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 Objections
Claim 5 is objected to because of the following informalities: claim 5 recites “wherein the receiver comprises a tissue volume separator transducer is configured to”, however this should be read as “wherein the receiver comprises a tissue volume separator configured to”. Appropriate correction is required.
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.
Claim 19 is 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 19, claim 19 recites “monitor variations in first TDF at a first set of time points and the second TDF at a second set of time points”. However TDF is not defined and the second TDF has not been defined in claim 1 therefore it is unclear what the terms are referring to. The first TDH and the second TDF were defined in claim 11 therefore for examination purposes claim 19 will be interpreted as being dependent upon claim 11,
Claim Rejections - 35 USC § 103
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.
Claims 1-3, 5, 10, 13-15, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Dione (US20050054924) and further in view of Rather (US20020065466).
Regarding claim 1, Dione discloses a system for analyzing a volume of breast tissue determining present or future cancer risk from a volume of breast tissue (Abstract — “A three-dimensional (3-D) ultrasound computed tomography (UCT) system”, Para [0180] — “Therefore, there is a need for a non-invasive, safe, sensitive and specific modality to diagnosis and/or screen for breast cancer. 3D UCT may provide such a modality”), the system comprising:
(a) a non-ionizing apparatus comprising a transducer configured to transmit acoustic signals through the volume of breast tissue (Para [0157] — “It consists of a ring of 32 elements (2 mm piezoelectric transducers, 1 MHz)”, Para [0154] — “The 3D UCT imaging system of the present invention can create a 3D image of the breast”, Para [0033] — “selectively activating one of the omni-directional transceivers to transmit an acoustic wave at the target”);
(b) a receiver configured to receive acoustic signals and collect a measurement of a distribution of sound speed for the volume of breast tissue (Para [0033] — “The apparatus also includes a controller coupled to each of the omni-directional transceivers for selectively activating one of the omni-directional transceivers to transmit an acoustic wave at the target and a predetermined number of the omni-directional transceivers to receive acoustic waves propagated through the target”, [0100] – “a final speed-of sound image is determined”); and
(c) a processor operatively connected to a non-transitory computer-readable storage medium with instructions stored thereon which when executed by the processor (Para [0047] — “The personal computer also includes a conventional processor 110, such as a Pentium® microprocessor manufactured by Intel, data ports including but not limited to USB Ports 116 and conventional memory devices such as hard drive 108, floppy drive 112, and RAM 114”) are configured to:
(i) obtain an average whole breast sound speed of the breast tissue based on a first distribution of sound speed (Para [0154] — “The 3D UCT imaging system of the present invention can create a 3D image of the breast”, [0024] – “the speed-of-sound and the attenuation-of-sound could be combined with specialized statistical methods to differentiate tissue types in vivo”, paragraph [0025] then discloses average speed-of-sound of a breast to differentiate between pre-menopausal and postmenopausal women due to the difference in tissue, [0026] also discloses average speed-of- sound for malignant tissue and for normal tissue, therefore one with ordinary skill in the art would find it obvious to use an average as the specialized statistical method)
(iii) characterize the breast tissue based at least in part on […] the first average whole breast sound speed ([0024] – “the speed-of-sound and the attenuation-of-sound could be combined with specialized statistical methods to differentiate tissue types in vivo”, paragraph [0025] then discloses average speed-of-sound of a breast to differentiate between pre-menopausal and postmenopausal women due to the difference in tissue, [0026] also discloses average speed-of- sound for malignant tissue and for normal tissue, therefore one with ordinary skill in the art would find it obvious to use an average as the specialized statistical method) […].
Conversely Dione does not teach (ii)obtain a second average whole breast sound speed of the breast tissue based on a second distribution of sound speed
(iii) characterize the breast tissue based at least in part on a comparison of the first average whole breast sound speed to second average whole breast sound speed.
However Dione and Rather combined teach (ii)obtain a second average whole breast sound speed of the breast tissue based on a second distribution of sound speed (As cited above Dione discloses obtaining an average whole breast sound speed of the breast tissue based on a first distribution of sound speed, Rather discloses in [0122] the description of Fig. 9 which are volume images used to show a change in the tissue sample which can lead to the conclusion that there is a cancer growth, therefore one with ordinary skill in the art would find it obvious to use an average whole breast sound speed at a second time to show a change in the tissue sample.)
