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).
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 1-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,471,132. Although the claims at issue are not identical, they are not patentably distinct from each other because the present application and patent both require the features of an ultrasound endoscope comprising an ultrasound operation portion using an ultrasound transducer array including single crystal transducers, as well as an ultrasound processor apparatus comprising a transmission circuit and a reception circuit as well a diagnostic driving pulse in a case of acquiring the ultrasound image as well as a polarization driving pulse in a case of performing the polarization processing and a voltage which is different depending on the polarization or diagnostic driving pulse. The patent includes additional features; however, the patent anticipates the present application.
Claims 1-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,998,396. Although the claims at issue are not identical, they are not patentably distinct from each other because both the present application and the patent disclose imaging steps to acquire an ultrasound image to perform an ultrasound diagnosis using a plurality of ultrasound transducers, applying a polarization processing to the plurality of ultrasound transducers, and a polarization processing which is separate from the imaging process and occurs at a distinct time. The present application does not explicitly disclose a “non-diagnostic period from an end of scanning of a last scanning line of the plurality of scanning lines to a start of scanning of a first scanning line within a new one frame time”; however, the present application does disclose two distinct periods, one in which a diagnostic driving pulse is provided and another in which a polarization driving pulse is provided. These are considered obvious variants as they both provide distinct time periods for performing the different processes.
Drawings
The drawings are objected to because the boxes in figure 1 are not properly labeled. Reference numerals alone are insufficient. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 12 is objected to because of the following informalities: “Wherein” should be “wherein”. 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.
Claims 9 and 24 are 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.
Claims 9 and 24 recites the limitation "the minimum number of clocks" in line 4. There is insufficient antecedent basis for this limitation in the claim.
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.
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, 5, 10-12, 17, 21 and 25-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nakanishi (2014/0066779) in view of Specht et al (2015/0080727).
Regarding claim 1, Nakanishi disclose an ultrasound diagnostic apparatus acquiring an ultrasound image, comprising:
an ultrasound probe comprising an ultrasound portion that transmits ultrasound waves using an ultrasound transducer array, in which a plurality of ultrasound transducers are arranged, and receives reflected waves of the ultrasound waves (fig.3, [0065] – ultrasound transducer device 100 included in the ultrasonic probe, comprises a plurality of ultrasonic elements, arranged in an arrayed shape; [0075];[0076] – comprises a transmission circuit 210 and a received circuit 220);
an ultrasound processor apparatus (processing apparatus 200) comprising a transmission circuit that transmits a transmission signal to the plurality of ultrasound transducers in order to generate the ultrasound waves from the plurality of ultrasound transducers (transmission circuit 210), a reception circuit that outputs a reception signal based on the reflected waves received by the plurality of ultrasound transducers (receiver circuit 220) (fig.3, [0075]), and an ultrasound image generation unit that generates the ultrasound image by converting the reception signal into an image in order to acquire the ultrasound image ([0134] – processing unit 420 receives detection data from receiver circuit 220 and carries out necessary image processing, generates image data for display, and the like);
the ultrasound processor apparatus further comprises a control circuit (410) that performs transmission of the ultrasound waves and reception of the reflected waves and that performs polarization processing on the plurality of ultrasound transducers using the transmission circuit (fig.12 – transmit ultrasonic waves S21, receive echo signals S23 and apply voltage for polarization S25);
the control circuit controls the transmission circuit to generate the transmission signal, which includes a diagnostic driving pulse applied to each of the plurality of ultrasound transducers in a case of acquiring the ultrasound image ([0134]) controls the transmission circuit to generate a polarization driving pulse in a case of performing the polarization processing, and applies the polarization driving pulse to the plurality of ultrasound transducers to perform the polarization processing of the plurality of ultrasound transducers with the polarization driving pulse ([0131] – the transmission circuit 210 outputs a voltage for polarization to each of the ultrasonic elements);
wherein a voltage of the polarization driving pulse is different in magnitude from the voltage of the diagnostic driving pulse ([0131] – the voltage for polarization is voltage by which the piezoelectric body films PE of each of the elements can be uniformly polarized, and is a higher voltage than that of the transmission signal VT when the ultrasonic waves are being transmitted), and a frequency band of a main lobe of a driving waveform of the polarization driving pulse is different from a probe frequency band of the diagnostic driving pulse (fig.12, [0131] – the polarization voltage is applied until the receipt signal is the target level or higher).
Nakanishi fail to explicitly disclose an ultrasound endoscope and wherein the plurality of ultrasound transducers are single crystal transducers.
