DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This Office Action is in response to Applicant’s Amendment/Remarks filed 09/11/2024. Claims 1, 7, and 15 have been amended. Claim 18 has been canceled. No claims have been added. Claims 1-17 and 19-22 are pending.
Response to Arguments
Applicant’s arguments, see pgs. 5-6, filed 10/29/2025, with respect to the rejections of claims 1-14 under 35 USC 103 as being unpatentable over U.S. Patent Publication 2016/0278653 (Clark) and U.S. Patent Publication 2008/0252293 (Lagae) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Kelleher et al. (US 2014/0163385)(“Kelleher”)
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kelleher et al. (US 2014/0163385) hereinafter known as Kelleher, and further in view of Libove et al. (US 10,660,531).
With regards to claim 1, Kelleher discloses a portable cranial anatomy injury evaluation systems, apparatus, and methods (Abstract) utilizing computer-implemented process for medical sensing ([0008]; FIG. 5A-5H; cranial anatomy evaluation processing algorithms), the process including the steps of:
accessing scattering data representing successive sets of measurements of electromagnetic wave scattering by internal features of a body part of a living subject ([0021][0036]; “…the received data may be correlated with stored data representing tissue or anatomy in various states to determine prognosis or status of tissue or anatomy at or near the receiving devices 33A, 32B, 32C, 32E…”) ([0040]; “Analysis of received scattered low energy microwave signals at antennas 32E may enable identification of the stroke type (ischemic or hemorrhagic) and severity.”), each said measurement representing scattering of electromagnetic waves ([0013]; received/reflected optical signals)[0039][0040] emitted by a corresponding antenna of an array of antennas disposed about the body part as measured by a corresponding antenna of the array of antennas at a corresponding time [0040], wherein the successive sets of measurements are temporally spaced apart ([0040][0027]; 4A-4B).
Kelleher teaches “Transmitted and received/reflected optical signals may be communicated with/within the patient's cranium 22. The received/reflected optical signals may be evaluated using digital signal processing (DSP) techniques including evaluating the frequency content of the received signals via frequency transforms including Fast Fourier Transforms (FFT).” [0013]. Also, the reference teaches that the antenna 32E enables radiation on a patient's 22 ophthalmic artery and internal carotid artery and a controller 54 utilizes DSP to determine FFT to evaluate the frequency content of the received antenna signal. The transformed signals may be used to determine pulsatility index [0020]. Finally, Kelleher teaches of a method that teaches of processing received response signals using various signal processing algorithms including FFTs to determine a patient's cranium anatomy status [0030]. Also, [0019] teaches “The electrical antennas 32E may generate and receive various frequency electrical energy and signal processing may be performed to evaluate the received signal(s).
Kelleher do not specifically disclose;
processing each of the measurements to generate corresponding spectral data representing intensities measured by the corresponding antenna at the corresponding time as a function of frequency; and
processing the spectral data of each antenna for successive times to generate corresponding pulsatility data representing successive blood pulsations within a corresponding spatially localized region within the body part.
In the same field of endeavor, Libove discloses functional and structural medical imaging based on the transmission and reflection of short radio-frequency pulses (Abstract). Libove teaches of pulse-based or square wave edge-based microwave imaging using either time domain reflectivity (TDR) techniques or time domain transmission (TDT) techniques, Further, the TDR technique utilizes signals from a transmit antenna to penetrate the body and the signals are reflected off of various internal tissue boundaries and the signals are reflected back to the same antenna or nearby antennae. For the TDT technique, a transmitter and antenna launch pulses into one side of the volume of interest and a group of antennae and receivers on the surface detects the signals that have traversed the body (col. 1; lines 46-59). Also, the reference teaches of pulser/sampler/antenna (PAS) assembly 100 that is capable of both TDR and TDT (col. 8; lines 8-13). The reference further teaches that using TDR and/or TDT data from a large number of sequential pulses, and performing Fourier transform on said data, the data is utilized to obtain the frequency spectral content data from a wavefront that propagates through body tissue. A change in spectrum over time is monitored for the functional changes. The obtained data is used to determine the level of functional activity in said body tissue (col. 12-13; lines 54-4). The reference further teaches of utilizing a first PAS to measure the pulsatility at a first location and a second PAS for measuring pulsatility along a second location along an artery where blood is traveling (col. 18; lines 34-65). Finally, the reference teaches of digital signal processor (DSP), or other conventional hardware signal processing apparatus that can be used to process multiple successive pulses that are transformed to digitized signals and the processed signals are used to enhance the signal-to-noise ratio (col. 6-7; lines 57-21).
In view of Libove, it would have been obvious to one of ordinary skill within the art before the effective filing date of the claimed invention to modify the evaluation system, of Kelleher, to utilize a signal processor or computer to obtain and process electromagnetic signals, such as microwave signals, that has traversed the body region and received by the antenna/antennae. The obtained signals are then transformed into FFT frequency spectral data and used to observe and measure the functional changes within body tissue and/or body region. The motivation is to measure pulsatility of a body region for diagnostic purposes and/or develop a pulsatility index.