(iii) characterize the breast tissue based at least in part on a comparison of the first average whole breast sound speed to second average whole breast sound speed (As cited above Dione discloses obtaining an average whole breast sound speed of the breast tissue based on a first distribution of sound speed, Rather discloses in [0122] the description of Fig. 9 which are volume images used to show a change in the tissue sample by comparing the tissue at the two times which can lead to the conclusion that there is a cancer growth, therefore one with ordinary skill in the art would find it obvious to use an average whole breast sound speed at a second time to show a change in the tissue sample and compare the two to determine that there is a cancer growth).
Rather is an analogous art considering it is in the field of ultrasound imaging of the breast.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Dione to incorporate the comparison of tissue over time of Rather to achieve the same results. One would have motivation to combine because it allows one to determine if the tissue has changed in a positive or negative way and would also allow one to see if treatments are working.
Regarding claim 2, Dione and Rather disclose all the elements of the claimed invention as cited in claim 1.
Dione further discloses wherein the non-ionizing apparatus comprises a platform disposed substantially adjacent to a tank including a coupling fluid (Fig. 1b-1 – patient interface (table), [0053] – “a table (some modification to a biopsy table), which not only houses the imager”, [0057] – “The imaging chamber 12 of FIG. 2 a comprises, in the present embodiment, a cylinder 13”, [0060] – “The preferred fluid for use in the imaging chamber 12 is saline because saline closely matches the refractive index of the human body and therefore bending is reduced”).
Regarding claim 3, Dione and Rather disclose all the elements of the claimed invention as cited in claims 1 and 2.
Dione further discloses wherein the platform is configured to facilitate insertion of the volume of breast tissue into the tank and proximate to the transducer (Fig. 1b-1 – patient interface (table), [0053] – “a table (some modification to a biopsy table), which not only houses the imager”, [0178] – “The image chamber for a small animal would be smaller than the chamber for a human breast”).
Regarding claim 5, Dione and Rather disclose all the elements of the claimed invention as cited in claim 1.
Dione further discloses wherein the receiver comprises a tissue volume separator transducer is configured to receive the acoustic signal transmitted through the breast tissue (Abstract — “The 3-D UCT system also includes a processor coupled to the imaging chamber. The processor receives and processes the ultrasound signal and constructs the 3-D image of the target”, therefore the processor is interpreted as a tissue volume separator).
Regarding claim 10, Dione and Rather disclose all the elements of the claimed invention as cited in claim 1.
As cited above Dione and Rather can be combined to disclose wherein the non-transitory computer- readable storage medium further comprises instructions stored thereon which when executed by the processor are configured to analyze […] the first average whole breast sound speed and second average whole breast sound speed
Dione further discloses wherein the non-transitory computer- readable storage medium further comprises instructions stored thereon which when executed by the processor are configured to analyze one or more risk factors in combination with the […] sound speed [..] to further refine the tissue characterization, wherein the one or more risk factors comprise: an age ([0010] – “Greenleaf et al. also showed that by combining the speed-of-sound with the patient's age and a measure of image texture that malignant and benign lesions could be differentiated”), menopausal status, age at menarche, parity, age at first birth, number of first and second degree relatives with breast cancer, prior breast biopsies, hormonal usage, history of atypical hyperplasia, and history of lobular carcinoma.
Regarding claim 13, Dione and Rather disclose all the elements of the claimed invention as cited in claim 1.
Dione further discloses wherein obtaining at least one of the first average whole breast sound speed or the second average whole breast sound speed comprises obtaining a statistical measure of central tendency including one of a mean ([0024] – “speed-of-sound and the attenuation-of-sound could be combined with specialized statistical methods to differentiate tissue types in vivo”, [0025] – “the average speed-of-sound in the breast…the mean speed-of-sound”), a mode, a median, a range, and a standard deviation of at least one of sound speed and attenuation.
Regarding claim 14, Dione and Rather disclose all the elements of the claimed invention as cited in claims 1 and 13.
Dione further discloses wherein the statistical measure of central tendency is obtained from analyzing data derived from an interaction between the acoustic signal and the volume of breast tissue ([0024] – “speed-of-sound and the attenuation-of-sound could be combined with specialized statistical methods to differentiate tissue types in vivo”, [0025] – “the average speed-of-sound in the breast…the mean speed-of-sound”, the speed-of-sound measurement is based on an interaction between the acoustic signal and the volume of breast tissue).
