outer radius, and width of each coil that produces the desired current density, as shown in Table I. Based on the model results, such system design can achieve a 0.5 T magnetic field within the ellipsoid FOV with better than 10 ppm homogeneity and a magnet opening length or coil span of <80 cm. Such a set of coils is suitable to provide a wide-bore class MRI superconducting magnet.
Similar to the cited paragraph above, the disclosure doesn’t provide a description of how the optimization and/or tunning to increase homogeneity is performed, or what steps a user must follow to achieve the claimed system, what calculations to make or how to do go about performing iterative experimentation. The disclosure doesn’t explain how the wire diameter is chosen based on the experimentation (what parameter or characteristic in the wire the user aiming to achieve?). Also, the paragraph is silent about how the positions are determined or the model used to arrive at the inner radius, outer radius, and width of each coil that produces the desired current density. In short, the disclosure describes what the system design can allegedly achieve (0.5 T magnetic field within the ellipsoid FOV with a measure of homogeneity better than 100 parts per million), but doesn’t describe how.
Similarly, the examiner notes that, the steps of modeling (306) and optimizing (404) as shown in Figures 3 and 4, appear significant to the invention. The Specification however is silent about how the modeling or optimization is performed, the steps it comprises, or describes it in a way that a person having ordinary skill in the art would arrive at the claimed invention without undue experimentation.
Thus, as it relates to claims 1, 18 and 19, the Specification doesn’t contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same. In order to determine compliance with the enablement requirement of 35 U.S.C. 112(a), the Federal Circuit developed a framework of factors in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), referred to as the Wands factors to assess whether any necessary experimentation required by the specification is “reasonable” or is “undue.” These factors, as they related to the claimed invention include, but are not limited to:
(A) The breadth of the claims; An MRI system having a ratio of opening length over opening diameter smaller than 1.2 and electromagnetic coils configured to generate a static magnetic field within a non-spherical shaped field of view that has a measure of homogeneity better than 100 parts per million
(B) The nature of the invention; Magnetic resonance imaging systems and variations to achieve reduced dimensions by generating a static magnetic field within a non-spherical field of view and ellipsoidal or oblate spheroidal harmonics in order to achieve a static magnetic field having a non-spherical FOV, while also achieving a measure of homogeneity better than 100 parts per million.
(C) The state of the prior art; Conventionally, MRI imaging processing uses spherical harmonics in the processing of images.
(D) The level of one of ordinary skill; A person versed on MRI systems and equipment would have to undergo extensive experimentation and educated guesses as to the proper position and or parameters needed in the system as claimed
(E) The level of predictability in the art; Conventionally, MRI systems employ spherical FOV as it yields for simpler processing when generated within a cylindrical space. It wouldn’t be predictable to attempt to achieve the achieve the recited static magnetic field having a non-spherical FOV, while also achieving a measure of homogeneity better than 100 parts per million without knowing for example, how to model the system with non-spheroidal harmonics.
(F) The amount of direction provided by the inventor; As explained above, although the disclosure explains conventional elements of an MRI system, it doesn’t explain how the recited system is capable of performing the functions as claimed
(G) The existence of working examples; The provided examples describe physical attributes of the system and what the system supposedly does (see for example paragraphs 0028 and 0046), but fails to explain how the system is designed so that it performs the functions as recited.
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. A person versed on MRI systems and equipment would have to experiment with vast combinations of coil current and coil positions/orientation in an attempt to achieve the recited static magnetic field having a non-spherical FOV, while also achieving a measure of homogeneity better than 100 parts per million.
Claims 2-13 are also rejected as they inherit the deficiencies in claim 1 noted above.
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.
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.
Claim(s) 1-2, 4-13 and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over the US Patent Application Publication PGPub 2007/0052419 by Overweg, (Overweg hereafter) in view of the US Patent Application Publication PGPub 2007/0262776 by Petropoulos, (Petropoulos hereafter).
Regarding claim 1, Overweg teaches in Figures 1-3, a magnetic resonance imaging (MRI) system comprising:
a magnet opening having a ratio of an opening length (Lbore; see paragraph 0023 line 9) over an opening diameter (dbore; see paragraph 0023 line 9), the ratio being smaller than 1.2 (the ratio is approximately 800mm/800mm = 1; See paragraph 0023 lines 9-11); and
a plurality of electromagnetic coils (for example, 30, 32 in Figure 2) configured to generate a static magnetic field within a field of view (FOV), wherein the FOV is a non-spherical shape (FOV1, having an ellipsoidal shape; see paragraph 0023 line 6).
Overweg substantially teaches all of the recited elements as discussed above, except for explicitly mentioning that the static magnetic field within the FOV has a measure of homogeneity better than 100 parts per million.
