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 .
Election/Restrictions
Newly submitted claims 21-30 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Original claims 1-20, drawn to an NMR apparatus/method for elastography using a constant magnetic field gradient, classified in G01R33/34092.
II. Claims 21-30, drawn to a method for elastography using an NRM apparatus, classified in A61B5/055.
The inventions are independent or distinct, each from the other because:
Inventions I and are related as combination and subcombination. Inventions in this relationship are distinct if it can be shown that (1) the combination as claimed does not require the particulars of the subcombination as claimed for patentability, and (2) that the subcombination has utility by itself or in other combinations (MPEP § 806.05(c)). In the instant case, the combination as claimed does not require the particulars of the subcombination as claimed because the combination of Invention I does not require inducing inducing shear waves in the sample to cause cyclic spin displacement of protons in the sample and determining stiffness within the sample base d on phase shifts in the NMR signals. The subcombination has separate utility such as stiffness determination/shear wave elasticity evaluation.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
--the inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries)
In this case, Invention II would require as search strategy related to inducing shear waves and determining tissue stiffness within the sample based on the phase shifts in the NMR signals without generating images of the sample which are not required of invention I and Invention I would require a search strategy related to a data acquisition unit, processing unit, and display unit which are not required of invention II.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these 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.
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, claims 21-30 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.
Response to Arguments
Regarding drawings
Examiner notes the drawings objections are withdrawn in view of the amendments to the claims.
Regarding 35 U.S.C. 112
Examiner notes that the previously set forth 112(b) rejections are withdrawn in view of the amendments to the claims, however, new 112(b) rejections are necessitated by amendment.
Examiner further notes that the 112(f) claim interpretations are withdrawn in view of the amendments to the claims.
Regarding 35 U.S.C. 101
Examiner notes that the 101 rejection is withdrawn in view of the amendments to the claims.
Regarding prior art
Applicant's arguments filed 12/02/2025 have been fully considered but they are not persuasive. For example, applicant argues independent claim 1 requires 5 steps including determination of tissue stiffness within the sample based on the phase shifts in the NMR signals without generating images of the sample and that “applicant submits that Ehman has not been shown to teach such subject matter as recited in amended independent claim 1” (REMARKS pg. 12). Examiner respectfully disagrees in that the claim merely requires that tissue stiffness is determined, however, does not relate such determination towards any specific element of the apparatus, therefore, it has been interpreted that the prior art must merely teach the cited elements (i.e. the magnet and RF coil) and be capable of being used to determine tissue stiffness. Such cited elements are taught by Ehman and applicant has not specifically pointed to why the teachings of Ehman do not teach the elements of claim 1 other than the conclusory statement that Ehman has not been shown to teach such subject matter. Furthermore, although the claim has been interpreted to merely require the claimed elements of the magnet and coil, examiner notes that an alternative secondary reference is used to teach wherein tissue stiffness is determined based on phase shifts in NMR signals without generating images of the sample. Therefore, if tissue stiffness determination is required of the system, it is noted that applicant’s arguments are considered moot in view of the new grounds of rejection necessitated by amendment.
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 1-7, 17, and 19-20 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.
Claim 1 recites the limitation “wherein the NMR signals are received from the sample with shear waves induced in the sample”. The limitation is unclear as the claim is directed to an apparatus comprising a magnet and a coil, it is therefore unclear what induces the shear waves into the sample. In other words, while the claim appears to recite that shear waves are induced in the sample, there is no such recited element which induces the shear waves into the sample. For examination purposes, it has been interpreted that the coil must merely be capable of receiving NMR signals which are received when shear waves are induced, however, clarification is required.
Claim 1 recites the limitation “tissue stiffness within the sample is determined based on the phase shifts in the NMR signals without generating images of the sample”. The limitation is unclear because it is noted that the claim is directed to an apparatus comprising a magnet and a coil and it is noted that the magnet and the coil would not be capable of determining tissue stiffness, thus it is unclear what structure of the apparatus performs such tissue stiffness determination. In other words, the claim recites tissue stiffness within the sample is determine, however, does not recite any specific structure of the apparatus which performs such a function. For examination purposes, it has been interpreted that the system must merely be capable of being used such that a stiffness within the sample is determine as recited (e.g. via a user, computer, software, etc.).