Regarding claim 15, Dione and Rather disclose all the elements of the claimed invention as cited in claim 1.
As cited above Dione discloses obtaining an average whole breast sound speed of the breast tissue based on a first distribution of sound speed and Rather discloses in [0122] the description of Fig. 9 which are volume images used to show a change in the tissue sample by comparing the tissue at the two times which can lead to the conclusion that there is a cancer growth, therefore one with ordinary skill in the art would find it obvious to use an average whole breast sound speed at a second time to show a change in the tissue sample and compare the two to determine that there is a cancer growth, therefore Dione and Rather can be combined to teach wherein the non-transitory computer-readable storage medium further comprises instructions stored thereon which when executed by the processor are configured to obtain the first average whole breast sound speed at a first time points and obtain the second average whole breast sound speed at a second time point.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Dione to incorporate the use of data from two different times of Rather to achieve the same results. One would have motivation to combine because it allows one to determine if the tissue has changed in a positive or negative way and would also allow one to see if treatments are working.
Regarding claim 18, Dione and Rather disclose all the elements of the claimed invention as cited in claim 1.
Dione further discloses wherein the acoustic signal comprises at least one of a sequential series of waves and a sequential series of pulses ([0075] – “Each element, in turn, is selected to be the transmitter with the remaining elements designated to act as receivers. The timing of each transmission is also determined”, [0033] – “transmit an acoustic wave at the target and a predetermined number of the omni-directional transceivers to receive acoustic waves propagated through the target”).
Claims 4, 8, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Dione (US20050054924) and Rather (US20020065466) as applied to claim 1 above and further in view of Peterson (US20040181154).
Regarding claim 4, Dione and Rather disclose all the elements of the claimed invention as cited in claim 1.
Dione further discloses wherein the non-ionizing apparatus comprises an imaging device (Abstract — “The 3-D UCT system also includes a processor coupled to the imaging chamber”), a waveform generator (Fig. 3 element 1), [...], an acoustic transmit amplifier (Fig. 3 element 2) coupled to the digital-to-analog converter, wherein the acoustic transmit amplifier is connected to a transmitter end of the imaging device (Fig. 3 element 2 — “from an element”).
Conversely Dione does not teach a digital-to-analog converter coupled to the waveform generator.
However Peterson discloses a digital-to-analog converter coupled to the waveform generator (fig. 4 element 30).
Peterson is an analogous art considering it is in the field of an ultrasound imaging device for diagnosis.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Dione to incorporate the digital to analog converter of Peterson to achieve the same results. One would have motivation to combine because it would be appropriate for waveform generator producing digital waveforms used with an analog probe for the purpose of being able to read the signals.
Regarding claim 8, Dione and Rather disclose all the elements of the claimed invention as cited in claims 1 and 4.
Dione further discloses wherein the receiver (Fig. 1b-1 transceiver 22) comprises:
a receiver end coupled to the imaging device (Fig. 1b-1 transceiver 22);
a receive amplifier wherein the receiver amplifier coupled to the receiver end ([0081] – “The received electrical is amplified using standard methods”);
an analog-to-digital converter coupled to the receive amplifier ([0083] – “The amplified analog signals are then digitized using a high-speed analog-to-digital converter”); and
a value generator connected to the analog-to-digital converter (Fig. 3 element 6, [0085] – “Transit-time is determined for each projection, the ray connecting each receiver to the transmitter. It is crucial that transit-time measurements be done precisely so that the ultimate, quantitative, reconstructed image accurately reflects the true tissue properties”).
Regarding claim 9, Dione and Rather disclose all the elements of the claimed invention as cited in claims 1 and 4.
Dione further discloses wherein the imaging device is an ultrasound tomography device comprises a transducer ring configured to scan the volume of breast tissue ([0049] – “Imaging chamber 12 comprises two or more rings 14 including a plurality of piezoelectric elements 16 mounted thereon”, [0102] – “The user interface can enable switching between volume and slice views”).
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Dione (US20050054924) and Rather (US20020065466) as applied to claim 1 above and further in view of Holdaway (US6083166).
Regarding claim 6, Dione and Rather disclose all the elements of the claimed invention as cited in claim 1.
