Detailed Action
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function.
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
The following claim limitations, found in claim 1 invoke 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph): “A radio frequency matching liquid configured to…” , “a radio frequency absorbing material configured to…”. Accordingly, such claims have been interpreted to cover the corresponding structure described in the specification that achieves the claimed function, and equivalents thereof.
Claim limitation “A radio frequency matching liquid configured to …” of claim 1 has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “module” coupled with functional language “configured to …. Furthermore, the generic placeholder is not preceded by a structural modifier of the type that one of ordinary skill in the art at the time of the invention would understand to denote a type of structural device with a generally understood meaning.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Akazzim et al. (Akazzim), Multi-Element UWB Probe Optimization for Medical Microwave Imaging in view of Kurs et al., (Kurs), US PGPUB 20240298914 A1, effective filing date of March 9, 2023 (see also Kurs et al., US Patent No. 12736481)
Regarding claim 1, Akazzim discloses the invention substantially as claimed. Akazzim discloses a portable medical imaging device (see Akazzim, see Introduction, a compact or portable microwave-imaging system for medical applications and a multi-element UWB probe evaluated for brain imaging), comprising: a housing defining an interior cavity sized (see Akazzim, abstract, Akazzim teaches a brain phantom or object positioned within a cylindrical or enclosed imaging region, with antennas arranged around the imaging region).
Even though Akazzim does providing some teachings of a housing defining an interior cavity sized to receive a patient (see Akazzim, abstract); a radio frequency matching liquid configured to be positioned between the radio frequency absorbing material and the patient's head received within the interior cavity of the housing (see Akazzim, page 5, section 3); a radio frequency array comprising a plurality of ultra-wide band (UWB) transceivers distributed in the radio frequency absorbing material configured to direct radio frequency signals towards the patient's head and to detect the radio frequency signals emitted by other transceivers of the plurality of UWB transceivers; multiple UWB EGRH antennas arranged around a brain-mimicking phantom, with antennas alternately transmitting and receiving and measurements taken between antenna port and antenna measurements whereas one antenna transmitting and others receiving signals propagated through a brain-like phantom (abstract and introduction, pages 1 and 2). However, Akazzim does not explicitly describe the details of a housing defining an interior cavity sized to receive a head of a patient; a radio frequency absorbing material positioned in the interior cavity of the housing; a radio frequency array comprising a plurality of ultra-wide band (UWB) transceivers distributed in the radio frequency absorbing material configured to direct radio frequency signals towards the patient's head and to detect the radio frequency signals emitted by other transceivers of the plurality of UWB transceivers; and at least one controller configured to receive and process information about the radio frequency signals detected by the plurality of UWB transceivers for generation of medical images of the patient's head.
But in the same field of endeavor Kurs discloses a housing defining an interior cavity sized to receive a head of a patient (see Kurs, Fig. 18, para. 0126, Kurs teaches Referring to FIG. 18, an example dielectric tomography sensor 1806 configured for use on a human head 1802 is shown. The sensor 1806 is configured to accept at least a portion of a human head 1802 and obtain RF measurements based on one or more antennas 1810. A portion of the head 1802 may be held in place by a deformable membrane 1808 containing a coupling medium 1804 within the sensor 1806. In an example, such as described in FIG. 11, the coupling medium 1804 may be pumped in to or out from the area inside the deformable membrane so that the volume and/or compartment is a snug fit to the portion of the head (1802) (the fluid control module not shown in FIG. 18). In an example, the portion of the head 1802 may move through the sensor 1806, or the sensor may move while the head remains static. In an example, the sensor 1806 may be configured to detect changes in permittivity and conductivity of brain tissue that are associated with Alzheimer's disease. Detecting distinctions in the dielectric properties of grey and white brain matter based on RF signals between 10 MHz and 10 GHz may be used as a diagnostic method for detecting Alzheimer's disease. For example, at 2.4 GHz, the relative permittivity is 48.93 for grey matter in a healthy brain and 43.48 in a brain infected by Alzheimer's disease. Other frequencies and permittivity correlations may also be used to detect Alzheimer's by the dielectric tomography sensor 1806.); a radio frequency absorbing material positioned in the interior cavity of the housing (see Kurs, paras. 0055, 0061 and 0089-0092, 0097 and 0130, Kurs teaches states that antennas may be backed with an electromagnetic absorbing material or surface, It further teaches RF-absorbing layers and structures in the sensor walls, including resistive sheets, laminates, RAM …); a radio frequency matching liquid configured to be positioned between the radio frequency absorbing material and the patient's head received within the interior cavity of the housing (see Kurs, paras. 0004, 0035, 0093-0095, 0101-0107); a radio frequency array comprising a plurality of ultra-wide band (UWB) transceivers distributed in the radio frequency absorbing material configured to direct radio frequency signals towards the patient's head (see Kurs, 0050-0052 and 0126) and to detect the radio frequency signals emitted by other transceivers of the plurality of UWB transceivers (see Kurs, paras. 0035, 0059, 0061, 0067-0069, 0085-0088, 0089-0092, 0097, and 0167-0175, Kurs teaches transmit/receive antennas, scattered signals, phase and magnitude measurements, scattering matrices, and receiving signals transmitted or scattered by the object); and at least one controller configured to receive and process information about the radio frequency signals detected by the plurality of UWB transceivers for generation of medical images of the patient's head (see Kurs, para. 0007, 0033-0038, 0041, 0126 and 0155, 0166 and 0171, Kurs teaches a head sensor for detecting brain-tissue differences and further teaches reconstruction from radio frequency measurements).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have implemented Akazzim’s multi-element UWB microwave imaging system with Kur’s dielectric-tomography sensor architecture, to improve antenna-to-tissue coupling, to reduce reflections and external interference as well as to improve measurement and calibration of the antenna and system errors..