However, it’s well known in the art of MRI systems, that the lower the parts per million (PPM) value of the static magnetic field inhomogeneity, the better the quality of the magnetic field. See for example, Petropoulos, paragraph 0008. Thus, it would have been obvious to a person having ordinary skill in the art to optimize Overweg’s system to arrive at the desired level of homogeneity (better than 100 parts per million). Such optimization of the generated static magnetic fields would involve routine experimentation in a manner as to optimize the conditions of the apparatus disclosed by the prior art. As MPEP 2144.05, section II explains:
In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) (“It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.”)
A person having ordinary skill in the art would have found it obvious to optimize the current provided to the coils and/or their positions within the magnetic resonance imaging system so as to generate the desired measure of homogeneity (100 parts per million), in order to achieve a level of high homogeneity which is critical for accurate imaging, as inhomogeneities can cause geometric distortion and/or banding artifacts.
Regarding claim 2, Overweg teaches the magnet opening has a length of less than 100 cm (Lbore approximately 80cm; see paragraph 0023 line 10).
Regarding claim 4, Overweg teaches the non-spherical shape is an ellipsoid extending with a maximum radius aligned transversely to a length of the magnet opening (see Figure 3).
Regarding claim 5, Overweg teaches the magnet opening is cylindrical (see paragraph 0018, line 3).
Regarding claim 6, Overweg teaches each of the plurality of electromagnetic coils has an inner radius, an outer radius, a width, and a current density (all inherent qualities of the coils within Overweg’s MRI system), and wherein the magnet opening (dbore; see paragraph 0023) has a center axis (corresponding to axis “z” shown in Figure 3) and each of the plurality of electromagnetic coils is characterized by a position along the center axis (as shown in Figure 2).
Regarding claim 7, Overweg doesn’t explicitly mention the static magnetic field has a field strength of at least 250 mT within the field of view. However, similar to that stated in regards to claim 1, it’s well known in the art of MRI system to use high field strengths. For example, Petropoulos teaches in paragraph 0052, Table III, the use of a magnet design outputting 1.50T in order to generate a FOV of 41.6 ppm homogeneity.
It would have been obvious to a person having ordinary skill in the art to optimize Overweg’s system to arrive at the desired level of field strength (at least 250mT). Such optimization of the generated static magnetic fields would involve routine experimentation in a manner as to optimize the conditions of the apparatus disclosed by the prior art. As MPEP 2144.05, section II explains:
In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) (“It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.”)
A person having ordinary skill in the art would have found it obvious to optimize the current provided to the coils and/or their positions within the magnetic resonance imaging system so as to generate the desired field strength, in order to achieve a level of high homogeneity which is critical for accurate imaging, as inhomogeneities can cause geometric distortion and/or banding artifacts.
Regarding claim 8, Overweg substantially teaches the recited elements as discussed above, except for explicitly mentioning that the minimum inner radius of each of the plurality of electromagnetic coils is at least 40 cm.
However, as MPEP 2144.05, section II explains:
In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) (“It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.”)
A person having ordinary skill in the art would have found it obvious to change/adjust the proportions/dimensions of the coils inner radius to within the recited constraint in order to achieve an optimal magnetic field as desired, or to ensure the coils have dimensions that can fit within the system’s housing, In re Williams.
Regarding claim 9, Overweg teaches the cylindrical opening has a maximum length of 80 cm (dbore approximately 80cm; see paragraph 0023 lines 9-10).
Regarding claim 10, although Overweg teaches the MRI system uses short magnet bores (see paragraph 0001, line 2), Overweg doesn’t explicitly mention the MRI system is portable.
However, it would have been obvious to a person having ordinary skill in the art before the application was effectively filed, to allow for the system to be movable and portable, as doing so would have allowed the system to be easily transported or moved for maintenance and service, In reLindberg, 194 F.2d 732, 93 USPQ 23 (CCPA 1952) (Fact that a claimed device is portable or movable is not sufficient by itself to patentably distinguish over an otherwise old device unless there are new or unexpected results.).
Regarding claim 11, Overweg teaches the non-spherical FOV is an ellipsoid (shown in Figure 3 or 4) characterized by orthogonal axes a, b, and c, (“a” interpreted to correspond to the axis along d1 shown in Figure 3; “b” interpreted to correspond to a not shown axis perpendicular to d1 and perpendicular to z; and “c” interpreted to correspond to the axis along Z), wherein axes a and b extend radially from a center axis of the magnet opening and axis c extends long the center axis of the magnet opening.
Regarding claim 12, Overweg teaches the ellipsoid is a spheroid characterized by a = b (the axis “a” as explained in regards to claim 11 is the same as the axis “b”) and b ≠ c (the axis “c” is about the size of L1, which is not equal to either “a” or “b”).
