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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the wearable helmet as set forth in claims 4 and 5 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 claim 1,
Line 1, “the free electron density of a sample” lacks antecedent basis.
Line 6, “a sample containing free electrons” is unclear in that “a sample” is already set forth in line 1 and it is unclear if line 6 intends to set forth an additional different sample or is the same sample as set forth in line 1.
Line 7, “the distribution and state of the free electrons” lacks antecedent basis.
Regarding claim 6,
Line 1-2, “the collected information” lacks antecedent basis.
Regarding claim 8,
Line 6, “the distribution and state of the free electrons” lacks antecedent basis.
Regarding claim 11,
Line 1-2, “the collected information” lacks antecedent basis.
Regarding claim 12,
Line 3, “utilizing coils” is unclear if the claim intends to utilize the coils set forth in claim 8 or other additional coils to perform the treatment.
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.
Claim(s) 1,3,6-9 and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ardenkjaer-Larsen et al.( US 20110270073) hereinafter Ardenkjaer-Larsen et al.
Ardenkjaer-Larsen et al. teaches an electron paramagnetic resonance imaging (EPRI) system includes a resistive magnet driven by a power supply such as a power supply module to generate radio frequency signals in a substantially coherent polyphase perfect sequence scheme. The EPRI system further includes image acquisition and processing electronics configured to generate, acquire, quantify and map pO2 information associated with a free radical agent in vivo and having a resonance line width that is sensitive to oxygen and in response to the radio frequency signals without imparting harmful heating effects to a corresponding human or animal body.
Regarding claims 1 and 8, Ardenkjaer-Larsen et al. teaches at least one array of at least three coils, and
a controller configured to control the at least one array to apply polarizing and gradient magnetic pulses, with pulse durations of less than 10 microseconds per pulse, and an evolution field of less than 15 milliTeslas, are applied to a sample containing free electrons in order to collect information about the distribution and state of the free electrons. [0016] FIG. 1 is a simplified high order system diagram illustrating an electron paramagnetic resonance imaging (EPRI) system 10 that operates to quantify pO2 information associated with a human body according to one embodiment of the invention. EPRI system 10 comprises an EPR pulse modulator and amplifier module 12 having an output coupled to the input of an EPR transmit/receive gate 14, an EPR field gradient controller 16, and an EPR receiver, amplifier and ADC/summer 18. EPRI system 10 further comprises a radio frequency source 20, a programmable timing unit 22, a power amplifier 24, EPR resonators, magnet and gradient coil assembly 26, and a work station for automation and image processing 28. The magnet and gradient coil assembly 26 comprises a primary magnet for generating a static magnetic field and gradient coils for generating gradient magnetic fields. [0017] – [0025] EPRI system 100 is controlled from an operator console 112, which includes a keyboard or other input device 113, a control panel 114, and a display screen 116. [0025] an EPRI scanner comprises a resistive magnet driven via a standard gradient amplifier module. This allows the imaging field to be settable anywhere from 0 T (Tesla) to about 20 mT which defines the highest achievable resonance frequency. For example, 10.7 mT using EPRI corresponds to about 300 MHz, which equates to about 7 T for 1 H (proton) using MRI, while 21.4 mT using EPRI corresponds to about 600 MHz. [0020] An Electron Paramagnetic Imaging system imposes new hardware challenges when compared to its MRI counterpart. One of the major difficulties is the fast switching from the transmit phase to receive phase. While in MRI timing is measured in 10-100 microseconds, in EPRI this would have to be in tens of nanoseconds.
Regarding claims 3 and 9, Ardenkjaer-Larsen et al. teaches wherein at least one of the pulse durations is less than 2 microseconds per pulse. [0020] An Electron Paramagnetic Imaging system imposes new hardware challenges when compared to its MRI counterpart. One of the major difficulties is the fast switching from the transmit phase to receive phase. While in MRI timing is measured in 10-100 microseconds, in EPRI this would have to be in tens of nanoseconds.
Regarding claims 6 and 11, Ardenkjaer-Larsen et al. teaches wherein the controller uses the collected information to form an image. [0009] image acquisition and processing electronics configured to acquire EPR signals coherent with the pulse sequence. [0017] The console 112 communicates through a link 118 with a separate computer system 120 that enables an operator to control the production and display of images on the display screen 116.
Regarding claim 7, Ardenkjaer-Larsen et al. teaches wherein the controller uses the collected information to form an image. [0026] This allows the exact frequency to be chosen depending on the particular application, e.g. whole body, brain, liver, extremity . . . ). It may also provide a degree of freedom during signal acquisition by field switching.