Dione further discloses wherein the non-ionizing apparatus comprises an ultrasound […transmitter/receiver] disposed upon the coupling fluid and proximate to the breast tissue ([0057] – “a cylinder 13 comprising cylinder wall 13 a and an acoustic (sound absorbing) coating 13 b, and eight rings 14 of piezoelectric elements”, [0060] – “The preferred fluid for use in the imaging chamber 12 is saline because saline closely matches the refractive index of the human body and therefore bending is reduced”, [0051] – “transceiver 22, which is capable of receiving multiple input signals, one from each of the piezoelectric elements 16 and is also capable of providing an input, preferably an impulse, to one of the piezoelectric elements 16 which acts as an omnidirectional (or hemispherical) transmitter).
Conversely Dione does not teach the non-ionizing apparatus comprises an ultrasound caliper.
However Holdaway discloses the non-ionizing apparatus comprises an ultrasound caliper (Col. 2 lines 56-58 “ultrasonic calipers containing an ultrasonic emitter and receiver have been used to measure the amplitude and velocity of an ultrasonic signal”).
Holdaway is an analogous art considering it is in the field of velocity measurements of ultrasound.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Dione to incorporate the ultrasound caliper of Holdaway to achieve the same results. One would have motivation to combine because the transducers transmitting and receiving signals of Dione would be functionally equivalent to the ultrasound caliper of Holdaway.
Regarding claim 7, Dione and Rather disclose all the elements of the claimed invention as cited in claims 1 and 6.
Dione further discloses wherein the ultrasound […] comprises a transmitting end and a receiving end for transmitting the acoustic signal through the volume of breast tissue for receipt at the receiver. ([0057] – “a cylinder 13 comprising cylinder wall 13 a and an acoustic (sound absorbing) coating 13 b, and eight rings 14 of piezoelectric elements”, [0060] – “The preferred fluid for use in the imaging chamber 12 is saline because saline closely matches the refractive index of the human body and therefore bending is reduced”, [0051] – “transceiver 22, which is capable of receiving multiple input signals, one from each of the piezoelectric elements 16 and is also capable of providing an input, preferably an impulse, to one of the piezoelectric elements 16 which acts as an omnidirectional (or hemispherical) transmitter).
Conversely Dione does not teach wherein the ultrasound caliper comprises a transmitting end and a receiving end.
However Holdaway discloses wherein the ultrasound caliper comprises a transmitting end and a receiving end (Col. 2 lines 56-58 “ultrasonic calipers containing an ultrasonic emitter and receiver have been used to measure the amplitude and velocity of an ultrasonic signal”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Dione to incorporate the ultrasound caliper of Holdaway to achieve the same results. One would have motivation to combine because the transducers transmitting and receiving signals of Dione would be functionally equivalent to the ultrasound caliper of Holdaway.
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).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-10, 13-15, and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 7-11 of U.S. Patent No. US12161505B2 in view of Dione (US20050054924) and Rather (US20020065466).
Regarding claim 1, Patent No. US12161505B2 discloses a system for analyzing a volume of breast tissue determining present or future cancer risk from a volume of breast tissue, the system (Claims 1 and 7 – “A system for determining present or future cancer risk from a volume of breast tissue… generate a comparison between the average whole breast sound speed and at least one threshold condition”) comprising:
(a) a non-ionizing apparatus comprising a transducer configured to transmit[[ an]] acoustic signals through the volume of breast tissue (claims 1 and 7 – “a non-ionizing apparatus comprising a transducer configured to transmit an acoustic signal through the volume of breast tissue”);
(b) […] collect a measurement of a distribution of sound speed for the volume of breast tissue (claims 1 and 7 – “the tissue volume separator is configured to facilitate measurement of a distribution of sound speed for the volume of breast tissue based upon an analysis of the acoustic signal”); and
(c) a processor operatively connected to a non-transitory computer-readable storage medium with instructions stored thereon which when executed by the processor are configured to (claims 1 and 7 – “a processor operatively connected to a non-transitory computer-readable storage medium with instructions stored thereon which when executed by the processor are configured to”):
(i)obtain a first average whole breast sound speed of the breast tissue based on a first distribution of sound speed (claims 1 and 7 – “obtain an average whole breast sound speed based on the distribution of sound speed over a volume of the breast”)
Conversely Patent No. US12161505B2 does not teach a receiver configured to receive acoustic signals
(ii)obtain a second average whole breast sound speed of the breast tissue based on a second distribution of sound speed
(iii) characterize the breast tissue based at least in part on a comparison of the first average whole breast sound speed to second average whole breast sound speed.
