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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
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Claims 1-2, 4-6, 9-20 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,426,429. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘429 anticipates:
1. A method for producing orthopedic data using acoustic waveforms, comprising: transmitting acoustic signals from an array of acoustic transducer elements of an acoustic probe device toward a target volume of an orthopedic structure of a body part of a biological subject to which the acoustic probe device is in contact, wherein the acoustic probe device includes an acoustic coupling medium coupled to the array of acoustic transducer elements and is operable to conduct the acoustic signals between the acoustic transducer elements and the body part of the biological subject when in contact with the acoustic coupling medium; receiving acoustic echoes that return from at least part of the target volume at one or more of the acoustic transducer elements, wherein the received acoustic echoes include at least some waveform components corresponding to the transmitted acoustic signals; determining coordinate positions of the acoustic transducer elements of the acoustic probe device during the transmitting of the acoustic signals and the receiving of the acoustic echoes; processing the received acoustic echoes with the determined coordinate positions of the acoustic transducer elements to produce spatial information corresponding to returned acoustic echoes from the orthopedic structure, wherein the spatial information includes position data of the orthopedic structure and vector data of the orthopedic structure's movement derived from the determined coordinate positions of the acoustic transducer elements (claim 1, 19, 3D coordinate points is spatial information).
2. The method of claim 1, wherein the processing the received acoustic echoes comprises: determining (i) motion of the orthopedic structure of the body and (ii) a location or an orientation, or both, of the orthopedic structure in a six degrees of freedom (6DoF) coordinate space based on the position data of the orthopedic structure and vector data of the orthopedic structure's movement by quantitatively comparing to sample patterns using positional data of the acoustic transducer elements during the transmitting the acoustic signals and the receiving the acoustic echoes (claim 1).
4. The method of claim 1, wherein the determining the coordinate positions of the acoustic transducer elements includes determining location of the transducer elements relative to a fixed point in three dimensional space (claim 3).
5. The method of claim 1, wherein the transmitting the acoustic signals includes transmitting sequentially one-at-a-time, simultaneously, or in a time-staggered or time-delayed pattern (claim 15).
6. The method of claim 1, wherein the processing the received acoustic echoes comprises: amplifying, filtering, and digitally sampling the acoustic echoes corresponding to the spatial information from the soft tissue and the bone of the orthopedic structure; and storing the spatial information as data (claim 1, 6).
9. The method of claim 1, further comprising: providing the position data of the orthopedic structure and vector data of the orthopedic structure's movement in a data set to a surgical system operable to perform an operation or procedure on the orthopedic structure based on information contained in the data set (claim 2).
10. The method of claim 9, wherein the data set is provided by transferring the data set to the surgical system in real time during the operation or procedure (claim 2).
11. The method of claim 1, wherein the acoustic coupling medium of the acoustic probe device includes a hydrogel including one or more polymerizable materials that form a network structured to entrap an aqueous fluid inside the hydrogel, wherein the hydrogel is structured to conform to an outer surface of the body part and the acoustic transducer elements (claim 4, 5).
12. The method of claim 1, wherein, when the acoustic coupling medium is in contact with the outer surface of the body part, the acoustic coupling medium provides an acoustic impedance matching between the body part and the acoustic signal transducer elements (claim 4 and 5).
13. The method of claim 1, comprising: generating waveforms to be transduced and transmitted as the acoustic signals from the array of acoustic transducer elements of the acoustic probe device (claim 1, 6).
14. The method of claim 13, wherein the generated waveforms comprise arbitrary waveforms, wherein the arbitrary waveforms include an arbitrary waveform describable mathematically (claims 8-10).
15. The method of claim 14, wherein the arbitrary waveforms include one or more of rectangular pulses, triangular pulses, impulse pulses, Gaussian pulses, sinusoidal pulses, sinc pulses, Mexican hat wavelet pulses, Haar wavelet pulses, linear FM chirped pulses, hyperbolic FM chirped pulses, coded pulses, binary coded pulses, ternary coded pulses, phase coded pulses, complementary binary coded pulses, amplitude coded pulses, phase and amplitude coded pulses, frequency coded pulses, stepped sine wave pulses, shaped spectrum pulses, or combinations thereof (claim 9).