Claim 4 recites the limitation “the sensitivity of the NMR signals is increased by using excited or observed bandwidth or using a pulse sequence”. Examiner notes that the limitation is unclear as to what the sensitivity of the NMR signals is increased with respect to and how increasing the sensitivity is done by using excited or observed bandwidth or using a pulse sequence. In other words, it is unclear what the natures of the bandwidth/pulse sequence is such that it would increase and what the increase is relative to. For examination purposes, it has been interpreted that to mean that any excited or observed bandwidth or a pulse sequence necessarily results in an increased sensitivity at least with respect to another system having a lower sensitivity, however, clarification is required.
Claim 19 recites the limitation “wherein T1p is measured and used in determining the tissue stiffness”. It is first unclear what measures T1p as the apparatus merely includes a magnet and coil, thus it is unclear which elements of the apparatus would perform measurement of T1p. It is further unclear how the T1p is used in determining the tissue stiffness. Examiner notes that the originally filed specification merely discloses in [0037] that T1p may be deterministic of a degree of fibrosis in a body under influence and in that T1p can be used in combination with shear waves to probe the stiffness of a tissue, the specification does not make clear how T1p is used in determining stiffness. For examination purposes, it has been interpreted that any T1p measurement used for fibrosis evaluation is used for stiffness determination, however, clarification is required.
Claim Rejections - 35 USC § 102/103
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 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.
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 1, 5-7, and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ehman et al. (US 20120010497 A1), hereinafter Ehman, or in the alternative under 103 over Ehman in view of Foreign Wu (CN 110916663 A1), hereinafter Wu.
Regarding claim 1,
Ehman discloses a nuclear magnetic resonance (NMR) apparatus (at least fig. 7 and corresponding disclosure in at least for elastography using a constant magnetic field gradient, comprising:
A single-sided magnet(at least fig. 1B (110) and corresponding disclosure in at least [0036]) configured to generate the constant magnetic field gradient within a sample ([0037] which discloses the size of the magnet assembly may be chosen to produce an average static magnetic field B.sub.0, of .5 Tesla (“T”)) , the sample being part of a body (102).
A radiofrequency (RF) coil (at least fig. 2B (200 or 202) and corresponding disclosure in at least [0036]) configured to emit RF signals into the sample and receive NMR signals from the sample ([0054] which discloses RF excitation waveforms are applied to the RF coil 202 by the RF system 740 to perform the prescribed magnetic resonance pulse sequence. Responsive MR signals detected by the RF coil 202 are received by the RF system 740), wherein the NMR signals are received from the sample with shear waves induced in the sample the shear waves propagating in a direction parallel to a plane of the sample, the shear waves induced in the sample causing cyclic spin displacement of protons in the sample, further wherein the cyclic spin displacement of the protons in the sample in the presence of the constant magnetic field gradient results in phase shifts in the NMR signals ([0017] which discloses The unilateral MRI device also includes a motion source coupled to the imaging assembly that imparts a vibratory motion to a subject such that MRE can be performed. To this end, the unilateral MRI device also includes system for driving the magnetic field gradient coil and the motion source at a selected frequency to encode received MR signals with respect to the imparted vibratory motion. Examiner notes that the vibratory motion caused by the motion source would necessarily induce shear waves propagating in a direction parallel to a plane of the sample and performing MRE would require that the signals received are from the sample with the shear waves induced), and tissue stiffness within the sample is determined based on the phase shifts in the NMR signals without generating images of the sample (Examiner notes that the claim is directed towards a single-sided magnet and a radio-frequency (RF) coil as noted in the 112(b) rejection above, thus the system would be capable of being used for such tissue stiffness determination)
However, if tissue stiffness determination is considered to be required of the claimed invention, examiner notes that Ehman fails to explicitly teach tissue stiffness within the sample is determined based on the phase shifts in the NMR signals without generating images of the sample.
Wu, in a similar field of endeavor involving portable NMR, teaches wherein tissue stiffness within a sample is determined based on phase shifts caused by shear waves induced in the sample in NMR signals without generating images of the sample (pg. 7 which discloses by changing the excitation frequency of the radio frequency pulse, an excited thin layer moves in the AP direction of the shear wave propagation, the phases of the central portions of the echoes at a plurality of layer position are collected, the spatial phase distribution also satisfies the formula and the expressed sinusoid may also be used to estimate the wavelength or wave velocity of the shear wave and thereby determine the shear elastic modulus (i.e. stiffness) value).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Ehman to include determining a stiffness as taught by Wu in order to allow for determination of stiffness of the tissue thus diagnostic abilities having the advantage of no need for imaging and short measurement tim with high accuracy (Wu pg. 6). Such a modification would thereby improve the MRE evaluation of Ehman providing bedside detection and rapid screening (Wu abstract).