Regarding claim 2, Akazzim-Kurs discloses The portable medical imaging device of claim 1, wherein the housing comprises a helmet configured to be used for at least one of the following diagnostic purposes (see Kurs, para. 0126): Alzheimer's screening, amyloid rated imaging abnormalities (ARIA) monitoring, evaluation of traumatic brain injury (TBI), tumor screening, detection of stroke, detection of migraines, or detection of concussions, the helmet comprising a front clam-shell portion configured to cover at least a forehead and crown of the head and a rear clam-shell portion pivotally connected to the front clam-shell portion configured to cover an occipital portion of the head (see Kurs, para. 0126).
Regarding claim 3, Akazzim-Kurs discloses The portable medical imaging device of claim 2, wherein the helmet comprises a window configured to allow the patient to see objects and/or people outside of the helmet, the window comprising an opening in a shell of the helmet covered by a transparent or translucent pane comprising a material configured to block the radio frequency signals from the plurality of UWB transceivers (see Kurs, page 1, section 1).
Regarding claim 4, Akazzim-Kurs discloses The portable medical imaging device of claim 1, wherein the imaging device is configured to be carried by a single staff member of a medical facility (see Kurs, 0180).
Regarding claim 5, Akazzim-Kurs discloses The portable medical imaging device of claim 1, wherein the radio frequency absorbing material comprises doped rubber supporting the plurality of UWB transceivers, and the matching liquid comprises a liquid material having a permittivity configured to match brain permittivity and positioned to avoid air gaps between the plurality of UWB transceivers and the patient (see Kurs, para. 0093).
Regarding claim 6, Akazzim-Kurs discloses The portable medical imaging device of claim 1, further comprising a compressible celled support comprising a plurality of cells containing the matching liquid and a liquid reservoir in fluid communication with the plurality of cells configured so that matching liquid passes between the plurality of cells and the reservoir to accommodate heads of different sizes (see Kurs, paras. 0094., 0101).
Regarding claim 7, Akazzim-Kurs discloses The portable medical imaging device of claim 1, wherein the radio frequency array comprises at least 300 UWB transceivers, and wherein the plurality of UWB transceivers operate at a frequency of about 3 GHz to about 8 GHz (see Kurs, para. 0001, 0050).
Regarding claim 8, Akazzim-Kurs discloses The portable medical imaging device of claim 1, wherein the received and processed information comprises information representative of times-of-flight between pairs of the plurality of UWB transceivers, which are representative of materials through which propagation of the radio frequency signals has occurred (see Kurs, para 0038).
Regarding claim 9, Akazzim-Kurs discloses The portable medical imaging device of claim 1, wherein the at least one controller is configured to generate the medical images by applying a transfer function to the received and processed information about the radio frequency signals detected by the plurality of UWB transceivers, the transfer function comprising a function determined by modeling images established for all possible image cases detectable by the radio frequency array (see Kurs, 0007, 0048).
Regarding claim 10, Akazzim-Kurs discloses The portable medical imaging device of claim 1, wherein the at least one controller is configured to auto-calibrate in order to remove effects within electronics and up to a skull of the patient from detected measurements made by the device, and wherein auto-calibration is based on measurements for one or more propagation paths between pairs of the plurality of USB transceivers that occur irrespective of a presence of the patient's head in the interior of the housing (see Kurs, 0004-0008, 0035-0036).