With regards to claim 2, Kelleher, in view of Libove, discloses the process of claim 1, wherein the temporal spacing between successive measurements of each antenna is about 0.03 seconds or less. (Libove; col. 9; lines 40-51 “…the sampler 120 is driven by clock 130 at a frequency slightly lower than that of the pulser 110. Heterodyning enables very fast signals to be observed, using a sequence of samples, and reconstituted at a lower frequency for convenient measurement using a low-cost slow ADC….this heterodyned output effectively portrays the 10 ns interval between the 100 MHz pulses as a 50 microsecond period…”)
With regards to claim 3, Kelleher, in view of Libove, discloses the process of claim 1, wherein the body part is the subject’s head (Kelleher; [0010]; “The system …. may include devices 32A, 33A, 32B, 32C, 32E that are to be placed around the upper cranium 24 of a patient's head 22…”), and the pulsatility data represents blood pulsations within a corresponding spatially localized region within the subject’s brain. (Kelleher; [0020])(Libove; col. 4-5; lines 59-2)
With regards to claim 4, Kelleher, in view of Libove, discloses the process of claim 3, including processing the pulsatility data of each antenna to diagnose a brain condition of the subject. (Libove; col. 4-5; lines 59-2) (Kelleher; [0018][0020][0022])
With regards to claim 5, Kelleher, in view of Libove, discloses the process of claim 4, wherein the brain condition is a brain condition selected from: haemorrhagic stroke, ischemic stroke and traumatic brain injury (Kelleher; [0034]; “…the patient has suffered a traumatic event to their cranium and experienced or is experiencing a stroke including a hemorrhagic or ischemic stroke,…”).
With regards to claim 6, Kelleher, in view of Libove, discloses the process of claim 1, wherein said processing includes processing time domain signals representing the measurements of electromagnetic wave scattering to select a portion of each time domain signal corresponding to scattering within the body part, and processing the selected portions of the time domain signals to generate the spectral data. (Libove; col. 1; lines 46-59 in view of the rejection of claim 1)
With regards to claim 7, Kelleher, in view of Libove, discloses an apparatus for medical sensing, the apparatus (Kelleher; Abstract) including at least one processor (Kelleher; [0053][0055]) configured to execute the process of claim 1.
With regards to claim 8, Kelleher, in view of Libove, discloses a computer-readable storage medium having stored thereon executable instructions that, when executed by at least one processor of a data processing apparatus, cause the apparatus to execute the process of claim 1. (Kelleher; [0051])
With regards to claim 9, Kelleher, in view of Libov, discloses portable cranial anatomy injury evaluation systems and apparatus, including:
an acquisition component [0010] configured to access scattering data representing successive sets of measurements of electromagnetic wave scattering by internal features of a body part of a living subject (see the rejection of claim 1), each said measurement representing scattering of electromagnetic waves emitted by a corresponding antenna of an array of antennas disposed about the body part as measured by a corresponding antenna of the array of antennas at a corresponding time, wherein the successive sets of measurements are temporally spaced apart (see the rejection of claim 1);
a spectral generation component (Kelleher; [0020]; “It is noted that an antenna 32E may generate signals having various frequency content including signals with radio frequency content.”; [0028][0029]; a signal generator that generates pulses 272, 274 having different frequency spectrums ) configured to process each of the measurements to generate corresponding spectral data representing intensities measured by the corresponding antenna at the corresponding time as a function of frequency (Kelleher; [0029] “The frequency separation between the respective pulses may enable simultaneous energization of a first, second, and third PGD 32A, 32B, 33, 332, transducer 32B, or antenna 32E module and subsequent and independent spectrum generation.”)(see the rejection of claim 1); and
a pulsatility generation component (Libov; col. 17; lines 40-52; PAS 100) configured to process the spectral data of each antenna for successive times to generate corresponding pulsatility data representing successive blood pulsations within a corresponding spatially localized region within the body part (see the rejection of claim 1).
With regards to claim 10, Kelleher, in view of Libove, discloses the apparatus of claim 9, wherein the temporal spacing between successive measurements of each antenna is about 0.03 seconds or less. (Libove; col. 9; lines 40-51 “…the sampler 120 is driven by clock 130 at a frequency slightly lower than that of the pulser 110. Heterodyning enables very fast signals to be observed, using a sequence of samples, and reconstituted at a lower frequency for convenient measurement using a low-cost slow ADC….this heterodyned output effectively portrays the 10 ns interval between the 100 MHz pulses as a 50 microsecond period…”)
With regards to claim 11, Kelleher, in view of Libove, discloses the apparatus of claim 9, wherein the body part is the subject’s head (Kelleher; [0010]; “The system …. may include devices 32A, 33A, 32B, 32C, 32E that are to be placed around the upper cranium 24 of a patient's head 22…”), and the pulsatility data represents blood pulsations within a corresponding spatially localized region within the subject’s brain. (Kelleher; [0020])(Libove; col. 4-5; lines 59-2)
With regards to claim 12, Kelleher, in view of Libove, discloses the apparatus of claim 11, including a diagnosis component (Kelleher; [0020] controller 54) configured to process the pulsatility data of each antenna to diagnose a brain condition of the subject. (Libove; col. 4-5; lines 59-2) (Kelleher; [0020][0022])
With regards to claim 13, Kelleher, in view of Libove, discloses the apparatus of claim 12, wherein the brain condition is a brain condition selected from: haemorrhagic stroke, ischemic stroke and traumatic brain injury (Kelleher; [0034]; “…the patient has suffered a traumatic event to their cranium and experienced or is experiencing a stroke including a hemorrhagic or ischemic stroke,…”).
With regards to claim 14, Kelleher, in view of Libove, discloses the apparatus of claim 11, wherein the spectral generation component (see the rejection of claim 9) is configured to process time domain signals representing the measurements of electromagnetic wave scattering to select a portion of each time domain signal corresponding to scattering within the body part, and processing the selected portions of the time domain signals to generate the spectral data. (Libove; col. 1; lines 46-59 in view of the rejection of claim 1)
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Tran (US 2007/0276270)
Schwartz (US 2014/0288412)
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 HUGH H MAUPIN whose telephone number is (571)270-1495. The examiner can normally be reached M-F 7:30 - 5:00 pm.
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/HUGH MAUPIN/ Primary Examiner, Art Unit 2884