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(s) 2,4 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ardenkjaer-Larsen et al.( US 20110270073) hereinafter Ardenkjaer-Larsen et al. in view of Rosen et al. (US 20160128592) hereinafter Rosen et al.
Regarding claims 2, 4-5 Ardenkjaer-Larsen et al. teaches the claimed invention as set forth above but does not specifically teach wherein the at least one array weighs less than 10 kilograms or wherein the at least one array is wearable as a helmet.
Rosen et al. teaches in the same field of endeavor a low-field imaging system comprising a low-field magnetic resonance (MR) device, at least one electrophysiological device, and at least one controller configured to operate the low-field MR device to obtain MR data and to operate the at least one electrophysiological device to obtain electrophysiological data. [0087] FIGS. 6A-C illustrate brain imaging helmets for low-field MRI configured that can be used in conjunction with other electrophysiological measurements such as EEG to provide an integrated neuroimaging device. The helmets may include a B.sub.0 magnet in a solenoid geometry about the surface of the helmet to produce a B.sub.0 field in an axially direction through the head (i.e., from the top of the head to the bottom or vice versa.) The helmets may further have incorporated therein a gradient system having one or more gradient coils and an Rx/Tx coil array from excitation and detection. Note also paragraphs [0088] – [0091].
It is noted that changes in size, shape, or portability are not sufficient by themselves to distinguish patentability. Note:
In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955) (Claims directed to a lumber package "of appreciable size and weight requiring handling by a lift truck" were held unpatentable over prior art lumber packages which could be lifted by hand because limitations relating to the size of the package were not sufficient to patentably distinguish over the prior art.); In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976) ("mere scaling up of a prior art process capable of being scaled up, if such were the case, would not establish patentability in a claim to an old process so scaled." 531 F.2d at 1053, 189 USPQ at 148.).
In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.
In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.).
In re Lindberg, 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.).
Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to include in the device of Ardenkjaer-Larsen et al. where the coils may be reduced in size and incorporated into a wearable helmet as taught by Rosen et al. to allow for more open and accessible imaging of a patient during low-field imaging.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ardenkjaer-Larsen et al.( US 20110270073) hereinafter Ardenkjaer-Larsen et al. in view of Hashimshony et al. (US 20060264738) hereinafter Hashimshony et al.
Ardenkjaer-Larsen et al. teaches the claimed invention as set forth above including [0002] EPRI is an imaging modality based on the imaging of exogenous electron paramagnetic resonance probes. It is thus a combination of a scanner and a contrast agent. Molecules suitable for use with EPRI to map pO2 have been developed and are well known.
Hashimshony et al. teaches in the same field of endeavor method and apparatus are disclosed, for examining a substance of a given volume to characterize its type, with an integrated sensing head. The method comprises applying locally to the substance of the given volume a polarizing magnetic field, with a component defining a polarizing axis; applying locally RF pulses to the substance of the given volume, the RF pulses having a B component, orthogonal to the polarizing axis, such as to invoke EI response signals corresponding to the electrical impedance (EI) of the examined substance of the given volume, and magnetic resonance (MR) response signals corresponding to the MR properties of the examined substance of the given volume; detecting locally EI response signals from the substance of the given volume; and detecting locally MR response signals from the substance of the given volume. [0013] The MR response of the tissue probed can result from two general types/classes of microscopic spins: electronic and nuclear. Electronic spins are from paramagnetic species/molecules/atoms having a non-zero spin due to their electron configuration. This type of response is known in the literature as Electron Magnetic Resonance (EMR), or Electron Spin Resonance (ESR), or Electron Paramagnetic Resonance (EPR). Nuclear spins are from atoms with a non-zero nuclear magnetic moment. This type of response is known in the literature as Nuclear Magnetic Resonance (NMR). [0016] While the NMR process is preferred, and is particularly referred to in the description below, the invention may also be implemented by detecting other types of MR properties particularly EMR properties, and with other means for detecting MR responses. However, there are some important differences between the NMR and EMR processes, including the following: [0017] EMR probes completely different tissue parameters/states than NMR probes, including metabolism rates, pH, NO concentration, free radicals, reactive oxygen species, and oxygenation state. [0018] 2. EMR is usually preformed in conjugation with contrasting agents. These are spin-trap molecules that stabilize the paramagnetic species. [0019] The polarizing magnetic fields used in EMR are much lower than those used in NMR.
Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to include in the system of Ardenkjaer-Larsen et al. a contrast agent of spin-trap molecules as is well known for EPRI and taught by Hashimshony et al. to stabilize the paramagnetic species.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ardenkjaer-Larsen et al.( US 20110270073) hereinafter Ardenkjaer-Larsen et al. in view of Applicant’s own admission of prior art to S. Jafari et al. (“Opening the Blood Brain Barrier with an Electropermanent Magnet System,” published in Pharmaceutics, vol. 14, no. 7, p. 1503, Jul. 2022, doi: 10.3390/pharmaceutics14071503) hereinafter S. Jafari et al.
Ardenkjaer-Larsen et al. teaches the claimed invention as set forth above but does not specifically teach utilizing coils to open a blood-brain barrier, to impel one or more magnetizable tools, or apply neuromodulation or neuroprotection.
S. Jafari et al. teaches interventions for opening the blood-brain barrier to drugs or genes with pulsed magnetic fields from one or more electropermanent magnetic coils. Opening the blood brain barrier (BBB) under imaging guidance may be useful for the treatment of many brain disorders. Rapidly applied magnetic fields have the potential to generate electric fields in brain tissue that, if properly timed, may enable safe and effective BBB opening. By tuning magnetic pulses generated by a novel electropermanent magnet (EPM) array, we demonstrate the opening of tight junctions in a BBB model culture in vitro, and show that induced monophasic electrical pulses are more effective than biphasic ones. We confirmed, with in vivo contrast-enhanced MRI, that the BBB can be opened with monophasic pulses. As electropermanent magnets have demonstrated efficacy at tuning B0 fields for magnetic resonance imaging studies, our results suggest the possibility of implementing an EPM-based hybrid theragnostic device that could both image the brain and enhance drug transport across the BBB in a single sitting.
Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to include in the system of Ardenkjaer-Larsen et al. to open a blood-brain barrier, to impel one or more magnetizable tools, or apply neuromodulation or neuroprotection as taught by S. Jafari et al. to allow the option of both imaging and treatment in a single setting utilizing the coils.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lin et al.( US 9720059) teaches a coil array in a helmet for parallel magnetic resonance imaging data acquisition, comprising: a plurality of coil elements, wherein each of the coil elements is formed by a loop of wire, wherein the plurality of coil elements are arranged such that the coil elements are covering the imaged sample and uniformly distributed over a plane comprising the encoding directions not in parallel with the frequency encoding directions, which are the directions of the static magnetic field variation generated by a plurality of gradient coils of a magnetic resonance imaging system during magnetic resonance data sampling.
Halpern(US 8664955) teaches an apparatus and a corresponding method useful for electron paramagnetic resonance imaging, in situ and in vivo, using high-isolation transmit/receive (TX/RX) coils, which, in some embodiments, provide microenvironmental images that are representative of particular internal structures in the human body and spatially resolved images of tissue/cell protein signals responding to conditions (such as hypoxia) that show the temporal sequence of certain biological processes, and, in some embodiments, that distinguish malignant tissue from healthy tissue. In some embodiments, the TX/RX coils are in a surface, volume or surface-volume configuration. In some embodiments, the transmit coils are oriented to generate an RF magnetic field in directions substantially orthogonal to a static gradient field, and the receive coils are oriented to sense RF EPR signal in directions substantially orthogonal to the transmitted field and to the static field, to minimize coupling of the transmitted signal to the receive coils.
UTSUMI(WO 2021107112) teaches imaging/analysis method of electron spin information, provided is a method comprising: a step (S01) for acquiring nuclear magnetization information related to the promotion of paramagnetic relaxation; a step (S02) for acquiring nuclear magnetization information related to dynamic nuclear polarization; and a step (S03) for imaging and/or analyzing electron spin information in the sample, on the basis of the nuclear magnetization information related to the promotion of paramagnetic relaxation and the nuclear magnetization information related to dynamic nuclear polarization. FIG. 8 is an ESR spectrum in which the generation of active oxygen in the water treatment process is captured by the spin trap method.
TIMMINS(WO 2005117698) teaches methods and apparatus use electron paramagnetic resonance spectroscopy to provide a signal from melanin to image a melanoma. Embodiments of methods and apparatus use electron paramagnetic resonance spectroscopy to provide a signal from melanin to detect metastatic melanoma in a sentinel lymph node. Embodiments of methods and apparatus use electron paramagnetic resonance spectroscopy to provide a signal from melanin to measure light penetration in melanocytes in skin.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN L CASLER whose telephone number is (571)272-4956. The examiner can normally be reached M-Th 6:30 to 4:30.
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/BRIAN L CASLER/Primary Examiner, Art Unit 3791
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