16. The method of claim 14, wherein the generating the waveforms includes beamforming and steering the arbitrary waveforms (claim 10).
17. The method of claim 13, wherein the generated waveforms include a composite waveform comprising two or more of individual orthogonal coded waveforms corresponding to one or more frequency bands that are generated by the one or more waveform synthesizers according to the waveform information, wherein the individual orthogonal coded waveforms are mutually orthogonal to each other and correspond to different frequency bands, such that each of the individual orthogonal coded waveforms includes a unique frequency with a corresponding phase (claims 11-13).
18. The method of claim 17, wherein each of the individual orthogonal coded waveforms includes a plurality of amplitudes and a plurality of phases that are individually amplitude weighted and individually phase weighted, respectively (claim 12).
19. The method of claim 17, wherein the generating the composite waveform includes determining one or more of a frequency band, an amplitude, a time-bandwidth product parameter, or a phase parameter of each individual orthogonal coded waveform (claim 13).
20. The method of claim 19, wherein the phase parameter is determined from a set of a pseudo-random numbers or from a set of deterministic numbers (claim 14).
Claims 3, 7, 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,737,726 in view of Sela et al. (US 2005/0154302, hereinafter Sela ‘302).
In re claim 3, ‘726 fails to teach:
Claim 3. The method of claim 1, comprising: determining a topography of the bone of the orthopedic structure in the six degrees of freedom (6DoF) coordinate space based on the spatial information from the orthopedic structure.
Claim 7. The method of claim 1, wherein the processing the received acoustic echoes comprises: determining an echo signature including a unique specular pattern data associated with the acoustic echoes returned from a tissue-bone interface of the orthopedic structure.
Claim 8. The method of claim 7, wherein the unique specular pattern data includes cross-sectional patterns over a length of the bone for sampled spatial information.
Sela ‘302 teaches Claim 3. determining a topography of the bone of the orthopedic structure in the six degrees of freedom (6DoF) coordinate space based on the spatial information from the orthopedic structure. (0023-0025, 0079, 0080, 0082-0087, 0089-0091, 0114, 0116); Claim 7. The method of claim 1, wherein the processing the received acoustic echoes comprises: determining an echo signature including a unique specular pattern data associated with the acoustic echoes returned from a tissue-bone interface of the orthopedic structure (0062, 0067, 0069, 0071-0074); Claim 8. The method of claim 7, wherein the unique specular pattern data includes cross-sectional patterns over a length of the bone for sampled spatial information (fig. 5s, 0018, 0074, a 3D reflection and image can be used to make any cross-sectional (2D image) pattern as well).
It would have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of ‘726 to include the features of Sela ‘302 in order to generate a map of the irregularities in the surface of the hard tissue.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,737,726 in view of Kruse et al. (US 2017/0100092, which then became Patent 10,426,429, hereinafter ‘092).
‘726 anticipates:
1. A method for producing orthopedic data using acoustic waveforms, comprising: transmitting acoustic signals from an array of acoustic transducer elements of an acoustic probe device toward a target volume of an orthopedic structure of a body part of a biological subject to which the acoustic probe device is in contact, information includes position data of the orthopedic structure and vector data of the orthopedic structure's movement derived from the determined coordinate positions of the acoustic transducer elements (claim 1).
Even if it were not obvious, ‘092 teaches wherein the acoustic probe device includes an acoustic coupling medium coupled to the array of acoustic transducer elements and is operable to conduct the acoustic signals between the acoustic transducer elements and the body part of the biological subject when in contact with the acoustic coupling medium (0184).
It would have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of ‘726 to include the features of ‘092 in order to provide optimal ultrasound transmission.