However Dione discloses a receiver configured to receive acoustic signals (Para [0033] — “The apparatus also includes a controller coupled to each of the omni-directional transceivers for selectively activating one of the omni-directional transceivers to transmit an acoustic wave at the target and a predetermined number of the omni-directional transceivers to receive acoustic waves propagated through the target”)
(i) obtain an average whole breast sound speed of the breast tissue based on a first distribution of sound speed (Para [0154] — “The 3D UCT imaging system of the present invention can create a 3D image of the breast”, [0024] – “the speed-of-sound and the attenuation-of-sound could be combined with specialized statistical methods to differentiate tissue types in vivo”, paragraph [0025] then discloses average speed-of-sound of a breast to differentiate between pre-menopausal and postmenopausal women due to the difference in tissue, [0026] also discloses average speed-of- sound for malignant tissue and for normal tissue, therefore one with ordinary skill in the art would find it obvious to use an average as the specialized statistical method)
(iii) characterize the breast tissue based at least in part on […] the first average whole breast sound speed ([0024] – “the speed-of-sound and the attenuation-of-sound could be combined with specialized statistical methods to differentiate tissue types in vivo”, paragraph [0025] then discloses average speed-of-sound of a breast to differentiate between pre-menopausal and postmenopausal women due to the difference in tissue, [0026] also discloses average speed-of- sound for malignant tissue and for normal tissue, therefore one with ordinary skill in the art would find it obvious to use an average as the specialized statistical method) […].
Dione is an analogous art considering it is in the field of three dimensional ultrasound imaging of the breast.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Patent No. US12161505B2 to incorporate the receiver and the characterization of tissue of Dione to achieve the same results. One would have motivation to combine because “the present invention could be used to quantitatively classify tissue” (Dione – [0151]).
Conversely Patent No. US12161505B2 and Dione does not teach (ii)obtain a second average whole breast sound speed of the breast tissue based on a second distribution of sound speed
(iii) characterize the breast tissue based at least in part on a comparison of the first average whole breast sound speed to second average whole breast sound speed.
However Dione and Rather combined teach (ii)obtain a second average whole breast sound speed of the breast tissue based on a second distribution of sound speed (As cited above Dione discloses obtaining an average whole breast sound speed of the breast tissue based on a first distribution of sound speed, Rather discloses in [0122] the description of Fig. 9 which are volume images used to show a change in the tissue sample which can lead to the conclusion that there is a cancer growth, therefore one with ordinary skill in the art would find it obvious to use an average whole breast sound speed at a second time to show a change in the tissue sample.)
(iii) characterize the breast tissue based at least in part on a comparison of the first average whole breast sound speed to second average whole breast sound speed (As cited above Dione discloses obtaining an average whole breast sound speed of the breast tissue based on a first distribution of sound speed, Rather discloses in [0122] the description of Fig. 9 which are volume images used to show a change in the tissue sample by comparing the tissue at the two times which can lead to the conclusion that there is a cancer growth, therefore one with ordinary skill in the art would find it obvious to use an average whole breast sound speed at a second time to show a change in the tissue sample and compare the two to determine that there is a cancer growth).
Rather is an analogous art considering it is in the field of ultrasound imaging of the breast.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Patent No. US12161505B2 to incorporate the comparison of tissue over time of Rather to achieve the same results. One would have motivation to combine because it allows one to determine if the tissue has changed in a positive or negative way over time and would also allow one to see if treatments are working.
Regarding claim 2, Patent No. US12161505B2 further discloses wherein the non-ionizing apparatus comprises a platform disposed substantially adjacent to a tank including a coupling fluid (claims 2 and 8 – “wherein the non-ionizing apparatus comprises a platform disposed substantially adjacent a tank including a coupling fluid”).
Regarding claim 3, Patent No. US12161505B2 further discloses wherein the platform is configured to facilitate insertion of the volume of breast tissue into the tank and proximate to the transducer (claims 2 and 8 – “wherein the platform is configured to facilitate insertion of the volume of breast tissue into the tank and proximate to the transducer”).
