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 .
Election/Restrictions
Applicant’s election without traverse of Claims 1-9 & 16-20 in the reply filed on 01/26/2026 is acknowledged.
Claim Objections
Claim 8 is objected to because of the following informalities: “while the second ultrasonic transmitter is rotated around a subject” should read –while the second ultrasonic transmitter is rotated around the subject--.
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 1-9 & 16-20 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 1 & 16 recite “energy waves” after a first recitation of energy waves. It is unclear if these second and third recitations of energy waves refers to the same energy waves as the first recitation, or entirely separate energy waves. Thus, the claim is rendered indefinite. For the purposes of examination, it will be assumed that they are the same energy waves.
Claim 1 recites “modulated energy waves” after a first recitation of modulated energy waves. It is unclear if these second and third recitations of modulated energy waves refers to the same modulated energy waves as the first recitation, or entirely separate modulated energy waves. Thus, the claim is rendered indefinite. For the purposes of examination, it will be assumed that they are the same modulated energy waves.
Claims 2 & 8 recite “ultrasonic signals” after a first recitation of ultrasonic signals in claim 1. It is unclear if these second or third recitations of ultrasonic signals refers to the same ultrasonic signals as the first recitation, or entirely separate ultrasonic signals. Thus, the claim is rendered indefinite. For the purposes of examination, it will be assumed that they are the same ultrasonic signals.
Claim 8 recites “modulated acoustic waves” after a first recitation of modulated acoustic waves in claim 3. It is unclear if this second recitation of modulated acoustic waves refers to the same modulated acoustic waves as the first recitation, or entirely separate modulated acoustic waves. Thus, the claim is rendered indefinite. For the purposes of examination, it will be assumed that they are the same modulated acoustic waves.
Claim 18 recites “acoustic waves” after a first recitation of acoustic waves. It is unclear if this second recitation of acoustic waves refers to the same acoustic waves as the first recitation, or entirely separate acoustic waves. Thus, the claim is rendered indefinite. For the purposes of examination, it will be assumed that they are the same acoustic waves.
Claims 8 & 18 recite emitting acoustic signals/waves “at or near” the needle tip. It is unclear how near to the needle tip the waves must be emitted in order to be considered “near” the needle tip. The language of the claims does not allow one to fully understand the invention, and, thus, the claim is rendered indefinite.
Claims 3-7, 9, & 18-19 depend from claims 1 & 18, and, therefore, inherit the deficiencies of their parent claims.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 18-19 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Cummins (US 2016/0302772).
Regarding claim 18, Cummins teaches an imaging method, comprising:
causing a first ultrasonic transmitter (ultrasound transducer 128, [0049]) in electrical communication with a biopsy needle (needle 112, [0047]) ([0049]) to emit acoustic waves (ultrasound pulse, [0054]) at or near a needle tip (distal end 120, [0049]) inserted into a subject (patient 116, [0046]) being imaged; and
determining a location of the needle tip within the subject using a first set of ultrasonic signals detected by an ultrasonic detector array (ultrasound imaging probe 108, [0045]) while the biopsy needle emits acoustic waves ([0050], Figure 3).
Regarding claim 19, Cummins teaches the imaging method of claim 18, wherein the location of the needle tip is determined during an in vivo imaging procedure ([0050], Figure 3).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3 & 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Cummins in view of Okada (US 2006/0058677).
Regarding claim 1, Cummins teaches an imaging apparatus, comprising:
one or more energy sources (ultrasound transducer 128, [0049]) configured to generate energy waves ([0054]);
a waveform generator (electrical subsystem 130, [0054]) configured to generate one or more signals (ultrasound pulse, [0054]), the waveform generator in electrical communication with the one or more energy sources ([0054]);
a needle (needle 112, [0047]) comprising a needle tip (distal end 120, [0049]), the needle in electrical communication with the one or more energy sources ([0049]), the needle configured to emit the energy waves at or near the needle tip ([0049] & [0054]); and
an ultrasonic detector array (ultrasound imaging probe 108, [0045]) configured to detect ultrasonic signals based on the energy waves emitted by the needle ([0053]).
However, Cummins fails to disclose that the waveform generator is an arbitrary waveform generator and the one or more signals are chirp signals, wherein the one or more chirp signals modulate the energy waves from the one or more energy sources to generate modulated energy waves.
Okada teaches an arbitrary waveform generator (arbitrary waveform generator 9, [0027]) configured to generate one or more chirp signals (chirp waveform, [0051]), wherein the one or more chirp signals modulate the energy waves from the one or more energy sources to generate modulated energy waves.
By combining Okada with Cummins, the waveforms transmitted by the transducer of Cummins would be chirp waveforms. These comprise modulated energy waves.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the apparatus of Cummins such that the waveform generator is an arbitrary waveform generator and the one or more signals are chirp signals, wherein the one or more chirp signals modulate the energy waves from the one or more energy sources to generate modulated energy waves, as taught by Okada. The use of arbitrary waveform generators is known to increase signal-to-noise ratio in a system, and the use of chirp signals provides an easily-identifiable signal for the detector array to attribute to the needle tip.
Regarding claim 2, Cummins in view of Okada teach the imaging apparatus of claim 1, and Cummins further teaches one or more data acquisition systems (FPGA 326, [0095]) configured to record and digitize the ultrasonic signals detected by the ultrasonic detector array ([0097]).