2. The method of claim 1, wherein the processing the received acoustic echoes comprises: determining (i) motion of the orthopedic structure of the body and (ii) a location or an orientation, or both, of the orthopedic structure in a six degrees of freedom (6DoF) coordinate space based on the position data of the orthopedic structure and vector data of the orthopedic structure's movement by quantitatively comparing to sample patterns using positional data of the acoustic transducer elements during the transmitting the acoustic signals and the receiving the acoustic echoes (claim 11).
3. The method of claim 1, comprising: determining a topography of the bone of the orthopedic structure in the six degrees of freedom (6DoF) coordinate space based on the spatial information from the orthopedic structure (claim 2).
4. The method of claim 1, wherein the determining the coordinate positions of the acoustic transducer elements includes determining location of the transducer elements relative to a fixed point in three dimensional space (claim 3).
5. The method of claim 1, wherein the transmitting the acoustic signals includes transmitting sequentially one-at-a-time, simultaneously, or in a time-staggered or time-delayed pattern (claim 4).
6. The method of claim 1, wherein the processing the received acoustic echoes comprises: amplifying, filtering, and digitally sampling the acoustic echoes corresponding to the spatial information from the soft tissue and the bone of the orthopedic structure; and storing the spatial information as data (claim 5).
7. The method of claim 1, wherein the processing the received acoustic echoes comprises: determining an echo signature including a unique specular pattern data associated with the acoustic echoes returned from a tissue-bone interface of the orthopedic structure (claim 6).
8. The method of claim 7, wherein the unique specular pattern data includes cross-sectional patterns over a length of the bone for sampled spatial information (claim 7).
9. The method of claim 1, further comprising: providing the position data of the orthopedic structure and vector data of the orthopedic structure's movement in a data set to a surgical system operable to perform an operation or procedure on the orthopedic structure based on information contained in the data set (claim 9).
10. The method of claim 9, wherein the data set is provided by transferring the data set to the surgical system in real time during the operation or procedure (claim 10).
13. The method of claim 1, comprising: generating waveforms to be transduced and transmitted as the acoustic signals from the array of acoustic transducer elements of the acoustic probe device (claim 1 or 12).
Furthermore, ‘092 teaches:
11. The method of claim 1, wherein the acoustic coupling medium of the acoustic probe device includes a hydrogel including one or more polymerizable materials that form a network structured to entrap an aqueous fluid inside the hydrogel, wherein the hydrogel is structured to conform to an outer surface of the body part and the acoustic transducer elements (0161).
12. The method of claim 1, wherein, when the acoustic coupling medium is in contact with the outer surface of the body part, the acoustic coupling medium provides an acoustic impedance matching between the body part and the acoustic signal transducer elements (0161).
13. The method of claim 1, comprising: generating waveforms to be transduced and transmitted as the acoustic signals from the array of acoustic transducer elements of the acoustic probe device (0184).
14. The method of claim 13, wherein the generated waveforms comprise arbitrary waveforms, wherein the arbitrary waveforms include an arbitrary waveform describable mathematically (0165).
15. The method of claim 14, wherein the arbitrary waveforms include one or more of rectangular pulses, triangular pulses, impulse pulses, Gaussian pulses, sinusoidal pulses, sinc pulses, Mexican hat wavelet pulses, Haar wavelet pulses, linear FM chirped pulses, hyperbolic FM chirped pulses, coded pulses, binary coded pulses, ternary coded pulses, phase coded pulses, complementary binary coded pulses, amplitude coded pulses, phase and amplitude coded pulses, frequency coded pulses, stepped sine wave pulses, shaped spectrum pulses, or combinations thereof (0166).
16. The method of claim 14, wherein the generating the waveforms includes beamforming and steering the arbitrary waveforms (0167).
17. The method of claim 13, wherein the generated waveforms include a composite waveform comprising two or more of individual orthogonal coded waveforms corresponding to one or more frequency bands that are generated by the one or more waveform synthesizers according to the waveform information, wherein the individual orthogonal coded waveforms are mutually orthogonal to each other and correspond to different frequency bands, such that each of the individual orthogonal coded waveforms includes a unique frequency with a corresponding phase (0168).