Regarding claim 4, Patent No. US12161505B2 further discloses wherein the non-ionizing apparatus (claims 1 and 7 – “a tissue volume separator coupled to the non-ionizing apparatus”, claims 4 and 10 - “wherein the tissue volume separator comprises”) comprises: an imaging device; a waveform generator; a digital-to-analog converter coupled to the waveform generator; and an acoustic transmit amplifier coupled to the digital-to-analog converter, wherein the acoustic transmit amplifier is connected to a transmitter end of the imaging device (claims 4 and 10 - “an imaging device, a waveform generator, a digital-to-analog converter coupled to the waveform generator, an acoustic transmit amplifier coupled to the digital-to-analog converter, wherein the acoustic transmit amplifier is connected to a transmitter end of the imaging device”).
Regarding claim 5, Patent No. US12161505B2, Dione, and Rather disclose all the elements of the claimed invention as cited in claim 1.
Conversely Patent No. US12161505B2 does not teach wherein the receiver comprises a tissue volume separator transducer is configured to receive the acoustic signal transmitted through the breast tissue.
However Dione discloses wherein the receiver comprises a tissue volume separator transducer is configured to receive the acoustic signal transmitted through the breast tissue (Abstract — “The 3-D UCT system also includes a processor coupled to the imaging chamber. The processor receives and processes the ultrasound signal and constructs the 3-D image of the target”, therefore the processor is interpreted as a tissue volume separator).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Patent No. US12161505B2 to incorporate the receiver of Dione to achieve the same results. One would have motivation to combine because “the present invention could be used to quantitatively classify tissue” (Dione – [0151]).
Regarding claim 6, Patent No. US12161505B2 further discloses wherein the non-ionizing apparatus comprises an ultrasound caliper disposed upon the coupling fluid and proximate to the breast tissue (claims 3 and 9 – “wherein the non-ionizing apparatus comprises an ultrasound caliper disposed upon the coupling fluid and proximate to the breast tissue”).
Regarding claim 7, Patent No. US12161505B2 further discloses wherein the ultrasound caliper comprises a transmitting end and a receiving end for transmitting the acoustic signal through the volume of breast tissue for receipt at the receiver (claims 3 and 9 – “wherein the ultrasound caliper comprises a transmitting end and a receiving end for transmitting the acoustic signal through the volume of breast tissue for receipt at the tissue volume separator”).
Regarding claim 8, Patent No. US12161505B2 further discloses wherein the receiver comprises: a receiver end coupled to the imaging device; a receive amplifier wherein the receiver amplifier coupled to the receiver end; an analog-to-digital converter coupled to the receive amplifier; and a value generator connected to the analog-to-digital converter (claims 4 and 10 – “a receive amplifier, wherein the receive amplifier is connected to a receiver end of the imaging device, an analog-to-digital converter coupled to the receive amplifier, and a value generator connected to the analog-to-digital converter”).
Regarding claim 9, Patent No. US12161505B2 further discloses wherein the imaging device is an ultrasound tomography device comprises a transducer ring configured to scan the volume of breast tissue (claims 5 and 11 – “wherein the imaging device is an ultrasound tomography device defined, at least in part, by a transducer ring configured to scan the volume of breast tissue”).
Regarding claim 10, Patent No. US12161505B2, Dione, and Rather disclose all the elements of the claimed invention as cited in claim 1.
Conversely Patent No. US12161505B2 does not teach wherein the non-transitory computer- readable storage medium further comprises instructions stored thereon which when executed by the processor are configured to (iv) generate a first tissue density factor based on a first high sound speed volume and a total breast volume and a second tissue density factor base on a second high sound speed volume and the total breast volume, and(v) analyze the first TDF and the second TDF in combination with the first average whole breast sound speed and second average whole breast sound speed for characterizing the breast tissue.
As cited above Dione and Rather can be combined to disclose wherein the non-transitory computer- readable storage medium further comprises instructions stored thereon which when executed by the processor are configured to analyze […] the first average whole breast sound speed and second average whole breast sound speed
Dione further discloses wherein the non-transitory computer- readable storage medium further comprises instructions stored thereon which when executed by the processor are configured to analyze one or more risk factors in combination with the […] sound speed [..] to further refine the tissue characterization, wherein the one or more risk factors comprise: an age ([0010] – “Greenleaf et al. also showed that by combining the speed-of-sound with the patient's age and a measure of image texture that malignant and benign lesions could be differentiated”), menopausal status, age at menarche, parity, age at first birth, number of first and second degree relatives with breast cancer, prior breast biopsies, hormonal usage, history of atypical hyperplasia, and history of lobular carcinoma.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Patent No. US12161505B2 to incorporate the analyzing of age as a risk factor of Dione to achieve the same results. One would have motivation to combine because “the present invention could be used to quantitatively classify tissue” (Dione – [0151]) and by considering the age one would be able to provide a more accurate diagnosis.