Regarding claim 3, Cummins in view of Okada teach the imaging apparatus of claim 1, and Cummins further teaches:
the needle is a biopsy needle ([0049]);
the one or more energy sources comprises a first ultrasonic transmitter (ultrasound transducer 128, [0049]) in acoustic communication with the biopsy needle ([0049]); and
the ultrasonic detector array is configured to detect a first set of ultrasonic signals while the biopsy needle emits modulated acoustic waves at or near the needle tip ([0053]).
Regarding claim 16, Cummins in view of Okada teach the imaging apparatus of claim 16, and Cummins further teaches a power amplifier (amplifier 150, [0055]) in electrical communication with the one or more energy sources ([0055]), the power amplifier configured to amplify energy waves generated by the one or more energy sources ([0055]).
Regarding claim 17, Cummins in view of Okada teach the imaging apparatus of claim 1, and Cummins further teaches that the one or more energy sources comprise an ultrasonic source (ultrasound transducer 128, [0049]).
Claims 4-9 are rejected under 35 U.S.C. 103 as being unpatentable over Cummins in view of Okada, as applied to claim 3, above, in further view of Bates (US 2020/0405260).
Regarding claim 4, Cummins in view of Okada teach the imaging apparatus of claim 3.
However, Cummins in view of Okada fail to disclose: the one or more energy sources comprises a second ultrasonic transmitter; and the ultrasonic detector array is configured to detect a second set of ultrasonic signals while the second ultrasonic transmitter is rotated around a subject being imaged.
Bates teaches:
the one or more energy sources comprises a second ultrasonic transmitter (transducers 210 or 214, [0052], Figure 2); and
the ultrasonic detector array (transducers 210 or 214, [0053], Figure 2) is configured to detect a second set of ultrasonic signals (acoustic information, [0053]) while the second ultrasonic transmitter is rotated ([0060]) around a subject (patient, [0051]) being imaged.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the apparatus of Cummins and Okada such that: the one or more energy sources comprises a second ultrasonic transmitter; and the ultrasonic detector array is configured to detect a second set of ultrasonic signals while the second ultrasonic transmitter is rotated around a subject being imaged, as taught by Bates. When applied to Cummins, a second transmitter that rotates around the subject allows multiple angles of the needle to be detected, allowing for a 3D reconstruction of the location.
Regarding claim 5, Cummins in view of Okada and Bates teach the imaging apparatus of claim 4, and Bates further teaches:
a motor (servo-mechanical system, [0060]); and
a gear coupled to the motor and to the second ultrasonic transmitter, wherein the motor is configured to move the second ultrasonic transmitter along an arc or a circle (scanning circle, [0060]).
In order for the transducers to undergo rotational movement, a gear or other equivalent part must be present in the system.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the apparatus of Cummins and Okada to include: a motor; and a gear coupled to the motor and to the second ultrasonic transmitter, wherein the motor is configured to move the second ultrasonic transmitter along an arc or a circle, as taught by Bates. This facilitates an automation of the transmitter rotation, allowing the second ultrasonic transmitter to be easily controlled during the imaging procedure.
Regarding claim 6, Cummins in view of Okada and Bates teach the imaging apparatus of claim 5, and Bates further teaches a rotational shaft (posts 208 & 212, [0061], Figure 2) coupled to the motor and to the gear ([0061], Figure 2), wherein the motor is configured to rotate the second ultrasonic transmitter ([0061]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the apparatus of Cummins and Okada to include a rotational shaft coupled to the motor and to the gear, wherein the motor is configured to rotate the second ultrasonic transmitter, as taught by Bates. This connects the transmitter to the motor and allows it to rotate about the subject.
Regarding claim 7, Cummins in view of Okada and Bates teach the imaging apparatus of claim 4, and Bates further teaches that the second ultrasonic transmitter is a single element ultrasonic transducer (single element focused transducer, [0023]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the apparatus of Cummins and Okada such that the second ultrasonic transmitter is a single element ultrasonic transducer, as taught by Bates. This simplifies the design and manufacturing of the transmitter and reduces its price.
Regarding claim 8, Cummins in view of Okada and Bates teach the imaging apparatus of claim 4, and Cummins further teaches a computing device (computer 104, [0045]) configured to determine a location of the needle tip within the subject (patient 116, [0046]) from the ultrasonic signals detected by the ultrasonic detector array while the biopsy needle emits the modulated acoustic waves at or near the needle tip ([0050], Figure 3).
Bates further teaches generating one or more two-dimensional images ([0056]) of the subject based on the ultrasonic signals detected by the ultrasonic detector array while the second ultrasonic transmitter is rotated around the subject being imaged ([0056] & [0060]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the apparatus of Cummins and Okada to include generating one or more two-dimensional images of the subject based on the ultrasonic signals detected by the ultrasonic detector array while the second ultrasonic transmitter is rotated around the subject being imaged, as taught by Bates. Capturing the images while rotating the transmitter allows for the needle to be imaged from various angles, allowing for a precise triangulation of its position.
Regarding claim 9, Cummins in view of Okada and Bates teach the imaging apparatus of claim 8, and Cummins further teaches that the computing device is further configured to superimpose an indicator (visual cue, [0085]) of the location of the needle tip ([0073]) onto at least one of the one or more two-dimensional images ([0073]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Cummins in view of Bates, as applied to claim 18, above.
Claim 20 is rejected for similar reasons to claims 4 & 8-9.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM KOLKIN whose telephone number is (571)272-5480. The examiner can normally be reached Monday-Friday 1:00PM-10:00PM EDT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached at (572)-270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ADAM D. KOLKIN/Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798