Regarding claim 13, Overweg teaches the MRI system of claim 12, wherein a = [35 cm ± 5 cm], b = [35 cm ± 5 cm], and c = [3.5 cm ± 5 cm]. See page paragraph 0023; the examiner interprets d1 to correspond to axis “a”, which is equal to 40cm. The examiner interprets a not labeled axis within the elliptical FOV, which is perpendicular to “a” and “Z”, to the recited axis “b” which has the same size as “a”. Finally, the examiner interprets L1, to correspond to axis “c”, which is equal to 8cm.
Regarding claim 18, Overweg teaches in Figures 1-3, a magnetic resonance imaging (MRI) magnet system comprising:
a plurality of electromagnetic coils (for example, 30, 32) arranged around a magnet opening with a length of 100 cm or less (Lbore approximately 80cm; see paragraph 0023);
wherein the plurality of electromagnetic coils is configured to generate a static magnetic field within a non-spherical field of view (FOV1, having an ellipsoidal shape; see paragraph 0023).
Overweg substantially teaches all of the recited elements as discussed above, except for explicitly mentioning that the static magnetic field within the FOV has a measure of homogeneity better than 100 parts per million.
However, it’s well known in the art of MRI systems, that the lower the parts per million (PPM) value of the static magnetic field inhomogeneity, the better the quality of the magnetic field. See for example, Petropoulos, paragraph 0008. Thus, it would have been obvious to a person having ordinary skill in the art to optimize Overweg’s system to arrive at the desired level of homogeneity (better than 100 parts per million). Such optimization of the generated static magnetic fields appears would involve routine experimentation in a manner as to optimize the conditions of the apparatus disclosed by the prior art. As MPEP 2144.05, section II explains:
In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) (“It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.”)
A person having ordinary skill in the art would have found it obvious to optimize the current provided to the coils and/or their positions within the magnetic resonance imaging system so as to generate the desired measure of homogeneity (100 parts per million), in order to achieve a level of high homogeneity which is critical for accurate imaging, as inhomogeneities can cause geometric distortion and/or banding artifacts.
Regarding claim 19, Overweg teaches in Figures 1-3, a whole-body magnetic resonance imaging (MRI) system for humans comprising:
a magnet opening (dbore; see paragraph 0023) with a length (Lbore) of less than 100 cm (Lbore approximately 80cm; see paragraph 0023); and
a plurality of electromagnetic coils (for example, 30, 32) configured to generate a static magnetic field within a field of view (FOV1), wherein the FOV is a non-spherical shape (FOV1, having an ellipsoidal shape; see paragraph 0023).
Overweg substantially teaches all of the recited elements as discussed above, except for explicitly mentioning that the static magnetic field within the FOV has a measure of homogeneity better than 100 parts per million.
However, it’s well known in the art of MRI systems, that the lower the parts per million (PPM) value of the static magnetic field inhomogeneity, the better the quality of the magnetic field. See for example, Petropoulos, paragraph 0008. Thus, it would have been obvious to a person having ordinary skill in the art to optimize Overweg’s system to arrive at the desired level of homogeneity (better than 100 parts per million). Such optimization of the generated static magnetic fields appears would involve routine experimentation in a manner as to optimize the conditions of the apparatus disclosed by the prior art. As MPEP 2144.05, section II explains:
In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) (“It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.”)
A person having ordinary skill in the art would have found it obvious to optimize the current provided to the coils and/or their positions within the magnetic resonance imaging system so as to generate the desired measure of homogeneity (100 parts per million), in order to achieve a level of high homogeneity which is critical for accurate imaging, as inhomogeneities can cause geometric distortion and/or banding artifacts.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Overweg in view of Petropoulos and further in view of the US Patent US 5,359,310 by Pissanetzky, (Pissanetzky hereafter).
In terms of claim(s) 3, Overweg in view of Petropoulos substantially teaches all of the elements disclosed above. However, although Overweg mentions the use of cryostat supports for minimizing induced eddy-currents (see paragraph 0033, line 13), Overweg doesn’t explicitly mention the use of a cryostat that contains the plurality of electromagnetic coils, the cryostat having an inner wall that defines a cryostat bore.
Pissanetzky teaches a magnetic resonance imaging system comprising electromagnetic coils contained within a cryostat (Figure 1, unit 2. See col. 7, lines 1-4).
It would have been obvious to a person having ordinary skill in the art before the invention was effectively filed, to apply the teaching of cryostats as taught by Pissanetzky, in the device/system/method of Overweg, in order to gain the advantage of provide a means for minimizing eddy-currents in the coil conductors.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
- The US Patent US 5,428,292 by Dorri et al.
- The US Patent Application Publication PGPub 2007/0229077 A1 by Punzo et al.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Richard Isla whose telephone number is (571)272-5056. The examiner can normally be reached Monday-Friday 9a - 5:30p.
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/RICHARD ISLA/Primary Patent Examiner, Art Unit 2858 August 4, 2026
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