18. The method of claim 17, wherein each of the individual orthogonal coded waveforms includes a plurality of amplitudes and a plurality of phases that are individually amplitude weighted and individually phase weighted, respectively (0169).
19. The method of claim 17, wherein the generating the composite waveform includes determining one or more of a frequency band, an amplitude, a time-bandwidth product parameter, or a phase parameter of each individual orthogonal coded waveform (0170).
20. The method of claim 19, wherein the phase parameter is determined from a set of a pseudo-random numbers or from a set of deterministic numbers (0171).
It would have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of ‘726 to include the features of ‘092 in order to use conventional ultrasound method to assist standard ultrasound scans and to utilize various available method to better the diagnose when facing different patients.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter:
Sela et al. (US 2005/0154302, hereinafter Sela ‘302) teaches a method for producing orthopedic data using acoustic waveforms, comprising: transmitting acoustic signals from an array of acoustic transducer elements of an acoustic probe device (0082) toward a target volume of an orthopedic structure of a body part of a biological subject to which the acoustic probe device is in contact,
receiving acoustic echoes that return from at least part of the target volume at one or more of the acoustic transducer elements (0023-0025, 0054, 0057, 0061, 0071, 0084, etc.), wherein the received acoustic echoes include at least some waveform components corresponding to the transmitted acoustic signals (0062, 0067, wavelength, 0075, it would have been inherent that an ultrasound echo includes some waveform because it is the fundamental operation of ultrasound echo and detection. It would also have been obvious that acoustic echoes include at least some waveform components because one of ordinary skill in the art would know that any ultrasound operation would use at least a waveform component, i.e. delay, frequency, amplitude of a waveform, in echo calculation for imaging analysis because such calculation are standard calculation for ultrasound imaging and detection);
determining
processing the received acoustic echoes with the determined
Sela ‘302 fails to teach “wherein the acoustic probe device includes an acoustic coupling medium coupled to the array of acoustic transducer elements and is operable to conduct the acoustic signals between the acoustic transducer elements and the body part of the biological subject when in contact with the acoustic coupling medium.” However, this limitation would have been obvious as it is a conventional operation of ultrasound to include acoustic coupling medium between the acoustic transducer elements and the body part of the biological subject in order to reduce noise.
However, Sela ‘302 still fails to teach a) “coordinate positions,” and b) wherein the spatial information includes position data of the orthopedic structure and vector data of the orthopedic structure's movement derived from the determined coordinate positions of the acoustic transducer elements.
JP WO2014/103512 (hereinafter JPWO ‘512) teaches a "moving vector vm" that is used in determining the depth of the target region in two states of the body part for distinguishing one type of structure (cartilage) from another (bone), which is illustrate in Figure 7 and introduced at page 31, lines 19-23:
[F]ig. 7 shows the case of using the target area for target area is lower compared to the bone. The moving vector vm is (sic) most similar to the target area for each determined from the position of the representative point of the object region with defined points of the subchondral bone. The moving vector vm, the (sic) region of interest as a representative point, the lower end of the representative point vector [are] compared for bone area, defined by the moving direction.
JPWO-512's moving vector vm accounts for as the moving direction and moving amount of the subchondral bone in the detected echo signals from state 1 to state 2. However, the moving vector vm does not account for such subchondral bone movement with respect to determined [coordinate] positions of transducers ("vibrators") of probe 100. See JPWO-512 at pg. 31, lines 15-40. Moreover, the moving vector vm does not include bone movement information that is derived from the position data of the vibrators of probe 100, which is in contrast with the claimed method.
Hence, the closest prior art of records fail to teach that: a) “coordinate positions,” and b) wherein the spatial information includes position data of the orthopedic structure and vector data of the orthopedic structure's movement derived from the determined coordinate positions of the acoustic transducer elements, in combination with the rest of the claim limitations.
Conclusion
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/BO JOSEPH PENG/Primary Examiner, Art Unit 3797