Regarding claim 13, Patent No. US12161505B2, Dione, and Rather disclose all the elements of the claimed invention as cited in claim 1.
Conversely Patent No. US12161505B2 does not teach wherein obtaining at least one of the first average whole breast sound speed or the second average whole breast sound speed comprises obtaining a statistical measure of central tendency including one of a mean, a mode, a median, a range, and a standard deviation of at least one of sound speed and attenuation.
However Dione discloses wherein obtaining at least one of the first average whole breast sound speed or the second average whole breast sound speed comprises obtaining a statistical measure of central tendency including one of a mean ([0024] – “speed-of-sound and the attenuation-of-sound could be combined with specialized statistical methods to differentiate tissue types in vivo”, [0025] – “the average speed-of-sound in the breast…the mean speed-of-sound”), a mode, a median, a range, and a standard deviation of at least one of sound speed and attenuation.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Patent No. US12161505B2 to incorporate the statistical measure of Dione to achieve the same results. One would have motivation to combine because “the present invention could be used to quantitatively classify tissue” (Dione – [0151]).
Regarding claim 14, Patent No. US12161505B2, Dione, and Rather disclose all the elements of the claimed invention as cited in claims 1 and 13.
Conversely Patent No. US12161505B2 does not teach wherein the statistical measure of central tendency is obtained from analyzing data derived from an interaction between the acoustic signal and the volume of breast tissue.
However Dione discloses wherein the statistical measure of central tendency is obtained from analyzing data derived from an interaction between the acoustic signal and the volume of breast tissue ([0024] – “speed-of-sound and the attenuation-of-sound could be combined with specialized statistical methods to differentiate tissue types in vivo”, [0025] – “the average speed-of-sound in the breast…the mean speed-of-sound”, the speed-of-sound measurement is based on an interaction between the acoustic signal and the volume of breast tissue).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Patent No. US12161505B2 to incorporate the statistical measure of Dione to achieve the same results. One would have motivation to combine because “the present invention could be used to quantitatively classify tissue” (Dione – [0151]).
Regarding claim 15, Patent No. US12161505B2, Dione, and Rather disclose all the elements of the claimed invention as cited in claim 1.
Conversely Patent No. US12161505B2 does not teach wherein the non-transitory computer-readable storage medium further comprises instructions stored thereon which when executed by the processor are configured to obtain the first average whole breast sound speed at a first time points and obtain the second average whole breast sound speed at a second time point.
As cited above Dione discloses obtaining an average whole breast sound speed of the breast tissue based on a first distribution of sound speed and Rather discloses in [0122] the description of Fig. 9 which are volume images used to show a change in the tissue sample by comparing the tissue at the two times which can lead to the conclusion that there is a cancer growth, therefore one with ordinary skill in the art would find it obvious to use an average whole breast sound speed at a second time to show a change in the tissue sample and compare the two to determine that there is a cancer growth, therefore Dione and Rather can be combined to teach wherein the non-transitory computer-readable storage medium further comprises instructions stored thereon which when executed by the processor are configured to obtain the first average whole breast sound speed at a first time points and obtain the second average whole breast sound speed at a second time point.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Patent No. US12161505B2 to incorporate the use of data from two different times of Rather to achieve the same results. One would have motivation to combine because it allows one to determine if the tissue has changed in a positive or negative way over time and would also allow one to see if treatments are working.
Regarding claim 18, Patent No. US12161505B2, Dione, and Rather disclose all the elements of the claimed invention as cited in claim 1.
Conversely Patent No. US12161505B2 does not teach wherein the acoustic signal comprises at least one of a sequential series of waves and a sequential series of pulses.