Regarding 11, Akazzim-Kurs discloses The portable medical imaging device of claim 1, wherein the at least one controller is further configured to apply a filter process to the received and processed information and generate reconstructed medical images based on the filtered information in which areas meeting particular criteria are highlighted or otherwise identified (see Kurs, paras. 0007, 0034), and wherein the filtering process by the at least one controller comprises analyzing the generated medical image based on previously obtained MRI/CT to RF comparison data in order to identify areas in the generated medical image corresponding to physician segmented areas identified in a prior MRI/CT dataset (see Akazzim, page 1, section 1).
Regarding claim 12, Akazzim-Kurs discloses The portable medical imaging device of claim 1, further comprising at least one location beacon configured to transmit radio frequency signals indicating a location of the device, the at least one location beacon comprising: at least one cellular transmitter for transmission of wireless signals via a cellular network (see Kurs, para. 0042) and at least one ultra-wide band (UWB) transmitter for transmission of radio signals over a short-range network (see Kurs, para. 0042).
Regarding claim 13, Akazzim-Kurs discloses The portable medical imaging device of claim 12, further comprising a battery, wherein the at least one controller is configured to apportion battery power from the battery by radio type providing about 90% for the at least one cellular transmitter and less than about 10% to the at least one UWB transmitter (This feature is very well known in the art).
Regarding claim 14, Akazzim-Kurs discloses The portable medical imaging device of claim 12, further comprising at least one environmental sensor disposed on the housing configured to detect acceleration and temperature information for the device, and wherein the at least one controller is configured to modify power usage of the at least one cellular transmitter and/or the at least one UWB transmitter based on the detected acceleration and temperature information (see rejection of claim 12, above).
Regarding claim 15, The portable medical imaging device of claim 1, further comprising a wireless data transceiver configured to wirelessly transmit received and processed information collected by the device to a remote computing device and/or computer network (see Kurs, para. 0164).
Regarding claim 16, Akazzim-Kurs discloses A portable medical imaging device, comprising: a blanket comprising an outwardly facing surface and an inwardly facing surface configured to be positioned proximate to a patient; a radio frequency absorbing material positioned in the blanket between the inwardly facing surface and the outwardly facing surface of the blanket; a radio frequency matching liquid configured to be positioned between the radio frequency absorbing material and the patient, while the patient is covered by the blanket; a radio frequency array comprising a plurality of ultra-wide band (UWB) transceivers distributed in the radio frequency absorbing material configured to direct radio frequency signals to the patient and to detect the radio frequency signals emitted by other transceivers of the plurality of UWB transceivers; and at least one controller configured to receive and process information about signals detected by the plurality of UWB transceivers to generate medical images (see rejection of claim 1, above).
Regarding claim 17, Akazzim-Kurs discloses A tracking and data collection system for medical imaging, the system comprising: a plurality of the portable medical imaging devices of claim 1; and a computer server configured to receive and process signals communicated from the plurality of imaging devices, determine a location for one or more of the plurality of portable medical imaging device based on the received and processed signals, generate medical images based on the received and processed signals, and store the generated medical images in electronic medical records associated with one or more of a plurality of patients (see Kurs, para. 0036. Also, this limitation is extremely well known in the art).
Regarding claim 18, Akazzim-Kurs discloses A method of treatment for a patient suspected of having and/or diagnosed with Alzheimer's disease, comprising: capturing at least one medical image of the patient using the portable medical imaging device of claim 1; analyzing the captured at least one medical image to determine a characteristic of Alzheimer's tissue visible in the captured at least one medical image; and providing at least one medication at a dosage determined based, at least in part, on the analysis of the captured at least one medical image (see Kurs, para. 0164).
Regarding claim 19, Akazzim-Kurs discloses The method of claim 19, wherein analysis of the captured at least one medical image identifies Amyloid-Related Imaging Abnormalities (ARIA) in the captured at least one medical image and wherein providing the at least one medication comprises administering a drug targeting amyloid beta plaques to the patient (see Kurs, para.0033).
Regarding claim 20, Akazzim-Kurs discloses A method of triage for a patient who has suffered and/or is suffering a stroke, comprising: capturing at least one medical image of a head of the patient using the portable medical imaging device of claim 1; analyzing the captured at least one medical image to distinguish between areas of the at least one captured medical image evidencing an ischemic stroke and a hemorrhagic stroke; and treating the patient for either the identified ischemic stroke or the identified hemorrhagic stroke (see Akazzim, page 1, section 1, Introduction).
Conclusion
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/WILLIAM C VAUGHN JR/Supervisory Patent Examiner, Art Unit 2481
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