Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The limitations of insonify the entire phantom with an unfocused ultrasound pulse from the at least one transmit transducer element, receive echo data with the receive transducer elements, and store echo data in a third memory device, form a first image of the pattern of reflectors by beamforming the stored echo data from the unfocused ultrasound pulse using the transducer element position data are not described in the instant disclosure.
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.
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Claims 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,171,621 in view of Call (US 2013/0253325 A1). (see below)
Regarding claim 1, ‘621 teaches an ultrasound probe calibration system, comprising:
an ultrasound probe having a plurality of at least one transmit transducer element and a plurality of receive transducer elements;
a phantom having a pattern of reflectors;
a first memory device containing reference data describing the pattern of reflectors of the phantom;
a second memory device containing transducer element position data describing a position of each transmit transducer element and each receive transducer element relative to a common coordinate system; and
an imaging control system containing calibration program code configured to direct the system to:
determine measurement data describing a position of the pattern of reflectors as indicated by the first image,
quantify an error between the measurement data and the reference data, and
iteratively optimize the transducer element position data based on the quantified error.
‘621 does not explicitly teach and yet Call teaches insonify the entire phantom with an unfocused ultrasound pulse from the at least one transmit transducer element [[0025] ultrasound transmitter configured to transmit unfocused ultrasound signals into a region of interest ; [0130] phantom … each view may be tested for a given pixel to determine whether each view improves image quality or makes it worse. Repeating this process for each view and for each pixel location], receive echo data with the receive transducer elements, and store echo data in a third memory device [[0071] ultrasound echo signals received by each individual receive element in a raw data memory device 220 before performing any further receive beamforming, filtering, image layer combining or other image processing. ], form a first image of the pattern of reflectors by beamforming the stored echo data from the unfocused ultrasound pulse using the transducer element position data [[0025] echo signals returned by reflectors in the region of interest … displaying images of the reflectors on a display; [0058] transmitted ultrasound signals may be focused in a particular direction, or may be unfocused, transmitting in all directions or a wide range of directions.; [0072] image generation subsystem 230 may include a beamforming block 232 and an image layer combining (“ILC”) block 234. In some embodiments, a beamformer 232 may be in communication with a calibration memory 238 that contains probe calibration data. Probe calibration data may include information about the precise position, operational quality, and/or other information about individual probe transducer elements.].
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the invention with a reasonable expectation of success to combine the iterative calibration as taught by ‘621, with the use of focused or unfocused transmissions as taught by Call so that beamforming may be used reciprocally during transmit or during receive.
Regarding claim 2, ‘621 teaches the system of claim 1, wherein the imaging control system is configured to iteratively optimize the phantom by: adjusting the transducer element position data; forming a second plurality of complete images of the pattern of reflectors by re- beamforming the stored echo data from the unfocused ultrasound pulse using the adjusted transducer element position data; forming a second combined image of the pattern of reflectors by combining the second plurality of complete images; quantifying a second error based on the second combined image; and evaluating the second error to determine whether the adjusted transducer element position data improves the image.
Regarding claim 3, ‘621 teaches the system of claim 1, wherein the reference data is based on physical measurements of the phantom.
Regarding claim 4, ‘621 teaches the system of claim 1, wherein the reference data is based on a reference image.
Regarding claim 5, ‘621 teaches the system of claim 1, wherein the imaging control system is configured to iteratively optimize the transducer element position data using a least squares optimization process.
Regarding claim 6, ‘621 teaches the system of claim 1, wherein the phantom further comprises at least one region that absorbs ultrasound signals.
Regarding claim 7, ‘621 teaches the system of claim 1, wherein the ultrasound probe comprises a plurality of transducer arrays.
Regarding claim 8, ‘621 teaches the system of claim 1, wherein the ultrasound probe comprises a single continuous transducer array.
Regarding claim 9, ‘621 teaches the system of claim 1, wherein the ultrasound probe comprises a transducer array with a concave curvature.
Regarding claim 10, ‘621 teaches the system of claim 1, wherein the phantom comprises a pattern of pins.
Regarding claim 11, ‘621 teaches the system of claim 1, wherein the phantom comprises living tissue.
Regarding claim 12, ‘621 teaches the system of claim 1, wherein the calibration program code is configured to determine measurement data by fitting a curve to a detected pattern of reflectors.
Regarding claim 13, ‘621 teaches the system of claim 12, wherein the calibration program code is configured to quantify an error by determining a coefficient of determination quantifying a degree of fit of the curve.
Regarding claim 14, ‘621 teaches the system of claim 1, wherein at least two of the first memory device, the second memory device, and the third memory device are logical portions of a single physical memory device.
Regarding claim 15, ‘621 teaches the system of claim 1, wherein the at least one transmit transducer element comprises a single transmit transducer element.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN D ARMSTRONG whose telephone number is (571)270-7339. The examiner can normally be reached M - F 9am-5pm.
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/JONATHAN D ARMSTRONG/ Examiner, Art Unit 3645