Regarding claim 5,
Ehman further discloses further comprising:
an external actuator (at least fig. 2C or fig. 7 (212) and corresponding disclosure in at least Abstract [0050] and [0063]) configured to transfer vibrations to the body to induce the shear waves in the sample (abstract which discloses the unilateral MRI device may also include a motion source (212) to impart a vibratory motion to a subject for performing an MRE process and [0065] which discloses the MRE transducer 212 is directed to apply an oscillating stress 916 to the subject).
Regarding claim 6,
Ehman further discloses further comprising:
an external actuator (at least fig. 2C or fig. 7 (212) and corresponding disclosure in at least Abstract [0050] and [0063]) configured to be positioned above the body (see at least fig. 1A depicting in which the external actuator is positioned above a body when the actuator is included in the probe 100 as disclosed in [0050] and fig. 7 depicting the external actuator positioned above the body placed on an NMR probe 100), said external actuator (212) being configured to transfer vibrations to the body to induce the shear waves in the sample (abstract which discloses the unilateral MRI device may also include a motion source (212) to impart a vibratory motion to a subject for performing an MRE process and [0065] which discloses the MRE transducer 212 is directed to apply an oscillating stress 916 to the subject).
Regarding claim 7,
Ehman further discloses further comprising:
An external actuator (at least fig. 2C or fig. 7 (212) and corresponding disclosure in at least Abstract [0050] and [0063]) configured to be positioned on a side of the body(see at least fig. 1A depicting in which the external actuator is positioned on a side of a body when the actuator is included in the probe 100 as disclosed in [0050] and fig. 7 depicting the external actuator positioned above the body placed on an NMR probe 100), said external actuator being configured to transfer vibrations to the body to induce the shear waves in the sample (abstract which discloses the unilateral MRI device may also include a motion source (212) to impart a vibratory motion to a subject for performing an MRE process and [0065] which discloses the MRE transducer 212 is directed to apply an oscillating stress 916 to the subject).
Regarding claim 17,
Ehman further discloses wherein the determination of the tissue stiffness within the sample does not depend on a T2* measurement of the NMR signals, which minimizes influence of iron overload and enhances accuracy of the determination of the tissue stiffness (As noted above, the tissue stiffness is capable of being determine in any manner including one that does not depend on T2* measurement of the NMR signals)
In the alternative, Wu further teaches wherein the determination of the tissue stiffness within the sample does not depend on a T2* measurement of the NMR signals, which minimizes influence of iron overload and enhances accuracy of the determination of the tissue stiffness (See at least pg. 7 in which the shear elastic modulus value is determined according to the phase distribution which does not rely on T2* measurements)
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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Ehman, or Ehman and Wu.
Regarding claim 2,
Ehman, or in the alternative Ehman, as modified, teaches the elements of claim 1 as previously stated. Ehman fails to explicitly teach wherein the constant magnetic field gradient is on an order of 2 T/m, however, teaches that currently designed magnets for single-sided MRI produce static gradient strengths between 1 and 20 Tesla-per-meter in [0009].
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Ehman, or Ehman, as currently modified to use a magnet producing a constant magnetic field gradient on an order of 2 T/m as currently available. Such a modification would produce useful, cost-effective imaging performance for their intended application (Ehman [0010]). Such a modification further amounts to merely a simple substitution of one known magnet for another yielding predictable results with respect to NMR evaluation, thereby rendering the claim obvious (MPEP 2143).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Ehman, or Ehman, and Wu, as applied to claim 1 above, and further in view of Foreign Wu et. al. (CN 112244813 A), hereinafter Wu(2). Examiner notes that citations to Wu are with respect to the translated copy provided herein.
Regarding claim 3,
Ehman, or in the alternative Ehman, as modified, teaches the elements of claim 1 as previously stated. Ehman further teaches further comprising an actuator (at least fig. 2C or fig. 7 (212) and corresponding disclosure in at least Abstract [0050] and [0063]) configured to transfer vibrations to the body to induce the shear waves in the sample (abstract which discloses the unilateral MRI device may also include a motion source (212) to impart a vibratory motion to a subject for performing an MRE process and [0065] which discloses the MRE transducer 212 is directed to apply an oscillating stress 916 to the subject); and
Ehman fails to explicitly teach the actuator comprising a rigid bar.