However, Specht et al teach in the same medical field of endeavor, an ultrasound endoscope ([0175] - the probe may be built into a housing mounted to an endoscope) and a plurality of ultrasound transducers that are single crystal transducers ([0097] – an array of piezoelectric transducer elements, each element may be a single piezoelectric crystal or a single machined section of piezoelectric crystal).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the transducer array and ultrasound probe of Nakanishi with a plurality of ultrasound transducers are single crystal transducers and an endoscope as it would provide a well-known and conventional type of transducer element and endoscopic structure for ultrasound image acquisition as set forth in Specht et al.
Regarding claims 5 and 21, Nakanishi discloses wherein the probe frequency band is located between 2.7 MHz and 11.7 MHz ([0063] – the frequency is, for example, 1 to 10 MHz).
Regarding claims 10 and 25, Nakanishi discloses wherein a magnitude of the polarization driving voltage is larger than a magnitude of an image driving voltage for the diagnostic driving pulse ([0131] - the voltage for polarization is…a higher voltage than that of the transmission signal).
Regarding claims 11 and 26, Nakanishi disclose wherein an imaging driving voltage of the diagnostic driving pulse and the polarization driving voltage of the polarization driving pulse have the same settable voltage range, and the transmission circuit uses the image driving voltage and the polarization driving voltage so as to be switched therebetween ([0077] – frequency and amplitude voltage can be set by the control unit – since the polarization voltage is applied by the transmission circuit, it is inevitably within the driving pulse settable voltage range).
Regarding claims 12 and 27, Nakanishi discloses wherein the plurality of ultrasonic transducers on the ultrasonic transducer array are organized into a plurality of groups, and the ultrasonic transducers of each group are independently subjected to performing the polarization processing by a different transmission signal for performing polarization processing for each group ([0125] - adjust may be directed to individual ultrasound elements, or may be directed to an ultrasonic element column including a plurality of elements).
Regarding claim 17, Nakanishi discloses an operation method of an ultrasound diagnostic apparatus acquiring an ultrasound image, wherein the ultrasound diagnostic apparatus comprises:
an ultrasound probe comprising an ultrasound portion that transmits ultrasound waves using an ultrasound transducer array, in which a plurality of ultrasound transducers are arranged, and receives reflected waves of the ultrasound waves (fig.3, [0065] – ultrasound transducer device 100 included in the ultrasonic probe, comprises a plurality of ultrasonic elements, arranged in an arrayed shape; [0075];[0076] – comprises a transmission circuit 210 and a received circuit 220);
an ultrasound processor apparatus (processing apparatus 200) comprising a transmission circuit that transmits a transmission signal to the plurality of ultrasound transducers in order to generate the ultrasound waves from the plurality of ultrasound transducers (transmission circuit 210), a reception circuit that outputs a reception signal based on the reflected waves received by the plurality of ultrasound transducers (receiver circuit 220) (fig.3, [0075]), and an ultrasound image generation unit that generates the ultrasound image by converting the reception signal into an image in order to acquire the ultrasound image ([0134] – processing unit 420 receives detection data from receiver circuit 220 and carries out necessary image processing, generates image data for display, and the like); and
the method comprises:
a step in which the transmission circuit is controlled so as to generate the transmission signal, which includes a diagnostic driving pulse applied to each of the plurality of ultrasound transducers in a case of acquiring the ultrasound image ([0134]);
a step in which the transmission signal generated from the transmission circuit is transmitted to the plurality of ultrasound transducers and the diagnostic driving pulse is applied to the plurality of ultrasound transducers to generate the ultrasound waves (fig.12 – transmit ultrasonic waves S21);
a step in which the reflected waves of the ultrasound waves are received by the plurality of ultrasound transducers ([0134] – transmission and receipt of ultrasonic waves);
a step of outputting a reception signal based on the reflected waves received from the reception circuit by the plurality of ultrasound transducers ([0134] – receives detection data); and
a step in which the ultrasound image generation unit receives the reception signal and converts the reception signal into an image to generate the ultrasound image ([0134] – generates image data for display);
a step in which the transmission circuit is controlled so as to generate a polarization driving pulse that has a polarization driving voltage different from voltage of the diagnostic driving pulse within the same settable voltage range as the diagnostic driving pulse ([0131] – the voltage for polarization is voltage by which the piezoelectric body films PE of each of the elements can be uniformly polarized, and is a higher voltage than that of the transmission signal VT when the ultrasonic waves are being transmitted) and has a frequency band different from a probe frequency band of the diagnostic driving pulse for acquiring the ultrasound image in order to perform polarization processing of the plurality of ultrasound transducers (fig.12, [0131] – the polarization voltage is applied until the receipt signal is the target level or higher); and
a step of applying the polarization driving pulse to the plurality of ultrasound transducers to perform the polarization processing of the plurality of ultrasound transducers with the polarization driving pulse ([0131] – the transmission circuit 210 outputs a voltage for polarization to each of the ultrasonic elements).