Dione further discloses wherein the acoustic signal comprises at least one of a sequential series of waves and a sequential series of pulses ([0075] – “Each element, in turn, is selected to be the transmitter with the remaining elements designated to act as receivers. The timing of each transmission is also determined”, [0033] – “transmit an acoustic wave at the target and a predetermined number of the omni-directional transceivers to receive acoustic waves propagated through the target”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Patent No. US12161505B2 to incorporate the sequential series of waves of Dione to achieve the same results. One would have motivation to combine because “the present invention could be used to quantitatively classify tissue” (Dione – [0151]).
Claims 1-6, 8-10, 13-15, and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21-25 of U.S. Patent No. US8870771B2 in view of Dione (US20050054924) and Rather (US20020065466).
Regarding claim 1, Patent No. US8870771B2 discloses a system for analyzing a volume of breast tissue (claim 21 – “An apparatus… configured to measure a distribution of one or more acoustic parameters comprising sound speed based upon an analysis of the acoustic signal; a first module configured to obtain an average whole breast sound speed velocity based on the measured distribution of sound speed”), the system comprising:
(a) a non-ionizing apparatus comprising a transducer configured to transmit acoustic signals through the volume of breast tissue (claim 21 – “a non-ionizing apparatus located proximate breast tissue, wherein the non-ionizing apparatus comprises a transducer configured to expose the breast tissue to an acoustic signal by transmitting the acoustic signal through the breast tissue”);
(b) […] collect a measurement of a distribution of sound speed for the volume of breast tissue (claim 21 – “wherein the tissue volume separator is configured to measure a distribution of one or more acoustic parameters comprising sound speed based upon an analysis of the acoustic signal”); and
(i)obtain a first average whole breast sound speed of the breast tissue based on a first distribution of sound speed (claim 21 – “a first module configured to obtain an average whole breast sound speed velocity based on the measured distribution of sound speed”)
Conversely Patent No. US8870771B2 does not teach a receiver configured to receive acoustic signals
(c) a processor operatively connected to a non-transitory computer-readable storage medium with instructions stored thereon which when executed by the processor are configured to:
(ii)obtain a second average whole breast sound speed of the breast tissue based on a second distribution of sound speed
(iii) characterize the breast tissue based at least in part on a comparison of the first average whole breast sound speed to second average whole breast sound speed.
However Dione discloses a receiver configured to receive acoustic signals (Para [0033] — “The apparatus also includes a controller coupled to each of the omni-directional transceivers for selectively activating one of the omni-directional transceivers to transmit an acoustic wave at the target and a predetermined number of the omni-directional transceivers to receive acoustic waves propagated through the target”)
(c) a processor operatively connected to a non-transitory computer-readable storage medium with instructions stored thereon which when executed by the processor (Para [0047] — “The personal computer also includes a conventional processor 110, such as a Pentium® microprocessor manufactured by Intel, data ports including but not limited to USB Ports 116 and conventional memory devices such as hard drive 108, floppy drive 112, and RAM 114”) are configured to:
(i) obtain an average whole breast sound speed of the breast tissue based on a first distribution of sound speed (Para [0154] — “The 3D UCT imaging system of the present invention can create a 3D image of the breast”, [0024] – “the speed-of-sound and the attenuation-of-sound could be combined with specialized statistical methods to differentiate tissue types in vivo”, paragraph [0025] then discloses average speed-of-sound of a breast to differentiate between pre-menopausal and postmenopausal women due to the difference in tissue, [0026] also discloses average speed-of- sound for malignant tissue and for normal tissue, therefore one with ordinary skill in the art would find it obvious to use an average as the specialized statistical method)
(iii) characterize the breast tissue based at least in part on […] the first average whole breast sound speed ([0024] – “the speed-of-sound and the attenuation-of-sound could be combined with specialized statistical methods to differentiate tissue types in vivo”, paragraph [0025] then discloses average speed-of-sound of a breast to differentiate between pre-menopausal and postmenopausal women due to the difference in tissue, [0026] also discloses average speed-of- sound for malignant tissue and for normal tissue, therefore one with ordinary skill in the art would find it obvious to use an average as the specialized statistical method) […].
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Patent No. US8870771B2 to incorporate the receiver and the characterization of tissue of Dione to achieve the same results. One would have motivation to combine because “the present invention could be used to quantitatively classify tissue” (Dione – [0151]).
Conversely Patent No. US12161505B2 and Dione does not teach (ii)obtain a second average whole breast sound speed of the breast tissue based on a second distribution of sound speed
(iii) characterize the breast tissue based at least in part on a comparison of the first average whole b