Wu(2), in a similar field of endeavor involving Magnetic resonance elastography, teaches an actuator configured to transfer vibrations a body to induce shear waves in a sample, the actuator comprising a rigid bar (pg. 5 which discloses transmitting the vibration to the detected object through the transmission rod); and
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Ehman to include an actuator as taught by Wu in order to provide mechanical vibrations to the tissue so that the object generates a shear wave corresponding to the frequency of the transmission rod (Wu(2) pg. 5). Such a modification amounts to merely a simple substitution of one known shear wave generator for another yielding predictable results with respect to magnetic resonance elastography.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Ehman, or Ehman and Wu as applied to claim 1 above, and further in view of NPL Manduca et al. (“MR elastography: Principles, guidelines, and terminology”), hereinafter Manduca.
Regarding claim 4,
Ehman, or Ehman as modified, teaches the elements of claim 1 a previously stated. Ehman further teaches wherein sensitivity of the NMR signals is increased by using a pulse sequence ([0005] which discloses he measurement cycle used to acquire each MR signal is performed under the direction of a pulse sequence produced by a pulse sequencer. Clinically available MRI systems store a library of such pulse sequences that can be prescribed to meet the needs of many different clinical applications and [0057] which discloses For example, during prescans, MR data is acquired and used to calibrate the pulse sequence performed by the pulse sequencer. Examiner notes that such a pulse sequence would increase the sensitivity at least with respect to another sensitivity of NMR signals in its broadest reasonable interpretation) Ehman fails to explicitly teach wherein the cyclic spin displacement of protons in the sample caused by the shear waves induced in the sample is in tens of microns.
Nonetheless, Manduca teaches it is desired for cyclic spin displacement of protons in a sample caused by shear waves induced in a sample to be tens of microns (pg. 4 which discloses displacements of tens of microns are often ideal).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Ehman, or Ehman, as modified, to include cyclic spin displacements in tens of microns as taught by Manduca in order to provide ideal displacements for magnetic resonance elastography accordingly. Such a modification would allow for sufficient displacements for performing the magnetic resonance elastography.
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Ehman, or in the alternative Ehman and Wu, as applied to claim 1 above and further in view of Wang et al. (US 20120226136 A1), hereinafter Wang.
Regarding claim 19,
Ehman, or ehman, as modified, teaches the elements of claim 1 as previously stated. Ehman fails to explicitly teach wherein measuring T1ρ is measured and used in determining the tissue stiffness.
Wang, in a similar field of endeavor involving nuclear magnetic resonance evaluation teaches wherein T1ρ is measured ([0007] which discloses a method of detecting or monitoring fibrosis in a tissue or organ of a subject using nuclear magnetic resonance imaging comprising generating a spin-lattice relaxation time in the rotating frame (T1ρ) weighted image of the region of interest and measuring T1rho value of the region of interest which compared to other T1ρ values indicates the subject is suffering from tissue or organ fibrosis or indicate the progression or regression of the tissue or organ fibrosis)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Ehman to include measuring T1ρ as taught by Wang in order to provide additional diagnostic information of a patient. Such a modification therefore allows for detection, grading monitoring, and follow-up of fibrosis in a subject using nuclear magnetic resonance imaging (Wang [0002]), thus providing additional uses of the system/method of Ehman which would provide a non-invasive diagnostic test to better manage individuals with progressive fibrosis (Wang [0005]).
It would have been further obvious to a person having ordinary skill in the art before the effective filing date to have modified Ehman, as currently modified, to include using T1p in determining the tissue stiffness in order to perform stiffness determination non a subject experiencing fibrosis. Such a modification would ensure that a patient suffering from fibrosis has their stiffness evaluated and/or a region in which the fibrosis exists is measured for tissue stiffness. In other words, using the T1p in the modified system in determining the stiffness is considered to mean that the T1p is used for identifying fibrosis and subsequently determining stiffness.
Regarding claim 20,
Ehman, as modified, teaches the elements of claim 8 as previously stated.
Wang, as applied to claim 19 above, further teaches wherein the T1ρ is measured by evaluating an NMR signal recovery ([0061] which discloses [0061] In still another embodiment, T1rho maps of pixel-by-pixel are generated by fitting the imaging signal intensity of each pixel obtained at different times of spin lock (TSL) using a mono-exponential decay model as described by the following equation: M(TSL)=M0*exp(-TSL/T1rho))
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE L KLEIN whose telephone number is (571)270-5204. The examiner can normally be reached Mon-Fri 7:30-4.
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/BROOKE LYN KLEIN/Primary Examiner, Art Unit 3797