Nakanishi fail to explicitly disclose an ultrasound endoscope and wherein the plurality of ultrasound transducers are single crystal transducers.
However, Specht et al teach in the same medical field of endeavor, an ultrasound endoscope ([0175] - the probe may be built into a housing mounted to an endoscope) and a plurality of ultrasound transducers that are single crystal transducers ([0097] – an array of piezoelectric transducer elements, each element may be a single piezoelectric crystal or a single machined section of piezoelectric crystal).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the transducer array and ultrasound probe of Nakanishi with a plurality of ultrasound transducers are single crystal transducers and an endoscope as it would provide a well-known and conventional type of transducer element and endoscopic structure for ultrasound image acquisition as set forth in Specht et al.
Regarding claim 28, Nakanishi discloses wherein the polarization processing is performed on the plurality of the ultrasonic transducers by dividing them into a group of ultrasonic transducers at the center of the ultrasonic transducer array and a group of ultrasound transducers at both ends of the ultrasonic transducer array ([0125] - adjust may be directed to individual ultrasound elements, or may be directed to an ultrasonic element column including a plurality of elements).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nakanishi (2014/0066779) in view of Specht et al (2015/0080727) as applied to claim 1 above, and further in view of Nakagawa (2016/0282117).
Regarding claim 7, Nakanishi as modified by Specht et al disclose the invention as claimed and discussed above, but fail to explicitly disclose wherein a thickness of a piezoelectric element forming each of the plurality of ultrasound transducers is 75 μm to 125 μm.
However, Nakagawa teaches in the same medical field of endeavor, a thickness of a piezoelectric element forming each of a plurality of ultrasound transducers is 75 μm to 125 μm ([0059] - the thickness of the piezoelectric substrate 2 is not particularly limited, and can be set to a value in a range of, for example, 50 μm through 250 μm).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the thickness of the piezoelectric film of Nakanishi as modified by Specht et al with the explicit disclosure of a thickness of 75 μm to 125 μm as it would provide a thickness suitable for imaging using an ultrasound endoscope.
Claim(s) 8, 9, 23 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nakanishi (2014/0066779) in view of Specht et al (2015/0080727) as applied to claims 1 and 17 above, and further in view of Sato (JP 2006255014).
Regarding claims 8, 9, 23 and 24, Nakanishi as modified by Specht et al disclose the invention as claimed and discussed above, but fail to explicitly disclose wherein the driving waveform of the polarization driving pulse is a unipolar waveform and wherein the transmission circuit outputs a plurality of unipolar waveforms as the polarization driving pulse with a time of the minimum number of clocks defined in the transmission circuit as an interval between the unipolar waveforms.
However, Sato teaches in the same medical field of endeavor, wherein a driving waveform of a polarization driving pulse is a unipolar waveform (abstract – an ultrasonic observation device 11 has an unipolar type pulse that emits a drive pulse for exciting an ultrasonic transducer in an ultrasonic endoscope); and wherein a transmission circuit outputs a plurality of unipolar waveforms as a polarization driving pulse with a time of a minimum number of clocks defined in the transmission circuit as an interval between the unipolar waveforms (p.3, paragraph 5 – timing controller 22 connected to the pulser, abstract – wherein the pulser is a unipolar type pulser).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the ultrasonic endoscope of Nakanishi as modified by Specht et al with a unipolar driving pulse and a time of minimum number of clocks of Sato as it would provide a well-known and conventional pulse for exciting an ultrasound transducer to generate ultrasonic waves having different frequency bandwidths with a simple and inexpensive configuration (p.4, paragraph 2).
Allowable Subject Matter
Claims 2-4, 6, 13-16, 18-20, 22 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROCHELLE DEANNA TURCHEN whose telephone number is (571)270-7104. The examiner can normally be reached Mon - Fri 6:30-2:30.
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/ROCHELLE D TURCHEN/Primary Examiner, Art Unit 3797